Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 12, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | OPGEN, INC. | |
Trading Symbol | OPGN | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 48,326,942 | |
Amendment Flag | false | |
Entity Central Index Key | 0001293818 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-37367 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 06-1614015 | |
Entity Address, Address Line One | 9717 Key West Avenue | |
Entity Address, Address Line Two | Suite 100 | |
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 | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 16,586,577 | $ 36,080,392 |
Accounts receivable, net | 738,148 | 1,172,396 |
Inventory, net | 1,196,956 | 1,239,456 |
Prepaid expenses and other current assets | 1,687,564 | 1,250,331 |
Total current assets | 20,209,245 | 39,742,575 |
Property and equipment, net | 3,209,311 | 4,011,748 |
Finance lease right-of-use assets, net | 19,660 | 90,467 |
Operating lease right-of-use assets | 1,582,325 | 1,814,396 |
Goodwill | 6,884,915 | 7,453,007 |
Intangible assets, net | 12,969,215 | 14,530,209 |
Strategic inventory | 3,492,602 | 3,472,337 |
Other noncurrent assets | 441,320 | 551,794 |
Total assets | 48,808,593 | 71,666,533 |
Current liabilities | ||
Accounts payable | 731,845 | 1,307,081 |
Accrued compensation and benefits | 1,575,299 | 1,621,788 |
Accrued liabilities | 788,153 | 1,965,845 |
Current maturities of long-term debt | 10,887,469 | 14,519,113 |
Short-term finance lease liabilities | 16,731 | 43,150 |
Short-term operating lease liabilities | 394,027 | 459,792 |
Total current liabilities | 14,393,524 | 19,916,769 |
Long-term debt, net | 4,024,413 | 7,176,251 |
Long-term finance lease liabilities | 1,962 | 3,644 |
Long-term operating lease liabilities | 2,721,233 | 2,977,402 |
Derivative liabilities | 175,498 | 228,589 |
Other long-term liabilities | 130,983 | 146,798 |
Total liabilities | 21,447,613 | 30,449,453 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2022 and December 31, 2021 | ||
Common stock, $0.01 par value; 100,000,000 shares authorized; 46,623,618 and 46,450,250 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 466,237 | 464,503 |
Additional paid-in capital | 276,205,778 | 275,708,490 |
Accumulated deficit | (248,185,670) | (235,541,539) |
Accumulated other comprehensive (loss) income | (1,125,365) | 585,626 |
Total stockholders’ equity | 27,360,980 | 41,217,080 |
Total liabilities and stockholders’ equity | $ 48,808,593 | $ 71,666,533 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) (in Dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value (in dollars per share) (in Dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares outstanding | 46,623,618 | 46,450,250 |
Common stock, shares issued | 46,623,618 | 46,450,250 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue | ||||
Total revenue | $ 967,205 | $ 811,615 | $ 1,436,950 | $ 1,641,331 |
Operating expenses | ||||
Cost of products sold | 646,389 | 342,580 | 938,386 | 896,634 |
Cost of services | 15,650 | 137,934 | 46,212 | 242,918 |
Research and development | 2,273,756 | 2,859,590 | 4,590,197 | 5,673,081 |
General and administrative | 2,134,266 | 2,692,255 | 4,759,319 | 5,355,912 |
Sales and marketing | 1,169,349 | 802,549 | 2,220,781 | 1,701,801 |
Impairment of right-of-use asset | 115,218 | 170,714 | ||
Total operating expenses | 6,239,410 | 6,950,126 | 12,554,895 | 14,041,060 |
Operating loss | (5,272,205) | (6,138,511) | (11,117,945) | (12,399,729) |
Other (expense) income | ||||
Gain on extinguishment of debt | 259,353 | 259,353 | ||
Warrant inducement expense | (7,755,541) | |||
Interest and other income | 13,851 | 4,702 | 16,972 | 9,627 |
Interest expense | (779,912) | (1,198,169) | (2,049,493) | (2,363,151) |
Foreign currency transaction gains (losses) | 271,967 | (915) | 470,707 | 426,700 |
Change in fair value of derivative financial instruments | (74,116) | (13,021) | 35,628 | (114,411) |
Total other expense | (568,210) | (948,050) | (1,526,186) | (9,537,423) |
Loss before income taxes | (5,840,415) | (7,086,561) | (12,644,131) | (21,937,152) |
Provision for income taxes | ||||
Net loss | (5,840,415) | (7,086,561) | (12,644,131) | (21,937,152) |
Net loss available to common stockholders | $ (5,840,415) | $ (7,086,561) | $ (12,644,131) | $ (21,937,152) |
Net loss per common share - basic and diluted (in Dollars per share) | $ (0.13) | $ (0.19) | $ (0.27) | $ (0.65) |
Weighted average shares outstanding - basic and diluted (in Shares) | 46,574,512 | 38,268,293 | 46,529,718 | 33,900,964 |
Net loss | $ (5,840,415) | $ (7,086,561) | $ (12,644,131) | $ (21,937,152) |
Other comprehensive income (loss) - foreign currency translation | (1,227,142) | 529,651 | (1,710,991) | (548,828) |
Comprehensive loss | (7,067,557) | (6,556,910) | (14,355,122) | (22,485,980) |
Product sales | ||||
Revenue | ||||
Total revenue | 889,271 | 307,804 | 1,255,323 | 835,383 |
Laboratory services | ||||
Revenue | ||||
Total revenue | 20,570 | 266,784 | 63,499 | 450,849 |
Collaboration revenue | ||||
Revenue | ||||
Total revenue | $ 57,364 | $ 237,027 | $ 118,128 | $ 355,099 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Net loss per common share - basic and diluted (in Dollars per share) | $ (0.13) | $ (0.19) | $ (0.27) | $ (0.65) |
Weighted average shares outstanding - basic and diluted (in Shares) | 46,574,512 | 38,268,293 | 46,529,718 | 33,900,964 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) | Common Stock | Preferred Stock | Additional Paid- in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balances (in Shares) at Dec. 31, 2020 | 25,085,534 | |||||
Balances at Dec. 31, 2020 | $ 250,855 | $ 219,129,045 | $ 2,547,182 | $ (200,735,827) | $ 21,191,255 | |
Offering of common stock and warrants, net of issuance costs (in Shares) | 8,333,333 | |||||
Offering of common stock and warrants, net of issuance costs | $ 83,334 | 23,390,628 | 23,473,962 | |||
Inducement expense related to warrant reprice | 7,755,541 | 7,755,541 | ||||
Common stock warrant exercises, net of issuance costs | $ 48,476 | 9,045,696 | 9,094,172 | |||
Common stock warrant exercises, net of issuance costs (in Shares) | 4,847,615 | |||||
Proceeds from issuance of common stock warrants | 255,751 | 255,751 | ||||
Stock compensation expense | 189,670 | 189,670 | ||||
Foreign currency translation | (1,078,479) | (1,078,479) | ||||
Net loss | (14,850,591) | (14,850,591) | ||||
Balances (in Shares) at Mar. 31, 2021 | 38,266,482 | |||||
Balances at Mar. 31, 2021 | $ 382,665 | 259,766,331 | 1,468,703 | (215,586,418) | 46,031,281 | |
Balances (in Shares) at Dec. 31, 2020 | 25,085,534 | |||||
Balances at Dec. 31, 2020 | $ 250,855 | 219,129,045 | 2,547,182 | (200,735,827) | 21,191,255 | |
Inducement expense related to warrant reprice | 7,755,541 | |||||
Net loss | (21,937,152) | |||||
Balances (in Shares) at Jun. 30, 2021 | 38,270,250 | |||||
Balances at Jun. 30, 2021 | $ 382,703 | 260,027,841 | 1,998,354 | (222,672,979) | 39,735,919 | |
Balances (in Shares) at Mar. 31, 2021 | 38,266,482 | |||||
Balances at Mar. 31, 2021 | $ 382,665 | 259,766,331 | 1,468,703 | (215,586,418) | 46,031,281 | |
Issuance of RSUs | $ 38 | (38) | ||||
Issuance of RSUs (in Shares) | 3,768 | |||||
Stock compensation expense | 261,548 | 261,548 | ||||
Foreign currency translation | 529,651 | 529,651 | ||||
Net loss | (7,086,561) | (7,086,561) | ||||
Balances (in Shares) at Jun. 30, 2021 | 38,270,250 | |||||
Balances at Jun. 30, 2021 | $ 382,703 | 260,027,841 | 1,998,354 | (222,672,979) | 39,735,919 | |
Balances (in Shares) at Dec. 31, 2021 | 46,450,250 | |||||
Balances at Dec. 31, 2021 | $ 464,503 | 275,708,490 | 585,626 | (235,541,539) | 41,217,080 | |
Issuance of RSUs | $ 1,075 | (1,075) | ||||
Issuance of RSUs (in Shares) | 107,500 | |||||
Stock compensation expense | 241,619 | 241,619 | ||||
Foreign currency translation | (483,849) | (483,849) | ||||
Net loss | (6,803,716) | (6,803,716) | ||||
Balances (in Shares) at Mar. 31, 2022 | 46,557,750 | |||||
Balances at Mar. 31, 2022 | $ 465,578 | 275,949,034 | 101,777 | (242,345,255) | 34,171,134 | |
Balances (in Shares) at Dec. 31, 2021 | 46,450,250 | |||||
Balances at Dec. 31, 2021 | $ 464,503 | 275,708,490 | 585,626 | (235,541,539) | 41,217,080 | |
Inducement expense related to warrant reprice | ||||||
Net loss | (12,644,131) | |||||
Balances (in Shares) at Jun. 30, 2022 | 46,623,618 | |||||
Balances at Jun. 30, 2022 | $ 466,237 | 276,205,778 | (1,125,365) | (248,185,670) | 27,360,980 | |
Balances (in Shares) at Mar. 31, 2022 | 46,557,750 | |||||
Balances at Mar. 31, 2022 | $ 465,578 | 275,949,034 | 101,777 | (242,345,255) | 34,171,134 | |
Issuance of RSUs | $ 659 | (659) | ||||
Issuance of RSUs (in Shares) | 65,868 | |||||
Stock compensation expense | 257,403 | 257,403 | ||||
Foreign currency translation | (1,227,142) | (1,227,142) | ||||
Net loss | (5,840,415) | (5,840,415) | ||||
Balances (in Shares) at Jun. 30, 2022 | 46,623,618 | |||||
Balances at Jun. 30, 2022 | $ 466,237 | $ 276,205,778 | $ (1,125,365) | $ (248,185,670) | $ 27,360,980 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (12,644,131) | $ (21,937,152) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 978,287 | 1,290,139 |
Noncash interest expense | 1,613,662 | 1,934,356 |
Loss on disposal of equipment | 15,979 | |
Stock compensation expense | 499,022 | 451,218 |
Gain on extinguishment of debt | (259,353) | |
Inducement expense related to warrant reprice | 7,755,541 | |
Change in fair value of derivative liabilities | (35,628) | 114,411 |
Impairment of right-of-use asset | 170,714 | |
Changes in operating assets and liabilities | ||
Accounts receivable | 361,943 | 172,048 |
Inventory | (288,447) | (1,253,260) |
Other assets | (350,237) | (303,073) |
Accounts payable | (508,949) | (627,285) |
Accrued compensation and other liabilities | (1,342,405) | (57,706) |
Deferred revenue | (9,808) | |
Net cash used in operating activities | (11,700,904) | (12,559,210) |
Cash flows from investing activities | ||
Purchases of property and equipment | (83,563) | (1,723,064) |
Net cash used in investing activities | (83,563) | (1,723,064) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock warrants | 255,751 | |
Proceeds from issuance of common stock and pre-funded warrants in registered offering, net of selling costs | 23,473,962 | |
Proceeds from the exercise of common stock warrants, net of issuance costs | 9,094,172 | |
Payments on debt | (6,819,405) | (441,076) |
Payments on finance lease obligations | (28,101) | (177,742) |
Net cash (used in) provided by financing activities | (6,847,506) | 32,205,067 |
Effects of exchange rates on cash | (972,316) | (296,403) |
Net (decrease) increase in cash and cash equivalents and restricted cash | (19,604,289) | 17,626,390 |
Cash and cash equivalents and restricted cash at beginning of period | 36,632,186 | 14,107,255 |
Cash and cash equivalents and restricted cash at end of period | 17,027,897 | 31,733,645 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 838,452 | 888,374 |
Supplemental disclosures of noncash investing and financing activities | ||
Right-of-use assets acquired through operating leases | 748,294 | |
Property and equipment transferred to inventory | $ 152,243 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [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”). 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 its subsidiaries, Curetis GmbH and Ares Genetics GmbH, the Company is 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. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, 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 10). The Company's FISH customers and distribution partners had 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, the FDA-cleared Acuitas AMR Gene Panel diagnostic test, as well as the Unyvero UTI Panel as an 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 | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern and Management’s Plans | Note 2 – Going Concern and Management’s Plans The accompanying unaudited condensed 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 June 24, 2022, the Company entered into an At the Market Common Offering (the “2022 Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as a sales agent, 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 $10.65 million of shares of the Company's common stock through the sales agent (the “2022 ATM Offering”). As of June 30, 2022, the Company had not sold any shares under the 2022 ATM Offering (see Note 11). ● On May 23, 2022, the Company, as guarantor, the Company’s German operating subsidiary Curetis GmbH, as borrower, the Company’s operating subsidiary Ares Genetics GmbH, as an additional guarantor, and the European Investment Bank (the “EIB”) entered into a Waiver and Amendment Letter (the “Amendment”) relating to the amendment of that certain Finance Contract, dated December 12, 2016 (the “Finance Contract”), as amended, between the EIB and Curetis pursuant to which Curetis borrowed an aggregate amount of €18.0 million in three tranches. The Amendment restructured the first tranche of approximately €13.35 million (including accumulated and deferred interest) of the Company’s indebtedness with the EIB. Pursuant to the Amendment, the Company repaid €5.0 million to the EIB in April 2022. The Company also agreed, among other things, to amortize the remainder of the debt tranche over the twelve-month period beginning in May 2022. The Amendment also provides for the increase of the percent participation interest (“PPI”) under the Finance Contract from 0.3% to 0.75% beginning in June 2024. The terms of the second and third tranches of the Company’s indebtedness of €3.0 million and €5.0 million in principal, respectively, plus accumulated deferred interest remain unchanged pursuant to the Amendment. ● 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 shares of preferred stock sold in the October 2021 Offering were converted into 7,500,000 shares of common stock in December 2021 so that there were no shares of preferred stock outstanding as of June 30, 2022. The warrants have an exercise price of $2.05 per share, became 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. ● 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. 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 were exercised. ● On February 11, 2020, the Company entered into an At the Market Common Offering (the “ATM Agreement”) with Wainwright which was amended and restated on November 13, 2020 to add BTIG, LLC (“BTIG”) as a sales agent, 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, 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. The Company terminated the ATM Agreement in conjunction with the execution of the 2022 ATM Agreement. On February 28, 2022 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 first quarter of 2023. 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 first quarter of 2023, 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 | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 – Summary of Significant Accounting Policies Basis of presentation and consolidation The Company has prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited condensed consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s latest Annual Report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2021 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but does not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen and its wholly-owned subsidiaries as of June 30, 2022 including Curetis GmbH and subsidiaries acquired on April 1, 2020; all intercompany transactions and balances have been eliminated. Foreign currency The Company has subsidiaries located in Holzgerlingen, Germany; and Vienna, Austria, 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 June 30, 2022 and December 31, 2021. 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 unaudited condensed 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. 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. At June 30, 2022 and December 31, 2021, the Company had funds totaling $441,320 and $551,794, 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 unaudited condensed consolidated balance sheets. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 16,586,577 $ 36,080,392 $ 31,182,385 $ 13,360,463 Restricted cash 441,320 551,794 551,260 746,792 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 17,027,897 $ 36,632,186 $ 31,733,645 $ 14,107,255 Accounts receivable The Company’s accounts receivable result from revenues earned but not yet 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 90 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 as of June 30, 2022 and December 31, 2021, respectively. At June 30, 2022, the Company had accounts receivable from one customer which individually represented 75% of total accounts receivable. At December 31, 2021, the Company had accounts receivable from two customers which individually represented 52% and 14% of total accounts receivable, respectively. For the three months ended June 30, 2022, revenue earned from two customers represented 57% and 12% of total revenues, respectively. For the three months ended June 30, 2021, revenue earned from two customers represented 29% and 13% of total revenues, respectively. For the six months ended June 30, 2022, revenue earned from two customers represented 47% and 15% of total revenues, respectively. For the six months ended June 30, 2021, revenue earned from three customers represented 21%, 13%, and 11% of total revenues, respectively. Inventory Inventories are valued using the first-in, first-out cost method and stated at the lower of cost or net realizable value and consist of the following: June 30, 2022 December 31, 2021 Raw materials and supplies $ 884,474 $ 866,963 Work-in-process 48,680 100,801 Finished goods 3,756,404 3,744,029 Total $ 4,689,558 $ 4,711,793 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 $105,722 and $98,064 at June 30, 2022 and December 31, 2021, 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 unaudited condensed consolidated balance sheets date as strategic inventory, a non-current asset. Long-lived assets Property and equipment Property and equipment 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 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 three and six months ended June 30, 2022 and 2021, the Company determined that its property and equipment were 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 six months ended June 30, 2021 , Intangible assets and goodwill Intangible assets and goodwill as of June 30, 2022 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 June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Subsidiary Cost Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (373,698 ) $ (107,132 ) $ 1,287,170 $ (316,930 ) $ 43,015 $ 1,494,085 Distributor relationships Curetis 2,362,000 (332,838 ) (143,124 ) 1,886,038 (282,277 ) 57,465 2,137,188 A50 - Developed technology Curetis 349,000 (105,393 ) (21,147 ) 222,460 (89,384 ) 8,492 268,108 Ares - Developed technology Curetis 5,333,000 (805,142 ) (323,155 ) 4,204,703 (682,833 ) 129,745 4,779,912 A30 - In-Process Research & Development Curetis 5,706,000 — (337,156 ) 5,368,844 — 144,916 5,850,916 $ 15,518,000 $ (1,617,071 ) $ (931,714 ) $ 12,969,215 $ (1,371,424 ) $ 383,633 $ 14,530,209 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 in-process research and development (“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 its 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. Total amortization expense of intangible assets was $182,993 and $204,800 for the three months ended June 30, 2022 and 2021, respectively. Total amortization expense of intangible assets was $375,018 and $402,642 for the six months ended June 30, 2022 and 2021, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2022 (Six months) $ 359,349 2023 718,697 2024 718,697 2025 718,697 2026 718,697 2027 683,530 Thereafter 3,682,704 Total $ 7,600,371 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 June 30, 2022 and December 31, 2021 was $ 6,884,915 7,453,007 The changes in the carrying amount of goodwill as of June 30, 2022, and since December 31, 2021, were as follows: Balance as of December 31, 2021 $ 7,453,007 Changes in currency translation (568,092 ) Balance as of June 30, 2022 $ 6,884,915 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 three and six months ended June 30, 2022 and 2021, 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, and 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 subset of the proprietary ARESdb data asset. 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. Research and development costs 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, and fees paid to consultants and outside service partners. 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 from Austrian government agencies in the condensed 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 three months ended June 30, 2022 and 2021, the Company recognized $111,414 and $154,850 as a reduction of research and development expense related to government grant arrangements, respectively. For the six months ended June 30, 2022 and 2021, the Company recognized $219,879 and $374,072 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $572,133 and $396,365 related to these agreements and incentives included in prepaid expenses and other current assets, as of June 30, 2022 and December 31, 2021, respectively. 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. 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 may have state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. 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 NOLs 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. 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 19.3 million shares and 11.0 million shares as of June 30, 2022 and 2021, respectively. 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. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from contracts with customers | Note 4 – 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: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Product sales $ 889,271 $ 307,804 $ 1,255,323 $ 835,383 Laboratory services 20,570 266,784 63,499 450,849 Collaboration revenue 57,364 237,027 118,128 355,099 Total revenue $ 967,205 $ 811,615 $ 1,436,950 $ 1,641,331 Revenues by geography are as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Domestic $ 123,659 $ 305,617 $ 280,069 $ 649,624 International 843,546 505,998 1,156,881 991,707 Total revenue $ 967,205 $ 811,615 $ 1,436,950 $ 1,641,331 Deferred revenue The Company had no deferred revenue at June 30, 2022 and December 31, 2021. Contract assets The Company had $51,935 and $0 of contract assets as of June 30, 2022 and December 31, 2021, 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 June 30, 2022 and December 31, 2021. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 5 – 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 three and six months ended June 30, 2022, 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 €5.0 million from the EIB. In return for the EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15.0 million to disburse this €5.0 million tranche, the parties agreed on a 2.1% PPI. Upon maturity of the tranche, the 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 €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. On May 23, 2022, the Company entered into a Waiver and Amendment Letter which increased the PPI to 0.75% 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. The fair value of Level 3 liabilities measured at fair value on a recurring basis for the six months ended June 30, 2022 was as follows: Description Balance at December 2021 Change in Fair Value Effect of Foreign Exchange Rates Balance at June 30, 2022 Participation percentage interest liability $ 228,589 $ (35,628 ) $ (17,463 ) $ 175,498 Total $ 228,589 $ (35,628 ) $ (17,463 ) $ 175,498 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 three months ended June 30, 2021, the Company recorded impairment expense of $115,218 related to its ROU assets. During the six months ended June 30, 2021, the Company recorded impairment expense of $170,714 related to its ROU assets. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 – Debt The following table summarizes the Company’s long-term debt and short-term borrowings as of June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 EIB $ 17,026,715 $ 25,161,855 Total debt obligations 17,026,715 25,161,855 Unamortized debt discount (2,114,833 ) (3,466,491 ) Carrying value of debt 14,911,882 21,695,364 Less current portion (10,887,469 ) (14,519,113 ) Long-term debt $ 4,024,413 $ 7,176,251 EIB Loan Facility In 2016, Curetis entered into a contract for an up to €25.0 million senior, unsecured loan financing facility from the 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 €10.0 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, a second tranche of €3.0 million was drawn down. The terms and conditions are analogous to the first one. In June 2019, Curetis drew down a third tranche of €5.0 million from the EIB. In line with all prior tranches, the majority of interest is also deferred until repayment upon maturity. In return for the EIB waiving the condition precedent of a minimum cumulative equity capital raised of €15.0 million to disburse this €5.0 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), the 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 an amendment between the Company and the EIB on July 9, 2020, the parties adjusted the PPI percentage applicable to the third EIB tranche of €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. This right constitutes an embedded derivative, which is separated and measured at fair value with changes being accounted for through income or loss. The 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 is being amortized over the life of the EIB debt as an increase to interest expense. On May 23, 2022, the Company and the EIB entered into a Waiver and Amendment Letter (the “2022 EIB Amendment”) relating to the amendment of the EIB loan facility, between the EIB and Curetis pursuant to which Curetis borrowed an aggregate amount of €18.0 million in three tranches. The 2022 EIB Amendment restructured the first tranche of approximately €13.35 million (including accumulated and deferred interest) of the Company’s outstanding indebtedness with the EIB. Pursuant to the 2022 EIB Amendment, the Company repaid €5.0 million to the EIB in April 2022. The Company also agreed, among other things, to amortize the remainder of the debt tranche over the twelve-month period beginning in May 2022. The Amendment also provides for an increase of the PPI applicable to the third tranche under the loan facility from 0.3% to 0.75% beginning in June 2024. The terms of the second and third tranches of the Company’s indebtedness of €3.0 million and €5.0 million, respectively, plus accumulated deferred interest remain unchanged pursuant to the 2022 EIB Amendment. As the effective borrowing rate under the amended agreement is less than the effective borrowing rate under the previous agreement, a concession is deemed to have been granted under ASC 470-60. As a concession has been granted, the agreement was accounted for as a troubled debt restructuring under ASC 470-60. The amendment did not result in a gain on restructuring as the future undiscounted cash outflows required under the amended agreement exceed the carrying value of the debt immediately prior to the amendment. As of June 30, 2022, the outstanding borrowings under all tranches were €16,392,331 ($17,026,715 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. In accordance with the requirements of the CARES Act, the Borrowers used 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 accrued on the Notes at the rate of 1.00% per annum. The Borrowers applied 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 amortization of debt discounts and financing fees) on all debt instruments was $779,912 and $1,198,169 for the three months ended June 30, 2022 and 2021, respectively. Total interest expense (including accretion of fair value to book value and amortization of debt discounts and financing fees) on all debt instruments was $2,049,493 and $2,363,151 for the six months ended June 30, 2022 and 2021, respectively. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders’ equity | Note 7 – Stockholders’ equity As of June 30, 2022, the Company had 100,000,000 shares of authorized common stock and 46,623,618 shares issued and outstanding, and 10,000,000 shares of authorized preferred stock, 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 Quarterly Report have been adjusted to reflect the reverse stock splits. On June 24, 2022, the Company entered into the 2022 ATM Agreement with Wainwright, as a sales agent, 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 $10.65 million of shares of the Company's common stock through the sales agent. As of June 30, 2022, the Company had not sold any shares under the 2022 ATM Offering (see Note 11). On December 8, 2021, the Company received stockholder 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. 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 June 30, 2022. 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 in the fourth quarter of 2021. 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 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 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 Note 1, and paid, as the sole consideration, 2,028,208 shares of the Company’s common stock to the Seller. On February 11, 2020, the Company entered into an ATM Agreement with Wainwright, which was amended and restated on November 13, 2020 to add BTIG, LLC as a sales agent, pursuant to which the Company could 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, 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. The Company terminated the ATM Agreement in June 2022 in conjunction with the execution of the 2022 ATM Agreement. Stock options In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors could grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Company 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 initial public offering in May 2015. Following the effectiveness of the 2015 Plan, no further grants will be 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. 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. Following Board of Director approval, 1,858,010 shares were automatically added to the 2015 Plan in 2022. 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 June 30, 2022, 1,284,296 shares remain available for issuance under the 2015 Plan. On September 30, 2020, the Company held its 2020 Annual Meeting of Stockholders (the “Annual Meeting”). At the 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 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 June 30, 2022, no shares remain available for issuance under the 2020 Stock Options Plan. In connection with the appointment of Albert Weber as Chief Financial Officer, OpGen granted Mr. Weber an inducement grant of stock options to purchase an aggregate of 210,000 shares of OpGen’s common stock with a grant date of January 3, 2022. The equity award was granted as a component of Mr. Weber’s employment compensation and was granted as an inducement material to his acceptance of employment with OpGen. The options have an exercise price of $1.08, a ten-year term and a vesting schedule of 25% vesting of the award on the first annual anniversary of the date of grant and then 6.25% vesting each quarter thereafter over three additional years. The award is subject to Mr. Weber’s continued service with OpGen through the applicable vesting dates. Replacement awards In connection with the acquisition of Curetis, the Company issued equity awards to Curetis employees 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 three and six months ended June 30, 2022 and 2021, the Company recognized share-based compensation expense as follows: Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Cost of services $ 8,266 $ 2,944 $ 11,101 $ 4,346 Research and development 73,981 67,783 140,979 102,756 General and administrative 138,438 172,790 279,320 314,781 Sales and marketing 36,718 18,031 67,622 29,335 $ 257,403 $ 261,548 $ 499,022 $ 451,218 No income tax benefit for share-based compensation arrangements was recognized in the condensed consolidated statements of operations and comprehensive loss due to the Company’s net loss position. The Company granted no options during the three months ended June 30, 2022. During the three months ended June 30, 2022, 7,691 options were forfeited, and 28,367 options expired. The Company granted 542,500 options during the six months ended June 30, 2022. During the six months ended June 30, 2022, 10,191 options were forfeited, and 29,903 options expired. The Company had total stock options to acquire 2,215,755 shares of common stock outstanding at June 30, 2022 under all of its equity compensation plans. Restricted stock units The Company granted 60,000 restricted stock units during the three months ended June 30, 2022, and 65,868 restricted stock units vested and 7,826 were forfeited. The Company granted 730,572 restricted stock units during the six months ended June 30, 2022, and 173,368 restricted stock units vested and 10,402 were forfeited. The Company had 833,066 total restricted stock units outstanding at June 30, 2022. Stock purchase warrants At June 30, 2022 and December 31, 2021, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration June 30, 2022 (1) December 31, 2021 (1) February 2015 $ 3,300.00 February 2025 451 451 June 2017 $ 390.00 June 2022 — 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 354,000 354,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 2.52 May 2026 242,130 242,130 February 2021 $ 3.55 August 2026 4,166,666 4,166,666 February 2021 $ 3.90 August 2026 416,666 416,666 March 2021 $ 3.56 March 2026 3,147,700 3,147,700 October 2021 $ 2.05 April 2027 7,500,000 7,500,000 16,217,008 16,217,946 The warrants listed above were issued in connection with various debt, equity 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. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8 – Commitments and Contingencies Registration and other stockholder rights In connection with the various investment transactions, the Company entered into certain 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 June 30, 2022, the Company had acquired twenty-four QuantStudio 5s including none during the three and six months ended June 30, 2022. As of June 30, 2022, 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 several 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 $0.5 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, 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 | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Note 9 – Leases The following table presents the Company’s ROU assets and lease liabilities as of June 30, 2022 and December 31, 2021: Lease Classification June 30, 2022 December 31, 2021 ROU Assets: Operating $ 1,582,325 $ 1,814,396 Financing 19,660 90,467 Total ROU assets $ 1,601,985 $ 1,904,863 Liabilities Current: Operating $ 394,027 $ 459,792 Finance 16,731 43,150 Noncurrent: Operating 2,721,233 2,977,402 Finance 1,962 3,644 Total lease liabilities $ 3,133,953 $ 3,483,988 Maturities of lease liabilities as of June 30, 2022 by fiscal year are as follows: Maturity of Lease Liabilities Operating Finance Total 2022 (Six months) $ 329,771 $ 15,336 $ 345,107 2023 615,068 3,364 618,432 2024 624,663 280 624,943 2025 529,481 — 529,481 2026 378,279 — 378,279 Thereafter 2,126,368 — 2,126,368 Total lease payments 4,603,630 18,980 4,622,610 Less: Interest (1,488,370 ) (287 ) (1,488,657 ) Present value of lease liabilities $ 3,115,260 $ 18,693 $ 3,133,953 Condensed consolidated statements of operations classification of lease costs as of the three and six months ended June 30, 2022 and 2021 are as follows: Three months ended June 30, Six months ended June 30, Lease Cost Classification 2022 2021 2022 2021 Operating Operating expenses $ 152,784 $ 298,331 $ 327,699 $ 646,369 Finance: Amortization Operating expenses 31,096 111,464 70,807 222,420 Interest expense Other expenses 509 4,491 1,414 11,350 Total lease costs $ 184,389 $ 414,286 $ 399,920 $ 880,139 Other lease information as of June 30, 2022 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 7.7 Finance leases 0.6 Weighted average discount rate: Operating leases 9.2 % Finance leases 7.3 % Supplemental cash flow information as of the six months ended June 30, 2022 and 2021 is as follows: Supplemental Cash Flow Information 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 327,699 $ 646,369 Finance leases $ 1,414 $ 11,350 Cash used in financing activities Finance leases $ 28,101 $ 177,742 ROU assets obtained in exchange for lease obligations: Operating leases $ — $ 748,294 |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 6 Months Ended |
Jun. 30, 2022 | |
License Agreements Research Collaborations And Development Agreements Disclosure [Abstract] | |
License agreements, research collaborations and development agreements | Note 10 – 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 was 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 three months ended June 30, 2022 and 2021, the Company recognized $0 and $237,000 of revenue related to the contract, respectively. During the six months ended June 30, 2022 and 2021, the Company recognized $0 and $345,000 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 framework agreement, which had an initial term of 36 months that was subsequently extended to 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 have 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. 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. 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 effective as of June 30, 2021 in conjunction with its announced exit of the FISH business in June 2021. The Company paid a one-time settlement fee of $350,000 and paid a 10% royalty on the sale of eligible products through June 2021 but is no longer subject to any minimum royalty obligations. The Company recognized net royalty expense of $0 for the three months ended June 30, 2022 and 2021, respectively. The Company recognized net royalty expense of $0 and $8,996 for the six months ended June 30, 2022 and 2021, respectively. 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 $703 and $178 for the three months ended June 30, 2022 and 2021, respectively. The total net royalty expense related to this agreement was $3,482 and $794 for the six months ended June 30, 2022 and 2021, respectively. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 11 - Subsequent Events Subsequent to June 30, 2022, the Company sold 1,703,324 shares of its common stock under the 2022 ATM Offering resulting in aggregate gross proceeds to the Company of approximately $1.0 million. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation and consolidation | Basis of presentation and consolidation The Company has prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the unaudited condensed consolidated financial statements be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s latest Annual Report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2021 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but does not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen and its wholly-owned subsidiaries as of June 30, 2022 including Curetis GmbH and subsidiaries acquired on April 1, 2020; all intercompany transactions and balances have been eliminated. |
Foreign Currency | Foreign currency The Company has subsidiaries located in Holzgerlingen, Germany; and Vienna, Austria, 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 June 30, 2022 and December 31, 2021. 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 unaudited condensed 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. |
Cash and 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. At June 30, 2022 and December 31, 2021, the Company had funds totaling $441,320 and $551,794, 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 unaudited condensed consolidated balance sheets. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 16,586,577 $ 36,080,392 $ 31,182,385 $ 13,360,463 Restricted cash 441,320 551,794 551,260 746,792 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 17,027,897 $ 36,632,186 $ 31,733,645 $ 14,107,255 |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not yet 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 90 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 as of June 30, 2022 and December 31, 2021, respectively. At June 30, 2022, the Company had accounts receivable from one customer which individually represented 75% of total accounts receivable. At December 31, 2021, the Company had accounts receivable from two customers which individually represented 52% and 14% of total accounts receivable, respectively. For the three months ended June 30, 2022, revenue earned from two customers represented 57% and 12% of total revenues, respectively. For the three months ended June 30, 2021, revenue earned from two customers represented 29% and 13% of total revenues, respectively. For the six months ended June 30, 2022, revenue earned from two customers represented 47% and 15% of total revenues, respectively. For the six months ended June 30, 2021, revenue earned from three customers represented 21%, 13%, and 11% of total revenues, respectively. |
Inventory | Inventory Inventories are valued using the first-in, first-out cost method and stated at the lower of cost or net realizable value and consist of the following: June 30, 2022 December 31, 2021 Raw materials and supplies $ 884,474 $ 866,963 Work-in-process 48,680 100,801 Finished goods 3,756,404 3,744,029 Total $ 4,689,558 $ 4,711,793 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 $105,722 and $98,064 at June 30, 2022 and December 31, 2021, 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 unaudited condensed consolidated balance sheets date as strategic inventory, a non-current asset. |
Long-lived assets | Long-lived assets Property and equipment Property and equipment 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 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 three and six months ended June 30, 2022 and 2021, the Company determined that its property and equipment were not impaired. |
ROU assets | 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 six months ended June 30, 2021 , |
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. |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of June 30, 2022 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 June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Subsidiary Cost Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (373,698 ) $ (107,132 ) $ 1,287,170 $ (316,930 ) $ 43,015 $ 1,494,085 Distributor relationships Curetis 2,362,000 (332,838 ) (143,124 ) 1,886,038 (282,277 ) 57,465 2,137,188 A50 - Developed technology Curetis 349,000 (105,393 ) (21,147 ) 222,460 (89,384 ) 8,492 268,108 Ares - Developed technology Curetis 5,333,000 (805,142 ) (323,155 ) 4,204,703 (682,833 ) 129,745 4,779,912 A30 - In-Process Research & Development Curetis 5,706,000 — (337,156 ) 5,368,844 — 144,916 5,850,916 $ 15,518,000 $ (1,617,071 ) $ (931,714 ) $ 12,969,215 $ (1,371,424 ) $ 383,633 $ 14,530,209 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 in-process research and development (“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 its 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. Total amortization expense of intangible assets was $182,993 and $204,800 for the three months ended June 30, 2022 and 2021, respectively. Total amortization expense of intangible assets was $375,018 and $402,642 for the six months ended June 30, 2022 and 2021, respectively. Expected future amortization of intangible assets is as follows: Year Ending December 31, 2022 (Six months) $ 359,349 2023 718,697 2024 718,697 2025 718,697 2026 718,697 2027 683,530 Thereafter 3,682,704 Total $ 7,600,371 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 June 30, 2022 and December 31, 2021 was $ 6,884,915 7,453,007 The changes in the carrying amount of goodwill as of June 30, 2022, and since December 31, 2021, were as follows: Balance as of December 31, 2021 $ 7,453,007 Changes in currency translation (568,092 ) Balance as of June 30, 2022 $ 6,884,915 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 three and six months ended June 30, 2022 and 2021, 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, and 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 subset of the proprietary ARESdb data asset. 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. |
Research and development costs | Research and development costs 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, and fees paid to consultants and outside service partners. |
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 from Austrian government agencies in the condensed 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 three months ended June 30, 2022 and 2021, the Company recognized $111,414 and $154,850 as a reduction of research and development expense related to government grant arrangements, respectively. For the six months ended June 30, 2022 and 2021, the Company recognized $219,879 and $374,072 as a reduction of research and development expense related to government grant arrangements, respectively. The Company had earned but not yet received $572,133 and $396,365 related to these agreements and incentives included in prepaid expenses and other current assets, as of June 30, 2022 and December 31, 2021, respectively. |
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. |
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 may have state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. 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 NOLs 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. 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 19.3 million shares and 11.0 million shares as of June 30, 2022 and 2021, respectively. |
Recently issued accounting standards | 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_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of reconciliation of cash, cash equivalents and restricted cash | June 30, 2022 December 31, 2021 June 30, 2021 December 31, 2020 Cash and cash equivalents $ 16,586,577 $ 36,080,392 $ 31,182,385 $ 13,360,463 Restricted cash 441,320 551,794 551,260 746,792 Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows $ 17,027,897 $ 36,632,186 $ 31,733,645 $ 14,107,255 |
Schedule of inventories | June 30, 2022 December 31, 2021 Raw materials and supplies $ 884,474 $ 866,963 Work-in-process 48,680 100,801 Finished goods 3,756,404 3,744,029 Total $ 4,689,558 $ 4,711,793 |
Schedule of finite-lived and indefinite-lived intangible assets | June 30, 2022 December 31, 2021 Subsidiary Cost Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Accumulated Amortization Effect of Foreign Exchange Rates Net Balance Trademarks and tradenames Curetis $ 1,768,000 $ (373,698 ) $ (107,132 ) $ 1,287,170 $ (316,930 ) $ 43,015 $ 1,494,085 Distributor relationships Curetis 2,362,000 (332,838 ) (143,124 ) 1,886,038 (282,277 ) 57,465 2,137,188 A50 - Developed technology Curetis 349,000 (105,393 ) (21,147 ) 222,460 (89,384 ) 8,492 268,108 Ares - Developed technology Curetis 5,333,000 (805,142 ) (323,155 ) 4,204,703 (682,833 ) 129,745 4,779,912 A30 - In-Process Research & Development Curetis 5,706,000 — (337,156 ) 5,368,844 — 144,916 5,850,916 $ 15,518,000 $ (1,617,071 ) $ (931,714 ) $ 12,969,215 $ (1,371,424 ) $ 383,633 $ 14,530,209 |
Schedule of estimated useful lives of identifiable intangible assets | 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 | Year Ending December 31, 2022 (Six months) $ 359,349 2023 718,697 2024 718,697 2025 718,697 2026 718,697 2027 683,530 Thereafter 3,682,704 Total $ 7,600,371 |
Schedule of changes in carrying amount of goodwill | Balance as of December 31, 2021 $ 7,453,007 Changes in currency translation (568,092 ) Balance as of June 30, 2022 $ 6,884,915 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of revenues by type of service | Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Product sales $ 889,271 $ 307,804 $ 1,255,323 $ 835,383 Laboratory services 20,570 266,784 63,499 450,849 Collaboration revenue 57,364 237,027 118,128 355,099 Total revenue $ 967,205 $ 811,615 $ 1,436,950 $ 1,641,331 |
Schedule of revenues by geography | Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Domestic $ 123,659 $ 305,617 $ 280,069 $ 649,624 International 843,546 505,998 1,156,881 991,707 Total revenue $ 967,205 $ 811,615 $ 1,436,950 $ 1,641,331 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | Description Balance at December 2021 Change in Fair Value Effect of Foreign Exchange Rates Balance at June 30, 2022 Participation percentage interest liability $ 228,589 $ (35,628 ) $ (17,463 ) $ 175,498 Total $ 228,589 $ (35,628 ) $ (17,463 ) $ 175,498 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt and short-term borrowings | June 30, 2022 December 31, 2021 EIB $ 17,026,715 $ 25,161,855 Total debt obligations 17,026,715 25,161,855 Unamortized debt discount (2,114,833 ) (3,466,491 ) Carrying value of debt 14,911,882 21,695,364 Less current portion (10,887,469 ) (14,519,113 ) Long-term debt $ 4,024,413 $ 7,176,251 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of company recognized stock compensation expense | Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Cost of services $ 8,266 $ 2,944 $ 11,101 $ 4,346 Research and development 73,981 67,783 140,979 102,756 General and administrative 138,438 172,790 279,320 314,781 Sales and marketing 36,718 18,031 67,622 29,335 $ 257,403 $ 261,548 $ 499,022 $ 451,218 |
Schedule of outstanding warrants to purchase shares of common stock | Outstanding at Issuance Exercise Price Expiration June 30, 2022 (1) December 31, 2021 (1) February 2015 $ 3,300.00 February 2025 451 451 June 2017 $ 390.00 June 2022 — 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 354,000 354,000 October 2019 $ 2.60 October 2024 235,000 235,000 November 2020 $ 2.52 May 2026 242,130 242,130 February 2021 $ 3.55 August 2026 4,166,666 4,166,666 February 2021 $ 3.90 August 2026 416,666 416,666 March 2021 $ 3.56 March 2026 3,147,700 3,147,700 October 2021 $ 2.05 April 2027 7,500,000 7,500,000 16,217,008 16,217,946 (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. |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Schedule of ROU assets and lease liabilities | Lease Classification June 30, 2022 December 31, 2021 ROU Assets: Operating $ 1,582,325 $ 1,814,396 Financing 19,660 90,467 Total ROU assets $ 1,601,985 $ 1,904,863 Liabilities Current: Operating $ 394,027 $ 459,792 Finance 16,731 43,150 Noncurrent: Operating 2,721,233 2,977,402 Finance 1,962 3,644 Total lease liabilities $ 3,133,953 $ 3,483,988 |
Schedule of maturities of lease liabilities | Maturity of Lease Liabilities Operating Finance Total 2022 (Six months) $ 329,771 $ 15,336 $ 345,107 2023 615,068 3,364 618,432 2024 624,663 280 624,943 2025 529,481 — 529,481 2026 378,279 — 378,279 Thereafter 2,126,368 — 2,126,368 Total lease payments 4,603,630 18,980 4,622,610 Less: Interest (1,488,370 ) (287 ) (1,488,657 ) Present value of lease liabilities $ 3,115,260 $ 18,693 $ 3,133,953 |
Schedule of lease cost classifications | Three months ended June 30, Six months ended June 30, Lease Cost Classification 2022 2021 2022 2021 Operating Operating expenses $ 152,784 $ 298,331 $ 327,699 $ 646,369 Finance: Amortization Operating expenses 31,096 111,464 70,807 222,420 Interest expense Other expenses 509 4,491 1,414 11,350 Total lease costs $ 184,389 $ 414,286 $ 399,920 $ 880,139 |
Schedule of other lease information | Other Information Total Weighted average remaining lease term (in years) Operating leases 7.7 Finance leases 0.6 Weighted average discount rate: Operating leases 9.2 % Finance leases 7.3 % |
Schedule of supplemental cash flow information | Supplemental Cash Flow Information 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 327,699 $ 646,369 Finance leases $ 1,414 $ 11,350 Cash used in financing activities Finance leases $ 28,101 $ 177,742 ROU assets obtained in exchange for lease obligations: Operating leases $ — $ 748,294 |
Going Concern and Management__2
Going Concern and Management’s Plans (Details) $ / shares in Units, € in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Mar. 09, 2021 USD ($) $ / shares shares | Feb. 11, 2021 USD ($) $ / shares shares | May 23, 2022 EUR (€) | Oct. 18, 2021 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) $ / shares shares | Apr. 30, 2022 EUR (€) | Feb. 28, 2022 USD ($) $ / shares | Feb. 11, 2020 USD ($) | |
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Repaid amount (in Euro) | $ | $ 6,819,405 | $ 441,076 | ||||||||
Preferred stock stated value per share (in Dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Common Stock, value | $ | $ 466,237 | $ 464,503 | ||||||||
Holder pursuant to company issued to Holder securities [Member] | Warrants [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Aggregate gross proceeds | $ | $ 9,650,000 | |||||||||
European Investment Bank [Member] | Third Tranches [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Aggregate of borrowing amount (in Euro) | € | € 18,000 | |||||||||
European Investment Bank [Member] | Tranche One [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Accumulated and deferred interest (in Euro) | € | 13,350 | |||||||||
Repaid amount (in Euro) | € | 5,000 | |||||||||
Tranche 1 payment (in Euro) | € | € 5,000 | |||||||||
European Investment Bank [Member] | Second Tranches [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Tranche 1 payment (in Euro) | € | € 3,000 | |||||||||
2022 ATM Offering [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Maximum value of common stock shares issuable through sales agent | $ | $ 10,650,000 | |||||||||
PPI [Member] | European Investment Bank [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Old PPI debt, percentage | 0.30% | |||||||||
Increased PPI debt, percentage | 0.75% | |||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 150,000 | |||||||||
Preferred stock stated value per share (in Dollars per share) | $ / shares | $ 100 | |||||||||
Converted common shares (in Shares) | shares | 7,500,000 | 7,500,000 | ||||||||
Common stock conversion price (in Dollars per share) | $ / shares | $ 2 | |||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 2.05 | |||||||||
Warrants expiry period | 5 years | |||||||||
Net proceeds | $ | $ 13,900,000 | |||||||||
Gross proceeds | $ | $ 15,000,000 | |||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Warrants [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 7,500,000 | |||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Pre Funded Warrant [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 7,500,000 | |||||||||
October 2021 Offering [Member] | Investor [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 2.05 | |||||||||
February 2021 Offering [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 3.55 | |||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 2,784,184 | |||||||||
Preferred stock stated value per share (in Dollars per share) | $ / shares | $ 3 | |||||||||
Converted common shares (in Shares) | shares | 2.99 | |||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 0.01 | |||||||||
Gross proceeds | $ | $ 25,000,000 | |||||||||
Proceeds from issuances | $ | $ 23,500,000 | |||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Warrants [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 5,549,149 | |||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Pre Funded Warrant [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 5,549,149 | 5,549,149 | ||||||||
February 2021 Offering [Member] | Investor [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 3.55 | |||||||||
Warrants expiry period | 5 years 6 months | |||||||||
Stock and warrants net of issuance costs in shares (in Shares) | shares | 4,166,666 | |||||||||
Shares issued (in Dollars per share) | $ / shares | $ 3 | |||||||||
February 2021 Offering [Member] | Investor [Member] | Pre Funded Warrant [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Exercise price per share (in Dollars per share) | $ / shares | 0.01 | |||||||||
Shares issued (in Dollars per share) | $ / shares | $ 2.99 | |||||||||
Warrant [Member] | Exercise Agreement [Member] | Holder [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Exercise price per share (in Dollars per share) | $ / shares | $ 3.56 | |||||||||
Price per common shares (in Shares) | shares | 0.65 | |||||||||
Common stock shares (in Shares) | shares | 3,147,700 | |||||||||
Warrants expiry period | 5 years | |||||||||
Aggregate gross proceeds | $ | $ 255,751 | |||||||||
Warrant [Member] | Purchase Agreement [Member] | Alliance Global Partners [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Cash fee compensation | $ | $ 200,000 | |||||||||
Nasdaq Stock Market LLC [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Per share price (in Dollars per share) | $ / shares | $ 1 | |||||||||
Common Stock, value | $ | $ 1 | |||||||||
2020 ATM Offering [Member] | Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||
Going Concern and Management’s Plans (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | shares | 680,000 | |||||||||
Gross proceeds | $ | $ 1,550,000 | |||||||||
Proceeds from issuances | $ | $ 1,480,000 | |||||||||
Aggregate of common stock | $ | $ 22,100,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) shares in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
FDIC limit of insurable cash | $ 250,000 | $ 250,000 | ||||
Restricted cash | 441,320 | $ 551,260 | 441,320 | $ 551,260 | $ 551,794 | $ 746,792 |
Allowance for doubtful accounts receivable | 0 | 0 | ||||
Inventory valuation reserves | 105,722 | 105,722 | 98,064 | |||
Amortization of intangible assets | 182,993 | 204,800 | 375,018 | 402,642 | ||
Goodwill | 6,884,915 | 6,884,915 | 7,453,007 | |||
Research and development expense | 111,414 | 154,850 | 219,879 | $ 374,072 | ||
Earned but not yet received | $ 572,133 | $ 572,133 | 396,365 | |||
Antidilutive securities excluded from computation of earnings per share, amount (in Shares) | 19.3 | 11 | ||||
Minimum [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Accounts receivable period due | 30 days | |||||
Maximum [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Accounts receivable period due | 90 days | |||||
Accounting Standards Update 2016-02 [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Impairment charge | $ 115,218 | $ 170,714 | ||||
Domestic Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Operating loss carryforwards | 202,015,062 | $ 196,511,928 | ||||
Foreign Tax Authority [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Operating loss carryforwards | 170,607,782 | |||||
Undistributed earnings of foreign subsidiaries | $ 147,313,786 | |||||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 75% | 52% | ||||
Customer One [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 57% | 29% | 47% | 21% | ||
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 14% | |||||
Customer Two [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 12% | 13% | 15% | 13% | ||
Customer Three [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Concentration risk, percentage | 11% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of reconciliation of cash, cash equivalents and restricted cash - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Schedule of reconciliation of cash, cash equivalents and restricted cash [Abstract] | ||||
Cash and cash equivalents | $ 16,586,577 | $ 36,080,392 | $ 31,182,385 | $ 13,360,463 |
Restricted cash | 441,320 | 551,794 | 551,260 | 746,792 |
Total cash and cash equivalents and restricted cash in the condensed consolidated statements of cash flows | $ 17,027,897 | $ 36,632,186 | $ 31,733,645 | $ 14,107,255 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of inventories - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of inventories [Abstract] | ||
Raw materials and supplies | $ 884,474 | $ 866,963 |
Work-in-process | 48,680 | 100,801 |
Finished goods | 3,756,404 | 3,744,029 |
Total | $ 4,689,558 | $ 4,711,793 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of finite-lived and indefinite-lived intangible assets - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 15,518,000 | |
Accumulated Amortization | (1,617,071) | $ (1,371,424) |
Effect of Foreign Exchange Rates | (931,714) | 383,633 |
Net Balance | 12,969,215 | 14,530,209 |
Trademarks and tradenames [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,768,000 | |
Accumulated Amortization | (373,698) | (316,930) |
Effect of Foreign Exchange Rates | (107,132) | 43,015 |
Net Balance | 1,287,170 | 1,494,085 |
Distributor relationships [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 2,362,000 | |
Accumulated Amortization | (332,838) | (282,277) |
Effect of Foreign Exchange Rates | (143,124) | 57,465 |
Net Balance | 1,886,038 | 2,137,188 |
A50 - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 349,000 | |
Accumulated Amortization | (105,393) | (89,384) |
Effect of Foreign Exchange Rates | (21,147) | 8,492 |
Net Balance | 222,460 | 268,108 |
Ares - Developed technology [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,333,000 | |
Accumulated Amortization | (805,142) | (682,833) |
Effect of Foreign Exchange Rates | (323,155) | 129,745 |
Net Balance | 4,204,703 | 4,779,912 |
A30 - In-Process Research & Development [Member] | Curetis N.V [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 5,706,000 | |
Accumulated Amortization | ||
Effect of Foreign Exchange Rates | (337,156) | 144,916 |
Net Balance | $ 5,368,844 | $ 5,850,916 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets | 6 Months Ended |
Jun. 30, 2022 | |
Trademarks and Tradenames [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 10 years |
Customer/Distributor Relationships [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 15 years |
A50 - Developed technology [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 7 years |
Ares - Developed technology [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | 14 years |
A30 - Acquired in-process research & development [Member] | |
Summary of Significant Accounting Policies (Details) - Schedule of estimated useful lives of identifiable intangible assets [Line Items] | |
Weighted-average amortization periods for definite-lived intangible assets acquired | Indefinite |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Details) - Schedule of expected amortization of intangible assets | Jun. 30, 2022 USD ($) |
Schedule of expected amortization of intangible assets [Abstract] | |
2022 (Six months) | $ 359,349 |
2023 | 718,697 |
2024 | 718,697 |
2025 | 718,697 |
2026 | 718,697 |
2027 | 683,530 |
Thereafter | 3,682,704 |
Total | $ 7,600,371 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Details) - Schedule of changes in carrying amount of goodwill | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Schedule of changes in carrying amount of goodwill [Abstract] | |
Balance | $ 7,453,007 |
Changes in currency translation | (568,092) |
Balance | $ 6,884,915 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Revenue from Contract with Customer [Abstract] | ||
Contract assets | $ 51,935 | $ 0 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Details) - Schedule of revenues by type of service - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 967,205 | $ 811,615 | $ 1,436,950 | $ 1,641,331 |
Product sales [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 889,271 | 307,804 | 1,255,323 | 835,383 |
Laboratory services [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 20,570 | 266,784 | 63,499 | 450,849 |
Collaboration revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 57,364 | $ 237,027 | $ 118,128 | $ 355,099 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | $ 967,205 | $ 811,615 | $ 1,436,950 | $ 1,641,331 |
Domestic [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | 123,659 | 305,617 | 280,069 | 649,624 |
International [Member] | ||||
Revenue from Contracts with Customers (Details) - Schedule of revenues by geography [Line Items] | ||||
Total revenue | $ 843,546 | $ 505,998 | $ 1,156,881 | $ 991,707 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
May 23, 2022 | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jul. 09, 2020 | Jul. 31, 2019 EUR (€) | Jun. 30, 2019 EUR (€) | |
Fair Value Measurements (Details) [Line Items] | ||||||||
Operating lease, impairment loss (in Dollars) | $ | $ 115,218 | $ 170,714 | ||||||
Fair Value, Nonrecurring [Member] | ||||||||
Fair Value Measurements (Details) [Line Items] | ||||||||
Operating lease, impairment loss (in Dollars) | $ | $ 115,218 | $ 170,714 | ||||||
Curetis GmbH [Member] | European Investment Bank [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | ||||||||
Fair Value Measurements (Details) [Line Items] | ||||||||
Drew down amount (in Euro) | € 5 | |||||||
Additional payment percentage | 2.10% | |||||||
Curetis GmbH [Member] | European Investment Bank [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | Fair Value, Recurring [Member] | ||||||||
Fair Value Measurements (Details) [Line Items] | ||||||||
Drew down amount (in Euro) | € 5 | |||||||
Additional payment percentage | 2.10% | |||||||
Participation percentage interest | 2.10% | |||||||
Curetis GmbH [Member] | European Investment Bank [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | Fair Value, Recurring [Member] | Minimum [Member] | ||||||||
Fair Value Measurements (Details) [Line Items] | ||||||||
Previous debt (in Euro) | € 15 | |||||||
OpGen's Equity [Member] | European Investment Bank [Member] | Share-Based Payment Arrangement, Tranche Three [Member] | Fair Value, Recurring [Member] | ||||||||
Fair Value Measurements (Details) [Line Items] | ||||||||
Participation percentage interest | 0.75% | 0.30% | ||||||
Maturity period | On May 23, 2022, the Company entered into a Waiver and Amendment Letter which increased the PPI to 0.75% upon maturity between mid-2024 and mid-2025. |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items] | |
Balance at the beginning of the period | $ 228,589 |
Change in Fair Value | (35,628) |
Effect of Foreign Exchange Rates | (17,463) |
Balance at the end of the period | 175,498 |
Participation percentage interest liability [Member] | |
Fair Value Measurements (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items] | |
Balance at the beginning of the period | 228,589 |
Change in Fair Value | (35,628) |
Effect of Foreign Exchange Rates | (17,463) |
Balance at the end of the period | $ 175,498 |
Debt (Details)
Debt (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
May 23, 2022 EUR (€) | Jun. 30, 2019 USD ($) | Jun. 30, 2019 EUR (€) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2022 EUR (€) | Jun. 30, 2021 USD ($) | Dec. 31, 2016 EUR (€) | Jun. 30, 2022 EUR (€) | Dec. 31, 2021 USD ($) | Jul. 09, 2020 EUR (€) | Apr. 22, 2020 USD ($) | Jun. 30, 2018 EUR (€) | Apr. 30, 2017 EUR (€) | |
Debt (Details) [Line Items] | |||||||||||||||
Interest rate payable | 4% | ||||||||||||||
Disburse tranche amount | € 5,000,000 | ||||||||||||||
Repaid amount | $ | $ 6,819,405 | $ 441,076 | |||||||||||||
Total debt obligations | $ | $ 17,026,715 | 17,026,715 | $ 25,161,855 | ||||||||||||
EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Fund drawn period | 36 months | ||||||||||||||
Debt instrument, term | 5 years | ||||||||||||||
Percentage of participation percentage interest | 2.10% | 2.10% | |||||||||||||
Repaid amount | € 5,000,000 | ||||||||||||||
Total debt obligations | $ | 17,026,715 | 17,026,715 | $ 25,161,855 | ||||||||||||
Deferred interest payable | $ | $ 1,697,808 | ||||||||||||||
PPI [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Percentage of participation percentage interest | 2.10% | ||||||||||||||
PPI of CURETIS amended, percentage | 0.30% | ||||||||||||||
PPI of OPGEN amended, percentage | 0.75% | ||||||||||||||
EIB debt financing facility [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Defer total interest payments (in Dollars) | $ | $ 15,800,000 | ||||||||||||||
PPP [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Debt instrument, face amount (in Dollars) | $ | $ 879,630 | ||||||||||||||
Percentage of interest accrued | 1% | 1% | |||||||||||||
Interest expense, debt (in Dollars) | $ | $ 779,912 | $ 1,198,169 | $ 2,049,493 | $ 2,363,151 | |||||||||||
PPP [Member] | Subsidiaries [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Debt instrument, face amount (in Dollars) | $ | $ 259,353 | ||||||||||||||
First Tranche [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Debt instrument, interest rate, stated percentage | 6% | ||||||||||||||
Accumulated and deferred interest | € 13,350,000 | ||||||||||||||
Second Tranche [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Indebtedness amount | 3,000,000 | ||||||||||||||
Third Tranche [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Indebtedness amount | 5,000,000 | ||||||||||||||
Third Tranche [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Total debt borrowed | € 18,000,000 | ||||||||||||||
OpGen's equity value [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Percentage of participation percentage interest | 0.30% | ||||||||||||||
Euro Member Countries, Euro | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Maximum of unsecured loan financing facility | € 25,000,000 | ||||||||||||||
Previous debt | € 15,000,000 | ||||||||||||||
Total debt obligations | € 16,392,331 | ||||||||||||||
Deferred interest payable | € 1,634,551 | ||||||||||||||
Euro Member Countries, Euro | First Tranche [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Unsecured debt | € 10,000,000 | ||||||||||||||
Euro Member Countries, Euro | Second Tranche [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Unsecured debt | € 3,000,000 | ||||||||||||||
Euro Member Countries, Euro | Third Tranche [Member] | EIB [Member] | |||||||||||||||
Debt (Details) [Line Items] | |||||||||||||||
Unsecured debt | € 5,000,000 | € 5,000,000 |
Debt (Details) - Schedule of lo
Debt (Details) - Schedule of long-term debt and short-term borrowings - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Debt (Details) - Schedule of long-term debt and short-term borrowings [Line Items] | ||
Total debt obligations | $ 17,026,715 | $ 25,161,855 |
Unamortized debt discount | (2,114,833) | (3,466,491) |
Carrying value of debt | 14,911,882 | 21,695,364 |
Less current portion | (10,887,469) | (14,519,113) |
Long-term debt | 4,024,413 | 7,176,251 |
EIB [Member] | ||
Debt (Details) - Schedule of long-term debt and short-term borrowings [Line Items] | ||
Total debt obligations | $ 17,026,715 | $ 25,161,855 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Mar. 09, 2021 | Feb. 11, 2021 | Apr. 02, 2020 | Feb. 11, 2020 | Oct. 18, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2022 | Sep. 30, 2020 | Dec. 31, 2021 | Jun. 24, 2022 | Dec. 08, 2021 | |
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Common stock share authorized | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | ||||||||
Common stock share issued | 46,623,618 | 46,450,250 | 46,623,618 | 46,450,250 | ||||||||
Preferred shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||
Common shares issued for conversion of preferred stock | 7,500,000 | |||||||||||
Price per share (in Dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Sole consideration of shares issued | 2,028,208 | |||||||||||
ATM agreement | the Company entered into an ATM Agreement with Wainwright, which was amended and restated on November 13, 2020 to add BTIG, LLC as a sales agent, pursuant to which the Company could 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, 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. The Company terminated the ATM Agreement in June 2022 in conjunction with the execution of the 2022 ATM Agreement. | |||||||||||
Common stock share outstanding | 46,623,618 | 46,450,250 | 46,623,618 | 46,450,250 | ||||||||
Before Amendment [Member] | Common Stock [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Common stock share authorized | 50,000,000 | |||||||||||
After Amendment [Member] | Common Stock [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Common stock share authorized | 100,000,000 | |||||||||||
2015 Plan [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Authorized issuance share | 2,710 | 2,710 | ||||||||||
Stock option description | 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 added | 1,858,010 | 1,858,010 | ||||||||||
Remaining shares | 1,284,296 | 1,284,296 | ||||||||||
First Annual Anniversary [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Vesting percentage for three years | 25% | |||||||||||
Vesting percentage per quarter, | 6.25% | |||||||||||
Holder pursuant to company issued to Holder securities [Member] | New Warrants [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 3.56 | |||||||||||
Purchase of share warrant | 0.65 | |||||||||||
Warrants purchase | 3,147,700 | |||||||||||
Aggregate purchase of warrants (in Dollars) | $ 255,751 | |||||||||||
Holder pursuant to company issued to Holder securities [Member] | Warrants [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Gross proceeds before expenses (in Dollars) | 9,650,000 | |||||||||||
Non-cash warrant inducement expense (in Dollars) | $ 7,800,000 | |||||||||||
October 2021 Offering [Member] | Common Stock [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Net proceeds (in Dollars) | $ 13,900,000 | |||||||||||
Gross proceeds (in Dollars) | $ 15,000,000 | $ 15,000,000 | ||||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 150,000 | |||||||||||
Exercise price (in Dollars per share) | $ 2.05 | |||||||||||
Shares issued for unregistered common warrants to purchase common stock | 4,166,666 | |||||||||||
Price per share (in Dollars per share) | $ 100 | |||||||||||
Aggregate share | 7,500,000 | 7,500,000 | 7,500,000 | |||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Pre Funded Warrant [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 7,500,000 | |||||||||||
Preferred stock, per share (in Dollars per share) | $ 100 | |||||||||||
Aggregate conversion of common stock | 7,500,000 | |||||||||||
Conversion price per share (in Dollars per share) | $ 2 | |||||||||||
October 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Warrants [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 7,500,000 | |||||||||||
October 2021 Offering [Member] | Investor [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 2.05 | |||||||||||
Preferred stock deemed dividend (in Dollars) | $ 7,166,752 | |||||||||||
2020 PIPE [Member] | Healthcare-focused U.S. Institutional Investor [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
March 2021 Warrant Exercise Agreement | 4,842,615 | |||||||||||
February 2021 Offering [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 3.55 | |||||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 2,784,184 | |||||||||||
Exercise price (in Dollars per share) | $ 0.01 | |||||||||||
Price per share (in Dollars per share) | $ 3 | |||||||||||
Aggregate share | 2.99 | |||||||||||
Net proceeds (in Dollars) | $ 23,500,000 | |||||||||||
Gross proceeds (in Dollars) | $ 25,000,000 | |||||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Pre Funded Warrant [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 5,549,149 | 5,549,149 | ||||||||||
February 2021 Offering [Member] | Healthcare-focused Institutional Investor [Member] | Warrants [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share issued | 5,549,149 | |||||||||||
February 2021 Offering [Member] | Investor [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 3.55 | |||||||||||
February 2021 Offering [Member] | Investor [Member] | Pre Funded Warrant [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 0.01 | |||||||||||
Stock options [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Common stock share outstanding | 2,215,755 | 2,215,755 | ||||||||||
Replacement Awards [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Share options forfeited | 7,691 | 10,191 | ||||||||||
Share options expired | 28,367 | 29,903 | ||||||||||
Share options granted | 542,500 | |||||||||||
Replacement Awards [Member] | 2016 Stock Option Plan [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Stock options | 134,371 | |||||||||||
Weighted average grant date fair value (in Dollars per share) | $ 1.68 | |||||||||||
Restricted stock units [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Stock units granted | 60,000 | 730,572 | ||||||||||
Stock units vested | 65,868 | 173,368 | ||||||||||
Stock units forfeited | 7,826 | 10,402 | ||||||||||
Stock units outstanding | 833,066 | |||||||||||
Executive Officers And Non-Employee Directors [Member] | 2020 Stock Options Plan [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Common stock share authorized | 1,300,000 | |||||||||||
Share issued | 1,300,000 | |||||||||||
Purchase of aggregate share | 1,300,000 | |||||||||||
Chief Financial Officer [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Exercise price (in Dollars per share) | $ 1.08 | $ 1.08 | ||||||||||
Purchase of aggregate share | 210,000 | |||||||||||
2020 ATM Offering [Member] | Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Aggregate share (in Dollars) | $ 22,100,000 | |||||||||||
Share issued | 680,000 | |||||||||||
2020 ATM Offering [Member] | Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | Minimum [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Aggregate share (in Dollars) | $ 10,650,000 | |||||||||||
2020 ATM Offering [Member] | Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | ||||||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||||||
Aggregate share (in Dollars) | $ 150,000 | $ 150,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of company recognized stock compensation expense - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | $ 257,403 | $ 261,548 | $ 499,022 | $ 451,218 |
Cost of services [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 8,266 | 2,944 | 11,101 | 4,346 |
Research and development [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 73,981 | 67,783 | 140,979 | 102,756 |
General and administrative [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | 138,438 | 172,790 | 279,320 | 314,781 |
Sales and marketing [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Allocated share-based compensation expense | $ 36,718 | $ 18,031 | $ 67,622 | $ 29,335 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock - $ / shares | 6 Months Ended | ||
Jun. 30, 2022 | Dec. 31, 2021 | ||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Shares of Common Stock Subject to Warrants | [1] | 16,217,008 | 16,217,946 |
June 2017 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 390 | ||
Expiration | 2022-06 | ||
Shares of Common Stock Subject to Warrants | [1] | 938 | |
Warrants Exercise Price One [Member] | February 2015 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 3,300 | ||
Expiration | 2025-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 451 | 451 |
Warrants Exercise Price Three [Member] | July 2017 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 345 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 318 | 318 |
Warrants Exercise Price Four [Member] | July 2017 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 250 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 2,501 | 2,501 |
Warrants Exercise Price Five [Member] | July 2017 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 212.6 | ||
Expiration | 2022-07 | ||
Shares of Common Stock Subject to Warrants | [1] | 50,006 | 50,006 |
Warrants Exercise Price Six [Member] | February 2018 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 81.25 | ||
Expiration | 2023-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 9,232 | 9,232 |
Warrants Exercise Price Seven [Member] | February 2018 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 65 | ||
Expiration | 2023-02 | ||
Shares of Common Stock Subject to Warrants | [1] | 92,338 | 92,338 |
Warrant Exercise Price Eight [Member] | October 2019 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 2 | ||
Expiration | 2024-10 | ||
Shares of Common Stock Subject to Warrants | [1] | 354,000 | 354,000 |
Warrants Exercise Price Nine [Member] | October 2019 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 2.6 | ||
Expiration | 2024-10 | ||
Shares of Common Stock Subject to Warrants | [1] | 235,000 | 235,000 |
Warrants Exercise Price Ten [Member] | November 2020 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 2.52 | ||
Expiration | 2026-05 | ||
Shares of Common Stock Subject to Warrants | [1] | 242,130 | 242,130 |
Warrants Exercise Price Eleven [Member] | February 2021 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 3.55 | ||
Expiration | 2026-08 | ||
Shares of Common Stock Subject to Warrants | [1] | 4,166,666 | 4,166,666 |
Warrant Exercise Price Twelve [Member] | February 2021 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 3.9 | ||
Expiration | 2026-08 | ||
Shares of Common Stock Subject to Warrants | [1] | 416,666 | 416,666 |
Warrant Exercise Price Thirteen [Member] | March 2021 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 3.56 | ||
Expiration | 2026-03 | ||
Shares of Common Stock Subject to Warrants | [1] | 3,147,700 | 3,147,700 |
Warrant Exercise Price Fourteen [Member] | October 2021 [Member] | |||
Stockholders' Equity (Details) - Schedule of outstanding warrants to purchase shares of common stock [Line Items] | |||
Exercise Price (in Dollars per share) | $ 2.05 | ||
Expiration | 2027-04 | ||
Shares of Common Stock Subject to Warrants | [1] | 7,500,000 | 7,500,000 |
[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. |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Quant Studio Five Real Time PCR Systems [Member] | Life Technologies Corporation Supply Agreement [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Aggregate purchase commitments | $ 0.5 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of ROU assets and lease liabilities - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
ROU Assets: | ||
Operating | $ 1,582,325 | $ 1,814,396 |
Financing | 19,660 | 90,467 |
Total ROU assets | 1,601,985 | 1,904,863 |
Current: | ||
Operating | 394,027 | 459,792 |
Finance | 16,731 | 43,150 |
Noncurrent: | ||
Operating | 2,721,233 | 2,977,402 |
Finance | 1,962 | 3,644 |
Total lease liabilities | $ 3,133,953 | $ 3,483,988 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of maturities of lease liabilities | Jun. 30, 2022 USD ($) |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 (Six months) | $ 345,107 |
2023 | 618,432 |
2024 | 624,943 |
2025 | 529,481 |
2026 | 378,279 |
Thereafter | 2,126,368 |
Total lease payments | 4,622,610 |
Less: Interest | (1,488,657) |
Present value of lease liabilities | 3,133,953 |
Operating [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 (Six months) | 329,771 |
2023 | 615,068 |
2024 | 624,663 |
2025 | 529,481 |
2026 | 378,279 |
Thereafter | 2,126,368 |
Total lease payments | 4,603,630 |
Less: Interest | (1,488,370) |
Present value of lease liabilities | 3,115,260 |
Finance [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 (Six months) | 15,336 |
2023 | 3,364 |
2024 | 280 |
2025 | |
2026 | |
Thereafter | |
Total lease payments | 18,980 |
Less: Interest | (287) |
Present value of lease liabilities | $ 18,693 |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of lease cost classifications - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Finance: | ||||
Total lease costs | $ 184,389 | $ 414,286 | $ 399,920 | $ 880,139 |
Operating Expenses [Member] | ||||
Leases (Details) - Schedule of lease cost classifications [Line Items] | ||||
Operating | 152,784 | 298,331 | 327,699 | 646,369 |
Finance: | ||||
Amortization | 31,096 | 111,464 | 70,807 | 222,420 |
Other Expenses [Member] | ||||
Finance: | ||||
Interest expense | $ 509 | $ 4,491 | $ 1,414 | $ 11,350 |
Leases (Details) - Schedule o_4
Leases (Details) - Schedule of other lease information | Jun. 30, 2022 |
Weighted average remaining lease term (in years) | |
Operating leases | 7 years 8 months 12 days |
Finance leases | 7 months 6 days |
Weighted average discount rate: | |
Operating leases | 9.20% |
Finance leases | 7.30% |
Leases (Details) - Schedule o_5
Leases (Details) - Schedule of supplemental cash flow information - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash used in operating activities | ||
Operating leases | $ 327,699 | $ 646,369 |
Finance leases | 1,414 | 11,350 |
Cash used in financing activities | ||
Finance leases | 28,101 | 177,742 |
ROU assets obtained in exchange for lease obligations: | ||
Operating leases | $ 748,294 |
License Agreements, Research _2
License Agreements, Research Collaborations and Development Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 15 Months Ended | ||||||
Jun. 30, 2021 | Apr. 30, 2021 | Oct. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2020 | Apr. 30, 2020 | |
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Revenue contract | $ 967,205 | $ 811,615 | $ 1,436,950 | $ 1,641,331 | ||||||
Collaborations Revenue [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Revenue contract | 57,364 | $ 237,027 | 118,128 | $ 355,099 | ||||||
Fish License [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Agreement termination date | Jun. 30, 2021 | |||||||||
Settlement fee | $ 350,000 | |||||||||
Royalty percentage | 10% | 10% | 10% | |||||||
Royalty expenses | 0 | $ 0 | 0 | $ 8,996 | ||||||
New York State Department of Health and ILUM Health Solutions, LLC [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Revenue received over 15 month demonstration period | $ 1,600,000 | |||||||||
Demonstration period | 15 months | |||||||||
Contract value | $ 540,000 | $ 450,000 | ||||||||
Agreement termination date | 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 (Details) [Line Items] | ||||||||||
Revenue contract | 0 | 237,000 | $ 0 | 345,000 | ||||||
Sandoz [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Agreement termination date | Jan. 31, 2025 | |||||||||
Initial agreement period | 36 months | |||||||||
Qiagen [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Contractual agreement period | 20 years | |||||||||
Siemens [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Royalty expenses | $ 703 | $ 178 | $ 3,482 | $ 794 | ||||||
Siemens [Member] | Minimum [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Royalty rate | 1.30% | |||||||||
Siemens [Member] | Maximum [Member] | ||||||||||
License Agreements, Research Collaborations and Development Agreements (Details) [Line Items] | ||||||||||
Royalty rate | 40% |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | Jun. 30, 2022 USD ($) shares |
Subsequent Events [Abstract] | |
Shares issued | shares | 1,703,324 |
Aggregate gross proceeds | $ | $ 1 |