Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2020 | |
Cover [Abstract] | |
Entity Registrant Name | Hancock Jaffe Laboratories, Inc. |
Entity Central Index Key | 0001661053 |
Document Type | S-1/A |
Amendment Flag | true |
Amendment Description | Amendment No. 2 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business Flag | true |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | true |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Current Assets: | |||
Cash and cash equivalents | $ 5,629,003 | $ 1,307,231 | $ 2,740,645 |
Accounts receivable | 32,022 | ||
Prepaid expenses and other current assets | 348,653 | 116,647 | 64,306 |
Total Current Assets | 5,977,656 | 1,423,878 | 2,836,973 |
Property and equipment, net | 425,526 | 344,027 | 26,153 |
Restricted Cash | 810,055 | ||
Operating lease right-of-use assets, net | 609,656 | 826,397 | |
Intangible assets, net | 666,467 | ||
Security deposits and other assets | 29,843 | 29,843 | 29,843 |
Total Assets | 7,042,681 | 3,434,200 | 3,559,436 |
Current Liabilities: | |||
Accounts payable | 974,229 | 1,221,189 | 1,077,122 |
Accrued expenses and other current liabilities | 287,672 | 333,438 | 412,871 |
Note Payable | 312,700 | ||
Deferred revenue - related party | 33,000 | 33,000 | 33,000 |
Current portion of operating lease liabilities | 307,823 | 288,685 | |
Total Current Liabilities | 1,915,424 | 1,876,312 | 1,522,993 |
Long-term operating lease liabilities | 332,296 | 567,948 | |
Total Liabilities | 2,247,720 | 2,444,260 | 1,522,993 |
Commitments and Contingencies | |||
Stockholders' Equity: | |||
Convertible preferred stock, par value $0.00001, 10,000,000 shares authorized: 4,205,406, 0 and 0 shares issued or outstanding as of September 30, 2020, December 31, 2019 and December 31, 2018 respectively | 42 | ||
Common stock, par value $0.00001, 250,000,000 shares authorized, 1,609,710, 717,275 and 468,906 shares issued and outstanding as of September 30, 2020, December 31, 2019 and December 31, 2018 respectively | 16 | 7 | 5 |
Additional paid-in capital | 65,744,311 | 57,177,858 | 50,598,966 |
Accumulated deficit | (60,949,408) | (56,187,925) | (48,562,528) |
Total Stockholders' Equity | 4,794,961 | 989,940 | 2,036,443 |
Total Liabilities and Stockholders' Equity | $ 7,042,681 | $ 3,434,200 | $ 3,559,436 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Preferred stock, par value | $ 0.00001 | $ 0.00001 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, shares issued | |||
Preferred stock, shares outstanding | |||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 | 50,000,000 |
Common stock, shares issued | 1,609,710 | 717,275 | 468,906 |
Common stock, shares outstanding | 1,609,710 | 717,275 | 468,906 |
Convertible Preferred Stock [Member] | |||
Preferred stock, par value | $ 0.00001 | $ 0.00001 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, shares issued | 4,205,406 | 0 | |
Preferred stock, shares outstanding | 4,205,406 | 0 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | ||||||
Total Revenues | $ 31,243 | $ 31,243 | $ 186,552 | |||
Selling, general and administrative expenses | 1,164,089 | 1,157,064 | 3,001,720 | 3,989,274 | 4,911,613 | 6,482,953 |
Research and development expenses | 758,198 | 676,970 | 1,974,995 | 1,418,293 | 2,206,120 | 1,238,749 |
Loss on impairment of intangible asset | 588,822 | 319,635 | ||||
Loss from Operations | (1,922,287) | (1,834,034) | (4,976,715) | (5,376,324) | (7,675,312) | (7,854,785) |
Other (Income) Expense: | ||||||
Amortization of debt discount | 6,562,736 | |||||
Gain on extinguishment of convertible notes payable | (1,481,317) | |||||
Interest (income) expense, net | (564) | (19,139) | (3,425) | (41,680) | (49,915) | 298,161 |
Change in fair value of derivative liabilities | 53,046 | (211,807) | (191,656) | |||
Total Other (Income) Expense | 52,482 | (19,139) | (215,232) | (41,680) | (49,915) | 5,187,924 |
Net Loss | (1,974,769) | (1,814,895) | (4,761,483) | (5,334,644) | (7,625,397) | (13,042,709) |
Deemed dividend to Series C Preferred Stockholders | (23,859) | (23,859) | (3,310,001) | |||
Net Loss Attributable to Common Stockholders | $ (1,998,628) | $ (1,814,895) | $ (4,785,342) | $ (5,334,644) | $ (7,625,397) | $ (16,352,710) |
Net Loss Per Basic and Diluted Common Share: | $ (1.38) | $ (2.53) | $ (4.70) | $ (8.87) | $ (12.10) | $ (43.67) |
Weighted Average Number of Common Shares Outstanding: Basic and Diluted | 1,445,820 | 716,886 | 1,018,420 | 601,199 | 630,418 | 374,499 |
Royalty Income [Member] | ||||||
Revenues: | ||||||
Total Revenues | $ 31,243 | $ 31,243 | $ 116,152 | |||
Contract Research - Related Party [Member] | ||||||
Revenues: | ||||||
Total Revenues | $ 70,400 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity (Deficiency) - USD ($) | Series C Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total | |||||
Balance at Dec. 31, 2017 | $ 2 | $ 24,389,366 | $ (35,519,819) | $ (11,130,451) | ||||||
Balance, shares at Dec. 31, 2017 | 245,348 | |||||||||
Common stock issued in initial public offering | $ 1 | [1] | 6,082,443 | [1] | [1] | 6,082,444 | [1] | |||
Common stock issued in initial public offering, shares | 69,000 | [1] | ||||||||
Reclassification of Warrant Derivatives to Equity | ||||||||||
Derivative liabilities reclassified to equity | 3,594,002 | 3,594,002 | ||||||||
Redeemable convertible preferred stock converted to common stock | $ 1 | 5,170,754 | 5,170,755 | |||||||
Redeemable convertible preferred stock converted to common stock, shares | 69,730 | |||||||||
Common stock issued in connection with May Bridge Notes | 228,966 | 228,966 | ||||||||
Common stock issued in connection with May Bridge Notes, shares | 2,200 | |||||||||
Common stock issued in satisfaction of Advisory Board fees payable | 90,000 | 90,000 | ||||||||
Common stock issued in satisfaction of Advisory Board fees payable, shares | 1,200 | |||||||||
Common stock issued upon conversion of convertible debt and interest | $ 1 | 8,252,685 | 8,252,686 | |||||||
Common stock issued upon conversion of convertible debt and interest, shares | 66,022 | |||||||||
Common stock issued upon conversion of related party convertible debt and interest | 517,742 | 517,742 | ||||||||
Common stock issued upon conversion of related party convertible debt and interest, shares | 4,817 | |||||||||
Common stock issued upon exchange of related party notes payable and interest | 150,553 | 150,553 | ||||||||
Common stock issued upon exchange of related party notes payable and interest, shares | 1,401 | |||||||||
Common stock issued in satisfaction of deferred salary | 200,000 | 200,000 | ||||||||
Common stock issued in satisfaction of deferred salary, shares | 1,778 | |||||||||
Stock-based compensation: Amortization of stock options | 864,625 | 864,625 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net | 878,830 | 878,830 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net, shares | 7,414 | |||||||||
Stock-based compensation: Warrants granted to consultants | 179,000 | 179,000 | ||||||||
Net loss | (13,042,709) | (13,042,709) | ||||||||
Balance at Dec. 31, 2018 | $ 5 | $ 50,598,966 | (48,562,528) | $ 2,036,443 | ||||||
Balance, shares at Dec. 31, 2018 | 468,906 | |||||||||
Common stock issued in public offering, shares | ||||||||||
Common stock issued in private placement offering | $ 1 | [2] | $ 2,317,275 | [2] | [2] | $ 2,317,276 | [2] | |||
Common stock issued in private placement offering, shares | 93,920 | [2] | ||||||||
Stock-based compensation: Amortization of stock options | 82,720 | 82,720 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net | ||||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net, shares | 3,400 | |||||||||
Stock-based compensation: Warrants granted to consultants | 2,334 | 2,334 | ||||||||
Net loss | (1,573,726) | (1,573,726) | ||||||||
Balance at Mar. 31, 2019 | $ 6 | 53,001,295 | (50,136,254) | 2,865,047 | ||||||
Balance, shares at Mar. 31, 2019 | 566,226 | |||||||||
Balance at Dec. 31, 2018 | $ 5 | 50,598,966 | (48,562,528) | 2,036,443 | ||||||
Balance, shares at Dec. 31, 2018 | 468,906 | |||||||||
Reclassification of Warrant Derivatives to Equity | ||||||||||
Net loss | (5,334,644) | |||||||||
Balance at Sep. 30, 2019 | $ 7 | 56,981,163 | (53,897,172) | 3,083,998 | ||||||
Balance, shares at Sep. 30, 2019 | 716,886 | |||||||||
Balance at Dec. 31, 2018 | $ 5 | 50,598,966 | (48,562,528) | 2,036,443 | ||||||
Balance, shares at Dec. 31, 2018 | 468,906 | |||||||||
Common stock issued in public offering | [3] | $ 1 | 3,319,655 | 3,319,656 | ||||||
Common stock issued in public offering, shares | [3] | 144,625 | ||||||||
Common stock issued in private placement offering | [2] | $ 1 | 2,317,252 | 2,317,276 | ||||||
Common stock issued in private placement offering, shares | [2] | 93,920 | ||||||||
Reclassification of Warrant Derivatives to Equity | ||||||||||
Stock-based compensation: Amortization of stock options and restricted stock units | [4] | 492,084 | 492,084 | |||||||
Stock-based compensation: Amortization of stock options and restricted stock units, shares | [4] | 390 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net | [5] | 419,379 | 419,379 | |||||||
Stock-based compensation: Common stock issued to consultants/settlement, net, shares | [5] | 9,435 | ||||||||
Stock-based compensation: Warrants granted to consultants | 30,499 | 30,499 | ||||||||
Net loss | (7,625,397) | (7,625,397) | ||||||||
Balance at Dec. 31, 2019 | $ 7 | 57,177,858 | (56,187,925) | 989,940 | ||||||
Balance, shares at Dec. 31, 2019 | 717,275 | |||||||||
Balance at Mar. 31, 2019 | $ 6 | 53,001,295 | (50,136,254) | 2,865,047 | ||||||
Balance, shares at Mar. 31, 2019 | 566,226 | |||||||||
Common stock issued in public offering | [3] | $ 1 | 3,319,655 | 3,319,656 | ||||||
Common stock issued in public offering, shares | [3] | 144,625 | ||||||||
Stock-based compensation: Amortization of stock options | 86,870 | 86,870 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net | [5] | 298,300 | [5] | [5] | 298,300 | [5] | ||||
Stock-based compensation: Common stock issued to consultants/settlement, net, shares | 6,035 | [5] | ||||||||
Stock-based compensation: Warrants granted to consultants | 28,165 | 28,165 | ||||||||
Net loss | (1,946,023) | (1,946,023) | ||||||||
Balance at Jun. 30, 2019 | $ 7 | 56,734,285 | (52,082,277) | 4,652,015 | ||||||
Balance, shares at Jun. 30, 2019 | 716,886 | |||||||||
Stock-based compensation: Amortization of stock options | 159,864 | 159,864 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net | 87,014 | 87,014 | ||||||||
Stock-based compensation: Common stock issued to consultants/settlement, net, shares | ||||||||||
Net loss | (1,814,895) | (1,814,895) | ||||||||
Balance at Sep. 30, 2019 | $ 7 | 56,981,163 | (53,897,172) | 3,083,998 | ||||||
Balance, shares at Sep. 30, 2019 | 716,886 | |||||||||
Balance at Dec. 31, 2019 | $ 7 | 57,177,858 | (56,187,925) | 989,940 | ||||||
Balance, shares at Dec. 31, 2019 | 717,275 | |||||||||
Common stock issued in private placement offering | $ 1 | [6] | 24,304 | [6] | [6] | 24,305 | [6] | |||
Common stock issued in private placement offering, shares | 52,000 | [6] | ||||||||
Stock-based compensation: Amortization of stock options | 116,820 | 116,820 | ||||||||
Stock-based compensation: Warrants granted to consultants | 14,070 | 14,070 | ||||||||
Net loss | (1,159,758) | (1,159,758) | ||||||||
Balance at Mar. 31, 2020 | $ 8 | 57,332,052 | (57,347,683) | (14,623) | ||||||
Balance, shares at Mar. 31, 2020 | 769,275 | |||||||||
Balance at Dec. 31, 2019 | $ 7 | 57,177,858 | (56,187,925) | $ 989,940 | ||||||
Balance, shares at Dec. 31, 2019 | 717,275 | |||||||||
Common stock issued for exercise of warrants, shares | 72,748 | |||||||||
Reclassification of Warrant Derivatives to Equity | $ (334,229) | |||||||||
Net loss | (4,761,483) | |||||||||
Balance at Sep. 30, 2020 | $ 42 | $ 16 | 65,744,311 | (60,949,408) | 4,794,961 | |||||
Balance, shares at Sep. 30, 2020 | 4,205,406 | 1,609,711 | ||||||||
Balance at Mar. 31, 2020 | $ 8 | 57,332,052 | (57,347,683) | (14,623) | ||||||
Balance, shares at Mar. 31, 2020 | 769,275 | |||||||||
Common stock issued in public offering | [7] | $ 2 | 1,973,306 | 1,973,308 | ||||||
Common stock issued in public offering, shares | [7] | 192,688 | ||||||||
Stock-based compensation: Amortization of stock options | 37,717 | 37,717 | ||||||||
Net loss | (1,626,956) | (1,626,956) | ||||||||
Balance at Jun. 30, 2020 | $ 10 | 59,344,075 | (58,974,639) | 369,446 | ||||||
Balance, shares at Jun. 30, 2020 | 961,963 | |||||||||
Common stock issued in public offering | [8] | $ 6 | 3,881,901 | 3,881,907 | ||||||
Common stock issued in public offering, shares | [8] | 575,000 | ||||||||
Preferred stock issued in private placement | [9] | $ 42 | 1,358,060 | 1,358,102 | ||||||
Preferred stock issued in private placement, shares | [9] | 4,205,406 | ||||||||
Common stock issued for exercise of warrants | 631,626 | $ 631,626 | ||||||||
Common stock issued for exercise of warrants, shares | 72,748 | 72,748 | ||||||||
Reclassification of Warrant Derivatives to Equity | 334,229 | $ 334,229 | ||||||||
Stock-based compensation: Amortization of stock options | 194,420 | 194,420 | ||||||||
Net loss | (1,974,769) | (1,974,769) | ||||||||
Balance at Sep. 30, 2020 | $ 42 | $ 16 | $ 65,744,311 | $ (60,949,408) | $ 4,794,961 | |||||
Balance, shares at Sep. 30, 2020 | 4,205,406 | 1,609,711 | ||||||||
[1] | net of offering costs of $2,542,555. | |||||||||
[2] | net of offering costs of $386,724. | |||||||||
[3] | net of offering costs of $549,060. | |||||||||
[4] | stock issued for vested restricted stock units. | |||||||||
[5] | net of forfeiture of 246 shares. | |||||||||
[6] | net of offering costs of $79,658. | |||||||||
[7] | net of offering costs of $360,026. | |||||||||
[8] | net of offering costs of $718,093. | |||||||||
[9] | net of offering costs of $197,901. |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Equity (Deficiency) (Parenthetical) - USD ($) | 3 Months Ended | 12 Months Ended | |||||
Jun. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2018 | |
Number of shares forfeitured during period, shares | 246 | ||||||
Private Placement Offering [Member] | |||||||
Net offering cost | $ 386,724 | $ 197,901 | $ 360,026 | $ 79,658 | $ 386,724 | ||
Public Offering [Member] | |||||||
Net offering cost | $ 549,060 | $ 549,060 | $ 718,093 | $ 2,542,555 | |||
Number of shares forfeitured during period, shares | 246 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |||||
Cash Flows from Operating Activities | ||||||||
Net loss | $ (4,761,483) | $ (5,334,644) | $ (7,625,397) | $ (13,042,709) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Amortization of debt discount | 6,562,736 | |||||||
Gain on extinguishment of convertible notes payable | (1,481,317) | |||||||
Stock-based compensation | 363,027 | 745,269 | 941,962 | 1,922,455 | ||||
Depreciation and amortization | 71,252 | 85,060 | 123,660 | 133,419 | ||||
Amortization of right-of-use assets | 216,741 | 206,618 | 273,005 | |||||
Change in fair value of derivatives | (211,807) | (191,656) | ||||||
Loss on impairment | 588,822 | 319,635 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | 32,022 | 32,022 | 3,159 | |||||
Prepaid expenses and other current assets | (232,006) | (52,547) | (52,341) | (6,762) | ||||
Security deposit and other assets | 700 | |||||||
Accounts payable | (246,960) | 134,205 | 144,067 | (294,122) | ||||
Accrued expenses | (45,766) | 109,768 | (56,960) | (210,976) | ||||
Payments on lease liabilities | (216,514) | (198,930) | (265,240) | |||||
Deferred revenues | (70,400) | |||||||
Total adjustments | (302,033) | 1,061,465 | 1,728,997 | 6,686,871 | ||||
Net Cash Used in Operating Activities | (5,063,516) | (4,273,179) | (5,896,400) | (6,355,838) | ||||
Cash Flows from Investing Activities | ||||||||
Purchase of property and equipment | (152,751) | (350,934) | (363,891) | (12,422) | ||||
Net Cash Used in Investing Activities | (152,751) | (350,934) | (363,891) | (12,422) | ||||
Cash Flows from Financing Activities | ||||||||
Proceeds from private placements of common stock and warrants, net | 570,341 | [1] | 2,317,276 | [1] | ||||
Preferred stock issued in private placement | 1,358,102 | [2] | [2] | 2,317,276 | [3] | [3] | ||
Proceeds from public offerings, net | 5,855,215 | [4] | 3,319,656 | [4] | 3,319,656 | [5] | 7,657,427 | [6] |
Initial public offering costs paid in cash | (706,596) | |||||||
Repayments of notes payable | (1,125,000) | |||||||
Repayments of notes payable - related party | (120,864) | |||||||
Proceeds from issuance of note payable | 312,700 | 722,500 | ||||||
Proceeds from issuance of convertible notes, net | [7] | 2,603,750 | [7] | |||||
Proceeds from Warrant Exercises | 631,626 | |||||||
Net Cash Provided by Financing Activities | 8,727,984 | 5,636,932 | 5,636,932 | 9,031,217 | ||||
Net Increase in Cash, Cash Equivalent, and Restricted Cash | 3,511,717 | 1,012,819 | (623,359) | 2,662,957 | ||||
Cash, cash equivalents and restricted cash - Beginning of period | 2,117,286 | 2,740,645 | 2,740,645 | 77,688 | ||||
Cash, cash equivalents and restricted cash - End of period | 5,629,003 | 3,753,464 | 2,117,286 | 2,740,645 | ||||
Supplemental Disclosures of Cash Flow Information: | ||||||||
Cash Paid (Received) During the Years For: Interest, net | (3,425) | 933 | 933 | 286,551 | ||||
Cash Paid During the Period For: Income taxes paid | ||||||||
Non-Cash Financing Activities: | ||||||||
Fair value of warrants issued in connection with common stock included in derivative liabilities | 513,534 | |||||||
Conversion of convertible note payable - related party and accrued interest into common stock | 517,742 | |||||||
Exchange of note payable - related party and accrued interest into common stock | 150,553 | |||||||
Fair value of placement agent warrants issued in connection with common stock included in derivative liabilities | 32,502 | 1,046,763 | ||||||
Reclassification of warrant derivatives to equity | (334,229) | |||||||
Embedded conversion option in convertible debt included in derivative liabilities | 1,239,510 | |||||||
Derivative liabilities reclassified to equity | 6,059,823 | |||||||
Conversion of convertible notes payable and accrued interest into common stock | 5,743,391 | |||||||
Conversion of preferred stock into common stock | $ 5,170,755 | |||||||
[1] | Net of cash offering costs of $79,568 and $386,724 in 2020 and 2019, respectively. | |||||||
[2] | Net of cash offering costs of $197,901. | |||||||
[3] | Net of cash offering costs of $386,724. | |||||||
[4] | Net of cash offering costs of $1,078,119 and $549,060 in 2020 and 2019, respectively. | |||||||
[5] | Net of cash offering costs of $549,060. | |||||||
[6] | Net of cash offering costs of $967,573. | |||||||
[7] | Net of cash offering costs of $293,750. |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Parenthetical) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Convertible Notes [Member] | ||||
Net of cash offering costs | $ 293,750 | |||
Private Placement Offering [Member] | ||||
Net of cash offering costs | $ 79,568 | $ 386,724 | $ 386,724 | |
Net offering cost | 197,901 | |||
Public Offering [Member] | ||||
Net of cash offering costs | $ 549,060 | $ 967,573 | ||
Net offering cost | $ 1,078,119 | $ 549,060 |
Business Organization and Natur
Business Organization and Nature of Operations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Business Organization and Nature of Operations | Note 1 – Business Organization and Nature of Operations Hancock Jaffe Laboratories, Inc. (“we”, “us”, “our”, “HJLI” or the “Company”) is a medical device company developing tissue-based solutions that are designed to be life sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease. The Company’s products are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially increasing the current standards of care. Our two lead products which we are developing are: the VenoValve®, a porcine based device to be surgically implanted in the deep venous system of the leg to treat a debilitating condition called chronic venous insufficiency (“CVI”); and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart during coronary artery bypass graft (“CABG”) surgeries. Both of our current products are being developed for approval by the U.S. Food and Drug Administration (“FDA”). We currently receive tissue for development of our products from one domestic suppliers and one international supplier. Our current business model is to license, sell, or enter into strategic alliances with large medical device companies with respect to our products, either prior to or after FDA approval. Our current senior management team has been affiliated with more than 50 products that have received FDA approval or CE marking. We currently lease a 14,507 sq. ft. manufacturing facility in Irvine, California, where we manufacture products for our clinical trials, and which has previously been FDA certified for commercial manufacturing of product. Each of our product candidates will be required to successfully complete clinical trials and other testing to demonstrate the safety and efficacy of the product candidate before it will be approved by the FDA. The completion of these clinical trials and testing will require a significant amount of capital and the hiring of additional personnel. On September 15, 2020, at a special stockholders meeting, the Company’s stockholders approved the increase of its authorized common shares to 250,000,000 for a sufficient authorized number to settle all outstanding stock options, warrants and convertible preferred stock. | Note 1 – Business Organization and Nature of Operations Hancock Jaffe Laboratories, Inc. is a medical device company developing tissue based solutions that are designed to be life sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease. The Company’s products are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially increasing the current standards of care. Our two lead products are: the VenoValve®, a porcine based device to be surgically implanted in the deep venous system of the leg to treat a debilitating condition called CVI; and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart during CABG surgeries. Both of our current products are being developed for approval by the FDA. We currently receive tissue for our products from one domestic supplier and one international supplier. Our current business model is to license, sell, or enter into strategic alliances with large medical device companies with respect to our products, either prior to or after FDA approval. Our current senior management team has been affiliated with more than 50 products that have received FDA approval or CE marking. We currently lease a 14,507 sq. ft. manufacturing facility in Irvine, California, where we manufacture products for our clinical trials and which has previously been FDA certified for commercial manufacturing of product. Each of our product candidates will be required to successfully complete clinical trials and other testing to demonstrate the safety and efficacy of the product candidate before it will be approved by the FDA. The completion of these clinical trials and testing will require a significant amount of capital and the hiring of additional personnel. |
Going Concern and Management's
Going Concern and Management's Liquidity Plan | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Going Concern and Management's Liquidity Plan | Note 2 – Going Concern and Management’s Liquidity Plan The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern for the next twelve months from the filing of this Form 10-Q. The Company incurred a net loss of $4,761,483 and $5,334,644 for the nine months ended September 30, 2020 and 2019, respectively, and had an accumulated deficit of $60,949,408 at September 30, 2020. Cash used in operating activities was $5,063,516 and $4,273,179 for the nine months ended September 30, 2020 and 2019, respectively. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of the financial statements. The Company expects to continue incurring losses for the foreseeable future and recognizes the need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products. Toward that end, the Company has completed five separate equity sales in 2020 through the filing date of this report raising aggregate net proceeds of approximately $12,200,000 (see Notes 10 and 11). As of September 30, 2020, the Company had cash balances of $5,629,003 and working capital of $4,062,232. Management believes the proceeds from these transactions should provide sufficient cash to sustain the Company’s operations at least one year after the issuance date of these financial statements. If necessary, after one year, management believes that the Company could have access to additional capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means. However, there is a material risk that the Company will be unable to raise additional capital or obtain new financing when needed on commercially acceptable terms, if at all, or if it will be successful in implementing its business plan and developing its medical devices. Further, the COVID-19 pandemic has disrupted the global economy and eroded capital markets which makes it more difficult to obtain the financing that we need to fund and continue our operations. The inability of the Company to raise needed capital would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to curtail or discontinue its operations, liquidate and/or seek reorganization in bankruptcy. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. | Note 2 – Going Concern and Management’s Liquidity Plan The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern for the next twelve months from the filing of this Form 10-K. The Company incurred a net loss of $7,625,397 during the year ended December 31, 2019 and had an accumulated deficit of $56,187,925 as of December 31, 2019. Cash used in operating activities was $5,896,400 for the year ended December 31, 2019. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of the financial statements. As of December 31, 2019, the Company had a cash balance of $1,307,231 and working capital deficiency of $452,434. The Company expects to continue incurring losses for the foreseeable future and will need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products. Management believes that the Company could have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means. However, there is a material risk that the Company will be unable to raise additional capital or obtain new financing when needed on commercially acceptable terms, if at all. The inability of the Company to raise needed capital would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to curtail or discontinue its operations, liquidate and/or seek reorganization in bankruptcy. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Significant Accounting Policies | Note 3 – Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of September 30, 2020 and December 31, 2019, and for the three and nine months ended September 30, 2020 and 2019. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2019 included in the Company’s Form 10-K filed with the SEC on March 18, 2020. The condensed balance sheet as of December 31, 2019 has been derived from the Company’s audited financial statements. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include the valuation allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities. Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. FASB ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices available in active markets for identical assets or liabilities trading in active markets. Level 2 Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. Financial instruments, including accounts receivable and accounts payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. The Company’s other financial instruments include notes payable, the carrying value of which approximates fair value, as the notes bear terms and conditions comparable to market for obligations with similar terms and maturities. Derivative liabilities are accounted for at fair value on a recurring basis. On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved the increase of its authorized shares of capital stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock The following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair value on a recurring basis: Derivative Liabilities Balance – January 1, 2020 $ - Derivative liabilities associated with the issuance of common stock warrants 513,534 Derivative liabilities associated with the issuance of placement agent warrants 32,502 Change in fair value of derivative liabilities (346,129 ) Balance – March 31,2020 199,907 Change in fair value of derivative liabilities 81,276 Balance June 30, 2020 281,183 Change in fair value of derivative liabilities 53,046 Reclassification of warrant derivatives to equity (334,229 ) Balance – September 30, 2020 $ - Derivative Liabilities On February 25, 2020 in connection with a private placement of its securities (Note 10), the Company issued warrants to purchase 57,200 shares of its common stock. The Company determined these warrants were derivative financial instruments when issued. Derivative financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date. The change in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations for each reporting period. The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification of the financial instruments at each balance sheet date. If the classification changes as a result of events during the period, the financial instrument is marked to market and reclassified as of the date of the event that caused the reclassification. On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved the increase of its authorized shares of capital stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock The Company recorded a gain on the change in fair value of derivative liabilities of $211,807 during the nine months ended September 30, 2020 and a loss on the change in fair value of derivative liabilities of $53,046 during the quarter ended September 30, 2020. Sequencing Policy On July 15, 2020, the Company adopted a sequencing policy, whereby, in the event that reclassification of contracts from equity to assets or liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be allocated on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest grants receiving the first allocation of shares. Pursuant to ASC 815, issuances of securities to the Company’s employees and directors, or to compensate grantees in a share-based payment arrangement, are not subject to the sequencing policy. Net Loss per Share The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common stock outstanding during the period. Net loss attributable to common stockholders consists of net loss, adjusted for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock (see Note 10 - Stockholders Equity (Deficiency) Series C Convertible Preferred Stock The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of September 30, 2020 and 2019: September 30, 2020 2019 Shares of common stock issuable upon exercise of warrants 1,360,883 174,679 Shares of common stock issuable upon exercise of options 212,622 60,680 Potentially dilutive common stock equivalents excluded from diluted net loss per share 1,573,505 235,359 Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and recognized over the period services are required to be provided in exchange for the award, usually the vesting period. Forfeitures of unvested stock options are recorded when they occur. Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $5,379,003 and $1,867,286 as of September 30, 2020 and December 31, 2019, respectively. The Company periodically evaluates the financial stability of the financial institutions with whom it maintains its cash balances. As of September 30, 2020, and as of the date of filing this report, the Company is not aware of any circumstances which would indicate they are not financially sound. For the nine months ended September 30, 2019, all of the Company’s revenues were from royalties as a result of the three-year Post-Acquisition Supply Agreement with LeMaitre Vascular, Inc. that was effective from March 18, 2016 to March 18, 2019. The Company did not have any similar revenue in the nine months ended September 30, 2020. Subsequent Events The Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued. Based upon the evaluation and transactions, the Company did not identify any other subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed in Note 11 - Subsequent Events. Recent Accounting Pronouncements In December 2019, the FASB issued ASU No. 2019-12,Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects of the income tax accounting guidance, including requirements such as tax basis step-up in goodwill obtained in a transaction that is not a business combination, ownership changes in investments, and interim-period accounting for enacted changes in tax law. ASU 2019-12 is effective for public business entities for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact that this guidance will have on our condensed financial statements. | Note 3 – Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include the valuation allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities. Investments Equity investments over which the Company exercises significant influence, but does not control, are accounted for using the equity method, whereby investment accounts are increased (decreased) for the Company’s proportionate share of income (losses), but investment accounts are not reduced below zero. The Company holds a 28.0% ownership investment, consisting of founders’ shares acquired at nominal cost, in HJLA. To date, HJLA has recorded cumulative losses. Since the Company’s investment is recorded at $0, the Company has not recorded its proportionate share of HJLA’s losses. If HJLA reports net income in future years, the Company will apply the equity method only after its share of HJLA’s net income equals its share of net losses previously incurred. Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives, which range from 5 to 7 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Impairment of Long-lived Assets The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. Derivative Liabilities Derivative financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date. The change in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations for each reporting period. The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification of the financial instruments at each balance sheet date. If the classification changes as a result of events during the period, the financial instrument is marked to market and reclassified as of the date of the event that caused the reclassification. On June 4, 2018, in connection with the Company’s IPO, all of its previously issued convertible notes were converted and paid in full and the embedded conversion options and warrants no longer qualified as derivatives; accordingly, the derivative liabilities were remeasured to fair value on June 4, 2018 and the fair value of derivative liabilities of $3,594,002 was reclassified to additional paid in capital. The Company recorded a gain and a loss on the change in fair value of derivative liabilities of $0.0 and $191,656 during the years ended December 31, 2019 and 2018, respectively. Net Loss per Share The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common stock outstanding during the period. Net loss income attributable to common stockholders consists of net loss, adjusted for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock. Basic and diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and options, plus the conversion of preferred stock or convertible notes, in the calculation of diluted net loss per common shares would have been anti-dilutive. The following table summarizes net loss attributable to common stockholders used in the calculation of basic and diluted loss per common share: For the Years Ended December 31, 2019 2018 Net loss $ (7,625,397 ) $ (13,042,709 ) Deemed dividend to Series A and B preferred stockholders - (3,310,001 ) Net loss attributable to common stockholders $ (7,625,397 ) $ (16,352,710 ) The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of December 31, 2019 and 2018: December 31, 2019 2018 Shares of common stock issuable upon exercise of warrants 174,679 151,223 Shares of common stock issuable upon exercise of options and restricted stock units 107,495 115,331 Potentially dilutive common stock equivalents excluded from diluted net loss per share 282,174 266,554 Revenue Recognition In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-08, “Revenue from Contracts with Customers - Principal versus Agent Considerations”, in April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606) - Identifying Performance Obligations and Licensing” and in May 9, 2016, the FASB issued ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606)”, or ASU 2016-12. This update provides clarifying guidance regarding the application of ASU No. 2014-09 - Revenue From Contracts with Customers which is not yet effective. These new standards provide for a single, principles-based model for revenue recognition that replaces the existing revenue recognition guidance. In July 2015, the FASB deferred the effective date of ASU 2014-09 until annual and interim periods beginning on or after December 15, 2017. It has replaced most existing revenue recognition guidance under U.S. GAAP. The ASU may be applied retrospectively to historical periods presented or as a cumulative-effect adjustment as of the date of adoption. The Company adopted Topic 606 using a modified retrospective approach and was applied prospectively in the Company’s financial statements from January 1, 2018 forward. Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time”, depending on the facts and circumstances of the arrangement, and are evaluated using a five-step model. The adoption of Topic 606 did not have a material impact on the Company’s financial statements, at initial implementation nor will it have a material impact on an ongoing basis. The Company recognizes revenue when goods or services are transferred to customers in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. In determining when and how revenue is recognized from contracts with customers, the Company performs the following five-step analysis: (i) identification of contract with customer; (ii) determination of performance obligations; (iii) measurement of the transaction price; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The following table summarizes the Company’s revenue recognized in the accompanying statements of operations: For the Years Ended December 31, 2019 2018 Royalty income 31,243 116,152 Contract research - related party - 70,400 Total Revenues $ 31,243 $ 186,552 Revenue from sales of products is recognized at the point where the customer obtains control of the goods and the Company satisfies its performance obligation, which generally is at the time the product is shipped to the customer. Royalty revenue, which is based on resales of ProCol Vascular Bioprosthesis to third-parties, will be recorded when the third-party sale occurs and the performance obligation has been satisfied. Contract research and development revenue is recognized over time using an input model, based on labor hours incurred to perform the research services, since labor hours incurred over time is thought to best reflect the transfer of service. Information on Remaining Performance Obligations and Revenue Recognized from Past Performance Information about remaining performance obligations pertaining to contracts that have an original expected duration of one year or less is not disclosed. The transaction price allocated to remaining unsatisfied or partially unsatisfied performance obligations with an original expected duration exceeding one year was not material at December 31, 2019. Contract Balances The timing of our revenue recognition may differ from the timing of payment by our customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, deferred revenue is recorded until the performance obligations are satisfied. The Company had deferred revenue of $33,000 and $33,000 as of December 31, 2019 and 2018, respectively, related to cash received in advance for contract research and development services. Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and recognized over the period services are required to be provided in exchange for the award, usually the vesting period. Forfeitures of unvested stock options are recorded when they occur. Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $1,867,286 and $2,490,645 as of December 31, 2019 and 2018, respectively. During the year ended December 31, 2019, 100% of the Company’s revenues were from royalties earned from the sale of product by LeMaitre. The three-year Post-Acquisition Supply Agreement from which the Company earned royalty from the sale of product by LeMaitre ended on March 18, 2019. During the year ended December 31, 2018, 62% of the Company’s revenues were from royalties earned from the sale of product by LeMaitre and 38% were from contract research revenue related to research and development services performed pursuant to the HJLA Agreement. Subsequent Events The Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued. Based upon the evaluation and transactions, the Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed in Note 14 to the Financial Statements - Subsequent Events. Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018. As a result of the new standard, all of our leases greater than one year in duration will be recognized in our Balance Sheets as both operating lease liabilities and right-of-use assets upon adoption of the standard. We adopted the standard using the prospective approach. Upon adoption on January 1, 2019, we recorded approximately $1.1 million in right-of-use assets and operating lease liabilities in our Balance Sheets. In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Restricted Cash | Note 4 – Restricted Cash As of September 30, 2020, the Company did not have any restricted cash. Previously, the Company had maintained a restricted cash balance in connection with a vendor litigation matter with ATSCO, Inc. (see Note 9 - Commitments and Contingencies - Litigations Claims and Assessments The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheet as of September 30, 2019 and that sum to the total of the same amounts shown in the statement of cash flows for the nine months ending September 30, 2019 with the comparative cash balance without restricted cash as of September 30, 2020. As of September 30, 2020 2019 Cash and cash equivalents $ 5,629,003 $ 2,943,409 Restricted cash - 810,055 Total cash, cash equivalents, and restricted cash in the balance sheets $ 5,629,003 $ 3,753,464 |
Property and Equipment
Property and Equipment | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Property and Equipment | Note 5 – Property and Equipment As of September 30, 2020 and December 31, 2019, property and equipment consist of the following: September 30, December 31, 2020 2019 Laboratory equipment $ 332,126 $ 214,838 Furniture and fixtures 93,417 93,417 Computer software and equipment 61,771 50,403 Leasehold improvements 158,092 158,092 Construction Work in Progress – Software 244,479 220,384 889,885 737,134 Less: accumulated depreciation (464,359 ) (393,107 ) Property and equipment, net $ 425,526 $ 344,027 Depreciation expense amounted to $66,857 and $26,828 for the nine months ended September 30, 2020 and 2019, respectively. Depreciation expense is reflected in general and administrative expenses in the accompanying statements of operations. | Note 4 – Property and Equipment As of December 31, 2019 and 2018, property and equipment consist of the following: December 31, 2019 2018 Laboratory equipment $ 214,838 $ 94,905 Furniture and fixtures 93,417 93,417 Computer equipment 50,403 26,830 Leasehold improvements 158,092 158,092 Software 220,384 - Total property and equipment 737,134 373,244 Less: accumulated depreciation (393,107 ) (347,091 ) Property and equipment, net $ 344,027 $ 26,153 Depreciation expense amounted to $46,017 and $10,112 for the years ended December 31, 2019 and 2018, respectively. Depreciation expense is reflected in general and administrative expenses in the accompanying statements of operations. |
Right-of-Use Assets and Lease L
Right-of-Use Assets and Lease Liability | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Right-of-Use Assets and Lease Liability | Note 6 – Right-of-Use Assets and Lease Liability On September 20, 2017, the Company renewed its operating lease for its manufacturing facility in Irvine, California, effective October 1, 2017, for five years with an option to extend the lease for an additional 60-month term at the end of lease term. The initial lease rate was $26,838 per month with escalating payments. In connection with the lease, the Company is obligated to pay $7,254 monthly for operating expenses for building repairs and maintenance. The Company has no other operating or financing leases with terms greater than 12 months. The Company adopted Accounting Standards Codification (“ASC”) Topic 842, Leases (Topic 842) effective January 1, 2019 using the modified-retrospective method and elected the package of transition practical expedients for expired or existing contracts, which does not require reassessment of previous conclusions related to contracts containing leases, lease classification and initial direct costs, and therefore the comparative periods presented are not adjusted. In addition, the Company elected to adopt the short-term lease exception and not apply Topic 842 to arrangements with lease terms of 12 months or less. On January 1, 2019, upon adoption of Topic 842, the Company recorded right-of-use assets of $1,099,400, lease liabilities of $1,121,873 and eliminated deferred rent of $22,473. The Company determined the lease liabilities using the Company’s estimated incremental borrowing rate of 8.5% to estimate the present value of the remaining monthly lease payments. Our operating lease cost is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2020 Operating lease cost $ 85,492 $ 256,475 Supplemental cash flow information related to our operating lease is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2020 Operating Cash Flow Information: Cash paid for amounts in the measurement of lease liabilities $ 85,416 $ 256,248 Remaining lease term and discount rate for our operating lease is as follows: September 30, 2020 Remaining lease term 2 years Discount rate 8.5 % Maturity of our lease liabilities by fiscal year for our operating lease is as follows: Three months ended December 31, 2020 $ 87,981 Year ended December 31, 2021 354,561 Year Ended December 31, 2022 271,854 Total $ 714,396 Less: Imputed Interest (74,277 ) Present value of our lease liability $ 640,119 | Note 5 – Right-of-Use Assets and Lease Liabilities On September 20, 2017, the Company renewed its operating lease for its manufacturing facility in Irvine, California, effective October 1, 2017, for five years with an option to extend the lease for an additional 60-month term at the end of lease term. The initial lease rate was $26,838 per month with escalating payments. In connection with the lease, the Company is obligated to pay $7,254 monthly for operating expenses for building repairs and maintenance. The Company has no other operating or financing leases with terms greater than 12 months. The Company adopted Accounting Standards Codification (“ASC”) Topic 842, Leases (Topic 842) effective January 1, 2019 using the modified-retrospective method and elected the package of transition practical expedients for expired or existing contracts, which does not require reassessment of previous conclusions related to contracts containing leases, lease classification and initial direct costs, and therefore the comparative periods presented are not adjusted. In addition, the Company elected to adopt the short-term lease exception and not apply Topic 842 to arrangements with lease terms of 12 months or less. On January 1, 2019, upon adoption of Topic 842, the Company recorded right-of-use assets of $1,099,400, lease liabilities of $1,121,873 and eliminated deferred rent of $22,473. The Company determined the lease liabilities using the Company’s estimated incremental borrowing rate of 8.5% to estimate the present value of the remaining monthly lease payments. Our operating lease cost is as follows: For the Year Ended December 31, 2019 Operating lease cost $ 341,966 Supplemental cash flow information related to our operating lease is as follows: For the Year Ended December 31, 2019 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 334,203 Remaining lease term and discount rate for our operating lease is as follows: December 31, 2019 Remaining lease term 2.7 years Discount rate 8.5 % Maturity of our lease liabilities by fiscal year for our operating lease is as follows: Year ended December 31, 2020 344,229 Year ended December 31, 2021 354,561 Year ended December 31, 2022 271,854 Total $ 970,644 Less: Imputed interest (114,011 ) Present value of our lease liability $ 856,633 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 6 – Intangible Assets On May 10, 2013, the Company purchased United States Patent 7,815,677, “lntraparietal Aortic Valve Reinforcement Device and a Reinforced Biological Aortic Valve” from Leman Cardiovascular, S.A, (the “Patent”), which protects the critical design components and function relationships unique to the Company’s BHV. The BHV is a bioprosthetic, pig heart valve designed to function like a native heart valve and early clinical testing has demonstrated that the BHV may be suitable for the pediatric population, as it accommodates for the growth concomitant with the patient. As of December 31, 2019, the Company performed an impairment analysis and determined that since it is focusing its research and development efforts on its VenoValve and CoreoGraft products and unlikely to continue the development of the BHV in the near future, the Company recorded an impairment loss of $588,822, equal to the remaining unamortized value as of December 31, 2019. As of December 31, 2019 and 2018, the Company’s intangible asset consisted of the following: December 31, 2019 2018 Patent $ - $ 1,100,000 Less: accumulated amortization - (433,533 ) Total $ - $ 666,467 Amortization expense charged to operations for the years ended December 31, 2019 and 2018 was $77,643 and $111,893, respectively, and is reflected in general and administrative expense in the accompanying statements of operations. |
Accrued Expenses and Accrued In
Accrued Expenses and Accrued Interest | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Payables and Accruals [Abstract] | ||
Accrued Expenses and Accrued Interest | Note 7 – Accrued Expenses and Accrued Interest As of September 30, 2020, and December 31, 2019, accrued expenses consist of the following: September 30, December 31, 2020 2019 Accrued compensation costs $ 233,428 $ 151,858 Accrued professional fees 23,000 141,310 Accrued franchise taxes 25,607 30,270 Accrued research and development 5,637 - Other accrued expenses - 10,000 Accrued expenses $ 287,672 $ 333,438 | Note 7 – Accrued Expenses As of December 31, 2019 and 2018, accrued expenses consist of the following: December 31, 2019 2018 Accrued compensation costs $ 151,858 $ 288,549 Accrued professional fees 141,310 55,300 Deferred rent - 22,473 Accrued franchise taxes 30,270 26,985 Accrued research and development - 17,064 Other accrued expenses 10,000 2,500 Accrued expenses $ 333,438 $ 412,871 Included in accrued compensation costs in the table above as of December 31, 2018 is accrued severance expense of $166,154 pursuant to the terms of the employment agreement for the Company’s prior Chief Financial Officer, who was terminated effective July 20, 2018, and whose severance was fully paid in 2019 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8 – Income Taxes The following summarizes the Company’s income tax provision (benefit): For the Years Ended December 31, 2019 2018 Federal: Current $ - $ - Deferred (1,449,778 ) (1,710,997 ) State and local: Current - - Deferred (483,259 ) (570,332 ) (1,933,037 ) (2,281,329 ) Change in valuation allowance 1,933,037 2,281,329 Income tax provision (benefit) $ - $ - The reconciliation between the U.S. statutory federal income tax rate and the Company’s effective tax rate for the year’s ended December 31, 2019 and 2018 is as follows: For the Years Ended December 31, 2019 2018 Tax benefit at federal statutory rate (21.0 )% (21.0 )% State taxes, net of federal benefit (7.0 )% (7.0 )% Permanent differences 0.5 % 11.4 % True up adjustments 2.1 % (0.9 )% Change in valuation allowance 25.4 % 17.5 % Effective income tax rate 0.0 % 0.0 % Significant components of the Company’s deferred tax assets at December 31, 2019 and 2018 are as follows: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 7,329,760 $ 5,298,599 Research and development credit carryforwards 185,680 185,680 Intangible assets 309,865 152,109 Operating lease liability 239,857 - Property and equipment - 30,957 Stock-based compensation 329,136 526,945 Deferred rent - 6,292 Impairment loss 136,612 136,612 Total gross deferred tax assets 8,530,910 6,337,194 Deferred tax liabilities Operating lease asset (231,391 ) - Property and equipment (29,289 ) - Total net deferred tax assets 8,270,230 6,337,194 Less: valuation allowance (8,270,230 ) (6,337,194 ) Total $ - $ - Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes to offset its post-change income taxes may be limited. In accordance with Section 382 of the Internal Revenue Code, the usage of the Company’s NOL carry forwards are subject to annual limitations due to a greater than 50% ownership change in 2018. At December 31, 2019 and 2018, the Company had post-ownership change net operating loss carryforwards for federal income tax purposes of approximately $26.1 million and $17.4 million, respectively. Pre-2018 federal NOLs of $12.0 million carryovers may be carried forward for twenty years and begin to expire in 2029. Under the Tax Act, post-2017 federal NOLs in the aggregate of $14.1 million can be carried forward indefinitely and the annual limit of deduction equals 80% of taxable income. However, to the extent the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax return in which the attribute is utilized. The Company also has federal research and development tax credit carryforwards of approximately $0.2 million which begin to expire in 2027. As of December 31, 2019 and 2018, the Company had net operating loss carryforwards for state income tax purposes of approximately $26.1 million and $17.4 million, respectively, which can be carried forward for twenty years and begin to expire in 2029. The Company files income tax returns in the U.S. federal jurisdiction as well as California and local jurisdictions and is subject to examination by those taxing authorities. The Company’s federal income tax returns for the years beginning in 2016 remain subject to examination. The Company’s state and local income tax returns for the years beginning in 2015 remain subject to examination. No tax audits were initiated during 2019 or 2018. Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s financial statements as of December 31, 2019 and 2018. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrative expenses in the statements of operations. |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Note Payable | Note 8 – Note Payable On April 12, 2020, the Company obtained loan (the “Loan”) in the amount of $312,700, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020. The Loan, which was in the form of a Note dated April 12, 2020, matures on April 12, 2022 and bears interest at a rate of 1% per annum, payable monthly commencing on November 12, 2020. The Note may be prepaid at any time before maturity with no prepayment penalties. Funds from the Loan may only be used for payroll costs, costs used to continue group health care benefits, mortgage payments, rent, utilities, and interest on other debt obligations incurred before February 15, 2020. The Company believes it has used the entire Loan amount for qualifying expenses. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. As of September 30, 2020, the note payable balance was $312,700. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Commitments and Contingencies | Note 9 – Commitments and Contingencies Litigations Claims and Assessments In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. On September 21, 2018, ATSCO, Inc., a vendor, filed a lawsuit with the Superior Court seeking payment of $809,520 plus legal costs for disputed invoices to the Company dated from 2015 to June 30, 2018. The Company had entered into a Services and Material Supply Agreement (“Agreement”), dated March 4, 2016 for ATSCO to supply porcine and bovine tissue to the Company. On January 18, 2019, the Orange County Superior Court granted a Right to Attach Order and Order for Issuance of Writ of Attachment in the amount of $810,055 (the “Disputed Amount”) and on March 21, 2019, the Santa Clara, CA sheriff department served the Writ of Attachment and took custody of and was holding the Disputed Amount (see Note 4 – Restricted Cash). On July 20, 2020, the Company and ATSCO agreed to settle the dispute. Pursuant to the terms of the settlement, the Company agreed to release the Disputed Amount of restricted cash in exchange for a full release from all claims made by ATSCO related to this matter. On August 28, 2020, ATSCO took possession of the Restricted Cash. Accordingly, as of September 30, 2020, the Company has removed the restricted cash and related accounts payable from its financial statements. The Company has replaced ATSCO and has entered into new supply relationships with two domestic and one international company to supply porcine and bovine tissues. On October 8, 2018, Gusrae Kaplan Nusbaum PLLC (“Gusrae”) filed a complaint with the Supreme Court of the State of New York seeking payment of $178,926 plus interest and legal costs for invoices to the Company dated from November 2016 to December 2017. In July 2016, the Company retained Gusrae to represent the Company in connection with certain specific matters. The Company believes that Gusrae has not applied all of the payments made by the Company along with billing irregularities and errors and is disputing the amount owed. The Company recorded the disputed invoices in accounts payable and as of June 30, 2020, the Company has fully accrued for the outstanding claim against the Company. On December 4, 2020 the Company and Gusrae settle the dispute. See Note 11 – Subsequent Events. On July 9, 2020, the Company was served with a civil complaint filed in the Superior Court for the State of California, County of Orange by a former employee, Robert Rankin, who resigned as the Company’s Chief Financial Officer, Secretary and Treasurer on March 30, 2020. The complaint asserts several causes of action, including a cause of action for failure to timely pay Mr. Rankin’s accrued and unused vacation and three months’ severance under his July 16, 2018 employment agreement with the Company. The complaint seeks, among other things, back pay, unpaid wages, compensatory damages, punitive damages, attorneys’ fees, and costs. The Company intends to vigorously defend the claims, investigate the allegations, and assert counterclaims. | Note 9 – Commitments and Contingencies Litigations Claims and Assessments In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. On September 21, 2018, ATSCO, Inc., filed a complaint with the Superior Court seeking payment of $809,520 plus legal costs for disputed invoices to the Company dated from 2015 to June 30, 2018. The Company had entered into a Services and Material Supply Agreement (“Agreement”), dated March 4, 2016 for ATSCO to supply porcine and bovine tissue. The Company is disputing the amount owed and that the Agreement called for a fixed monthly fee regardless of whether tissue was delivered to the Company. On January 18, 2019, the Orange County Superior Court granted a Right to Attach Order and Order for Issuance of Writ of Attachment in the amount of $810,055. We contend at least $188,000 of the ATSCO claim relates to a wholly separate company, and over $500,000 of the claim is attributable to invoices sent without delivery of any tissue to the Company. The Company also believes it has numerous defenses and rights of setoff including without limitation: that ATSCO had an obligation to mitigate claimed damages, particularly when they were not delivering tissues; $188,000 of the amount that ATSCO is seeking are for invoices to Hancock Jaffe Laboratory Aesthetics, Inc. (in which the Company owns a minority interest of 28.0%) and is not the obligation of the Company; the Company has a right of setoff against any amounts owed to ATSCO for 4,800 shares of the Company’s stock transferred to ATSCO’s principal and owner; the yields of the materials delivered by ATSCO to the Company were inferior; and the Agreement was constructively terminated. On March 26, 2019, ATSCO filed a First Amended Complaint with the Superior Court increasing its claim to $1,606,820 plus incidental damages and interest, on the basis of an alleged additional oral promise not alleged in its original Complaint. The Company recently deposed ATSCO’s sole owner and principal and believes that the merits of its key defenses have been buttressed and supported as a result. While the Company expects and intends to continue a vigorous defense, the Company and ATSCO have recently agreed to proceed with informal settlement discussions. A trial date of July 20, 2020 has been set by the court. The Company recorded the disputed invoices in accounts payable and as of December 31, 2019, the Company believes that it has fully accrued for the outstanding claims against the Company. The Company has entered into new supply relationships with one domestic and one international company to supply porcine and bovine tissues. On October 8, 2018, Gusrae Kaplan Nusbaum PLLC (“Gusrae”) filed a complaint with the Supreme Court of the State of New York seeking payment of $178,926 plus interest and legal costs for invoices to the Company dated from November 2016 to December 2017. In July 2016, the Company retained Gusrae to represent the Company in connection with certain specific matters. The Company believes that Gusrae has not applied all of the payments made by the Company along with billing irregularities and errors and is disputing the amount owed. The Company recorded the disputed invoices in accounts payable and as of December 31, 2019 and 2018, the Company has fully accrued for the outstanding claim against the Company. On May 31, 2019, the Company entered into an agreement (“Boxer Settlement Agreement”) with Allen Boxer and Donna Mason (collectively, the “Boxer Parties”) for the purposes of settling a previously disclosed dispute in which the Boxer Parties claimed to be owed fees for introducing the Company to Alexander Capital and Network 1 Securities who assisted the Company for the capital raise of the convertible notes issued in 2017 and 2018, which raised over $5.6 million in gross proceeds. Pursuant to the Boxer Settlement Agreement, the Boxer Parties agreed to a complete release of claims of fees relating to past and future capital raises and the Company agreed to issue 6,280 shares of common stock and a five year warrant to purchase 6,000 shares of common stock that vested immediately with an exercise price of $150 per share. Employment Agreement Senior Vice President and Chief Medical Officer On July 22, 2016, the Company entered into an employment agreement with Marc H. Glickman, M.D., the Company’s Senior Vice President and Chief Medical Officer (the “Pre-existing Employment Agreement”). On July 26, 2019, the Company entered an employment agreement with Dr. Glickman (the “New Employment Agreement”) that shall supersede the terms of the Pre-existing Employment Agreement. Pursuant to the terms of the New Employment Agreement, Dr. Glickman’s base salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board. In connection with entering into the New Employment Agreement, Dr. Glickman’s existing seven thousand three hundred and eighty (7,380) options (“Existing Options”) to purchase Company common stock, $0.00001 par value per share (the “Common Stock”) at ten dollars ($250.00) per share until October 1, 2026, were repriced to two dollars ($50.00) per share. This was accounted for as a modification and the excess fair value of $20,295 was expensed since the options had fully vested. Additionally, Dr. Glickman, in connection to the New Employment Agreement shall be granted stock options (“New Options”) for the right to purchase seven thousand two hundred (7,200) Common Stock at a price equal to two dollars ($50.00) per share exercisable until July 26, 2029, which shall vest quarterly over a three (3) year period, and shall be granted in accordance with the Hancock Jaffe 2016 Omnibus Incentive Plan (the “Option Plan”), and shall be subject to such other terms and conditions as are set forth in the Option Plan and the option agreement issued pursuant to the Option Plan. The New Options had a grant date fair value of $28,800. Pursuant to the terms of the New Employment Agreement, Dr. Glickman is an at-will employee and is entitled to severance in the event of certain terminations of his employment. In the event that Dr. Glickman’s employment is terminated by the Company without Cause (as defined in the New Employment Agreement), other than by reason of Disability (as defined in the New Employment Agreement), or he resigns for Good Reason (as defined in the New Employment Agreement), subject to his timely executing a release of claims in favor of the Company and in addition to certain other accrued benefits, Dr. Glickman is entitled to receive three months of his base salary for each year that he has been employed by the Company at the time of termination, up to a total of one year of his base salary. |
Stockholders' Equity (Deficienc
Stockholders' Equity (Deficiency) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Equity [Abstract] | ||
Stockholders' Equity (Deficiency) | Note 10 –Stockholders’ Equity (Deficiency On September 15, 2020, the Company completed a special meeting of stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders, among other things, (i) approved an amendment to the Company’s Amended and Restated Certificate of Incorporation (the “A&R Certificate of Incorporation”) to increase the aggregate number of authorized shares of common stock by 200,000,000 shares from 50,000,000 to 250,000,000 shares; (ii) approved an amendment to the A&R Certificate of Incorporation to reduce the vote required to amend, repeal, or adopt any provisions of the A&R Certificate of Incorporation from the approval of 66 2/3% of the voting power of the shares of the then outstanding voting stock of the Company entitled to vote to a majority of such shares; and (iii) approved a reverse stock split of the Company’s common stock at a ratio of between one-for-five and one-for-twenty-five, with such ratio to be determined at the sole discretion of the Company’s Board of Directors (the “Board”) and with such reverse stock split to be effected at such time and date, if at all, as determined by the Board in its sole discretion. Common Stock On February 25, 2020, the Company raised $650,000 in gross proceeds through a private placement bridge offering of its common stock and warrants to purchase its common stock to certain accredited investors (the “Bridge Offering”). The Company sold an aggregate of 52,000 shares of common stock and warrants to purchase 52,000 shares of common stock in the Bridge Offering pursuant to a securities purchase agreement between the Company and each of the investors in the Bridge Offering (the “Purchase Agreement”). The warrants are exercisable for a the period commencing the date the Company’s stockholders approve either an increase in the number of the Company’s authorized shares or a reverse stock split and ending on February 25, 2025 and have an exercise price of $19.75 per share. Pursuant to the terms of the Purchase Agreement, the Company agreed to hold a meeting of its stockholders on or prior to May 25, 2020 for the purpose of seeking approval of either an increase in the number of shares of common stock the Company is authorized to issue or a reverse split of the Company’s common stock (a “Capital Event”). The Company did not hold a meeting until September 15, 2020, at which time the Company’s stockholders approved various measures including those comprising a Capital Event. On April 24, 2020, the Company entered into a Securities Purchase Agreement (the “April 2020 Purchase Agreement”) with certain investors for the purpose of raising approximately $1.0 million in gross proceeds for the Company. Pursuant to the terms of the April 2020 Purchase Agreement, the Company agreed to sell, in a registered direct offering, an aggregate of 75,472 shares of the Company’s common stock, at a purchase price of $10.125 per share, and in a concurrent private placement, warrants to purchase up to 75,472 shares of common stock, at a purchase price of $3.125 per warrant, for a combined purchase price per share and warrant of $13.25. The warrants are exercisable immediately on the date of issuance at an exercise price of $10.125 per share and will expire five years following the date of issuance. The closing of the sales of these securities under the April 2020 Purchase Agreement occurred on April 28, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were $811,641. On June 1, 2020, the Company entered into a Securities Purchase Agreement (the “June 2020 Purchase Agreement”) with certain investors for the purpose of raising approximately $1,333,000 in gross proceeds for the Company. Pursuant to the terms of the June 2020 Purchase Agreement, the Company agreed to sell, in a registered direct offering, an aggregate of 117,217 shares of the Company’s common stock at a purchase price of $8.25 per share, and in a concurrent private placement, warrants to purchase up to 117,217 shares of common stock at a purchase price of $3.125 per warrant, for a combined purchase price per share and warrant of $11.375. The warrants are exercisable immediately on the date of issuance at an exercise price of $8.25 per share and will expire five years following the date of issuance. The closing of the sales of these securities under the June 2020 Purchase Agreement occurred on June 3, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were $1,161,667. On July 17, 2020, the Company entered into an Underwriting Agreement relating to a firm commitment public offering (the “Public Offering”) of 500,000 units (the “Units”), consisting of an aggregate of 500,000 shares of common stock and warrants to purchase up to 500,000 shares of common stock at a public offering price of $8.00 per Unit. Pursuant to the terms of the Underwriting Agreement, the underwriters also exercised their overallotment option in full, purchasing an additional 75,000 shares of common stock and warrants to purchase up to 75,000 shares of common stock for an aggregate purchase of 575,000 shares and warrants to purchase up to 575,000 shares of common stock. The warrants have an initial exercise price of $8.00 per share, subject to customary adjustments, and will expire seven years from the date of issuance. Exercisability of the warrants was subject to stockholder approval of an increase in the number of authorized shares of common stock or a reverse stock split, in either case, in an amount sufficient to permit exercise in full of the warrants, which was obtained on September 15, 2020. Pursuant to the Underwriting Agreement, the Company also issued to the underwriters as compensation a warrant to purchase up to 30,000 shares of common stock with substantially the same terms as the warrants issued in the Public Offering. The closing of this transaction occurred on July 21, 2020. Net proceeds to the Company, after deducting the underwriters and placement agent’s fees and expenses, including the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the Public Offering, were $3,882,000. As of the July 21, 2020 closing, did not have sufficient authorized common shares to share settle all outstanding stock options and warrants. On February 7, 2019, the Company entered into an Agreement (“MZ Agreement”) with MZHCI, LLC a MZ Group Company (“MZ”) for MZ to provide investor relations advisory services. The MZ Agreement was for an initial term of twelve (12) months with six-month automatic extension periods. MZ received cash compensation of $8,000 per month and eighty-five thousand (3,400) restricted shares which vested quarterly over the initial twelve-month term. Effective on July 24, 2020, the Company and MZ terminated the agreement. Series C Convertible Preferred Stock In a private placement occurring concurrently with the Public Offering, the Company entered into a Securities Purchase Agreement with certain investors pursuant to which the Company agreed to sell 4,205,406 shares of its Series C Convertible Preferred Stock (the “Preferred Stock”) and 6,078,125 warrants to purchase up to 243,125 shares of its common stock for a combined purchase price per share and warrant of $9.25. Pursuant to its terms, the Preferred Stock may convert into 243,125 shares of common stock. The warrants issued have an initial per share exercise price of $8.00, subject to customary adjustments, and will expire seven years from the date of issuance. The gross proceeds were $1,556,000 and the net proceeds to the Company from the transaction, after deducting the underwriters and placement agent’s fees and expenses, including the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the private placement, were $1,358,000. The holders of the Company’s Preferred Stock vote with holders of the Common Stock, and with any other shares of preferred stock that vote with the Common Stock, with each holder of Preferred Stock being entitled to one vote per share of Preferred Stock, and are entitled to receive 8% non-compounding cumulative dividends, payable when, as and if declared by the Board of Directors. The Series C Preferred Stock ranks senior to the common stock as to dividends and the distribution of assets in the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary or any sale of the Company. In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or any sale of the Company, the holders of Preferred Stock are entitled to receive, before and in preference to any distribution of any of the assets to the holders of the common stock, or any other series of the Company’s preferred stock that is junior to the Preferred Stock, an amount per share equal to $0.37 for each outstanding share of Preferred Stock (the “Original Series C Issue Price”), plus all accrued but unpaid dividends thereon through the date of such event. As of September 30, 2020, the holders of Preferred Stock are entitled to receive a liquidation preference payment of $0.37 per share, plus accrued and unpaid dividends totaling, in the aggregate, $23,859. During the three and nine months ended September 30, 2020, the Company recognized the $23,859 as a deemed dividend for the purpose of calculating loss attributable to common stockholders and loss per share. The liquidation preference of the Preferred Stock is subordinate and ranks junior to all indebtedness of the Company. The Company may elect to convert the Preferred Stock to common stock in the event the Company either (i) consummates a merger, or (ii) raises an aggregate of at least $8,000,000 in gross proceeds in a transaction or series of transactions within any twelve (12) month period. In the event the Company elects to effect such a conversion, each share of Series C Preferred Stock is convertible into 0.05781 shares of common stock. The Company determined that the Preferred Stock represented permanent equity due to the absence of a redemption feature and the embedded conversion option was clearly and closely related to the equity host and did not require bifurcation. The $2,431,250 fair value of the warrants was calculated using the Black-Scholes option pricing model, using the $11.00 stock price, an expected term of 7.0 years, volatility of 118.7%, a risk-free rate of 0.47% and expected dividends of 0.00%. The $1,556,000 of gross proceeds were allocated on a relative fair value basis of $607,220 to the Preferred Stock and $948,781 to the warrants. The Preferred Stock includes a contingent beneficial conversion feature (“BCF”) which was valued at its $2,067,155 intrinsic value using the commitment date stock price of $11 per share and the effective conversion price of $2.50 per share, but was limited to the $607,220 of proceeds that were allocated to the Preferred Stock. The contingent BCF will be recognized when the contingency is resolved. If the BCF is recognized, it will be recorded as a deemed dividend for the purposes of calculating earnings per share. In addition, since the Company does not have retained earnings, the dividend will be recorded against additional paid-in capital. Warrants Certain investors in the Public Offering agreed with the underwriter to enter into a lock-up and voting agreement (the “Lock-Up and Voting Agreements”) whereby each such investor was subject to a lock-up period through July 21, 2020 and agreed to vote all shares of common stock each beneficially owned on the closing date of the Public Offering with respect to any proposals presented to the stockholders of the Company. Additionally, certain investors that agreed to enter into the Lock-Up and Voting Agreements, as consideration for their waiver of certain rights described in the April 2020 Purchase Agreement and June 2020 Purchase Agreement, were issued unregistered warrants (the “Waiver Warrants”) to purchase an aggregate of 139,800 shares of common stock. These warrants were substantially similar to the warrants issued in the concurrent private placement, except that they warrants have a term of five (5) years, an exercise price equal to $9.25 per share and carry piggy-back registration rights. Exercisability of the warrants issued in the February 25 transaction was subject to stockholder approval of a Capital Event. The warrants issued in the April and June transactions were immediately exercisable. Exercisability of the warrants issued in the July Public Offering and Private Placement was subject to the later to occur of (i) date that the Company files an amendment to its amended and restated certificate of incorporation to reflecting stockholder approval of either an increase in the number of our authorized shares of Common Stock or a reverse stock split (in either case in an amount sufficient to permit the conversion in full of the Preferred Stock and exercise in full of the warrants), and (ii) the date of approval as may be required by the applicable rules and regulations of The Nasdaq Stock Market LLC (or any successor entity) from the stockholders of the Company with respect to the transactions contemplated by the Securities Purchase Agreement, including the issuance of all of the shares issuable upon conversion of the Preferred Stock and warrants in excess of 19.99% of the issued and outstanding common stock on the closing date of the private placement. On June 15, 2020, the Company filed a registration statement covering the warrants issued in the April and June transactions. The registration statement was declared effective on June 23, 2020. At the Special Meeting held on September 15, 2020, the Company’s stockholders approved measures comprising a Capital Event, as defined in the February transaction, increasing the authorized common shares by an amount sufficient to cover the exercise of warrants purchased in that transaction as well as the Public Offering and Private Placement, and including common shares issuable upon conversion of the Company’s Series C Preferred Stock. The Company filed its amended and restated certificate of incorporation on September 17, 2020 and filed a registration statement covering the warrants issued in the February and July transactions. This registration statement became effective on October 22, 2020, such that all of the warrants issued in 2020 are now exercisable. On January 3, 2019, the Company entered into an Agreement (“Alere Agreement”) with Alere Financial Partners, a division of Cova Capital Partners LLC (“Alere”) for Alere to provide capital markets advisory services. The Alere Agreement is on a month to month basis that can be cancelled by either party with thirty (30) days advance notice. The Company will pay a monthly fee of $7,500 and issued to Alere five-year warrants to purchase 1,400 shares of the Company’s common stock at an exercise price of $39.75, equal to the closing price of the Company’s common stock on February 7, 2019, the date of approval by the Company’s board of directors. On June 11, 2019, both parties agreed to terminate the Alere Agreement as of June 30, 2019 and the unvested warrants as of June 30, 2019, totaling 700, were forfeited. In addition to the warrants issued to investors in the Bridge Offering described above, the placement agent received a warrant to purchase 5,200 shares of the Company’s common stock containing substantially the same terms as the warrant issued to investors in that transaction. The Company determined that all of the warrants issued in connection with the Bridge Offering were derivative instruments because the Company did not have control of the obligation to obtain shareholder approval by May 25, 2020 to increase the number of authorized shares or to approve a reverse stock split. The accounting treatment of derivative financial instruments requires that the Company record the warrants as a liability at fair value and mark-to-market the instruments at fair values as of each subsequent balance sheet date. Any change in fair value is recorded as a change in the fair value of derivative liabilities for each reporting period at each balance sheet date. The fair value of the warrants was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification at each balance sheet date. If the classification changes as a result of events during the period, the contract will be reclassified as of the date of the event that causes the reclassification. The warrant derivatives were valued as of the February 25, 2020 issuance date, as of the quarter ended March 31, 2020, as of June 30, 2020, and as of September 15, 2020 when the Company’s stockholders approved an increase in authorized shares in an amount sufficient to allow full exercise of these warrants. The value at issuance was $546,036 and was recorded as a derivative liability. The value of the derivative liability was $199,907 at March 31, 2020, $281,183 at June 30, 2020, and $334,229 at September 15, 2020. The derivative liability increased $53,046 and decreased $211,807 during the three and nine months ended September 30, 2020, respectively. The changes in derivative liability is reflected in Other Income on the Condensed Statement of Operations. On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved items comprising a Capital Event. Accordingly, there is no fair value of derivative liabilities as of September 30, 2020. The following inputs and assumptions were used for the valuation of the derivative liability: February 25, March 31, June 30, September 15, Stock Price $ 17.50 $ 7.38 $ 9.65 $ 10.87 Projected Volatility 97.1 % 102.7 % 102.7 % 110.7 % Risk-Free Rate 1.36 % 0.38 % 0.29 % 0.31 % ● It was assumed the stock price would fluctuate with the Company’s projected volatility. ● The projected volatility was based on the historical volatility of the Company. ● If the Company was required to pay the fair value of the warrant in cash as of May 25, 2020, the obligation was discounted at the Company’s estimated cost of debt based on short-term C-CCC bond ratings of 19.5% and 28.5%. ● The likelihood of the Company calling a shareholder meeting and achieving shareholder approval was 90% as of February 25, 2020. ● As June 30, 2020, the Company projected shareholder approval would not be obtained until approximately 8/31/20. No mandatory exercise was allowed prior to that date. ● Until the Company obtained shareholder approval to increase the authorized shares on September 15, 2020, we assumed the warrant holders have an option to require the Company to pay the fair value of the warrants. The derivative value at that date was $334,229. Warrant Exercises During the three and nine months ending September 30, 2020, warrants to purchase 72,748 shares of common stock were exercised resulting in proceeds to the Company of $631,626. Stock Options From time to time, the Company issues options for the purchase of its common stock to employees and others. On July 18, 2020, the Company granted 4,000 options to each of its four independent directors and a total of 106,000 options to various executive officers, other employees and a consultant. The exercise price for these stock options is $10.00 per share, the closing price of the Company’s stock on the business day preceding the grant date. The Company recognized $194,421 and $159,865 of stock-based compensation related to stock options during the three months ended September 30, 2020 and 2019, respectively, and recognized $363,027 and $329,454 of stock-based compensation related to stock options during the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, there was $1,138,934 of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 2.5 years. Restricted Stock Units On September 13, 2019, under the Company’s nonemployee director compensation program, the Company granted two of its independent directors 3,125 restricted a stock units each in connection with their appointment to the Board in accordance with the Option Plan, which, based on the Company’s closing stock price on the grant date were valued at $24.00 per unit for an aggregate grant date value of $150,000. These units vest in equal annual portions on the anniversary of their grant. | Note 10 – Common Stock On April 26, 2018, the Company issued 1,778 shares of common stock with an aggregate fair value of $200,000, in satisfaction of deferred salary to its Chief Medical Officer Outside the United States. On May 30, 2018, the Company’s registration statement on Form S-1 relating to its initial public offering of its common stock (the “IPO”) was declared effective by the Securities and Exchange Commission (“SEC”). The Company completed the IPO with an offering of 60,000 units (the “Units”) at $125.00 per unit on June 4, 2018, each consisting of one share of the Company’s common stock, par value $0.00001 per share (the “Common Stock”), and a warrant to purchase one-twenty fifth of a share of common stock with an exercise price of $150.00 per share. Aggregate gross proceeds from the IPO were $7,500,000, before underwriting discounts and commissions. On June 8, 2018, the underwriters notified the Company of their exercise in full of their option to purchase an additional 9,000 Units (the “Additional Units”) to cover over-allotments. On June 12, 2018, the underwriters purchased the Additional Units at the IPO price of $125.00 per Unit, generating $1,125,000 in gross proceeds before underwriting discounts and commissions. On June 18, 2018, the Company issued 1,200 shares of common stock with an aggregate fair value of $90,000, in satisfaction of fees payable to its Medical Advisory Board and granted 6,400 shares of immediately vested common stock with an aggregate fair value of $798,400 to certain consultants. On June 18, 2018, the Company also granted 800 shares of common stock to a consultant with a fair value of $99,800, which per the Consulting Agreement with the consultant will vest monthly over next twelve months. However, the Company terminated the Consulting Agreement with that consultant as of December 26, 2018. Per the Agreement, the 246 unvested shares are to be returned to the Company by the consultant. The Company recognized $69,176 of stock-based compensation expense related to the vested shares of common stock in 2018. On May 1, 2018, Dr Broennimann entered into a Service Agreement to perform the role of Chief Medical Officer (Out of US) for a fee of $15,000 monthly provided that the Company may, at its sole option, elect to pay 25% of the monthly fee in company common stock with the number of common stock determined by dividing the 25% of the monthly fee by the closing price of the Company’s common stock on the 2nd work day of each month. On November 27, 2018, the Company elected to issue 134 shares of common stock for the 25% of the monthly fee for the months of October and November 2018 and on December 2, 2018, the Company elected to issue 81 shares of common stock for the 25% of the monthly fee for the month of December 2018. On February 7, 2019, the Company entered into an Agreement (“MZ Agreement”) with MZHCI, LLC, a MZ Group Company (“MZ”) for MZ to provide investor relations advisory services. The MZ Agreement is for a term of twelve (12) months and can be cancelled by either party at the end of six (6) months with thirty (30) days’ notice. MZ will receive compensation of $8,000 per month and three thousand four hundred (3,400) restricted shares that vest quarterly over a year, with a 6 month cliff with an aggregate fair value of $135,150 and recognized $121,079 of stock-based compensation expense related to the vested shares in 2019. On March 12, 2019, the Company raised $2,704,000 in gross proceeds, with cash offering costs of $386,724 in a private placement offering of its common stock to certain accredited investors (the “Offering”). The Company sold an aggregate of 93,185shares of common stock in the Offering for a purchase price of $28.75 per share pursuant to a share purchase agreement between the Company and each of the investors in the Offering. Our CEO also participated in the Offering purchasing 736 shares at a price of $34 per share, the final bid price of our common stock as reported on The Nasdaq Capital Market on the date of the Offering. On April 18, 2019, 246 unvested shares were returned to the Company by a consultant as a result of the December 26, 2018 termination of such consultant’s consulting agreement. On May 31, 2019, the Company issued 6,280 restricted shares of common stock to the Boxer Parties pursuant to the Boxer Settlement Agreement valued at $298,300 or $47.50 per share, the closing price of the Company’s common stock on the date the shares were issued. On June 14, 2019, the Company completed a public offering of 144,625 shares of its common stock at a price to the public of $26.75 per share, for total gross proceeds of $3,868,716 (the “Public Offering”), with cash offering costs of $549,060. The shares were offered pursuant to a registration statement that was declared effective on June 11, 2019. On November 5, 2019, the Company issued 390 restricted shares of common stock to Dr. Francis Duhay, our director for the 390 restricted stock units that were granted on November 27, 2018 at a fair value of $19,164 for compensation as our director and that vested on November 5, 2019. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Warrants | Note 11 - Warrants On January 3, 2019, the Company entered into an Agreement (“Alere Agreement”) with Alere Financial Partners, a division of Cova Capital Partners LLC (“Alere”), for Alere to provide capital markets advisory services. The Alere Agreement was on a month to month basis that could be cancelled by either party with thirty (30) days advance notice. The Company paid a monthly fee of $7,500 and issued to Alere five-year warrants to purchase 1,400 shares of the Company’s common stock at an exercise price of $39.75, equal to the closing price of the Company’s common stock on February 7, 2019, the date of approval by the Company’s board of directors (the “Board”). The warrants had a grant date fair value of $14,000 using the Black-Scholes pricing model, with the following assumptions used: stock price of $39.75, risk free interest rate of 2.46%, expected term of 2.8 years, volatility of 34.4% and an annual rate of quarterly dividends of 0%. The warrants vested monthly equally over a 12 month period provided that the Alere Agreement remained in effect. On June 11, 2019, both parties agreed to terminate the Alere Agreement as of June 30, 2019 and the unvested warrants as of June 30, 2019 totaling 700 were forfeited with a fair value of $7,000. The net charge to the statement of operations for the year ended 2019 was $7,000. The placement agent for the Offering on March 12, 2019 received a warrant to purchase such number of shares of the Company’s common stock equal to 8% of the total shares of common stock sold in the Offering or 7,525 shares. Such warrant is exercisable for a period of five years from the date of issuance and has an exercise price of $37.50 per share. On May 31, 2019, the Company issued a five-year warrant to purchase 6,000 shares of common stock pursuant to the Boxer Settlement Agreement that vested immediately with an exercise price of $150 per share to the Boxer Parties. The warrants had a grant date fair value of $3,000 using the Black-Scholes pricing model, with the following assumptions used: stock price of $47.50, risk free interest rate of 1.93%, expected term of 2.5 years, volatility of 35.1% and an annual rate of quarterly dividends of 0%. On May 31, 2019, the Company issued a five-year warrant to purchase 2,000 shares of common stock that vested immediately with an exercise price of $50 to DFC Advisory Services LLC, D.B.A. Tailwinds Research Group, LLC (“Tailwinds”) to provide digital marketing services. The warrants had a grant date fair value of $20,500 using the Black-Scholes pricing model, with the following assumptions used: stock price of $47.50, risk free interest rate of 1.93%, expected term of 2.5 years, volatility of 35.1% and an annual rate of quarterly dividends of 0%. The placement agent for the Public Offering on June 14, 2019 received a warrant to purchase such number of shares of the Company’s common stock equal to 5% of the total shares of common stock sold in the Public Offering or 7,232 shares. Such warrant is exercisable for a period from December 8, 2019 through June 11, 2024 and has an exercise price of $32.10 per share. A summary of warrant activity during the years ended December 31, 2019 and 2018 is presented below: Series A Preferred Stock Common Stock Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Outstanding, 100,570 $ 5.00 14,849 300.00 Issued 131,698 152.25 Exercised Cancelled - - - - Amendment of placement agent warrants [1] (100,570 ) 5.00 4,677 107.50 Outstanding, - $ - - $ - 151,224 $ 137.00 4.1 $ - Issued - - - 24,156 65.00 Exercised - - - - - Cancelled - - - (700 ) 39.75 Outstanding, - $ - - $ - 174,680 $ 127.50 3.3 $ - Exercisable, - $ - - $ - 173,979 $ 127.75 3.3 $ - [1] In connection with the IPO, placement agent warrants for the purchase of Series A Preferred Stock were amended such that the warrants became exercisable for the number of common stock that would have been issued upon the exercise of the Series A warrant and subsequent conversion to common stock upon the consummation of the IPO. The exercise price was amended to the price equal to the total proceeds that would have been required upon the exercise of the original warrant, divided by the amended number of warrant shares. The amendment was accounted for as a modification of a stock award. The Company determined that there was no incremental increase in the fair value for the amendment of the award and accordingly there was no charge to the statement of operations for the years ended December 31, 2018. A summary of outstanding and exercisable warrants as of December 31, 2019 is presented below: Warrants Outstanding Warrants Exercisable Exercise Price Exercisable Into Outstanding Number of Warrants Weighted Average Remaining Life in Years Exercisable Number of Warrants $ 300.00 Common Stock 7,359 3.5 7,359 $ 156.25 Common Stock 3,000 3.4 3,000 $ 150.00 Common Stock 75,000 3.5 75,000 $ 124.75 Common Stock 4,000 3.5 4,000 $ 115.50 Common Stock 5,536 2.9 5,536 $ 107.50 Common Stock 4,677 1.1 4,677 $ 105.00 Common Stock 57,652 2.8 57,652 $ 50.00 Common Stock 2,000 4.4 2,000 $ 39.75 Common Stock 700 4.0 - $ 37.50 Common Stock 7,525 4.2 7,525 $ 32.00 Common Stock 7,232 4.4 7,232 174,681 173,981 |
Stock Based Compensation
Stock Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock Based Compensation | Note 12 – Stock Based Compensation Omnibus Incentive Plan On November 21, 2016, the board of directors approved the Company’s 2016 Omnibus Incentive Plan, which enables the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based awards and cash awards to associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the ability of the Company to attract, retain, and motivate individuals upon whom the Company’s sustained growth and financial success depend, by providing such persons with an opportunity to acquire or increase their proprietary interest in the Company. Stock options granted under the 2016 Plan may be non-qualified stock options or incentive stock options, within the meaning of Section 422(b) of the Internal Revenue Code of 1986, except that stock options granted to outside directors and any consultants or advisers providing services to the Company or an affiliate shall in all cases be non-qualified stock options. The option price must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant. The 2016 Plan is to be administered by the Board, which shall have discretion over the awards and grants thereunder. No awards may be issued after November 21, 2026. On December 11, 2017 the board of directors approved an amendment to the 2016 Omnibus Incentive Plan, whereby the number of common shares reserved for issuance under the plan was increased from 66,000 to 100,000. On April 26, 2018, our board of directors and our stockholders adopted and approved the Amended and Restated 2016 Omnibus Incentive Plan (the “2016 Plan”), whereby the number of common shares reserved for issuance under the plan was increased from 100,000 to180,000, plus an annual increase on each anniversary of April 26, 2018 equal to 3% of the total issued and outstanding shares of our common stock as of such anniversary (or such lesser number of shares as may be determined by our board of directors). Stock Options On February 7, 2019, in connection with her Employment Agreement, the Board approved the grant in accordance with the Hancock Jaffe 2016 Omnibus Incentive Plan (the “Option Plan”) of 6,000 non-qualified stock options for the purchase shares of the Company’s common stock at an exercise price of $39.75 to H. Chris Sarner, our Vice President Regulatory Affairs and Quality Assurances. The exercise price was equal to the closing price of our common stock on the date that the Board approved the option grant. The options have a ten-year term and 2,000 of the options will vest on the first anniversary of Ms. Sarner’s employment with the Company, and the remaining 4,000 options will vest on a quarterly basis over the following two-year period. The options had grant date fair value of $14.50 per share for an aggregate grant date fair value of $87,000, using the Black Scholes method with the following assumptions used: stock price of $39.75, risk-free interest rate of 2.47%, volatility of 36.3%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. Ms. Sarner resigned her employment with the Company effective December 2, 2019 prior to any options vesting. On February 7, 2019, the Board approved the grant in accordance with the Option Plan of 1,200 non-qualified stock options to purchase shares of the Company’s common stock to H. Jorge Ulloa as compensation for services provided as the Company’s Primary Investigator for the first-in-human trials of our VenoValve in Colombia in February and April 2019. The stock options were granted at an exercise price of $39.75, equal to the closing price of our common stock on the date that the Board approved the option grant. The options vest monthly over a one (1) year period. The options had grant date fair value of $14.50 per share for an aggregate grant date fair value of $17,400, using the Black Scholes method with the following assumptions used: stock price of $39.75, risk-free interest rate of 2.47%, volatility of 36.1%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On January 7, 2019, Dr. Peter Pappas agreed to join the Company’s Medical Advisory Board for a term of two years. The Board approved in accordance with the Option Plan the grant on March 6, 2019 of 800 non-qualified options to purchase shares of the Company’s common stock to Dr. Pappas as compensation. The stock options were granted at an exercise price of $34.50, equal to the closing price of our common stock on the date that the Board approved the option grant. The options will vest monthly in twenty-four (24) equal installments for each month that he remains a member of the Company’s Medical Advisory Board. The options had grant date fair value of $12.50 per share for an aggregate grant date fair value of $10,000, using the Black Scholes method with the following assumptions used: stock price of $34.50, risk-free interest rate of 2.50%, volatility of 35.9%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On July 3, 2019, in connection with his Employment Agreement dated June 24, 2019, the Board approved the grant in accordance with the Option Plan of 4,600 non-qualified stock options for the purchase of shares of common stock at an exercise price of $50.00 to Brian Roselauf, our Director of Research and Development. The options have a ten-year term and 1,534 of the options will vest on the first anniversary of Mr. Roselauf’s employment with the Company, and the remaining 3,067 options will vest on a quarterly basis over the following two-year period. The options had grant date fair value of $3.75 per share for an aggregate grant date fair value of $17,250, using the Black Scholes method with the following assumptions used: stock price of $25.50, risk-free interest rate of 1.76%, volatility of 35.9%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On July 3, 2019, the Company granted in accordance with the Option Plan non-qualified stock options for the purchase of an aggregate of 1,600 shares of common stock at an exercise price of $50.00 to two members of its Medical Advisory Board. The options have a ten-year term and vest monthly over two years. The options had grant date value of $3.75 per share for an aggregate grant date value of $6,000, using the Black Scholes method with the following assumptions used: stock price of $25.50, risk-free interest rate of 1.76%, volatility of 35.9%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On July 3, 2019, the Company granted in accordance with the Option Plan non-qualified stock options for the purchase of an aggregate of 2,400 shares of common stock at an exercise price of $50.00 to three key employees: Araceli Palacios, Maria Ruiz and Lydia Sepulveda. The options have a ten-year term and vest quarterly over three years. The options had grant date value of $3.75 per share for an aggregate grant date value of $9,000, using the Black Scholes method with the following assumptions used: stock price of $25.50, risk-free interest rate of 1.76%, volatility of 35.9%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On July 22, 2016, the Company entered into an employment agreement with Marc H. Glickman, M.D., the Company’s Senior Vice President and Chief Medical Officer (the “Pre-existing Employment Agreement”). On July 26, 2019, the Company entered an employment agreement with Dr. Glickman (the “New Employment Agreement”) that superseded the terms of the Pre-existing Employment Agreement. In connection with entering into the New Employment Agreement, Dr. Glickman’s existing 7,380 options (“Existing Options”) to purchase Company common stock at $250.00 per share until October 1, 2026 that were granted in connection with his Pre-existing Employment Agreement, were repriced to $50.00 per share. The Existing Options had the repriced date fair value of $2.75 per share for an aggregate grant date fair value of $20,295 using the Black Scholes method with the following assumptions used: stock price of $26.25, risk-free interest rate of 1.84%, volatility of 36.7%, annual rate of quarterly dividends of 0%, and a contractual term of 3.6 years. The repricing of his Existing Options was accounted for as a modification and the excess fair value of $20,295 was expensed since the options had fully vested Additionally, Dr. Glickman, in connection to the New Employment Agreement was granted in accordance with the Option Plan stock options (“New Options”) to purchase 7,200 common stock at a price equal to $50.00 per share exercisable until July 26, 2029, which vest quarterly over a three (3) year period. The New Options had a grant date fair value of $4.00 per share for an aggregate grant date fair value of $28,800, using the Black Scholes method with the following assumptions used: stock price of $26.25, risk-free interest rate of 1.86%, volatility of 35.7%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. On September 13, 2019, under the Company’s nonemployee director compensation program, Robert Gray and Matthew Jenusaitis in connection with their appointment to the Board were each granted 2,400 options to purchase shares of our common stock at an exercise price of $50.00 per share in accordance with the Option Plan. All of these options vest in equal quarterly portions over a 3 year period starting from the September 13, 2019 grant date. The Options had grant date fair value of $3.25 per share for an aggregate grant date fair value of $15,600 using the Black-Scholes method with the following assumptions used: stock price of $24.00, risk-free interest rate of 1.75%, volatility of 35.7%, annual rate of quarterly dividends of 0%, and a contractual term of 5.3 years. A summary of the option activity during the years ended December 31, 2019 and 2018 is presented below: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2018 56,880 $ 254.00 Granted 60,809 111.50 Forfeited (5,860 ) 250.00 Outstanding, December 31, 2018 111,829 $ 176.75 9.0 $ - Granted 28,600 47.00 Forfeited (40,740 ) 210.50 Outstanding, December 31, 2019 99,689 $ 111.00 8.6 $ - Exercisable, December 31, 2019 68,101 $ 132.00 8.5 $ - A summary of outstanding and exercisable options and Restricted Stock units as of December 31, 2019 is presented below: Options Outstanding Options Exercisable Exercise Price Exercisable Into Outstanding Number of Options Weighted Average Remaining Life In Years Exercisable Number of Options $ 300.00 Common Stock 4,800 7.7 4,800 $ 250.00 Common Stock 5,860 6.8 5,860 $ 175.00 Common Stock 240 7.9 240 $ 124.75 Common Stock 43,209 8.7 38,888 $ 123.25 Common Stock 3,200 8.5 2,400 $ 74.50 Common Stock 6,000 8.5 2,500 $ 72.50 Common Stock 1,200 8.9 1,200 $ 64.25 Common Stock 5,200 8.9 2,000 $ 50.00 Common Stock 27,980 8.9 8,914 $ 39.75 Common Stock 1,200 9.1 1,000 $ 34.50 Common Stock 800 9.2 300 Total 99,689 68,101 The Company recognized stock-based compensation related to stock options and restricted stock units of $492,084 and $864,626 during the years ended December 31, 2019 and 2018, respectively. As of December 31, 2019, there was $517,806 of unrecognized stock-based compensation expense related to outstanding stock options and restricted stock units that will be recognized over the weighted average remaining vesting period of 1.8 years. The employment of William Abbott, our prior Chief Financial Officer was terminated effective July 20, 2018. Pursuant to the provisions of the 2016 Omnibus Incentive Plan and terms and conditions of his stock option Award Agreement, the non-exercisable portion of his option grant or 586 expired upon his termination and the exercisable portion or 5,275 options remained exercisable for 90 days following his termination. The prior Chief Financial Officer failed to exercise his exercisable options within the 90 day period and they were forfeited as of October 18, 2018. Susan Montoya, our Senior Vice President of Operations and Quality Assurance/Regulatory Affairs resigned as of November 15, 2018 from the Company. Pursuant to the provisions of the 2016 Omnibus Incentive Plan and terms and conditions of her stock option Award Agreement, the exercisable portion or 32,740 options remained exercisable for 90 days following her resignation date. Ms. Montoya failed to exercise her exercisable options within the 90 day period and they were forfeited as of February 13, 2019. Restricted Stock Units In April 2019, Mr. Marcus Robins, a Director on the Board passed away. Per his restricted stock unit Award Agreement, upon his death, 1,168 units representing the non-vested portion of his restricted stock units were forfeited. On September 13, 2019, under the Company’s nonemployee director compensation program, Robert Gray and Matthew Jenusaitis in connection with their appointment to the Board were each granted 3,125 restricted stock units in accordance with the Option Plan, which based on the Company’s closing stock price on the grant date were valued at $24.00 per unit for an aggregate grant date value of $150,000. These units vest in equal annual portions on the September 13, 2020, September 13, 2021 and September 13, 2022. Restricted Stock Units Exercisable Grant Date Exercisable Into Outstanding Number of Units Weighted Average Remaining Life In Years 11/27/2018 Common Stock 1,557 1.8 9/13/2019 Common Stock 6,250 2.7 Total 7,807 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 13 – Related Party Transactions Contract & Research Revenue – Related Party During the years ended December 31, 2019 and 2018, the Company recognized $0.0 and $70,400, respectively of revenue for contract research services provided pursuant to a Development and Manufacturing Agreement with HJLA dated April 1, 2016. |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Subsequent Events [Abstract] | ||
Subsequent Events | Note 11 – Subsequent Events On October 7, 2020, the Company entered into a Securities Purchase Agreement (the “October 2020 Purchase Agreement”) with certain investors for the purpose of raising approximately $5,100,000 million in gross proceeds for the Company. Pursuant to the terms of the October 2020 Purchase Agreement, the Company agreed to sell, in a registered direct offering, an aggregate of 381,309 shares of the Company’s common stock at a purchase price of $10.25 per share, and in a concurrent private placement, warrants to purchase up to 381,309 of common stock at a purchase price of $3.125 per warrant, for a combined purchase price per share and warrant of $13.375. The warrants are exercisable immediately on the date of issuance at an exercise price of $10.25 per share and will expire five years following the date of issuance. The closing of the sales of these securities under the October 2020 Purchase Agreement occurred on October 9, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were approximately $4,450,000. On November 10, 2020 the Company agreed to pay Spartan Capital Securities LLC $355,000 in cash, and warrants to purchase 17,618 shares of common stock at a purchase price of $8.00 per share, and warrants to purchase 18,057 shares of common stock at a purchase price of $10.25 per share. These amounts were in dispute and were paid pursuant to an investment banking agreement dated February 12, 2020 in connection with financings which occurred in July and October. The investment banking agreement has now been terminated with no further obligations. On November 24, 2020, the Company completed the exchange of all its outstanding Series C Convertible Preferred Stock into common stock, exchanging 4,205,406 shares of its Series C Convertible Preferred stock for 243,125 shares of its common stock. On November 30, 2020, the Company effected a one-for-twenty five (1:25) reverse stock split of the shares of the Company’s common stock. As a result of the reverse stock split, every twenty five (25) shares of issued and outstanding common stock was automatically combined into one (1) issued and outstanding share of common stock, without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split and any fractional shares resulting from the reverse stock split were rounded up to the nearest whole share. Following the reverse stock split, the number of shares of Common Stock outstanding was reduced from 55,853,569 shares to 2,234,143 shares. Pursuant to their terms, proportional adjustments were also made to the Company’s outstanding stock options and warrants such that the number of shares of Common Stock underlying such securities were reduced by a factor of 25 and the exercise prices of such securities were increased by a factor of 25. The condensed financial statements and accompanying notes including per share amounts give effect to each of these reverse stock splits as if they occurred at the beginning of the first period presented. There have been no changes to previously reported earnings. On December 4, 2020, the Company and Gusrae entered a Settlement Agreement and Release resolving their dispute and the related complaint filed in the Supreme Court of the State of New York (See Note 9 – Commitments and Contingencies - Litigations Claims and Assessments In December 2020 and through the date of filing this prospectus, warrants to purchase 290,924 shares of common stock were exercised resulting in proceeds to the Company of approximately $2,354,000. In January 2021, we entered into warrant exercise agreements with certain purchasers of our warrants to purchase common stock issued in February 2020. In accordance with the terms of such agreements, eight of the nine the warrant holders have exercised warrants to purchase an aggregate of up to 48,000 shares of common stock for total gross proceeds of $240,000 to the company. | Note 14 – Subsequent Events On February 25, 2020, the Company raised $650,000 in gross proceeds through a private placement bridge offering of its common stock and warrants to purchase its common stock to certain accredited investors (the “Bridge Offering”). The Company sold an aggregate of 52,000 shares of common stock and warrants to purchase 52,000 shares of common stock at an exercise price per share equal to $19.75 in the Bridge Offering pursuant to a securities purchase agreement between the Company and each of the investors in the Bridge Offering. The Company engaged Spartan Capital Securities, LLC, a FINRA-member as the exclusive placement agent for the Bridge Offering and to pay a fee in cash equal to 10% of the aggregate gross proceeds of the Bridge Offering and a warrant to purchase 3,292 shares of the Company’s common stock containing substantially the same terms as the warrant issued to investors in the Bridge Offering. |
Reverse Stock Split
Reverse Stock Split | 12 Months Ended |
Dec. 31, 2019 | |
Reverse Stock Split | |
Reverse Stock Split | Note 15 – Reverse Stock Split On November 30, 2020, the Company effected a one-for-twenty five (1:25) reverse stock split of the shares of the Company’s common stock. As a result of the reverse stock split, every twenty five (25) shares of issued and outstanding common stock was automatically combined into one (1) issued and outstanding share of common stock, without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split and any fractional shares resulting from the reverse stock split were rounded up to the nearest whole share. Following the reverse stock split, the number of shares of Common Stock outstanding was reduced from 55,853,569 shares to 2,234,143 shares. Pursuant to their terms, proportional adjustments were also made to the Company’s outstanding stock options and warrants such that the number of shares of Common Stock underlying such securities were reduced by a factor of 25 and the exercise prices of such securities were increased by a factor of 25. The financial statements and accompanying notes including per share amounts give effect to each of these reverse stock splits as if they occurred at the beginning of the first period presented. There have been no changes to previously reported earnings. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of September 30, 2020 and December 31, 2019, and for the three and nine months ended September 30, 2020 and 2019. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2019 included in the Company’s Form 10-K filed with the SEC on March 18, 2020. The condensed balance sheet as of December 31, 2019 has been derived from the Company’s audited financial statements. | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include the valuation allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities. | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include the valuation allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities. |
Investments | Investments Equity investments over which the Company exercises significant influence, but does not control, are accounted for using the equity method, whereby investment accounts are increased (decreased) for the Company’s proportionate share of income (losses), but investment accounts are not reduced below zero. The Company holds a 28.0% ownership investment, consisting of founders’ shares acquired at nominal cost, in HJLA. To date, HJLA has recorded cumulative losses. Since the Company’s investment is recorded at $0, the Company has not recorded its proportionate share of HJLA’s losses. If HJLA reports net income in future years, the Company will apply the equity method only after its share of HJLA’s net income equals its share of net losses previously incurred. | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives, which range from 5 to 7 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. | |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. FASB ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices available in active markets for identical assets or liabilities trading in active markets. Level 2 Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. Financial instruments, including accounts receivable and accounts payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. The Company’s other financial instruments include notes payable, the carrying value of which approximates fair value, as the notes bear terms and conditions comparable to market for obligations with similar terms and maturities. Derivative liabilities are accounted for at fair value on a recurring basis. On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved the increase of its authorized shares of capital stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock The following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair value on a recurring basis: Derivative Liabilities Balance – January 1, 2020 $ - Derivative liabilities associated with the issuance of common stock warrants 513,534 Derivative liabilities associated with the issuance of placement agent warrants 32,502 Change in fair value of derivative liabilities (346,129 ) Balance – March 31,2020 199,907 Change in fair value of derivative liabilities 81,276 Balance June 30, 2020 281,183 Change in fair value of derivative liabilities 53,046 Reclassification of warrant derivatives to equity (334,229 ) Balance – September 30, 2020 $ - | |
Derivative Liabilities | Derivative Liabilities On February 25, 2020 in connection with a private placement of its securities (Note 10), the Company issued warrants to purchase 57,200 shares of its common stock. The Company determined these warrants were derivative financial instruments when issued. Derivative financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date. The change in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations for each reporting period. The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification of the financial instruments at each balance sheet date. If the classification changes as a result of events during the period, the financial instrument is marked to market and reclassified as of the date of the event that caused the reclassification. On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved the increase of its authorized shares of capital stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock The Company recorded a gain on the change in fair value of derivative liabilities of $211,807 during the nine months ended September 30, 2020 and a loss on the change in fair value of derivative liabilities of $53,046 during the quarter ended September 30, 2020. | Derivative Liabilities Derivative financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date. The change in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations for each reporting period. The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification of the financial instruments at each balance sheet date. If the classification changes as a result of events during the period, the financial instrument is marked to market and reclassified as of the date of the event that caused the reclassification. On June 4, 2018, in connection with the Company’s IPO, all of its previously issued convertible notes were converted and paid in full and the embedded conversion options and warrants no longer qualified as derivatives; accordingly, the derivative liabilities were remeasured to fair value on June 4, 2018 and the fair value of derivative liabilities of $3,594,002 was reclassified to additional paid in capital. The Company recorded a gain and a loss on the change in fair value of derivative liabilities of $0.0 and $191,656 during the years ended December 31, 2019 and 2018, respectively. |
Sequencing Policy | Sequencing Policy On July 15, 2020, the Company adopted a sequencing policy, whereby, in the event that reclassification of contracts from equity to assets or liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be allocated on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest grants receiving the first allocation of shares. Pursuant to ASC 815, issuances of securities to the Company’s employees and directors, or to compensate grantees in a share-based payment arrangement, are not subject to the sequencing policy. | |
Net Loss Per Share | Net Loss per Share The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common stock outstanding during the period. Net loss attributable to common stockholders consists of net loss, adjusted for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock (see Note 10 - Stockholders Equity (Deficiency) Series C Convertible Preferred Stock The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of September 30, 2020 and 2019: September 30, 2020 2019 Shares of common stock issuable upon exercise of warrants 1,360,883 174,679 Shares of common stock issuable upon exercise of options 212,622 60,680 Potentially dilutive common stock equivalents excluded from diluted net loss per share 1,573,505 235,359 | Net Loss per Share The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common stock outstanding during the period. Net loss income attributable to common stockholders consists of net loss, adjusted for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock. Basic and diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and options, plus the conversion of preferred stock or convertible notes, in the calculation of diluted net loss per common shares would have been anti-dilutive. The following table summarizes net loss attributable to common stockholders used in the calculation of basic and diluted loss per common share: For the Years Ended December 31, 2019 2018 Net loss $ (7,625,397 ) $ (13,042,709 ) Deemed dividend to Series A and B preferred stockholders - (3,310,001 ) Net loss attributable to common stockholders $ (7,625,397 ) $ (16,352,710 ) The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of December 31, 2019 and 2018: December 31, 2019 2018 Shares of common stock issuable upon exercise of warrants 174,679 151,223 Shares of common stock issuable upon exercise of options and restricted stock units 107,495 115,331 Potentially dilutive common stock equivalents excluded from diluted net loss per share 282,174 266,554 |
Revenue Recognition | Revenue Recognition In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-08, “Revenue from Contracts with Customers - Principal versus Agent Considerations”, in April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606) - Identifying Performance Obligations and Licensing” and in May 9, 2016, the FASB issued ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606)”, or ASU 2016-12. This update provides clarifying guidance regarding the application of ASU No. 2014-09 - Revenue From Contracts with Customers which is not yet effective. These new standards provide for a single, principles-based model for revenue recognition that replaces the existing revenue recognition guidance. In July 2015, the FASB deferred the effective date of ASU 2014-09 until annual and interim periods beginning on or after December 15, 2017. It has replaced most existing revenue recognition guidance under U.S. GAAP. The ASU may be applied retrospectively to historical periods presented or as a cumulative-effect adjustment as of the date of adoption. The Company adopted Topic 606 using a modified retrospective approach and was applied prospectively in the Company’s financial statements from January 1, 2018 forward. Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time”, depending on the facts and circumstances of the arrangement, and are evaluated using a five-step model. The adoption of Topic 606 did not have a material impact on the Company’s financial statements, at initial implementation nor will it have a material impact on an ongoing basis. The Company recognizes revenue when goods or services are transferred to customers in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. In determining when and how revenue is recognized from contracts with customers, the Company performs the following five-step analysis: (i) identification of contract with customer; (ii) determination of performance obligations; (iii) measurement of the transaction price; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The following table summarizes the Company’s revenue recognized in the accompanying statements of operations: For the Years Ended December 31, 2019 2018 Royalty income 31,243 116,152 Contract research - related party - 70,400 Total Revenues $ 31,243 $ 186,552 Revenue from sales of products is recognized at the point where the customer obtains control of the goods and the Company satisfies its performance obligation, which generally is at the time the product is shipped to the customer. Royalty revenue, which is based on resales of ProCol Vascular Bioprosthesis to third-parties, will be recorded when the third-party sale occurs and the performance obligation has been satisfied. Contract research and development revenue is recognized over time using an input model, based on labor hours incurred to perform the research services, since labor hours incurred over time is thought to best reflect the transfer of service. Information on Remaining Performance Obligations and Revenue Recognized from Past Performance Information about remaining performance obligations pertaining to contracts that have an original expected duration of one year or less is not disclosed. The transaction price allocated to remaining unsatisfied or partially unsatisfied performance obligations with an original expected duration exceeding one year was not material at December 31, 2019. Contract Balances The timing of our revenue recognition may differ from the timing of payment by our customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, deferred revenue is recorded until the performance obligations are satisfied. The Company had deferred revenue of $33,000 and $33,000 as of December 31, 2019 and 2018, respectively, related to cash received in advance for contract research and development services. | |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and recognized over the period services are required to be provided in exchange for the award, usually the vesting period. Forfeitures of unvested stock options are recorded when they occur. | Stock-Based Compensation The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and recognized over the period services are required to be provided in exchange for the award, usually the vesting period. Forfeitures of unvested stock options are recorded when they occur. |
Concentrations | Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $5,379,003 and $1,867,286 as of September 30, 2020 and December 31, 2019, respectively. The Company periodically evaluates the financial stability of the financial institutions with whom it maintains its cash balances. As of September 30, 2020, and as of the date of filing this report, the Company is not aware of any circumstances which would indicate they are not financially sound. For the nine months ended September 30, 2019, all of the Company’s revenues were from royalties as a result of the three-year Post-Acquisition Supply Agreement with LeMaitre Vascular, Inc. that was effective from March 18, 2016 to March 18, 2019. The Company did not have any similar revenue in the nine months ended September 30, 2020. | Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $1,867,286 and $2,490,645 as of December 31, 2019 and 2018, respectively. During the year ended December 31, 2019, 100% of the Company’s revenues were from royalties earned from the sale of product by LeMaitre. The three-year Post-Acquisition Supply Agreement from which the Company earned royalty from the sale of product by LeMaitre ended on March 18, 2019. During the year ended December 31, 2018, 62% of the Company’s revenues were from royalties earned from the sale of product by LeMaitre and 38% were from contract research revenue related to research and development services performed pursuant to the HJLA Agreement. |
Subsequent Events | Subsequent Events The Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued. Based upon the evaluation and transactions, the Company did not identify any other subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed in Note 11 - Subsequent Events. | Subsequent Events The Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued. Based upon the evaluation and transactions, the Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed in Note 14 to the Financial Statements - Subsequent Events. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the FASB issued ASU No. 2019-12,Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects of the income tax accounting guidance, including requirements such as tax basis step-up in goodwill obtained in a transaction that is not a business combination, ownership changes in investments, and interim-period accounting for enacted changes in tax law. ASU 2019-12 is effective for public business entities for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years, and early adoption is permitted. We are currently evaluating the impact that this guidance will have on our condensed financial statements. | Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“ASU 2016-02”). ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018. As a result of the new standard, all of our leases greater than one year in duration will be recognized in our Balance Sheets as both operating lease liabilities and right-of-use assets upon adoption of the standard. We adopted the standard using the prospective approach. Upon adoption on January 1, 2019, we recorded approximately $1.1 million in right-of-use assets and operating lease liabilities in our Balance Sheets. In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Schedule of Fair Value of Level 3 Derivative Liabilities on Fair Value of Recurring Basic | The following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair value on a recurring basis: Derivative Liabilities Balance – January 1, 2020 $ - Derivative liabilities associated with the issuance of common stock warrants 513,534 Derivative liabilities associated with the issuance of placement agent warrants 32,502 Change in fair value of derivative liabilities (346,129 ) Balance – March 31,2020 199,907 Change in fair value of derivative liabilities 81,276 Balance June 30, 2020 281,183 Change in fair value of derivative liabilities 53,046 Reclassification of warrant derivatives to equity (334,229 ) Balance – September 30, 2020 $ - | |
Summary of Potentially Dilutive Common Stock Equivalents | The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of September 30, 2020 and 2019: September 30, 2020 2019 Shares of common stock issuable upon exercise of warrants 1,360,883 174,679 Shares of common stock issuable upon exercise of options 212,622 60,680 Potentially dilutive common stock equivalents excluded from diluted net loss per share 1,573,505 235,359 | The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of December 31, 2019 and 2018: December 31, 2019 2018 Shares of common stock issuable upon exercise of warrants 4,366,960 3,780,571 Shares of common stock issuable upon exercise of options and restricted stock units 2,687,367 2,883,256 Potentially dilutive common stock equivalents excluded from diluted net loss per share 7,054,327 6,663,827 |
Schedule of Basic and Diluted Loss Per Common Share | The following table summarizes net loss attributable to common stockholders used in the calculation of basic and diluted loss per common share: For the Years Ended December 31, 2019 2018 Net loss $ (7,625,397 ) $ (13,042,709 ) Deemed dividend to Series A and B preferred stockholders - (3,310,001 ) Net loss attributable to common stockholders $ (7,625,397 ) $ (16,352,710 ) | |
Schedule of Revenue Recognized | The following table summarizes the Company’s revenue recognized in the accompanying statements of operations: For the Years Ended December 31, 2019 2018 Royalty income 31,243 116,152 Contract research - related party - 70,400 Total Revenues $ 31,243 $ 186,552 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheet as of September 30, 2019 and that sum to the total of the same amounts shown in the statement of cash flows for the nine months ending September 30, 2019 with the comparative cash balance without restricted cash as of September 30, 2020. As of September 30, 2020 2019 Cash and cash equivalents $ 5,629,003 $ 2,943,409 Restricted cash - 810,055 Total cash, cash equivalents, and restricted cash in the balance sheets $ 5,629,003 $ 3,753,464 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Schedule of Property and Equipment | As of September 30, 2020 and December 31, 2019, property and equipment consist of the following: September 30, December 31, 2020 2019 Laboratory equipment $ 332,126 $ 214,838 Furniture and fixtures 93,417 93,417 Computer software and equipment 61,771 50,403 Leasehold improvements 158,092 158,092 Construction Work in Progress – Software 244,479 220,384 889,885 737,134 Less: accumulated depreciation (464,359 ) (393,107 ) Property and equipment, net $ 425,526 $ 344,027 | As of December 31, 2019 and 2018, property and equipment consist of the following: December 31, 2019 2018 Laboratory equipment $ 214,838 $ 94,905 Furniture and fixtures 93,417 93,417 Computer equipment 50,403 26,830 Leasehold improvements 158,092 158,092 Software 220,384 - Total property and equipment 737,134 373,244 Less: accumulated depreciation (393,107 ) (347,091 ) Property and equipment, net $ 344,027 $ 26,153 |
Right-of-Use Assets and Lease_2
Right-of-Use Assets and Lease Liability (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Schedule of Operating Lease Cost | Our operating lease cost is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2020 Operating lease cost $ 85,492 $ 256,475 | Our operating lease cost is as follows: For the Year Ended December 31, 2019 Operating lease cost $ 341,966 |
Schedule of Supplemental Cash Flow Information Related to Operating Lease | Supplemental cash flow information related to our operating lease is as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2020 Operating Cash Flow Information: Cash paid for amounts in the measurement of lease liabilities $ 85,416 $ 256,248 | Supplemental cash flow information related to our operating lease is as follows: For the Year Ended December 31, 2019 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 334,203 |
Schedule of Operating Remaining Lease Term and Discount Rate | Remaining lease term and discount rate for our operating lease is as follows: September 30, 2020 Remaining lease term 2 years Discount rate 8.5 % | Remaining lease term and discount rate for our operating lease is as follows: December 31, 2019 Remaining lease term 2.7 years Discount rate 8.5 % |
Schedule of Maturity of Lease Liability | Maturity of our lease liabilities by fiscal year for our operating lease is as follows: Three months ended December 31, 2020 $ 87,981 Year ended December 31, 2021 354,561 Year Ended December 31, 2022 271,854 Total $ 714,396 Less: Imputed Interest (74,277 ) Present value of our lease liability $ 640,119 | Maturity of our lease liabilities by fiscal year for our operating lease is as follows: Year ended December 31, 2020 344,229 Year ended December 31, 2021 354,561 Year ended December 31, 2022 271,854 Total $ 970,644 Less: Imputed interest (114,011 ) Present value of our lease liability $ 856,633 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | As of December 31, 2019 and 2018, the Company’s intangible asset consisted of the following: December 31, 2019 2018 Patent $ - $ 1,100,000 Less: accumulated amortization - (433,533 ) Total $ - $ 666,467 |
Accrued Expenses and Accrued _2
Accrued Expenses and Accrued Interest (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Payables and Accruals [Abstract] | ||
Schedule of Accrued Expenses | As of September 30, 2020, and December 31, 2019, accrued expenses consist of the following: September 30, December 31, 2020 2019 Accrued compensation costs $ 233,428 $ 151,858 Accrued professional fees 23,000 141,310 Accrued franchise taxes 25,607 30,270 Accrued research and development 5,637 - Other accrued expenses - 10,000 Accrued expenses $ 287,672 $ 333,438 | As of December 31, 2019 and 2018, accrued expenses consist of the following: December 31, 2019 2018 Accrued compensation costs $ 151,858 $ 288,549 Accrued professional fees 141,310 55,300 Deferred rent - 22,473 Accrued franchise taxes 30,270 26,985 Accrued research and development - 17,064 Other accrued expenses 10,000 2,500 Accrued expenses $ 333,438 $ 412,871 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Provision (Benefit) | The following summarizes the Company’s income tax provision (benefit): For the Years Ended December 31, 2019 2018 Federal: Current $ - $ - Deferred (1,449,778 ) (1,710,997 ) State and local: Current - - Deferred (483,259 ) (570,332 ) (1,933,037 ) (2,281,329 ) Change in valuation allowance 1,933,037 2,281,329 Income tax provision (benefit) $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between the U.S. statutory federal income tax rate and the Company’s effective tax rate for the year’s ended December 31, 2019 and 2018 is as follows: For the Years Ended December 31, 2019 2018 Tax benefit at federal statutory rate (21.0 )% (21.0 )% State taxes, net of federal benefit (7.0 )% (7.0 )% Permanent differences 0.5 % 11.4 % True up adjustments 2.1 % (0.9 )% Change in valuation allowance 25.4 % 17.5 % Effective income tax rate 0.0 % 0.0 % |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets at December 31, 2019 and 2018 are as follows: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 7,329,760 $ 5,298,599 Research and development credit carryforwards 185,680 185,680 Intangible assets 309,865 152,109 Operating lease liability 239,857 - Property and equipment - 30,957 Stock-based compensation 329,136 526,945 Deferred rent - 6,292 Impairment loss 136,612 136,612 Total gross deferred tax assets 8,530,910 6,337,194 Deferred tax liabilities Operating lease asset (231,391 ) - Property and equipment (29,289 ) - Total net deferred tax assets 8,270,230 6,337,194 Less: valuation allowance (8,270,230 ) (6,337,194 ) Total $ - $ - |
Stockholders' Equity (Deficie_2
Stockholders' Equity (Deficiency) (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Schedule of Assumption Used for Valuation of Derivative Liability | The following inputs and assumptions were used for the valuation of the derivative liability: February 25, March 31, June 30, September 15, Stock Price $ 17.50 $ 7.38 $ 9.65 $ 10.87 Projected Volatility 97.1 % 102.7 % 102.7 % 110.7 % Risk-Free Rate 1.36 % 0.38 % 0.29 % 0.31 % |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Schedule of Stock Warrant Activity | A summary of warrant activity during the years ended December 31, 2019 and 2018 is presented below: Series A Preferred Stock Common Stock Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Outstanding, 100,570 $ 5.00 14,849 300.00 Issued 131,698 152.25 Exercised Cancelled - - - - Amendment of placement agent warrants [1] (100,570 ) 5.00 4,677 107.50 Outstanding, - $ - - $ - 151,224 $ 137.00 4.1 $ - Issued - - - 24,156 65.00 Exercised - - - - - Cancelled - - - (700 ) 39.75 Outstanding, - $ - - $ - 174,680 $ 127.50 3.3 $ - Exercisable, - $ - - $ - 173,979 $ 127.75 3.3 $ - [1] In connection with the IPO, placement agent warrants for the purchase of Series A Preferred Stock were amended such that the warrants became exercisable for the number of common stock that would have been issued upon the exercise of the Series A warrant and subsequent conversion to common stock upon the consummation of the IPO. The exercise price was amended to the price equal to the total proceeds that would have been required upon the exercise of the original warrant, divided by the amended number of warrant shares. The amendment was accounted for as a modification of a stock award. The Company determined that there was no incremental increase in the fair value for the amendment of the award and accordingly there was no charge to the statement of operations for the years ended December 31, 2018. |
Schedule of Outstanding and Exercisable Warrants | A summary of outstanding and exercisable warrants as of December 31, 2019 is presented below: Warrants Outstanding Warrants Exercisable Exercise Price Exercisable Into Outstanding Number of Warrants Weighted Average Remaining Life in Years Exercisable Number of Warrants $ 300.00 Common Stock 7,359 3.5 7,359 $ 156.25 Common Stock 3,000 3.4 3,000 $ 150.00 Common Stock 75,000 3.5 75,000 $ 124.75 Common Stock 4,000 3.5 4,000 $ 115.50 Common Stock 5,536 2.9 5,536 $ 107.50 Common Stock 4,677 1.1 4,677 $ 105.00 Common Stock 57,652 2.8 57,652 $ 50.00 Common Stock 2,000 4.4 2,000 $ 39.75 Common Stock 700 4.0 - $ 37.50 Common Stock 7,525 4.2 7,525 $ 32.00 Common Stock 7,232 4.4 7,232 174,681 173,981 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | A summary of the option activity during the years ended December 31, 2019 and 2018 is presented below: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2018 56,880 $ 254.00 Granted 60,809 111.50 Forfeited (5,860 ) 250.00 Outstanding, December 31, 2018 111,829 $ 176.75 9.0 $ - Granted 28,600 47.00 Forfeited (40,740 ) 210.50 Outstanding, December 31, 2019 99,689 $ 111.00 8.6 $ - Exercisable, December 31, 2019 68,101 $ 132.00 8.5 $ - |
Schedule of Outstanding and Exercisable Options | A summary of outstanding and exercisable options and Restricted Stock units as of December 31, 2019 is presented below: Options Outstanding Options Exercisable Exercise Price Exercisable Into Outstanding Number of Options Weighted Average Remaining Life In Years Exercisable Number of Options $ 300.00 Common Stock 4,800 7.7 4,800 $ 250.00 Common Stock 5,860 6.8 5,860 $ 175.00 Common Stock 240 7.9 240 $ 124.75 Common Stock 43,209 8.7 38,888 $ 123.25 Common Stock 3,200 8.5 2,400 $ 74.50 Common Stock 6,000 8.5 2,500 $ 72.50 Common Stock 1,200 8.9 1,200 $ 64.25 Common Stock 5,200 8.9 2,000 $ 50.00 Common Stock 27,980 8.9 8,914 $ 39.75 Common Stock 1,200 9.1 1,000 $ 34.50 Common Stock 800 9.2 300 Total 99,689 68,101 |
Schedule of Outstanding and Exercisable Restricted Stock Units | Restricted Stock Units Exercisable Grant Date Exercisable Into Outstanding Number of Units Weighted Average Remaining Life In Years 11/27/2018 Common Stock 1,557 1.8 9/13/2019 Common Stock 6,250 2.7 Total 7,807 |
Business Organization and Nat_2
Business Organization and Nature of Operations (Details Narrative) | Sep. 30, 2020ft²shares | Sep. 15, 2020shares | Dec. 31, 2019ft²shares | Dec. 31, 2018shares |
Common stock, shares authorized | shares | 250,000,000 | 250,000,000 | 250,000,000 | 50,000,000 |
Irvine, California [Member] | ||||
Area of land leased | ft² | 14,507 | 14,507 |
Business Organization and Nat_3
Business Organization and Nature of Operations (Details Narrative) (10-K) - ft² | Sep. 30, 2020 | Dec. 31, 2019 |
Irvine, California [Member] | ||
Area of land leased | 14,507 | 14,507 |
Going Concern and Management'_2
Going Concern and Management's Liquidity Plan (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net loss | $ (1,974,769) | $ (1,626,956) | $ (1,159,758) | $ (1,814,895) | $ (1,946,023) | $ (1,573,726) | $ (4,761,483) | $ (5,334,644) | $ (7,625,397) | $ (13,042,709) | |
Accumulated deficit | (60,949,408) | (60,949,408) | (56,187,925) | (48,562,528) | |||||||
Net cash used in operating activities | (5,063,516) | $ (4,273,179) | (5,896,400) | $ (6,355,838) | |||||||
Cash balances | 5,629,003 | 5,629,003 | 1,307,231 | ||||||||
Working capital deficit | $ 4,062,232 | $ 4,062,232 | $ 452,434 | ||||||||
Forecast [Member] | |||||||||||
Aggregate net proceeds from sale of equity | $ 12,200,000 |
Going Concern and Management'_3
Going Concern and Management's Liquidity Plan (Details Narrative) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||
Net loss | $ 1,974,769 | $ 1,626,956 | $ 1,159,758 | $ 1,814,895 | $ 1,946,023 | $ 1,573,726 | $ 4,761,483 | $ 5,334,644 | $ 7,625,397 | $ 13,042,709 |
Accumulated deficit | 60,949,408 | 60,949,408 | 56,187,925 | 48,562,528 | ||||||
Net cash used in operating activities | 5,063,516 | $ 4,273,179 | 5,896,400 | $ 6,355,838 | ||||||
Cash balance | 5,629,003 | 5,629,003 | 1,307,231 | |||||||
Working capital deficiency | $ 4,062,232 | $ 4,062,232 | $ 452,434 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 25, 2020 | |
Change in fair value of derivative liabilities | $ 53,046 | $ (211,807) | $ (191,656) | ||||
Cumulative dividend on preferred stock | 8.00% | ||||||
FDIC insured amount | 250,000 | 250,000 | $ 250,000 | ||||
Uninsured cash balance | $ 5,379,003 | $ 5,379,003 | $ 1,867,286 | $ 2,490,645 | |||
Series C Convertible Preferred Stock [Member] | Securties Purchase Agreement [Member] | |||||||
Cumulative dividend on preferred stock | 8.00% | ||||||
Private Placement Offering [Member] | |||||||
Warrants to purchase common stock | 57,200 |
Significant Accounting Polici_5
Significant Accounting Policies (Details Narrative) (10-K) - USD ($) | Jun. 04, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 02, 2019 |
Change in fair value of derivative liabilities | $ 53,046 | $ (211,807) | $ (191,656) | |||||
Cumulative dividend percentage | 8.00% | |||||||
Deferred revenue related to contract | 33,000 | 33,000 | $ 33,000 | 33,000 | ||||
FDIC insured amount | 250,000 | 250,000 | 250,000 | |||||
Uninsured cash balance | 5,379,003 | 5,379,003 | 1,867,286 | 2,490,645 | ||||
Right of usee assets and operating lease liabilities | $ 609,656 | $ 609,656 | $ 826,397 | |||||
ASC Topic 842 [Member] | ||||||||
Right of usee assets and operating lease liabilities | $ 1,099,400 | |||||||
Revenue [Member] | LeMaitre Vascular, Inc [Member] | ||||||||
Concentration risk percentage | 100.00% | 62.00% | ||||||
Revenue [Member] | Hancock Jaffe Laboratory Aesthetics, Inc [Member] | ||||||||
Concentration risk percentage | 38.00% | |||||||
Public Offering [Member] | ||||||||
Fair value of derivative liabilities reclassified to additional paid in capital | $ 3,594,002 | |||||||
Minimum [Member] | ||||||||
Estimated useful life of property and equipment | 5 years | |||||||
Maximum [Member] | ||||||||
Estimated useful life of property and equipment | 7 years | |||||||
Hancock Jaffe Laboratory Aesthetics, Inc [Member] | ||||||||
Ownership percentage | 28.00% | |||||||
Investments | $ 0 |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Fair Value of Level 3 Derivative Liabilities on Fair Value of Recurring Basic (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Balance - Beginning | $ 281,183 | $ 199,907 | ||||||
Change in fair value of derivative liabilities | 53,046 | $ (211,807) | $ (191,656) | |||||
Reclassification of Warrant Derivatives to Equity | 334,229 | (334,229) | ||||||
Balance - Ending | 281,183 | $ 199,907 | ||||||
Derivative Liabilities [Member] | ||||||||
Balance - Beginning | 281,183 | 199,907 | ||||||
Derivative liabilities associated with the issuance of common stock warrants | 513,534 | |||||||
Derivative liabilities associated with the issuance of placement agent warrants | 32,502 | |||||||
Change in fair value of derivative liabilities | 53,046 | 81,276 | (346,129) | |||||
Reclassification of Warrant Derivatives to Equity | (334,229) | |||||||
Balance - Ending | $ 281,183 | $ 199,907 |
Significant Accounting Polici_7
Significant Accounting Policies - Summary of Potentially Dilutive Common Stock Equivalents (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 1,573,505 | 235,359 | 282,174 | 266,554 |
Warrants [Member] | ||||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 1,360,883 | 174,679 | 174,679 | 151,223 |
Stock Option [Member] | ||||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 212,622 | 60,680 |
Significant Accounting Polici_8
Significant Accounting Policies - Summary of Potentially Dilutive Common Stock Equivalents (Details) (10-K) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 1,573,505 | 235,359 | 282,174 | 266,554 |
Warrants [Member] | ||||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 1,360,883 | 174,679 | 174,679 | 151,223 |
Options and Restricted Stock Units [Member] | ||||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 107,495 | 115,331 |
Significant Accounting Polici_9
Significant Accounting Policies - Schedule of Basic and Diluted Loss Per Common Share (Details) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||||||||||
Net loss | $ (1,974,769) | $ (1,626,956) | $ (1,159,758) | $ (1,814,895) | $ (1,946,023) | $ (1,573,726) | $ (4,761,483) | $ (5,334,644) | $ (7,625,397) | $ (13,042,709) |
Deemed dividend to Series A and B preferred stockholders | (23,859) | (23,859) | (3,310,001) | |||||||
Net loss attributable to common stockholders | $ (1,998,628) | $ (1,814,895) | $ (4,785,342) | $ (5,334,644) | $ (7,625,397) | $ (16,352,710) |
Significant Accounting Polic_10
Significant Accounting Policies - Schedule of Revenue Recognized (Details) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total Revenues | $ 31,243 | $ 31,243 | $ 186,552 | |||
Royalty Income [Member] | ||||||
Total Revenues | $ 31,243 | 31,243 | 116,152 | |||
Contract Research - Related Party [Member] | ||||||
Total Revenues | $ 70,400 |
Restricted Cash (Details Narrat
Restricted Cash (Details Narrative) | Sep. 30, 2020USD ($) |
Cash and Cash Equivalents [Abstract] | |
Restricted cash |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 5,629,003 | $ 1,307,231 | $ 2,943,409 | $ 2,740,645 |
Restricted cash | $ 810,055 | 810,055 | ||
Total cash, cash equivalents, and restricted cash in the balance sheets | $ 5,629,003 | $ 3,753,464 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 66,857 | $ 26,828 | $ 46,017 | $ 10,112 |
Property and Equipment (Detai_2
Property and Equipment (Details Narrative) (10-K) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 66,857 | $ 26,828 | $ 46,017 | $ 10,112 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Total property and equipment | $ 889,885 | $ 737,134 | $ 373,244 |
Less: accumulated depreciation | (464,359) | (393,107) | (347,091) |
Property and equipment, net | 425,526 | 344,027 | 26,153 |
Laboratory Equipment [Member] | |||
Total property and equipment | 332,126 | 214,838 | 94,905 |
Furniture and Fixtures [Member] | |||
Total property and equipment | 93,417 | 93,417 | 93,417 |
Computer Software and Equipment [Member] | |||
Total property and equipment | 61,771 | 50,403 | 26,830 |
Leasehold Improvements [Member] | |||
Total property and equipment | 158,092 | 158,092 | $ 158,092 |
Construction Work in Progress - Software [Member] | |||
Total property and equipment | $ 244,479 | $ 220,384 |
Property and Equipment - Sche_2
Property and Equipment - Schedule of Property and Equipment (Details) (10-K) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Total property and equipment | $ 889,885 | $ 737,134 | $ 373,244 |
Less: accumulated depreciation | (464,359) | (393,107) | (347,091) |
Property and equipment, net | 425,526 | 344,027 | 26,153 |
Laboratory Equipment [Member] | |||
Total property and equipment | 332,126 | 214,838 | 94,905 |
Furniture and Fixtures [Member] | |||
Total property and equipment | 93,417 | 93,417 | 93,417 |
Computer Software and Equipment [Member] | |||
Total property and equipment | 61,771 | 50,403 | 26,830 |
Leasehold Improvements [Member] | |||
Total property and equipment | $ 158,092 | 158,092 | 158,092 |
Software [Member] | |||
Total property and equipment | $ 220,384 |
Right-of-Use Assets and Lease_3
Right-of-Use Assets and Lease Liability (Details Narrative) - USD ($) | Sep. 20, 2017 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Jan. 02, 2019 | Dec. 31, 2018 |
Operating lease term | 5 years | |||||
Operating lease renewal term | 60 months | |||||
Initial lease rate per month | $ 26,838 | $ 85,416 | $ 256,248 | $ 334,203 | ||
Operating expenses for building repairs and maintenance per month | $ 7,254 | |||||
Financing leases term description | The Company has no other operating or financing leases with terms greater than 12 months. | |||||
Right-of-use assets | 609,656 | 609,656 | 826,397 | |||
Lease liabilities | $ 640,119 | $ 640,119 | $ 856,633 | |||
Incremental borrowing rate used to determine lease liability | 8.50% | 8.50% | 8.50% | |||
ASC Topic 842 [Member] | ||||||
Right-of-use assets | $ 1,099,400 | |||||
Lease liabilities | 1,121,873 | |||||
Deferred rent | $ 22,473 | |||||
Incremental borrowing rate used to determine lease liability | 8.50% |
Right-of-Use Assets and Lease_4
Right-of-Use Assets and Lease Liabilities (Details Narrative) (10-K) - USD ($) | Sep. 20, 2017 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Jan. 02, 2019 | Dec. 31, 2018 |
Operating lease term | 5 years | |||||
Operating lease renewal term | 60 months | |||||
Initial lease rate per month | $ 26,838 | $ 85,416 | $ 256,248 | $ 334,203 | ||
Operating expenses for building repairs and maintenance per month | $ 7,254 | |||||
Financing leases term description | The Company has no other operating or financing leases with terms greater than 12 months. | |||||
Right-of-use assets | 609,656 | 609,656 | 826,397 | |||
Lease liabilities | $ 640,119 | $ 640,119 | $ 856,633 | |||
Incremental borrowing rate used to determine lease liability | 8.50% | 8.50% | 8.50% | |||
ASC Topic 842 [Member] | ||||||
Right-of-use assets | $ 1,099,400 | |||||
Lease liabilities | 1,121,873 | |||||
Deferred rent | $ 22,473 | |||||
Incremental borrowing rate used to determine lease liability | 8.50% |
Right-of-Use Assets and Lease_5
Right-of-Use Assets and Lease Liability - Schedule of Operating Lease Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease cost | $ 85,492 | $ 256,475 | $ 341,966 |
Right-of-Use Assets and Lease_6
Right-of-Use Assets and Lease Liabilities - Schedule of Operating Lease Cost (Details) (10-K) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease cost | $ 85,492 | $ 256,475 | $ 341,966 |
Right-of-Use Assets and Lease_7
Right-of-Use Assets and Lease Liability - Schedule of Supplemental Cash Flow Information Related to Operating Lease (Details) - USD ($) | Sep. 20, 2017 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||||
Cash paid for amounts in the measurement of lease liabilities | $ 26,838 | $ 85,416 | $ 256,248 | $ 334,203 |
Right-of-Use Assets and Lease_8
Right-of-Use Assets and Lease Liabilities - Schedule of Supplemental Cash Flow Information Related to Operating Lease (Details) (10-K) - USD ($) | Sep. 20, 2017 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||||
Cash paid for amounts included in the measurement of lease liabilities | $ 26,838 | $ 85,416 | $ 256,248 | $ 334,203 |
Right-of-Use Assets and Lease_9
Right-of-Use Assets and Lease Liability - Schedule of Operating Remaining Lease Term and Discount Rate (Details) | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Remaining lease term | 2 years | 2 years 8 months 12 days |
Discount rate | 8.50% | 8.50% |
Right-of-Use Assets and Leas_10
Right-of-Use Assets and Lease Liabilities - Schedule of Operating Remaining Lease Term and Discount Rate (Details) (10-K) | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Remaining lease term | 2 years | 2 years 8 months 12 days |
Discount rate | 8.50% | 8.50% |
Right-of-Use Assets and Leas_11
Right-of-Use Assets and Lease Liability - Schedule of Maturity of Lease Liability (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Three months ended December 31, 2020 | $ 87,981 | |
Year ended December 31, 2021 | 354,561 | $ 344,229 |
Year ended December 31, 2022 | 271,854 | 354,561 |
Total | 714,396 | 970,644 |
Less: Imputed Interest | (74,277) | (114,011) |
Present value of our lease liability | $ 640,119 | $ 856,633 |
Right-of-Use Assets and Leas_12
Right-of-Use Assets and Lease Liabilities - Schedule of Maturity of Lease Liability (Details) (10-K) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
Year ended December 31, 2020 | $ 354,561 | $ 344,229 |
Year ended December 31, 2021 | 271,854 | 354,561 |
Year ended December 31, 2022 | 271,854 | |
Total | 714,396 | 970,644 |
Less: Imputed interest | (74,277) | (114,011) |
Present value of our lease liability | $ 640,119 | $ 856,633 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) (10-K) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Impairment loss | $ 588,822 | |
Amortization expense | $ 77,643 | $ 111,893 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) (10-K) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Less: accumulated amortization | $ (433,533) | |
Total | 666,467 | |
Patents [Member] | ||
Intangible assets | $ 1,100,000 |
Accrued Expenses (Details Narra
Accrued Expenses (Details Narrative) (10-K) | Dec. 31, 2018USD ($) |
Chief Financial Officer [Member] | |
Accrued severance expense | $ 166,154 |
Accrued Expenses and Accrued _3
Accrued Expenses and Accrued Interest - Schedule of Accrued Expenses (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | |||
Accrued compensation costs | $ 233,428 | $ 151,858 | $ 288,549 |
Accrued professional fees | 23,000 | 141,310 | 55,300 |
Accrued franchise taxes | 25,607 | 30,270 | 26,985 |
Accrued research and development | 5,637 | ||
Other accrued expenses | 10,000 | 2,500 | |
Accrued expenses | $ 287,672 | $ 333,438 | $ 412,871 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) (10-K) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | |||
Accrued compensation costs | $ 233,428 | $ 151,858 | $ 288,549 |
Accrued professional fees | 23,000 | 141,310 | 55,300 |
Deferred rent | 22,473 | ||
Accrued franchise taxes | 25,607 | 30,270 | 26,985 |
Accrued research and development | 17,064 | ||
Other accrued expenses | 10,000 | 2,500 | |
Accrued expenses | $ 287,672 | $ 333,438 | $ 412,871 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) (10-K) - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 02, 2018 | Nov. 27, 2018 | |
Ownership interest | 50.00% | 25.00% | 25.00% | |
Net operating loss carryforwards | $ 26,100,000 | $ 17,400,000 | ||
Net operating loss carryforwards, expiration | Pre-2018 federal NOLs of $12.0 million carryovers may be carried forward for twenty years and begin to expire in 2029. | |||
Deduction percentage of taxable income | 80.00% | |||
Rresearch and development tax credit carryforwards | $ 200,000 | |||
Rresearch and development tax credit carryforwards, expiration | Expire in 2027 | |||
Pre-2018 Federal [Member] | ||||
Net operating loss carryforwards | $ 12,000,000 | |||
Post-2017 Federal [Member] | ||||
Net operating loss carryforwards | $ 14,100,000 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Provision (Benefit) (Details) (10-K) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal: Current | ||
Federal: Deferred | (1,449,778) | (1,710,997) |
State and local: Current | ||
State and local: Deferred | (483,259) | (570,332) |
Current and Deferred Federal, State and Local, Tax Expense (Benefit) | (1,933,037) | (2,281,329) |
Change in valuation allowance | 1,933,037 | 2,281,329 |
Income tax provision (benefit) |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) (10-K) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Tax benefit at federal statutory rate | (21.00%) | (21.00%) |
State taxes, net of federal benefit | (7.00%) | (7.00%) |
Permanent differences | 0.50% | 11.40% |
True up adjustments | 2.10% | (0.90%) |
Change in valuation allowance | 25.40% | 17.50% |
Effective income tax rate | 0.00% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) (10-K) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 7,329,760 | $ 5,298,599 |
Research and development credit carryforwards | 185,680 | 185,680 |
Intangible assets | 309,865 | 152,109 |
Operating lease liability | 239,857 | |
Property and equipment | 30,957 | |
Stock-based compensation | 329,136 | 526,945 |
Deferred rent | 6,292 | |
Impairment loss | 136,612 | 136,612 |
Total gross deferred tax assets | 8,530,910 | 6,337,194 |
Operating lease asset | (231,391) | |
Property and equipment | (29,289) | |
Total net deferred tax assets | 8,270,230 | 6,337,194 |
Less: valuation allowance | (8,270,230) | (6,337,194) |
Total |
Note Payable (Details Narrative
Note Payable (Details Narrative) - USD ($) | Apr. 12, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Note payable | $ 312,700 | |||
Paycheck Protection Program [Member] | ||||
Proceeds from loan | $ 312,700 | |||
Debt, instrument maturity date | Apr. 12, 2022 | |||
Debt instrument, interest rate | 1.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Oct. 08, 2019 | Sep. 21, 2019 | Mar. 26, 2019 | Jan. 18, 2019 | Oct. 08, 2018 | Sep. 21, 2018 |
ATSCO, Inc [Member] | ||||||
Payment on legal cost | $ 809,520 | $ 810,055 | $ 809,520 | |||
Litigation settlement amount | $ 810,055 | |||||
Seeking payment | $ 1,606,820 | |||||
Gusrae Kaplan Nusbaum PLLC [Member] | ||||||
Seeking payment | $ 178,926 | $ 178,926 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) (10-K) - USD ($) | Oct. 08, 2019 | Sep. 21, 2019 | Jul. 26, 2019 | May 31, 2019 | Mar. 26, 2019 | Jan. 18, 2019 | Jan. 18, 2019 | Dec. 02, 2018 | Nov. 27, 2018 | Oct. 08, 2018 | Sep. 21, 2018 | Jun. 04, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | May 30, 2018 | ||
Number of common stock shares issued | 81 | 134 | 60,000 | |||||||||||||||||
Proceeds from convertible notes | [1] | $ 2,603,750 | [1] | |||||||||||||||||
Warrants exercise price | $ 150 | |||||||||||||||||||
Common stock par value | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||||||||
New Employment Agreement [Member] | ||||||||||||||||||||
Annual base salary | $ 350,000 | |||||||||||||||||||
New Employment Agreement [Member] | Existing Options [Member] | ||||||||||||||||||||
Number of common stock shares issued | 7,380 | |||||||||||||||||||
Common stock par value | $ 0.00001 | |||||||||||||||||||
Agreement description | In connection with entering into the New Employment Agreement, Dr. Glickman's existing seven thousand three hundred and eighty (7,380) options ("Existing Options") to purchase Company common stock, $0.00001 par value per share (the "Common Stock") at ten dollars ($250.00) per share until October 1, 2026, were repriced to two dollars ($50.00) per share. | |||||||||||||||||||
New Employment Agreement [Member] | New Options [Member] | ||||||||||||||||||||
Number of common stock shares issued | 7,200 | |||||||||||||||||||
Agreement description | In connection to the New Employment Agreement shall be granted stock options ("New Options") for the right to purchase seven thousand two hundred (7,200) Common Stock at a price equal to two dollars ($50.00) per share exercisable until July 26, 2029, which shall vest quarterly over a three (3) year period, and shall be granted in accordance with the Hancock Jaffe 2016 Omnibus Incentive Plan (the "Option Plan"), and shall be subject to such other terms and conditions as are set forth in the Option Plan and the option agreement issued pursuant to the Option Plan. | |||||||||||||||||||
Modification and excess fair value options vested | $ 20,295 | |||||||||||||||||||
Agreement term | 3 years | |||||||||||||||||||
Fair value of option grants | $ 28,800 | |||||||||||||||||||
Allen Boxer and Donna Mason [Member] | ||||||||||||||||||||
Proceeds from convertible notes | $ 5,600,000 | $ 5,600,000 | ||||||||||||||||||
Number of restricted shares of common stock | 6,280 | |||||||||||||||||||
Warrants term | 5 years | |||||||||||||||||||
Warrants to purchase of common stock | 6,000 | |||||||||||||||||||
Warrants exercise price | $ 150 | |||||||||||||||||||
Hancock Jaffe Laboratory Aesthetics, Inc [Member] | ||||||||||||||||||||
Ownership percentage | 28.00% | |||||||||||||||||||
ATSCO, Inc [Member] | ||||||||||||||||||||
Payment on legal cost | $ 809,520 | $ 810,055 | $ 809,520 | |||||||||||||||||
Payment for legal settlements | 188,000 | |||||||||||||||||||
Product liability contingency unasserted claims | $ 500,000 | |||||||||||||||||||
Number of common stock shares issued | 4,800 | |||||||||||||||||||
Litigation interest and legal costs seeking payment | $ 1,606,820 | |||||||||||||||||||
ATSCO, Inc [Member] | Hancock Jaffe Laboratory Aesthetics, Inc [Member] | ||||||||||||||||||||
Number of common stock shares issued | 188,000 | |||||||||||||||||||
Ownership percentage | 28.00% | 28.00% | ||||||||||||||||||
Gusrae Kaplan Nusbaum PLLC [Member] | ||||||||||||||||||||
Litigation interest and legal costs seeking payment | $ 178,926 | $ 178,926 | ||||||||||||||||||
[1] | Net of cash offering costs of $293,750. |
Stockholders' Equity (Deficie_3
Stockholders' Equity (Deficiency) (Details Narrative) | Jul. 21, 2020USD ($)$ / sharesshares | Jul. 18, 2020$ / sharesshares | Jul. 17, 2020$ / sharesshares | Jun. 01, 2020USD ($)$ / sharesshares | Apr. 24, 2020USD ($)$ / sharesshares | Feb. 25, 2020USD ($)$ / sharesshares | Sep. 13, 2019USD ($)$ / sharesshares | Sep. 13, 2019USD ($)$ / sharesshares | Jun. 11, 2019shares | Feb. 07, 2019USD ($)shares | Jan. 03, 2019USD ($)$ / sharesshares | Dec. 02, 2018shares | Nov. 27, 2018shares | Jun. 04, 2018shares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 15, 2020USD ($)shares | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | May 30, 2018$ / shares | |||||
Common stock, shares authorized | 250,000,000 | 250,000,000 | 250,000,000 | 50,000,000 | 250,000,000 | ||||||||||||||||||||||||
Common stock voting rights | Approved an amendment to the A&R Certificate of Incorporation to reduce the vote required to amend, repeal, or adopt any provisions of the A&R Certificate of Incorporation from the approval of 66 2/3% of the voting power of the shares of the then outstanding voting stock of the Company entitled to vote to a majority of such shares; and (iii) approved a reverse stock split of the Company's common stock at a ratio of between one-for-five and one-for-twenty-five, with such ratio to be determined at the sole discretion of the Company's Board of Directors (the "Board") and with such reverse stock split to be effected at such time and date, if at all, as determined by the Board in its sole discretion. | ||||||||||||||||||||||||||||
Gross proceeds raised in private placement offering | $ | $ 1,358,102 | [1] | [1] | $ 2,317,276 | [2] | [2] | |||||||||||||||||||||||
Number of common stock shares issued | 81 | 134 | 60,000 | ||||||||||||||||||||||||||
Warrants to purchase common stock | 5,200 | 5,200 | |||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 150 | ||||||||||||||||||||||||||||
Common stock par value | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||||||||||||||||
Net proceeds from warrant exercises after deducting underwrites and placement agents fees and expenses | $ | $ 3,882,000 | $ 631,626 | $ 631,626 | ||||||||||||||||||||||||||
Percentage of non-compounding cumulative deemed dividends | 8.00% | ||||||||||||||||||||||||||||
Deemed dividend | $ | 23,859 | 23,859 | |||||||||||||||||||||||||||
Fair value adjustment | $ | 1,556,000 | ||||||||||||||||||||||||||||
Derivative liability | $ | $ 546,036 | $ 334,229 | $ 281,183 | $ 199,907 | |||||||||||||||||||||||||
Change in fair value of derivative liabilities | $ | $ 53,046 | $ (211,807) | (191,656) | ||||||||||||||||||||||||||
Derivative liability, description | If the Company was required to pay the fair value of the warrant in cash as of May 25, 2020, the obligation was discounted at the Company's estimated cost of debt based on short-term C-CCC bond ratings of 19.5% and 28.5%. The likelihood of the Company calling a shareholder meeting and achieving shareholder approval was 90% as of February 25, 2020. | ||||||||||||||||||||||||||||
Common stock issued for exercise of warrants | 72,748 | 72,748 | |||||||||||||||||||||||||||
Stock-based compensation | $ | $ 363,027 | 745,269 | $ 941,962 | $ 1,922,455 | |||||||||||||||||||||||||
Stock Option [Member] | |||||||||||||||||||||||||||||
Vesting period | 2 years 6 months | ||||||||||||||||||||||||||||
Stock-based compensation | $ | $ 194,421 | $ 159,865 | $ 363,027 | $ 329,454 | |||||||||||||||||||||||||
Unrecognized stock-based compensation | $ | $ 1,138,934 | $ 1,138,934 | |||||||||||||||||||||||||||
Independent Directors One [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 4,000 | ||||||||||||||||||||||||||||
Independent Directors Two [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 4,000 | ||||||||||||||||||||||||||||
Independent Directors Three [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 4,000 | ||||||||||||||||||||||||||||
Independent Directors Four [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 4,000 | ||||||||||||||||||||||||||||
Various Employees and Consultants [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 106,000 | ||||||||||||||||||||||||||||
Stock option, exercise price | $ / shares | $ 10 | ||||||||||||||||||||||||||||
Independent Directors [Member] | |||||||||||||||||||||||||||||
Stock option, exercise price | $ / shares | $ 10 | ||||||||||||||||||||||||||||
Stock Price [Member] | |||||||||||||||||||||||||||||
Warrants and rights outstanding measurement input | 11 | 11 | |||||||||||||||||||||||||||
Projected Volatility [Member] | |||||||||||||||||||||||||||||
Warrants and rights outstanding measurement input | 118.7 | 118.7 | |||||||||||||||||||||||||||
Measurement Input, Risk Free Interest Rate [Member] | |||||||||||||||||||||||||||||
Warrants and rights outstanding measurement input | 0.47 | 0.47 | |||||||||||||||||||||||||||
Measurement Input, Expected Dividend Rate [Member] | |||||||||||||||||||||||||||||
Warrants and rights outstanding measurement input | 0 | 0 | |||||||||||||||||||||||||||
Series C Convertible Preferred Stock [Member] | |||||||||||||||||||||||||||||
Net proceeds from warrant exercises after deducting underwrites and placement agents fees and expenses | $ | $ 1,556,000 | ||||||||||||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Robert Gray [Member] | |||||||||||||||||||||||||||||
Number of stock option grants | 3,125 | ||||||||||||||||||||||||||||
Restricted stock units granted to directors | 3,125 | ||||||||||||||||||||||||||||
Exercise price of options granted | $ / shares | $ 24 | $ 24 | |||||||||||||||||||||||||||
Options aggregate grant date fair value | $ | $ 150,000 | $ 150,000 | |||||||||||||||||||||||||||
Option vesting period, description | These units vest in equal annual portions on the anniversary of their grant. | These units vest in equal annual portions on the September 13, 2020, September 13, 2021 and September 13, 2022. | |||||||||||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||||||||||||
Number of common stock shares issued | [3] | 69,000 | |||||||||||||||||||||||||||
Number of unvested warrants, forfeited | (700) | ||||||||||||||||||||||||||||
Common stock issued for exercise of warrants | 72,748 | ||||||||||||||||||||||||||||
Restricted stock units granted to directors | 24,156 | 131,698 | |||||||||||||||||||||||||||
Warrants [Member] | |||||||||||||||||||||||||||||
Warrant term | 7 years | 7 years | |||||||||||||||||||||||||||
Fair value of warrants | $ | $ 2,431,250 | ||||||||||||||||||||||||||||
Fair value adjustment | $ | 948,781 | ||||||||||||||||||||||||||||
Warrants intrinstic | $ | $ 2,067,155 | $ 2,067,155 | |||||||||||||||||||||||||||
Warrants description | The Preferred Stock includes a contingent beneficial conversion feature ("BCF") which was valued at its $2,067,155 intrinsic value using the commitment date stock price of $0.11 per share and the effective conversion price of $2.50 per share, but was limited to the $607,220 of proceeds that were allocated to the Preferred Stock. The contingent BCF will be recognized when the contingency is resolved. | ||||||||||||||||||||||||||||
Preferred Stock | |||||||||||||||||||||||||||||
Fair value adjustment | $ | $ 607,220 | ||||||||||||||||||||||||||||
April 2020 Purchase Agreement [Member] | |||||||||||||||||||||||||||||
Number of common stock shares issued | 75,472 | ||||||||||||||||||||||||||||
Proceeds from contributed capital | $ | $ 1,000,000 | ||||||||||||||||||||||||||||
Common stock par value | $ / shares | $ 10.125 | ||||||||||||||||||||||||||||
Warrants exercised, value | $ | $ 811,641 | ||||||||||||||||||||||||||||
June 2020 Purchase Agreement [Member] | |||||||||||||||||||||||||||||
Number of common stock shares issued | 117,217 | ||||||||||||||||||||||||||||
Proceeds from contributed capital | $ | $ 1,333,000 | ||||||||||||||||||||||||||||
Common stock par value | $ / shares | $ 8.25 | ||||||||||||||||||||||||||||
Warrants exercised, value | $ | $ 1,161,667 | ||||||||||||||||||||||||||||
Underwriting Agreement, Public Offering [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 30,000 | ||||||||||||||||||||||||||||
Underwriting Agreement, Public Offering [Member] | Common Stock [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 500,000 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 8 | ||||||||||||||||||||||||||||
Public offering, description | The Company entered into an Underwriting Agreement relating to a firm commitment public offering (the "Public Offering") of 500,000 units (the "Units"), consisting of an aggregate of 500,000 shares of common stock and warrants to purchase up to 500,000 shares of common stock at a public offering price of $8.00 per Unit. | ||||||||||||||||||||||||||||
Underwriting Agreement, Public Offering [Member] | Common Stock [Member] | Purchasing an Additional Shares [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 75,000 | ||||||||||||||||||||||||||||
Underwriting Agreement, Public Offering [Member] | Common Stock [Member] | Purchasing an Additional Shares [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 575,000 | ||||||||||||||||||||||||||||
MZ Agreement [Member] | |||||||||||||||||||||||||||||
Compensation per month, value | $ | $ 8,000 | ||||||||||||||||||||||||||||
Stock-based compensation | $ | $ 121,079 | ||||||||||||||||||||||||||||
MZ Agreement [Member] | Restricted Stock [Member] | |||||||||||||||||||||||||||||
Number of restricted shares vested | 3,400 | ||||||||||||||||||||||||||||
Vesting period | 12 months | ||||||||||||||||||||||||||||
Securties Purchase Agreement [Member] | Series C Convertible Preferred Stock [Member] | |||||||||||||||||||||||||||||
Number of warrants sold during period | 6,078,125 | 6,078,125 | |||||||||||||||||||||||||||
Warrants to purchase common stock | 243,125 | 243,125 | |||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 9.25 | $ 9.25 | |||||||||||||||||||||||||||
Net proceeds from warrant exercises after deducting underwrites and placement agents fees and expenses | $ | $ 1,358,000 | ||||||||||||||||||||||||||||
Number of shares sold during period, shares | 4,205,406 | ||||||||||||||||||||||||||||
Convertible preferred stock, shares issued upon conversion | 243,125 | 243,125 | |||||||||||||||||||||||||||
Initial warrant conversion price | $ / shares | $ 8 | $ 8 | |||||||||||||||||||||||||||
Warrant agreement term, description | The warrants issued have an initial per share exercise price of $8.00, subject to customary adjustments, and will expire seven years from the date of issuance. | ||||||||||||||||||||||||||||
Percentage of non-compounding cumulative deemed dividends | 8.00% | ||||||||||||||||||||||||||||
Preferred stock, liquidation preference per share | $ / shares | $ 0.37 | $ 0.37 | |||||||||||||||||||||||||||
Preferred stock, liquidation preference accrued and unpaid dividends amount | $ | $ 23,859 | $ 23,859 | |||||||||||||||||||||||||||
Conversion of stock, description | The Company may elect to convert the Series C Preferred Stock to common stock in the event the Company either (i) consummates a merger, or (ii) raises an aggregate of at least $8,000,000 in gross proceeds in a transaction or series of transactions within any twelve (12) month period. In the event the Company elects to effect such a conversion, each share of Series C Preferred Stock is convertible into 0.05781 shares of common stock. | ||||||||||||||||||||||||||||
Lock-Up and Voting Agreements [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 139,800 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 9.25 | ||||||||||||||||||||||||||||
Alere Agreement [Member] | Alere Financial Partners [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 1,400 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 39.75 | ||||||||||||||||||||||||||||
Warrant term | 5 years | ||||||||||||||||||||||||||||
Warrant agreement term, description | The Alere Agreement is on a month to month basis that can be cancelled by either party with thirty (30) days advance notice. | ||||||||||||||||||||||||||||
Payment for monthly fee | $ | $ 7,500 | ||||||||||||||||||||||||||||
Alere Agreement [Member] | Warrants [Member] | |||||||||||||||||||||||||||||
Number of unvested warrants, forfeited | 700 | ||||||||||||||||||||||||||||
Alere Agreement [Member] | Warrants [Member] | Alere Financial Partners [Member] | |||||||||||||||||||||||||||||
Vesting period | 12 months | ||||||||||||||||||||||||||||
Bridge Offering [Member] | |||||||||||||||||||||||||||||
Gross proceeds raised in private placement offering | $ | $ 650,000 | ||||||||||||||||||||||||||||
Number of common stock shares issued | 52,000 | ||||||||||||||||||||||||||||
Warrants to purchase common stock | 52,000 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 19.75 | ||||||||||||||||||||||||||||
Private Placement Offering [Member] | April 2020 Purchase Agreement [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 75,472 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 10.125 | ||||||||||||||||||||||||||||
Purchase price per warrant | $ / shares | 3.125 | ||||||||||||||||||||||||||||
Combined purchase price per share and warrant | $ / shares | $ 13.25 | ||||||||||||||||||||||||||||
Warrant term | 5 years | ||||||||||||||||||||||||||||
Private Placement Offering [Member] | June 2020 Purchase Agreement [Member] | |||||||||||||||||||||||||||||
Warrants to purchase common stock | 117,217 | ||||||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 8.25 | ||||||||||||||||||||||||||||
Purchase price per warrant | $ / shares | 3.125 | ||||||||||||||||||||||||||||
Combined purchase price per share and warrant | $ / shares | $ 11.375 | ||||||||||||||||||||||||||||
Warrant term | 5 years | ||||||||||||||||||||||||||||
Minimum [Member] | |||||||||||||||||||||||||||||
Common stock, shares authorized | 200,000,000 | ||||||||||||||||||||||||||||
Maximum [Member] | |||||||||||||||||||||||||||||
Common stock, shares authorized | 50,000,000 | ||||||||||||||||||||||||||||
[1] | Net of cash offering costs of $197,901. | ||||||||||||||||||||||||||||
[2] | Net of cash offering costs of $386,724. | ||||||||||||||||||||||||||||
[3] | net of offering costs of $2,542,555. |
Stockholders' Equity (Deficie_4
Stockholders' Equity (Deficiency) - Schedule of Assumption Used for Valuation of Derivative Liability (Details) | Sep. 15, 2020$ / shares | Jun. 30, 2020$ / shares | Mar. 31, 2020$ / shares | Feb. 25, 2020$ / shares |
Stock Price [Member] | ||||
Derivative liability, measurement input price per share | $ 10.87 | $ 9.65 | $ 7.38 | $ 17.50 |
Projected Volatility [Member] | ||||
Derivative liability, measurement input percentage | 110.7 | 102.7 | 102.7 | 97.1 |
Risk-free Rate [Member] | ||||
Derivative liability, measurement input percentage | 0.31 | 0.29 | 0.38 | 1.36 |
Common Stock (Details Narrative
Common Stock (Details Narrative) (10-K) - USD ($) | Nov. 05, 2019 | Jun. 14, 2019 | May 31, 2019 | Apr. 18, 2019 | Mar. 12, 2019 | Feb. 07, 2019 | Dec. 02, 2018 | Nov. 27, 2018 | Jun. 18, 2018 | Jun. 12, 2018 | Jun. 08, 2018 | Jun. 04, 2018 | May 30, 2018 | May 01, 2018 | Apr. 26, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |||||
Number of common stock shares issued | 81 | 134 | 60,000 | |||||||||||||||||||||
Number of common stock issed, value | [1] | $ 6,082,444 | ||||||||||||||||||||||
Sale of stock price per share | $ 125 | |||||||||||||||||||||||
Sale of stock description | Consisting of one share of the Company's common stock, par value $0.00001 per share (the "Common Stock"), and a warrant to purchase one-twenty fifth of a share of common stock with an exercise price of $150.00 per share. | |||||||||||||||||||||||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||||||||||||
Stock of warrant exercise price | $ 150 | |||||||||||||||||||||||
Gross proceeds from initial public offering | $ 7,500,000 | $ 5,855,215 | [2] | $ 3,319,656 | [2] | $ 3,319,656 | [3] | $ 7,657,427 | [4] | |||||||||||||||
Stock-based compensation | 363,027 | 745,269 | $ 941,962 | 1,922,455 | ||||||||||||||||||||
Common stock percentage | 25.00% | 25.00% | 50.00% | |||||||||||||||||||||
Gross proceeds raised in private placement offering | 1,358,102 | [5] | [5] | $ 2,317,276 | [6] | [6] | ||||||||||||||||||
Boxer Parties [Member] | ||||||||||||||||||||||||
Stock issued price per shares | $ 47.50 | |||||||||||||||||||||||
Number of restricted shares of common stock | 6,280 | |||||||||||||||||||||||
Number of restricted shares of common stock value | $ 298,300 | |||||||||||||||||||||||
Consulting Agreement [Member] | ||||||||||||||||||||||||
Stock options vesting description | Which per the Consulting Agreement with the consultant will vest monthly over next twelve months. | |||||||||||||||||||||||
Unvested shares of common stock | 246 | |||||||||||||||||||||||
Stock-based compensation | $ 69,176 | |||||||||||||||||||||||
MZ Agreement [Member] | ||||||||||||||||||||||||
Number of common stock issed, value | $ 135,150 | |||||||||||||||||||||||
Stock-based compensation | 121,079 | |||||||||||||||||||||||
Compensation per month, value | $ 8,000 | |||||||||||||||||||||||
MZ Agreement [Member] | Restricted Stock [Member] | ||||||||||||||||||||||||
Number of restricted shares vested | 3,400 | |||||||||||||||||||||||
Vesting period | 12 months | |||||||||||||||||||||||
Public Offering [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 144,625 | |||||||||||||||||||||||
Gross proceeds from initial public offering | $ 3,868,716 | |||||||||||||||||||||||
Cash offering costs | $ 549,060 | |||||||||||||||||||||||
Stock issued price per shares | $ 26.75 | |||||||||||||||||||||||
Private Placement Offering [Member] | ||||||||||||||||||||||||
Cash offering costs | $ 79,568 | $ 386,724 | $ 386,724 | |||||||||||||||||||||
Additional Units [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 9,000 | |||||||||||||||||||||||
Sale of stock description | On June 8, 2018, the underwriters notified the Company of their exercise in full of their option to purchase an additional 9,000 Units (the "Additional Units") to cover over-allotments. | |||||||||||||||||||||||
Additional Units [Member] | Public Offering [Member] | ||||||||||||||||||||||||
Sale of stock price per share | $ 125 | |||||||||||||||||||||||
Gross proceeds from initial public offering | $ 1,125,000 | |||||||||||||||||||||||
Chief Medical Officer [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 1,778 | |||||||||||||||||||||||
Number of common stock issed, value | $ 200,000 | |||||||||||||||||||||||
Chief Medical Officer [Member] | Service Agreement [Member] | ||||||||||||||||||||||||
Monthly fee | $ 15,000 | |||||||||||||||||||||||
Sole option payable monthly fee description | Its sole option, elect to pay 25% of the monthly fee in company common stock with the number of common stock determined by dividing the 25% of the monthly fee by the closing price of the Company's common stock on the 2nd work day of each month. | |||||||||||||||||||||||
Dividing percentage | 25.00% | |||||||||||||||||||||||
Medical Advisory Board [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 1,200 | |||||||||||||||||||||||
Number of common stock issed, value | $ 90,000 | |||||||||||||||||||||||
Consultants [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 6,400 | |||||||||||||||||||||||
Number of common stock issed, value | $ 798,400 | |||||||||||||||||||||||
Share based compensation granted, shares | 800 | |||||||||||||||||||||||
Stock option grant fair value | $ 99,800 | |||||||||||||||||||||||
Accredited Investors [Member] | Share Purchase Agreement [Member] | ||||||||||||||||||||||||
Sale of stock price per share | $ 28.75 | |||||||||||||||||||||||
Gross proceeds raised in private placement offering | $ 2,704,000 | |||||||||||||||||||||||
Aggregate number of shares sold in the offering | 93,185 | |||||||||||||||||||||||
Accredited Investors [Member] | Private Placement Offering [Member] | Share Purchase Agreement [Member] | ||||||||||||||||||||||||
Cash offering costs | $ 386,724 | |||||||||||||||||||||||
Chief Executive Officer [Member] | ||||||||||||||||||||||||
Number of common stock shares issued | 736 | |||||||||||||||||||||||
Stock issued price per shares | $ 34 | |||||||||||||||||||||||
Consultant [Member] | Consulting Agreement [Member] | ||||||||||||||||||||||||
Number of unvested shares were returned | 246 | |||||||||||||||||||||||
Dr. Francis Duhay [Member] | ||||||||||||||||||||||||
Number of restricted shares of common stock | 390 | |||||||||||||||||||||||
Dr. Francis Duhay [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||||||||
Stock-based compensation | $ 19,164 | |||||||||||||||||||||||
Number of restricted shares of common stock | 390 | |||||||||||||||||||||||
[1] | net of offering costs of $2,542,555. | |||||||||||||||||||||||
[2] | Net of cash offering costs of $1,078,119 and $549,060 in 2020 and 2019, respectively. | |||||||||||||||||||||||
[3] | Net of cash offering costs of $549,060. | |||||||||||||||||||||||
[4] | Net of cash offering costs of $967,573. | |||||||||||||||||||||||
[5] | Net of cash offering costs of $197,901. | |||||||||||||||||||||||
[6] | Net of cash offering costs of $386,724. |
Warrants (Details Narrative) (1
Warrants (Details Narrative) (10-K) - USD ($) | Jun. 14, 2019 | Jun. 11, 2019 | May 31, 2019 | Mar. 12, 2019 | Jan. 03, 2019 | Dec. 31, 2019 | Sep. 30, 2020 | May 30, 2018 |
Number of warrants to purchase shares of common stock | 5,200 | |||||||
Warrants exercise price | $ 150 | |||||||
Initial Public Offering [Member] | Placement Agent [Member] | ||||||||
Warrant term | 5 years | |||||||
Number of warrants to purchase shares of common stock | 7,232 | 7,525 | ||||||
Warrants exercise price | $ 32.10 | $ 1.50 | ||||||
Placement agent's entitlement description | A warrant to purchase such number of shares of the Company's common stock equal to 5% of the total shares of common stock sold in the Public Offering or 7,232 shares. | A warrant to purchase such number of shares of the Company's common stock equal to 8% of the total shares of common stock sold in the Offering or 7,525 shares. | ||||||
Warrants [Member] | ||||||||
Warrant term | 7 years | |||||||
DFC Advisory Services LLC [Member] | Warrants [Member] | ||||||||
Number of warrants to purchase shares of common stock | 2,000 | |||||||
Warrants exercise price | $ 50 | |||||||
Grant date value warrant | $ 20,500 | |||||||
Stock price | $ 47.50 | |||||||
Risk free interest rate | 1.93% | |||||||
Expected term | 2 years 6 months | |||||||
Expected volatility | 35.10% | |||||||
Annual rate of quarterly dividends | 0.00% | |||||||
Alere Agreement [Member] | ||||||||
Fair value forfeited | $ 7,000 | $ 7,000 | ||||||
Alere Agreement [Member] | Warrants [Member] | ||||||||
Number of unvested warrants, forfeited | 700 | |||||||
Alere Agreement [Member] | Alere Financial Partners [Member] | ||||||||
Warrant agreement term, description | The Alere Agreement is on a month to month basis that can be cancelled by either party with thirty (30) days advance notice. | |||||||
Payment for monthly fee | $ 7,500 | |||||||
Warrant term | 5 years | |||||||
Number of warrants to purchase shares of common stock | 1,400 | |||||||
Warrants exercise price | $ 39.75 | |||||||
Grant date value warrant | $ 14,000 | |||||||
Stock price | $ 39.75 | |||||||
Risk free interest rate | 2.46% | |||||||
Expected term | 2 years 9 months 18 days | |||||||
Expected volatility | 34.40% | |||||||
Annual rate of quarterly dividends | 0.00% | |||||||
Alere Agreement [Member] | Alere Financial Partners [Member] | Warrants [Member] | ||||||||
Vesting period | 12 months | |||||||
Boxer Settlement Agreement [Member] | Warrants [Member] | ||||||||
Number of warrants to purchase shares of common stock | 6,000 | |||||||
Warrants exercise price | $ 150 | |||||||
Grant date value warrant | $ 3,000 | |||||||
Stock price | $ 47.50 | |||||||
Risk free interest rate | 1.93% | |||||||
Expected term | 2 years 6 months | |||||||
Expected volatility | 35.10% | |||||||
Annual rate of quarterly dividends | 0.00% |
Warrants - Schedule of Stock Wa
Warrants - Schedule of Stock Warrant Activity (Details) (10-K) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | ||
Common Stock [Member] | |||
Number of Warrants Outstanding Beginning | 151,224 | 14,849 | |
Number of Warrants, Issued | 24,156 | 131,698 | |
Number of Warrants, Exercised | |||
Number of Warrants, Cancelled | (700) | ||
Number of Warrants, Amendment of Placement Agent Warrants | [1] | 4,677 | |
Number of Warrants Outstanding Ending | 174,680 | 151,224 | |
Number of Warrants, Exercisable | 173,979 | ||
Weighted Average Exercise Price Outstanding Beginning | $ 137 | $ 300 | |
Weighted Average Exercise Price, Issued | 65 | 152.25 | |
Weighted Average Exercise Price, Exercised | |||
Weighted Average Exercise Price, Cancelled | 39.75 | ||
Weighted Average Exercise Price, Amendment of Placement Agent Warrants | [1] | 107.50 | |
Weighted Average Exercise Price, Outstanding Ending | 127.50 | $ 137 | |
Weighted Average Exercise Price, Exercisable | $ 127.75 | ||
Weighted Average Remaining Life in Years, Beginning | 4 years 1 month 6 days | ||
Weighted Average Remaining Life in Years, Ending | 3 years 3 months 19 days | ||
Weighted Average Remaining Life in Years, Exercisable | 3 years 3 months 19 days | ||
Intrinsic Value, Beginning | |||
Intrinsic Value, Issued | |||
Intrinsic Value, Exercised | |||
Intrinsic Value, Cancelled | |||
Intrinsic Value, Exercisable | |||
Series A Preferred Stock [Member] | |||
Number of Warrants Outstanding Beginning | 100,570 | ||
Number of Warrants, Exercised | |||
Number of Warrants, Cancelled | |||
Number of Warrants, Amendment of Placement Agent Warrants | [1] | (100,570) | |
Number of Warrants Outstanding Ending | |||
Number of Warrants, Exercisable | |||
Weighted Average Exercise Price Outstanding Beginning | $ 5 | ||
Weighted Average Exercise Price, Cancelled | |||
Weighted Average Exercise Price, Amendment of Placement Agent Warrants | [1] | 5 | |
Weighted Average Exercise Price, Outstanding Ending | |||
Weighted Average Exercise Price, Exercisable | |||
Weighted Average Remaining Life in Years, Beginning | 0 years | ||
Weighted Average Remaining Life in Years, Ending | 0 years | ||
Weighted Average Remaining Life in Years, Exercisable | 0 years | ||
Intrinsic Value, Beginning | |||
Intrinsic Value, Issued | |||
Intrinsic Value, Exercised | |||
Intrinsic Value, Cancelled | |||
Intrinsic Value, Exercisable | |||
[1] | In connection with the IPO, placement agent warrants for the purchase of Series A Preferred Stock were amended such that the warrants became exercisable for the number of common stock that would have been issued upon the exercise of the Series A warrant and subsequent conversion to common stock upon the consummation of the IPO. The exercise price was amended to the price equal to the total proceeds that would have been required upon the exercise of the original warrant, divided by the amended number of warrant shares. The amendment was accounted for as a modification of a stock award. The Company determined that there was no incremental increase in the fair value for the amendment of the award and accordingly there was no charge to the statement of operations for the years ended December 31, 2018. |
Warrants - Schedule of Outstand
Warrants - Schedule of Outstanding and Exercisable Warrants (Details) (10-K) - Warrants [Member] | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Warrants Outstanding, Number of Warrants | 174,681 |
Warrants Exercisable, Exercisable Number of Warrants | 173,981 |
Exercise Price Range 1 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 300 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 7,359 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 3 years 6 months |
Warrants Exercisable, Exercisable Number of Warrants | 7,359 |
Exercise Price Range 2 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 156.25 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 3,000 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 3 years 4 months 24 days |
Warrants Exercisable, Exercisable Number of Warrants | 3,000 |
Exercise Price Range 3 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 150 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 75,000 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 3 years 6 months |
Warrants Exercisable, Exercisable Number of Warrants | 75,000 |
Exercise Price Range 4 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 124.75 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 4,000 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 3 years 6 months |
Warrants Exercisable, Exercisable Number of Warrants | 4,000 |
Exercise Price Range 5 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 115.50 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 5,536 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 2 years 10 months 25 days |
Warrants Exercisable, Exercisable Number of Warrants | 5,536 |
Exercise Price Range 6 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 107.50 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 4,677 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 1 year 1 month 6 days |
Warrants Exercisable, Exercisable Number of Warrants | 4,677 |
Exercise Price Range 7 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 105 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 57,652 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 2 years 9 months 18 days |
Warrants Exercisable, Exercisable Number of Warrants | 57,652 |
Exercise Price Range 8 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 50 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 2,000 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 4 years 4 months 24 days |
Warrants Exercisable, Exercisable Number of Warrants | 2,000 |
Exercise Price Range 9 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 39.75 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 700 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 4 years |
Warrants Exercisable, Exercisable Number of Warrants | |
Exercise Price Range 10 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 37.50 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 7,525 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 4 years 2 months 12 days |
Warrants Exercisable, Exercisable Number of Warrants | 7,525 |
Exercise Price Range 11 [Member] | |
Warrants Outstanding, Exercise Price | $ / shares | $ 32 |
Warrants Outstanding, Exercisable Into Common stock | Common Stock |
Warrants Outstanding, Number of Warrants | 7,232 |
Warrants Exercisable, Weighted Average Remaining Life in Years | 4 years 4 months 24 days |
Warrants Exercisable, Exercisable Number of Warrants | 7,232 |
Stock Based Compensation (Detai
Stock Based Compensation (Details Narrative) (10-K) - USD ($) | Sep. 13, 2019 | Sep. 13, 2019 | Jul. 26, 2019 | Jul. 22, 2019 | Jul. 03, 2019 | Mar. 06, 2019 | Feb. 07, 2019 | Nov. 15, 2018 | Nov. 21, 2016 | Apr. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 02, 2018 | Nov. 27, 2018 | Apr. 26, 2018 | Dec. 11, 2017 |
Common stock percentage | 50.00% | 25.00% | 25.00% | |||||||||||||
Stock Options [Member] | ||||||||||||||||
Exercise price of options granted | $ 47 | $ 111.5 | ||||||||||||||
Options term | 9 years | |||||||||||||||
Stock option shares exercisable | 68,101 | |||||||||||||||
Non-Qualified Stock Options [Member] | Three Key Employees [Member] | ||||||||||||||||
Number of stock option grants | 2,400 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options term | 10 years | |||||||||||||||
Options grant date fair value | $ 3.75 | |||||||||||||||
Options aggregate grant date fair value | $ 9,000 | |||||||||||||||
Stock price | $ 25.50 | |||||||||||||||
Risk-free interest rate | 1.76% | |||||||||||||||
Volatility | 35.90% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Vesting period | 3 years | |||||||||||||||
Non-Qualified Stock Options [Member] | H. Jorge Ulloa [Member] | ||||||||||||||||
Number of stock option grants | 1,200 | |||||||||||||||
Exercise price of options granted | $ 39.75 | |||||||||||||||
Options term | 1 year | |||||||||||||||
Options grant date fair value | $ 14.50 | |||||||||||||||
Options aggregate grant date fair value | $ 17,400 | |||||||||||||||
Stock price | $ 39.75 | |||||||||||||||
Risk-free interest rate | 2.47% | |||||||||||||||
Volatility | 36.10% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Non-Qualified Stock Options [Member] | Dr. Peter Pappas [Member] | ||||||||||||||||
Number of stock option grants | 800 | |||||||||||||||
Exercise price of options granted | $ 34.50 | |||||||||||||||
Options grant date fair value | $ 12.50 | |||||||||||||||
Options aggregate grant date fair value | $ 10,000 | |||||||||||||||
Stock price | $ 34.50 | |||||||||||||||
Risk-free interest rate | 2.50% | |||||||||||||||
Volatility | 35.90% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Non-Qualified Stock Options [Member] | Two Members [Member] | Medical Advisory Board [Member] | ||||||||||||||||
Number of stock option grants | 1,600 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options term | 10 years | |||||||||||||||
Options grant date fair value | $ 3.75 | |||||||||||||||
Options aggregate grant date fair value | $ 6,000 | |||||||||||||||
Stock price | $ 25.50 | |||||||||||||||
Risk-free interest rate | 1.76% | |||||||||||||||
Volatility | 35.90% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Vesting period | 2 years | |||||||||||||||
Options [Member] | Robert Gray [Member] | ||||||||||||||||
Number of stock option grants | 2,400 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options grant date fair value | $ 3.25 | |||||||||||||||
Options aggregate grant date fair value | $ 15,600 | |||||||||||||||
Stock price | $ 24 | $ 24 | ||||||||||||||
Risk-free interest rate | 1.75% | |||||||||||||||
Volatility | 35.70% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Vesting period | 3 years | |||||||||||||||
Options [Member] | Matthew Jenusaitis [Member] | ||||||||||||||||
Number of stock option grants | 2,400 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options grant date fair value | $ 3.25 | |||||||||||||||
Options aggregate grant date fair value | $ 15,600 | |||||||||||||||
Stock price | 24 | $ 24 | ||||||||||||||
Risk-free interest rate | 1.75% | |||||||||||||||
Volatility | 35.70% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Vesting period | 3 years | |||||||||||||||
Stock Options [Member] | ||||||||||||||||
Number of restricted stock units | $ 492,084 | $ 864,626 | ||||||||||||||
Unrecognized stock-based compensation expense | $ 517,806 | |||||||||||||||
Weighted average remaining vesting period | 1 year 9 months 18 days | |||||||||||||||
Restricted Stock Units (RSUs) [Member] | Robert Gray [Member] | ||||||||||||||||
Number of stock option grants | 3,125 | |||||||||||||||
Exercise price of options granted | $ 24 | $ 24 | ||||||||||||||
Options aggregate grant date fair value | $ 150,000 | $ 150,000 | ||||||||||||||
Option vesting period, description | These units vest in equal annual portions on the anniversary of their grant. | These units vest in equal annual portions on the September 13, 2020, September 13, 2021 and September 13, 2022. | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | Matthew Jenusaitis [Member] | ||||||||||||||||
Number of stock option grants | 3,125 | |||||||||||||||
Exercise price of options granted | $ 24 | |||||||||||||||
Options aggregate grant date fair value | $ 150,000 | |||||||||||||||
Option vesting period, description | These units vest in equal annual portions on the September 13, 2020, September 13, 2021 and September 13, 2022. | |||||||||||||||
Employment Agreement [Member] | Non-Qualified Stock Options [Member] | Brian Roselauf [Member] | ||||||||||||||||
Number of stock option grants | 4,600 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options term | 10 years | |||||||||||||||
Options grant date fair value | $ 3.75 | |||||||||||||||
Options aggregate grant date fair value | $ 17,250 | |||||||||||||||
Stock price | $ 25.50 | |||||||||||||||
Risk-free interest rate | 1.76% | |||||||||||||||
Volatility | 35.90% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Employment Agreement [Member] | Non-Qualified Stock Options [Member] | Brian Roselauf [Member] | Quarterly Basis [Member] | ||||||||||||||||
Number of options vested | 3,067 | |||||||||||||||
Vesting period | 2 years | |||||||||||||||
Employment Agreement [Member] | Non-Qualified Stock Options [Member] | Brian Roselauf [Member] | First Anniversary of Mr. Roselauf's Employment [Member] | ||||||||||||||||
Number of options vested | 1,534 | |||||||||||||||
New Employment Agreement [Member] | Options [Member] | Dr. Marc Glickman [Member] | ||||||||||||||||
Number of stock option grants | 7,380 | |||||||||||||||
Exercise price of options granted | $ 250 | $ 50 | ||||||||||||||
Options grant date fair value | $ 2.75 | |||||||||||||||
Options aggregate grant date fair value | $ 20,295 | |||||||||||||||
Stock price | $ 26.25 | |||||||||||||||
Risk-free interest rate | 1.84% | |||||||||||||||
Volatility | 36.70% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 3 years 7 months 6 days | |||||||||||||||
New Employment Agreement [Member] | New Options [Member] | Dr. Marc Glickman [Member] | ||||||||||||||||
Number of stock option grants | 7,200 | |||||||||||||||
Exercise price of options granted | $ 50 | |||||||||||||||
Options grant date fair value | $ 4 | |||||||||||||||
Options aggregate grant date fair value | $ 28,800 | |||||||||||||||
Stock price | $ 26.25 | |||||||||||||||
Risk-free interest rate | 1.86% | |||||||||||||||
Volatility | 35.70% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
Vesting period | 3 years | |||||||||||||||
Award Agreement [Member] | Restricted Stock Units (RSUs) [Member] | Mr. Marcus Robins [Member] | ||||||||||||||||
Number of unvested shares were returned | 1,168 | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | ||||||||||||||||
Stock option percentage description | The option price must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant. | |||||||||||||||
Common stock percentage | 3.00% | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | Stock Options [Member] | ||||||||||||||||
Stock option shares expired | 32,740 | 586 | ||||||||||||||
Stock option shares exercisable | 5,275 | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | Employment Agreement [Member] | Non-Qualified Stock Options [Member] | H. Chris Sarner [Member] | ||||||||||||||||
Number of stock option grants | 6,000 | |||||||||||||||
Exercise price of options granted | $ 39.75 | |||||||||||||||
Options term | 10 years | |||||||||||||||
Options grant date fair value | $ 14.50 | |||||||||||||||
Options aggregate grant date fair value | $ 87,000 | |||||||||||||||
Stock price | $ 39.75 | |||||||||||||||
Risk-free interest rate | 2.47% | |||||||||||||||
Volatility | 36.30% | |||||||||||||||
Annual rate of quarterly dividends | 0.00% | |||||||||||||||
Contractual term | 5 years 3 months 19 days | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | Employment Agreement [Member] | Non-Qualified Stock Options [Member] | H. Chris Sarner [Member] | First Anniversary of Ms. Sarner's Employment [Member] | ||||||||||||||||
Number of options vested | 2,000 | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | Employment Agreement [Member] | Non-Qualified Stock Options [Member] | H. Chris Sarner [Member] | Quarterly Basis [Member] | ||||||||||||||||
Number of options vested | 4,000 | |||||||||||||||
Vesting period | 2 years | |||||||||||||||
2016 Omnibus Incentive Plan [Member] | Minimum [Member] | ||||||||||||||||
Common stock, capital shares reserved for future issuance | 100,000 | 66,000 | ||||||||||||||
2016 Omnibus Incentive Plan [Member] | Maximum [Member] | ||||||||||||||||
Common stock, capital shares reserved for future issuance | 180,000 | 100,000 |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Stock Option Activity (Details) (10-K) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Options, Forfeited | 246 | |
Stock Options [Member] | ||
Number of Options Outstanding beginning | 111,829 | 56,880 |
Number of Options, Granted | 28,600 | 60,809 |
Number of Options, Forfeited | (40,740) | (5,860) |
Number of Options Outstanding Ending | 99,689 | 111,829 |
Number of Options Exercisable | 68,101 | |
Weighted Average Exercise Price Outstanding beginning | $ 176.75 | $ 254 |
Weighted Average Exercise Price, Granted | 47 | 111.5 |
Weighted Average Exercise Price, Forfeited | 210.5 | 250 |
Weighted Average Exercise Price Outstanding Ending | 111 | $ 176.75 |
Weighted Average Exercise Price Exercisable | $ 132 | |
Weighted Average Remaining Life In Years Outstanding, Beginning | 9 years | |
Weighted Average Remaining Life In Years Outstanding, Ending | 8 years 7 months 6 days | 9 years |
Weighted Average Remaining Life In Years Exercisable | 8 years 6 months | |
Aggregate Intrinsic Value Outstanding | ||
Aggregate Intrinsic Value Exercisable |
Stock Based Compensation - Sc_2
Stock Based Compensation - Schedule of Outstanding and Exercisable Options (Details) (10-K) - Stock Options [Member] | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Options Outstanding, Number of Options | 99,689 |
Options Exercisable, Exercisable Number of Options | 68,101 |
Exercise Price Range 1 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 300 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 4,800 |
Options Exercisable, Weighted Average Remaining Life in Years | 7 years 8 months 12 days |
Options Exercisable, Exercisable Number of Options | 4,800 |
Exercise Price Range 2 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 250 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 5,860 |
Options Exercisable, Weighted Average Remaining Life in Years | 6 years 9 months 18 days |
Options Exercisable, Exercisable Number of Options | 5,860 |
Exercise Price Range 3 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 175 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 240 |
Options Exercisable, Weighted Average Remaining Life in Years | 7 years 10 months 25 days |
Options Exercisable, Exercisable Number of Options | 240 |
Exercise Price Range 4 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 124.75 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 43,209 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 8 months 12 days |
Options Exercisable, Exercisable Number of Options | 38,888 |
Exercise Price Range 5 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 123.25 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 3,200 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 6 months |
Options Exercisable, Exercisable Number of Options | 2,400 |
Exercise Price Range 6 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 74.50 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 6,000 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 6 months |
Options Exercisable, Exercisable Number of Options | 2,500 |
Exercise Price Range 7 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 72.50 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 1,200 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 10 months 25 days |
Options Exercisable, Exercisable Number of Options | 1,200 |
Exercise Price Range 8 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 64.25 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 5,200 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 10 months 25 days |
Options Exercisable, Exercisable Number of Options | 2,000 |
Exercise Price Range 9 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 50 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 27,980 |
Options Exercisable, Weighted Average Remaining Life in Years | 8 years 10 months 25 days |
Options Exercisable, Exercisable Number of Options | 8,914 |
Exercise Price Range 10 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 39.75 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 1,200 |
Options Exercisable, Weighted Average Remaining Life in Years | 9 years 1 month 6 days |
Options Exercisable, Exercisable Number of Options | 1,000 |
Exercise Price Range 11 [Member] | |
Options Outstanding, Exercise Price | $ / shares | $ 34.50 |
Options Outstanding, Exercisable Into Common stock | Common Stock |
Options Outstanding, Number of Options | 800 |
Options Exercisable, Weighted Average Remaining Life in Years | 9 years 2 months 12 days |
Options Exercisable, Exercisable Number of Options | 300 |
Stock Based Compensation - Sc_3
Stock Based Compensation - Schedule of Outstanding and Exercisable Restricted Stock Units (Details) (10-K) - Restricted Stock Units (RSUs) [Member] - shares | Sep. 13, 2019 | Nov. 27, 2018 | Dec. 31, 2019 |
Restricted Stock Units Exercisable, Exercisable Into Common stock | Common Stock | Common Stock | |
Restricted Stock Units Exercisable, Outstanding Number of Units | 6,250 | 1,557 | 7,807 |
Restricted Stock Units Exercisable, Weighted Average Remaining Life in Years | 2 years 8 months 12 days | 1 year 9 months 18 days |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) (10-K) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Development and Manufacturing Agreement [Member] | ||
Contract revenue cost | $ 0 | $ 70,400 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Jan. 15, 2021 | Dec. 04, 2020 | Nov. 30, 2020 | Nov. 24, 2020 | Nov. 10, 2020 | Oct. 09, 2020 | Oct. 07, 2020 | Dec. 02, 2018 | Nov. 27, 2018 | Jun. 04, 2018 | Dec. 31, 2020 | Dec. 31, 2018 | Sep. 30, 2020 | Dec. 31, 2019 | May 30, 2018 | |
Number of shares agreed to sell, amount | [1] | $ 6,082,444 | ||||||||||||||
Share price | $ 125 | |||||||||||||||
Warrants to purchase common stock | 5,200 | |||||||||||||||
Warrants exercise price | $ 150 | |||||||||||||||
Number of common stock shares | 81 | 134 | 60,000 | |||||||||||||
Common stock, shares outstanding | 468,906 | 1,609,710 | 717,275 | |||||||||||||
Subsequent Event [Member] | ||||||||||||||||
Warrants to purchase common stock | 48,000 | 18,057 | 290,924 | |||||||||||||
Warrants exercise price | $ 10.25 | |||||||||||||||
Proceeds from exercise of warrants | $ 2,354,000 | |||||||||||||||
Reverse stock split description | one-for-twenty five (1:25) reverse stock split | |||||||||||||||
Effect of reverse stock split on common stock description | As a result of the reverse stock split, every twenty five (25) shares of issued and outstanding common stock was automatically combined into one (1) issued and outstanding share of common stock, without any change in the par value per share. | |||||||||||||||
Shares issued as a result of reverse stock split | ||||||||||||||||
Proceeds from issuance of common stock | $ 240,000 | |||||||||||||||
Subsequent Event [Member] | Maximum [Member] | ||||||||||||||||
Common stock, shares outstanding | 55,853,569 | |||||||||||||||
Subsequent Event [Member] | Minimum [Member] | ||||||||||||||||
Common stock, shares outstanding | 2,234,143 | |||||||||||||||
Subsequent Event [Member] | Series C Convertible Preferred Stock [Member] | ||||||||||||||||
Number of common stock exchanging shares | 4,205,406 | |||||||||||||||
Number of common stock shares | 243,125 | |||||||||||||||
Subsequent Event [Member] | Spartan Capital Securities LLC [Member] | ||||||||||||||||
Warrants to purchase common stock | 17,618 | |||||||||||||||
Warrants exercise price | $ 8 | |||||||||||||||
Payments to warrants | $ 355,000 | |||||||||||||||
Subsequent Event [Member] | October 2020 Securties Purchase Agreement [Member] | ||||||||||||||||
Number of shares agreed to sell, amount | $ 5,100,000 | |||||||||||||||
Number of shares sold during period, shares | 381,309 | |||||||||||||||
Share price | $ 10.25 | |||||||||||||||
Warrants to purchase common stock | 381,309 | |||||||||||||||
Warrants purchase price per share | $ 3.125 | |||||||||||||||
Combined purchase price per share and warrant | 13.375 | |||||||||||||||
Warrants exercise price | $ 10.25 | |||||||||||||||
Warrant term | 5 years | |||||||||||||||
Proceeds from exercise of warrants | $ 4,450,000 | |||||||||||||||
Subsequent Event [Member] | Settlement Agreement [Member] | Gusrae Kaplan Nusbaum PLLC [Member] | ||||||||||||||||
Litigation settlement amount | $ 120,000 | |||||||||||||||
[1] | net of offering costs of $2,542,555. |
Subsequent Events (Details Na_2
Subsequent Events (Details Narrative) (10-K) - USD ($) | Feb. 25, 2020 | Dec. 02, 2018 | Nov. 27, 2018 | Jun. 04, 2018 | Nov. 10, 2020 | May 30, 2018 |
Number of common stock shares issued | 81 | 134 | 60,000 | |||
Warrants exercise price | $ 150 | |||||
Private Placement Offering [Member] | ||||||
Warrants to purchase of common stock | 57,200 | |||||
Bridge Offering [Member] | ||||||
Number of common stock shares issued | 52,000 | |||||
Warrants exercise price | $ 19.75 | |||||
Subsequent Event [Member] | ||||||
Warrants exercise price | $ 10.25 | |||||
Subsequent Event [Member] | Private Placement Offering [Member] | ||||||
Gross proceeds of private placement offerings | $ 650,000 | |||||
Number of common stock shares issued | 52,000 | |||||
Warrants to purchase of common stock | 52,000 | |||||
Warrants exercise price | $ 19.75 | |||||
Subsequent Event [Member] | Bridge Offering [Member] | ||||||
Warrants to purchase of common stock | 3,292 | |||||
Offering fee percentage | 10.00% |
Reverse Stock Split (Details Na
Reverse Stock Split (Details Narrative) (10-K) - shares | Nov. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Common stock, shares outstanding | 1,609,710 | 717,275 | 468,906 | |
Subsequent Event [Member] | ||||
Reverse stock split description | one-for-twenty five (1:25) reverse stock split | |||
Effect of reverse stock split on common stock description | As a result of the reverse stock split, every twenty five (25) shares of issued and outstanding common stock was automatically combined into one (1) issued and outstanding share of common stock, without any change in the par value per share. | |||
Shares issued as a result of reverse stock split | ||||
Subsequent Event [Member] | Maximum [Member] | ||||
Common stock, shares outstanding | 55,853,569 | |||
Subsequent Event [Member] | Minimum [Member] | ||||
Common stock, shares outstanding | 2,234,143 |