Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Entity Central Index Key | 0001293818 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 001-37367 | ||
Entity Registrant Name | OPGEN, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 06-1614015 | ||
Entity Address, Address Line One | 9717 Key West Avenue | ||
Entity Address, City or Town | Rockville | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20850 | ||
City Area Code | 240 | ||
Local Phone Number | 813-1260 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | OPGN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 86,778,295 | ||
Entity Common Stock, Shares Outstanding | 46,557,750 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement to be filed with respect to its 2022 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The proxy statement will be filed with the Securities and Exchange Commission within 120 days after the registrant’s fiscal year ended December 31, 2021. | ||
Auditor Name | CohnReznick LLP | ||
Auditor Location | Tysons, Virginia | ||
Auditor Firm Id | 596 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 36,080,392 | $ 13,360,463 |
Accounts receivable, net | 1,172,396 | 653,104 |
Inventory, net | 1,239,456 | 1,485,986 |
Prepaid expenses and other current assets | 1,250,331 | 1,388,090 |
Total current assets | 39,742,575 | 16,887,643 |
Property and equipment, net | 4,011,748 | 3,259,487 |
Finance lease right-of-use assets, net | 90,467 | 449,628 |
Operating lease right-of-use assets | 1,814,396 | 2,082,300 |
Goodwill | 7,453,007 | 8,024,729 |
Intangible assets, net | 14,530,209 | 16,580,963 |
Strategic inventory | 3,472,337 | 1,686,342 |
Other noncurrent assets | 551,794 | 779,953 |
Total assets | 71,666,533 | 49,751,045 |
Current liabilities | ||
Accounts payable | 1,307,081 | 1,868,666 |
Accrued compensation and benefits | 1,621,788 | 2,126,511 |
Accrued liabilities | 1,965,845 | 1,437,141 |
Deferred revenue | 9,808 | |
Short-term notes payable | 14,519,113 | 699,000 |
Short-term finance lease liabilities | 43,150 | 266,470 |
Short-term operating lease liabilities | 459,792 | 964,434 |
Total current liabilities | 19,916,769 | 7,372,030 |
Note payable | 7,176,251 | 19,378,935 |
Derivative liabilities | 228,589 | 112,852 |
Long-term finance lease liabilities | 3,644 | 46,794 |
Long-term operating lease liabilities | 2,977,402 | 1,492,544 |
Other long-term liabilities | 146,798 | 156,635 |
Total liabilities | 30,449,453 | 28,559,790 |
Commitments and Contingencies (Note 10) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2021 and 2020, respectively | ||
Common stock, $0.01 par value; 100,000,000 shares authorized; 46,450,250 and 25,085,534 shares issued and outstanding at December 31, 2021 and 2020, respectively | 464,503 | 250,855 |
Additional paid-in capital | 275,708,490 | 219,129,045 |
Accumulated deficit | (235,541,539) | (200,735,827) |
Accumulated other comprehensive income | 585,626 | 2,547,182 |
Total stockholders' equity | 41,217,080 | 21,191,255 |
Total liabilities and stockholders' equity | $ 71,666,533 | $ 49,751,045 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 08, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 50,000,000 |
Common stock, shares issued | 46,450,250 | 25,085,534 | |
Common stock, shares outstanding | 46,450,250 | 25,085,534 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue | ||
Total revenue | $ 4,306,031 | $ 4,214,441 |
Operating expenses | ||
Research and development, net | 10,910,679 | 9,964,720 |
General and administrative | 9,935,963 | 8,801,661 |
Sales and marketing | 3,713,263 | 3,094,092 |
Transaction costs | 471,522 | |
Impairment of right-of-use asset | 170,714 | 101,838 |
Impairment of intangible assets | 750,596 | |
Gain on sale of equipment | (100,000) | |
Total operating expenses | 27,579,067 | 26,932,920 |
Operating loss | (23,273,036) | (22,718,479) |
Other expense | ||
Gain on extinguishment of debt | 259,353 | 884,970 |
Warrant inducement expense | (7,755,541) | |
Interest and other income, net | 45,179 | 105,627 |
Interest expense | (4,799,331) | (3,399,384) |
Foreign currency transaction gains/(losses) | 891,223 | (1,468,855) |
Change in fair value of derivative financial instruments | (129,731) | 517,680 |
Total other expense | (11,488,848) | (3,359,962) |
Loss before income taxes | (34,761,884) | (26,078,441) |
Provision for income taxes | 43,828 | 132,403 |
Net loss | (34,805,712) | (26,210,844) |
Deemed dividend on beneficial conversion feature | (7,166,752) | |
Net loss available to common stockholders | $ (41,972,464) | $ (26,210,844) |
Basic and diluted net loss per share attributable to common stockholders | $ (1.14) | $ (1.66) |
Weighted average shares outstanding - basic and diluted | 36,674,083 | 15,800,781 |
Net loss | $ (34,805,712) | $ (26,210,844) |
Other comprehensive (loss) income - foreign currency translation | (1,961,556) | 2,564,497 |
Comprehensive loss | (36,767,268) | (23,646,347) |
Product sales [Member] | ||
Revenue | ||
Total revenue | 2,656,669 | 2,704,364 |
Operating expenses | ||
Cost of products and services | 2,295,828 | 3,360,280 |
Laboratory services [Member] | ||
Revenue | ||
Total revenue | 813,210 | 167,736 |
Operating expenses | ||
Cost of products and services | 552,620 | 488,211 |
Collaborations Revenue [Member] | ||
Revenue | ||
Total revenue | $ 836,152 | $ 1,342,341 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Preferred Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 55,823 | $ 178,779,814 | $ (17,315) | $ (174,524,983) | $ 4,293,339 | |
Balance (in shares) at Dec. 31, 2019 | 5,582,280 | |||||
Offering of common stock and warrants, net of issuance costs | $ 48,426 | 9,240,703 | 9,289,129 | |||
Offering of common stock and warrants, net of issuance costs (in shares) | 4,842,615 | |||||
Beneficial conversion option on convertible preferred stock | ||||||
Deemed dividend on beneficial conversion feature | ||||||
At the market offering, net of offering costs | $ 75,216 | 15,746,706 | 15,821,922 | |||
At the market offering, net of offering costs (in shares) | 7,521,610 | |||||
Warrant exercises | $ 43,410 | 8,638,590 | 8,682,000 | |||
Warrant exercises (in shares) | 4,341,000 | |||||
Issuance of RSUs | $ 59 | (59) | ||||
Issuance of RSUs (in shares) | 5,916 | |||||
Stock compensation expense | 316,086 | 316,086 | ||||
Shares issued to settle convertible notes | $ 7,639 | 1,443,158 | 1,450,797 | |||
Shares issued to settle convertible notes (in shares) | 763,905 | |||||
Shares issued in business combination | $ 20,282 | 4,827,135 | 4,847,417 | |||
Shares issued in business combination (in shares) | 2,028,208 | |||||
Value of equity awards assumed in business combination | 136,912 | 136,912 | ||||
Foreign currency translation | 2,564,497 | 2,564,497 | ||||
Net loss | (26,210,844) | (26,210,844) | ||||
Balance at Dec. 31, 2020 | $ 250,855 | 219,129,045 | 2,547,182 | (200,735,827) | 21,191,255 | |
Balance (in shares) at Dec. 31, 2020 | 25,085,534 | |||||
Offering of common stock and warrants, net of issuance costs | $ 83,334 | 23,390,628 | 23,473,962 | |||
Offering of common stock and warrants, net of issuance costs (in shares) | 8,333,333 | |||||
Offering of preferred stock and warrants, net of issuance costs | $ 1,500 | 13,849,759 | 13,851,259 | |||
Offering of preferred stock and warrants, net of issuance costs, shares | 150,000 | |||||
Conversion of preferred stock into common stock | $ 75,000 | $ (1,500) | (73,500) | |||
Conversion of preferred stock into common stock, shares | 7,500,000 | (150,000) | ||||
Beneficial conversion option on convertible preferred stock | 7,166,752 | 7,166,752 | ||||
Deemed dividend on beneficial conversion feature | (7,166,752) | (7,166,752) | ||||
At the market offering, net of offering costs | $ 6,800 | 1,477,033 | 1,483,833 | |||
At the market offering, net of offering costs (in shares) | 680,000 | |||||
Warrant exercises | $ 48,476 | 9,045,696 | 9,094,172 | |||
Warrant exercises (in shares) | 4,847,615 | |||||
Proceeds from the issuance of warrants | 255,751 | 255,751 | ||||
Warrant inducement | 7,755,541 | 7,755,541 | ||||
Issuance of RSUs | $ 38 | (38) | ||||
Issuance of RSUs (in shares) | 3,768 | |||||
Stock compensation expense | 878,575 | 878,575 | ||||
Shares issued in business combination | ||||||
Foreign currency translation | (1,961,556) | (1,961,556) | ||||
Net loss | (34,805,712) | (34,805,712) | ||||
Balance at Dec. 31, 2021 | $ 464,503 | $ 275,708,490 | $ 585,626 | $ (235,541,539) | $ 41,217,080 | |
Balance (in shares) at Dec. 31, 2021 | 46,450,250 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (34,805,712) | $ (26,210,844) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 2,713,907 | 2,334,739 |
Noncash interest expense | 3,988,755 | 2,632,241 |
Noncash interest income | (87,233) | |
Stock compensation expense | 878,575 | 316,086 |
Gain on sale of equipment | (100,000) | |
Gain on extinguishment of debt | (259,353) | (884,970) |
Warrant inducement expense | 7,755,541 | |
Change in fair value of derivative financial instruments | 129,731 | (517,680) |
Impairment of right-of-use asset | 170,714 | 101,838 |
Impairment of intangible assets | 750,596 | |
Changes in operating assets and liabilities, net of acquisition | ||
Accounts receivable | (575,123) | 438,284 |
Inventory | (2,336,714) | (410,341) |
Other assets | 739,429 | 1,152,200 |
Accounts payable | (471,824) | (481,453) |
Accrued compensation and other liabilities | 602,605 | (1,559,881) |
Deferred revenue | (9,808) | (870,114) |
Net cash used in operating activities | (21,479,277) | (23,396,532) |
Cash flows from investing activities | ||
Acquisition of business net of cash acquired | 1,266,849 | |
Note receivable | (2,200,000) | |
Purchases of property and equipment | (1,983,614) | (130,354) |
Net cash used in investing activities | (1,983,614) | (1,063,505) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 1,483,833 | 15,821,922 |
Proceeds from issuance of common stock warrants | 255,751 | |
Proceeds from issuance of common stock and pre-funded warrants in private placement, net of selling costs | 9,289,129 | |
Proceeds from issuance of common stock and pre-funded warrants in registered direct offering, net of selling costs | 23,473,962 | |
Proceeds from the exercise of common warrants | 9,094,172 | 8,682,000 |
Proceeds from issuance of preferred stock and warrants, net of issuance costs | 13,851,259 | |
Proceeds from debt, net of issuance costs | 1,871,308 | |
Payments on debt | (441,076) | (998,182) |
Payments on finance lease obligations | (266,470) | (579,029) |
Net cash provided by financing activities | 47,451,431 | 34,087,148 |
Effects of exchange rates on cash | (1,463,609) | 1,586,541 |
Net increase in cash, cash equivalents and restricted cash | 22,524,931 | 11,213,652 |
Cash and cash equivalents and restricted cash at beginning of year | 14,107,255 | 2,893,603 |
Cash and cash equivalents and restricted cash at end of year | 36,632,186 | 14,107,255 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 895,200 | 952,050 |
Supplemental disclosures of noncash investing and financing activities | ||
Right-of-use assets acquired through operating leases | 615,761 | 1,008,039 |
Deemed dividend - beneficial conversion option on preferred stock | 7,166,752 | |
Inventory transferred to property and equipment | 530,638 | |
Shares issued in business combination | 4,847,417 | |
Shares issued to settle convertible notes | 1,450,797 | |
Note receivable from sale of equipment included in other assets | $ 100,000 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 - Organization OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. On April 1, 2020, OpGen completed its business combination transaction (the “Transaction”) with Curetis N.V., a public company with limited liability under the laws of the Netherlands (the “Seller” or “Curetis N.V.”), as contemplated by the Implementation Agreement, dated as of September 4, 2019 (the “Implementation Agreement”), by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and wholly-owned subsidiary of the Company (the “Purchaser”). Pursuant to the Implementation Agreement, the Purchaser acquired all of the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany (“Curetis GmbH”), and certain other assets and liabilities of the Seller (together, “Curetis”) (see Note 4). References to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Rockville, Maryland and the Company’s principal operations are in Rockville, Maryland; Holzgerlingen and Bodelshausen, Germany; and Vienna, Austria. The Company operates in one business segment. OpGen Overview OpGen is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. Our current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit. Following its initial announcement in October 2020, the Company discontinued its QuickFISH and PNA FISH product portfolio in its entirety during the first quarter of 2021 (see Note 12). The Company's FISH customers and distribution partners have been informed accordingly and last orders were received and processed in the first quarter of 2021. The discontinuance of these product lines did not qualify for discontinued operations reporting. The focus of OpGen is on its combined broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret Antimicrobial resistance (AMR) genetic data. OpGen will continue to develop and seek FDA and other regulatory clearances or approvals, as applicable, for the Unyvero UTI and IJI products. OpGen will continue to offer the FDA-cleared Unyvero LRT and LRT BAL Panels, Acuitas AMR Gene Panel diagnostic test, as well as the Unyvero UTI Panel as a RUO product to hospitals, public health departments, clinical laboratories, pharmaceutical companies and contract research organizations, or CROs. OpGen will also continue to commercialize its CE Marked Unyvero Panels in Europe and other global markets via distributors. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2021 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management's Plans | Note 2 - Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations and negative operating cash flows and has a significant amount of debt coming due in 2022. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company, including the following: • On October 18, 2021, the Company closed a registered direct offering (the “October 2021 Offering”) with a single healthcare-focused institutional investor of 150,000 shares of convertible preferred stock and warrants to purchase up to an aggregate of 7,500,000 shares of common stock. The shares of preferred stock had a stated value of $100 per share and were converted into an aggregate of 7,500,000 shares of common stock at a conversion price of $2.00 per share after the Company received stockholder approval for an increase to its number of authorized shares of common stock, which approval occurred at the Company’s special meeting of stockholders held in December 2021. Thereafter, all preferred stock was converted into 7,500,000 common shares in December 2021 so that there were no shares of preferred stock outstanding as of December 31, 2021. The warrants have an exercise price of $2.05 per share, will become exercisable six months following the date of issuance, and will expire five years following the initial exercise date. The October 2021 Offering raised aggregate net proceeds of $13.9 million, and gross proceeds of $15.0 million. F-9 • On March 9, 2021, the Company entered into a Warrant Exercise Agreement (the “Exercise Agreement”) with the institutional investor (the “Holder”) from our 2020 PIPE financing (see discussion below for a description of the 2020 PIPE). Pursuant to the Exercise Agreement, in order to induce the Holder to exercise all of the remaining 4,842,615 outstanding warrants acquired in the 2020 PIPE (the “Existing Warrants”) for cash, pursuant to the terms of and subject to beneficial ownership limitations contained in the Existing Warrants, the Company agreed to issue to the Holder new warrants (the “New Warrants”) to purchase 0.65 shares of common stock for each share of common stock issued upon such exercise of the Existing Warrants pursuant to the Exercise Agreement for an aggregate of 3,147,700 New Warrants. The terms of the New Warrants are substantially similar to those of the Existing Warrants, except that the New Warrants have an exercise price of $3.56. The New Warrants are immediately exercisable and will expire five years from the date of the Exercise Agreement. The Holder paid an aggregate of $255,751 to the Company for the purchase of the New Warrants. The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of the remaining Existing Warrants held by the Holder and the payment of the purchase price for the New Warrants (together, the “2021 Warrant Exercise”). As additional compensation, A.G.P./Alliance Global Partners, the Company’s placement agent for such warrant exchange, will receive a cash fee equal to $200,000 upon the cash exercise in full of the New Warrants. • On February 11, 2021, the Company closed a registered direct offering (the "February 2021 Offering”) with a single U.S.-based, healthcare-focused institutional investor for the purchase of (i) 2,784,184 shares of common stock and (ii) 5,549,149 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. The Company also issued to the investor, in a concurrent private placement, unregistered common share purchase warrants to purchase 4,166,666 shares of the Company's common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $3.00, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.99. The pre-funded warrants were immediately exercisable, at an exercise price of $0.01, and could be exercised at any time until all of the pre-funded warrants are exercised in full. The common warrants have an exercise price of $3.55 per share, are exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one-half (5.5) years from the date of issuance. The February 2021 Offering raised aggregate net proceeds of $23.5 million, and gross proceeds of $25.0 million. As of December 31, 2021, all 5,549,149 pre-funded warrants issued in the February 2021 Offering have been exercised. • On November 25, 2020, the Company closed a private placement (the “2020 PIPE”) with one healthcare-focused U.S. institutional investor for the purchase of (i) 2,245,400 shares of common stock, (ii) 4,842,615 warrants to purchase shares of common stock and (iii) 2,597,215 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $2.065, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.055. The common warrants have an exercise price of $1.94 per share, and are exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one-half (5.5) years from the date of issuance. The 2020 PIPE raised aggregate net proceeds of $9.3 million, and gross proceeds of $10.0 million. As of December 31, 2020, all 2,597,215 pre-funded warrants issued in the 2020 PIPE were exercised. • On February 11, 2020, the Company entered into an At the Market Common Offering (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), which was amended and restated on November 13, 2020 to add BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell from time to time in an “at the market offering”, at its option, up to an aggregate of $22.1 million of shares of the Company's common stock through the sales agents (the “2020 ATM Offering”). During the year ended December 31, 2020, the Company sold 7,521,610 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $15.8 million, and gross proceeds of $16.7 million. During the year ended December 31, 2021, the Company sold 680,000 shares of its common stock under the 2020 ATM Offering, resulting in aggregate net proceeds to the Company of approximately $1.48 million, and gross proceeds of approximately $1.55 million. F-10 To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash, will be sufficient to repay or refinance the current portion of the Company’s debt and fund operations into the fourth quarter of 2022. This has led management to conclude that there is substantial doubt about the Company’s ability to continue as a going concern. In the event the Company is unable to successfully raise additional capital during or before the end of the fourth quarter of 2022, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances, the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, pause or abort clinical trials including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. Foreign Currency The Company has subsidiaries located in Holzgerlingen, Germany; Vienna, Austria; and Copenhagen, Denmark, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income (loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at December 31, 2021 and 2020. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, inducement expense related to warrant repricing, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 6. Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. F-11 At December 31, 2021 and 2020, the Company had funds totaling $551,794 and $746,792, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 December 31, 2020 Cash and cash equivalents $ 36,080,392 $ 13,360,463 Restricted cash 551,794 746,792 Total cash and cash equivalents and restricted cash in the consolidated statements of cash flows $ 36,632,186 $ 14,107,255 Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $0 and $20,753 as of December 31, 2021 and 2020, respectively. At December 31, 2021, the Company had accounts receivable from two customers which individually represented 52% and 14% of total accounts receivable, respectively. At December 31, 2020, the Company had accounts receivable from one customer which individually represented 20% of total accounts receivable. For the year ended December 31, 2021, revenue earned from three customers represented 15%, 13%, and 12% of total revenues, respectively. For the year ended December 31, 2020, revenue earned from one customer represented 21% of total revenues. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2021 2020 Raw materials and supplies $ 866,963 $ 773,021 Work-in-process 100,801 87,159 Finished goods 3,744,029 2,312,148 Total $ 4,711,793 $ 3,172,328 Inventory includes Unyvero instrument systems, Unyvero cartridges, reagents and components for Unyvero, Acuitas, Curetis SARS CoV-2 test kits, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $98,064 and $288,378 at December 31, 2021 and 2020, respectively. The Company reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the consolidated balance sheets date as strategic inventory, a non-current asset. F-12 Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives range from three to ten years. Depreciation expense was $1,541,561 and $1,152,954 for the years ended December 31, 2021 and 2020, respectively. Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, 2021 2020 Laboratory and manufacturing equipment $ 4,613,324 $ 6,317,340 Office furniture and equipment 810,574 1,259,838 Computers and network equipment 491,183 1,692,154 Leasehold improvements 1,634,692 752,493 7,549,773 10,021,825 Less accumulated depreciation (3,538,025 ) (6,762,338 ) Property and equipment, net $ 4,011,748 $ 3,259,487 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2021 and 2020, the Company determined that its property and equipment was not impaired. Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the effective interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. ROU Assets ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the year ended December 31, 2021, the Company determined that the ROU asset associated with its San Diego, California office lease may not be recoverable. As a result, during the year ended December 31, 2021, the Company recorded an impairment charge of $170,714. The Company also recorded an impairment charge of $101,838 during the year ended December 31, 2020 related to its ROU asset associated with its Woburn, Massachusetts office lease. F-13 Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2021 consist of finite-lived and indefinite-lived intangible assets and goodwill. Finite-lived and indefinite-lived intangible assets Intangible assets include trademarks, developed technology, In-Process Research & Development, software and customer relationships and consisted of the following as of December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Subsidiary Cost Accumulated Amortization and Prior Year Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (461,000 ) $ — $ — $ (217,413 ) $ (243,587 ) $ — $ — Developed technology AdvanDx 458,000 (458,000 ) — — (308,526 ) (149,474 ) — — Customer relationships AdvanDx 1,094,000 (1,094,000 ) — — (736,465 ) (357,535 ) — — Trademarks and tradenames Curetis 1,768,000 (316,930 ) 43,015 1,494,085 (147,161 ) — 194,119 1,814,958 Distributor relationships Curetis 2,362,000 (282,277 ) 57,465 2,137,188 (131,070 ) — 259,336 2,490,266 A50 - Developed technology Curetis 349,000 (89,384 ) 8,492 268,108 (41,504 ) — 38,319 345,815 Ares - Developed technology Curetis 5,333,000 (682,833 ) 129,745 4,779,912 (317,060 ) — 585,536 5,601,476 A30 - In-Process Research & Development Curetis 5,706,000 — 144,916 5,850,916 — — 622,448 6,328,448 $ 17,531,000 $ (3,384,424 ) $ 383,633 $ 14,530,209 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 Identifiable intangible assets will be amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. F-14 Total amortization expense of intangible assets was $813,184 and $672,823 for the years ended December 31, 2021 and 2020, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2022 $ 783,669 2023 783,669 2024 783,669 2025 783,669 2026 783,669 Thereafter 4,760,948 Total $ 8,679,293 Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of December 31, 2021 and 2020 was $7,453,007 and $8,024,729, respectively. The changes in the carrying amount of goodwill as of December 31, 2021, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Changes in currency translation 735,263 Balance as of December 31, 2020 8,024,729 Changes in currency translation (571,722 ) Balance as of December 31, 2021 $ 7,453,007 The Company conducts an impairment test of goodwill on an annual basis, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the years ended December 31, 2021 and 2020, the Company determined that its goodwill was not impaired. Revenue recognition The Company derives revenues from (i) the sale of Unyvero Application cartridges, Unyvero Systems, SARS CoV-2 tests, Acuitas AMR Gene Panel test products, (ii) providing laboratory services, (iii) providing collaboration services including funded software arrangements, and license arrangements, and (iv) granting access to a small subset of the proprietary ARESdb data asset. F-15 The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. Government grant agreements and research incentives From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and research incentives received European government agencies in the consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the year ended December 31, 2021, the Company recognized $692,701 as a reduction of research and development expense related to government grant arrangements. For the year ended December 31, 2020, the Company recognized $495,153 as a reduction of research and development expense related to government grant arrangements. As of December 31, 2021 and 2020, the Company had earned but not yet received $396,365 and $413,530, respectively related to these agreements and incentives included in prepaid expenses and other current assets. Research and development costs, net Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, development materials, fees paid to consultants and outside service partners. Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock The Company uses the quoted market price of its common stock as its fair value. F-16 Expected volatility Through 2020, since OpGen did not have sufficient history to estimate the expected volatility of its common stock price, expected volatility was based on the volatility of peer public entities that were similar in size and industry. Beginning in 2021, for stock options with an expected term where there is sufficient history available, expected volatility is based on the volatility of OpGen's common stock. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $202,015,062 and $196,511,928 at December 31, 2021 and 2020, respectively. Despite the NOL carryforwards, which begin to expire in 2022 The Company also has foreign NOL carryforwards of $170,607,782 at December 31, 2021 from their foreign subsidiaries. $147,313,786 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOL’s within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized. Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. F-17 For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 18.2 million shares and 7.5 million shares as of December 31, 2021 and 2020, respectively. Adopted accounting pronouncements In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Reform on Financial Reporting Recently issued accounting standards The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2021 | |
Business Combinations [Abstract] | |
Business Combination | Note 4 - Business Combination On April 1, 2020, the Company completed its business combination transaction with Curetis N.V., a public company with limited liability under the laws of the Netherlands, as contemplated by the Implementation Agreement, dated as of September 4, 2019, by and among the Company, the Seller, and Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and wholly-owned subsidiary of the Company. Pursuant to the Implementation Agreement, the Purchaser acquired all of the shares of Curetis GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany, and certain other assets and liabilities of the Seller, as further described below, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock, to the Seller, and reserved for future issuance (a) 134,356 shares of common stock, in connection with its assumption of the Seller’s 2016 Stock Option Plan, as amended (the “Seller Stock Option Plan”), and the outstanding awards thereunder, and (b) 500,000 shares of common stock to be issued upon the conversion, if any, of certain convertible notes issued by the Seller. At the closing, the Company assumed all of the liabilities of the Seller solely and exclusively related to the acquired business, which is providing innovative solutions, through development of proprietary platforms, diagnostic content, applied bioinformatics, lab services, research services and commercial collaborations and agreements, for molecular microbiology, diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patients. Pursuant to the Implementation Agreement, the Company also assumed and adopted the Seller Stock Option Plan as an Amended and Restated Stock Option Plan of the Company. In connection with the foregoing, the Company assumed all awards thereunder that were outstanding as of the closing date and converted such awards into options to purchase shares of the Company’s common stock pursuant to the terms of the applicable award. In addition, the Company assumed, at the closing, all of the outstanding convertible notes issued by the Seller in favor of YA II PN, LTD, pursuant to the Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares, dated February 24, 2020, and entered into pursuant to the Implementation Agreement. F-18 Curetis’ assets and liabilities were measured and recognized at their fair values as of the transaction date and combined with the assets, liabilities and results of operations of OpGen after the consummation of the business combination. The allocation of the purchase price to acquired assets and assumed liabilities based on their underlying fair values requires the extensive use of significant estimates and management’s judgment. The components of the purchase price and net assets acquired are as follows: Purchase Price Number of shares issued to Curetis N.V 2,028,208 Multiplied by the market value per share of OpGen's common stock (i) $ 2.39 Total fair value of common stock issued to Curetis N.V shareholders 4,847,417 Fair value of replacement stock awards related to precombination service (ii) 136,912 Fair value of convertible notes assumed (iii) 1,323,750 Fair value of EIB debt assumed (iv) 15,784,892 Funds advanced to Curetis GmbH under Interim Facility 4,808,712 Cash, cash equivalents, and restricted cash acquired (1,266,849 ) $ 25,634,834 (i) The price per share of OpGen’s common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. (ii) The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. (iii) To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. (iv) The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. Net Assets Acquired Assets acquired Receivables $ 482,876 Inventory 2,022,577 Property and equipment 3,802,431 Right of use assets 1,090,812 Other current assets 925,364 Finite-lived intangible assets Trade names/trademarks 1,768,000 Customer/distributor relationships 2,362,000 A50 - Developed technology 349,000 Ares - Developed technology 5,333,000 Indefinite-lived intangible assets A30 - In-process research & development 5,706,000 Goodwill 6,688,652 Liabilities assumed Accounts payable (1,168,839 ) Accrued expenses and other current liabilities (1,953,927 ) Derivative liabilities (615,831 ) Lease liabilities (1,108,193 ) Other long-term liabilities (49,088 ) Net assets acquired $ 25,634,834 The fair value of identifiable intangible assets has been determined using the income approach, which involves significant unobservable inputs (Level 3 inputs). These inputs include projected sales, margin, required rate of return and tax rate, as well as an estimated royalty rate in the case of the trade names/trademarks intangibles. The trade names/trademarks intangibles are valued using a relief-from-royalty method. The customer/distributor relationships are valued using the with and without method. The developed technology intangibles are valued using a multi-period earnings method. F-19 The Company determined the fair value of an IPR&D asset resulting from the acquisition of Curetis using the multi-period earnings method under the income approach. This method reflects the present value of the projected cash flows that are expected to be generated by the IPR&D, less charges representing the required return on other assets to sustain those cash flows. The weighted-average amortization periods for finite-lived intangible assets acquired are 15 years for customer/distributor relationships, 10 years for developed technology and 10 years for trade names/trademarks. The total consideration paid in the acquisition exceeded the estimated fair value of the tangible and identifiable intangible assets acquired and liabilities assumed, resulting in approximately $6.7 million of goodwill. Goodwill, primarily related to expected synergies gained from combining operations, sales growth from future product offerings and customers, together with certain intangible assets that do not qualify for separate recognition, including assembled workforce, is not tax deductible in all relevant taxing jurisdictions. The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Transaction had been completed as of January 1, 2020. Pro forma information primarily reflects adjustments relating to the amortization of intangibles acquired and elimination of interest expense due under the interim facility. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2020 or that may be obtained in the future. Unaudited pro forma results Year ended December 31, 2020 Revenues $ 5,239,192 Net loss (29,319,303 ) Net loss per share (1.86 ) |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | Note 5 - Revenue from Contracts with Customers Disaggregated Revenue The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Years Ended December, 2021 2020 Product sales $ 2,656,669 $ 2,704,364 Laboratory services 813,210 167,736 Collaboration revenue 836,152 1,342,341 Total revenue $ 4,306,031 $ 4,214,441 Revenues by geography are as follows: Years Ended December, 2021 2020 Domestic $ 1,203,748 $ 1,917,367 International 3,102,283 2,297,074 Total revenue $ 4,306,031 $ 4,214,441 F-20 Deferred revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Acquired deferrals from Curetis 829,275 Revenue recognized in the period from amounts acquired from Curetis (870,114 ) Effect of foreign exchange rates 40,839 Balance at December 31, 2020 9,808 New deferrals, net of amounts recognized in the current period — Amounts returned to customers (9,808 ) Effect of foreign exchange rates — Balance at December 31, 2021 $ — Contract assets The Company had approximately $0 and $18,000 of contract assets as of December 31, 2021 and 2020 respectively, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. Unsatisfied performance obligations The Company had no unsatisfied performance obligations related to its contracts with customers at December 31, 2021 and 2020. |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 6 - Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - defined as observable inputs such as quoted prices in active markets; • Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and • Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the year ended December 31, 2021, the Company has not transferred any assets between fair value measurement levels. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. In June 2019, Curetis drew down a third tranche of EUR 5.0 million from the European Investment Bank (“EIB”). In return for EIB waiving the condition precedent of a minimum cumulative equity capital raised of EUR 15 million to disburse this EUR 5.0 million tranche, the parties agreed on a 2.1% participation percentage interest (“PPI”). Upon maturity of the tranche, EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. On July 9, 2020, the Company negotiated an amendment to the EIB debt financing facility. As part of the amendment, the parties adjusted the PPI percentage applicable to the previous EIB tranche of EUR 5.0 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen's equity value upon maturity between mid-2024 and mid-2025. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through profit or loss. The Company determines the fair value of the derivative using a Monte Carlo simulation model. Using this model, level 3 unobservable inputs include estimated discount rates and estimated risk-free interest rates. F-21 The Company’s convertible debt with YA II PN, LTD (see Note 7) included a conversion feature which constitutes an embedded derivative, which was separated and measured at fair value with subsequent changes being accounted for through profit or loss. The Company determines the fair value of the derivative using a Monte Carlo simulation model. Using this model, level 3 unobservable inputs include estimated volatility rates and estimated risk-free interest rates. The fair value of level 3 liabilities measured at fair value on a recurring basis for the years ended December 31, 2021 and 2020 was as follows: Description Balance at December 31, 2020 Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2021 Participation percentage interest liability $ 112,852 $ 129,731 $ (13,994 ) $ 228,589 Total revenue $ 112,852 $ 129,731 $ (13,994 ) $ 228,589 Description Balance at December 31, 2019 Acquired from Curetis Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2020 Participation percentage interest liability $ — $ 173,373 $ (75,222 ) $ 14,701 $ 112,852 Embedded conversion option liability — 442,458 (442,458 ) — — Total revenue $ — $ 615,831 $ (517,680 ) $ 14,701 $ 112,852 Financial assets and liabilities carried at fair value on a non-recurring basis The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-financial assets and liabilities carried at fair value on a recurring basis The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis. Non-financial assets and liabilities carried at fair value on a non-recurring basis The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when a triggering event requires such evaluation. During the year ended December 31, 2020, the Company recorded impairment expense of $750,596 related to its intangible assets and $101,838 related to its ROU assets (see Note 3). During the year ended December 31, 2021, the Company recorded impairment expense of $170,714 related to its ROU assets (see Note 3). |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 - Debt The following table summarizes the Company’s long-term debt and short-term borrowings as December 31, 2021 and 2020: December 31, 2021 2020 EIB $ 25,161,855 $ 25,936,928 PPP — 259,353 MGHIF — 331,904 Insurance financings — 107,742 Total debt obligations 25,161,855 26,635,927 Unamortized debt discount (3,466,491 ) (6,557,992 ) Carrying value of debt 21,695,364 20,077,935 Less current portion (14,519,113 ) (699,000 ) Long-term debt $ 7,176,251 $ 19,378,935 MGHIF financing In July 2015, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 2,273 shares of common stock of the Company at $2,200 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the “MGHIF Note”) in the principal amount of $1.0 million with a two-year On June 28, 2017, the MGHIF Note was amended and restated, and the maturity date of the MGHIF Note was extended by one year to July 14, 2018. As consideration for the agreement to extend the maturity date, the Company issued an amended and restated secured promissory note to MGHIF that (1) increased the interest rate to ten percent (10%) per annum and (2) provided for the issuance of common stock warrants to purchase 656 shares of its common stock to MGHIF. On June 11, 2018, the Company executed an Allonge to the MGHIF Note. The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen's common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the MGHIF Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. The Allonge to the MGHIF Note was treated as a debt modification and, as such, the unamortized issuance costs of approximately $7,000 as of June 11, 2018 were deferred and amortized as incremental expense over the term of the MGHIF Note. During the year ended December 31, 2021, the Company made the final payment under the MGHIF Note and the lien on the Company’s assets was released. Yorkville Convertible Notes The Company agreed to assume, as a condition to closing the business combination with Curetis all of the outstanding convertible notes (the “Convertible Notes”) issued by Curetis N.V. in favor of YA II PN, LTD (“Yorkville”), pursuant to that certain Agreement for the Issuance of and Subscription to Notes Convertible into Shares and Share Subscription Warrants, dated October 2, 2018, by and between Curetis N.V. and Yorkville. On February 24, 2020, the Company entered into an Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares (the “Assignment Agreement”) with Curetis N.V. and Yorkville. Pursuant to the Assignment Agreement, upon assumption of the Convertible Notes by the Company, the Convertible Notes ceased to be convertible into shares of Curetis N.V. and are instead convertible into shares of the Company’s common stock, par value $0.01. The Assignment Agreement provided that an amount of 500,000 shares of the Company’s common stock that comprise a portion of the consideration payable by the Company under the Implementation Agreement be reserved for issuance under the Convertible Notes. On June 17, 2020, the Company registered for resale an additional 450,000 shares of Company common stock issuable upon conversion of the Convertible Notes. F-23 At closing of the Transaction, an aggregate amount of €1.3 million of unconverted Convertible Notes was assumed by the Company. The Convertible Notes were measured and recognized at fair value at the acquisition date. The fair value of the Convertible Notes as of the closing of the Transaction was approximately $1.3 million. The resulting debt discount was amortized over the life of the Convertible Notes as an increase in interest expense. During year ended December 31, 2020, the Company issued 763,905 shares of common stock in satisfaction of approximately $1,451,000 of Convertible Notes. As of December 31, 2020, all notes have been converted. EIB Loan Facility In 2016, Curetis entered into a contract for an up to €25 million senior, unsecured loan financing facility from the European Investment Bank (“EIB”). The financing is in the first growth capital loan under the European Growth Finance Facility (“EGFF”), launched in November 2016. It is backed by a guarantee from the European Fund for Strategic Investment (“EFSI”), EFSI is an essential pillar of the Investment Plan for Europe (“IPE”), under which the EIB and the European Commission are working as strategic partners to support investments and bring back jobs and growth to Europe. The funding can be drawn in up to five tranches within 36 months, under the EIB amendment, and each tranche is to be repaid upon maturity five years after draw-down. In April 2017, Curetis drew down a first tranche of €10 million from this facility. This tranche has a floating interest rate of EURIBOR plus 4% payable after each 12-month-period from the draw-down-date and another additional 6% interest per annum that is deferred and payable at maturity together with the principal. In June 2018, another tranche of €3 million was drawn down. The terms and conditions are analogous to the first one. In June 2019, Curetis drew down a third tranche of €5 million from the EIB. In line with all prior tranches, the majority of interest is also deferred into the bullet repayment structure upon maturity. In return for EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15 million to disburse this €5 million tranche, the parties agreed on a 2.1% PPI. Upon maturity of the tranche, not before approximately mid-2024 (and no later than mid-2025) EIB would be entitled to an additional payment that is equity-linked and equivalent to 2.1% of the then total valuation of Curetis N.V. As part of the amendment between the Company and EIB on July 9, 2020, the parties adjusted the PPI percentage applicable to the previous EIB tranche of €5 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.’s equity value upon maturity to a new 0.3% PPI in OpGen’s equity value upon maturity. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through income or loss. On July 10, 2020, EIB agreed to defer total interest payments of €720k due in April and June 2020 under the first three tranches of the debt financing facility until December 31, 2021. The Company made these interest payments in December 2020. The EIB debt was measured and recognized at fair value as of the acquisition date. The fair value of the EIB debt was approximately $15.8 million as of the acquisition date. The resulting debt discount will be amortized over the life of the EIB debt as an increase to interest expense. As of December 31, 2021, the outstanding borrowings under all tranches were €22,216,012 (approximately USD $25,161,855), including deferred interest payable at maturity of €4,216,012 (approximately USD $4,775,055). PPP On April 22, 2020, the Company entered into a Term Note (the “Company Note”) with Silicon Valley Bank (the “Bank”) pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by the U.S. Small Business Administration. The Company’s wholly-owned subsidiary, Curetis USA Inc. (“Curetis USA” and collectively with the Company, the “Borrowers”), also entered into a Term Note with the Bank (the “Subsidiary Note,” and collectively with the Company Note, the “Notes”). The Notes were dated April 22, 2020. The principal amount of the Company Note was $879,630, and the principal amount of the Subsidiary Note was $259,353. F-24 In accordance with the requirements of the CARES Act, the Borrowers will use the proceeds from the Notes in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Notes at the rate of 1.00% per annum. The Borrowers may apply for forgiveness of amounts due under the Notes, in an amount equal to the sum of qualified expenses under the PPP, which include payroll costs, rent obligations, and covered utility payments incurred during the twenty-four weeks following disbursement under the Notes. The entire proceeds were used under the Notes for such qualifying expenses. The Company Note was forgiven in November 2020. In May 2021, the Subsidiary Note was forgiven. Total interest expense (including accretion of fair value to face value and amortization of debt discounts and financing fees) on all debt instruments was $4,799,331 and $3,399,984 for the years ended December 31, 2021 and 2020, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Note 8 - Stockholders’ Equity As of December 31, 2021, the Company has 100,000,000 shares of authorized common shares and 46,450,250 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding. Following receipt of approval from stockholders at a special meeting of stockholders held on December 8, 2021, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to increase the authorized shares of common stock from 50,000,000 to 100,000,000 shares. Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares. Additionally, following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, the Company filed an additional amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock splits. On October 28, 2019, the Company closed the October 2019 Public Offering of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit. The offering raised gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million. During the year ended December 31, 2021, 5,000 common warrants were exercised raising net proceeds of $10,000. During the year ended December 31, 2020, 4,341,000 common warrants were exercised raising net proceeds of approximately $8.7 million. On February 11, 2020, the Company entered into an ATM Agreement with Wainwright, which we amended and restated on November 13, 2020 to add BTIG, LLC pursuant to which the Company may offer and sell from time to time in an “at the market offering,” at its option, up to an aggregate of $22.1 million of shares of the Company's common stock through the sales agents. During the year ended December 31, 2020, the Company sold 7,521,610 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $15.8 million, and gross proceeds of $16.7 million. During the year ended December 31, 2021, the Company sold 680,000 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $1.48 million, and gross proceeds of $1.55 million. As of December 31, 2021, remaining availability under the ATM Agreement is $3.9 million. On April 1, 2020, the Company acquired all of the shares of Curetis GmbH, and certain other assets and liabilities of Curetis N.V., as further described in Notes 1 and 4, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock to the Seller. On November 25, 2020, the Company closed a private placement with one healthcare-focused U.S. institutional investor of (i) 2,245,400 shares of common stock together with 2,245,400 common warrants to purchase up to 2,245,400 shares of common stock and (ii) 2,597,215 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with 2,597,215 common warrants to purchase up to 2,597,215 shares of common stock (the “2020 PIPE”). Each share of common stock and accompanying common warrant were sold together at a combined offering price of $2.065, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.055. The common warrants have an exercise price of $1.94 per share, and are exercisable commencing on the six month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance. The 2020 PIPE raised aggregate net proceeds of $9.3 million, and gross proceeds of $10.0 million. As of December 31, 2020, all 2,597,215 pre-funded warrants issued in the 2020 PIPE have been exercised. F-25 On February 11, 2021, the Company closed the February 2021 Offering with a single U.S.-based, healthcare-focused institutional investor for the purchase of (i) 2,784,184 shares of common stock and (ii) 5,549,149 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock. The Company also issued to the investor, in a concurrent private placement, unregistered common warrants to purchase 4,166,666 shares of the Company’s common stock. Each share of common stock and accompanying common warrant were sold together at a combined offering price of $3.00, and each pre-funded warrant and accompanying common warrant were sold together at a combined offering price of $2.99. The pre-funded warrants are immediately exercisable, at an exercise price of $0.01, and may be exercised at any time until all of the pre-funded warrants are exercised in full. The common warrants will have an exercise price of $3.55 per share, will be exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one-half (5.5) years from the date of issuance. The February 2021 Offering raised aggregate net proceeds of $23.5 million, and gross proceeds of $25.0 million. As of December 31, 2021, all pre-funded warrants issued in the February 2021 Offering have been exercised. On March 9, 2021, the Company entered into an Exercise Agreement with the Holder from our 2020 PIPE financing. Pursuant to the Exercise Agreement, in order to induce the Holder to exercise all of the remaining 4,842,615 Existing Warrants for cash, pursuant to the terms of and subject to beneficial ownership limitations contained in the Existing Warrants, the Company agreed to issue to the Holder, New Warrants to purchase 0.65 shares of common stock for each share of common stock issued upon such exercise of the remaining Existing Warrants pursuant to the Exercise Agreement for an aggregate of 3,147,700 New Warrants. The terms of the New Warrants are substantially similar to those of the Existing Warrants, except that the New Warrants have an exercise price of $3.56. The New Warrants are immediately exercisable and will expire five years from the date of the Exercise Agreement. The Holder paid an aggregate of $255,751 to the Company for the purchase of the New Warrants. The Company received aggregate gross proceeds before expenses of approximately $9.65 million from the exercise of the remaining Existing Warrants held by the Holder and the payment of the purchase price for the New Warrants. The Company recognized approximately $7.8 million of non-cash warrant inducement expense during year ended December 31, 2021 related to this transaction representing the fair value of the New Warrants issued to induce the exercise. The fair values were calculated using the Black-Scholes option pricing model. On October 18, 2021, the Company closed the October 2021 Offering with a single healthcare-focused institutional investor of 150,000 shares of convertible preferred stock and warrants to purchase up to an aggregate of 7,500,000 shares of common stock. The shares of preferred stock had a stated value of $100 per share and were converted into an aggregate of 7,500,000 shares of common stock at a conversion price of $2.00 per share after the Company received stockholder approval for an increase to its number of authorized shares of common stock, which approval occurred at the Company’s special meeting of stockholders held in December 2021. The warrants have an exercise price of $2.05 per share, will become exercisable six months following the date of issuance, and will expire five years following the initial exercise date. The warrants are classified as permanent equity at December 31, 2021. In connection with the issuance of convertible preferred stock, the Company recognized a beneficial conversion feature of $7,166,752 as a deemed dividend to the preferred stockholders. On December 8, 2021, the Company received shareholder approval to increase the number of authorized shares of common stock of the Company. As of December 31, 2021, all 150,000 shares of convertible preferred stock were converted into an aggregate of 7,500,000 shares of common stock. The October 2021 Offering raised aggregate net proceeds of $13.9 million, and gross proceeds of $15.0 million. Stock options In 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. F-26 Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 2,710 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2021, 465,586 shares remain available for issuance under the 2015 Plan. On September 30, 2020, the Company held its 2020 Annual Meeting of Stockholders (the “2020 Annual Meeting”). At the 2020 Annual Meeting, stockholders of the Company voted to approve, among other things, a plan under which stock options to purchase an aggregate of 1,300,000 shares of the Company’s common stock would be made by the Board of Directors of the Company outside of the stockholder-approved equity incentive plan to its executive officers and non-employee directors (the “2020 Stock Options Plan”). The 2020 Stock Options Plan and the grant made thereunder were approved by the Board of Directors on August 6, 2020, subject to receipt of stockholder approval at the 2020 Annual Meeting. The aggregate number of shares of the Company’s common stock authorized for issuance is 1,300,000 shares of common stock and all 1,300,000 stock options were issued on September 30, 2020. Shares subject to awards granted under the 2020 Stock Options Plan that are forfeited or terminated before being exercised will not be available for re-issuance under the 2020 Stock Options Plan. As of December 31, 2021, no shares remain available for issuance under the 2020 Stock Options Plan. Replacement awards In connection with the business combination with Curetis, the Company issued equity awards to Curetis employees (“2016 Plan”), consisting of stock options (“replacement awards”) in exchange for their Curetis equity awards. The replacement awards consisted of 134,371 stock options with a weighted average grant date fair value of $1.68. The terms of these replacement awards are substantially similar to the original Curetis equity awards. The fair value of the replacement awards for services rendered through April 1, 2020, the acquisition date, was recognized as a component of the purchase consideration, with the remaining fair value of the replacement awards related to the post-combination services recorded as stock-based compensation over the remaining vesting period. For the years ended December 31, 2021 and 2020, the Company recognized stock compensation expense as follows: Years Ended December 31, 2021 2020 Cost of services $ 10,299 $ 2,927 Research and development 232,319 62,783 General and administrative 553,557 231,010 Sales and marketing 82,400 19,366 $ 878,575 $ 316,086 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position. As of December 31, 2021, the Company had unrecognized expense related to its stock options of $1.0 million, which will be recognized over a weighted average period of 2.5 years. F-27 A summary of the status of options granted is presented below as of and for the years ended December 31, 2021 and 2020: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Granted 1,525,000 $ 2.13 Exercised — $ — Assumed in business combination 134,371 $ 48.40 Forfeited (3,631 ) $ 21.11 Expired (872 ) $ 473.92 Outstanding at December 31, 2020 1,664,522 $ 7.99 9.4 $ — Granted 415,000 $ 1.99 Exercised — $ — Forfeited (363,554 ) $ 2.17 Expired (2,619 ) $ 544.38 Outstanding at December 31, 2021 1,713,349 $ 6.88 8.5 $ — Vested and expected to vest 1,713,349 $ 6.88 8.5 $ — Exercisable at December 31, 2021 731,090 $ 10.45 8.0 $ — The total fair value of options vested in the years ended December 31, 2021 and 2020 was $622,757 and $549,341, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2021 2020 Annual dividend — — Expected life (in years) 5.75 - 6.00 5.25 - 6.25 Risk free interest rate 0.9% - 1.1% 0.3% - 0.5% Expected volatility 121.3% - 123.1% 40.9% - 46.6% Restricted stock units A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2021 and 2020: Number of Units Weighted-Average Grant Date Fair Value Unvested at December 31, 2019 14,975 $ 8.76 Granted — $ — Vested (5,924 ) $ 8.51 Forfeited (933 ) $ 8.84 Unvested at December 31, 2020 8,118 $ 8.93 Granted 360,000 $ 1.99 Vested (3,768 ) $ 8.94 Forfeited (78,085 ) $ 2.23 Unvested at December 31, 2021 286,265 $ 2.03 As of December 31, 2021, there was approximately $320,000 of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 1 years. F-28 Stock purchase warrants At December 31, 2021 and 2020, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2021 (1) 2020 (1) November 2011 $ 3,955.00 November 2021 — 15 December 2011 $ 3,955.00 December 2021 — 2 February 2015 $ 3,300.00 February 2025 451 451 May 2016 $ 656.20 May 2021 — 9,483 June 2016 $ 656.20 May 2021 — 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 354,000 359,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 1.94 May 2026 — 4,842,615 November 2020 $ 2.68 May 2026 242,130 242,130 February 2021 $ 3.55 August 2026 4,166,666 — February 2021 $ 3.90 August 2026 416,666 — March 2021 $ 3.56 March 2026 3,147,700 — October 2021 $ 2.05 April 2027 7,500,000 — 16,217,946 5,848,131 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 9 - Income Taxes The Company’s loss before income taxes was $34.8 million and $26.1 million for the years ended December 31, 2021 and 2020, respectively. The Company’s provision for income taxes consists of the following for the years ended December 31, 2021 and 2020: December 31, 2021 2020 Current income tax provision Federal $ 36,084 $ — State 7,744 — Foreign — 132,403 Total 43,828 132,403 Deferred income tax provision Federal — — State — — Foreign — — Total — — Total provision for income taxes $ 43,828 $ 132,403 F-29 At December 31, 2021 and 2020, the Company had deferred tax assets of $106,839,267 and $103,185,302, respectively, primarily consisting of NOL carryforwards, research and development (“R&D”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2021 and 2020 have been offset by a valuation allowance of $106,088,316 and $98,874,420, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2021 and 2020 are as follows: December 31, 2021 2020 Deferred tax assets: NOL carryforward $ 102,388,393 $ 98,165,790 R&D credit carryforward 2,559,479 2,559,479 Share-based compensation 498,658 319,397 Depreciation — 100,157 Interest expense 502,575 1,233,203 ROU liabilities 567,624 475,645 Accruals and other 322,538 331,631 Total deferred tax assets 106,839,267 103,185,302 Valuation allowance (106,088,316 ) (98,874,420 ) Deferred tax liabilities: Intangible assets (178,478 ) (3,885,485 ) ROU assets (225,057 ) (425,397 ) Depreciation (347,416 ) — Net $ — $ — The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2021 2020 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment (4.4 )% 0.6 % Provision to return adjustment (0.1 )% — State income tax benefit, net of federal benefit 1.6 % 3.5 % Foreign rate differential 2.4 % 2.8 % Change in valuation allowance (20.6 )% (28.4 )% (0.1 )% (0.5 )% Management followed the guidance in ASC 740, which states that “a cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome” and concluded that the Company’s net deferred tax assets were not realizable as of December 31, 2021 and 2020. Accordingly, a valuation allowance of $106.1 million and $98.9 million has been recorded to offset the net deferred tax assets. The Company has federal NOL carryforwards of $202,015,062 and $196,511,928 at December 31, 2021 and 2020, respectively. The Company also has total Foreign NOL carryforwards at December 31, 2021 of $170,607,782 which is primarily driven by the Company's operations in Germany. The NOL carryforwards incurred prior to 2018 begin to expire in 2022 F-30 On March 27, 2020, the United States enacted the CARES Act. The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions which are expected to impact the Company's financial statements include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company doesn't believe that the CARES Act will have a material impact on its financial position, results of operations, or cash flows. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10 - Commitments and Contingencies Registration and other stockholder rights In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock. Supply agreements In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”), to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement, the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2021, the Company had acquired twenty-four QuantStudio 5s including none during the year ended December 31, 2021. As of December 31, 2021, the Company has not committed to acquiring additional QuantStudio 5s in the next three months. Curetis places frame-work orders for Unyvero-Systems and for raw materials for its cartridge manufacturing to ensure availability during commercial ramp-up-phase and also to gain volume-scale-effects with regards to purchase prices. Some of the electronic parts used for the production of Unyvero-Systems have lead times of many months, hence it is necessary to order such systems with long-term framework-orders to ensure the demands from the market are covered. The aggregate purchase commitments over the next twelve months are approximately $0.9 million. COVID-19 Impact In December 2019 and early 2020, the coronavirus known as COVID-19 was reported to have surfaced in China. The spread of this virus including its variants and mutations globally in 2020 and 2021 as well as into 2022 has caused significant business disruption domestically in the United States and in Europe, as well as China, the areas in which the Company primarily operates or has significant business interest. While the disruption is currently expected to be temporary, such disruption is still ongoing and there remains considerable uncertainty around the duration of this disruption. Therefore, while the Company expects that this matter will continue to impact the Company’s financial condition, results of operations, or cash flows, the extent of the financial impact and duration cannot be reasonably estimated at this time. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Note 11 - Leases The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2021 and 2020: Lease Classification December 31, 2021 December 31, 2020 ROU Assets: Operating $ 1,814,396 $ 2,082,300 Financing 90,467 449,628 Total ROU assets $ 1,904,863 $ 2,531,928 Liabilities Current: Operating $ 459,792 $ 964,434 Finance 43,150 266,470 Noncurrent: Operating 2,977,402 1,492,544 Finance 3,644 46,794 Total lease liabilities $ 3,483,988 $ 2,770,242 Maturities of lease liabilities as of December 31, 2021 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2022 $ 745,850 $ 44,850 $ 790,700 2023 639,172 3,364 642,536 2024 648,767 280 649,047 2025 544,080 — 544,080 2026 378,279 — 378,279 Thereafter 2,126,371 — 2,126,371 Total lease payments 5,082,519 48,494 5,131,013 Less: Interest (1,645,325 ) (1,700 ) (1,647,025 ) Present value of lease liabilities $ 3,437,194 $ 46,794 $ 3,483,988 Consolidated statements of operations classification of lease costs as of the years ended December 31, 2021 and 2020 are as follows: Years ended December 31, Lease Cost Classification 2021 2020 Operating Operating expenses $ 1,055,595 $ 1,205,551 Finance: Amortization Operating expenses 359,162 508,962 Interest expense Other expenses 15,481 57,247 Total lease costs $ 1,430,238 $ 1,771,760 Other lease information as of December 31, 2021 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 7.6 Finance leases 0.9 Weighted average discount rate: Operating leases 8.9 % Finance leases 9.1 % F-32 Supplemental cash flow information for the years ended December 31, 2021, and 2020 is as follows: Supplemental Cash Flow Information 2021 2020 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 1,055,595 $ 1,205,551 Finance leases $ 15,481 $ 57,247 Cash used in financing activities Finance leases $ 266,470 $ 579,029 ROU assets obtained in exchange for lease obligations: Operating leases $ 615,761 $ 1,008,039 Finance leases $ — $ — |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 2021 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 12 - License Agreements, Research Collaborations and Development Agreements NYSDOH In 2018, the Company announced a collaboration with the New York State Department of Health (“DOH”) and ILÚM Health Solutions, LLC (“ILÚM”), a wholly-owned subsidiary of Merck’s Healthcare Services and Solutions division, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. ILÚM has since been acquired by Infectious Disease Connect, Inc. (“IDC”), a University of Pittsburgh Medical Center (“UPMC”) Enterprise company. The Company is working together with DOH’s Wadsworth Center and IDC to continue development of an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance. As part of the collaboration, the Company received approximately $1.6 million over the 15-month demonstration portion of the project. The demonstration project began in early 2019 and was completed in the first quarter of 2020. In April 2020, the Company began a second-year expansion phase to build on the successes and experience of the first-year pilot phase while focusing on accomplishing the goal of the effort to improve patient outcomes and save healthcare dollars by integrating real-time epidemiologic surveillance with rapid delivery of antibiotic resistance results to care-givers via web-based and mobile platforms. The second-year contract included a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to $450,000 to OpGen. In April 2021, the Company extended its second-year expansion phase by another six months through September 30, 2021 at which point the project was completed and has ended. The six-month extension and expansion contract included a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to an additional $540,000. During the years ended December 31, 2021 and 2020, the Company recognized $558,000 and $388,000 of revenue related to the contract, respectively. Sandoz In December 2018, Ares Genetics entered into a service frame agreement with Sandoz International GmbH (“Sandoz”), to leverage Ares Genetics’ database on the genetics of antibiotic resistance, ARESdb, and the ARES Technology Platform for Sandoz’ anti-infective portfolio. Under the terms of the frame agreement, which had an initial term of 36 months and recently been extended to end January 31, 2025, Ares Genetics and Sandoz intend to develop a digital anti-infectives platform, combining established microbiology laboratory methods with advanced bioinformatics and artificial intelligence methods to support drug development and life-cycle management. The collaboration, in the short- to mid-term, aims to both rapidly and cost-effectively re-purpose existing antibiotics and design value-added medicines with the objective of expanding indication areas and to overcome antibiotic resistance, in particular with regards to infections with bacteria that has already developed resistance against multiple treatment options. In the longer-term, the platform is expected to enable surveillance for antimicrobial resistant pathogens to inform antimicrobial stewardship and the development of novel anti-infectives that are less prone to encounter resistance and thereby preserve antibiotics as an effective treatment option. F-33 The agreement covers the first phases of the collaboration with Sandoz and provides certain moderate six-figure R&D funding to Ares Genetics . Qiagen On February 18, 2019, Ares Genetics and Qiagen GmbH, or Qiagen, entered into a strategic licensing agreement for ARESdb and AREStools, in the area of antimicrobial resistance (“AMR”) research. The agreement has a term of 20 years and may be terminated by Qiagen for convenience with 180 days written notice. Ares Genetics has retained the rights to use ARESdb and AREStools for AMR research, customized bioinformatics services, and for the development of specific AMR assays and applications for the Curetis Group (including Ares Genetics), as well as third parties (e.g., other diagnostics companies or partners in the pharmaceutical industry). As the Qiagen research offering is expected to also enable advanced molecular diagnostic services and products, Qiagen’s customers may obtain a diagnostic use license from Ares Genetics. Under the terms of the original agreement, Qiagen, in exchange for a moderate six figure up-front licensing payment, has received an exclusive RUO license to develop and commercialize general bioinformatics offerings and services for AMR research use only, based on Ares Genetics’ database on the genetics of antimicrobial resistance, ARESdb, as well as on the ARES bioinformatics AMR toolbox, AREStools. Under the agreement, the parties had agreed to a mid-single digit percentage royalty rate on Qiagen net sales, which is subject to a minimum royalty rate that steps up upon certain achieved milestones, which is payable to Ares Genetics. The parties also agreed to further modest six figure milestone payments upon certain product launches. The contract was subsequently amended in May 2021 to a non-exclusive license and a flat annual license fee as well as a royalty percentage on potential future panel based products that are developed by Qiagen. Global leading IVD corporation On September 16, 2019, Ares Genetics entered into a multi-phase partnership with an undisclosed leading global in vitro diagnostics corporation, or the Partner, to jointly develop diagnostic solutions for infectious disease testing, based on next-generation sequencing, or NGS, technology. Ares Genetics and the Partner also entered into an R&D option agreement for the first phase of the partnership. Ares Genetics received an option fee of approximately $550,000. The initial 10-month term of the R&D collaboration, ended July 13, 2020, with payments excluding the option fee of approximately $1.2 million. In the first phase of the collaboration, which lasted 10 months, the parties have further enriched ARESdb with a focus on certain pathogens relevant in a first, undisclosed infectious disease indication. Additional clinical isolates of such pathogens have been sequenced by Ares Genetics at its recently established NGS laboratory in Vienna, Austria. Based on this enlarged and enriched dataset, Ares Genetics has further developed the algorithms for predictive antibiotic resistance testing for drug/pathogen combinations particularly relevant in the targeted indication to enable NGS-based infectious disease diagnostics. Under the initial agreement, the Partner funded Ares Genetics’ R&D activities for the genotypic and phenotypic characterization of additional bacterial strains to augment ARESdb and the development of optimized algorithms for predicting antibiotic resistance. Furthermore, in return for the up-front option fee, the Partner obtained a three-month right for first negotiation for an exclusive human clinical diagnostic use license to ARESdb and the ARES Technology Platform. A license was not executed and the collaboration ended in early 2021. The Company recognized approximately $0 and $870,000 of revenue related to the contract during the years ended December 31, 2021 and 2020, respectively. F-34 FISH License The Company was party to one license agreement with Life Technologies to acquire certain patent rights and technologies related to its FISH product line. Royalties were incurred upon the sale of a product or service which utilizes the licensed technology. The Company terminated this license agreement in October 2020 June 2021 Siemens In 2016, Ares Genetics acquired the GEAR assets from Siemens Technology Accelerator GmbH (STA), providing the original foundation to ARESdb. Under the agreement with STA, Ares Genetics incurs royalties on revenues from licensed product sales or sublicensing proceeds. Royalty rates under the Siemens agreement range from 1.3% to 40% depending on the specifics of the licenses and rights provided by Ares Genetics to third parties and whether such third parties may have been originally introduced by Siemens to Ares Genetics. The total net royalty expense related to this agreement was $146,375 and $2,775 for the years ended December 31, 2021 and 2020, respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 13 - Related Party Transactions On April 1, 2020, as part of the Transaction, Oliver Schacht, Ph.D., the former CEO of Curetis N.V., was appointed as the CEO of the Company, and Johannes Bacher the former COO of Curetis N.V. was appointed as the COO of the Company. Effective April 1, 2020, Mr. Schacht and Mr. Bacher were appointed as liquidators of Curetis N.V. in liquidation and Curetis GmbH was designated as Custodian of the Books for Curetis N.V. During a portion of the year ended December 31, 2020, Curetis N.V. in liquidation processed payroll for Mr. Schacht and Mr. Bacher and invoiced OpGen and Curetis GmbH, respectively, in line with their signed management agreements. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14 - Subsequent Events The Company’s management reviewed all material events through the date the consolidated financial statements were issued for subsequent event disclosure consideration, and none were noted. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. |
Foreign Currency | Foreign Currency The Company has subsidiaries located in Holzgerlingen, Germany; Vienna, Austria; and Copenhagen, Denmark, each of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income (loss), a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive income (loss) at December 31, 2021 and 2020. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, inducement expense related to warrant repricing, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, discount rates used to discount unpaid lease payments to present values, valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, determining the fair value of assets acquired and liabilities assumed in business combinations, the estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. |
Fair value of financial instruments | Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 6. |
Cash, cash equivalents and restricted cash | Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. F-11 At December 31, 2021 and 2020, the Company had funds totaling $551,794 and $746,792, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 December 31, 2020 Cash and cash equivalents $ 36,080,392 $ 13,360,463 Restricted cash 551,794 746,792 Total cash and cash equivalents and restricted cash in the consolidated statements of cash flows $ 36,632,186 $ 14,107,255 |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $0 and $20,753 as of December 31, 2021 and 2020, respectively. At December 31, 2021, the Company had accounts receivable from two customers which individually represented 52% and 14% of total accounts receivable, respectively. At December 31, 2020, the Company had accounts receivable from one customer which individually represented 20% of total accounts receivable. For the year ended December 31, 2021, revenue earned from three customers represented 15%, 13%, and 12% of total revenues, respectively. For the year ended December 31, 2020, revenue earned from one customer represented 21% of total revenues. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2021 2020 Raw materials and supplies $ 866,963 $ 773,021 Work-in-process 100,801 87,159 Finished goods 3,744,029 2,312,148 Total $ 4,711,793 $ 3,172,328 Inventory includes Unyvero instrument systems, Unyvero cartridges, reagents and components for Unyvero, Acuitas, Curetis SARS CoV-2 test kits, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $98,064 and $288,378 at December 31, 2021 and 2020, respectively. The Company reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and its estimated sales forecast, which is based on sales history and anticipated future demand. The Company’s estimates of future product demand may not be accurate, and it may understate or overstate the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of the Company’s inventory and results of operations. The Company classifies finished good inventory it does not expect to sell or use in clinical studies within 12 months of the consolidated balance sheets date as strategic inventory, a non-current asset. |
Long-lived assets | Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives range from three to ten years. Depreciation expense was $1,541,561 and $1,152,954 for the years ended December 31, 2021 and 2020, respectively. Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, 2021 2020 Laboratory and manufacturing equipment $ 4,613,324 $ 6,317,340 Office furniture and equipment 810,574 1,259,838 Computers and network equipment 491,183 1,692,154 Leasehold improvements 1,634,692 752,493 7,549,773 10,021,825 Less accumulated depreciation (3,538,025 ) (6,762,338 ) Property and equipment, net $ 4,011,748 $ 3,259,487 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2021 and 2020, the Company determined that its property and equipment was not impaired. |
Leases | Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the effective interest method of recognition. The Company has made certain accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases. ROU Assets ROU assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which the Company can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the year ended December 31, 2021, the Company determined that the ROU asset associated with its San Diego, California office lease may not be recoverable. As a result, during the year ended December 31, 2021, the Company recorded an impairment charge of $170,714. The Company also recorded an impairment charge of $101,838 during the year ended December 31, 2020 related to its ROU asset associated with its Woburn, Massachusetts office lease. |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2021 consist of finite-lived and indefinite-lived intangible assets and goodwill. Finite-lived and indefinite-lived intangible assets Intangible assets include trademarks, developed technology, In-Process Research & Development, software and customer relationships and consisted of the following as of December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Subsidiary Cost Accumulated Amortization and Prior Year Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (461,000 ) $ — $ — $ (217,413 ) $ (243,587 ) $ — $ — Developed technology AdvanDx 458,000 (458,000 ) — — (308,526 ) (149,474 ) — — Customer relationships AdvanDx 1,094,000 (1,094,000 ) — — (736,465 ) (357,535 ) — — Trademarks and tradenames Curetis 1,768,000 (316,930 ) 43,015 1,494,085 (147,161 ) — 194,119 1,814,958 Distributor relationships Curetis 2,362,000 (282,277 ) 57,465 2,137,188 (131,070 ) — 259,336 2,490,266 A50 - Developed technology Curetis 349,000 (89,384 ) 8,492 268,108 (41,504 ) — 38,319 345,815 Ares - Developed technology Curetis 5,333,000 (682,833 ) 129,745 4,779,912 (317,060 ) — 585,536 5,601,476 A30 - In-Process Research & Development Curetis 5,706,000 — 144,916 5,850,916 — — 622,448 6,328,448 $ 17,531,000 $ (3,384,424 ) $ 383,633 $ 14,530,209 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 Identifiable intangible assets will be amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite Acquired IPR&D represents the fair value assigned to those research and development projects that were acquired in a business combination for which the related products have not received regulatory approval and have no alternative future use. IPR&D is capitalized at its fair value as an indefinite-lived intangible asset, and any development costs incurred after the acquisition are expensed as incurred. Upon achieving regulatory approval or commercial viability for the related product, the indefinite-lived intangible asset is accounted for as a finite-lived asset and is amortized on a straight-line basis over the estimated useful life. If the project is not completed or is terminated or abandoned, the Company may have an impairment related to the IPR&D which is charged to expense. Indefinite-lived intangible assets are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. F-14 Total amortization expense of intangible assets was $813,184 and $672,823 for the years ended December 31, 2021 and 2020, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2022 $ 783,669 2023 783,669 2024 783,669 2025 783,669 2026 783,669 Thereafter 4,760,948 Total $ 8,679,293 Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid when the Company acquired AdvanDx, Inc. in July 2015 and Curetis in April 2020, over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of December 31, 2021 and 2020 was $7,453,007 and $8,024,729, respectively. The changes in the carrying amount of goodwill as of December 31, 2021, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Changes in currency translation 735,263 Balance as of December 31, 2020 8,024,729 Changes in currency translation (571,722 ) Balance as of December 31, 2021 $ 7,453,007 The Company conducts an impairment test of goodwill on an annual basis, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During the years ended December 31, 2021 and 2020, the Company determined that its goodwill was not impaired. |
Revenue recognition | Revenue recognition The Company derives revenues from (i) the sale of Unyvero Application cartridges, Unyvero Systems, SARS CoV-2 tests, Acuitas AMR Gene Panel test products, (ii) providing laboratory services, (iii) providing collaboration services including funded software arrangements, and license arrangements, and (iv) granting access to a small subset of the proprietary ARESdb data asset. F-15 The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. |
Government grant agreements and research incentives | Government grant agreements and research incentives From time to time, the Company may enter into arrangements with governmental entities for the purposes of obtaining funding for research and development activities. The Company recognizes funding from grants and research incentives received European government agencies in the consolidated statements of operations and comprehensive loss in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grants or incentives were provided have been met. For grants under funding agreements and for proceeds under research incentive programs, the Company recognizes grant and incentive income in an amount equal to the estimated qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred. The Company analyzes each arrangement on a case-by-case basis. For the year ended December 31, 2021, the Company recognized $692,701 as a reduction of research and development expense related to government grant arrangements. For the year ended December 31, 2020, the Company recognized $495,153 as a reduction of research and development expense related to government grant arrangements. As of December 31, 2021 and 2020, the Company had earned but not yet received $396,365 and $413,530, respectively related to these agreements and incentives included in prepaid expenses and other current assets. |
Research and development costs, net | Research and development costs, net Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, development materials, fees paid to consultants and outside service partners. |
Stock-based compensation | Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock The Company uses the quoted market price of its common stock as its fair value. F-16 Expected volatility Through 2020, since OpGen did not have sufficient history to estimate the expected volatility of its common stock price, expected volatility was based on the volatility of peer public entities that were similar in size and industry. Beginning in 2021, for stock options with an expected term where there is sufficient history available, expected volatility is based on the volatility of OpGen's common stock. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $202,015,062 and $196,511,928 at December 31, 2021 and 2020, respectively. Despite the NOL carryforwards, which begin to expire in 2022 The Company also has foreign NOL carryforwards of $170,607,782 at December 31, 2021 from their foreign subsidiaries. $147,313,786 of those foreign NOL carryforwards are from the Company’s operations in Germany. Despite the NOL carryforwards, the Company may have a current and future tax liability due to the nuances of German tax law around the use of NOL’s within a consolidated group. There is no assurance that the NOL carryforwards will ever be fully utilized. |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. F-17 For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 18.2 million shares and 7.5 million shares as of December 31, 2021 and 2020, respectively. |
Adopted accounting pronouncements | Adopted accounting pronouncements In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Reform on Financial Reporting Recently issued accounting standards The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31, 2021 December 31, 2020 Cash and cash equivalents $ 36,080,392 $ 13,360,463 Restricted cash 551,794 746,792 Total cash and cash equivalents and restricted cash in the consolidated statements of cash flows $ 36,632,186 $ 14,107,255 |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2021 2020 Raw materials and supplies $ 866,963 $ 773,021 Work-in-process 100,801 87,159 Finished goods 3,744,029 2,312,148 Total $ 4,711,793 $ 3,172,328 |
Schedule of Property and equipment | Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives range from three to ten years. Depreciation expense was $1,541,561 and $1,152,954 for the years ended December 31, 2021 and 2020, respectively. Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, 2021 2020 Laboratory and manufacturing equipment $ 4,613,324 $ 6,317,340 Office furniture and equipment 810,574 1,259,838 Computers and network equipment 491,183 1,692,154 Leasehold improvements 1,634,692 752,493 7,549,773 10,021,825 Less accumulated depreciation (3,538,025 ) (6,762,338 ) Property and equipment, net $ 4,011,748 $ 3,259,487 |
Schedule of Finite-Lived and Indefinite-Lived Intangible Assets | Intangible assets include trademarks, developed technology, In-Process Research & Development, software and customer relationships and consisted of the following as of December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Subsidiary Cost Accumulated Amortization and Prior Year Impairment Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Impairment Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames AdvanDx $ 461,000 $ (461,000 ) $ — $ — $ (217,413 ) $ (243,587 ) $ — $ — Developed technology AdvanDx 458,000 (458,000 ) — — (308,526 ) (149,474 ) — — Customer relationships AdvanDx 1,094,000 (1,094,000 ) — — (736,465 ) (357,535 ) — — Trademarks and tradenames Curetis 1,768,000 (316,930 ) 43,015 1,494,085 (147,161 ) — 194,119 1,814,958 Distributor relationships Curetis 2,362,000 (282,277 ) 57,465 2,137,188 (131,070 ) — 259,336 2,490,266 A50 - Developed technology Curetis 349,000 (89,384 ) 8,492 268,108 (41,504 ) — 38,319 345,815 Ares - Developed technology Curetis 5,333,000 (682,833 ) 129,745 4,779,912 (317,060 ) — 585,536 5,601,476 A30 - In-Process Research & Development Curetis 5,706,000 — 144,916 5,850,916 — — 622,448 6,328,448 $ 17,531,000 $ (3,384,424 ) $ 383,633 $ 14,530,209 $ (1,899,199 ) $ (750,596 ) $ 1,699,758 $ 16,580,963 |
Schedule of Estimated Useful Lives of Identifiable Intangible Assets | Identifiable intangible assets will be amortized on a straight-line basis over their estimated useful lives. The estimated useful lives of the intangibles are: Estimated Useful Life Trademarks and tradenames 10 years Customer/distributor relationships 15 years A50 – Developed technology 7 years Ares – Developed technology 14 years A30 – Acquired in-process research & development Indefinite |
Schedule of Expected Amortization of Intangible Assets | Total amortization expense of intangible assets was $813,184 and $672,823 for the years ended December 31, 2021 and 2020, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2022 $ 783,669 2023 783,669 2024 783,669 2025 783,669 2026 783,669 Thereafter 4,760,948 Total $ 8,679,293 |
Schedule of Changes in Carrying Amount of Goodwill | The changes in the carrying amount of goodwill as of December 31, 2021, and since December 31, 2019, were as follows: Balance as of December 31, 2019 $ 600,814 Acquisition of Curetis 6,688,652 Changes in currency translation 735,263 Balance as of December 31, 2020 8,024,729 Changes in currency translation (571,722 ) Balance as of December 31, 2021 $ 7,453,007 |
Business Combination (Tables)
Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Business Combinations [Abstract] | |
Schedule of Components of Purchase Price and Net Assets Acquired | The components of the purchase price and net assets acquired are as follows: Purchase Price Number of shares issued to Curetis N.V 2,028,208 Multiplied by the market value per share of OpGen's common stock (i) $ 2.39 Total fair value of common stock issued to Curetis N.V shareholders 4,847,417 Fair value of replacement stock awards related to precombination service (ii) 136,912 Fair value of convertible notes assumed (iii) 1,323,750 Fair value of EIB debt assumed (iv) 15,784,892 Funds advanced to Curetis GmbH under Interim Facility 4,808,712 Cash, cash equivalents, and restricted cash acquired (1,266,849 ) $ 25,634,834 (i) The price per share of OpGen’s common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. (ii) The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. (iii) To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. (iv) The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. |
Schedule of Net Assets Acquired | Net Assets Acquired Assets acquired Receivables $ 482,876 Inventory 2,022,577 Property and equipment 3,802,431 Right of use assets 1,090,812 Other current assets 925,364 Finite-lived intangible assets Trade names/trademarks 1,768,000 Customer/distributor relationships 2,362,000 A50 - Developed technology 349,000 Ares - Developed technology 5,333,000 Indefinite-lived intangible assets A30 - In-process research & development 5,706,000 Goodwill 6,688,652 Liabilities assumed Accounts payable (1,168,839 ) Accrued expenses and other current liabilities (1,953,927 ) Derivative liabilities (615,831 ) Lease liabilities (1,108,193 ) Other long-term liabilities (49,088 ) Net assets acquired $ 25,634,834 |
Schedule of Unaudited Pro Forma Results | The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Transaction had been completed as of January 1, 2020. Pro forma information primarily reflects adjustments relating to the amortization of intangibles acquired and elimination of interest expense due under the interim facility. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2020 or that may be obtained in the future. Unaudited pro forma results Year ended December 31, 2020 Revenues $ 5,239,192 Net loss (29,319,303 ) Net loss per share (1.86 ) |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenues by Type of Service | The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Years Ended December, 2021 2020 Product sales $ 2,656,669 $ 2,704,364 Laboratory services 813,210 167,736 Collaboration revenue 836,152 1,342,341 Total revenue $ 4,306,031 $ 4,214,441 |
Schedule of Revenues by Geography | Revenues by geography are as follows: Years Ended December, 2021 2020 Domestic $ 1,203,748 $ 1,917,367 International 3,102,283 2,297,074 Total revenue $ 4,306,031 $ 4,214,441 |
Summary of Changes in Deferred Revenue | Deferred revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Acquired deferrals from Curetis 829,275 Revenue recognized in the period from amounts acquired from Curetis (870,114 ) Effect of foreign exchange rates 40,839 Balance at December 31, 2020 9,808 New deferrals, net of amounts recognized in the current period — Amounts returned to customers (9,808 ) Effect of foreign exchange rates — Balance at December 31, 2021 $ — |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The fair value of level 3 liabilities measured at fair value on a recurring basis for the years ended December 31, 2021 and 2020 was as follows: Description Balance at December 31, 2020 Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2021 Participation percentage interest liability $ 112,852 $ 129,731 $ (13,994 ) $ 228,589 Total revenue $ 112,852 $ 129,731 $ (13,994 ) $ 228,589 Description Balance at December 31, 2019 Acquired from Curetis Change in Fair Value Effect of Foreign Exchange Rates Balance at December 31, 2020 Participation percentage interest liability $ — $ 173,373 $ (75,222 ) $ 14,701 $ 112,852 Embedded conversion option liability — 442,458 (442,458 ) — — Total revenue $ — $ 615,831 $ (517,680 ) $ 14,701 $ 112,852 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt and Short-term Borrowings | The following table summarizes the Company’s long-term debt and short-term borrowings as December 31, 2021 and 2020: December 31, 2021 2020 EIB $ 25,161,855 $ 25,936,928 PPP — 259,353 MGHIF — 331,904 Insurance financings — 107,742 Total debt obligations 25,161,855 26,635,927 Unamortized debt discount (3,466,491 ) (6,557,992 ) Carrying value of debt 21,695,364 20,077,935 Less current portion (14,519,113 ) (699,000 ) Long-term debt $ 7,176,251 $ 19,378,935 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Company Recognized Stock-Based Compensation Expense | For the years ended December 31, 2021 and 2020, the Company recognized stock compensation expense as follows: Years Ended December 31, 2021 2020 Cost of services $ 10,299 $ 2,927 Research and development 232,319 62,783 General and administrative 553,557 231,010 Sales and marketing 82,400 19,366 $ 878,575 $ 316,086 |
Schedule of Status of Options Granted | A summary of the status of options granted is presented below as of and for the years ended December 31, 2021 and 2020: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Granted 1,525,000 $ 2.13 Exercised — $ — Assumed in business combination 134,371 $ 48.40 Forfeited (3,631 ) $ 21.11 Expired (872 ) $ 473.92 Outstanding at December 31, 2020 1,664,522 $ 7.99 9.4 $ — Granted 415,000 $ 1.99 Exercised — $ — Forfeited (363,554 ) $ 2.17 Expired (2,619 ) $ 544.38 Outstanding at December 31, 2021 1,713,349 $ 6.88 8.5 $ — Vested and expected to vest 1,713,349 $ 6.88 8.5 $ — Exercisable at December 31, 2021 731,090 $ 10.45 8.0 $ — |
Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model | The total fair value of options vested in the years ended December 31, 2021 and 2020 was $622,757 and $549,341, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2021 2020 Annual dividend — — Expected life (in years) 5.75 - 6.00 5.25 - 6.25 Risk free interest rate 0.9% - 1.1% 0.3% - 0.5% Expected volatility 121.3% - 123.1% 40.9% - 46.6% |
Schedule of Status of Restricted Stock Units Granted | A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2021 and 2020: Number of Units Weighted-Average Grant Date Fair Value Unvested at December 31, 2019 14,975 $ 8.76 Granted — $ — Vested (5,924 ) $ 8.51 Forfeited (933 ) $ 8.84 Unvested at December 31, 2020 8,118 $ 8.93 Granted 360,000 $ 1.99 Vested (3,768 ) $ 8.94 Forfeited (78,085 ) $ 2.23 Unvested at December 31, 2021 286,265 $ 2.03 |
Schedule of Warrants to Purchase Shares of Common Stock | At December 31, 2021 and 2020, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2021 (1) 2020 (1) November 2011 $ 3,955.00 November 2021 — 15 December 2011 $ 3,955.00 December 2021 — 2 February 2015 $ 3,300.00 February 2025 451 451 May 2016 $ 656.20 May 2021 — 9,483 June 2016 $ 656.20 May 2021 — 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 354,000 359,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 1.94 May 2026 — 4,842,615 November 2020 $ 2.68 May 2026 242,130 242,130 February 2021 $ 3.55 August 2026 4,166,666 — February 2021 $ 3.90 August 2026 416,666 — March 2021 $ 3.56 March 2026 3,147,700 — October 2021 $ 2.05 April 2027 7,500,000 — 16,217,946 5,848,131 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision Income Taxes Expense | The Company’s provision for income taxes consists of the following for the years ended December 31, 2021 and 2020: December 31, 2021 2020 Current income tax provision Federal $ 36,084 $ — State 7,744 — Foreign — 132,403 Total 43,828 132,403 Deferred income tax provision Federal — — State — — Foreign — — Total — — Total provision for income taxes $ 43,828 $ 132,403 |
Schedule of Deferred Tax Assets and Liabilities | At December 31, 2021 and 2020, the Company had deferred tax assets of $106,839,267 and $103,185,302, respectively, primarily consisting of NOL carryforwards, research and development (“R&D”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2021 and 2020 have been offset by a valuation allowance of $106,088,316 and $98,874,420, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2021 and 2020 are as follows: December 31, 2021 2020 Deferred tax assets: NOL carryforward $ 102,388,393 $ 98,165,790 R&D credit carryforward 2,559,479 2,559,479 Share-based compensation 498,658 319,397 Depreciation — 100,157 Interest expense 502,575 1,233,203 ROU liabilities 567,624 475,645 Accruals and other 322,538 331,631 Total deferred tax assets 106,839,267 103,185,302 Valuation allowance (106,088,316 ) (98,874,420 ) Deferred tax liabilities: Intangible assets (178,478 ) (3,885,485 ) ROU assets (225,057 ) (425,397 ) Depreciation (347,416 ) — Net $ — $ — |
Schedule of Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) | The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2021 2020 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment (4.4 )% 0.6 % Provision to return adjustment (0.1 )% — State income tax benefit, net of federal benefit 1.6 % 3.5 % Foreign rate differential 2.4 % 2.8 % Change in valuation allowance (20.6 )% (28.4 )% (0.1 )% (0.5 )% |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of ROU Assets and Lease Liabilities | The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2021 and 2020: Lease Classification December 31, 2021 December 31, 2020 ROU Assets: Operating $ 1,814,396 $ 2,082,300 Financing 90,467 449,628 Total ROU assets $ 1,904,863 $ 2,531,928 Liabilities Current: Operating $ 459,792 $ 964,434 Finance 43,150 266,470 Noncurrent: Operating 2,977,402 1,492,544 Finance 3,644 46,794 Total lease liabilities $ 3,483,988 $ 2,770,242 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of December 31, 2021 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2022 $ 745,850 $ 44,850 $ 790,700 2023 639,172 3,364 642,536 2024 648,767 280 649,047 2025 544,080 — 544,080 2026 378,279 — 378,279 Thereafter 2,126,371 — 2,126,371 Total lease payments 5,082,519 48,494 5,131,013 Less: Interest (1,645,325 ) (1,700 ) (1,647,025 ) Present value of lease liabilities $ 3,437,194 $ 46,794 $ 3,483,988 |
Schedule of Statement of Operations Classification of Lease Costs and Other Information | Consolidated statements of operations classification of lease costs as of the years ended December 31, 2021 and 2020 are as follows: Years ended December 31, Lease Cost Classification 2021 2020 Operating Operating expenses $ 1,055,595 $ 1,205,551 Finance: Amortization Operating expenses 359,162 508,962 Interest expense Other expenses 15,481 57,247 Total lease costs $ 1,430,238 $ 1,771,760 Other lease information as of December 31, 2021 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 7.6 Finance leases 0.9 Weighted average discount rate: Operating leases 8.9 % Finance leases 9.1 % |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information for the years ended December 31, 2021, and 2020 is as follows: Supplemental Cash Flow Information 2021 2020 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 1,055,595 $ 1,205,551 Finance leases $ 15,481 $ 57,247 Cash used in financing activities Finance leases $ 266,470 $ 579,029 ROU assets obtained in exchange for lease obligations: Operating leases $ 615,761 $ 1,008,039 Finance leases $ — $ — |
Going Concern and Management'_2
Going Concern and Management's Plans (Details) - USD ($) | Dec. 08, 2021 | Mar. 09, 2021 | Feb. 11, 2021 | Oct. 18, 2021 | Nov. 25, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 11, 2020 |
Conversion of Stock [Line Items] | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,483,833 | $ 15,821,922 | ||||||
Healthcare-focused Institutional Investor [Member] | October 2021 Offering [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Convertible preferred stock | 7,500,000 | 7,500,000 | 7,500,000 | |||||
Stock issued during period, shares, new issues | 150,000 | 150,000 | ||||||
Preferred Stock, Par or Stated Value Per Share | $ 100 | |||||||
Conversion preferred stock per share | $ 2 | |||||||
Gross proceeds from sale of common stock | $ 15,000,000 | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 13,900,000 | |||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.05 | |||||||
Warrants exercisable period | 6 months | |||||||
Warrants expiry period | 5 years | |||||||
Healthcare-focused Institutional Investor [Member] | October 2021 Offering [Member] | Warrants [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 7,500,000 | |||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 2,784,184 | |||||||
Gross proceeds from sale of common stock | $ 25,000,000 | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 23,500,000 | |||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock | |||||||
Healthcare-focused Institutional Investor [Member] | February 2021 Offering [Member] | Pre Funded Warrant [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 5,549,149 | 5,549,149 | ||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock. | |||||||
Warrants exercised | 4,166,666 | |||||||
Holder [Member] | Exercise Agreement [Member] | Warrant [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.56 | |||||||
Warrants expiry period | 5 years | |||||||
Number of each warrant issue to purchase common stock | 0.65 | |||||||
New warrants issue against outstanding warrants | 3,147,700 | |||||||
Payment to purchase new warrants | $ 255,751 | |||||||
Alliance Global Partners [Member] | Purchase Agreement [Member] | Warrant [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Cash fee compensation | $ 200,000 | |||||||
Investor [Member] | February 2021 Offering [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Offering of common stock and warrants | 4,166,666 | |||||||
Shares issued, price per share | $ 3 | |||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.55 | |||||||
Warrants exercisable period | 6 months | |||||||
Warrants expiry period | 5 years 6 months | |||||||
Investor [Member] | February 2021 Offering [Member] | Pre Funded Warrant [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Shares issued, price per share | $ 2.99 | |||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | |||||||
Healthcare-focused U.S. Institutional Investor [Member] | 2020 PIPE [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 2,245,400 | |||||||
Shares issued, price per share | $ 2.065 | |||||||
Gross proceeds from sale of common stock | $ 10,000,000 | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 9,300,000 | |||||||
Sale of stock, description of transaction | with each pre-funded warrant exercisable for one share of common stock | |||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | |||||||
Warrants exercisable period | 6 months | |||||||
Warrants exercised | 4,842,615 | 4,842,615 | ||||||
Warrants expiry period | 5 years 6 months | |||||||
New warrants issue against outstanding warrants | 2,245,400 | |||||||
Healthcare-focused U.S. Institutional Investor [Member] | 2020 PIPE [Member] | Maximum [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 2,245,400 | |||||||
Healthcare-focused U.S. Institutional Investor [Member] | 2020 PIPE [Member] | Pre Funded Warrant [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 2,597,215 | |||||||
Shares issued, price per share | $ 2.055 | |||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock | |||||||
Warrants exercised | 2,597,215 | |||||||
New warrants issue against outstanding warrants | 2,597,215 | 2,597,215 | ||||||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | 2020 ATM Offering [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Stock issued during period, shares, new issues | 680,000 | 7,521,610 | ||||||
Gross proceeds from sale of common stock | $ 1,550,000 | $ 16,700,000 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,480,000 | $ 15,800,000 | ||||||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | 2020 ATM Offering [Member] | Maximum [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Common shares available for future issuance amount | $ 22,100,000 | |||||||
Holder pursuant to company issued to Holder securities [Member] | Warrants [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Proceeds from issuance of warrant | $ 9,650,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) shares in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Significant Accounting Policies [Line Items] | |||
FDIC limit of insurable cash | $ 250,000 | ||
Letters of credit outstanding, amount | 551,794 | $ 746,792 | |
Allowance for doubtful accounts receivable | 0 | 20,753 | |
Inventory valuation reserves | 98,064 | 288,378 | |
Amortization of intangible assets | 813,184 | 672,823 | |
Impairment of finite-lived intangible assets | 750,596 | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||
Goodwill | $ 7,453,007 | $ 8,024,729 | $ 600,814 |
Finite-lived intangible assets, fair value | $ 0 | ||
Antidilutive securities excluded from computation of earnings per share, amount | 18.2 | 7.5 | |
Depreciation expense | $ 1,541,561 | $ 1,152,954 | |
Research and development expense to government grant | 692,701 | 495,153 | |
Earned but not yet received | 396,365 | 413,530 | |
Domestic Country [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 202,015,062 | 196,511,928 | |
Operating loss carryforwards, expiration terms | begin to expire in 2022 | ||
Foreign [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 170,607,782 | ||
Operating loss carryforwards, foreign subsidiaries | 147,313,786 | ||
ASU 2016-02 [Member] | |||
Significant Accounting Policies [Line Items] | |||
Impairment charge | $ 170,714 | $ 101,838 | |
Customer Two [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 13.00% | ||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 20.00% | ||
Customer One [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 15.00% | 21.00% | |
Customer Three [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 12.00% | ||
Minimum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 30 days | ||
Fair value assumptions, expected term | 5 years 9 months | 5 years 3 months | |
Minimum [Member] | Employee Stock Option [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 6 years 3 months | ||
Minimum [Member] | Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 52.00% | ||
Maximum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 60 days | ||
Fair value assumptions, expected term | 6 years | 6 years 3 months | |
Maximum [Member] | Employee Stock Option [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 10 years | ||
Maximum [Member] | Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 14.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents | $ 36,080,392 | $ 13,360,463 |
Restricted cash | 551,794 | 746,792 |
Total cash and cash equivalents and restricted cash in the consolidated statements of cash flows | $ 36,632,186 | $ 14,107,255 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Inventories) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Inventories | ||
Raw materials and supplies | $ 866,963 | $ 773,021 |
Work-in-process | 100,801 | 87,159 |
Finished goods | 3,744,029 | 2,312,148 |
Total | $ 4,711,793 | $ 3,172,328 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Schedule of Property and equipment) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property and equipment, Gross | $ 7,549,773 | $ 10,021,825 |
Less accumulated depreciation | (3,538,025) | (6,762,338) |
Property and equipment, net | 4,011,748 | 3,259,487 |
Laboratory and manufacturing equipment [Member] | ||
Property and equipment, Gross | 4,613,324 | 6,317,340 |
Office furniture and equipment [Member] | ||
Property and equipment, Gross | 810,574 | 1,259,838 |
Computers and network equipment [Member] | ||
Property and equipment, Gross | 491,183 | 1,692,154 |
Leasehold improvements [Member] | ||
Property and equipment, Gross | $ 1,634,692 | $ 752,493 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Schedule of Finite-Lived and Indefinite-Lived Intangible Assets) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 17,531,000 | $ 17,531,000 |
Accumulated Amortization | (1,899,199) | |
Impairment | (750,596) | |
Accumulated Amortization and Prior Year Impairment | (3,384,424) | |
Effect of foreign exchange rates | 383,633 | 1,699,758 |
Net Balance | 14,530,209 | 16,580,963 |
Trademarks and tradenames [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (217,413) | |
Impairment | (243,587) | |
Accumulated Amortization and Prior Year Impairment | (461,000) | |
Effect of foreign exchange rates | ||
Net Balance | ||
Trademarks and tradenames [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,768,000 | 1,768,000 |
Accumulated Amortization | (147,161) | |
Impairment | ||
Accumulated Amortization and Prior Year Impairment | (316,930) | |
Effect of foreign exchange rates | 43,015 | 194,119 |
Net Balance | 1,494,085 | 1,814,958 |
Developed Technology [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (308,526) | |
Impairment | (149,474) | |
Accumulated Amortization and Prior Year Impairment | (458,000) | |
Effect of foreign exchange rates | ||
Net Balance | ||
Customer/distributor relationships [Member] | AdvanDx [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (736,465) | |
Impairment | (357,535) | |
Accumulated Amortization and Prior Year Impairment | (1,094,000) | |
Effect of foreign exchange rates | ||
Net Balance | ||
Distributor Relationships [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 2,362,000 | 2,362,000 |
Accumulated Amortization | (131,070) | |
Impairment | ||
Accumulated Amortization and Prior Year Impairment | (282,277) | |
Effect of foreign exchange rates | 57,465 | 259,336 |
Net Balance | 2,137,188 | 2,490,266 |
A50 - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 349,000 | 349,000 |
Accumulated Amortization | (41,504) | |
Impairment | ||
Accumulated Amortization and Prior Year Impairment | (89,384) | |
Effect of foreign exchange rates | 8,492 | 38,319 |
Net Balance | 268,108 | 345,815 |
Ares - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,333,000 | 5,333,000 |
Accumulated Amortization | (317,060) | |
Impairment | ||
Accumulated Amortization and Prior Year Impairment | (682,833) | |
Effect of foreign exchange rates | 129,745 | 585,536 |
Net Balance | 4,779,912 | 5,601,476 |
A30 - Acquired in-process research & development [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,706,000 | 5,706,000 |
Accumulated Amortization | ||
Impairment | ||
Accumulated Amortization and Prior Year Impairment | ||
Effect of foreign exchange rates | 144,916 | 622,448 |
Net Balance | $ 5,850,916 | $ 6,328,448 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Schedule of Estimated Useful Lives of Identifiable Intangible Assets) (Details) | 12 Months Ended |
Dec. 31, 2021 | |
A50 - Developed technology [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 7 years |
Ares - Developed technology [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 14 years |
A30 - Acquired in-process research & development [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | Indefinite |
Trademarks and tradenames [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 10 years |
Customer/distributor relationships [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 15 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies (Schedule of Expected Amortization of Intangible Assets) (Details) | Dec. 31, 2021USD ($) |
Accounting Policies [Abstract] | |
2022 | $ 783,669 |
2023 | 783,669 |
2024 | 783,669 |
2025 | 783,669 |
2026 | 783,669 |
Thereafter | 4,760,948 |
Total | $ 8,679,293 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies (Schedule of Changes in Carrying Amount of Goodwill) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Balance as of December 31, 2020 | $ 8,024,729 | $ 600,814 |
Acquisition of Curetis | 6,688,652 | |
Changes in currency translation | (571,722) | 735,263 |
Balance as of December 31, 2021 | $ 7,453,007 | $ 8,024,729 |
Business Combination (Narrative
Business Combination (Narrative) (Details) | 12 Months Ended |
Dec. 31, 2021shares | |
Customer/distributor relationships [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 15 years |
Trademarks and tradenames [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | Customer/distributor relationships [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 15 years |
Curetis N.V [Member] | Developed Technology [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | Trademarks and tradenames [Member] | |
Business Acquisition [Line Items] | |
Weighted-average amortization periods for finite-lived intangible assets acquired | 10 years |
Curetis N.V [Member] | 2016 Stock Option Plan [Member] | |
Business Acquisition [Line Items] | |
Common stock reserved for future issuance | 134,356 |
Common stock to be issued upon conversion | 500,000 |
Business Combination (Schedule
Business Combination (Schedule of Components of Purchase Price and Net Assets Acquired) (Details) - Curetis N.V [Member] | 12 Months Ended | |
Dec. 31, 2021USD ($)$ / sharesshares | ||
Purchase Price | ||
Number of shares issued to Curetis N.V | shares | 2,028,208 | |
Multiplied by the market value per share of OpGen's common stock | $ / shares | $ 2.39 | [1] |
Total fair value of common stock issued to Curetis N.V shareholders | $ 4,847,417 | |
Fair value of replacement stock awards related to precombination service | 136,912 | [2] |
Fair value of convertible notes assumed | 1,323,750 | [3] |
Fair value of EIB debt assumed | 15,784,892 | [4] |
Funds advanced to Curetis GmbH under Interim Facility | 4,808,712 | |
Cash, cash equivalents, and restricted cash acquired | (1,266,849) | |
Purchase Price | $ 25,634,834 | |
[1] | The price per share of OpGen’s common stock was based on the closing price as reported on the Nasdaq Capital Market on April 1, 2020. | |
[2] | The fair value of the stock options assumed was determined using the Black-Scholes option pricing model. | |
[3] | To derive the fair value of the convertible notes, the Company estimated the fair value of the convertible notes with and without the derivative liability using a scenario analysis and Monte Carlo simulation. | |
[4] | The fair value of the EIB debt is determined using a discounted cash flow analysis with current applicable rates for similar instruments. |
Business Combination (Schedul_2
Business Combination (Schedule of Net Assets Acquired) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Assets acquired | |||
Goodwill | $ 7,453,007 | $ 8,024,729 | $ 600,814 |
Curetis N.V [Member] | |||
Assets acquired | |||
Receivables | 482,876 | ||
Inventory | 2,022,577 | ||
Property and equipment | 3,802,431 | ||
Right of use assets | 1,090,812 | ||
Other current assets | 925,364 | ||
Goodwill | 6,688,652 | ||
Liabilities assumed | |||
Accounts payable | (1,168,839) | ||
Accrued expenses and other current liabilities | (1,953,927) | ||
Derivative liabilities | (615,831) | ||
Lease liabilities | (1,108,193) | ||
Other long-term liabilities | (49,088) | ||
Net assets acquired | 25,634,834 | ||
Curetis N.V [Member] | Trademarks and tradenames [Member] | |||
Assets acquired | |||
Finite-lived intangible assets | 1,768,000 | ||
Curetis N.V [Member] | Customer/distributor relationships [Member] | |||
Assets acquired | |||
Finite-lived intangible assets | 2,362,000 | ||
Curetis N.V [Member] | A50 - Developed technology [Member] | |||
Assets acquired | |||
Finite-lived intangible assets | 349,000 | ||
Curetis N.V [Member] | Ares - Developed technology [Member] | |||
Assets acquired | |||
Finite-lived intangible assets | 5,333,000 | ||
Curetis N.V [Member] | A30 - Acquired in-process research & development [Member] | |||
Assets acquired | |||
Indefinite-lived intangible assets | $ 5,706,000 |
Business Combination (Schedul_3
Business Combination (Schedule of Unaudited Pro Forma Results) (Details) - Curetis N.V [Member] | 12 Months Ended |
Dec. 31, 2020USD ($)$ / shares | |
Business Acquisition [Line Items] | |
Revenues | $ 5,239,192 |
Net loss | $ (29,319,303) |
Net loss per share | $ / shares | $ (1.86) |
Revenue from contracts with c_3
Revenue from contracts with customers (Narrative) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Revenue from Contract with Customer [Abstract] | ||
Contract assets | $ 0 | $ 18,000 |
Revenue from contracts with c_4
Revenue from contracts with customers (Schedule of Revenues by Type of Service) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,306,031 | $ 4,214,441 |
Product sales [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,656,669 | 2,704,364 |
Laboratory services [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 813,210 | 167,736 |
Collaborations Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 836,152 | $ 1,342,341 |
Revenue from contracts with c_5
Revenue from contracts with customers (Schedule of Revenues by Geography) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 4,306,031 | $ 4,214,441 |
Domestic [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 1,203,748 | 1,917,367 |
International [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 3,102,283 | $ 2,297,074 |
Revenue from contracts with c_6
Revenue from contracts with customers (Summary of Changes in Deferred Revenue) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue Recognition and Deferred Revenue [Abstract] | ||
Balance at December 31, 2020 | $ 9,808 | $ 9,808 |
Acquired deferrals from Curetis | 829,275 | |
Revenue recognized in the period from the amounts acquired from Curetis | (870,114) | |
Effect of foreign exchange rates | 40,839 | |
New deferrals, net of amounts recognized in the current period | ||
Amounts returned to customers | (9,808) | |
Balance at December 31, 2021 | $ 9,808 |
Fair value measurements (Narrat
Fair value measurements (Narrative) (Details) € in Millions | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2019EUR (€) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Impairment of right-of-use asset | $ 170,714 | $ 101,838 | |
Fair Value on Non-Recurring Basis [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Impairment of non-financial assets and liabilities at fair value | 750,596 | ||
Impairment of right-of-use asset | $ 170,714 | $ 101,838 | |
Fair Value on Recurring Basis [Member] | Curetis GmbH [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Drew down amount | € | € 5 | ||
Participation percentage interest | 2.10% | ||
Additional payment percentage | 2.10% | ||
Fair Value on Recurring Basis [Member] | Curetis GmbH [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | Minimum [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Cumulative equity capital raised | € | € 15 | ||
Fair Value on Recurring Basis [Member] | OpGen's Equity [Member] | European Investment Bank [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Participation percentage interest | 0.30% | ||
Maturity period | mid-2024 and mid-2025 |
Fair value measurements (Schedu
Fair value measurements (Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | ||
Balance at the beginning of the period | $ 112,852 | |
Acquired from Curetis | 615,831 | |
Change in Fair Value | 129,731 | (517,680) |
Effect of Foreign Exchange Rates | (13,994) | 14,701 |
Balance at the end of the period | 228,589 | 112,852 |
Participation percentage interest liability [Member] | ||
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | ||
Balance at the beginning of the period | 112,852 | |
Acquired from Curetis | 173,373 | |
Change in Fair Value | 129,731 | (75,222) |
Effect of Foreign Exchange Rates | (13,994) | 14,701 |
Balance at the end of the period | 228,589 | 112,852 |
Embedded conversion option liability [Member] | ||
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | ||
Balance at the beginning of the period | ||
Acquired from Curetis | 442,458 | |
Change in Fair Value | (442,458) | |
Effect of Foreign Exchange Rates | ||
Balance at the end of the period |
Debt (Narrative) (Details)
Debt (Narrative) (Details) | Jul. 10, 2020EUR (€) | Jun. 11, 2018USD ($) | Jun. 11, 2018USD ($) | Jun. 17, 2020shares | Feb. 24, 2020$ / sharesshares | Jun. 30, 2019EUR (€) | Jun. 28, 2017shares | Jul. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2021EUR (€)shares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2016EUR (€) | Dec. 31, 2021EUR (€) | Dec. 31, 2020EUR (€) | Jul. 10, 2020USD ($) | Jul. 09, 2020EUR (€) | Apr. 22, 2020USD ($) | Jun. 30, 2018EUR (€) | Apr. 30, 2017EUR (€) |
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,483,833 | $ 15,821,922 | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||||||||||||||
EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Fund drawn period | 36 months | ||||||||||||||||||
Debt term | 5 years | ||||||||||||||||||
Percentage of participation percentage interest | 2.10% | ||||||||||||||||||
Fair value of debt | $ 15,800,000 | ||||||||||||||||||
Amount of outstanding borrowings | $ 25,161,855 | ||||||||||||||||||
Deferred interest payable | $ 4,775,055 | ||||||||||||||||||
EIB debt financing facility [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Defer total interest payments | € | € 720,000 | ||||||||||||||||||
PPP [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, face amount | $ 879,630 | ||||||||||||||||||
Percentage of interest accrues | 1.00% | 1.00% | |||||||||||||||||
Interest expense | $ 4,799,331 | $ 3,399,984 | |||||||||||||||||
PPP [Member] | Subsidiary Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, face amount | $ 259,353 | ||||||||||||||||||
Euro [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 25,000,000 | ||||||||||||||||||
Amount of cumulative equity capital raised | € | € 15,000,000 | ||||||||||||||||||
Amount of outstanding borrowings | € | € 22,216,012 | ||||||||||||||||||
Deferred interest payable | € | € 4,216,012 | ||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 680,000 | 680,000 | 7,521,610 | ||||||||||||||||
MGHIF Financing Agreement [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 2,273 | ||||||||||||||||||
Shares issued, price per share | $ / shares | $ 2,200 | ||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | ||||||||||||||||||
Debt instrument, interest rate, stated percentage | 8.00% | ||||||||||||||||||
Debt instrument, face amount | $ 1,000,000 | ||||||||||||||||||
Debt term | 2 years | ||||||||||||||||||
MGHIF Financing Agreement [Member] | Second Amended and Restated Senior Secured Promissory Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Revised and extended the maturity date, payment terms | six semi-annual payments | six semi-annual payments | |||||||||||||||||
Annual payments plus accrued and unpaid interest | $ 166,667 | $ 166,667 | |||||||||||||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||||||||||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||||||||||||||
Unamortized debt issuance costs | 7,000 | $ 7,000 | |||||||||||||||||
MGHIF Financing Agreement [Member] | Private Placement [Member] | Common Stock [Member] | Second Amended and Restated Senior Secured Promissory Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||||||||||
Accrued and unpaid interest due date | Jul. 14, 2018 | ||||||||||||||||||
Amended and Restated MGHIF Financing Agreement [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||||||||||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||||||||||||||
Issuance of common stock warrants to purchase | shares | 656 | ||||||||||||||||||
Assignment Agreement [Member] | Convertible Note [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 763,905 | ||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,451,000 | ||||||||||||||||||
Common stock, par value | $ / shares | $ 0.01 | ||||||||||||||||||
Issuance of convertible notes | shares | 450,000 | 500,000 | |||||||||||||||||
Fair value of Convertible notes | $ 1,300,000 | ||||||||||||||||||
Assignment Agreement [Member] | Convertible Note [Member] | Euro [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Unconverted Convertible Notes | € | € 1,300,000 | ||||||||||||||||||
First Tranche [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Debt instrument, interest rate, stated percentage | 6.00% | ||||||||||||||||||
Interst rate | EURIBOR plus 4% payable | EURIBOR plus 4% payable | |||||||||||||||||
First Tranche [Member] | Euro [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 10,000,000 | ||||||||||||||||||
Second Tranche [Member] | Euro [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 3,000,000 | ||||||||||||||||||
Third Tranche [Member] | Euro [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Senior unsecured Loan | € | € 5,000,000 | € 5,000,000 | |||||||||||||||||
OpGen's equity value [Member] | EIB [Member] | |||||||||||||||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||||||||||||||
Percentage of participation percentage interest | 0.30% |
Debt (Schedule of Long-term Deb
Debt (Schedule of Long-term Debt and Short-term Borrowings) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Total debt obligations | $ 25,161,855 | $ 26,635,927 |
Unamortized debt discount | (3,466,491) | (6,557,992) |
Carrying value of debt | 21,695,364 | 20,077,935 |
Less current portion | (14,519,113) | (699,000) |
Long-term debt | 7,176,251 | 19,378,935 |
EIB [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 25,161,855 | 25,936,928 |
PPP [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 259,353 | |
MGHIF [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | 331,904 | |
Insurance financings [Member] | ||
Debt Instrument [Line Items] | ||
Total debt obligations | $ 107,742 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - USD ($) | Dec. 08, 2021 | Mar. 09, 2021 | Feb. 11, 2021 | Apr. 01, 2020 | Oct. 18, 2021 | Nov. 25, 2020 | Oct. 28, 2019 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 11, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 50,000,000 | ||||||||
Common stock, shares issued | 46,450,250 | 25,085,534 | |||||||||
Common stock, shares outstanding | 46,450,250 | 25,085,534 | |||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||||
Preferred stock, shares issued | 0 | 0 | |||||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,483,833 | $ 15,821,922 | |||||||||
Stock options, granted | 415,000 | 1,525,000 | |||||||||
Share-based compensation, tax benefit from compensation expense | $ 1,000,000 | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 2 years 6 months | ||||||||||
Share-based compensation arrangement by share-based payment award, options, vested in period, fair value | $ 622,757 | $ 549,341 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||||
Deemed dividend on beneficial conversion feature | $ 7,166,752 | ||||||||||
Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 1 year | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ 320,000 | ||||||||||
2015 Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 2,710 | ||||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 465,586 | ||||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||||
2020 Stock Options Plan [Member] | ExecutiveOfficers And Non-Employee Directors [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common shares available for future issuance, shares | 1,300,000 | ||||||||||
Stock issued during period, shares, new issues | 1,300,000 | ||||||||||
Stock options, granted | 1,300,000 | ||||||||||
2016 Stock Option Plan [Member] | Replacement Awards [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Weighted average grant date fair value of options awarded | $ 1.68 | ||||||||||
Number of share options granted | 134,371 | ||||||||||
Curetis GmbH [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Acquisition of shares | 2,028,208 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 680,000 | 7,521,610 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 1,480,000 | $ 15,800,000 | |||||||||
Gross proceeds from sale of common stock | 1,550,000 | 16,700,000 | |||||||||
Remaining availability under market offering | 3,900,000 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common shares available for future issuance amount | $ 22,100,000 | ||||||||||
New Warrants [Member] | Holder pursuant to company issued to Holder securities [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of each warrant issue to purchase common stock | 0.65 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.56 | ||||||||||
Issuance of common stock warrants to purchase | 3,147,700 | ||||||||||
Warrants expiry period | 5 years | ||||||||||
Payment to purchase new warrants | $ 255,751 | ||||||||||
Warrants [Member] | Holder pursuant to company issued to Holder securities [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Proceeds from issuance of warrant | 9,650,000 | ||||||||||
Non-cash warrant inducement expense | $ 7,800,000 | ||||||||||
October 2019 Public Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,590,170 | ||||||||||
Shares issued, price per share | $ 2 | ||||||||||
October 2019 Public Offering [Member] | Common Warrants [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 10,000 | $ 8,700,000 | |||||||||
Warrants exercised | 5,000 | 4,341,000 | |||||||||
October 2019 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,109,830 | ||||||||||
Shares issued, price per share | $ 1.99 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||||
2020 PIPE [Member] | Healthcare-focused U.S. Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,245,400 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 9,300,000 | ||||||||||
Gross proceeds from sale of common stock | $ 10,000,000 | ||||||||||
Shares issued, price per share | $ 2.065 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.94 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants exercised | 4,842,615 | 4,842,615 | |||||||||
Issuance of common stock warrants to purchase | 2,245,400 | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
Sale of stock, description of transaction | with each pre-funded warrant exercisable for one share of common stock | ||||||||||
2020 PIPE [Member] | Healthcare-focused U.S. Institutional Investor [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,245,400 | ||||||||||
2020 PIPE [Member] | Pre Funded Warrant [Member] | Healthcare-focused U.S. Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,597,215 | ||||||||||
Shares issued, price per share | $ 2.055 | ||||||||||
Warrants exercised | 2,597,215 | ||||||||||
Issuance of common stock warrants to purchase | 2,597,215 | 2,597,215 | |||||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock | ||||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,784,184 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 23,500,000 | ||||||||||
Gross proceeds from sale of common stock | $ 25,000,000 | ||||||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock | ||||||||||
February 2021 Offering [Member] | Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares issued, price per share | $ 3 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.55 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants expiry period | 5 years 6 months | ||||||||||
February 2021 Offering [Member] | Pre Funded Warrant [Member] | Healthcare-focused Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 5,549,149 | 5,549,149 | |||||||||
Warrants exercised | 4,166,666 | ||||||||||
Sale of stock, description of transaction | each pre-funded warrant exercisable for one share of common stock. | ||||||||||
February 2021 Offering [Member] | Pre Funded Warrant [Member] | Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares issued, price per share | $ 2.99 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 150,000 | 150,000 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 13,900,000 | ||||||||||
Gross proceeds from sale of common stock | $ 15,000,000 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.05 | ||||||||||
Warrants exercisable period | 6 months | ||||||||||
Warrants expiry period | 5 years | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 100 | ||||||||||
Conversion preferred stock per share | $ 2 | ||||||||||
Convertible preferred stock | 7,500,000 | 7,500,000 | 7,500,000 | ||||||||
October 2021 Offering [Member] | Warrants [Member] | Healthcare-focused Institutional Investor [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 7,500,000 |
Stockholders' Equity (Schedule
Stockholders' Equity (Schedule of Company Recognized Stock-Based Compensation Expense) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 878,575 | $ 316,086 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 10,299 | 2,927 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 232,319 | 62,783 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 553,557 | 231,010 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 82,400 | $ 19,366 |
Stockholders' Equity (Schedul_2
Stockholders' Equity (Schedule of Status of Options Granted) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |||
Number of Options, Outstanding Balance | 1,664,522 | 9,654 | |
Number of Options, Granted | 415,000 | 1,525,000 | |
Number of Options, Exercised | |||
Number of Options, Assumed in business combination | 134,371 | ||
Number of Options, Forfeited | (363,554) | (3,631) | |
Number of Options, Expired | (2,619) | (872) | |
Number of Options, Outstanding Balance | 1,713,349 | 1,664,522 | 9,654 |
Number of Options, Vested and expected to vest | 1,713,349 | ||
Number of Options, Exercisable | 731,090 | ||
Weighted Average Exercise Price, Outstanding Balance | $ 7.99 | $ 418.10 | |
Weighted Average Exercise Price, Granted | 1.99 | 2.13 | |
Weighted Average Exercise Price, Exercised | |||
Weighted Average Exercise Price, Assumed in business combination | 48.40 | ||
Weighted Average Exercise Price, Forfeited | 2.17 | 21.11 | |
Weighted Average Exercise Price, Expired | 544.38 | 473.92 | |
Weighted Average Exercise Price, Outstanding Balance | 6.88 | $ 7.99 | $ 418.10 |
Weighted Average Exercise Price, Vested and expected to vest | 6.88 | ||
Weighted Average Exercise Price, Exercisable | $ 10.45 | ||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 8 years 6 months | 9 years 4 months 24 days | 8 years |
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 8 years 6 months | ||
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 8 years | ||
Aggregate Intrinsic Value, Outstanding | |||
Aggregate Intrinsic Value, Outstanding | |||
Aggregate Intrinsic Value, Vested and expected to vest | |||
Aggregate Intrinsic Value, Exercisable |
Stockholders' Equity (Schedul_3
Stockholders' Equity (Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model) (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | ||
Risk free interest rate, minimum | 0.90% | 0.30% |
Risk free interest rate, maximum | 1.10% | 0.50% |
Expected volatility, minimum | 121.30% | 40.90% |
Expected volatility, maximum | 123.10% | 46.60% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 9 months | 5 years 3 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years | 6 years 3 months |
Stockholders' Equity (Schedul_4
Stockholders' Equity (Schedule of Status of Restricted Stock Units Granted) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | ||
Number of Options, Outstanding Balance | 8,118 | 14,975 |
Number of Options, Granted | 360,000 | |
Number of Options, Vested | (3,768) | (5,924) |
Number of Options, Forfeited | (78,085) | (933) |
Number of Options, Outstanding Balance | 286,265 | 8,118 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 8.93 | $ 8.76 |
Weighted Average Grant Date Fair Value, Granted | 1.99 | |
Weighted Average Grant Date Fair Value, Vested | 8.94 | 8.51 |
Weighted Average Grant Date Fair Value, Forfeited | 2.23 | 8.84 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 2.03 | $ 8.93 |
Stockholders' Equity (Warrants
Stockholders' Equity (Warrants to Purchase Shares of Common Stock) (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of Common Stock Subject to Warrants | [1] | 16,217,946 | 5,848,131 | |
November 2011 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3,955 | |||
Expiration | 2021-11 | |||
Shares of Common Stock Subject to Warrants | [1] | 15 | ||
December 2011 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3,955 | |||
Expiration | 2021-12 | |||
Shares of Common Stock Subject to Warrants | [1] | 2 | ||
February 2015 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3,300 | |||
Expiration | 2025-02 | |||
Shares of Common Stock Subject to Warrants | [1] | 451 | 451 | |
May 2016 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 656.20 | |||
Expiration | 2021-05 | |||
Shares of Common Stock Subject to Warrants | [1] | 9,483 | ||
June 2016 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 656.20 | |||
Expiration | 2021-05 | |||
Shares of Common Stock Subject to Warrants | [1] | 4,102 | ||
June 2017 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 390 | |||
Expiration | 2022-06 | |||
Shares of Common Stock Subject to Warrants | [1] | 938 | 938 | |
July 2017 [Member] | Warrants Exercise Price One [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 345 | |||
Expiration | 2022-07 | |||
Shares of Common Stock Subject to Warrants | [1] | 318 | 318 | |
July 2017 [Member] | Warrants Exercise Price Two [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 250 | |||
Expiration | 2022-07 | |||
Shares of Common Stock Subject to Warrants | [1] | 2,501 | 2,501 | |
July 2017 [Member] | Warrants Exercise Price Three [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 212.60 | |||
Expiration | 2022-07 | |||
Shares of Common Stock Subject to Warrants | [1] | 50,006 | 50,006 | |
February 2018 [Member] | Warrants Exercise Price Four [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 81.25 | |||
Expiration | 2023-02 | |||
Shares of Common Stock Subject to Warrants | [1] | 9,232 | 9,232 | |
February 2018 [Member] | Warrants Exercise Price Five [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 65 | |||
Expiration | 2023-02 | |||
Shares of Common Stock Subject to Warrants | [1] | 92,338 | 92,338 | |
October 2019 [Member] | Warrants Exercise Price Six [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 2 | |||
Expiration | 2024-10 | |||
Shares of Common Stock Subject to Warrants | [1] | 354,000 | 359,000 | |
October 2019 [Member] | Warrants Exercise Price Seven [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 2.60 | |||
Expiration | 2024-10 | |||
Shares of Common Stock Subject to Warrants | [1] | 235,000 | 235,000 | |
November 2020 [Member] | Warrants Exercise Price Eight [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 1.94 | |||
Expiration | 2026-05 | |||
Shares of Common Stock Subject to Warrants | [1] | 4,842,615 | ||
November 2020 [Member] | Warrants Exercise Price Nine [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 2.68 | |||
Expiration | 2026-05 | |||
Shares of Common Stock Subject to Warrants | [1] | 242,130 | 242,130 | |
February 2021 [Member] | Warrants Exercise Price Ten [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3.55 | |||
Expiration | 2026-08 | |||
Shares of Common Stock Subject to Warrants | 4,166,666 | [1] | ||
February 2021 [Member] | Warrants Exercise Price Eleven [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3.90 | |||
Expiration | 2026-08 | |||
Shares of Common Stock Subject to Warrants | 416,666 | [1] | ||
March 2021 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 3.56 | |||
Expiration | 2026-03 | |||
Shares of Common Stock Subject to Warrants | 3,147,700 | [1] | ||
October 2021 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exercise Price | $ 2.05 | |||
Expiration | 2027-04 | |||
Shares of Common Stock Subject to Warrants | 7,500,000 | [1] | ||
[1] | Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax [Line Items] | ||
Loss before income taxes | $ 34,800,000 | $ 26,100,000 |
Net deferred tax assets | 106,839,267 | 103,185,302 |
Deferred tax assets, valuation allowance | $ 106,088,316 | 98,874,420 |
Maximum percentage of taxable income in which NOLs permitted to deduct | 80.00% | |
Domestic Country [Member] | ||
Income Tax [Line Items] | ||
Operating loss carryforwards | $ 202,015,062 | $ 196,511,928 |
Operating loss carryforwards incurred prior to 2018, expiration terms | begin to expire in 2022 | |
Foreign [Member] | ||
Income Tax [Line Items] | ||
Operating loss carryforwards | $ 170,607,782 |
Income Taxes (Schedule of Provi
Income Taxes (Schedule of Provision for Income Taxes) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current income tax provision | $ 43,828 | $ 132,403 |
Deferred income tax provision | ||
Total provision for income taxes | 43,828 | 132,403 |
Domestic Country [Member] | ||
Current income tax provision | 36,084 | |
Deferred income tax provision | ||
State [Member] | ||
Current income tax provision | 7,744 | |
Deferred income tax provision | ||
Foreign [Member] | ||
Current income tax provision | 132,403 | |
Deferred income tax provision |
Income Taxes (Schedule of Defer
Income Taxes (Schedule of Deferred Tax Assets and Liabilities) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
NOL carryforward | $ 102,388,393 | $ 98,165,790 |
R&D credit carryforward | 2,559,479 | 2,559,479 |
Share-based compensation | 498,658 | 319,397 |
Depreciation | 100,157 | |
Interest expense | 502,575 | 1,233,203 |
ROU liabilities | 567,624 | 475,645 |
Accruals and other | 322,538 | 331,631 |
Total deferred tax assets | 106,839,267 | 103,185,302 |
Valuation allowance | (106,088,316) | (98,874,420) |
Deferred tax liabilities: | ||
Intangible assets | (178,478) | (3,885,485) |
ROU assets | (225,057) | (425,397) |
Depreciation | (347,416) | |
Net |
Income Taxes (Schedule of Feder
Income Taxes (Schedule of Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit)) (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rates | 21.00% | 21.00% |
Permanent adjustment | (4.40%) | 0.60% |
Provision to return adjustment | (0.10%) | |
State income tax benefit, net of federal benefit | 1.60% | 3.50% |
Foreign rate differential | 2.40% | 2.80% |
Change in valuation allowance | (20.60%) | (28.40%) |
Total | (0.10%) | (0.50%) |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Life Technologies Corporation Supply Agreement [Member] | Quant Studio Five Real Time PCR Systems [Member] | |
Other Commitments [Line Items] | |
Agregate purchase commitment | $ 0.9 |
Leases (Schedule of ROU Assets
Leases (Schedule of ROU Assets and Lease Liabilities) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
ROU Assets: | ||
Operating | $ 1,814,396 | $ 2,082,300 |
Financing | 90,467 | 449,628 |
Total ROU assets | 1,904,863 | 2,531,928 |
Current: | ||
Operating | 459,792 | 964,434 |
Finance | 43,150 | 266,470 |
Noncurrent: | ||
Operating | 2,977,402 | 1,492,544 |
Finance | 3,644 | 46,794 |
Total lease liabilities | $ 3,483,988 | $ 2,770,242 |
Leases (Schedule of Maturities
Leases (Schedule of Maturities of Lease Liabilities) (Details) | Dec. 31, 2021USD ($) |
Operating | |
2022 | $ 745,850 |
2023 | 639,172 |
2024 | 648,767 |
2025 | 544,080 |
2026 | 378,279 |
Thereafter | 2,126,371 |
Total lease payments | 5,082,519 |
Less: Interest | (1,645,325) |
Present value of lease liabilities | 3,437,194 |
Finance | |
2022 | 44,850 |
2023 | 3,364 |
2024 | 280 |
2025 | |
2026 | |
Thereafter | |
Total lease payments | 48,494 |
Less: Interest | (1,700) |
Present value of lease liabilities | 46,794 |
Total | |
2022 | 790,700 |
2023 | 642,536 |
2024 | 649,047 |
2025 | 544,080 |
2026 | 378,279 |
Thereafter | 2,126,371 |
Total lease payments | 5,131,013 |
Less: Interest | (1,647,025) |
Present value of lease liabilities | $ 3,483,988 |
Leases (Schedule of Statement o
Leases (Schedule of Statement of Operations Classification of Lease Costs) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lease Cost | ||
Total lease costs | $ 1,430,238 | $ 1,771,760 |
Operating Expense [Member] | ||
Lease Cost | ||
Operating | 1,055,595 | 1,205,551 |
Amortization | 359,162 | 508,962 |
Other Expense [Member] | ||
Lease Cost | ||
Interest expense | $ 15,481 | $ 57,247 |
Leases (Schedule of Other Infor
Leases (Schedule of Other Information) (Details) | Dec. 31, 2021 |
Weighted average remaining lease term (in years) | |
Operating leases | 7 years 7 months 6 days |
Finance leases | 10 months 24 days |
Weighted average discount rate: | |
Operating leases | 8.90% |
Finance leases | 9.10% |
Leases (Schedule of Supplementa
Leases (Schedule of Supplemental Cash Flow Information) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash used in operating activities | ||
Operating leases | $ 1,055,595 | $ 1,205,551 |
Finance leases | 15,481 | 57,247 |
Cash used in financing activities | ||
Finance leases | 266,470 | 579,029 |
ROU assets obtained in exchange for lease obligations | ||
Operating leases | 615,761 | 1,008,039 |
Finance leases |
License agreements, research _2
License agreements, research collaborations and development agreements (Details) - USD ($) | 1 Months Ended | 10 Months Ended | 12 Months Ended | |||
Apr. 30, 2021 | Jul. 13, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2020 | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Revenue from contract | $ 4,306,031 | $ 4,214,441 | ||||
Collaborations Revenue [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Revenue from contract | $ 836,152 | 1,342,341 | ||||
FISH License [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Termination date of agreement | Oct. 30, 2020 | |||||
Exit date of agreement | Jun. 30, 2021 | |||||
Royalty expense | $ 11,721 | (68,854) | ||||
Settlement fee | $ 350,000 | |||||
Royalty percentage on sale of products | 10.00% | |||||
New York State Department of Health and ILUM Health Solutions, LLC [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Collaboration revenue receivable over 15 months of the project | $ 1,600,000 | |||||
Contractual agreement period | 15 months | |||||
Extended term of collaboration agreement | 6 months | |||||
Termination date of agreement | Sep. 30, 2021 | |||||
New York State Department of Health and ILUM Health Solutions, LLC [Member] | Collaborations Revenue [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Revenue from contract | $ 558,000 | 388,000 | ||||
OpGen [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Contract value | $ 540,000 | $ 450,000 | ||||
Sandoz [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Contractual agreement period | 36 months | |||||
Termination date of agreement | Jan. 31, 2025 | |||||
Qiagen [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Contractual agreement period | 20 years | |||||
Global leading IVD corporation [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Contractual agreement period | 10 months | |||||
Termination date of agreement | Jul. 13, 2020 | |||||
Revenue from contract | $ 1,200,000 | $ 0 | 870,000 | |||
Option fees received | $ 550,000 | |||||
Siemens [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Royalty expense | $ 146,375 | $ 2,775 | ||||
Siemens [Member] | Minimum [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Royalty rate | 1.30% | |||||
Siemens [Member] | Maximum [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Royalty rate | 40.00% |