Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 13, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | Akers Biosciences, Inc. | |
Entity Central Index Key | 0001321834 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2020 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Reporting Status Current | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,724,283 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2020 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash | $ 11,446,717 | $ 517,444 |
Marketable Securities | 6,856,805 | 9,164,273 |
Trade Receivables, net | 2,301 | 42,881 |
Inventories, net | 198,985 | |
Prepaid expenses | 172,096 | 387,231 |
Total Current Assets | 18,477,919 | 10,310,814 |
Non-Current Assets | ||
Prepaid Expenses | 252,308 | |
Restricted Cash | 115,094 | 115,094 |
Property, Plant and Equipment, net | 4,783 | 33,574 |
Operating Lease Right-of-Use Asset | 79,942 | |
Intangible Assets, net | 170,423 | |
Other Assets | 2,722 | |
Total Non-Current Assets | 199,819 | 574,121 |
Total Assets | 18,677,738 | 10,884,935 |
Current Liabilities | ||
Trade and Other Payables | 2,625,572 | 1,529,765 |
Operating Lease Liability | 80,018 | |
Total Current Liabilities | 2,705,590 | 1,529,765 |
Operating Lease Liability - non-current | ||
Total Liabilities | 2,705,590 | 1,529,765 |
Commitments and Contingencies | ||
SHAREHOLDERS' EQUITY | ||
Preferred stock, value | ||
Common stock, No par value, 100,000,000 shares authorized 6,125,039 and 1,738,837 issued and outstanding as of June 30, 2020 and December 31, 2019 | 142,330,116 | 128,920,414 |
Accumulated Other Comprehensive Income (Loss) | (21,153) | 17,886 |
Accumulated Deficit | (126,749,797) | (119,583,130) |
Total Shareholders' Equity | 15,972,148 | 9,355,170 |
Total Liabilities and Shareholders' Equity | 18,677,738 | 10,884,935 |
Series C Convertible Preferred Stock [Member] | ||
SHAREHOLDERS' EQUITY | ||
Preferred stock, value | ||
Series D Convertible Preferred Stock [Member] | ||
SHAREHOLDERS' EQUITY | ||
Preferred stock, value | 412,982 | |
Total Shareholders' Equity | $ 412,982 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Preferred stock, no par value | ||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, no par value | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 6,125,039 | 1,738,837 |
Common stock, shares outstanding | 6,125,039 | 1,738,837 |
Series C Convertible Preferred Stock [Member] | ||
Preferred stock, no par value | ||
Preferred stock, shares authorized | 1,990,000 | 1,990,000 |
Preferred stock, stated value | $ 4 | $ 4 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series D Convertible Preferred Stock [Member] | ||
Preferred stock, no par value | ||
Preferred stock, shares authorized | 211,353 | 211,353 |
Preferred stock, stated value | $ 0.01 | $ 0.01 |
Preferred stock, shares issued | 208,577 | 0 |
Preferred stock, shares outstanding | 208,577 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Product Revenue | $ (1,888) | $ 464,513 | $ 361,627 | $ 1,076,634 |
Product Cost of Sales | (377,169) | (219,864) | (550,040) | (465,801) |
Gross Income (Loss) | (379,057) | 244,649 | (188,413) | 610,833 |
Research and Development Expenses | 1,916,161 | 4,399,218 | ||
Administrative Expenses | 736,708 | 981,309 | 1,894,440 | 1,964,265 |
Sales and Marketing Expenses | 7,240 | 14,139 | 21,703 | 163,979 |
Regulatory and Compliance Expenses | 67,667 | 60,909 | 139,758 | 149,300 |
Litigation Settlement Expenses | 81,717 | 81,717 | 75,000 | |
Amortization of Non-Current Assets | 8,727 | 10,002 | 17,601 | 20,004 |
Impairment of Prepaid Royalties | 291,442 | 291,442 | ||
Impairment of Production Equipment | 18,680 | 18,680 | ||
Impairment of Intangible Assets | 149,870 | 152,822 | ||
Loss from Operations | (3,657,269) | (821,710) | (7,205,794) | (1,761,715) |
Other (Income) Expenses | ||||
Foreign Currency Transaction (Gain) Loss | (93) | 219 | (93) | 4,878 |
Loss on Investments | 543 | 36,714 | 4,258 | |
Interest and Dividend Income | (29,045) | (27,581) | (75,748) | (59,002) |
Total Other Income | (29,138) | (26,819) | (39,127) | (49,866) |
Loss Before Income Taxes | (3,628,131) | (794,891) | (7,166,667) | (1,711,849) |
Income Tax Benefit | ||||
Net Loss | (3,628,131) | (794,891) | (7,166,667) | (1,711,849) |
Other Comprehensive Income (Loss) | ||||
Net Unrealized Gain (Loss) on Marketable Securities | 201,898 | 18,059 | (39,039) | 47,402 |
Total Other Comprehensive Income (Loss) | 201,898 | 18,059 | (39,039) | 47,402 |
Comprehensive Loss | $ (3,426,233) | $ (776,832) | $ (7,205,706) | $ (1,664,447) |
Basic and Diluted loss per common share | $ (0.69) | $ (1.47) | $ (1.92) | $ (3.16) |
Weighted average basic and diluted common shares outstanding | 5,252,211 | 541,367 | 3,739,529 | 541,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Changes in Shareholders' Equity - USD ($) | Series D Convertible Preferred Stock [Member] | Common Stock [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income/(Loss) [Member] | Total |
Balance at Dec. 31, 2018 | $ 121,554,547 | $ (115,694,881) | $ (25,913) | $ 5,833,753 | |
Balance, shares at Dec. 31, 2018 | 540,607 | ||||
Net loss | (916,958) | (916,958) | |||
Issuance of stock grants to key employees | $ 15,874 | 15,874 | |||
Issuance of stock grants to key employees, shares | 625 | ||||
Share-based compensation - Directors - restricted stock units | $ 3,906 | 3,906 | |||
Net unrealized (gain) loss on marketable securities | 29,343 | 29,343 | |||
Balance at Mar. 31, 2019 | $ 121,574,327 | (116,611,839) | 3,430 | 4,965,918 | |
Balance, shares at Mar. 31, 2019 | 541,232 | ||||
Balance at Dec. 31, 2018 | $ 121,554,547 | (115,694,881) | (25,913) | 5,833,753 | |
Balance, shares at Dec. 31, 2018 | 540,607 | ||||
Net loss | (1,711,849) | ||||
Balance at Jun. 30, 2019 | $ 121,699,375 | (117,406,730) | 21,489 | 4,314,134 | |
Balance, shares at Jun. 30, 2019 | 541,702 | ||||
Balance at Mar. 31, 2019 | $ 121,574,327 | (116,611,839) | 3,430 | 4,965,918 | |
Balance, shares at Mar. 31, 2019 | 541,232 | ||||
Net loss | (794,891) | (794,891) | |||
Issuance of stock grants to key employees | $ 6,570 | 6,570 | |||
Issuance of stock grants to key employees, shares | 470 | ||||
Share-based compensation - Directors - restricted stock units | $ 118,478 | 118,478 | |||
Net unrealized (gain) loss on marketable securities | 18,059 | 18,059 | |||
Balance at Jun. 30, 2019 | $ 121,699,375 | (117,406,730) | 21,489 | 4,314,134 | |
Balance, shares at Jun. 30, 2019 | 541,702 | ||||
Balance at Dec. 31, 2019 | $ 128,920,414 | (119,583,130) | 17,886 | 9,355,170 | |
Balance, shares at Dec. 31, 2019 | 1,738,837 | ||||
Net loss | (3,538,536) | (3,538,536) | |||
Share-based compensation - Directors - restricted stock units | 1,302 | 1,302 | |||
Net unrealized (gain) loss on marketable securities | (240,937) | (240,937) | |||
Exercise of prepaid equity forward contracts for common stock | $ 77 | 77 | |||
Exercise of prepaid equity forward contracts for common stock, shares | 765,000 | ||||
Shares issued for the purchase of license | $ 418,479 | $ 814,578 | 1,233,057 | ||
Shares issued for the purchase of license, shares | 211,353 | 411,403 | |||
Stock-based compensation - shares issued to vendors | $ 7,318 | 7,318 | |||
Balance at Mar. 31, 2020 | $ 418,479 | $ 129,743,689 | (123,121,666) | (223,051) | 6,817,451 |
Balance, shares at Mar. 31, 2020 | 211,353 | 2,915,240 | |||
Balance at Dec. 31, 2019 | $ 128,920,414 | (119,583,130) | 17,886 | 9,355,170 | |
Balance, shares at Dec. 31, 2019 | 1,738,837 | ||||
Net loss | (7,166,667) | ||||
Conversion of Series D Convertible Preferred Shares for common stock, shares | 2,776 | ||||
Balance at Jun. 30, 2020 | $ 412,982 | $ 142,330,116 | (126,749,797) | (21,153) | 15,972,148 |
Balance, shares at Jun. 30, 2020 | 208,577 | 6,125,039 | |||
Balance at Mar. 31, 2020 | $ 418,479 | $ 129,743,689 | (123,121,666) | (223,051) | 6,817,451 |
Balance, shares at Mar. 31, 2020 | 211,353 | 2,915,240 | |||
Net loss | (3,628,131) | (3,628,131) | |||
Net unrealized (gain) loss on marketable securities | 201,898 | 201,898 | |||
Exercise of prepaid equity forward contracts for common stock | $ 3 | 3 | |||
Exercise of prepaid equity forward contracts for common stock, shares | 30,000 | ||||
Exercise of Series C Convertible Preferred warrants for common stock | $ 4,174,000 | 4,174,000 | |||
Exercise of Series C Convertible Preferred warrants for common stock, shares | 1,043,500 | ||||
Conversion of Series D Convertible Preferred Shares for common stock | $ (5,497) | $ 5,497 | |||
Conversion of Series D Convertible Preferred Shares for common stock, shares | (2,776) | 2,776 | |||
Registered direct offering of common stock net of offering costs of $513,795 | $ 4,086,207 | 4,086,207 | |||
Registered direct offering of common stock net of offering costs of $513,795, shares | 766,667 | ||||
Registered direct offering of common stock net of offering costs of $504,281 | $ 4,320,720 | 4,320,720 | |||
Registered direct offering of common stock net of offering costs of $504,281, shares | 1,366,856 | ||||
Balance at Jun. 30, 2020 | $ 412,982 | $ 142,330,116 | $ (126,749,797) | $ (21,153) | $ 15,972,148 |
Balance, shares at Jun. 30, 2020 | 208,577 | 6,125,039 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Changes in Shareholders' Equity (Parenthetical) | Jun. 30, 2020USD ($) |
Offering Costs [Member] | |
Net offering cost | $ 513,795 |
Offering Costs One [Member] | |
Net offering cost | $ 504,281 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (7,166,667) | $ (1,711,849) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on sale of securities | 36,714 | 4,258 |
Accrued (income)/loss on marketable securities | 348 | 3,514 |
Depreciation and amortization | 27,712 | 34,979 |
Impairment of Prepaid Royalties | 291,442 | |
Impairment of Production Equipment | 18,680 | |
Impairment of intangible assets | 152,822 | |
Inventory adjustment for net realizable value | 197,723 | |
Reserve for doubtful trade receivables | 1,273 | 4,247 |
Share based compensation to an employee - common stock | 22,444 | |
Share based compensation to directors - restricted stock units | 1,302 | 122,384 |
Share based compensation - shares issued to vendors | 7,318 | |
Shares issued for the purchase of a license | 1,233,057 | |
Change in assets and liabilities | ||
(Increase)/Decrease in trade receivables | 63,548 | (94,781) |
Decrease in deposits and other receivables | 9,347 | |
Decrease in inventories | 1,262 | 41,026 |
Decrease in prepaid expenses | 176,001 | 305,531 |
Decrease in other assets | 2,722 | 4,330 |
(Increase)/Decrease in trade and other payables | 1,071,566 | (355,782) |
Increase in operating lease liability | 76 | |
Net cash used by operating activities | (3,883,101) | (1,610,352) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (76,095) | (62,516) |
Proceeds from sale of marketable securities | 2,307,462 | 1,354,646 |
Net cash provided by investing activities | 2,231,367 | 1,292,130 |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock | 8,406,927 | |
Net proceeds from the exercise of Series C Convertible Preferred warrants and conversion into common stock | 4,174,000 | |
Net proceeds from the exercise of prepaid equity forward contracts for the purchase of common stock | 80 | |
Net cash provided by financing activities | 12,581,007 | |
Net increase/(decrease) in cash and restricted cash | 10,929,273 | (318,222) |
Cash and restricted cash at beginning of period | 632,538 | 681,755 |
Cash and restricted cash at end of period | 11,561,811 | 363,533 |
Cash paid for: | ||
Interest | ||
Income Taxes | ||
Supplemental Schedule of Non-Cash Financing and Investing Activities | ||
Net unrealized gains/(losses) on marketable securities | (39,039) | 47,402 |
Operating lease right-of-use asset obtained in exchange for lease obligation | $ (79,942) |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Note 1 – Organization and Description of Business Akers Biosciences, Inc. (“Akers”), is a New Jersey corporation. These consolidated financial statements include three wholly owned subsidiaries, Cystron Biotech, LLC, Akers Acquisition Sub, Inc. and Bout Time Marketing Corporation, (together, the “Company”). All material intercompany transactions have been eliminated in consolidation. The Company was historically a developer of rapid health information technologies but since March 2020, has been primarily focused on the development of a vaccine candidate against SARS-CoV-2, a coronavirus currently causing a pandemic throughout the world. In response to the global pandemic, the Company is pursuing rapid development and manufacturing of its COVID-19 vaccine candidate, or combination product candidate (the “COVID-19 Vaccine Candidate”) in collaboration with Premas Biotech PVT Ltd. (“Premas”). With Premas, the Company is currently conducting animal studies for its COVID-19 Vaccine Candidate in India with different dose amounts, including amounts that would be applicable to humans. The Company and Premas are currently engaged in communications with the U.S. Food and Drug Administration (“FDA”) and the office of the drug controller in India. On July 7, 2020, the Company immediately ceased the production and sale of its rapid, point-of-care screening and testing products. The Company will continue to provide support for these testing products that remain in the market through respective product expiration dates. For a more detailed discussion of the Company’s cessation of its screening and testing products, see Note 3 herein. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2 – Significant Accounting Policies (a) Basis of Presentation The Condensed Consolidated Financial Statements of the Company are prepared in U.S. Dollars and in accordance with accounting principles generally accepted in the United States of America (US GAAP). Certain information and note disclosures normally included in the financial statements prepared in accordance with US GAAP have been condensed. As such, the information included in these financial statements should be read in conjunction with the audited financial statements as of and for the years ended December 31, 2019 and 2018 included in the Company’s 2019 Form 10-K, as filed on March 25, 2020. In the opinion of the Company’s management, these condensed consolidated financial statements include all adjustments, which are of only a normal and recurring nature, necessary for a fair statement of the financial position of the Company as of June 30, 2020 and its results of operations and cash flows for the three and six months ended June 30, 2020 and 2019. The results of operations for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the full fiscal year ending December 31, 2020. (b) Use of Estimates and Judgments The preparation of financial statements in conformity with US GAAP requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Information about significant areas of estimation, uncertainty and critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the financial statements is included in the following notes for revenue recognition, recording research and development expenses, allowances for doubtful accounts, inventory and prepaid asset write-downs, impairment of equipment and intangible assets and valuation of share-based payments. (c) Functional and Presentation Currency These condensed consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency. All financial information has been rounded to the nearest dollar. Foreign Currency Transaction Gains or Losses, resulting from cash balances denominated in Foreign Currencies, are recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss. (d) Comprehensive Income (Loss) The Company follows Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 220 in reporting comprehensive income (loss). Comprehensive income is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income. (e) Cash and Cash Equivalents The Company considers all highly liquid investments, which include short-term bank deposits (up to three months from date of deposit) that are not restricted as to withdrawal date or use, to be cash equivalents. (f) Restricted Cash At June 30, 2020, restricted cash included in non-current assets on the Company’s Condensed Consolidated Balance Sheet was $115,094 representing cash in trust for the purpose of funding legal fees for certain litigations. (g) Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables. The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their short maturities. The framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under FASB ASC 820 are described as follows: Level 1 Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2 Inputs to the valuation methodology include: ● quoted prices for similar assets or liabilities in active markets; ● quoted prices for identical or similar assets or liabilities in inactive markets; ● inputs other than quoted prices that are observable for the asset or liability; ● inputs that are derived principally from or corroborated by observable market data by correlation or other means If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Following is a description of the valuation methodologies used for assets measured at fair value as of June 30, 2020 and December 31, 2019. Marketable Securities: Quoted Prices in Active Quoted Prices for Significant Fixed Income Bonds at June 30, 2020 $ 6,856,805 $ - $ - Fixed Income Bonds at December 31, 2019 $ 9,164,273 $ - $ - Marketable securities are classified as available for sale. The debt securities are valued at fair market value. Maturities of the securities are less than one year. Unrealized gains and losses relating to the available for sale investment securities were recorded in the Condensed Consolidated Statement of Changes in Shareholders’ Equity as other comprehensive (loss) income. These amounts were an unrealized gain of $201,898 and $18,059 for the three months ended June 30, 2020 and 2019, respectively and an unrealized loss of $39,039 and an unrealized gain of $47,402 for the six months ended June 30, 2020 and 2019, respectively. Losses resulting from the sales of marketable securities were $0 and $543 for the three months ended June 30, 2020 and 2019, respectively and were a loss of $36,714 and $4,258 for the six months ended June 30, 2020 and 2019, respectively Proceeds from the sales of marketable securities in the three and six months ended June 30, 2020 were $3,572 and $2,307,462, respectively and were $502,126 and $1,354,646 for the three and six months ended June 30, 2019, respectively. The carrying amounts of current trade receivables are stated at cost, net of allowance for doubtful accounts and approximates their fair value given their short-term nature. The normal credit terms extended to customers range between 30 and 90 days. Credit terms longer than these may be extended after considering the credit worthiness of the customers and the business requirements. The Company reviews all receivables that exceed terms and establishes an allowance for doubtful accounts based on management’s assessment of the collectability of trade and other receivables. A considerable amount of judgment is required in assessing the amount of allowance. The Company considers the historical level of credit losses, makes judgments about the credit worthiness of each customer based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. As of June 30, 2020 and December 31, 2019, allowances for doubtful accounts for trade receivables were $1,273 and $458,902, respectively. Bad debt expenses for trade receivables were $1,273 and $0 for the three months ended June 30, 2020 and 2019 and $1,273 and $4,247 for the six months ended June 30, 2020 and 2019, respectively. During the three and six months ended June 30, 2020, the Company charged off accounts receivable of $458,902 against the allowance for doubtful accounts. (i) Prepaid Expenses For expenses paid prior to the date that the related services are rendered or used are recorded as prepaid expenses. Prepaid expenses are comprised principally of prepaid insurance and prepaid royalties. As of June 30, 2020, the Company determined that, on account of the unfavorable factors existing within its rapid, point-of-care screening and testing products business, prepaid royalties in the amount of $291,442 would be fully impaired. For the three and six months ended June 30, 2020, this charge was reflected within Impairment of Prepaid Royalties in the Condensed Consolidated Statement of Operations and Comprehensive Loss. (j) Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash on deposit with financial institutions. At times, the Company’s cash in banks is in excess of the FDIC insurance limit. The Company has not experienced any loss as a result of these cash deposits. These cash balances are maintained with two banks. Major Customers For the three months ended June 30, 2020, revenues net of discounts and allowances, was a negative amount of $1,888. For the three months ended June 30, 2019, three customers generated 42%, 20% and 19%, or 81% in the aggregate, of the Company’s revenue. For the six months ended June 30, 2020, two customers generated 58% and 35%, or 93% in the aggregate, of the Company’s revenues. For the six months ended June 30, 2019, two customers generated 44% and 34%, or 78% in the aggregate, of the Company’s revenue. One customer accounted for 100%, and five customers accounted for 30%, 18%, 12%, 12% and 11%, or 83% in the aggregate, of trade receivables net of customer credits and allowances for doubtful accounts as of June 30, 2020 and December 31, 2019, respectively. Major Suppliers Three suppliers accounted for 37%, 28% and 11%, or 76% in the aggregate and two suppliers accounted for 70% and 11% or 81% in aggregate, of the Company’s purchases for the three months ended June 30, 2020 and 2019, respectively. Two suppliers accounted for 49% and 17%, or 66% in the aggregate and one supplier accounted for 63% of the Company’s purchases for the six months ended June 30, 2020 and 2019, respectively. None of the Company’s suppliers accounted for more than 10% of the Company’s outstanding accounts payable as of June 30, 2020 and December 31, 2019. (k) Property, Plant and Equipment Items of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are directly attributable to the acquisition of the asset. Gains and losses on disposal of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amounts of property, plant and equipment and are recognized within “other income” in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Depreciation is recognized in profit and loss on an accelerated basis over the estimated useful lives of the property, plant and equipment. Leased assets are depreciated over the shorter of the lease term or their useful lives. Depreciation expense totaled $3,214 and $10,111 for the three and six months ended June 30, 2020, respectively and $9,542 and $14,975 for the three and six months ended June 30, 2019, respectively. Impairment expense totaled $18,680 for the three and six months ended June 30, 2020, respectively and $0 for the three and six months ended June 30, 2019, respectively, in connection with the determination as of June 30, 2020 that equipment utilized in the production of the Company’s rapid, point-of-care screening and testing products was fully impaired. (l) Right-of-Use Assets The Company leases its facility in West Deptford, New Jersey (the “Thorofare Facility”) under an operating lease (“Thorofare Lease”) with annual rentals of $132,000 plus common area maintenance (CAM) charges. The Thorofare Facility houses the Company’s office, manufacturing, laboratory and warehouse space. The Thorofare Lease took effect on January 1, 2008. On January 7, 2013, the Company extended the Thorofare Lease extending the term to December 31, 2019. On November 11, 2019, the Company entered into another extension of the Thorofare Lease, extending the term to December 31, 2021, effective January 1, 2020, and providing for an early termination option with a 150-day notice period. On July 16, 2020, the Company exercised the early termination option under the lease agreement, with the effect of the post exercise lease maturity date changing to December 13, 2020. On January 1, 2020 (“Effective Date”), the Company adopted FASB Accounting Standards Codification, or ASC, Topic 842, Leases (“ASC 842”), which increases transparency and comparability by recognizing a lessee’s rights and obligations resulting from leases by recording them on the balance sheet as lease assets and lease liabilities. The new guidance requires the recognition of the right-of-use (“ROU”) assets and related operating and finance lease liabilities on the balance sheet. The Company adopted the new guidance using the modified retrospective approach on January 1, 2020. As a result, the consolidated balance sheet as of December 31, 2019 was not restated and is not comparative. The adoption of ASC 842 resulted in the recognition of ROU assets of $306,706 and lease liabilities for an operating lease of $306,706 on the Company’s Condensed Consolidated Balance Sheet as of January 1, 2020. The Company elected the package of practical expedients permitted within the standard, which allows an entity to forgo reassessing (i) whether a contract contains a lease, (ii) classification of leases, and (iii) whether capitalized costs associated with a lease meet the definition of initial direct costs. Also, the Company elected the expedient allowing an entity to use hindsight to determine the lease term and impairment of ROU assets and the expedient to allow the Company to not have to separate lease and non-lease components. The Company has also elected the short-term lease accounting policy under which the Company would not recognize a lease liability or ROU asset for any lease that at the commencement date has a lease term of twelve months or less and does not include a purchase option that the Company is more than reasonably certain to exercise. For contracts entered into on or after the Effective Date, at the inception of a contract, the Company will assess whether the contract is, or contains, a lease. The Company’s assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether the Company obtained the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether the Company has the right to direct the use of the asset. Leases entered into prior to January 1, 2020, which were accounted for under ASC 840, were not reassessed for classification. For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The Company generally uses its incremental borrowing rate as the discount rate for leases, unless an interest rate is implicitly stated in the lease. The present value of the lease payments is calculated using the incremental borrowing rate for operating leases, which was determined using a portfolio approach based on the rate of interest that the Company would have to pay to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend the lease that the Company is reasonably certain to exercise, or an option to extend the lease controlled by the lessor. All ROU assets are reviewed for impairment. Lease expense for operating leases consists of the lease payments plus any initial direct costs and is recognized on a straight-line basis over the lease term. Effective June 30, 2020, the Company recorded an adjustment to its right-of-use asset and liability in the amounts of $153,709 and $155,737, respectively, to adjust for the effect of the Company having elected to exercise the early termination option under the lease agreement, as discussed earlier. The following information reflects the effect of the adjustments discussed above in connection with the Company’s exercise of the early termination option. The Company’s operating lease is comprised solely of the lease of its Thorofare Facility. Condensed Consolidated Balance Sheet information related to its lease is presented below: Balance Sheet Location June 30, 2020 January 1, 2020 December 31, 2019 Operating Lease Right-of-use asset $ 79,942 $ 306,706 $ - Liability, current 80,018 143,018 - Liability, net of current - 163,688 - The following provides details of the Company’s lease expense, including CAM charges: Three months ended Six months ended Lease cost Operating lease $ 40,132 $ 83,076 Other information related to leases is presented below: Other information As of June 30, Operating cash used by operating leases $ 83,000 Weighted-average remaining lease term – operating leases (in months) 6 Weighted-average discount rate – operating leases 10.00 % As of June 30, 2020, the annual minimum lease payments of the Company’s operating lease liabilities were as follows: For Years Ending December 31, Operating leases 2020 (excluding the six months ended June 30, 2020) $ 82,368 Total future minimum lease payments, undiscounted $ 82,368 Less: Imputed interest (2,350 ) Present value of future minimum lease payments $ 80,018 (m) Intangible Assets The Company’s long-lived intangible assets, other than goodwill, are assessed for impairment when events or circumstances indicate there may be an impairment. These assets were initially recorded at their estimated fair value at the time of acquisition and assets not acquired in acquisitions were recorded at historical cost. However, if their estimated fair value is less than the carrying amount, other intangible assets with indefinite lives are reduced to their estimated fair value through an impairment charge to the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. As of June 30, 2020, on account of the unfavorable factors existing within its rapid, point-of-care screening and testing products business, the Company determined that the intellectual property comprising the remaining intangible assets was fully impaired. Accordingly, during the three and six months ended June 30, 2020, the Company recorded impairment charges of $149,870 and $152,822, respectively. There were no impairment charges of intangible assets during the three and six months ending June 30, 2019. Intangible assets as of June 30, 2020 and December 31, 2019 were $0 and $170,423, respectively. Intangible assets at June 30, 2020 consisted of patents, trademarks and customer lists of $3,897,635, net of accumulated amortization and impairment of $3,897,635. Intangible assets at December 31, 2019 consisted of patent, trademarks and customer lists of $3,897,635, net of accumulated amortization and impairment of $3,727,212. Amortization is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. Amortization expense was $8,727 and $10,002 for the three months ended June 30, 2020 and 2019 and $17,601 and $20,004 for the six months ended June 30, 2020 and 2019, respectively. (n) Revenue Recognition Beginning on January 1, 2019, the Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of this revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods and services transferred to the customer. The following five steps are applied to achieve that core principle: Step 1: Identify the contract with the customer Step 2: Identify the performance obligations in the contract Step 3: Determine the transaction price Step 4: Allocate the transaction price to the performance obligations in the contract Step 5: Recognize revenue when the Company satisfies a performance obligation The Company does not have any significant contracts with customers requiring performance beyond delivery. Shipping and handling activities are performed before the customer obtains control of the goods and therefore represent a fulfillment activity rather than a promised service to the customer. Revenue and costs of sales are recognized when control of the product transfers to the Company’s customer, which generally occurs upon delivery to the customer but can also occur when goods are shipped by the Company, depending on the shipment terms of the contract. The Company’s performance obligations are satisfied at that time. The Company uses the most likely amount approach to determine the variable consideration of the transaction price in order to account for the contractual rebates and incentives that are estimated and adjusted for over time. The Company provides for rebates to its distributors. The Company had accrued for rebates and incentives of $200 and $20,002 as of June 30, 2020 and December 31, 2019, respectively. Accounts receivable will be reduced when the rebates are applied by the customer. The Company recognized credits of $536 and $1,199 for the three and six months ended June 30, 2020 and rebates and incentives of $7,679 and $16,377 during the three and six months ended June 30, 2019. The Company recognized sales discounts of $10,632 and $11,366 for the three and six months ended June 30, 2020, and $7,406 and $20,957 for the three and six months ended June 30, 2019. These components are included as product revenue in the Condensed Consolidated Statement of Operations and Comprehensive Loss. (o) Research and Development Costs In accordance with FASB ASC 730, (p) Income Taxes The Company utilizes an asset and liability approach for financial accounting and reporting for income taxes. The provision for income taxes is based upon income or loss after adjustment for those permanent items that are not considered in the determination of taxable income. Deferred income taxes represent the tax effects of differences between the financial reporting and tax basis of the Company’s assets and liabilities at the enacted tax rates in effect for the years in which the differences are expected to reverse. The Company evaluates the recoverability of deferred tax assets and establishes a valuation allowance when it is more likely than not that some portion or all the deferred tax assets will not be realized. Management makes judgments as to the interpretation of the tax laws that might be challenged upon an audit and cause changes to previous estimates of tax liability. In management’s opinion, adequate provisions for income taxes have been made. If actual taxable income by tax jurisdiction varies from estimates, additional allowances or reversals of reserves may be necessary. Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of June 30, 2020, and December 31, 2019, no liability for unrecognized tax benefits was required to be reported. There is no income tax benefit for the losses for the three and six months ended June 30, 2020 and 2019 since management has determined that the realization of the net deferred assets is not assured and has created a valuation allowance for the entire amount of such tax benefits. The Company’s policy for recording interest and penalties associated with tax audits is to record such items as a component of general and administrative expense. There were no amounts accrued for penalties and interest for the three and six months ended June 30, 2020 and 2019. The Company does not expect its uncertain tax position to change during the next twelve months. Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position. (q) Shipping and Handling Fees and Costs The Company charges actual shipping costs plus a handling fee to customers, which amounted to $1,511 and $10,568 for the three and six months ended June 30, 2020 and $9,511 and $21,997 for the three and six months ended June 30, 2019, respectively. These fees are classified as part of product revenue in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Shipping and other related delivery costs, including those for incoming raw materials are classified as product cost of sales, which amounted to $5,261 and $17,918 for the three and six months ended June 30, 2020 and $15,660 and $27,579 for the three and six months ended June 30, 2019. (r) Basic and Diluted Earnings per Share of Common Stock Basic earnings per common share is based on the weighted average number of shares outstanding during the periods presented. Diluted earnings per share is computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the period. Potential common shares that would have the effect of increasing diluted earnings per share are considered anti-dilutive. The calculation of basic and diluted loss per share for the three months ended June 30, 2020 and 2019 was based on the net loss of $3,628,131 and $794,891, respectively and $7,166,667 and $1,711,849 for the six months ended June 30, 2020 and 2019, respectively. The basic and diluted weighted average number of common shares outstanding for the three months ended June 30, 2020 and 2019 was 5,252,211 and 541,367, respectively and 3,739,529 and 541,000 for the six months ended June 30, 2020, respectively. Diluted net loss per share is computed using the weighted average number of common and dilutive potential common shares outstanding during the period. As the Company reported a net loss for the three and six months ended June 30, 2020 and 2019, common share equivalents were anti-dilutive. Therefore, the amounts report for basic and diluted loss per share were the same. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Three and Six Months Ended 2020 2019 Stock Options 40 291 RSUs 15,603 15,603 Warrants to purchase common stock 417,896 88,015 Series D Preferred Convertible Stock 208,577 - Warrants to purchase Series C Preferred stock 946,500 - Total potentially dilutive shares 1,588,616 103,909 (s) Reclassifications Certain prior year amounts have been reclassified to conform to the current year’s presentation. (t) Recently Issued Accounting Pronouncements Recently Issued Accounting Pronouncements Adopted In February 2016, the FASB issued ASU 2016-02—Leases (Topic 842) (“ASU-2016-02”), which requires an entity to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor, and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The Company has adopted ASU-2016-02, effective January 1, 2020, and, as a result of this implementation, has recorded an operating lease right-of-use asset and an operating lease liability as of June 30, 2020. Recently Issued Accounting Pronouncements Not Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments (“ASU-2016-13”). ASU 2016-13 affects loans, debt securities, trade receivables, and any other financial assets that have the contractual right to receive cash. The ASU requires an entity to recognize expected credit losses rather than incurred losses for financial assets. ASU 2016-13 is effective for the fiscal year beginning after December 15, 2022, including interim periods within that fiscal year. The Company expects that there would be no material impact on the Company’s condensed consolidated financial statements upon the adoption of this ASU. |
Recent Developments, Liquidity
Recent Developments, Liquidity and Management's Plans | 6 Months Ended |
Jun. 30, 2020 | |
Expenses Related Public Offering [Domain] | |
Recent Developments, Liquidity and Management's Plans | Note 3 – Recent Developments, Liquidity and Management’s Plans Ceasing Production and Sale of Rapid, Point-Of-Care Screening and Testing Products As previously disclosed, in light of the unfavorable factors persistent in our rapid, point-of-care screening and testing product business and the progress the Company has made in its partnership with Premas, the Company conducted a strategic review of the screening and testing products business. Following such review, in early July 2020, the Company ceased the production and sale of its rapid, point-of-care screening and testing products. The Company will continue to provide support for these testing products that remain in the market through their respective product expiration dates. The Company had been experiencing declining sales revenue and production backlogs for these products and, as it previously reported, had eliminated its sales force for such products. The Company intends to devote its attention to its partnership with Premas for the development of its COVID-19 Vaccine Candidate and will continue to explore strategic alternatives that the Company believes will increase shareholder value. In connection with the ceasing production and sale of its existing product line, on July 16, 2020, the Company decided to close the Thorofare Facility and exercised the early termination option under the Thorofare Lease, which provided for a 150-day notice to terminate the lease. Pursuant to the early termination option, the Thorofare Lease will mature on December 13, 2020. Exploration of Strategic Alternatives In addition, the Company’s board of directors (the “Board”) continues to evaluate strategic alternatives to maximize shareholder value. This process will consider a range of potential strategic alternatives including, but not limited to, business combinations. The Company does not plan to disclose or comment on developments regarding the strategic review process until it is complete or further disclosure is deemed appropriate. There can be no assurance that the exploration of strategic alternatives will result in any transaction or other alternative. August Offering On August 13, 2020, pursuant to a securities purchase agreement with certain institutional and accredited investors, dated August 11, 2020, the Company issued and sold in a registered direct offering (the “August Offering”) an aggregate of 1,207,744 shares of its common stock at an offering price of $5.67 per share, for gross and net proceeds of approximately $6.8 million and $6.2 million, respectively. The Company issued to the placement agent or its designees warrants to purchase up to 96,620 shares of common stock at an exercise price of $7.0875 as compensation in connection with the August Offering. Such warrants are exercisable immediately and will expire on August 11, 2025. ChubeWorkx Settlement Agreement and General Release On August 3, 2020, the Company entered into a Settlement Agreement and General Release (the “SAGR”) with ChubeWorkx Guernsey Limited (“ChubeWorkx”). The Company and ChubeWorkx entered into the SAGR to terminate a prior Settlement Agreement, dated August 17, 2016, by and among the Company and ChubeWorkx, pursuant to which the Company granted ChubeWorkx a security interest in substantially all of the Company’s assets, and to fully and finally settle and compromise any and all current and future claims and liabilities of any nature arising between the Company and ChubeWorkx in relation to, or otherwise connected with, the Prior Agreements, on the terms set forth in the SAGR. For a more detailed discussion of the ChubeWorkx Settlement, see Note 7 herein. Corporate Governance Reforms On May 28, 2020, the United States District Court for the District of New Jersey approved that certain Amended Stipulation and Agreement of Settlement, dated October 1, 2019 (the “Settlement”) among the settling parties in connection with a consolidated shareholder derivative action, Case No.: 2:18-cv-15992. Pursuant to the Settlement, effective as of July 21, 2020, the Company made various modifications to its corporate governance and business ethics practices as further discussed below. On July 21, 2020, the Board adopted amended and restated bylaws (the “A&R Bylaws”) that became effective as of July 21, 2020 pursuant to the Settlement. The A&R Bylaws were adopted to require that, among other things: (i) each member of the Board attend each annual meeting of our shareholders in person, absent extraordinary circumstances; (ii) the role of the Chairman of the Board be rotated among our independent directors every five years; (iii) at least half (50%) of the Board be comprised of directors who qualify as independent directors under applicable listing standards of The Nasdaq Stock Market LLC; (iv) our independent directors to meet in executive session following each Board meeting, in no event less than four (4) times per year; (v) following November 27, 2020, the positions of Chairman of the Board and Chief Executive Officer are to be held by different individuals, and (vi) following November 27, 2020, no one person shall serve the positions of the chief executive officer and the chief financial officer. Pursuant to the Settlement, these changes will remain in place for at least four years. In addition, pursuant to the Settlement, on July 21, 2020, the Board formed a risk and disclosure committee (the “Risk and Disclosure Committee”) and adopted a new whistleblower policy (the “Whistleblower Policy”) and a charter for the Risk and Disclosure Committee (the “Risk and Disclosure Committee Charter”) to govern the Risk and Disclosure Committee. In order to align the Company’s Code of Ethics (the “Code”) that applies to all of its directors, officers, and employees with the newly adopted Whistleblower Policy and the Risk and Disclosure Committee Charter, the Board revised the Code. As required by the Settlement, any waivers of any provision of the Code may be granted only by the Risk and Disclosure Committee. In addition, the Code was revised to clarify the enforcement mechanism for violations of the Code. Furthermore, pursuant to the Settlement, the Board approved and adopted revised charters of our standing committees. Departure of Interim Chief Financial Officer On July 19, 2020, the Company and Howard R. Yeaton, our Interim Chief Financial Officer, agreed by mutual understanding that Mr. Yeaton’s employment as the Company’s officer and employee will cease effective August 19, 2020, in accordance with the terms of his employment agreement dated January 6, 2020. Appointment of Chief Financial Officer On July 21, 2020, the Company entered into a CFO Consulting Agreement (the “Consulting Agreement”) with Brio Financial Group (“Brio”), pursuant to which the Company appointed Mr. Stuart Benson as Chief Financial Officer, effective August 19, 2020, with a term ending June 30, 2021. Pursuant to the Consulting Agreement, the Company will pay Brio an initial retainer fee of $7,500 and a fixed monthly payment of $13,500, commencing August 15, 2020. The Company will also be billed for travel and other out-of-pocket costs, such as report production, postage, etc. Acquisition of Cystron On March 23, 2020, the Company acquired Cystron pursuant to that certain Membership Interest Purchase Agreement (the “MIPA”). Cystron was incorporated on March 10, 2020. Upon the Company’s purchase of Cystron, Cystron’s sole asset consisted of an exclusive license with respect to Premas’ vaccine platform for the development of a vaccine against COVID-19 and other coronavirus infections. Since its formation and through the date of its acquisition by the Company, Cystron did not have any employees. The acquisition of Cystron was accounted for as the purchase of an asset. As consideration for the Membership Interests (as defined in the MIPA), the Company delivered to the members of Cystron (the “Sellers”): (1) that number of newly issued shares of its common stock equal to 19.9% of the issued and outstanding shares of its common stock and pre-funded warrants as of the date of the MIPA, but, to the extent that the issuance of its common stock would have resulted in any Seller owning in excess of 4.9% of the Company’s outstanding common stock, then, at such Seller’s election, such Seller received “common stock equivalent” preferred shares with a customary 4.9% blocker (with such common stock and preferred stock collectively referred to as “Common Stock Consideration”), and (2) $1,000,000 in cash. On March 24, 2020 the Company paid $1,000,000 to the Sellers and delivered 411,403 shares of common stock and 211,353 shares of Series D Convertible Preferred Stock with a customary 4.9% blocker, with an aggregate fair market value of $1,233,057, and recorded $2,233,057 as a charge to research and development expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss. On April 22, 2020, Premas, one of the Sellers, returned to us $299,074 representing its portion of the cash purchase price to acquire Cystron. Premas has advised us that these funds were returned temporarily for Premas to meet certain regulatory requirements in India. Additionally, the Company shall (A) make an initial payment to the Sellers of up to $1,000,000 upon its receipt of cumulative gross proceeds from the consummation of an initial equity offering after the date of the MIPA of $8,000,000, and (B) pay to Sellers an amount in cash equal to 10% of the gross proceeds in excess of $8,000,000 raised from future equity offerings after the date of the MIPA until the Sellers have received an aggregate additional cash consideration equal to $10,000,000 (collectively, the “Equity Offering Payments”). On May 14, 2020, the Company and the Sellers entered into an Amendment No. 1 to the MIPA (the “Amendment”), which provided that any Equity Offering Payments in respect of an equity offering that is consummated prior to September 23, 2020, shall be accrued, but shall not be due and payable until September 24, 2020. The other provisions of the MIPA remain unmodified and in full force and effect. Upon the achievement of certain milestones, including the completion of a Phase 2 study for a COVID-19 Vaccine Candidate that meets its primary endpoints, Sellers will be entitled to receive an additional 750,000 shares of the Company’s common stock or, in the event the Company is unable to obtain stockholder approval for the issuance of such shares, 750,000 shares of non-voting preferred stock that are valued following the achievement of such milestones and shall bear a 10% annual dividend (the “Milestone Shares”). Sellers will also be entitled to contingent payments from the Company of up to $20,750,000 upon the achievement of certain milestones, including the approval of a new drug application by the FDA. Pursuant to the MIPA, upon the Company’s consummation of the registered direct equity offering closed on April 8, 2020, the Company paid the Sellers $250,000 on April 20, 2020 (the “April Payment”). On April 30, 2020, Premas, one of the Sellers, returned to us $83,334, representing their portion of the $250,000 amount paid to the Sellers on April 20, 2020. Premas has advised us that these funds were returned temporarily for Premas to meet certain regulatory requirements in India. The Company recorded liabilities of $892,500 (the “May Payment”) and $684,790 to the Sellers upon the consummation of the registered direct equity offering closed on May 18, 2020 and the consummation of the August Offering, respectively, which are payable on September 24, 2020 pursuant to the Amendment. For the three months period ended June 30, 2020, $1,142,500 is included in research and development expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss for the April Payment and the May Payment. The Company shall also make quarterly royalty payments to Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination product by the Company (the “COVID-19 Vaccine”) for a period of five (5) years following the first commercial sale of the COVID-19 Vaccine; provided, that such payment shall be reduced to 3% for any net sales of the COVID-19 Vaccine above $500 million. In addition, Sellers shall be entitled to receive 12.5% of the transaction value, as defined in the MIPA, of any change of control transaction, as defined in the MIPA, that occurs prior to the fifth (5th) anniversary of the closing date of the MIPA, provided that the Company is still developing the COVID-19 Vaccine Candidate at that time. Following the consummation of any change of control transaction, the Sellers shall not be entitled to any payments as described above under the MIPA. License Agreement Cystron is a party to a License and Development Agreement (the “Initial License Agreement”) with Premas. As a condition to the Company’s entry into the MIPA, Cystron amended and restated the Initial License Agreement on March 19, 2020 (as amended and restated, the “License Agreement”). Pursuant to the License Agreement, Premas granted Cystron, amongst other things, an exclusive license with respect to Premas’ vaccine platform for the development of a vaccine against COVID-19 and other coronavirus infections. Upon the achievement of certain developmental milestones by Cystron, Cystron shall pay to Premas a total of up to $2,000,000. On April 16, 2020, the Company paid Premas $500,000 for the achievement of the first two development milestones of which $250,000 was accrued as research and development expense for the three months ended March 31, 2020. On May 18, 2020, the Company paid Premas $500,000 for the achievement of the third development milestone. On July 7, 2020, the Company and Premas agreed that the fourth milestone under the License Agreement had been satisfied. Due to the achievement of this milestone, Premas is entitled to receive a payment of $1,000,000. Cystron Medical Panel On April 10, 2020, the Company established the Cystron Medical Panel and appointed its first member to the panel. Each member shall be compensated with an initial grant of the Company’s common stock with an aggregate fair market value of $25,000 and a monthly cash stipend in the initial amount of $2,500. During the three and six months ended June 30, 2020, the Company recorded $10,274 as a charge to research and development expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss. Series D Convertible Preferred Stock On March 24, 2020, the Company filed the Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of New Jersey. Pursuant to the Certificate of Designation, in the event of the Company’s liquidation or winding up of its affairs, the holders of its Series D Convertible Preferred Stock (the “Preferred Stock”) will be entitled to receive the same amount that a holder of the Company’s common stock would receive if the Preferred Stock were fully converted (disregarding for such purposes any conversion limitations set forth in the Certificate of Designation) to common stock which amounts shall be paid pari passu with all holders of the Company’s common stock. Each share of Preferred Stock has a stated value equal to $0.01 (the “Stated Value”), subject to increase as set forth in Section 7 of the Certificate of Designation. A holder of Preferred Stock is entitled at any time to convert any whole or partial number of shares of Preferred Stock into shares of the Company’s common stock determined by dividing the Stated Value of the Preferred Stock being converted by the conversion price of $0.01 per share. A holder of Preferred Stock will be prohibited from converting Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of the Company’s common stock then issued and outstanding (with such ownership restriction referred to as the “Beneficial Ownership Limitation”). However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice to us. In addition, a holder of Preferred Stock is prohibited from converting any portion of the Preferred Stock if, as a result of such conversion, the holder, together with its affiliates, would exceed the aggregate number shares of our common stock which we may issue under the MIPA without breaching our obligations under the rules or regulations of the Nasdaq Stock Market (the number of shares which may be issued without violating such rules and regulations, the “Exchange Cap”). Subject to the Beneficial Ownership Limitation and the Exchange Cap, on any matter presented to the Company’s stockholders for their action or consideration at any meeting of the Company’s stockholders (or by written consent of stockholders in lieu of a meeting), each holder of Preferred Stock will be entitled to cast the number of votes equal to the number of whole shares of the Company’s common stock into which the shares of Preferred Stock beneficially owned by such holder are convertible as of the record date for determining stockholders entitled to vote on or consent to such matter (taking into account all Preferred Stock beneficially owned by such holder). Except as otherwise required by law or by the other provisions of the Company’s certificate of incorporation, the holders of Preferred Stock will vote together with the holders of the Company’s common stock and any other class or series of stock entitled to vote thereon as a single class. A holder of Preferred Stock shall be entitled to receive dividends as and when paid to the holders of the Company’s common stock on an as-converted basis. During the three and six months ended June 30, 2020, 2,776 shares of Preferred Stock were converted to 2,776 common shares. As of June 30, 2020, 208,577 shares of Series D Preferred Stock were issued and outstanding. Liquidity As of June 30, 2020, the Company’s cash on hand was $11,561,811 (which included restricted cash of $115,094), and its marketable securities were $6,856,805. The Company has incurred net losses of $7,166,667 for the six months ended June 30, 2020. As of June 30, 2020, the Company had working capital of $15,772,329 and stockholder’s equity of $15,972,148. During the six months ended June 30, 2020, cash flows used in operating activities were $3,883,101, consisting primarily of a net loss of $7,166,667, which includes, principally, research and development costs in connection with the purchase of a license and milestone license fees of $4,375,557. Since its inception, the Company has met its liquidity requirements principally through the sale of its common stock in public and private placements. On April 8, 2020, pursuant to a securities purchase agreement with certain institutional and accredited investors, the Company issued and sold in a registered direct offering (the “April Offering”) an aggregate of 766,667 shares of common stock of the Company at an offering price of $6.00 per share, for gross and net proceeds of $4,600,002 and $4,086,207, respectively. In connection with the April Offering, the Company issued to the placement agent or designees warrants to purchase up to 61,333 shares of its common stock at an exercise price of $7.50 (the “April Placement Agent Warrants”) in a private placement. The April Placement Agent Warrants will be exercisable at any time and from time to time, in whole or in part, following the date of issuance and for a term of five years from the effective date of the April Offering. On April 20, 2020, the Company recorded $250,000 of the net proceeds from the April Offering to the former members of Cystron Biotech, LLC, pursuant to the terms of that certain MIPA as a charge to research and development expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss. During the period of April 6, 2020 through April 16, 2020, warrants to purchase an aggregate of 1,043,500 shares of Series C Convertible Preferred Stock were exercised at an exercise price of $4.00 per share, yielding proceeds of $4,174,000. On May 18, 2020, pursuant to a securities purchase agreement with certain institutional and accredited investors, the Company issued and sold in a registered direct offering (the “May Offering”) an aggregate of 1,366,856 shares of its common stock at an offering price of $3.53 per share, for gross and net proceeds of $4,825,002 and $4,320,720, respectively. In connection with the May Offering, the Company issued to the placement agent or designees warrants to purchase up to 109,348 shares of its common stock at an exercise price of $4.4125 (the “May Placement Agent Warrants”) in a private placement. The May Placement Agent Warrants will be exercisable at any time and from time to time, in whole or in part, following the date of issuance and for a term of five years from the effective date of the May Offering. During the period subsequent to June 30, 2020 and through August 11, 2020, warrants to purchase an aggregate of 891,500 shares of Series C Convertible Preferred Stock were exercised at an exercise price of $4.00 per share, yielding proceeds of $3,566,000. In connection with the August Offering, the Company issued and sold an aggregate of 1,207,744 shares of its common stock at an offering price of $5.67 per share, for gross and net proceeds of $6,847,908 and approximately $6,178,000, respectively. In connection with the August Offering, the Company issued to the placement agent or designees warrants to purchase up to 96,620 shares of its common stock at an exercise price of $7.0875 (the “August Placement Agent Warrants”) in a private placement. The August Placement Agent Warrants will be exercisable at any time and from time to time, in whole or in part, following the date of issuance and for a term of five years from the effective date of the August Offering. Liquidity The Company’s current cash resources will not be sufficient to fund the development of its COVID-19 Vaccine candidate through all of the required clinical trials to receive regulatory approval and commercialization. While the Company does not currently have an estimate of all of the costs that it will incur in the development of the COVID-19 Vaccine, the Company anticipates that it will need to raise significant additional funds in order to continue the development of the Company’s COVID-19 Vaccine candidate during the next 12-months. In addition, the Company could also have increased capital needs if it were to engage in strategic alternatives. The Company’s ability to obtain additional capital may depend on prevailing economic conditions and financial, business and other factors beyond its control. The COVID-19 pandemic has caused an unstable economic environment globally, and the ultimate impact of the COVID-19 pandemic on the Company’s operations is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence. These include but are not limited to the duration of the COVID-19 pandemic, new information which may emerge concerning the severity of the COVID-19 pandemic, and any additional preventative and protective actions that regulators, or the board or management of the Company, may determine are needed. Disruptions in the global financial markets may adversely impact the availability and cost of credit, as well as the Company’s ability to raise money in the capital markets. Current economic conditions have been and continue to be volatile. Continued instability in these market conditions may limit the Company’s ability to access the capital necessary to fund and grow its business. The Company believes that its current financial resources as of the date of the issuance of these consolidated financial statements, are sufficient to fund its current twelve month operating budget, alleviating any substantial doubt raised by the Company’s historical operating results and satisfying its estimated liquidity needs for twelve months from the issuance of these consolidated financial statements. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 4 – Inventories Inventories are measured at the lower of cost or net realizable value. The cost of inventories is based on the weighted-average principle, and includes expenditures incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition. In the case of manufactured inventories and work in progress, costs include an appropriate share of production overhead based on normal operating capacity. Inventories consist of the following: June 30, 2020 December 31, 2019 Raw Materials $ - $ 274,551 Sub-Assemblies - 303,461 Finished Goods - 28,223 Reserve for Obsolescence - (407,250 ) $ - $ 198,985 As of June 30, 2020, on account of the unfavorable factors existing within its rapid, point-of-care screening and testing products business, the Company determined that inventory would be written down to a net realizable value of $0. Accordingly, during the three and six months ended June 30, 2020, the Company recorded charges of $193,839 and $197,723, respectively, to adjust inventory to net realizable value. During the three and six months ended June 30, 2019, the Company recorded charges of $41,849 and $45,946, respectively, to adjust for obsolete inventory. These amounts were reflected within product cost of sales in the condensed consolidated statement of operations and comprehensive loss. |
Trade and Other Payables
Trade and Other Payables | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Trade and Other Payables | Note 5 - Trade and Other Payables Trade and other payables consist of the following: June 30, 2020 December 31, 2019 Accounts Payable – Trade $ 561,578 $ 657,293 Obligations to Cystron Sellers 1,274,906 - Accrued Expenses 789,088 812,722 Deferred Compensation - 59,750 $ 2,625,572 $ 1,529,765 See also Note 8 for related party information. |
Share-Based Payments
Share-Based Payments | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Note 6 - Share-based Payments Equity Incentive Plans 2013 Stock Incentive Plan On January 23, 2014, the Company adopted the 2013 Stock Incentive Plan (“2013 Plan”). The 2013 Plan was amended by the Board on January 9, 2015 and September 30, 2016, and such amendments were ratified by shareholders on December 7, 2018. The 2013 Plan provides for the issuance of up to 4,323 shares of the Company’s common stock. As of June 30, 2020, grants of restricted stock and options to purchase 2,853 shares of common stock have been issued pursuant to the 2013 Plan, and 1,470 shares of common stock remain available for issuance. 2017 Stock Incentive Plan On August 7, 2017, the shareholders approved, and the Company adopted the 2017 Stock Incentive Plan (“2017 Plan”). The 2017 Plan provides for the issuance of up to 7,031 shares of the Company’s common stock. As of June 30, 2020, grants of restricted stock and options to purchase 3,064 shares of common stock have been issued pursuant to the 2017 Plan, and 3,967 shares of common stock remain available for issuance. 2018 Stock Incentive Plan On December 7, 2018, the shareholders approved, and the Company adopted the 2018 Stock Incentive Plan (“2018 Plan”). The 2018 Plan provides for the issuance of up to 78,125 shares of the Company’s common stock. As of June 30, 2020, grants of RSUs to purchase 15,603 shares of common stock have been issued pursuant to the 2018 Plan, and 62,522 shares of common stock remain available for issuance. Stock Options The following table summarizes the option activities for the six months ended June 30, 2020: Weighted Weighted Weighted Average Average Average Grant Remaining Aggregate Number of Exercise Date Fair Contractual Intrinsic Shares Price Value Term (years) Value Balance at December 31, 2019 40 $ 236.16 $ 151.68 0.99 $ - Granted - - - - - Exercised - - - - - Forfeited - - - - - Canceled/Expired - - - - - Balance at June 30, 2020 40 $ 236.16 $ 151.68 0.50 $ - Exercisable as of June 30, 2020 40 $ 236.16 $ 151.68 0.50 $ - The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $3.48 for the Company’s common stock on June 30, 2020. As the closing stock price on June 30, 2020 is lower than the exercise price, there is no intrinsic value to disclose. As of June 30, 2020, all the Company’s outstanding stock options were fully vested and exercisable. During the three and six months ended June 30, 2020 and 2019, the Company did not incur any stock option expenses. Restricted Stock Units On March 29, 2019, the Compensation Committee of the Company’s board of directors approved the grant of 5,201 Restricted Stock Units (“RSUs”) to each of the three directors. Each RSU had a grant date fair value of $23.28 which was amortized on a straight-line basis over the vesting period into administrative expenses within the Condensed Consolidated Statement of Operations and Comprehensive Loss. Such RSUs were granted under the 2018 Plan and vested on January 1, 2020. Such RSUs are expected to be settled with the issuance of common stock during the three months ending September 30, 2020. At June 30, 2020, the unamortized value of the RSUs was $0. A summary of activity related to RSUs for the six months ended June 30, 2020 is presented below: Weighted Average Number of Grant Date RSUs Fair Value Balance at December 31, 2019 15,603 $ 23.28 Granted - - Exercised - - Forfeited - - Canceled/Expired - - Balance at June 30, 2020 15,603 $ 23.28 Exercisable as of June 30, 2020 15,603 $ 23.28 The Company incurred RSU expense of $0 and $118,478 during the three months ended June 30, 2020 and 2019, respectively and $1,302 and $122,384 during the six months ended June 30, 2020 and 2019, respectively. Common Stock Warrants The table below summarizes the warrant activity for the six month period ended June 30, 2020: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 247,215 $ 29.79 4.32 Granted 170,681 5.52 4.85 Exercised - - - Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 417,896 $ 19.88 4.24 Exercisable as of June 30, 2020 417,896 $ 19.88 4.24 All common stock warrants were vested on date of grant. Pre-funded Common Stock Warrants The table below summarizes the pre-funded warrant activity for the six month period ended June 30, 2020: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 795,000 $ 0.0001 - Granted - - - Exercised (795,000 ) 0.0001 - Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 - $ - - Exercisable as of June 30, 2020 - $ - - All pre-funded warrants were vested on the date of grant and are exercisable at any time. During the six months ended June 30, 2020, pre-funded warrants to purchase 795,000 shares of common stock issued on December 9, 2019 were exercised at an exercise price of $0.0001 per share, yielding net proceeds of $80.00. Warrants for the purchase of Series C Convertible Preferred Stock The table below summarizes the activity during the six month period ended June 30, 2020 for warrants issued in December 2019 for the purchase of Series C Convertible Preferred Stock: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 1,990,000 $ 4.00 4.95 Granted - - - Exercised (1,043,500 ) 4.00 4.45 Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 946,500 $ 4.00 4.45 Exercisable as of June 30, 2020 946,500 $ 4.00 4.45 All warrants to purchase Series C Convertible Preferred Stock were vested on the date of grant. During the six months ended June 30, 2020, 1,043,500 warrants to purchase 1,043,500 share of Series C Convertible Preferred Stock issued on December 9, 2019 were exercised and such shares of Series C Convertible Preferred Stock were immediately converted to 1,043,500 shares of common stock at an exercise price of $4.00 per share, yielding net proceeds of $4,174,000 (See Note 3). |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Advisory Board On December 4, 2019, the Company established a cannabinoid and hemp (“CBD”) Advisory Board, whose role was to provide input to management and the board of directors regarding the identification and assessment of business opportunities in the cannabinoid and hemp industry. The Company is no longer pursuing opportunities in the cannabinoid and hemp industry, and as such, the CBD Advisory Board will be disbanded during the third quarter of 2020. Each member was compensated for their initial 24 months of service with the issuance of Company stock with a fair market value of $25,000. Pursuant to the agreement, such shares, when issued, were fully vested. During the three and six months ended June 30, 2020, the Company recorded a charge of $8,333 and $50,000, respectively which is reflected in administrative expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss. Commitments ChubeWorkx Settlement Agreement and General Release On August 3, 2020, the Company entered into a Settlement Agreement and General Release (the “SAGR”) with ChubeWorkx. The Company and ChubeWorkx entered into the SAGR to terminate a prior Settlement Agreement, dated August 17, 2016, by and among the Company and ChubeWorkx, pursuant to which the Company granted ChubeWorkx a security interest in substantially all of the Company’s assets, and to fully and finally settle and compromise any and all current and future claims and liabilities of any nature arising between the Company and ChubeWorkx in relation to, or otherwise connected with, the Prior Agreements, on the terms set forth in the SAGR. As consideration for the settlement of claims pursuant to the SAGR, on August 5, 2020, the Company (i) paid to ChubeWorkx an amount equal to $300,000 and (ii) delivered to ChubeWorkx 500,000 shares of the Company’s common stock (the “Shares”). The Company granted ChubeWorkx registration rights with respect to the Shares. In the event that the Company fails to file a resale registration statement covering the Shares by August 18, 2020 (the “Filing Deadline”), or fails to cause such registration statement to be declared effective by the earlier of October 2, 2020 or 45 days after the filing of such registration statement (the “Effectiveness Deadline”), then, on each of the Filing Deadline and the Effectiveness Deadline, as the case may be, and on each monthly anniversary thereof (if the such registration statement shall not have been filed or declared effective by such date, as the case may be) until such registration statement is filed or declared effective, the Company shall pay to ChubeWorkx an amount in cash, as partial liquidated damages equal to 1.0% of the market value of the Shares. As of the earlier to occur, following and subject to delivery and complete full effective legal transfer to ChubeWorkx of the Shares and delivery of the cash payment to ChubeWorkx in full in accordance with the provisions of the SAGR, of (i) the date that the resale registration statement covering the Shares is declared effective by the U.S. Securities and Exchange Commission and (ii) the date that all of the Shares may be resold by ChubeWorkx under Rule 144 of the Securities Act of 1933, as amended, without restriction (the “Release Date”), any and all claims, differences, and disputes of any current and/or future claims and/or liabilities arising between the Company and ChubeWorkx in relation to, or otherwise connected with, the Prior Agreements shall be deemed fully and finally settled and compromised (with the exception of any claims arising under the SAGR or the Leak-Out and Support Agreement as described below). As of the Release Date, each of the Prior Agreements will be terminated, and ChubeWorkx will automatically and irrevocably release all security interests and liens created under the Security Agreement or otherwise as security for the Company obligations under the Prior Agreements. ChubeWorkx Leak-Out and Support Agreement On August 3, 2020, as an inducement to enter into the SAGR, and as one of the conditions to the consummation of the transactions contemplated by the SAGR, ChubeWorkx entered into a Leak-Out and Support Agreement with the Company (the “Support Agreement”), pursuant to which ChubeWorkx agreed to vote the Shares in favor of each matter proposed and recommended for approval by the Company’s board of directors or management at every meeting of the stockholders and on any action or approval by written consent of the stockholders and (ii) limit sales of its shares of common stock issued pursuant to the SAGR per day to no more than 10% of our daily traded volume per day on the Nasdaq Capital Market and we agreed to register the resale of such shares pursuant to a registration statement. Litigation Watts v. Gormally, et al., and Chan v. Gormally, et al. On November 9, 2018, Cale Watts (“Watts Plaintiff”) filed a verified shareholder derivative complaint alleging violations of the Securities Exchange Act of 1934, breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on alleged material weaknesses in controls, management, and documentation (the “Watts Action”). On January 14, 2019, the parties reached an agreement in principle to settle the Watts Action that included corporate reforms and a payment of attorneys’ fees of $200,000. The parties finalized a Stipulation of Settlement on March 4, 2019. On February 7, 2019, Tiffany Chan, Jasmine Henderson, and Don Danesh (“Chan Plaintiffs”) filed a verified shareholder derivative complaint alleging violations of Section 14(a) of the Exchange Act and SEC Rule 14a-9, breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on the same circumstances as the Watts Action (the “Chan Action”). The Chan Action further alleged that the Company should not have settled the Watts Action because the Watts Action plaintiffs lacked standing and the settlement would cause irreparable harm to the Company and its shareholders. On March 22, 2019, the Watts Plaintiff filed a motion for preliminary approval of the proposed settlement, approving the proposed form and method of providing notice of the settlement, scheduling a hearing for final approval of the settlement (“Watts Motion for Preliminary Approval”). On April 1, 2019, the Chan Plaintiffs filed an Opposition to the Motion for Preliminary Approval and a Motion to Intervene and Stay Proceedings (“Motion to Intervene and Stay”). Subsequently, the Watts Plaintiff, Chan Plaintiffs, and Defendants reached an agreement in principle to settle the Watts and Chan Actions that included corporate reforms and a payment of attorneys’ fees of $325,000. On October 2, 2019, the Watts Plaintiff filed an Unopposed Motion for Preliminary Approval of the Settlement (the “Omnibus Motion for Preliminary Approval”). The Omnibus Motion for Preliminary Approval was granted on January 8, 2020. Plaintiffs filed their motion for final approval of the proposed settlement on May 7, 2020. The Motion for Final Approval was approved on May 28, 2020. NovoTek Therapeutics Inc. and NovoTek Pharmaceuticals Limited v. Akers Biosciences, Inc. On June 21, 2019, the Company received a complaint, filed by Novotek Therapeutics Inc., and Novotek Pharmaceuticals Limited (collectively, “Novotek”), Beijing-based entities, in the United States District Court for the District of New Jersey, alleging, among other things, breach of contract. Novotek is seeking, among other things, damages in the amount of $1,551,562, plus interest, disbursements and attorneys’ fees. The Company vigorously disputes the allegations in the complaint and has retained counsel to defend it. On September 16, 2019, the Company filed a partial motion to dismiss the complaint, which was fully submitted as of November 4, 2019. On June 9, 2020, the Court denied the Company’s motion. The Company’s Answer to the Complaint is currently due on September 8, 2020. The Company is not yet able to determine the amount of the Company’s exposure, if any. Litigation, continued Neelima Varma v. Akers Biosciences, Inc. and St. David’s Healthcare Partnership, L.P., LLP CAUSE NO: D-1-GN-19-004262 On July 25, 2019, the Company was notified that on July 23, 2019, a complaint was filed by Neelima Varma, against the Company and St. David’s Healthcare Partnership, L.P., LLP (“St. David’s”), in the district court of Travis County, Texas, alleging, among other things, negligence, gross negligence and strict product liability, breach of express warranty, breach of implied warranty and fraudulent misrepresentation and omission, with respect to a medical device which the Company had sold through one its distributors to St. David’s. Ms. Varma was seeking aggregate monetary relief from the Company and St. David’s in excess of $1,000,000. The Company carries product liability insurance. On July 29, 2020, this matter was resolved. The resolution of this matter had no significant impact on the condensed consolidated financial statements of the Company. Douglas Carrara v. Akers Biosciences, Inc., John Does 1-10, and XYZ Corp. 1-10, Docket No. ESX-L-5272-19 (N.J. Super. Ct., Essex County): Douglas Carrara, a former executive, sued the Company for breach of contract in connection with the termination of his employment. In his operative Complaint, filed August 9, 2019, Carrara primarily alleged that the Company breached the terms of his employment agreement by failing to pay “severance” after terminating his employment “without cause.” Based on this alleged breach, Carrara sought compensatory damages and damages for lost wages and benefits. Carrara also sought punitive and/or liquidated damages and attorneys’ fees. On August 29, 2019, the Company filed an answer to the operative complaint, denying all substantive allegations of wrongdoing. As of July 23, 2020, the parties have resolved all material disputes. The parties are in the process of preparing the appropriate documentation to effectuate this resolution and expect to file a stipulation of dismissal with prejudice shortly. The resolution of this matter had no significant impact on the condensed consolidated financial statements of the Company. |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 8 – Related Parties Interim CFO Effective on October 5, 2018 and through December 31, 2019, the Board appointed Howard R. Yeaton, to serve as the Chief Executive Officer and interim Chief Financial Officer of the Company. Effective on January 1, 2020, Mr. Yeaton entered into a new agreement with the Company whereby he serves as the Company’s Interim Chief Financial Officer. Mr. Yeaton is the managing principal of Financial Consulting Strategies (“FCS”), and the Company had an ongoing relationship with FCS as of June 30, 2020, with FCS continuing to provide accounting services to the Company, and the company may continue to utilize the services of FCS in the future. FCS is considered to be a related party. During the six months ended June 30, 2020 and 2019, pursuant to his October 2018 employment agreement, the Company issued 0 and 1,095 shares of common stock under the 2017 Plan to Mr. Yeaton, with a fair value on the date of grant, of $0 and $22,444, respectively. As of June 30, 2020, included in accounts payable and accrued expenses was an obligation of $3,173, representing an obligation to issue 471 shares of common stock to Mr. Yeaton, earned during 2019, but not issued. The accrual is reflected in trade and other payables on the Condensed Consolidated Balance Sheet. |
Revenue Information
Revenue Information | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Revenue Information | Note 9 – Revenue Information Revenue by product lines was as follows: Three Months Ended Six Months Ended June 30, June 30, Product Line 2020 2019 2020 2019 MicroParticle Catalyzed Biosensor (“MPC”) $ - $ 65,344 $ - $ 88,664 Particle ImmunoFiltration Assay (“PIFA”) (3,399 ) 304,658 351,059 880,973 Rapid Enzymatic Assay (“REA”) - 85,000 - 85,000 Other 1,511 9,511 10,568 21,997 Total Revenue $ (1,888 ) $ 464,513 $ 361,627 $ 1,076,634 The total revenue by geographic area determined based on the location of the customers was as follows: Three Months Ended Six Months Ended June 30, June 30, Geographic Region 2020 2019 2020 2019 United States $ (1,888 ) $ 447,013 $ 361,627 $ 1,059,134 Rest of World - 17,500 - 17,500 Total Revenue $ (1,888 ) $ 464,513 $ 361,627 $ 1,076,634 The Company had long-lived assets totaling $0 and $9,823 located in the People’s Republic of China and $4,783 and $194,174 located in the United States as of June 30, 2020 and December 31, 2019, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 6 Months Ended |
Jun. 30, 2020 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Note 10 – Employee Benefit Plan The Company maintains a defined contribution benefit plan under section 401(k) of the Internal Revenue Code covering substantially all qualified employees of the Company (the “401(k) Plan”). Under the 401(k) Plan, the Company matches 100% up to a 3% contribution, and 50% over a 3% contribution, up to a maximum of 5%. The Company made matching contributions to the 401(k) Plan during the three months ended June 30, 2020 and 2019 of $5,097 and $7,425, respectively and $22,924 and $16,888 during the six months ended June 30, 2020 and 2019, respectively. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | (a) Basis of Presentation The Condensed Consolidated Financial Statements of the Company are prepared in U.S. Dollars and in accordance with accounting principles generally accepted in the United States of America (US GAAP). Certain information and note disclosures normally included in the financial statements prepared in accordance with US GAAP have been condensed. As such, the information included in these financial statements should be read in conjunction with the audited financial statements as of and for the years ended December 31, 2019 and 2018 included in the Company’s 2019 Form 10-K, as filed on March 25, 2020. In the opinion of the Company’s management, these condensed consolidated financial statements include all adjustments, which are of only a normal and recurring nature, necessary for a fair statement of the financial position of the Company as of June 30, 2020 and its results of operations and cash flows for the three and six months ended June 30, 2020 and 2019. The results of operations for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the full fiscal year ending December 31, 2020. |
Use of Estimates and Judgments | (b) Use of Estimates and Judgments The preparation of financial statements in conformity with US GAAP requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Information about significant areas of estimation, uncertainty and critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the financial statements is included in the following notes for revenue recognition, recording research and development expenses, allowances for doubtful accounts, inventory and prepaid asset write-downs, impairment of equipment and intangible assets and valuation of share-based payments. |
Functional and Presentation Currency | (c) Functional and Presentation Currency These condensed consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency. All financial information has been rounded to the nearest dollar. Foreign Currency Transaction Gains or Losses, resulting from cash balances denominated in Foreign Currencies, are recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss. |
Comprehensive Income (Loss) | (d) Comprehensive Income (Loss) The Company follows Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 220 in reporting comprehensive income (loss). Comprehensive income is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income. |
Cash and Cash Equivalents | (e) Cash and Cash Equivalents The Company considers all highly liquid investments, which include short-term bank deposits (up to three months from date of deposit) that are not restricted as to withdrawal date or use, to be cash equivalents. |
Restricted Cash | (f) Restricted Cash At June 30, 2020, restricted cash included in non-current assets on the Company’s Condensed Consolidated Balance Sheet was $115,094 representing cash in trust for the purpose of funding legal fees for certain litigations. |
Fair Value of Financial Instruments | (g) Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables. The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their short maturities. The framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under FASB ASC 820 are described as follows: Level 1 Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2 Inputs to the valuation methodology include: ● quoted prices for similar assets or liabilities in active markets; ● quoted prices for identical or similar assets or liabilities in inactive markets; ● inputs other than quoted prices that are observable for the asset or liability; ● inputs that are derived principally from or corroborated by observable market data by correlation or other means If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Following is a description of the valuation methodologies used for assets measured at fair value as of June 30, 2020 and December 31, 2019. Marketable Securities: Quoted Prices in Active Quoted Prices for Significant Fixed Income Bonds at June 30, 2020 $ 6,856,805 $ - $ - Fixed Income Bonds at December 31, 2019 $ 9,164,273 $ - $ - Marketable securities are classified as available for sale. The debt securities are valued at fair market value. Maturities of the securities are less than one year. Unrealized gains and losses relating to the available for sale investment securities were recorded in the Condensed Consolidated Statement of Changes in Shareholders’ Equity as other comprehensive (loss) income. These amounts were an unrealized gain of $201,898 and $18,059 for the three months ended June 30, 2020 and 2019, respectively and an unrealized loss of $39,039 and an unrealized gain of $47,402 for the six months ended June 30, 2020 and 2019, respectively. Losses resulting from the sales of marketable securities were $0 and $543 for the three months ended June 30, 2020 and 2019, respectively and were a loss of $36,714 and $4,258 for the six months ended June 30, 2020 and 2019, respectively Proceeds from the sales of marketable securities in the three and six months ended June 30, 2020 were $3,572 and $2,307,462, respectively and were $502,126 and $1,354,646 for the three and six months ended June 30, 2019, respectively. The carrying amounts of current trade receivables are stated at cost, net of allowance for doubtful accounts and approximates their fair value given their short-term nature. The normal credit terms extended to customers range between 30 and 90 days. Credit terms longer than these may be extended after considering the credit worthiness of the customers and the business requirements. The Company reviews all receivables that exceed terms and establishes an allowance for doubtful accounts based on management’s assessment of the collectability of trade and other receivables. A considerable amount of judgment is required in assessing the amount of allowance. The Company considers the historical level of credit losses, makes judgments about the credit worthiness of each customer based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. As of June 30, 2020 and December 31, 2019, allowances for doubtful accounts for trade receivables were $1,273 and $458,902, respectively. Bad debt expenses for trade receivables were $1,273 and $0 for the three months ended June 30, 2020 and 2019 and $1,273 and $4,247 for the six months ended June 30, 2020 and 2019, respectively. During the three and six months ended June 30, 2020, the Company charged off accounts receivable of $458,902 against the allowance for doubtful accounts. |
Trade Receivables and Allowance for Doubtful Accounts | (g) Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables. The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their short maturities. The framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under FASB ASC 820 are described as follows: Level 1 Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2 Inputs to the valuation methodology include: ● quoted prices for similar assets or liabilities in active markets; ● quoted prices for identical or similar assets or liabilities in inactive markets; ● inputs other than quoted prices that are observable for the asset or liability; ● inputs that are derived principally from or corroborated by observable market data by correlation or other means If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability. Level 3 Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Following is a description of the valuation methodologies used for assets measured at fair value as of June 30, 2020 and December 31, 2019. Marketable Securities: Quoted Prices in Active Quoted Prices for Significant Fixed Income Bonds at June 30, 2020 $ 6,856,805 $ - $ - Fixed Income Bonds at December 31, 2019 $ 9,164,273 $ - $ - Marketable securities are classified as available for sale. The debt securities are valued at fair market value. Maturities of the securities are less than one year. Unrealized gains and losses relating to the available for sale investment securities were recorded in the Condensed Consolidated Statement of Changes in Shareholders’ Equity as other comprehensive (loss) income. These amounts were an unrealized gain of $201,898 and $18,059 for the three months ended June 30, 2020 and 2019, respectively and an unrealized loss of $39,039 and an unrealized gain of $47,402 for the six months ended June 30, 2020 and 2019, respectively. Losses resulting from the sales of marketable securities were $0 and $543 for the three months ended June 30, 2020 and 2019, respectively and were a loss of $36,714 and $4,258 for the six months ended June 30, 2020 and 2019, respectively Proceeds from the sales of marketable securities in the three and six months ended June 30, 2020 were $3,572 and $2,307,462, respectively and were $502,126 and $1,354,646 for the three and six months ended June 30, 2019, respectively. The carrying amounts of current trade receivables are stated at cost, net of allowance for doubtful accounts and approximates their fair value given their short-term nature. The normal credit terms extended to customers range between 30 and 90 days. Credit terms longer than these may be extended after considering the credit worthiness of the customers and the business requirements. The Company reviews all receivables that exceed terms and establishes an allowance for doubtful accounts based on management’s assessment of the collectability of trade and other receivables. A considerable amount of judgment is required in assessing the amount of allowance. The Company considers the historical level of credit losses, makes judgments about the credit worthiness of each customer based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. As of June 30, 2020 and December 31, 2019, allowances for doubtful accounts for trade receivables were $1,273 and $458,902, respectively. Bad debt expenses for trade receivables were $1,273 and $0 for the three months ended June 30, 2020 and 2019 and $1,273 and $4,247 for the six months ended June 30, 2020 and 2019, respectively. During the three and six months ended June 30, 2020, the Company charged off accounts receivable of $458,902 against the allowance for doubtful accounts. |
Prepaid Expenses | (i) Prepaid Expenses For expenses paid prior to the date that the related services are rendered or used are recorded as prepaid expenses. Prepaid expenses are comprised principally of prepaid insurance and prepaid royalties. As of June 30, 2020, the Company determined that, on account of the unfavorable factors existing within its rapid, point-of-care screening and testing products business, prepaid royalties in the amount of $291,442 would be fully impaired. For the three and six months ended June 30, 2020, this charge was reflected within Impairment of Prepaid Royalties in the Condensed Consolidated Statement of Operations and Comprehensive Loss. |
Concentrations | (j) Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash on deposit with financial institutions. At times, the Company’s cash in banks is in excess of the FDIC insurance limit. The Company has not experienced any loss as a result of these cash deposits. These cash balances are maintained with two banks. Major Customers For the three months ended June 30, 2020, revenues net of discounts and allowances, was a negative amount of $1,888. For the three months ended June 30, 2019, three customers generated 42%, 20% and 19%, or 81% in the aggregate, of the Company’s revenue. For the six months ended June 30, 2020, two customers generated 58% and 35%, or 93% in the aggregate, of the Company’s revenues. For the six months ended June 30, 2019, two customers generated 44% and 34%, or 78% in the aggregate, of the Company’s revenue. One customer accounted for 100%, and five customers accounted for 30%, 18%, 12%, 12% and 11%, or 83% in the aggregate, of trade receivables net of customer credits and allowances for doubtful accounts as of June 30, 2020 and December 31, 2019, respectively. Major Suppliers Three suppliers accounted for 37%, 28% and 11%, or 76% in the aggregate and two suppliers accounted for 70% and 11% or 81% in aggregate, of the Company’s purchases for the three months ended June 30, 2020 and 2019, respectively. Two suppliers accounted for 49% and 17%, or 66% in the aggregate and one supplier accounted for 63% of the Company’s purchases for the six months ended June 30, 2020 and 2019, respectively. None of the Company’s suppliers accounted for more than 10% of the Company’s outstanding accounts payable as of June 30, 2020 and December 31, 2019. |
Property, Plant and Equipment | (k) Property, Plant and Equipment Items of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include expenditures that are directly attributable to the acquisition of the asset. Gains and losses on disposal of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying amounts of property, plant and equipment and are recognized within “other income” in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Depreciation is recognized in profit and loss on an accelerated basis over the estimated useful lives of the property, plant and equipment. Leased assets are depreciated over the shorter of the lease term or their useful lives. Depreciation expense totaled $3,214 and $10,111 for the three and six months ended June 30, 2020, respectively and $9,542 and $14,975 for the three and six months ended June 30, 2019, respectively. Impairment expense totaled $18,680 for the three and six months ended June 30, 2020, respectively and $0 for the three and six months ended June 30, 2019, respectively, in connection with the determination as of June 30, 2020 that equipment utilized in the production of the Company’s rapid, point-of-care screening and testing products was fully impaired. |
Right-of-Use Assets | (l) Right-of-Use Assets The Company leases its facility in West Deptford, New Jersey (the “Thorofare Facility”) under an operating lease (“Thorofare Lease”) with annual rentals of $132,000 plus common area maintenance (CAM) charges. The Thorofare Facility houses the Company’s office, manufacturing, laboratory and warehouse space. The Thorofare Lease took effect on January 1, 2008. On January 7, 2013, the Company extended the Thorofare Lease extending the term to December 31, 2019. On November 11, 2019, the Company entered into another extension of the Thorofare Lease, extending the term to December 31, 2021, effective January 1, 2020, and providing for an early termination option with a 150-day notice period. On July 16, 2020, the Company exercised the early termination option under the lease agreement, with the effect of the post exercise lease maturity date changing to December 13, 2020. On January 1, 2020 (“Effective Date”), the Company adopted FASB Accounting Standards Codification, or ASC, Topic 842, Leases (“ASC 842”), which increases transparency and comparability by recognizing a lessee’s rights and obligations resulting from leases by recording them on the balance sheet as lease assets and lease liabilities. The new guidance requires the recognition of the right-of-use (“ROU”) assets and related operating and finance lease liabilities on the balance sheet. The Company adopted the new guidance using the modified retrospective approach on January 1, 2020. As a result, the consolidated balance sheet as of December 31, 2019 was not restated and is not comparative. The adoption of ASC 842 resulted in the recognition of ROU assets of $306,706 and lease liabilities for an operating lease of $306,706 on the Company’s Condensed Consolidated Balance Sheet as of January 1, 2020. The Company elected the package of practical expedients permitted within the standard, which allows an entity to forgo reassessing (i) whether a contract contains a lease, (ii) classification of leases, and (iii) whether capitalized costs associated with a lease meet the definition of initial direct costs. Also, the Company elected the expedient allowing an entity to use hindsight to determine the lease term and impairment of ROU assets and the expedient to allow the Company to not have to separate lease and non-lease components. The Company has also elected the short-term lease accounting policy under which the Company would not recognize a lease liability or ROU asset for any lease that at the commencement date has a lease term of twelve months or less and does not include a purchase option that the Company is more than reasonably certain to exercise. For contracts entered into on or after the Effective Date, at the inception of a contract, the Company will assess whether the contract is, or contains, a lease. The Company’s assessment is based on: (i) whether the contract involves the use of a distinct identified asset, (ii) whether the Company obtained the right to substantially all the economic benefit from the use of the asset throughout the period, and (iii) whether the Company has the right to direct the use of the asset. Leases entered into prior to January 1, 2020, which were accounted for under ASC 840, were not reassessed for classification. For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The Company generally uses its incremental borrowing rate as the discount rate for leases, unless an interest rate is implicitly stated in the lease. The present value of the lease payments is calculated using the incremental borrowing rate for operating leases, which was determined using a portfolio approach based on the rate of interest that the Company would have to pay to borrow an amount equal to the lease payments on a collateralized basis over a similar term. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend the lease that the Company is reasonably certain to exercise, or an option to extend the lease controlled by the lessor. All ROU assets are reviewed for impairment. Lease expense for operating leases consists of the lease payments plus any initial direct costs and is recognized on a straight-line basis over the lease term. Effective June 30, 2020, the Company recorded an adjustment to its right-of-use asset and liability in the amounts of $153,709 and $155,737, respectively, to adjust for the effect of the Company having elected to exercise the early termination option under the lease agreement, as discussed earlier. The following information reflects the effect of the adjustments discussed above in connection with the Company’s exercise of the early termination option. The Company’s operating lease is comprised solely of the lease of its Thorofare Facility. Condensed Consolidated Balance Sheet information related to its lease is presented below: Balance Sheet Location June 30, 2020 January 1, 2020 December 31, 2019 Operating Lease Right-of-use asset $ 79,942 $ 306,706 $ - Liability, current 80,018 143,018 - Liability, net of current - 163,688 - The following provides details of the Company’s lease expense, including CAM charges: Three months ended Six months ended Lease cost Operating lease $ 40,132 $ 83,076 Other information related to leases is presented below: Other information As of June 30, Operating cash used by operating leases $ 83,000 Weighted-average remaining lease term – operating leases (in months) 6 Weighted-average discount rate – operating leases 10.00 % As of June 30, 2020, the annual minimum lease payments of the Company’s operating lease liabilities were as follows: For Years Ending December 31, Operating leases 2020 (excluding the six months ended June 30, 2020) $ 82,368 Total future minimum lease payments, undiscounted $ 82,368 Less: Imputed interest (2,350 ) Present value of future minimum lease payments $ 80,018 |
Intangible Assets | (m) Intangible Assets The Company’s long-lived intangible assets, other than goodwill, are assessed for impairment when events or circumstances indicate there may be an impairment. These assets were initially recorded at their estimated fair value at the time of acquisition and assets not acquired in acquisitions were recorded at historical cost. However, if their estimated fair value is less than the carrying amount, other intangible assets with indefinite lives are reduced to their estimated fair value through an impairment charge to the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. As of June 30, 2020, on account of the unfavorable factors existing within its rapid, point-of-care screening and testing products business, the Company determined that the intellectual property comprising the remaining intangible assets was fully impaired. Accordingly, during the three and six months ended June 30, 2020, the Company recorded impairment charges of $149,870 and $152,822, respectively. There were no impairment charges of intangible assets during the three and six months ending June 30, 2019. Intangible assets as of June 30, 2020 and December 31, 2019 were $0 and $170,423, respectively. Intangible assets at June 30, 2020 consisted of patents, trademarks and customer lists of $3,897,635, net of accumulated amortization and impairment of $3,897,635. Intangible assets at December 31, 2019 consisted of patent, trademarks and customer lists of $3,897,635, net of accumulated amortization and impairment of $3,727,212. Amortization is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. Amortization expense was $8,727 and $10,002 for the three months ended June 30, 2020 and 2019 and $17,601 and $20,004 for the six months ended June 30, 2020 and 2019, respectively. |
Revenue Recognition | (n) Revenue Recognition Beginning on January 1, 2019, the Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of this revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods and services transferred to the customer. The following five steps are applied to achieve that core principle: Step 1: Identify the contract with the customer Step 2: Identify the performance obligations in the contract Step 3: Determine the transaction price Step 4: Allocate the transaction price to the performance obligations in the contract Step 5: Recognize revenue when the Company satisfies a performance obligation The Company does not have any significant contracts with customers requiring performance beyond delivery. Shipping and handling activities are performed before the customer obtains control of the goods and therefore represent a fulfillment activity rather than a promised service to the customer. Revenue and costs of sales are recognized when control of the product transfers to the Company’s customer, which generally occurs upon delivery to the customer but can also occur when goods are shipped by the Company, depending on the shipment terms of the contract. The Company’s performance obligations are satisfied at that time. The Company uses the most likely amount approach to determine the variable consideration of the transaction price in order to account for the contractual rebates and incentives that are estimated and adjusted for over time. The Company provides for rebates to its distributors. The Company had accrued for rebates and incentives of $200 and $20,002 as of June 30, 2020 and December 31, 2019, respectively. Accounts receivable will be reduced when the rebates are applied by the customer. The Company recognized credits of $536 and $1,199 for the three and six months ended June 30, 2020 and rebates and incentives of $7,679 and $16,377 during the three and six months ended June 30, 2019. The Company recognized sales discounts of $10,632 and $11,366 for the three and six months ended June 30, 2020, and $7,406 and $20,957 for the three and six months ended June 30, 2019. These components are included as product revenue in the Condensed Consolidated Statement of Operations and Comprehensive Loss. |
Research and Development Costs | (o) Research and Development Costs In accordance with FASB ASC 730, |
Income Taxes | (p) Income Taxes The Company utilizes an asset and liability approach for financial accounting and reporting for income taxes. The provision for income taxes is based upon income or loss after adjustment for those permanent items that are not considered in the determination of taxable income. Deferred income taxes represent the tax effects of differences between the financial reporting and tax basis of the Company’s assets and liabilities at the enacted tax rates in effect for the years in which the differences are expected to reverse. The Company evaluates the recoverability of deferred tax assets and establishes a valuation allowance when it is more likely than not that some portion or all the deferred tax assets will not be realized. Management makes judgments as to the interpretation of the tax laws that might be challenged upon an audit and cause changes to previous estimates of tax liability. In management’s opinion, adequate provisions for income taxes have been made. If actual taxable income by tax jurisdiction varies from estimates, additional allowances or reversals of reserves may be necessary. Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. As of June 30, 2020, and December 31, 2019, no liability for unrecognized tax benefits was required to be reported. There is no income tax benefit for the losses for the three and six months ended June 30, 2020 and 2019 since management has determined that the realization of the net deferred assets is not assured and has created a valuation allowance for the entire amount of such tax benefits. The Company’s policy for recording interest and penalties associated with tax audits is to record such items as a component of general and administrative expense. There were no amounts accrued for penalties and interest for the three and six months ended June 30, 2020 and 2019. The Company does not expect its uncertain tax position to change during the next twelve months. Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position. |
Shipping and Handling Fees and Costs | (q) Shipping and Handling Fees and Costs The Company charges actual shipping costs plus a handling fee to customers, which amounted to $1,511 and $10,568 for the three and six months ended June 30, 2020 and $9,511 and $21,997 for the three and six months ended June 30, 2019, respectively. These fees are classified as part of product revenue in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Shipping and other related delivery costs, including those for incoming raw materials are classified as product cost of sales, which amounted to $5,261 and $17,918 for the three and six months ended June 30, 2020 and $15,660 and $27,579 for the three and six months ended June 30, 2019. |
Basic and Diluted Earnings Per Share of Common Stock | (r) Basic and Diluted Earnings per Share of Common Stock Basic earnings per common share is based on the weighted average number of shares outstanding during the periods presented. Diluted earnings per share is computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the period. Potential common shares that would have the effect of increasing diluted earnings per share are considered anti-dilutive. The calculation of basic and diluted loss per share for the three months ended June 30, 2020 and 2019 was based on the net loss of $3,628,131 and $794,891, respectively and $7,166,667 and $1,711,849 for the six months ended June 30, 2020 and 2019, respectively. The basic and diluted weighted average number of common shares outstanding for the three months ended June 30, 2020 and 2019 was 5,252,211 and 541,367, respectively and 3,739,529 and 541,000 for the six months ended June 30, 2020, respectively. Diluted net loss per share is computed using the weighted average number of common and dilutive potential common shares outstanding during the period. As the Company reported a net loss for the three and six months ended June 30, 2020 and 2019, common share equivalents were anti-dilutive. Therefore, the amounts report for basic and diluted loss per share were the same. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Three and Six Months Ended 2020 2019 Stock Options 40 291 RSUs 15,603 15,603 Warrants to purchase common stock 417,896 88,015 Series D Preferred Convertible Stock 208,577 - Warrants to purchase Series C Preferred stock 946,500 - Total potentially dilutive shares 1,588,616 103,909 |
Reclassifications | (s) Reclassifications Certain prior year amounts have been reclassified to conform to the current year’s presentation. |
Recently Issued Accounting Pronouncements | (t) Recently Issued Accounting Pronouncements Recently Issued Accounting Pronouncements Adopted In February 2016, the FASB issued ASU 2016-02—Leases (Topic 842) (“ASU-2016-02”), which requires an entity to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor, and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The Company has adopted ASU-2016-02, effective January 1, 2020, and, as a result of this implementation, has recorded an operating lease right-of-use asset and an operating lease liability as of June 30, 2020. Recently Issued Accounting Pronouncements Not Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments (“ASU-2016-13”). ASU 2016-13 affects loans, debt securities, trade receivables, and any other financial assets that have the contractual right to receive cash. The ASU requires an entity to recognize expected credit losses rather than incurred losses for financial assets. ASU 2016-13 is effective for the fiscal year beginning after December 15, 2022, including interim periods within that fiscal year. The Company expects that there would be no material impact on the Company’s condensed consolidated financial statements upon the adoption of this ASU. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Marketable Securities | Quoted Prices in Active Quoted Prices for Significant Fixed Income Bonds at June 30, 2020 $ 6,856,805 $ - $ - Fixed Income Bonds at December 31, 2019 $ 9,164,273 $ - $ - |
Schedule of Operating Lease | Condensed Consolidated Balance Sheet information related to its lease is presented below: Balance Sheet Location June 30, 2020 January 1, 2020 December 31, 2019 Operating Lease Right-of-use asset $ 79,942 $ 306,706 $ - Liability, current 80,018 143,018 - Liability, net of current - 163,688 - |
Schedule of Lease Expense | The following provides details of the Company’s lease expense, including CAM charges: Three months ended Six months ended Lease cost Operating lease $ 40,132 $ 83,076 |
Schedule of Other Information Related to Leases | Other information related to leases is presented below: Other information As of June 30, Operating cash used by operating leases $ 83,000 Weighted-average remaining lease term – operating leases (in months) 6 Weighted-average discount rate – operating leases 10.00 % |
Schedule of Operating Lease Liabilities | As of June 30, 2020, the annual minimum lease payments of the Company’s operating lease liabilities were as follows: For Years Ending December 31, Operating leases 2020 (excluding the six months ended June 30, 2020) $ 82,368 Total future minimum lease payments, undiscounted $ 82,368 Less: Imputed interest (2,350 ) Present value of future minimum lease payments $ 80,018 |
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share | The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: For the Three and Six Months Ended 2020 2019 Stock Options 40 291 RSUs 15,603 15,603 Warrants to purchase common stock 417,896 88,015 Series D Preferred Convertible Stock 208,577 - Warrants to purchase Series C Preferred stock 946,500 - Total potentially dilutive shares 1,588,616 103,909 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following: June 30, 2020 December 31, 2019 Raw Materials $ - $ 274,551 Sub-Assemblies - 303,461 Finished Goods - 28,223 Reserve for Obsolescence - (407,250 ) $ - $ 198,985 |
Trade and Other Payables (Table
Trade and Other Payables (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Trade and Other Payables | Trade and other payables consist of the following: June 30, 2020 December 31, 2019 Accounts Payable – Trade $ 561,578 $ 657,293 Obligations to Cystron Sellers 1,274,906 - Accrued Expenses 789,088 812,722 Deferred Compensation - 59,750 $ 2,625,572 $ 1,529,765 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Stock Options Activity | The following table summarizes the option activities for the six months ended June 30, 2020: Weighted Weighted Weighted Average Average Average Grant Remaining Aggregate Number of Exercise Date Fair Contractual Intrinsic Shares Price Value Term (years) Value Balance at December 31, 2019 40 $ 236.16 $ 151.68 0.99 $ - Granted - - - - - Exercised - - - - - Forfeited - - - - - Canceled/Expired - - - - - Balance at June 30, 2020 40 $ 236.16 $ 151.68 0.50 $ - Exercisable as of June 30, 2020 40 $ 236.16 $ 151.68 0.50 $ - |
Summary of Restricted Stock Units Activity | At June 30, 2020, the unamortized value of the RSUs was $0. A summary of activity related to RSUs for the six months ended June 30, 2020 is presented below: Weighted Average Number of Grant Date RSUs Fair Value Balance at December 31, 2019 15,603 $ 23.28 Granted - - Exercised - - Forfeited - - Canceled/Expired - - Balance at June 30, 2020 15,603 $ 23.28 Exercisable as of June 30, 2020 15,603 $ 23.28 |
Summary of Warrant Activity | The table below summarizes the warrant activity for the six month period ended June 30, 2020: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 247,215 $ 29.79 4.32 Granted 170,681 5.52 4.85 Exercised - - - Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 417,896 $ 19.88 4.24 Exercisable as of June 30, 2020 417,896 $ 19.88 4.24 |
Pre-funded Common Stock Warrants [Member] | |
Summary of Warrant Activity | The table below summarizes the pre-funded warrant activity for the six month period ended June 30, 2020: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 795,000 $ 0.0001 - Granted - - - Exercised (795,000 ) 0.0001 - Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 - $ - - Exercisable as of June 30, 2020 - $ - - |
Convertible Preferred Series C Stock Warrants [Member] | |
Summary of Warrant Activity | The table below summarizes the activity during the six month period ended June 30, 2020 for warrants issued in December 2019 for the purchase of Series C Convertible Preferred Stock: Weighted Average Average Remaining Number of Exercise Contractual Warrants Price Term (years) Balance at December 31, 2019 1,990,000 $ 4.00 4.95 Granted - - - Exercised (1,043,500 ) 4.00 4.45 Forfeited - - - Canceled/Expired - - - Balance at June 30, 2020 946,500 $ 4.00 4.45 Exercisable as of June 30, 2020 946,500 $ 4.00 4.45 |
Revenue Information (Tables)
Revenue Information (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of Revenue by Product Lines | Revenue by product lines was as follows: Three Months Ended Six Months Ended June 30, June 30, Product Line 2020 2019 2020 2019 MicroParticle Catalyzed Biosensor (“MPC”) $ - $ 65,344 $ - $ 88,664 Particle ImmunoFiltration Assay (“PIFA”) (3,399 ) 304,658 351,059 880,973 Rapid Enzymatic Assay (“REA”) - 85,000 - 85,000 Other 1,511 9,511 10,568 21,997 Total Revenue $ (1,888 ) $ 464,513 $ 361,627 $ 1,076,634 |
Schedule of Revenue by Geographic Area Determined Based On Location of Customers | The total revenue by geographic area determined based on the location of the customers was as follows: Three Months Ended Six Months Ended June 30, June 30, Geographic Region 2020 2019 2020 2019 United States $ (1,888 ) $ 447,013 $ 361,627 $ 1,059,134 Rest of World - 17,500 - 17,500 Total Revenue $ (1,888 ) $ 464,513 $ 361,627 $ 1,076,634 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020USD ($)Breathalyzersshares | Jun. 30, 2019USD ($)Breathalyzersshares | Jun. 30, 2020USD ($)Breathalyzersshares | Jun. 30, 2019USD ($)Breathalyzersshares | Dec. 31, 2019USD ($)Breathalyzers | Jan. 02, 2020USD ($) | |
Restricted cash | $ 115,094 | $ 115,094 | $ 115,094 | |||
Maturities of securities | less than one year | |||||
Increase in unrealized gain on securities | 201,898 | $ 18,059 | $ 47,402 | |||
Increase in unrealized loss on securities | $ 39,039 | |||||
Loss on sale of securities | 0 | 543 | 36,714 | 4,258 | ||
Proceeds from sale of marketable securities | 3,572 | 2,307,462 | 502,126 | 1,354,646 | ||
Allowances for doubtful accounts for trade receivables | 1,273 | 1,273 | 458,902 | |||
Bad debt expenses | 1,273 | 0 | 1,273 | 4,247 | ||
Impairment of prepaid royalties | 291,442 | 291,442 | ||||
Total revenues | (1,888) | 464,513 | 361,627 | 1,076,634 | 1,577,033 | |
Depreciation expense | 3,214 | 9,542 | 10,111 | 14,975 | ||
Impairment expense | 18,680 | 0 | 18,680 | 0 | ||
Operating lease, annual rentals | $ 132,000 | |||||
Operating lease description | The Company leases its facility in West Deptford, New Jersey (the "Thorofare Facility") under an operating lease ("Thorofare Lease") with annual rentals of $132,000 plus common area maintenance (CAM) charges. The Thorofare Facility houses the Company's office, manufacturing, laboratories and warehouse space. The lease, took effect on January 1, 2008. On January 7, 2013, the Company extended its lease agreement for a term of 7 years, expiring December 31 2019. On November 11, 2019, the Company entered into an extension of the Thorofare Lease, extending the term to December 31, 2021, effective January 1, 2020, and providing for an early termination option of the lease with a 150 day notice period. | |||||
Right-of-use asset | 79,942 | $ 79,942 | $ 306,706 | |||
Operating lease, liability | 80,018 | 80,018 | ||||
Impairment of intangible assets | 149,870 | 152,822 | ||||
Intangible assets | 170,423 | |||||
Amortization expense | 8,727 | 10,002 | 17,601 | 20,004 | ||
Accrued for rebates and incentives | 200 | 20,002 | ||||
Rebates recognized during period | 536 | 7,679 | 1,199 | 16,377 | ||
Sales discounts | 10,632 | 7,406 | $ 11,366 | 20,957 | ||
Income tax examination, likelihood percentage | The amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. | |||||
Unrecognized tax benefits | ||||||
Income tax benefit | ||||||
Accrued for penalties and interest | ||||||
Shipping and handling cost | 1,511 | 9,511 | 10,568 | 21,997 | ||
Product cost of sales | 377,169 | 219,864 | 550,040 | 465,801 | ||
Net loss attributable to common shareholders | $ 3,628,131 | $ 794,891 | $ 7,166,667 | $ 1,711,849 | ||
Weighted average basic and diluted common shares outstanding | shares | 5,252,211 | 541,367 | 3,739,529 | 541,000 | ||
Shipping and Handling [Member] | ||||||
Product cost of sales | $ 5,251 | $ 15,660 | $ 17,918 | $ 27,579 | ||
Patents, Trademarks and Customer Lists [Member] | ||||||
Intangible assets | $ 3,897,635 | 3,897,635 | 3,897,635 | |||
Amortization expense | $ 3,897,635 | $ 3,727,212 | ||||
Topic 842 [Member] | ||||||
Right-of-use asset | 306,706 | |||||
Operating lease, liability | $ 306,706 | |||||
No Suppliers [Member] | ||||||
Concentration risk percentage | 10.00% | 10.00% | ||||
Sales Revenue, Net [Member] | Customer One [Member] | ||||||
Concentration risk percentage | 58.00% | 42.00% | ||||
Sales Revenue, Net [Member] | Customer Two [Member] | ||||||
Concentration risk percentage | 35.00% | 20.00% | ||||
Sales Revenue, Net [Member] | Customer Three [Member] | ||||||
Concentration risk percentage | 19.00% | |||||
Sales Revenue, Net [Member] | Three Customers [Member] | ||||||
Concentration risk percentage | 81.00% | |||||
Concentration risk, number of customer | Breathalyzers | 3 | |||||
Sales Revenue, Net [Member] | Two Customers [Member] | ||||||
Concentration risk percentage | 93.00% | |||||
Concentration risk, number of customer | Breathalyzers | 2 | |||||
Trade Receivable [Member] | Customer One [Member] | ||||||
Concentration risk percentage | 30.00% | 44.00% | 30.00% | |||
Trade Receivable [Member] | Customer Two [Member] | ||||||
Concentration risk percentage | 18.00% | 34.00% | 18.00% | |||
Trade Receivable [Member] | Customer Three [Member] | ||||||
Concentration risk percentage | 12.00% | 12.00% | ||||
Trade Receivable [Member] | Two Customers [Member] | ||||||
Concentration risk percentage | 78.00% | |||||
Concentration risk, number of customer | Breathalyzers | 2 | |||||
Trade Receivable [Member] | Customer Four [Member] | ||||||
Concentration risk percentage | 12.00% | 12.00% | ||||
Trade Receivable [Member] | Customer Five [Member] | ||||||
Concentration risk percentage | 11.00% | 11.00% | ||||
Trade Receivable [Member] | Five Customers [Member] | ||||||
Concentration risk percentage | 83.00% | 83.00% | ||||
Concentration risk, number of customer | Breathalyzers | 5 | 5 | ||||
Accounts Payable [Member] | ||||||
Concentration risk percentage | 63.00% | 63.00% | ||||
Concentration risk, number of supplier | Breathalyzers | 2 | 2 | ||||
Accounts Payable [Member] | Suppliers One [Member] | ||||||
Concentration risk percentage | 37.00% | 70.00% | 49.00% | 49.00% | ||
Concentration risk, number of supplier | Breathalyzers | 1 | |||||
Accounts Payable [Member] | Suppliers Two [Member] | ||||||
Concentration risk percentage | 28.00% | 11.00% | 17.00% | 17.00% | ||
Accounts Payable [Member] | Supplier Three [Member] | ||||||
Concentration risk percentage | 11.00% | |||||
Accounts Payable [Member] | Three Supplier [Member] | ||||||
Concentration risk percentage | 76.00% | |||||
Concentration risk, number of customer | Breathalyzers | 3 | |||||
Accounts Payable [Member] | Two Supplier [Member] | ||||||
Concentration risk percentage | 81.00% | 66.00% | ||||
Concentration risk, number of customer | Breathalyzers | 2 | |||||
Accounts Payable [Member] | Two Suppliers [Member] | ||||||
Concentration risk percentage | 66.00% | |||||
Minimum [Member] | ||||||
Normal credit terms extended to customers | 30 days | |||||
Maximum [Member] | ||||||
Normal credit terms extended to customers | 90 days |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Marketable Securities (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Fixed Income Bonds | $ 6,856,805 | |
Level 1 [Member] | ||
Fixed Income Bonds | 6,856,805 | $ 9,164,273 |
Level 2 [Member] | ||
Fixed Income Bonds | ||
Level 3 [Member] | ||
Fixed Income Bonds |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Operating Lease (Details) - USD ($) | Jun. 30, 2020 | Jan. 02, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | |||
Right-of-use asset | $ 79,942 | $ 306,706 | |
Liability, current | 80,018 | 143,018 | |
Liability, net of current | $ 163,688 |
Significant Accounting Polici_7
Significant Accounting Policies - Schedule of Lease Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2020 | Jun. 30, 2020 | |
Accounting Policies [Abstract] | ||
Operating lease cost | $ 40,312 | $ 83,076 |
Significant Accounting Polici_8
Significant Accounting Policies - Schedule of Other Information Related to Leases (Details) | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Accounting Policies [Abstract] | |
Operating cash used by operating leases | $ 83,000 |
Weighted-average remaining lease term - operating leases (in months) | 6 months |
Weighted-average discount rate - operating leases | 10.00% |
Significant Accounting Polici_9
Significant Accounting Policies - Schedule of Operating Lease Liabilities (Details) | Jun. 30, 2020USD ($) |
Accounting Policies [Abstract] | |
2020 (excluding the six months ended June 30, 2020) | $ 82,368 |
Total future minimum lease payments, undiscounted | 82,368 |
Less: Imputed interest | (2,350) |
Present value of future minimum lease payments | $ 80,018 |
Significant Accounting Polic_10
Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Total potentially dilutive shares | 1,588,616 | 103,909 | 1,588,616 | 103,909 |
Stock Options [Member] | ||||
Total potentially dilutive shares | 40 | 291 | 40 | 291 |
Restricted Stock Units [Member] | ||||
Total potentially dilutive shares | 15,603 | 15,603 | 15,603 | 15,603 |
Warrants to Purchase Common Stock [Member] | ||||
Total potentially dilutive shares | 417,896 | 88,015 | 417,896 | 88,015 |
Series D Preferred Convertible Stock [Member] | ||||
Total potentially dilutive shares | 208,577 | 208,577 | ||
Warrants to Purchase Series C Preferred Stock [Member] | ||||
Total potentially dilutive shares | 946,500 | 946,500 |
Recent Developments, Liquidit_2
Recent Developments, Liquidity and Management's Plans (Details Narrative) | Aug. 13, 2020USD ($)$ / sharesshares | Aug. 11, 2020USD ($)$ / sharesshares | Jul. 21, 2020USD ($) | Jul. 20, 2020USD ($)$ / sharesshares | May 18, 2020USD ($)$ / sharesshares | May 14, 2020 | Apr. 30, 2020USD ($) | Apr. 22, 2020USD ($) | Apr. 20, 2020USD ($) | Apr. 16, 2020USD ($)$ / sharesshares | Apr. 10, 2020USD ($) | Apr. 07, 2020USD ($)$ / sharesshares | Mar. 24, 2020USD ($)$ / sharesshares | Mar. 23, 2020USD ($) | Dec. 09, 2019USD ($) | Aug. 11, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Mar. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($) |
Research and development expenses | $ 1,916,161 | $ 4,399,218 | ||||||||||||||||||||||
Liabilities | 2,705,590 | 2,705,590 | $ 1,529,765 | |||||||||||||||||||||
Cash and marketable securities | 11,561,811 | 11,561,811 | ||||||||||||||||||||||
Restricted cash | 115,094 | 115,094 | ||||||||||||||||||||||
Marketable securities | 6,856,805 | 6,856,805 | ||||||||||||||||||||||
Net loss | (3,628,131) | $ (3,538,536) | (794,891) | $ (916,958) | (7,166,667) | (1,711,849) | ||||||||||||||||||
Working capital | 15,772,329 | 15,772,329 | ||||||||||||||||||||||
Total shareholders' equity | $ 15,972,148 | 6,817,451 | 4,314,134 | 4,965,918 | 15,972,148 | 4,314,134 | $ 9,355,170 | $ 5,833,753 | ||||||||||||||||
Net cash used in operating activities | (3,883,101) | (1,610,352) | ||||||||||||||||||||||
Milestone license fees | 4,375,557 | |||||||||||||||||||||||
Sale of stock | shares | 1,043,500 | 766,667 | ||||||||||||||||||||||
Sale of stock price per share | $ / shares | $ 4 | $ 6 | ||||||||||||||||||||||
Proceeds from issuance of stock, gross | $ 250,000 | $ 4,600,002 | $ 8,406,927 | |||||||||||||||||||||
Proceeds from issuance of stock, net | $ 4,174,000 | $ 4,086,207 | ||||||||||||||||||||||
Warrants to purchase shares | shares | 61,333 | |||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 7.50 | $ 0.0001 | $ 0.0001 | |||||||||||||||||||||
Proceeds from issuance of warrant | $ 80 | |||||||||||||||||||||||
Securities Purchase Agreement [Member] | May Offering [Member] | ||||||||||||||||||||||||
Sale of stock | shares | 1,366,856 | |||||||||||||||||||||||
Sale of stock price per share | $ / shares | $ 3.53 | |||||||||||||||||||||||
Proceeds from issuance of stock, gross | $ 4,825,002 | |||||||||||||||||||||||
Proceeds from issuance of stock, net | $ 4,320,720 | |||||||||||||||||||||||
Placement Agent [Member] | May Offering [Member] | ||||||||||||||||||||||||
Warrants to purchase shares | shares | 109,348 | |||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 4.4125 | |||||||||||||||||||||||
COVID-19 Vaccine [Member] | ||||||||||||||||||||||||
Royalty payments, description | The Company shall also make quarterly royalty payments to Sellers equal to 5% of the net sales of a COVID-19 vaccine or combination product by the Company (the "COVID-19 Vaccine") for a period of five (5) years following the first commercial sale of the COVID-19 Vaccine; provided, that such payment shall be reduced to 3% for any net sales of the COVID-19 Vaccine above $500 million. | |||||||||||||||||||||||
Series D Convertible Preferred Stock [Member] | ||||||||||||||||||||||||
Preferred stock, stated value | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||||||||||||||
Conversion of series d convertible preferred shares for common stock, shares | shares | (2,776) | |||||||||||||||||||||||
Preferred stock, shares issued | shares | 208,577 | 208,577 | 0 | |||||||||||||||||||||
Preferred stock, shares outstanding | shares | 208,577 | 208,577 | 0 | |||||||||||||||||||||
Net loss | ||||||||||||||||||||||||
Total shareholders' equity | $ 412,982 | 418,479 | $ 412,982 | |||||||||||||||||||||
Series C Convertible Preferred Stock [Member] | ||||||||||||||||||||||||
Preferred stock, stated value | $ / shares | $ 4 | $ 4 | $ 4 | |||||||||||||||||||||
Preferred stock, shares issued | shares | 0 | 0 | 0 | |||||||||||||||||||||
Preferred stock, shares outstanding | shares | 0 | 0 | 0 | |||||||||||||||||||||
Warrants to purchase shares | shares | 1,043,500 | 1,043,500 | ||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 4 | $ 4 | ||||||||||||||||||||||
Proceeds from issuance of warrant | $ 4,174,000 | |||||||||||||||||||||||
Series C Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||
Warrants to purchase shares | shares | 891,500 | 60,000 | 891,500 | |||||||||||||||||||||
Warrants exercise price | $ / shares | $ 4 | $ 4 | $ 4 | |||||||||||||||||||||
Proceeds from issuance of warrant | $ 240,000 | $ 3,566,000 | ||||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||||||
Conversion of series d convertible preferred shares for common stock, shares | shares | 2,776 | 2,776 | ||||||||||||||||||||||
Net loss | ||||||||||||||||||||||||
Total shareholders' equity | $ 142,330,116 | $ 129,743,689 | $ 121,699,375 | $ 121,574,327 | $ 142,330,116 | $ 121,699,375 | $ 128,920,414 | $ 121,554,547 | ||||||||||||||||
Preferred Stock [Member] | ||||||||||||||||||||||||
Conversion of series d convertible preferred shares for common stock, shares | shares | 2,776 | 2,776 | ||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | ||||||||||||||||||||||||
Research and development expenses | $ 1,142,500 | |||||||||||||||||||||||
Portion of cash purchase price returned | $ 83,334 | |||||||||||||||||||||||
Payment to sellers | $ 1,000,000 | |||||||||||||||||||||||
Proceeds from initial equity offering | $ 8,000,000 | |||||||||||||||||||||||
Percentage of payment to sellers on equity offering | 10.00% | |||||||||||||||||||||||
Additional cash consideration | $ 10,000,000 | |||||||||||||||||||||||
Achievement of milestone, description | Upon the achievement of certain milestones, including the completion of a Phase 2 study for a COVID-19 vaccine that meets its primary endpoints, Sellers will be entitled to receive an additional 750,000 shares of our common stock or, in the event we are unable to obtain stockholder approval for the issuance of such shares, 750,000 shares of non-voting preferred stock that are valued following the achievement of such milestones and shall bear a 10% annual dividend (the "Milestone Shares"). Sellers will also be entitled to contingent payments from us of up to $20,750,000 upon the achievement of certain milestones, including the approval of a new drug application by the U.S. Food and Drug Administration ("FDA"). | |||||||||||||||||||||||
Contingent payments upon achievement of certain milestones | $ 250,000 | $ 20,750,000 | ||||||||||||||||||||||
Liabilities | $ 892,500 | |||||||||||||||||||||||
Payment to sellers upon consummation direct equity offering | $ 684,790 | |||||||||||||||||||||||
Royalty payments to sellers, percentage | 0.125 | |||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | Premas Biotech PVT Ltd [Member] | ||||||||||||||||||||||||
Achievement of milestone, description | The Company and Premas agreed that the fourth milestone under the License Agreement had been satisfied. Due to the achievement of this milestone, Premas is entitled to receive a payment of $1,000,000. | |||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | Cystron Biotech, LLC [Member] | ||||||||||||||||||||||||
Agreement description | As consideration for the Membership Interests, the Company delivered to the Sellers: (1) that number of newly issued shares of its common stock equal to 19.9% of the issued and outstanding shares of its common stock and pre-funded warrants as of the date of the MIPA, but, to the extent that the issuance of its common stock would have resulted in any Seller owning in excess of 4.9% of the Company's outstanding common stock, then, at such Seller's election, such Seller received "common stock equivalent" preferred shares with a customary 4.9% blocker (with such common stock and preferred stock collectively referred to as "Common Stock Consideration"), and (2) $1,000,000 in cash. On March 24, 2020 the Company paid $1,000,000 to the Sellers and delivered 411,403 shares of common stock and 211,353 shares of Series D Convertible Preferred Stock with a customary 4.9% blocker, with an aggregate fair market value of $1,233,057, and recorded $2,233,057 as a charge to research and development expense within the Condensed Consolidated Statements of Operations and Comprehensive Loss. On April 22, 2020, Premas, one of the Sellers, returned to us $299,074 representing its portion of the cash purchase price to acquire Cystron. Premas has advised us that these funds were returned temporarily in order for Premas to meet certain regulatory requirements in India. | |||||||||||||||||||||||
Proceeds from collaborators | $ 1,000,000 | |||||||||||||||||||||||
Payment to the sellers | $ 1,000,000 | |||||||||||||||||||||||
Portion of cash purchase price returned | $ 299,074 | |||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | Cystron Biotech, LLC [Member] | Premas Biotech PVT Ltd [Member] | ||||||||||||||||||||||||
Achievement of milestone, description | Upon the achievement of certain developmental milestones by Cystron, Cystron shall pay to Premas a total of up to $2,000,000. On April 16, 2020, the Company paid Premas $500,000 for the achievement of the first two development milestones, of which $250,000 was accrued as research and development expense for the three months ended March 31, 2020. | |||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | Cystron Biotech, LLC [Member] | Series D Convertible Preferred Stock [Member] | ||||||||||||||||||||||||
Number of shares delivered | shares | 211,353 | |||||||||||||||||||||||
Percentage of blocker | 4.90% | |||||||||||||||||||||||
Fair market value shares delivered | $ 1,233,057 | |||||||||||||||||||||||
Research and development expenses | $ 2,233,057 | |||||||||||||||||||||||
Membership Interest Purchase Agreement [Member] | Cystron Biotech, LLC [Member] | Common Stock [Member] | ||||||||||||||||||||||||
Number of shares delivered | shares | 411,403 | |||||||||||||||||||||||
Fair market value shares delivered | $ 1,233,057 | |||||||||||||||||||||||
Research and development expenses | $ 2,233,057 | |||||||||||||||||||||||
Cystron Medical Panel [Member] | ||||||||||||||||||||||||
Research and development expenses | $ 10,274 | $ 10,274 | ||||||||||||||||||||||
Achievement of milestone, description | The Cystron Medical Panel and appointed its first member to the panel. Each member shall be compensated with an initial grant of the Company's common stock with an aggregate fair market value of $25,000 and a monthly cash stipend in the initial amount of $2,500 | |||||||||||||||||||||||
Fair market value common stock | $ 25,000 | |||||||||||||||||||||||
Monthly cash stipend in initial amount | $ 2,500 | |||||||||||||||||||||||
Certificate of Designation [Member] | ||||||||||||||||||||||||
Preferred stock, stated value | $ / shares | $ 0.01 | |||||||||||||||||||||||
Conversion price, per share | $ / shares | $ 0.01 | |||||||||||||||||||||||
Stock issuance description | A holder of Preferred Stock will be prohibited from converting Preferred Stock into shares of our common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of our common stock then issued and outstanding (with such ownership restriction referred to as the "Beneficial Ownership Limitation"). However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice to us. | |||||||||||||||||||||||
August Offering [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||
Sale of stock price per share | $ / shares | $ 5.67 | |||||||||||||||||||||||
Proceeds from issuance of stock, gross | $ 6,847,908 | $ 6,178,000 | ||||||||||||||||||||||
Warrants to purchase shares | shares | 96,620 | |||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 7.0875 | |||||||||||||||||||||||
Aggregate number of shares of common stock issued during period | shares | 1,207,744 | |||||||||||||||||||||||
Warrant expire date | Aug. 11, 2025 | |||||||||||||||||||||||
Consulting Agreement [Member] | Chief Financial Officer [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||
Consulting appointment description | the Company appointed Mr. Stuart Benson as Chief Financial Officer, effective August 19, 2020, with a term ending June 30, 2021. | |||||||||||||||||||||||
Initial retainer fee | $ 7,500 | |||||||||||||||||||||||
Fixed monthly payment | $ 13,500 |
Inventories (Details Narrative)
Inventories (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Production related charges | $ 18,680 | $ 18,680 | ||
Inventories [Member] | ||||
Inventory written down | 0 | |||
Production related charges | $ 193,839 | $ 41,849 | $ 197,723 | $ 45,946 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw Materials | $ 274,551 | |
Sub-Assemblies | 303,461 | |
Finished Goods | 28,223 | |
Reserve for Obsolescence | (407,250) | |
Total Inventory, Net | $ 198,985 |
Trade and Other Payables - Sche
Trade and Other Payables - Schedule of Trade and Other Payables (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accounts Payable - Trade | $ 561,578 | $ 657,293 |
Obligations to Cystron Sellers | 1,274,906 | |
Accrued Expenses | 789,088 | 812,722 |
Deferred Compensation | 59,750 | |
Trade and Other Payables, Total | $ 2,625,572 | $ 1,529,765 |
Share-Based Payments (Details N
Share-Based Payments (Details Narrative) - USD ($) | Dec. 09, 2019 | Mar. 29, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Apr. 07, 2020 | Dec. 07, 2018 | Aug. 07, 2017 | Jan. 23, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Aggregate intrinsic value exercise price of options | $ 3.48 | |||||||||
Restricted stock unit expense | $ 1,302 | $ 122,384 | ||||||||
Pre-funded warrants issued | 795,000 | |||||||||
Warrant exercise price | $ 0.0001 | $ 0.0001 | $ 7.50 | |||||||
Proceeds from issuance of warrant | $ 80 | |||||||||
Warrants to purchase | 61,333 | |||||||||
Share-based payments exercised shares | 40 | 40 | ||||||||
Series C Convertible Preferred Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Warrant exercise price | $ 4 | $ 4 | ||||||||
Proceeds from issuance of warrant | $ 4,174,000 | |||||||||
Warrants to purchase | 1,043,500 | 1,043,500 | ||||||||
Share-based payments exercised shares | 1,043,500 | 1,043,500 | ||||||||
Restricted Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of stock option to purchase shares of common stock | 5,201 | |||||||||
Aggregate intrinsic value exercise price of options | $ 23.28 | |||||||||
Unamortized value | $ 0 | |||||||||
Restricted stock unit expense | $ 0 | $ 118,478 | $ 1,302 | $ 122,384 | ||||||
2013 Stock Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized during period | 4,323 | |||||||||
Amended Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of available for grants | 1,470 | 1,470 | ||||||||
Amended Plan [Member] | Restricted Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of stock option to purchase shares of common stock | 2,853 | |||||||||
2017 Stock Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized during period | 7,031 | |||||||||
Number of available for grants | 3,967 | 3,967 | ||||||||
2017 Stock Incentive Plan [Member] | Restricted Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of stock option to purchase shares of common stock | 3,064 | |||||||||
2018 Stock Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized during period | 78,125 | |||||||||
Number of available for grants | 62,522 | 62,522 | ||||||||
2018 Stock Incentive Plan [Member] | Restricted Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of stock option to purchase shares of common stock | 15,603 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Stock Options Activity (Details) | 6 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Number of Shares, Beginning Balance | shares | 40 |
Number of Shares, Granted | shares | |
Number of Shares, Exercised | shares | |
Number of Shares, Forfeited | shares | |
Number of Shares, Canceled/Expired | shares | |
Number of Shares, Ending Balance | shares | 40 |
Number of Shares, Exercisable | shares | 40 |
Weighted Average Exercise Price, Beginning Balance | $ 236.16 |
Weighted Average Exercise Price, Granted | |
Weighted Average Exercise Price, Exercised | |
Weighted Average Exercise Price, Forfeited | |
Weighted Average Exercise Price, Canceled/Expired | |
Weighted Average Exercise Price, Ending Balance | 236.16 |
Weighted Average Exercise Price, Exercisable | 236.16 |
Weighted Average Grant Date Fair Value, Beginning | 151.68 |
Weighted Average Grant Date Fair Value, Granted | |
Weighted Average Grant Date Fair Value, Exercised | |
Weighted Average Grant Date Fair Value, Forfeited | |
Weighted Average Grant Date Fair Value, Canceled/Expired | |
Weighted Average Grant Date Fair Value, Ending | 151.68 |
Weighted Average Grant Date Fair Value, Exercisable | $ 151.68 |
Weighted Average Remaining Contractual Term (Years), Beginning | 11 months 26 days |
Weighted Average Remaining Contractual Term (Years), Granted | 0 years |
Weighted Average Remaining Contractual Term (Years), Exercised | 0 years |
Weighted Average Remaining Contractual Term (Years), Forfeited | 0 years |
Weighted Average Remaining Contractual Term (Years), Canceled/Expired | 0 years |
Weighted Average Remaining Contractual Term (Years), Ending | 6 months |
Weighted Average Remaining Contractual Term (Years), Exercisable | 6 months |
Aggregate Intrinsic Value, Beginning Balance | $ | |
Aggregate Intrinsic Value, Ending Balance | $ | |
Aggregate Intrinsic Value, Exercisable | $ |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units [Member] | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Number of RSUs, Beginning Balance | shares | 15,603 |
Number of RSUs, Granted | shares | |
Number of RSUs, Exercised | shares | |
Number of RSUs, Forfeited | shares | |
Number of RSUs, Cancelled/Expired | shares | |
Number of RSUs, Ending Balance | shares | 15,603 |
Number of RSUs, Exercisable | shares | 15,603 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 23.28 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | |
Weighted Average Grant Date Fair Value, Exercised | $ / shares | |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | |
Weighted Average Grant Date Fair Value, Cancelled/Expired | $ / shares | |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | 23.28 |
Weighted Average Grant Date Fair Value, Exercisable | $ / shares | $ 23.28 |
Share-Based Payments - Summar_3
Share-Based Payments - Summary of Warrant Activity (Details) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Common Stock Warrants [Member] | |
Number of Warrants, Beginning Balance | shares | 247,215 |
Number of Warrants, Granted | shares | 170,681 |
Number of Warrants, Exercised | shares | |
Number of Warrants, Forfeited | shares | |
Number of Warrants, Cancelled/Expired | shares | |
Number of Warrants, Ending Balance | shares | 417,896 |
Number of Warrants, Exercisable | shares | 417,896 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 29.79 |
Weighted Average Exercise Price, Granted | $ / shares | 5.52 |
Weighted Average Exercise Price, Exercised | $ / shares | |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Weighted Average Exercise Price, Cancelled/Expired | $ / shares | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 19.88 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 19.88 |
Weighted Average Remaining Contractual Term (years), Beginning | 4 years 3 months 26 days |
Weighted Average Remaining Contractual Term (years), Granted | 4 years 10 months 6 days |
Weighted Average Remaining Contractual Term (years), Exercised | 0 years |
Weighted Average Remaining Contractual Term (years), Ending | 4 years 2 months 27 days |
Weighted Average Remaining Contractual Term (years), Exercisable | 4 years 2 months 27 days |
Pre-funded Common Stock Warrants [Member] | |
Number of Warrants, Beginning Balance | shares | 795,000 |
Number of Warrants, Granted | shares | |
Number of Warrants, Exercised | shares | (795,000) |
Number of Warrants, Forfeited | shares | |
Number of Warrants, Cancelled/Expired | shares | |
Number of Warrants, Ending Balance | shares | |
Number of Warrants, Exercisable | shares | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 0.0001 |
Weighted Average Exercise Price, Granted | $ / shares | |
Weighted Average Exercise Price, Exercised | $ / shares | 0.0001 |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Weighted Average Exercise Price, Cancelled/Expired | $ / shares | |
Weighted Average Exercise Price, Ending Balance | $ / shares | |
Weighted Average Exercise Price, Exercisable | $ / shares | |
Weighted Average Remaining Contractual Term (years), Beginning | 0 years |
Weighted Average Remaining Contractual Term (years), Granted | 0 years |
Weighted Average Remaining Contractual Term (years), Exercised | 0 years |
Weighted Average Remaining Contractual Term (years), Ending | 0 years |
Weighted Average Remaining Contractual Term (years), Exercisable | 0 years |
Convertible Preferred Series C Stock Warrants [Member] | |
Number of Warrants, Beginning Balance | shares | 1,990,000 |
Number of Warrants, Granted | shares | |
Number of Warrants, Exercised | shares | (1,043,500) |
Number of Warrants, Forfeited | shares | |
Number of Warrants, Cancelled/Expired | shares | |
Number of Warrants, Ending Balance | shares | 946,500 |
Number of Warrants, Exercisable | shares | 946,500 |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 4 |
Weighted Average Exercise Price, Granted | $ / shares | |
Weighted Average Exercise Price, Exercised | $ / shares | 4 |
Weighted Average Exercise Price, Forfeited | $ / shares | |
Weighted Average Exercise Price, Cancelled/Expired | $ / shares | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 4 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 4 |
Weighted Average Remaining Contractual Term (years), Beginning | 4 years 11 months 12 days |
Weighted Average Remaining Contractual Term (years), Granted | 0 years |
Weighted Average Remaining Contractual Term (years), Exercised | 4 years 5 months 12 days |
Weighted Average Remaining Contractual Term (years), Ending | 4 years 5 months 12 days |
Weighted Average Remaining Contractual Term (years), Exercisable | 4 years 5 months 12 days |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Aug. 03, 2020 | Dec. 04, 2019 | Jul. 25, 2019 | Jun. 21, 2019 | Apr. 02, 2019 | Jan. 14, 2019 | Aug. 17, 2016 | Jun. 30, 2020 | Jun. 30, 2020 |
Novotek Therapeutics Inc., and NovoTek Pharmaceuticals Limited [Member] | |||||||||
Loss contingency, damages sought, value | $ 1,551,562 | ||||||||
Neelima Varma and St.David's [Member] | |||||||||
Loss contingency, seeking description | On July 25, 2019, the Company was notified that on July 23, 2019, a complaint was filed by Neelima Varma, against the Company and St. David's Healthcare Partnership, L.P., LLP ("St. David's"), in the district court of Travis County, Texas, alleging, among other things, negligence, gross negligence and strict product liability, breach of express warranty, breach of implied warranty and fraudulent misrepresentation and omission, with respect to a medical device which the Company had sold through one its distributors to St. David's. Ms. Varma is seeking aggregate monetary relief from the Company and St. David's in excess of $1,000,000. | ||||||||
St.David's [Member] | |||||||||
Loss contingency, seeking excess value | $ 1,000,000 | ||||||||
Advisory Board [Member] | |||||||||
Number of shares issued | $ 25,000 | ||||||||
Stock based compensation | $ 8,333 | $ 50,000 | |||||||
Settlement Agreement [Member] | Watts Action [Member] | |||||||||
Payment of attorney' fees | $ 200,000 | ||||||||
Settlement Agreement [Member] | Watts and Chan Action [Member] | |||||||||
Payment of attorney' fees | $ 325,000 | ||||||||
Settlement Agreement [Member] | ChubeWorkx [Member] | |||||||||
Percentage of royalty received | 5.00% | ||||||||
Settlement Agreement and General Release [Member] | |||||||||
Number of shares issued | $ 300,000 | ||||||||
Stock issued during the period | 500,000 | ||||||||
Debt instrument, description | On August 5, 2020, the Company (i) paid to ChubeWorkx an amount equal to $300,000 and (ii) delivered to ChubeWorkx 500,000 shares of the Company's common stock (the "Shares"). The Company granted ChubeWorkx registration rights with respect to the Shares. In the event that the Company fails to file a resale registration statement covering the Shares by August 18, 2020 (the "Filing Deadline"), or fails to cause such registration statement to be declared effective by the earlier of October 2, 2020 or 45 days after the filing of such registration statement (the "Effectiveness Deadline"), then, on each of the Filing Deadline and the Effectiveness Deadline, as the case may be, and on each monthly anniversary thereof (if the such registration statement shall not have been filed or declared effective by such date, as the case may be) until such registration statement is filed or declared effective, the Company shall pay to ChubeWorkx an amount in cash, as partial liquidated damages equal to 1.0% of the market value of the Shares. |
Related Parties (Details Narrat
Related Parties (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Proceeds from contributed capital | $ 0 | $ 9,250 | $ 9,250 | $ 23,506 | |
Accounts payable and accrued expenses | 3,173 | $ 3,173 | $ 471 | ||
2017 Plan [Member] | |||||
Number of common stock shares issued for compensation services, shares | 0 | 1,095 | |||
Number of common stock shares issued for compensation services, value | $ 0 | $ 22,444 | |||
Financial Consulting Strategies LLC [Member] | |||||
Accounts payable | $ 9,250 | $ 9,250 | $ 18,323 |
Revenue Information (Details Na
Revenue Information (Details Narrative) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
People's Republic of China [Member] | ||
Long-lived assets | $ 0 | $ 9,823 |
United States [Member] | ||
Long-lived assets | $ 4,783 | $ 194,174 |
Revenue Information - Schedule
Revenue Information - Schedule of Revenue by Product Lines (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Total product revenues | $ (1,888) | $ 464,513 | $ 361,627 | $ 1,076,634 | $ 1,577,033 |
MicroParticle Catalyzed Biosensor ("MPC") [Member] | |||||
Total product revenues | 65,344 | 88,664 | |||
Particle ImmunoFiltration Assay ("PIFA") [Member] | |||||
Total product revenues | (3,399) | 304,658 | 351,059 | 880,973 | |
Rapid Enzymatic Assay ("REA") [Member] | |||||
Total product revenues | 85,000 | 85,000 | |||
Other [Member] | |||||
Total product revenues | $ 1,511 | $ 9,511 | $ 10,568 | $ 21,997 |
Revenue Information - Schedul_2
Revenue Information - Schedule of Revenue by Geographic Area Determined Based On Location of Customers (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Total product revenues | $ (1,888) | $ 464,513 | $ 361,627 | $ 1,076,634 | $ 1,577,033 |
United States [Member] | |||||
Total product revenues | (1,888) | 447,013 | 361,627 | 1,059,134 | |
Rest of World [Member] | |||||
Total product revenues | $ 17,500 | $ 17,500 |
Employee Benefit Plan (Details
Employee Benefit Plan (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Percentage of matching contribution | 100.00% | |||
Percentage of employers contribution based upon employee's pay | 3.00% | |||
Employer contribution amount | $ 5,097 | $ 7,425 | $ 22,924 | $ 16,888 |
401 (k) Plan Matches 50% [Member] | ||||
Percentage of matching contribution | 50.00% | |||
Percentage of employers contribution based upon employee's pay | 3.00% | |||
401 (k) Plan Maximum 5% [Member] | ||||
Percentage of employers contribution based upon employee's pay | 5.00% |