Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 07, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | OPGEN INC | |
Entity Central Index Key | 0001293818 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 15,070,107 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 11,469,455 | $ 2,708,223 |
Accounts receivable, net | 165,931 | 567,811 |
Inventory, net | 436,683 | 473,030 |
Note receivable | 4,808,712 | 2,521,479 |
Prepaid expenses and other current assets | 264,013 | 396,760 |
Total current assets | 17,144,794 | 6,667,303 |
Property and equipment, net | 102,579 | 130,759 |
Finance lease right-of-use assets, net | 826,243 | 958,590 |
Operating lease right-of-use assets | 885,882 | 1,043,537 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 817,550 | |
Other noncurrent assets | 203,212 | 203,271 |
Total assets | 19,763,524 | 10,421,824 |
Current liabilities | ||
Accounts payable | 1,054,261 | 1,056,035 |
Accrued compensation and benefits | 988,291 | 855,994 |
Accrued liabilities | 1,047,019 | 1,046,661 |
Deferred revenue | 9,808 | 9,808 |
Short-term notes payable | 348,494 | 373,599 |
Short-term finance lease liabilities | 517,042 | 579,030 |
Short-term operating lease liabilities | 947,610 | 1,017,414 |
Total current liabilities | 4,912,525 | 4,938,541 |
Note payable | 163,401 | 329,456 |
Long-term finance lease liabilities | 212,798 | 313,263 |
Long-term operating lease liabilities | 392,106 | 547,225 |
Total liabilities | 5,680,830 | 6,128,485 |
Commitments (Note 9) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at March 31, 2020 and December 31, 2019, respectively | ||
Common stock, $0.01 par value; 50,000,000 shares authorized; 12,468,214 and 5,582,280 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 124,682 | 55,823 |
Additional paid-in capital | 192,410,127 | 178,779,814 |
Accumulated deficit | (178,474,277) | (174,524,983) |
Accumulated other comprehensive income (loss) | 22,162 | (17,315) |
Total stockholders' equity | 14,082,694 | 4,293,339 |
Total liabilities and stockholders' equity | $ 19,763,524 | $ 10,421,824 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 12,468,214 | 5,582,280 |
Common stock, shares outstanding | 12,468,214 | 5,582,280 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue | ||
Total revenue | $ 616,933 | $ 1,020,177 |
Operating expenses | ||
Research and development | 1,217,556 | 1,776,382 |
General and administrative | 1,701,448 | 1,747,585 |
Sales and marketing | 282,277 | 372,233 |
Transaction costs | 245,322 | |
Impairment of right-of-use asset | 520,759 | |
Impairment of intangibles assets | 750,596 | |
Total operating expenses | 4,611,419 | 4,782,143 |
Operating loss | (3,994,486) | (3,761,966) |
Other income (expense) | ||
Interest and other income (expense) | 87,335 | (24,422) |
Interest expense | (38,267) | (56,444) |
Foreign currency transaction losses | (3,876) | (10,351) |
Change in fair value of derivative financial instruments | 67 | |
Total other income (expense) | 45,192 | (91,150) |
Loss before income taxes | (3,949,294) | (3,853,116) |
Provision for income taxes | ||
Net loss | (3,949,294) | (3,853,116) |
Net loss available to common stockholders | $ (3,949,294) | $ (3,853,116) |
Net loss per common share - basic and diluted | $ (0.53) | $ (8.25) |
Weighted average shares outstanding - basic and diluted | 7,393,232 | 467,286 |
Net loss | $ (3,949,294) | $ (3,853,116) |
Other comprehensive income - foreign currency translations | 39,477 | 2,826 |
Comprehensive loss | (3,909,817) | (3,850,290) |
Product sales [Member] | ||
Revenue | ||
Total revenue | 366,933 | 520,177 |
Operating expenses | ||
Cost of products and services | 276,554 | 220,702 |
Collaborations Revenue [Member] | ||
Revenue | ||
Total revenue | 250,000 | 500,000 |
Service [Member] | ||
Operating expenses | ||
Cost of products and services | $ 137,666 | $ 144,482 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) | Common Stock [Member] | Preferred Stock [Member] | Additional Paid In Capital [Member] | Accumulated Other Comprehensive (Loss) Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2018 | $ 4,323 | $ 165,396,036 | $ (13,093) | $ (162,078,525) | $ 3,308,741 | |
Balance (in shares) at Dec. 31, 2018 | 432,286 | |||||
Public offering of common stock and warrants, net of issuance costs | $ 4,500 | 4,778,009 | 4,782,509 | |||
Public offering of common stock and warrants, net of issuance costs (in shares) | 450,000 | |||||
Stock compensation expense | 98,033 | 98,033 | ||||
Foreign currency translation | 2,826 | 2,826 | ||||
Net loss | (3,853,116) | (3,853,116) | ||||
Balance at Mar. 31, 2019 | $ 8,823 | 170,272,078 | (10,267) | (165,931,641) | 4,338,993 | |
Balance (in shares) at Mar. 31, 2019 | 882,286 | |||||
Balance at Dec. 31, 2019 | $ 55,823 | 178,779,814 | (17,315) | (174,524,983) | 4,293,339 | |
Balance (in shares) at Dec. 31, 2019 | 5,582,280 | |||||
At the market offering, net of offering costs | $ 28,149 | 5,449,283 | 5,477,432 | |||
At the market offering, net of offering costs, shares | 2,814,934 | |||||
Common stock warrant exercises | $ 40,710 | 8,101,290 | 8,142,000 | |||
Common stock warrant exercises, shares | 4,071,000 | |||||
Stock compensation expense | 79,740 | 79,740 | ||||
Foreign currency translation | 39,477 | 39,477 | ||||
Net loss | (3,949,294) | (3,949,294) | ||||
Balance at Mar. 31, 2020 | $ 124,682 | $ 192,410,127 | $ 22,162 | $ (178,474,277) | $ 14,082,694 | |
Balance (in shares) at Mar. 31, 2020 | 12,468,214 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (3,949,294) | $ (3,853,116) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 228,538 | 223,115 |
Noncash interest expense | 4,397 | 29,265 |
Noncash interest income | (87,233) | |
Stock compensation expense | 79,740 | 98,033 |
Loss on sale of equipment | 24,439 | |
Change in fair value of warrant liability | (67) | |
Impairment of right-of-use asset | 520,759 | |
Impairment of intangible assets | 750,596 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 401,532 | (440,475) |
Inventory | 36,257 | 44,545 |
Other assets | 283,180 | 285,070 |
Accounts payable | (627) | (31,531) |
Accrued compensation and other liabilities | (91,828) | 120,015 |
Deferred revenue | (5,831) | |
Net cash used in operating activities | (2,344,742) | (2,985,779) |
Cash flows from investing activities | ||
Note receivable | (2,200,000) | |
Purchases of property and equipment | (1,057) | (8,493) |
Proceeds from sale of equipment | 1,250 | |
Net cash used in investing activities | (2,201,057) | (7,243) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 5,477,432 | 4,782,509 |
Proceeds from the exercise of common stock warrants | 8,142,000 | |
Payments on debt | (191,772) | (217,484) |
Payments on finance lease obligations | (162,453) | (116,538) |
Net cash provided by financing activities | 13,265,207 | 4,448,487 |
Effects of exchange rates on cash | 41,824 | 4,216 |
Net increase in cash, cash equivalents and restricted cash | 8,761,232 | 1,459,681 |
Cash, cash equivalents and restricted cash at beginning of period | 2,893,603 | 4,737,207 |
Cash, cash equivalents and restricted cash at end of period | 11,654,835 | 6,196,888 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 55,011 | 73,754 |
Supplemental disclosures of noncash investing and financing activities: | ||
Right-of-use assets acquired through finance leases | 161,116 | |
Conversion of accounts payable to finance lease | $ 63,600 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 Organization OpGen, Inc. (OpGen or the Company) was incorporated in Delaware in 2001. References in this report to the Company include OpGen and its wholly-owned subsidiaries. The Companys headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland. The Company also has operations in Copenhagen, Denmark and Bogota, Colombia. The Company operates in one business segment. Business Combination Transaction with Curetis N.V. On April 1, 2020 (the Closing Date), the Company 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), 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 (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, as further described below, and paid, as the sole consideration, 2,028,208 shares of the Companys common stock, par value $0.01 per share (the Common Stock), to the Seller, and reserved for future issuance (a) 134,356 shares of Common Stock, in connection with its assumption of the Sellers 2016 Stock Option Plan, as amended (the Seller Stock Option Plan), and the outstanding awards thereunder, and (b) 500,000 shares of Common Stock to be issued upon the conversion, if any, of certain convertible notes issued by the Seller, of which 265,002 shares have been issued as of May 8, 2020, in satisfaction of approximately $543,000 of outstanding principal and indebtedness under the assumed convertible notes. The 2,028,208 shares of Common Stock issued to the Seller represented approximately 13.8% of the outstanding Common Stock of the Company as of the Closing Date. At the closing, the Company assumed all of the liabilities of the Seller solely and exclusively related to the acquired business, which is providing innovative solutions, through development of proprietary platforms, diagnostic content, applied bioinformatics, lab services, research services and commercial collaborations and agreements, for molecular microbiology, diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patient (the Curetis Business). Pursuant to the Implementation Agreement, the Company also assumed and adopted the Seller Stock Option Plan as an Amended and Restated Stock Option Plan of the Company. In connection with the foregoing, the Company assumed all awards thereunder that were outstanding as of the Closing Date and converted such awards into options to purchase shares of the Companys Common Stock pursuant to the terms of the applicable award. In addition, the Company assumed, at the closing, all of the outstanding convertible notes issued by Seller in favor of YA II PN, LTD, pursuant to the previously disclosed Assignment of the Agreement for the Issuance of and Subscription to Notes Convertible into Shares, dated February 24, 2020 (the Assignment Agreement), and entered into pursuant to the Implementation Agreement. In this Quarterly Report we refer to the combined business following the consummation of the Transaction as Newco. OpGen Overview OpGen is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company is developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. Its proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize care decisions for patients with acute infections. The Companys molecular diagnostics and informatics products, product candidates and services combine its Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver products and services, some in development, to a global network of customers and partners. · The Companys Acuitas molecular diagnostic tests provide rapid microbial identification and antibiotic resistance gene information. These products include its Acuitas antimicrobial resistance, or AMR, Gene Panel Urine test in development for patients at risk for complicated urinary tract infection, or cUTI, and its Acuitas AMR Gene Panel test for use with bacterial isolates in development for testing bacterial isolates, and its QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures. Each of the Acuitas AMR Gene Panel tests is available for sale for research use only, or RUO and is not for use in diagnostic procedures. · The Companys Acuitas Lighthouse informatics systems are cloud-based HIPAA compliant informatics offerings that combine clinical lab test results with patient and hospital information to provide analytics and actionable insights to help manage MDROs in the hospital and patient care environment. Components of the informatics systems include the Acuitas Lighthouse Knowledgebase and the Acuitas Lighthouse Software. The Acuitas Lighthouse Knowledgebase is a relational database management system and a proprietary data warehouse of genomic data matched with antibiotic susceptibility information for bacterial pathogens. The Acuitas Lighthouse Software system includes the Acuitas Lighthouse Portal, a suite of web applications and dashboards, the Acuitas Lighthouse Prediction Engine, which is a data analysis software, and other supporting software components. The Acuitas Lighthouse Software can be customized and made specific to a healthcare facility or collaborator, such as a pharmaceutical company. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures. The Companys operations are subject to certain risks and uncertainties. The risks include the risk that the Company will not receive 510(k) clearance for its Acuitas AMR Gene Panel test for use with bacterial isolates on a timely basis, or at all, the timing and ultimate success of future 510(k) and De Novo Overview of the Curetis Business The Curetis Business develops, manufactures and commercializes innovative solutions for molecular microbiology. The Curetis business is based on two complementary business pillars: · The Unyvero A50 is a high-plex polymerase chain reaction, or PCR, platform for comprehensive and rapid diagnosis of severe infectious diseases in hospitalized patients. The platform is based on proven, intelligently integrated technologies, allowing for the testing of broad panels of pathogens and antibiotic resistance markers and the processing of a large variety of native patient samples with an intuitive workflow. The Unyvero A50 high-plex PCR platforms advantage is the timely access to comprehensive, actionable and reliable data. Curetis molecular tests for different indications are commercially available in Europe, the United States, Asia and the Middle East. The Curetis Group is also developing the Unyvero A30 RQ Analyzer, which is designed to serve as a platform with low-to medium-plex capabilities that it ultimately intends to commercially leverage predominantly in collaborations with one or more diagnostics industry partners. · The ARES AMR database, or ARES db db db Curetis GmbHs offices and R&D laboratories are based in Holzgerlingen, near Stuttgart with its cartridge manufacturing facility in Bodelshausen also in southern Germany, in addition to subsidiaries located in San Diego, California, USA and Vienna, Austria. Overview of Newco We anticipate that the focus of Newco will be on its combined broad portfolio of products, which include high impact rapid diagnostics and bioinformatics to interpret AMR genetic data. The products we expect Newco to focus on are for lower respiratory infection and urinary tract infection: · The Unyvero Lower Respiratory Tract, or LRT, test is the first FDA cleared test that can be used for more than 90% of infection cases of hospitalized pneumonia patients. According to the National Center for Health Statistics (2018), pneumonia is a leading cause of admissions to the hospital and is associated with substantial morbidity and mortality. The Unyvero LRT automated test detects 19 pathogens within less than five hours, with approximately two minutes of hands-on time and provides clinicians with a comprehensive overview of 10 genetic antibiotic resistance markers. We are also commercializing the Unyvero LRT test for testing bronchoalveolar lavage, or BAL, specimens of U.S. patients with lower respiratory tract infections following FDA clearance received by Curetis in December 2019. We believe the Unyvero LRT test has the ability to help address a significant, previously unmet medical need that causes over $10 billion in annual costs for the U.S. healthcare system, according to the Centers for Disease Control, or CDC. · The Acuitas AMR Gene Panel (Urine) ) test is being developed for patients at risk for cUTI, and is designed to test for up to five pathogens and up to 47 antimicrobial resistance genes. When paired with the Acuitas Lighthouse software, we believe the test will be able to help improve management of the more than one million patients in the United States with cUTI. The AMR Gene Panel (Urine) is in testing for preparation of a De Novo Newco will have an extensive offering of additional in vitro Newcos combined AMR informatics offerings, once all such products are cleared for marketing, if ever, will offer important new tools to clinicians treating patients with AMR infections. OpGen has collaborated with Merck, Inc. to establish the Acuitas Lighthouse Knowledgebase, which is currently commercially available in the United States for RUO. The Acuitas Lighthouse Knowledgebase includes approximately 15,000 bacterial isolates from the Merck SMART surveillance network of 192 hospitals in 52 countries and other sources. The Curetis ARES db db db The Unyvero A50 tests for up to 130 diagnostic targets (pathogens and resistance genes) in under five hours with approximately two minutes of hands-on time. The system was first CE Marked in 2012 and was FDA cleared in 2018 along with the LRT test through De Novo RQ Newco has extensive partner and distribution relationships to help accelerate the establishment of a global infectious disease diagnostic testing and informatics business. Partners will include A. Menarini Diagnostics for pan-European distribution to currently 11 countries; MGI/BGI for NGS-based molecular microbiology applications in China; and Beijing Clear Biotech Co. Ltd. for Unyvero A50 product distribution in China. Newco has a network currently consisting of 18 distributors covering 43 countries. Newco will continue to develop and seek FDA and other regulatory clearances or approvals, as applicable, for the Acuitas AMR Gene Panel (Urine) diagnostic test and the Acuitas Lighthouse Software products. Newco will continue to offer the Acuitas AMR Gene Panel (Isolates) and Acuitas Lighthouse Software as well as the Unyvero UTI Panel as RUO products to hospitals, public health departments, clinical laboratories, pharmaceutical companies and contract research organizations, or CROs. |
Liquidity and management's plan
Liquidity and management's plans | 3 Months Ended |
Mar. 31, 2020 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Liquidity and management's plans | Note 2 – Liquidity 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. The Company has funded its operations primarily through external investor , including the following in 2019 and 2020 to date: · On February 11, 2020, the Company entered into an At the Market Common Offering (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), 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 $15.7 million of shares of the Company's common stock through Wainwright, as sales agent, (the “2020 ATM Offering”). During the three months ended March 31, 2020, the Company sold 2,814,934 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $5.5 million, and gross proceeds of $5.8 million. · On October 28, 2019, the Company closed a public offering (the “October 2019 Public Offering”) of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit, raising gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million. Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. As of March 31, 2020, all 2,109,830 pre-funded warrants issued in the October 2019 Public Offering have been exercised. Additionally during the three months ended March 31, 2020, 4,071,000 common warrants issued in the October 2019 Public Offering were exercised for net proceeds of approximately $8.1 million. · On March 29, 2019, the Company closed a public offering (the “March 2019 Public Offering”) of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million. 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 and business combination transactions. 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 fund operations into the fourth quarter of 2020. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the end of the fourth quarter of 2020, 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, 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 | 3 Months Ended |
Mar. 31, 2020 | |
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 following 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, 2019 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 March 31, 2020 and excludes the Curetis Business which was acquired on April 1, 2020; all intercompany transactions and balances have been eliminated. Foreign currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both 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 (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at March 31, 2020 and 2019. 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, 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, 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, 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 government agency (“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 March 31, 2020 and December 31, 2019, the Company has funds totaling $185,380, 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, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: March 31, 2020 December 31, 2019 March 31, 2019 December 31, 2018 Cash and cash equivalents $ 11,469,455 $ 2,708,223 $ 6,011,508 $ 4,572,487 Restricted cash 185,380 185,380 185,380 164,720 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 11,654,835 $ 2,893,603 $ 6,196,888 $ 4,737,207 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 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 as of March 31, 2020 and December 31, 2019. At March 31, 2020, the Company had accounts receivable from one customer which individually represented 31% of total accounts receivable. At March 31, 2019, one individual customer represented 61% of total accounts receivable. For the three months ended March 31, 2020, revenue earned from one customer represented 41% of total revenues. For the three months ended March 31, 2019, revenue earned from one customer represented 49% of total revenues. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: March 31, 2020 December 31, 2019 Raw materials and supplies $ 266,444 $ 315,542 Work-in-process 22,291 35,080 Finished goods 147,948 122,408 Total $ 436,683 $ 473,030 Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $132,260 and $92,454 at March 31, 2020 and December 31, 2019, respectively. 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 months ended March 31, 2020 and 2019, the Company determined that its property and equipment was not impaired. Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the accelerated 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. In conjunction with adoption of Accounting Standards Update (“ASU”) 2016-02, Leases Intangible assets and goodwill Intangible assets and goodwill as of March 31, 2020 consist of finite-lived intangible assets and goodwill. Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Cost Accumulated Amortization Impairment Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 (217,413 ) $ (243,587 ) $ — $ (205,887 ) $ 255,113 Developed technology 458,000 (308,526 ) (149,474 ) — (292,170 ) 165,830 Customer relationships 1,094,000 (736,465 ) (357,535 ) — (697,393 ) 396,607 $ 2,013,000 (1,262,404 ) $ (750,596 ) $ — $ (1,195,450 ) $ 817,550 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. 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 $66,954 for each of the three months ended March 31, 2020 and 2019. Finite-lived 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 in a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) 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 March 31, 2020 and December 31, 2019 was $600,814. 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 months ended March 31, 2020 and 2019, the Company determined that its goodwill was not impaired. Revenue recognition The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. 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. 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 $ 188,282,298 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 1.1 million shares and 0.2 million shares as of March 31, 2020 and 2019, respectively. Adopted accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients: · The Company did not reassess if any expired or existing contracts are or contain leases. · The Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing 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. Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease right of use asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million. Prior to the adoption of ASC 842, deferred rent was recorded and amortized to the extent the total minimum rental payments allocated to the period on a straight-line basis exceeded or were less than the cash payments required. The Company adopted Accounting Standards Update 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments 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 | 3 Months Ended |
Mar. 31, 2020 | |
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 March 31, 2020 2019 Product sales $ 366,933 $ 520,177 Collaboration revenue 250,000 500,000 Total revenue $ 616,933 $ 1,020,177 Deferred revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Revenue recognized in the current period from the amounts in the beginning balance — New deferrals, net of amounts recognized in the current period — Balance at March 31, 2020 $ 9,808 Contract assets The Company had no contract assets as of March 31, 2020, 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 March 31, 2020. |
MGHIF financing
MGHIF financing | 3 Months Ended |
Mar. 31, 2020 | |
Common Stock And Note Purchase Agreement [Abstract] | |
MGHIF financing | Note 5 – MGHIF financing In July 2015, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 2,273 shares of common stock of the Company at $2,200 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the “MGHIF Note”) in the principal amount of $1.0 million with a two-year maturity date from the date of issuance. The Company’s obligations under the MGHIF Note are secured by a lien on all of the Company’s assets. On June 28, 2017, the MGHIF Note was amended and restated, and the maturity date of the MGHIF Note was extended by one year to July 14, 2018. As consideration for the agreement to extend the maturity date, the Company issued an amended and restated secured promissory note to MGHIF that (1) increased the interest rate to ten percent (10%) per annum and (2) provided for the issuance of common stock warrants to purchase 656 shares of its common stock to MGHIF. On June 11, 2018, the Company executed an Allonge to the MGHIF Note. The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. The Allonge to the MGHIF Note was treated as a debt modification and as such the unamortized issuance costs of approximately $7,000 as of June 11, 2018 is deferred and amortized as incremental expense over the term of the MGHIF Note. On July 30, 2018, the Company issued 7,212 shares of common stock to MGHIF in a private placement transaction in payment of the $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note. The Company’s outstanding debt under the MGHIF Note, net of discounts and financing costs as of March 31, 2020 was approximately $497,000. |
Fair value measurements
Fair value measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 6 – Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: · Level 1 - defined as observable inputs such as quoted prices in active markets; · Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and · Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the three months ended March 31, 2020, 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. As part of the Company’s bridge financing and amendment to the MGHIF Note, the Company issued stock purchase warrants that the Company considers to be mark-to-market liabilities due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. The Company determines the fair value of the warrant liabilities using the Black-Scholes option pricing model. Using this model, level 3 unobservable inputs include the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates. The fair value of level 3 liabilities measured at fair value on a recurring basis for the three months ended March 31, 2020 and December 31, 2019 was $0. 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 they are deemed to be impaired. During the three months ended March 31, 2020 the Company recorded impairment expense of $750,596 related to its intangible assets (See Note – 3). |
Debt
Debt | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 – Debt As of March 31, 2020, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as the f inancing arrangements for the Company’s insurance with note balances of approximately $ As of December 31, 2019, inancing arrangements for the Company’s insurance with note balances of approximately $40,000 Total principal payments of approximately $ are due annually in 2020 and 2021. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $38,267 and $56,444 for the three months ended March 31, 2020 and 2019, respectively. |
Stockholders' equity
Stockholders' equity | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' equity | Note 8 – Stockholders’ equity As of March 31, 2020, the Company has 50,000,000 shares of authorized common shares and 12,468,214 shares issued and outstanding, and 10,000,000 shares of authorized preferred shares, of which none were issued or outstanding. Following receipt of approval from stockholders at a special meeting of stockholders held on 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, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 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 March 29, 2019, the Company closed the March 2019 Public Offering of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million. On October 28, 2019, the Company closed the October 2019 Public Offering of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit. The offering raised gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million. As of March 31, 2020, the 2,109,830 pre-funded warrants issued in the October 2019 Public Offering have been exercised. Additionally, during the three months ended March 31, 2020, 4,071,000 common warrants were exercised raising net proceeds of approximately $8.1 million. In connection with the October 2019 Public Offering, the Company issued to its placement agent warrants to purchase 235,000 shares of common stock. The warrants issued to the placement agent have an exercise price of $2.60 per share and are exercisable for five years. On February 11, 2020, the Company entered into an ATM Agreement with Wainwright, 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 $15.7 million of shares of the Company's common stock through Wainwright, as sales agent. During the three months ended March 31, 2020, the Company sold 2,814,934 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $5.5 million, and gross proceeds of $5.8 million. As of March 31, 2020, remaining availability under the at the market offering is $9.9 million. 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) 54,200 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of March 31, 2020, 229,533 shares remain available for issuance under the 2015 Plan, which includes 223,291 shares automatically added to the 2015 Plan on January 1, 2020. For the three months ended March 31, 2020 and 2019, the Company recognized share-based compensation expense as follows: Three Months Ended March 31, 2020 2019 Cost of services $ 728 $ 38 Research and development 13,986 17,127 General and administrative 61,488 76,013 Sales and marketing 3,538 4,855 $ 79,740 $ 98,033 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 did not grant any stock options during the three months ended March 31, 2020. During the three months ended March 31, 2020, 28 options were forfeited and 230 options expired. The Company had total stock options to acquire 9,396 shares of common stock outstanding at March 31, 2020. Restricted stock units During the three months ended March 31, 2020, no restricted stock units vested and 200 restricted stock units were forfeited. The Company had 14,775 total restricted stock units outstanding at March 31, 2020. Stock purchase warrants At March 31, 2020 and December 31, 2019, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration March 31, 2020 December 31, 2019 January 2010 $ 3,955.00 January 2020 — 17 March 2010 $ 3,955.00 March 2020 — 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 February 2015 $ 3,300.00 February 2025 451 451 May 2015 $ 3,300.00 May 2020 6,697 6,697 May 2016 $ 656.20 May 2021 9,483 9,483 June 2016 $ 656.20 May 2021 4,102 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 629,000 4,700,000 October 2019 $ 2.60 October 2024 235,000 235,000 1,040,083 5,111,107 The warrants listed above were issued in connection with various debt, equity or development contract agreements. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies 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 March 31, 2020, the Company has acquired twenty-four QuantStudio 5s including none during the three months ended March 31, 2020. As of March 31, 2020, the Company has not committed to acquiring additional QuantStudio 5s in the next three months. Contingencies On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) as a global pandemic, which continues to spread throughout the United States and around the world. As of March 31, 2020, the Company is aware of changes in its business as a result of COVID-19 but uncertain of the impact of those changes on its financial position, results of operations or cash flows. Management believes any disruption, when and if experienced, could be temporary; however, there is uncertainty around when any disruption might occur, the duration and hence the potential impact. As a result, we are unable to estimate the potential impact on our business as of the date of this filing. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | Note 10 – Leases The following table presents the Company’s ROU assets and lease liabilities as of March 31, 2020 and December 31, 2019: Lease Classification March 31, 2020 December 31, 2019 ROU Assets: Operating $ 885,882 $ 1,043,537 Financing 826,243 958,590 Total ROU assets $ 1,712,125 $ 2,002,127 Liabilities Current: Operating $ 947,610 $ 1,017,414 Finance 517,042 579,030 Noncurrent: Operating 392,106 547,225 Finance 212,798 313,263 Total lease liabilities $ 2,069,556 $ 2,456,932 Maturities of lease liabilities as of March 31, 2020 by fiscal year are as follows: Maturity of Lease Liabilities Operating Finance Total 2020 $ 856,889 $ 452,206 $ 1,309,095 2021 547,019 281,914 828,933 2022 40,930 45,374 86,304 2023 — 3,364 3,364 2024 — 280 280 Thereafter — — — Total lease payments 1,444,838 783,138 2,227,976 Less: Interest (105,122 ) (53,298 ) (158,420 ) Present value of lease liabilities $ 1,339,716 $ 729,840 $ 2,069,556 Statement of operations classification of lease costs as of the three months ended March 31, 2020, and 2019 are as follows: Lease Cost Classification 2020 2019 Operating Operating expenses $ 214,336 $ 220,922 Finance: Amortization Operating expenses 132,348 97,193 Interest expense Other expenses 18,470 22,480 Total lease costs $ 365,154 $ 340,595 Other lease information as of March 31, 2020 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 1.5 Finance leases 1.4 Weighted average discount rate: Operating leases 10.0 % Finance leases 9.4 % Supplemental cash flow information as of the three months ended March 31, 2020, and 2019 is as follows: Supplemental Cash Flow Information 2020 2019 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 214,336 $ 214,622 Finance leases $ 18,470 $ 22,480 Cash used in financing activities Finance leases $ 162,455 $ 116,538 ROU assets obtained in exchange for lease obligations: Finance leases $ — $ 224,716 |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 3 Months Ended |
Mar. 31, 2020 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 11 – License agreements, research collaborations and development agreements 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. The Company is working together with DOH’s Wadsworth Center and ILÚM to develop 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. During the three months ended March 31, 2020 and 2019, the Company recognized $250,000 and $500,000 of revenue related to the contract, respectively. The Company is a party to one license agreement to acquire certain patent rights and technologies related to its FISH product line. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. The Company recognized net royalty expense of $62,500 for each of the three months ended March 31, 2020 and 2019. Annual future minimum royalty fees are $250,000 under this agreement. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 12 – Related party transactions In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp. (“MSD”), a wholly-owned subsidiary of Merck, and an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, MSD provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. MSD gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $171,646 of procurement costs which have been recognized as research and development expense. The Company did not recognize any research and development expense related to the agreement in the three months ended March 31, 2020 and 2019. |
Interim Facility
Interim Facility | 3 Months Ended |
Mar. 31, 2020 | |
Interim Facility | |
Interim Facility | Note 13 – Interim Facility On September 4, 2019, OpGen entered into the Implementation Agreement. Under the Implementation Agreement, OpGen agreed to purchase, through Crystal GmbH, all of the outstanding shares and acquire all of the related business assets of Curetis GmbH to create a combined business within OpGen. The Implementation Agreement required OpGen to enter into an interim facility with Curetis GmbH to support Curetis GmbH’s operations prior to the closing of the transaction under the Implementation Agreement. On November 12, 2019, Crystal GmbH, OpGen’s subsidiary, as Lender, and Curetis GmbH, as Borrower, entered into the Interim Facility Agreement. The Interim Facility was amended and restated by the parties on March 18, 2020, or the Interim Facility. Under the Interim Facility, the Lender has lent to the Borrower committed capital of $4.7 million between November 18, 2019 and the closing of the transaction. The purpose of the loans was to provide capital to fund the operations of Curetis GmbH, including the discharge of current liabilities when due. Each loan under the Interim Facility bears interest at 10% per annum and is due to be repaid on the first anniversary of the loan. The Interim Facility loans are subordinated to the current and future indebtedness of the Borrower. As of March 31, 2020, Curetis GmbH had borrowed approximately $4.7 million, and OpGen had recognized approximately $109,000 of interest income under the Interim Facility including approximately $87,000 during the three months ended March 31, 2020. On April 1, 2020, the Company completed the transaction with Curetis N.V. and acquired all of the assets and liabilities of Curetis GmbH (see Note 1). The Company will include the Interim Facility in the consideration transferred in the business combination and will account for the Interim Facility under ASC 805 as part of the opening balance sheet and purchase price allocation. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14– Subsequent Events On April 1, 2020, the Company completed the transaction with Curetis N.V. and acquired all of the assets and liabilities of Curetis GmbH (see Note 1). Subsequent to March 31, 2020, the Company sold 358,452 shares of its common stock under the 2020 ATM Offering resulting in aggregate net proceeds to the Company of approximately $942,000, and gross proceeds of $974,000. On April 22, 2020, OpGen, Inc. (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 are dated April 22, 2020. The principal amount of the Company Note is $879,630, and the principal amount of the Subsidiary Note is $259,353. In accordance with the requirements of the CARES Act, the Borrowers will use the proceeds from the Notes in accordance with the requirements of the PPP to cover certain qualified expenses, including payroll costs, rent and utility costs. Interest accrues on the Notes at the rate of 1.00% per annum. The Borrowers may apply for forgiveness of amount 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 eight weeks following disbursement under the Notes. The Borrowers intend to use the entire proceeds under the Notes for such qualifying expenses. Subject to any forgiveness under the PPP, the Notes mature two years following the date of issuance of the Notes and includes a period for the first six months during which time required payments of interest and principal are deferred. Beginning on the seventh month following the date of the Notes, the Borrowers are required to make 18 monthly payments of principal and interest. The Notes may be prepaid at any time prior to maturity with no prepayment penalties. The Notes provide for customary events of default, including, among others, those relating to breaches of their obligations under the Notes, including a failure to make payments, any bankruptcy or similar proceedings involving the Borrowers, and certain material effects on the Borrowers’ ability to repay the Notes. The Borrowers did not provide any collateral or guarantees for the Notes. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
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 following 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, 2019 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 March 31, 2020 and excludes the Curetis Business which was acquired on April 1, 2020; all intercompany transactions and balances have been eliminated. |
Foreign currency | Foreign currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both 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 (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at March 31, 2020 and 2019. 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, 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, 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, cash equivalents and restricted cash | Cash, 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 government agency (“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 March 31, 2020 and December 31, 2019, the Company has funds totaling $185,380, 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, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: March 31, 2020 December 31, 2019 March 31, 2019 December 31, 2018 Cash and cash equivalents $ 11,469,455 $ 2,708,223 $ 6,011,508 $ 4,572,487 Restricted cash 185,380 185,380 185,380 164,720 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 11,654,835 $ 2,893,603 $ 6,196,888 $ 4,737,207 |
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 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 as of March 31, 2020 and December 31, 2019. At March 31, 2020, the Company had accounts receivable from one customer which individually represented 31% of total accounts receivable. At March 31, 2019, one individual customer represented 61% of total accounts receivable. For the three months ended March 31, 2020, revenue earned from one customer represented 41% of total revenues. For the three months ended March 31, 2019, revenue earned from one customer represented 49% of total revenues. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: March 31, 2020 December 31, 2019 Raw materials and supplies $ 266,444 $ 315,542 Work-in-process 22,291 35,080 Finished goods 147,948 122,408 Total $ 436,683 $ 473,030 Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $132,260 and $92,454 at March 31, 2020 and December 31, 2019, respectively. |
Property and equipment | 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 months ended March 31, 2020 and 2019, the Company determined that its property and equipment was not impaired. |
Leases | Leases The Company determines if an arrangement is a lease at inception. For leases where the Company is the lessee, right-of-use (“ROU”) assets represent the Company’s right to use the underlying asset for the term of the lease and the lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date of the underlying lease arrangement to determine the present value of lease payments. The ROU asset also includes any prepaid lease payments and any lease incentives received. The lease term to calculate the ROU asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company’s lease agreements generally do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense while expense for financing leases is recognized as depreciation expense and interest expense using the accelerated 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. In conjunction with adoption of Accounting Standards Update (“ASU”) 2016-02, Leases |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of March 31, 2020 consist of finite-lived intangible assets and goodwill. Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Cost Accumulated Amortization Impairment Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 (217,413 ) $ (243,587 ) $ — $ (205,887 ) $ 255,113 Developed technology 458,000 (308,526 ) (149,474 ) — (292,170 ) 165,830 Customer relationships 1,094,000 (736,465 ) (357,535 ) — (697,393 ) 396,607 $ 2,013,000 (1,262,404 ) $ (750,596 ) $ — $ (1,195,450 ) $ 817,550 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. 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 $66,954 for each of the three months ended March 31, 2020 and 2019. Finite-lived 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 in a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) 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 March 31, 2020 and December 31, 2019 was $600,814. 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 months ended March 31, 2020 and 2019, the Company determined that its goodwill was not impaired. |
Revenue recognition | Revenue recognition The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. 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. |
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 $ 188,282,298 |
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 1.1 million shares and 0.2 million shares as of March 31, 2020 and 2019, respectively. |
Accounting pronouncements adopted and recently issued | Adopted accounting pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients: · The Company did not reassess if any expired or existing contracts are or contain leases. · The Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing 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. Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease right of use asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million. Prior to the adoption of ASC 842, deferred rent was recorded and amortized to the extent the total minimum rental payments allocated to the period on a straight-line basis exceeded or were less than the cash payments required. The Company adopted Accounting Standards Update 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments Recently issued accounting standards The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: March 31, 2020 December 31, 2019 March 31, 2019 December 31, 2018 Cash and cash equivalents $ 11,469,455 $ 2,708,223 $ 6,011,508 $ 4,572,487 Restricted cash 185,380 185,380 185,380 164,720 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 11,654,835 $ 2,893,603 $ 6,196,888 $ 4,737,207 |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: March 31, 2020 December 31, 2019 Raw materials and supplies $ 266,444 $ 315,542 Work-in-process 22,291 35,080 Finished goods 147,948 122,408 Total $ 436,683 $ 473,030 |
Schedule of Finite-Lived Intangible Assets | Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Cost Accumulated Amortization Impairment Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 (217,413 ) $ (243,587 ) $ — $ (205,887 ) $ 255,113 Developed technology 458,000 (308,526 ) (149,474 ) — (292,170 ) 165,830 Customer relationships 1,094,000 (736,465 ) (357,535 ) — (697,393 ) 396,607 $ 2,013,000 (1,262,404 ) $ (750,596 ) $ — $ (1,195,450 ) $ 817,550 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenues by Type of Service | The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Three Months Ended March 31, 2020 2019 Product sales $ 366,933 $ 520,177 Collaboration revenue 250,000 500,000 Total revenue $ 616,933 $ 1,020,177 |
Summary of Changes in Deferred Revenue | Changes in deferred revenue for the period were as follows: Balance at December 31, 2019 $ 9,808 Revenue recognized in the current period from the amounts in the beginning balance — New deferrals, net of amounts recognized in the current period — Balance at March 31, 2020 $ 9,808 |
Stockholders' equity (deficit)
Stockholders' equity (deficit) (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Company Recognized Stock-Based Compensation Expense | For the three months ended March 31, 2020 and 2019, the Company recognized share-based compensation expense as follows: Three Months Ended March 31, 2020 2019 Cost of services $ 728 $ 38 Research and development 13,986 17,127 General and administrative 61,488 76,013 Sales and marketing 3,538 4,855 $ 79,740 $ 98,033 |
Schedule of Warrants to Purchase Shares of Common Stock | At March 31, 2020 and December 31, 2019, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration March 31, 2020 December 31, 2019 January 2010 $ 3,955.00 January 2020 — 17 March 2010 $ 3,955.00 March 2020 — 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 February 2015 $ 3,300.00 February 2025 451 451 May 2015 $ 3,300.00 May 2020 6,697 6,697 May 2016 $ 656.20 May 2021 9,483 9,483 June 2016 $ 656.20 May 2021 4,102 4,102 June 2017 $ 390.00 June 2022 938 938 July 2017 $ 345.00 July 2022 318 318 July 2017 $ 250.00 July 2022 2,501 2,501 July 2017 $ 212.60 July 2022 50,006 50,006 February 2018 $ 81.25 February 2023 9,232 9,232 February 2018 $ 65.00 February 2023 92,338 92,338 October 2019 $ 2.00 October 2024 629,000 4,700,000 October 2019 $ 2.60 October 2024 235,000 235,000 1,040,083 5,111,107 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Schedule of ROU Assets and Lease Liabilities | The following table presents the Company’s ROU assets and lease liabilities as of March 31, 2020 and December 31, 2019: Lease Classification March 31, 2020 December 31, 2019 ROU Assets: Operating $ 885,882 $ 1,043,537 Financing 826,243 958,590 Total ROU assets $ 1,712,125 $ 2,002,127 Liabilities Current: Operating $ 947,610 $ 1,017,414 Finance 517,042 579,030 Noncurrent: Operating 392,106 547,225 Finance 212,798 313,263 Total lease liabilities $ 2,069,556 $ 2,456,932 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of March 31, 2020 by fiscal year are as follows: Maturity of Lease Liabilities Operating Finance Total 2020 $ 856,889 $ 452,206 $ 1,309,095 2021 547,019 281,914 828,933 2022 40,930 45,374 86,304 2023 — 3,364 3,364 2024 — 280 280 Thereafter — — — Total lease payments 1,444,838 783,138 2,227,976 Less: Interest (105,122 ) (53,298 ) (158,420 ) Present value of lease liabilities $ 1,339,716 $ 729,840 $ 2,069,556 |
Schedule of Statement of Operations Classification of Lease Costs and Other Information | Statement of operations classification of lease costs as of the three months ended March 31, 2020, and 2019 are as follows: Lease Cost Classification 2020 2019 Operating Operating expenses $ 214,336 $ 220,922 Finance: Amortization Operating expenses 132,348 97,193 Interest expense Other expenses 18,470 22,480 Total lease costs $ 365,154 $ 340,595 Other lease information as of March 31, 2020 is as follows: Other Information Total Weighted average remaining lease term (in years) Operating leases 1.5 Finance leases 1.4 Weighted average discount rate: Operating leases 10.0 % Finance leases 9.4 % |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information as of the three months ended March 31, 2020, and 2019 is as follows: Supplemental Cash Flow Information 2020 2019 Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 214,336 $ 214,622 Finance leases $ 18,470 $ 22,480 Cash used in financing activities Finance leases $ 162,455 $ 116,538 ROU assets obtained in exchange for lease obligations: Finance leases $ — $ 224,716 |
Organization (Details)
Organization (Details) | May 08, 2020shares | Apr. 02, 2020USD ($)$ / sharesshares | Mar. 31, 2020USD ($)Segment |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Number of operating business segment | Segment | 1 | ||
Annual healthcare costs | $ | $ 10,000,000,000 | ||
Stock split | Following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, 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 shares. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock split. | ||
Common Stock [Member] | Implementation Agreement [Member] | Curetis GmbH [Member] | Subsequent Event [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Shares of common stock issuable for consideration | 2,028,208 | ||
Share price of shares issued | $ / shares | $ 0.01 | ||
Shares issue under conversion feature | 265,002 | 500,000 | |
Principal and indebtedness conversion amount | $ | $ 543,000 | ||
Percentage of outstanding stock | 13.80% | ||
Common Stock [Member] | Implementation Agreement [Member] | Curetis GmbH [Member] | Subsequent Event [Member] | 2016 Stock Option Plan [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Shares reserved for future issuance | 134,356 |
Liquidity and Management's Pl_2
Liquidity and Management's Plans (Details) - USD ($) | Mar. 29, 2019 | Mar. 31, 2020 | Oct. 28, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | Feb. 11, 2020 |
Conversion of Stock [Line Items] | ||||||
Net proceeds from sale of common stock and warrants | $ 0 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,477,432 | $ 4,782,509 | ||||
October 2019 Public Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 2,590,170 | |||||
Shares issued, price per share | $ 2 | |||||
Each unit includes number of common shares apart from warrants | 1 | |||||
Each unit includes number of common stock warrants apart from common stock | 1 | |||||
Each prefunded unit included number prefunded warrants apart from common stock warrants | 1 | |||||
Each prefunded unit included number common stock warrants apart from prefunded warrants | 1 | |||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. | |||||
Class of warrant or right, exercise price of warrants or rights | $ 2 | |||||
Warrants exercisable period | 5 years | |||||
Pre-funded Units [Member] | October 2019 Public Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 2,109,830 | |||||
Shares issued, price per share | $ 1.99 | |||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | |||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | |||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | |||||
Warrants exercised | 2,109,830 | |||||
Common Stock [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 2,814,934 | |||||
Common Stock [Member] | October 2019 Public Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,100,000 | |||||
Common Stock [Member] | March 2019 Public Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 450,000 | |||||
Shares issued, price per share | $ 12 | |||||
Gross proceeds from sale of common stock | $ 5,400,000 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,800,000 | |||||
Common Stock [Member] | 2020 ATM Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 358,452 | |||||
Gross proceeds from sale of common stock | $ 974,000 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 942,000 | |||||
Common Warrants [Member] | October 2019 Public Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Warrants exercised | 4,071,000 | |||||
H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Common shares available for future issuance amount | $ 15,700,000 | |||||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | 2020 ATM Offering [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 2,814,934 | |||||
Gross proceeds from sale of common stock | $ 5,800,000 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,500,000 | |||||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | 2020 ATM Offering [Member] | Maximum [Member] | ||||||
Conversion of Stock [Line Items] | ||||||
Common shares available for future issuance amount | $ 15,700,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Jan. 02, 2019 | |
Significant Accounting Policies [Line Items] | ||||
FDIC limit of insurable cash | $ 250,000 | |||
Letters of credit outstanding, amount | 185,380 | $ 185,380 | ||
Allowance for doubtful accounts receivable | 20,753 | 20,753 | ||
Inventory valuation reserves | 132,260 | 92,454 | ||
Amortization of intangible assets | 66,954 | $ 66,954 | ||
Impairment of finite-lived intangible assets | 750,596 | |||
Goodwill | 600,814 | 600,814 | ||
Finite-lived intangible assets, fair value | $ 0 | |||
Antidilutive securities excluded from computation of earnings per share, amount | 1,100,000 | 200,000 | ||
Operating lease right of use asset | $ 885,882 | 1,043,537 | $ 2,200,000 | |
Operating lease liability | $ 1,339,716 | $ 2,500,000 | ||
Minimum [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Accounts receivable period due | 30 days | |||
Maximum [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Accounts receivable period due | 60 days | |||
Trademarks And Trade Names [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Finite-lived intangible asset, useful life | 10 years | |||
Impairment of finite-lived intangible assets | $ 243,587 | |||
Developed Technology [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Finite-lived intangible asset, useful life | 7 years | |||
Impairment of finite-lived intangible assets | $ 149,474 | |||
Customer Relationships [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Finite-lived intangible asset, useful life | 7 years | |||
Impairment of finite-lived intangible assets | $ 357,535 | |||
Domestic Country [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Operating loss carryforwards | $ 188,282,298 | |||
Operating loss carryforwards, expiration terms | begin to expire in 2022 | |||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk, percentage | 31.00% | 61.00% | ||
Customer One [Member] | Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Concentration risk, percentage | 41.00% | 49.00% | ||
ASU 2016-02 [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Impairment charge | $ 520,759 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Reconciliation of Cash Equivalents and Restricted Cash) (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 11,469,455 | $ 2,708,223 | $ 6,011,508 | $ 4,572,487 |
Restricted cash | 185,380 | 185,380 | 185,380 | 164,720 |
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows | $ 11,654,835 | $ 2,893,603 | $ 6,196,888 | $ 4,737,207 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Inventories) (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Inventories | ||
Raw materials and supplies | $ 266,444 | $ 315,542 |
Work-in-process | 22,291 | 35,080 |
Finished goods | 147,948 | 122,408 |
Total | $ 436,683 | $ 473,030 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Schedule of Finite-Lived Intangible Assets) (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (1,262,404) | (1,195,450) |
Impairment | (750,596) | |
Net Balance | 817,550 | |
Trademarks And Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (217,413) | (205,887) |
Impairment | (243,587) | |
Net Balance | 255,113 | |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (308,526) | (292,170) |
Impairment | (149,474) | |
Net Balance | 165,830 | |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (736,465) | (697,393) |
Impairment | (357,535) | |
Net Balance | $ 396,607 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Schedule of Revenues by Type of Service) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 616,933 | $ 1,020,177 |
Product sales [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 366,933 | 520,177 |
Collaborations Revenue [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 250,000 | $ 500,000 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers (Summary of Changes in Deferred Revenue) (Details) | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Balance at December 31, 2019 | $ 9,808 |
Revenue recognized in the current period from the amounts in the beginning balance | |
New deferrals, net of amounts recognized in the current period | |
Balance at March 31, 2020 | $ 9,808 |
MGHIF financing (Details)
MGHIF financing (Details) - USD ($) | Jul. 14, 2018 | Jun. 11, 2018 | Jul. 30, 2018 | Jun. 28, 2017 | Jul. 31, 2015 | Mar. 31, 2020 | Mar. 31, 2019 |
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,477,432 | $ 4,782,509 | |||||
MGHIF Financing Agreement [Member] | |||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 2,273 | ||||||
Shares issued, price per share | $ 2,200 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | ||||||
Debt instrument, interest rate, stated percentage | 8.00% | ||||||
Debt instrument, face amount | $ 1,000,000 | ||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Accrued and unpaid interest | $ 285,512 | ||||||
Revised and extended the maturity date, payment terms | Six semi-annual payments | ||||||
Annual payments plus accrued and unpaid interest | $ 166,667 | ||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||
Unamortized debt issuance costs | $ 7,000 | ||||||
Amended and Restated MGHIF Financing Agreement [Member] | |||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||
Issuance of common stock warrants to purchase | 656 | ||||||
Net of discounts and financing costs | $ 497,000 | ||||||
Common Stock [Member] | |||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 2,814,934 | ||||||
Private Placement [Member] | Common Stock [Member] | MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||
Common Stock And Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 7,212 | ||||||
Accrued and unpaid interest | $ 285,512 | ||||||
Accrued and unpaid interest due date | Jul. 14, 2018 |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Fair Value on Recurring Basis [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial liabilities measured at fair value | $ 0 | $ 0 |
Fair Value on Non-Recurring Basis [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Impairment of non-financial assets and liabilities at fair value | $ 750,596 |
Debt (Details)
Debt (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||
Short-term debt | $ 348,494 | $ 373,599 | |
Interest expense, debt | 38,267 | $ 56,444 | |
Due in 2020 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, annual principal payment | 333,000 | ||
Due in 2021 [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, annual principal payment | 333,000 | ||
Notes Payable, Other Payables [Member] | |||
Debt Instrument [Line Items] | |||
Short-term debt | 15,000 | 40,000 | |
MGHIF Financing Agreement [Member] | |||
Debt Instrument [Line Items] | |||
Short-term debt | 333,000 | 333,000 | |
Long-term debt, outstanding | $ 163,000 | $ 329,000 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||||||
Mar. 31, 2020 | Mar. 29, 2020 | Oct. 28, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | Feb. 11, 2020 | Dec. 31, 2019 | Jan. 17, 2018 | Jan. 16, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | ||||
Common stock, shares issued | 12,468,214 | 12,468,214 | 5,582,280 | ||||||
Common stock, shares outstanding | 12,468,214 | 12,468,214 | 5,582,280 | ||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,477,432 | $ 4,782,509 | |||||||
Net proceeds from sale of common stock and warrants | $ 0 | ||||||||
Stock split | Following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, 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 shares. All share amounts and per share prices in this Quarterly Report have been adjusted to reflect the reverse stock split. | ||||||||
Stock options, forfeited | 28 | ||||||||
Stock options, outstanding | 9,396 | 9,396 | |||||||
Stock options, expired | 230 | ||||||||
Restricted Stock Units [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period | 200 | ||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding | 14,775 | 14,775 | |||||||
2015 Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 54,200 | 54,200 | |||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 229,533 | 229,533 | |||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares added | 223,291 | ||||||||
H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Common shares available for future issuance amount | $ 15,700,000 | ||||||||
Common Stock [Member] | 2020 ATM Offering [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock issued during period, shares, new issues | 358,452 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 942,000 | ||||||||
Gross proceeds from sale of common stock | $ 974,000 | ||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | 2020 ATM Offering [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock issued during period, shares, new issues | 2,814,934 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,500,000 | ||||||||
Gross proceeds from sale of common stock | 5,800,000 | ||||||||
Remaining availability under market offering | $ 9,900,000 | ||||||||
March 2019 Public Offering [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock issued during period, shares, new issues | 450,000 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,800,000 | ||||||||
Gross proceeds from sale of common stock | $ 5,400,000 | ||||||||
Shares issued, price per share | $ 12 | ||||||||
October 2019 Public Offering [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock issued during period, shares, new issues | 2,590,170 | ||||||||
Shares issued, price per share | $ 2 | ||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $2.00 per share. | ||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2 | ||||||||
Warrants exercisable period | 5 years | ||||||||
October 2019 Public Offering [Member] | Common Warrants [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Warrants exercised | 4,071,000 | ||||||||
October 2019 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2.60 | ||||||||
Warrants exercisable period | 5 years | ||||||||
Issuance of common stock warrants to purchase | 235,000 | ||||||||
October 2019 Public Offering [Member] | Pre-funded Units [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock issued during period, shares, new issues | 2,109,830 | ||||||||
Shares issued, price per share | $ 1.99 | ||||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||
Warrants exercised | 2,109,830 | ||||||||
October 2019 Public Offering [Member] | Pre Funded Warrant [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Warrants exercised | 2,109,830 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) (Company Recognized Stock-Based Compensation Expense) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 79,740 | $ 98,033 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 728 | 38 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 13,986 | 17,127 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 61,488 | 76,013 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 3,538 | $ 4,855 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) (Warrants to Purchase Shares of Common Stock) (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 1,040,083 | 5,111,107 |
January 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,955 | |
Expiration | 2020-01 | |
Shares of Common Stock Subject to Warrants | 17 | |
March 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,955 | |
Expiration | 2020-03 | |
Shares of Common Stock Subject to Warrants | 7 | |
November 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,955 | |
Expiration | 2021-11 | |
Shares of Common Stock Subject to Warrants | 15 | 15 |
December 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,955 | |
Expiration | 2021-12 | |
Shares of Common Stock Subject to Warrants | 2 | 2 |
February 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,300 | |
Expiration | 2025-02 | |
Shares of Common Stock Subject to Warrants | 451 | 451 |
May 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,300 | |
Expiration | 2020-05 | |
Shares of Common Stock Subject to Warrants | 6,697 | 6,697 |
May 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 656.20 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 9,483 | 9,483 |
June 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 656.20 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 4,102 | 4,102 |
June 2017 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 390 | |
Expiration | 2022-06 | |
Shares of Common Stock Subject to Warrants | 938 | 938 |
July 2017 [Member] | Warrants Exercise Price One [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 345 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 318 | 318 |
July 2017 [Member] | Warrants Exercise Price Two [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 250 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 2,501 | 2,501 |
July 2017 [Member] | Warrants Exercise Price Three [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 212.60 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 50,006 | 50,006 |
February 2018 [Member] | Warrants Exercise Price Four [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 81.20 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 9,232 | 9,232 |
February 2018 [Member] | Warrants Exercise Price Five [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 65 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 92,338 | 92,338 |
October 2019 [Member] | Warrants Exercise Price Six [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 2 | |
Expiration | 2024-10 | |
Shares of Common Stock Subject to Warrants | 629,000 | 4,700,000 |
October 2019 [Member] | Warrants Exercise Price Seven [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 2.60 | |
Expiration | 2024-10 | |
Shares of Common Stock Subject to Warrants | 235,000 | 235,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 3 Months Ended |
Mar. 31, 2020Product | |
Life Technologies Corporation Supply Agreement [Member] | Quant Studio Five Real Time P C R Systems [Member] | |
Other Commitments [Line Items] | |
Number of products acquired | 24 |
Leases (Schedule of ROU Assets
Leases (Schedule of ROU Assets and Lease Liabilities) (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | Jan. 02, 2019 |
ROU Assets: | |||
Operating | $ 885,882 | $ 1,043,537 | $ 2,200,000 |
Financing | 826,243 | 958,590 | |
Total ROU assets | 1,712,125 | 2,002,127 | |
Current: | |||
Operating | 947,610 | 1,017,414 | |
Finance | 517,042 | 579,030 | |
Noncurrent: | |||
Operating | 392,106 | 547,225 | |
Finance | 212,798 | 313,263 | |
Total lease liabilities | $ 2,069,556 | $ 2,456,932 |
Leases (Schedule of Maturities
Leases (Schedule of Maturities of Lease Liabilities) (Details) - USD ($) | Mar. 31, 2020 | Jan. 02, 2019 |
Operating | ||
2020 | $ 856,889 | |
2021 | 547,019 | |
2022 | 40,930 | |
2023 | ||
2024 | ||
Thereafter | ||
Total lease payments | 1,444,838 | |
Less: Interest | (105,122) | |
Present value of lease liabilities | 1,339,716 | $ 2,500,000 |
Finance | ||
2020 | 452,206 | |
2021 | 281,914 | |
2022 | 45,374 | |
2023 | 3,364 | |
2024 | 280 | |
Thereafter | ||
Total lease payments | 783,138 | |
Less: Interest | (53,298) | |
Present value of lease liabilities | 729,840 | |
Total | ||
2020 | 1,309,095 | |
2021 | 828,933 | |
2022 | 86,304 | |
2023 | 3,364 | |
2024 | 280 | |
Thereafter | ||
Total lease payments | 2,227,976 | |
Less: Interest | (158,420) | |
Present value of lease liabilities | $ 2,069,556 |
Leases (Schedule of Statement o
Leases (Schedule of Statement of Operations Classification of Lease Costs) (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Lease Cost | ||
Total lease costs | $ 365,154 | $ 340,595 |
Operating Expense [Member] | ||
Lease Cost | ||
Operating | 214,336 | 220,922 |
Amortization | 132,348 | 97,193 |
Other Expense [Member] | ||
Lease Cost | ||
Interest expense | $ 18,470 | $ 22,480 |
Leases (Schedule of Other Infor
Leases (Schedule of Other Information) (Details) | Mar. 31, 2020 |
Weighted average remaining lease term (in years) | |
Operating leases | 1 year 6 months |
Finance leases | 1 year 4 months 24 days |
Weighted average discount rate: | |
Operating leases | 10.00% |
Finance leases | 9.40% |
Leases (Schedule of Supplementa
Leases (Schedule of Supplemental Cash Flow Information) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash used in operating activities | ||
Operating leases | $ 214,336 | $ 214,622 |
Finance leases | 18,470 | 22,480 |
Cash used in financing activities | ||
Finance leases | 162,453 | 116,538 |
ROU assets obtained in exchange for lease obligations | ||
Finance leases | $ 224,716 |
License Agreements, Research _2
License Agreements, Research Collaborations and Development Agreements (Details) | 3 Months Ended | |
Mar. 31, 2020USD ($)Agreement | Mar. 31, 2019USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Revenue from contract | $ 616,933 | $ 1,020,177 |
Royalty expense | 62,500 | 62,500 |
Annual future minimum royalty payments due | 250,000 | |
Collaborations Revenue [Member] | ||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Revenue from contract | $ 250,000 | 500,000 |
FISH Product Line [Member] | ||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Number of license agreements | Agreement | 1 | |
New York State Department of Health and ILUM Health Solutions, LLC [Member] | ||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Collaboration revenue receivable over 12 months of the project | $ 1,600,000 | |
Contractual agreement period | 15 months | |
New York State Department of Health and ILUM Health Solutions, LLC [Member] | Collaborations Revenue [Member] | ||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Revenue from contract | $ 250,000 | $ 500,000 |
Related Party Transactions (Det
Related Party Transactions (Details) - Merck Sharp & Dohme Corp [Member] - USD ($) | 3 Months Ended | 41 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2020 | Oct. 31, 2016 | |
Related Party Transaction [Line Items] | |||
Research and development agreement description | Under the agreement, MSD provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. MSD gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. | ||
Maximum required amount to expend for procurement of materials | $ 175,000 | ||
Research and Development [Member] | |||
Related Party Transaction [Line Items] | |||
Procurement costs recognized | $ 171,646 |
Interim Facility (Details)
Interim Facility (Details) - USD ($) | Nov. 12, 2019 | Mar. 31, 2020 | Dec. 31, 2019 |
Interim Facility [Line Items] | |||
Interim facility borrowed | $ 4,808,712 | $ 2,521,479 | |
Interim Facility [Member] | |||
Interim Facility [Line Items] | |||
Interest income recognized | 109,000 | ||
Curetis GmbH [Member] | Interim Facility [Member] | |||
Interim Facility [Line Items] | |||
Maximum committed capital lending capacity | $ 4,700,000 | ||
Interest rate | 10.00% | ||
Interim facility borrowed | 4,700,000 | ||
Interest income recognized | $ 87,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Apr. 22, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | |
Subsequent Event [Line Items] | |||
Proceeds from issuance of common stock, net of issuance costs | $ 5,477,432 | $ 4,782,509 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Interest accrues on notes | 1.00% | ||
Note term | 18 months | ||
Subsequent Event [Member] | Term Note [Member] | |||
Subsequent Event [Line Items] | |||
Principal amount note | $ 879,630 | ||
Subsequent Event [Member] | Term Note [Member] | Subsidiaries Note [Member] | |||
Subsequent Event [Line Items] | |||
Principal amount note | $ 259,353 | ||
2020 ATM Offering [Member] | Common Stock [Member] | |||
Subsequent Event [Line Items] | |||
Stock issued during period, shares, new issues | 358,452 | ||
Proceeds from issuance of common stock, net of issuance costs | $ 942,000 | ||
Gross proceeds from sale of common stock | $ 974,000 |