Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 20, 2020 | Jun. 30, 2019 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | OPGEN INC | ||
Entity Central Index Key | 0001293818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 6,934,767 | ||
Entity Common Stock, Shares Outstanding | 11,930,236 | ||
Entity Interactive Data Current | Yes | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 06-1614015 | ||
Entity File Number | 001-37367 | ||
Entity Address, Address Line One | 708 Quince Orchard Road | ||
Entity Address, Address Line Two | Suite 205 | ||
Entity Address, City or Town | Gaithersburg | ||
Entity Address, State or Province | MD | ||
Entity Address, Postal Zip Code | 20878 | ||
City Area Code | 240 | ||
Local Phone Number | 813-1260 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE None. | ||
Common Stock [Member] | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | OPGN | ||
Security Exchange Name | NASDAQ | ||
Common Warrants [Member] | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Common Warrants | ||
Trading Symbol | OPGNW | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 2,708,223 | $ 4,572,487 |
Accounts receivable, net | 567,811 | 373,858 |
Inventory, net | 473,030 | 543,747 |
Note receivable | 2,521,479 | 0 |
Prepaid expenses and other current assets | 396,760 | 292,918 |
Total current assets | 6,667,303 | 5,783,010 |
Property and equipment, net | 130,759 | 1,221,827 |
Finance lease right-of-use assets, net | 958,590 | 0 |
Operating lease right-of-use assets | 1,043,537 | 0 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 817,550 | 1,085,366 |
Other noncurrent assets | 203,271 | 259,346 |
Total assets | 10,421,824 | 8,950,363 |
Current liabilities | ||
Accounts payable | 1,056,035 | 1,623,751 |
Accrued compensation and benefits | 855,994 | 1,041,573 |
Accrued liabilities | 1,046,661 | 902,019 |
Deferred revenue | 9,808 | 15,824 |
Short-term notes payable | 373,599 | 398,595 |
Short-term finance lease liabilities | 579,030 | 399,345 |
Short-term operating lease liabilities | 1,017,414 | 0 |
Total current liabilities | 4,938,541 | 4,381,107 |
Deferred rent | 0 | 162,919 |
Note payable | 329,456 | 660,340 |
Warrant liability | 0 | 67 |
Long-term finance lease liabilities | 313,263 | 437,189 |
Long-term operating lease liabilities | 547,225 | 0 |
Total liabilities | 6,128,485 | 5,641,622 |
Commitments (Note 9) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 0 | 0 |
Common stock, $0.01 par value; 50,000,000 shares authorized; 5,582,280 and 432,286 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 55,823 | 4,323 |
Additional paid-in capital | 178,779,814 | 165,396,036 |
Accumulated deficit | (174,524,983) | (162,078,525) |
Accumulated other comprehensive loss | (17,315) | (13,093) |
Total stockholders’ equity | 4,293,339 | 3,308,741 |
Total liabilities and stockholders’ equity | $ 10,421,824 | $ 8,950,363 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
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 | 5,582,280 | 432,286 |
Common stock, shares outstanding | 5,582,280 | 432,286 |
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 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | ||
Total revenue | $ 3,498,614 | $ 2,946,307 |
Operating expenses | ||
Research and development | 5,121,168 | 5,677,243 |
General and administrative | 6,252,442 | 7,069,315 |
Sales and marketing | 1,464,721 | 1,531,556 |
Transaction costs | 779,048 | 0 |
Impairment of right-of-use asset | 520,759 | 0 |
Total operating expenses | 15,769,859 | 16,126,549 |
Operating loss | (12,271,245) | (13,180,242) |
Other (expense) income | ||
Interest and other income, net | 9,859 | 5,384 |
Interest expense | (187,549) | (191,195) |
Foreign currency transaction gains/(losses) | 2,410 | (10,431) |
Change in fair value of derivative financial instruments | 67 | 8,386 |
Total other expense | (175,213) | (187,856) |
Loss before income taxes | (12,446,458) | (13,368,098) |
Provision for income taxes | 0 | 0 |
Net loss | $ (12,446,458) | $ (13,368,098) |
Net loss per common share - basic and diluted | $ (7.70) | $ (44.49) |
Weighted average shares outstanding - basic and diluted | 1,616,939 | 300,453 |
Net loss | $ (12,446,458) | $ (13,368,098) |
Other comprehensive (loss)/income - foreign currency translation | (4,222) | 12,807 |
Comprehensive loss | (12,450,680) | (13,355,291) |
Product [Member] | ||
Revenue | ||
Total revenue | 2,168,179 | 2,395,626 |
Operating expenses | ||
Cost of products and services | 911,565 | 1,222,919 |
Laboratory Service Revenue [Member] | ||
Revenue | ||
Total revenue | 5,435 | 34,665 |
Collaborations Revenue [Member] | ||
Revenue | ||
Total revenue | 1,325,000 | 516,016 |
Service [Member] | ||
Operating expenses | ||
Cost of products and services | $ 720,156 | $ 625,516 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Public Offering [Member] | At the Market Offering [Member] | Common Stock [Member] | Common Stock [Member]Public Offering [Member] | Common Stock [Member]At the Market Offering [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Public Offering [Member] | Additional Paid-in Capital [Member]At the Market Offering [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2017 | $ 1,400,997 | $ 1,133 | $ 150,136,191 | $ (25,900) | $ (148,710,427) | ||||||
Balance (in shares) at Dec. 31, 2017 | 113,266 | ||||||||||
Issuance of units, net of offering costs | $ 13,530,403 | $ 597,742 | $ 2,956 | $ 159 | $ 13,527,447 | $ 597,583 | |||||
Issuance of units, net of offering costs (in shares) | 295,615 | 15,912 | |||||||||
Issuance of RSUs | $ 3 | (3) | |||||||||
Issuance of RSUs (in shares) | 283 | ||||||||||
Stock compensation expense | 862,281 | 862,281 | |||||||||
Stock cancellation (in shares) | (2) | ||||||||||
Interest settlement in common stock | 272,609 | $ 72 | 272,537 | ||||||||
Interest settlement in common stock, (in shares) | 7,212 | ||||||||||
Foreign currency translation | 12,807 | 12,807 | |||||||||
Net loss | (13,368,098) | (13,368,098) | |||||||||
Balance at Dec. 31, 2018 | 3,308,741 | $ 4,323 | 165,396,036 | (13,093) | (162,078,525) | ||||||
Balance (in shares) at Dec. 31, 2018 | 432,286 | ||||||||||
Issuance of units, net of offering costs | $ 13,062,408 | $ 51,500 | $ 13,010,908 | ||||||||
Issuance of units, net of offering costs (in shares) | 5,150,000 | ||||||||||
Issuance of RSUs (in shares) | 12 | ||||||||||
Stock compensation expense | 372,870 | 372,870 | |||||||||
Stock cancellation (in shares) | (18) | ||||||||||
Foreign currency translation | (4,222) | (4,222) | |||||||||
Net loss | (12,446,458) | (12,446,458) | |||||||||
Balance at Dec. 31, 2019 | $ 4,293,339 | $ 55,823 | $ 178,779,814 | $ (17,315) | $ (174,524,983) | ||||||
Balance (in shares) at Dec. 31, 2019 | 5,582,280 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (12,446,458) | $ (13,368,098) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 921,379 | 730,884 |
Noncash interest expense | 13,158 | 133,802 |
Noncash interest income | (21,479) | 0 |
Stock compensation expense | 372,870 | 862,281 |
Loss (gain) on sale of equipment | 9,904 | (5,253) |
Change in fair value of warrant liability | (67) | (8,386) |
Impairment of right-of-use asset | 520,759 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (195,019) | 432,814 |
Inventory | 70,286 | (11,273) |
Other assets | 577,193 | 486 |
Accounts payable | (503,516) | 89,493 |
Accrued compensation and other liabilities | (818,433) | 77,871 |
Deferred revenue | (6,016) | (8,618) |
Net cash used in operating activities | (11,505,439) | (11,073,997) |
Cash flows from investing activities | ||
Note receivable | (2,500,000) | 0 |
Purchases of property and equipment | (31,826) | (147,767) |
Proceeds from sale of equipment | 29,250 | 10,440 |
Net cash used in investing activities | (2,502,576) | (137,327) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 4,782,509 | 3,400,013 |
Proceeds from issuance of units and exercises of pre-funded warrants, net of selling costs | 8,279,899 | 10,728,131 |
Proceeds from debt, net of issuance costs | 470,519 | 381,253 |
Payments on debt | (828,850) | (371,573) |
Payments on finance lease obligations | (535,931) | (292,722) |
Net cash provided by financing activities | 12,168,146 | 13,845,102 |
Effects of exchange rates on cash | (3,735) | 12,878 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (1,843,604) | 2,646,656 |
Cash, cash equivalents and restricted cash at beginning of year | 4,737,207 | 2,090,551 |
Cash, cash equivalents and restricted cash at end of year | 2,893,603 | 4,737,207 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 187,359 | 57,393 |
Supplemental disclosures of noncash investing and financing activities: | ||
Shares issued to settle obligations | 0 | 272,610 |
Right-of-use assets acquired through finance leases | 528,413 | 706,778 |
Conversion of accounts payable to finance lease | $ 63,600 | $ 156,775 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2019 | |
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 Company’s 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. 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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) clearance submissions for additional Acuitas AMR Gene Panel tests and Acuitas Lighthouse Software, rapid technology changes, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company’s success depends, in part, on its ability to develop, obtain regulatory approval for and commercialize its proprietary technology as well as raise additional capital. 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 Annual Report have been adjusted to reflect the reverse stock splits. Implementation Agreement with Curetis N.V. As announced on September 4, 2019, OpGen has entered into an Implementation Agreement with Curetis N.V., a Dutch publicly-listed company on Euronext under ticker CURE, or the Implementation Agreement. Under the Implementation Agreement, OpGen has agreed to purchase, through Crystal GmbH, a private limited liability company organized under the laws of the Federal Republic of Germany and a wholly-owned subsidiary of OpGen, all of the outstanding shares and acquire all of the related business assets of Curetis GmbH, or Curetis, a private limited liability company organized under the laws of the Federal Republic of Germany and a wholly-owned subsidiary of Curetis N.V., to create a combined business within OpGen. Pursuant to the Implementation Agreement, OpGen has agreed to acquire (i) all of the issued and outstanding capital stock of Curetis, or the Transferred Shares, and (ii) all of the assets of Curetis N.V. that are solely and exclusively related to the business of Curetis, or the Transferred Assets. The Company will also assume all of the liabilities of Curetis N.V. that are solely and exclusively related to the business being acquired. Under the Implementation Agreement, the Company has agreed to issue, as the sole consideration, 2,662,564 shares of common stock, less the number of shares of common stock the issuance of which shall be reserved by the Company in connection with (a) its assumption of the 2016 Stock Option Plan and (b) shares of common stock reserved for future issuance upon the conversion, if any, of the Curetis Convertible Notes, or together, the Consideration. The number of shares of common stock to be reserved for the deductions described above are based on a conversion ratio of 0.0959, which is the ratio of the Consideration as contrasted with the number of ordinary shares of Curetis N.V. on a fully diluted basis. The number of shares of OpGen common stock to be issued to Curetis N.V. is fixed, therefore, the percentage ownership of the Company owned by Curetis will not be known until the closing occurs. The Company filed a Registration Statement on Form S-4 to register the Consideration which was declared effective by the U.S. Securities and Exchange Commission on January 23, 2020. The transactions under the Implementation Agreement are subject to approval by the stockholders of the Company and MGHIF, and the shareholders and debt holders of Curetis N.V and Curetis GmbH. The Company delivered a proxy statement to its stockholders and held a special meeting of its stockholders on March 10, 2020 to approve the transactions contemplated by the Implementation Agreement. Because a quorum was not represented at the special meeting, the stockholders present voted to adjourn the special meeting in order to allow additional time for stockholders to vote on the proposal. Accordingly, the special meeting was adjourned to March 30, 2020. The Implementation Agreement contains customary representations and warranties of the parties and the parties have agreed to use their commercially reasonable efforts to take all actions necessary to consummate the closing of the transactions contemplated by the Implementation Agreement. Pursuant to the Implementation Agreement, the Company committed to raise at least $10,000,000 of gross interim equity financing to support the continuing operations of both the Company and Curetis, and to lend funds to Curetis following such offering (See Note 13 – Interim Facility). The October 2019 Public Offering was such interim equity financing. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2019 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management's Plans | Note 2 - Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company to reduce costs, including: • 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 December 31, 2019, all 2,109,830 pre-funded warrants issued in the October 2019 Public Offering have been exercised. • 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. • On October 22, 2018, the Company closed a public offering (the “October 2018 Public Offering”) of 110,000 shares of its common stock at a public offering price of $29.00 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million. • On June 11, 2018, the Company executed an Allonge (the “Allonge”) to its Second Amended and Restated Senior Secured Promissory Note, dated June 28, 2017, with a principal amount of $1,000,000 issued to Merck Global Health Innovation Fund, LLC (“MGHIF”). 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. On July 30, 2018, the Company issued 7,212 shares of common stock to MGHIF in a private placement transaction for $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note. • On February 6, 2018, the Company closed a public offering (the “February 2018 Public Offering”) of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. As of April 19, 2018, all pre-funded warrants issued in the February 2018 Public Offering have been exercised. • On September 13, 2016, the Company entered into the Sales Agreement (the “Sales Agreement”) with Cowen and Company LLC (“Cowen”) pursuant to which the Company may offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. During the year ended December 31, 2018, the Company sold 15,912 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash will be sufficient to fund operations into the third 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 third 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 | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. Reclassification Certain prior period amounts in the consolidated statements of cash flows have been reclassified to conform to the current period presentation. $3.4 million was reclassified from “Proceeds from issuance of units and exercises of pre-funded warrants, net of selling costs” to “Proceeds from issuance of common stock, net of issuance costs” There is no change to consolidated operating loss, net loss or cash flows as a result of this change in classification. Foreign Currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2019 and 2018. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, 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. For additional fair value disclosures, see Note 14. Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limits 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. As of December 31, 2019 and 2018, the Company had funds totaling $185,380 and $164,720, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. Accounts Receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 and $18,332 as of December 31, 2019 and 2018, respectively. At December 31, 2019, the Company had accounts receivable from one customer which individually represented 44% of total accounts receivable. At December 31, 2018, the Company had accounts receivable from one customer which individually represented 12% of total accounts receivable. For the year ended December 31, 2019, revenue earned from one customer represented 38% of total revenues. For the year ended December 31, 2018, revenue earned from one customer represented 17% of total revenues. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2019 2018 Raw materials and supplies $ 315,542 $ 368,438 Work-in process 35,080 58,402 Finished goods 122,408 116,907 Total $ 473,030 $ 543,747 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 $92,454 and $71,270 at December 31, 2019 and 2018, respectively. Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $186,244 and $463,068 for the years ended December 31, 2019 and 2018, respectively. Property and equipment consisted of the following at December 31, 2019 and 2018: December 31, 2019 2018 Laboratory and manufacturing equipment $ 3,310,290 $ 4,829,323 Office furniture and equipment 631,774 700,299 Computers and network equipment 1,469,534 1,520,713 Leasehold improvements 745,800 745,800 6,157,398 7,796,135 Less accumulated depreciation (6,026,639 ) (6,574,308 ) Property and equipment, net $ 130,759 $ 1,221,827 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2019 and 2018, 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 December 31, 2019 and 2018 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) and 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 December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (205,887 ) $ 255,113 $ (159,783 ) $ 301,217 Developed technology 458,000 (292,170 ) 165,830 (226,746 ) 231,254 Customer relationships 1,094,000 (697,393 ) 396,607 (541,105 ) 552,895 $ 2,013,000 $ (1,195,450 ) $ 817,550 $ (927,634 ) $ 1,085,366 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 $267,816 for each of the years ended December 31, 2019 and 2018. Expected amortization of intangible assets for each of the next five fiscal years is as follows. Year Ending December 31, 2020 $ 267,816 2021 267,816 2022 165,117 2023 46,104 2024 46,104 2025 24,593 Total $ 817,550 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. During the years ended December 31, 2019 and 2018, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During 2019, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term, resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) 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 conducts an impairment test of goodwill on an annual basis as of December 31 of each year, 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. As of December 31, 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, fees paid to consultants and outside service partners. Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $188,282,298 and $178,163,456 at December 31, 2019 and 2018, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. 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 5.1 million shares and 0.2 million shares as of December 31, 2019 and 2018, respectively. Adopted accounting pronouncements On January 1, 2018, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASU 2016-18, Statement of Cash Flows: 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 consolidated statements of cash flows: December 31, 2019 December 31, 2018 December 31, 2017 Cash and cash equivalents $ 2,708,223 $ 4,572,487 $ 1,847,171 Restricted cash 185,380 164,720 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 2,893,603 $ 4,737,207 $ 2,090,551 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. Recently issued accounting standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments 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 | 12 Months Ended |
Dec. 31, 2019 | |
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: Years Ended December 31, 2019 2018 Product sales $ 2,168,179 $ 2,395,626 Laboratory services 5,435 34,665 Collaboration revenue 1,325,000 516,016 Total revenue $ 3,498,614 $ 2,946,307 Deferred Revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2018 $ 15,824 Revenue recognized in the current period from the amounts in the beginning balance (6,016 ) New deferrals, net of amounts recognized in the current period — Balance at December 31, 2019 $ 9,808 Contract Assets The Company had no contract assets as of December 31, 2019, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. Unsatisfied Performance Obligations The Company had no unsatisfied performance obligations related to its contracts with customers at December 31, 2019. |
MGHIF Financing
MGHIF Financing | 12 Months Ended |
Dec. 31, 2019 | |
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. On July 30, 2018, the 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. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 - Debt As of December 31, 2019, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as the financing arrangements for the Company’s insurance with note balances of approximately $40,000 with a final payment scheduled for May 2020. The Company’s outstanding long-term debt as of December 31, 2019 consisted of approximately $329,000 due under the MGHIF Note, net of discounts and financing costs (see Note 5 “MGHIF Financing”). As of December 31, 2018, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as the financing arrangements for the Company’s insurance with note balances of approximately $65,000. The Company’s outstanding long-term debt as of December 31, 2018 consisted of approximately $660,000 due under the MGHIF Note, net of discounts and financing costs. Total principal payments of approximately $333,000 are due annually in 2020, and 2021. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $187,549 and $191,195 for the years ended December 31, 2019 and 2018, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | Note 7 - Stockholders’ Equity As of December 31, 2019, the Company has 50,000,000 shares of authorized common shares and 5,582,280 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding. In September 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company could offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. 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 Annual Report have been adjusted to reflect the reverse stock splits. In the February 2018 Public Offering, the Company issued 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. The common warrants were exercisable immediately and have a five-year term from the date of issuance. The 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the year ended December 31, 2018. In connection with the February 2018 Public Offering, the Company issued to its placement agent warrants to purchase 9,231 shares of common stock. The warrants issued to the placement agent have an exercise price of $81.25 per share and are exercisable for five years. On October 22, 2018, the Company closed the October 2018 Public Offering of 110,000 shares of its common stock at a public offering price of $29.00 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million. 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 December 31, 2019, the 2,109,830 pre-funded warrants issued in the October 2019 Public Offering have been exercised. 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. Stock options In 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 2,710 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2019, 5,784 shares remain available for issuance under the 2015 Plan. For the years ended December 31, 2019 and 2018, the Company recognized stock compensation expense as follows: Years Ended December 31, 2019 2018 Cost of services $ 2,781 $ 964 Research and development 74,841 241,122 General and administrative 269,292 574,244 Sales and marketing 25,956 45,951 $ 372,870 $ 862,281 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position. As of December 31, 2019, the Company had unrecognized expense related to its stock options of $0.2 million, which will be recognized over a weighted average period of 1.3 years. A summary of the status of options granted is presented below as of and for the years ended December 31, 2019 and 2018: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2018 6,970 $ 623.20 8.3 $ 37,339 Granted 4,790 $ 76.80 Exercised — $ — Forfeited (941 ) $ 239.60 Expired (241 ) $ 1,122.40 Outstanding at December 31, 2018 10,578 $ 411.60 7.6 $ 522 Granted — $ — Exercised — $ — Forfeited (302 ) $ 222.17 Expired (622 ) $ 269.87 Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Vested and expected to vest 9,654 $ 418.10 8.0 $ — Exercisable at December 31, 2019 — $ — — $ — The total fair value of options vested in the years ended December 31, 2019 and 2018 was $375,789 and $930,921, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2019 2018 Annual dividend — — Expected life (in years) — 5.25 - 6.25 Risk free interest rate — 2.5 - 2.9% Expected volatility — 46.0 - 49.6% Restricted stock units A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2019 and 2018: Number of Options Weighted- Average Grant Date Fair Value Unvested at January 1, 2018 295 $ 623.20 Granted — — Vested (283 ) $ 178.60 Forfeited — — Unvested at December 31, 2018 12 $ 623.20 Granted 17,150 $ 8.77 Vested (12 ) $ 623.20 Forfeited (2,175 ) $ 8.80 Unvested at December 31, 2019 14,975 $ 8.76 As of December 31, 2019, there was approximately $96,000 of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 2.3 years. Stock purchase warrants At December 31, 2019 and 2018, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2019 (1) 2018 (1) November 2009 $ 3,955.00 November 2019 — 17 January 2010 $ 3,955.00 January 2020 17 17 March 2010 $ 3,955.00 March 2020 7 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 March 2012 $ 54,950.00 March 2019 — 8 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 4,700,000 — October 2019 $ 2.60 October 2024 235,000 — 5,111,107 176,132 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8 - Income Taxes At December 31, 2019 and 2018, the Company had net deferred tax assets of $54,359,488 and $52,348,036, respectively, primarily consisting of NOL carryforwards, research and experimental (“R&E”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2019 and 2018 have been offset by a valuation allowance of $54,359,488 and $52,348,036, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2019 and 2018 are as follows: December 31, 2019 2018 Deferred tax assets: NOL carryforward $ 51,247,762 $ 49,480,731 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 325,571 329,796 Inventory reserve 23,213 19,068 Depreciation 1,754 — Interest expense 95,077 51,152 Accruals and other 286,692 284,662 Total deferred tax assets 54,539,548 52,724,888 Valuation allowance (54,359,488 ) (52,348,036 ) Deferred tax liabilities: Intangible assets (180,060 ) (256,011 ) Depreciation — (120,841 ) Net $ — $ — The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2019 2018 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment (1.9 )% (1.4 )% Provision to return adjustment 0.4 % (0.2 )% State income tax benefit, net of Federal benefit 4.4 % (6.4 )% Tax reform impact — — Change in valuation allowance (23.9 )% (13.0 )% Change in state tax rates and other — — 0.0 % 0.0 % The Company has federal NOL carryforwards of $188,282,298 and $178,163,456 at December 31, 2019 and 2018, respectively. The NOL carryforwards incurred prior to 2018 begin to expire in 2022. Under the Tax Cuts and Jobs Act (the “Tax Act”), the amount of post 2017 NOLs that we are permitted to deduct in any taxable year is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself. In addition, the Tax Act generally eliminates the ability to carry back any NOL to prior taxable years, while allowing post 2017 unused NOLs to be carried forward indefinitely. Utilization of the NOL carryforward may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code. There can be no assurance that the NOL carryforward will ever be fully utilized. To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Code of 1986, as amended. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. In December 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act"), most of the provisions of which took effect starting in 2018. The Tax Act made broad and complex changes to the U.S. tax code, including, but not limited to: (i) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) creating a new limitation on deductible interest expense; and (iv) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017; and (v) changing the U.S. federal taxation of earnings of foreign subsidiaries. The U.S. change in federal taxation for foreign subsidiary earnings included a one-time toll charge on deemed repatriated earnings of foreign subsidiaries as of December 31, 2017. As a result of the accumulated losses in the Company’s foreign subsidiary, the Company had no toll tax liability for the tax year ended December 31, 2017. For 2018, the Company considered in its estimated annual effective tax rate additional provisions of Tax Reform including changes to the deduction for interest expense pursuant to IRC Section 163(j) interest limitation. As a result, the most significant impact on the Company’s consolidated financial statements was the reduction of approximately $14.6 million of the deferred tax assets related to net operating losses and other deferred tax assets. Such reduction is offset by a change in the Company’s valuation allowance. Additionally, the Company has foreign subsidiaries. At December 31, 2017 and November 2, 2017, the cumulative earnings and profits of these entities were negative. Accordingly, the Company was not liable for the transition tax on foreign earnings enacted under the Tax Act. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | Note 9 - Commitments Registration and other stockholder rights In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock. Supply In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”) to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2019, the Company has acquired twenty-four QuantStudio 5s including nine during the year ended December 31, 2019. As of December 31, 2019, the Company has not committed to acquiring additional QuantStudio 5s in the next three months. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Note 10 – Leases The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2019: Lease Classification December 31, 2019 ROU Assets: Operating $ 1,043,537 Financing 958,590 Total ROU assets $ 2,002,127 Liabilities Current: Operating $ 1,017,414 Finance 579,030 Noncurrent: Operating 547,225 Finance 313,263 Total lease liabilities $ 2,456,932 Maturities of lease liabilities as of December 31, 2019 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2020 $ 1,128,294 $ 633,130 $ 1,761,424 2021 536,819 281,914 818,733 2022 40,080 45,374 85,454 2023 — 3,364 3,364 2024 — 280 280 Total lease payments 1,705,193 964,062 2,669,255 Less: imputed interest (140,554 ) (71,769 ) (212,323 ) Present value of lease liabilities $ 1,564,639 $ 892,293 $ 2,456,932 Consolidated statement of operations classifications of lease costs are as follows: Year ended Lease Cost Classification December 31, 2019 Operating Operating expenses $ 869,968 Finance: Amortization Operating expenses 467,319 Interest expense Other expenses 75,018 Total lease costs $ 1,412,305 Other Information Total Weighted average remaining lease term (in years) Operating leases 1.7 Finance leases 1.6 Weighted average discount rate: Operating leases 10.0 % Finance leases 9.3 % Supplemental Cash Flow Information Total Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 869,968 Finance leases $ 75,018 Cash used in financing activities Finance leases $ 535,931 ROU assets obtained in exchange for lease obligations: Finance leases $ 592,014 Lease Commitments as of December 31, 2018 Minimum lease payments for future years as of December 31, 2018 were as follows: Year ending December 31, Total 2019 $ 1,615,679 2020 1,534,204 2021 639,829 2022 40,080 2023 and thereafter — Total $ 3,829,792 |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 2019 | |
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 will receive $1.6 million over the 15 month demonstration portion of the project. The demonstration project began in early 2019. During the year ended December 31, 2019, the Company recognized $1.3 million of revenue related to the contract. 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. Certain of the agreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized net royalty expense of $250,000 for each of the years ending December 31, 2019 and 2018. Annual future minimum royalty fees are $250,000 under these agreements. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
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, a wholly-owned subsidiary of Merck Co. & Inc. (“Merck”), an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, Merck 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. Merck 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, including $0 and $22,603 during the years ended December 31, 2019 and 2018. In December 2017, we entered into a subcontractor agreement with ILÚM Health Solutions, LLC, an entity created by Merck’s Healthcare Services and Solutions division, whereby ILÚM Health Solutions provided services to the Company in the performance of the Company’s CDC contract to deploy ILÚM’s commercially-available cloud- and mobile-based software platform for infectious disease management in up to three medical sites in Colombia with the aim of improving antibiotic use in resource-limited settings. During the years ended December 31, 2019 and 2018, the Company recognized $0 and $329,162 of cost of services expense related to the contract, respectively. |
Interim Facility
Interim Facility | 12 Months Ended |
Dec. 31, 2019 | |
Interim Facility [Abstract] | |
Interim Facility | Note 13 – Interim Facility On September 4, 2019, OpGen entered into the Implementation Agreement. Under the Implementation Agreement, OpGen has 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. On November 12, 2019, Crystal GmbH, OpGen’s subsidiary, as Lender, and Curetis GmbH, as Borrower, entered into the Interim Facility Agreement, or the Interim Facility. Under the Interim Facility, the Lender shall lend to the Borrower, for the benefit of Curetis, committed capital, up to $4 million, between November 18, 2019 and the closing of the transaction. The purpose of the loans is to provide capital to fund the operations of Curetis, 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 loans will be subject to mandatory pre-payment if the Implementation Agreement is terminated and the transaction abandoned. The Interim Facility loans are deeply subordinated to the current and future indebtedness of the Borrower. As of the year ended December 31, 2019, Curetis GmbH had borrowed approximately $2.5 million and OpGen had recognized approximately $23,000 of interest income under the Interim Facility. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 14 - 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. 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 Company originally accounted for the conversion option embedded in the Bridge Financing Notes as a mark-to-market derivative financial instrument. The Company determined the fair value of the embedded conversion option liability using a probability-weighted expected return method. Using this method, level 3 unobservable inputs include the probability of default, the probability of a qualified financing, the probability of conversion, the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates, among other inputs. The fair value of the conversion option was expensed at the time of repayment of the Bridge Financing Notes. The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2019: Description Balance at December 31, 2018 Change in Fair Value Balance at December 2019 Warrant liability $ 67 $ (67 ) $ - 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. No such fair value impairment was recognized in the year ended December 31, 2019. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 15 – Subsequent Events On February 11, 2020, the Company entered into an At the Market Common Stock Sales Agreement (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”). Pursuant to the ATM Agreement, Wainwright may sell the shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act, including, without limitation, sales made by means of ordinary brokers' transactions on The NASDAQ Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company. Wainwright will use commercially reasonable efforts to sell the shares from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Wainwright a commission equal to three percent (3.0%) of the gross sales proceeds of any shares sold through Wainwright in the 2020 ATM Offering, and has provided Wainwright with customary indemnification and contribution rights. As of March 20, 2020, the Company has sold an aggregate of 2,383,528 shares of its common stock under ATM Agreement resulting in aggregate net proceeds to the Company of approximately $4.4 million, and gross proceeds of $4.5 million. Subsequent to December 31, 2019, the Company issued 4,071,000 shares of common stock pursuant to the exercise of outstanding warrants sold in the October 2019 Public Offering for gross proceeds of approximately $8.1 million. As of March 20, 2019, 629,000 common warrants related to the October 2019 Public Offering remain outstanding. On March 18, 2020, the Company’s subsidiary, Crystal GmbH, as lender, and Curetis GmbH, as borrower and Curetis N.V. entered into an Amended and Restated Interim Facility Agreement, pursuant to which the parties amended and restated the Interim Facility Agreement and increased the available borrowing by the borrower to $5 million. Subsequent to December 31, 2019, the lender had provided an additional of borrowings to Curetis under the Interim Facility 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 23, 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. |
Reclassification | Reclassification Certain prior period amounts in the consolidated statements of cash flows have been reclassified to conform to the current period presentation. $3.4 million was reclassified from “Proceeds from issuance of units and exercises of pre-funded warrants, net of selling costs” to “Proceeds from issuance of common stock, net of issuance costs” There is no change to consolidated operating loss, net loss or cash flows as a result of this change in classification. |
Foreign Currency | Foreign Currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2019 and 2018. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, 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. For additional fair value disclosures, see Note 14. |
Cash and cash equivalents and restricted cash | Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limits 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. As of December 31, 2019 and 2018, the Company had funds totaling $185,380 and $164,720, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. |
Accounts Receivable | Accounts Receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $20,753 and $18,332 as of December 31, 2019 and 2018, respectively. At December 31, 2019, the Company had accounts receivable from one customer which individually represented 44% of total accounts receivable. At December 31, 2018, the Company had accounts receivable from one customer which individually represented 12% of total accounts receivable. For the year ended December 31, 2019, revenue earned from one customer represented 38% of total revenues. For the year ended December 31, 2018, revenue earned from one customer represented 17% of total revenues. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2019 2018 Raw materials and supplies $ 315,542 $ 368,438 Work-in process 35,080 58,402 Finished goods 122,408 116,907 Total $ 473,030 $ 543,747 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 $92,454 and $71,270 at December 31, 2019 and 2018, respectively. |
Property and equipment | Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $186,244 and $463,068 for the years ended December 31, 2019 and 2018, respectively. Property and equipment consisted of the following at December 31, 2019 and 2018: December 31, 2019 2018 Laboratory and manufacturing equipment $ 3,310,290 $ 4,829,323 Office furniture and equipment 631,774 700,299 Computers and network equipment 1,469,534 1,520,713 Leasehold improvements 745,800 745,800 6,157,398 7,796,135 Less accumulated depreciation (6,026,639 ) (6,574,308 ) Property and equipment, net $ 130,759 $ 1,221,827 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2019 and 2018, 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 December 31, 2019 and 2018 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) and 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 December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (205,887 ) $ 255,113 $ (159,783 ) $ 301,217 Developed technology 458,000 (292,170 ) 165,830 (226,746 ) 231,254 Customer relationships 1,094,000 (697,393 ) 396,607 (541,105 ) 552,895 $ 2,013,000 $ (1,195,450 ) $ 817,550 $ (927,634 ) $ 1,085,366 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 $267,816 for each of the years ended December 31, 2019 and 2018. Expected amortization of intangible assets for each of the next five fiscal years is as follows. Year Ending December 31, 2020 $ 267,816 2021 267,816 2022 165,117 2023 46,104 2024 46,104 2025 24,593 Total $ 817,550 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. During the years ended December 31, 2019 and 2018, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During 2019, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term, resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) 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 conducts an impairment test of goodwill on an annual basis as of December 31 of each year, 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. As of December 31, 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, fees paid to consultants and outside service partners. |
Stock-based compensation | Stock-based compensation Stock-based compensation expense is recognized at fair value. The fair value of stock-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $188,282,298 and $178,163,456 at December 31, 2019 and 2018, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. |
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 5.1 million shares and 0.2 million shares as of December 31, 2019 and 2018, respectively. |
Accounting pronouncements adopted and recently issued | Adopted accounting pronouncements On January 1, 2018, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASU 2016-18, Statement of Cash Flows: 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 consolidated statements of cash flows: December 31, 2019 December 31, 2018 December 31, 2017 Cash and cash equivalents $ 2,708,223 $ 4,572,487 $ 1,847,171 Restricted cash 185,380 164,720 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 2,893,603 $ 4,737,207 $ 2,090,551 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. Recently issued accounting standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2019 2018 Raw materials and supplies $ 315,542 $ 368,438 Work-in process 35,080 58,402 Finished goods 122,408 116,907 Total $ 473,030 $ 543,747 |
Property, Plant and Equipment | Property and equipment consisted of the following at December 31, 2019 and 2018: December 31, 2019 2018 Laboratory and manufacturing equipment $ 3,310,290 $ 4,829,323 Office furniture and equipment 631,774 700,299 Computers and network equipment 1,469,534 1,520,713 Leasehold improvements 745,800 745,800 6,157,398 7,796,135 Less accumulated depreciation (6,026,639 ) (6,574,308 ) Property and equipment, net $ 130,759 $ 1,221,827 |
Schedule of Finite-Lived Intangible Assets | Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (205,887 ) $ 255,113 $ (159,783 ) $ 301,217 Developed technology 458,000 (292,170 ) 165,830 (226,746 ) 231,254 Customer relationships 1,094,000 (697,393 ) 396,607 (541,105 ) 552,895 $ 2,013,000 $ (1,195,450 ) $ 817,550 $ (927,634 ) $ 1,085,366 |
Schedule of Expected Amortization of Intangible Assets | Expected amortization of intangible assets for each of the next five fiscal years is as follows. Year Ending December 31, 2020 $ 267,816 2021 267,816 2022 165,117 2023 46,104 2024 46,104 2025 24,593 Total $ 817,550 |
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 consolidated statements of cash flows: December 31, 2019 December 31, 2018 December 31, 2017 Cash and cash equivalents $ 2,708,223 $ 4,572,487 $ 1,847,171 Restricted cash 185,380 164,720 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 2,893,603 $ 4,737,207 $ 2,090,551 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Revenues by Type of Service | The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers. The revenues by type of service consist of the following: Years Ended December 31, 2019 2018 Product sales $ 2,168,179 $ 2,395,626 Laboratory services 5,435 34,665 Collaboration revenue 1,325,000 516,016 Total revenue $ 3,498,614 $ 2,946,307 |
Summary of Changes in Deferred Revenue | Changes in deferred revenue for the period were as follows: Balance at December 31, 2018 $ 15,824 Revenue recognized in the current period from the amounts in the beginning balance (6,016 ) New deferrals, net of amounts recognized in the current period — Balance at December 31, 2019 $ 9,808 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders Equity Note [Abstract] | |
Schedule of Company Recognized Stock Compensation Expense | For the years ended December 31, 2019 and 2018, the Company recognized stock compensation expense as follows: Years Ended December 31, 2019 2018 Cost of services $ 2,781 $ 964 Research and development 74,841 241,122 General and administrative 269,292 574,244 Sales and marketing 25,956 45,951 $ 372,870 $ 862,281 |
Summary of Status of Options Granted | A summary of the status of options granted is presented below as of and for the years ended December 31, 2019 and 2018: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2018 6,970 $ 623.20 8.3 $ 37,339 Granted 4,790 $ 76.80 Exercised — $ — Forfeited (941 ) $ 239.60 Expired (241 ) $ 1,122.40 Outstanding at December 31, 2018 10,578 $ 411.60 7.6 $ 522 Granted — $ — Exercised — $ — Forfeited (302 ) $ 222.17 Expired (622 ) $ 269.87 Outstanding at December 31, 2019 9,654 $ 418.10 8.0 $ — Vested and expected to vest 9,654 $ 418.10 8.0 $ — Exercisable at December 31, 2019 — $ — — $ — |
Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model | The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Years Ended December 31, 2019 2018 Annual dividend — — Expected life (in years) — 5.25 - 6.25 Risk free interest rate — 2.5 - 2.9% Expected volatility — 46.0 - 49.6% |
Summary of Status of Restricted Stock Unit Granted | A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2019 and 2018: Number of Options Weighted- Average Grant Date Fair Value Unvested at January 1, 2018 295 $ 623.20 Granted — — Vested (283 ) $ 178.60 Forfeited — — Unvested at December 31, 2018 12 $ 623.20 Granted 17,150 $ 8.77 Vested (12 ) $ 623.20 Forfeited (2,175 ) $ 8.80 Unvested at December 31, 2019 14,975 $ 8.76 |
Schedule of Warrants to Purchase Shares of Common Stock | At December 31, 2019 and 2018, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2019 (1) 2018 (1) November 2009 $ 3,955.00 November 2019 — 17 January 2010 $ 3,955.00 January 2020 17 17 March 2010 $ 3,955.00 March 2020 7 7 November 2011 $ 3,955.00 November 2021 15 15 December 2011 $ 3,955.00 December 2021 2 2 March 2012 $ 54,950.00 March 2019 — 8 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 4,700,000 — October 2019 $ 2.60 October 2024 235,000 — 5,111,107 176,132 (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on August 22, 2019 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Deferred Tax Assets and Liabilities | The Company’s deferred tax assets and liabilities as of December 31, 2019 and 2018 are as follows: December 31, 2019 2018 Deferred tax assets: NOL carryforward $ 51,247,762 $ 49,480,731 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 325,571 329,796 Inventory reserve 23,213 19,068 Depreciation 1,754 — Interest expense 95,077 51,152 Accruals and other 286,692 284,662 Total deferred tax assets 54,539,548 52,724,888 Valuation allowance (54,359,488 ) (52,348,036 ) Deferred tax liabilities: Intangible assets (180,060 ) (256,011 ) Depreciation — (120,841 ) Net $ — $ — |
Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) | The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2019 2018 Federal income tax benefit at statutory rates 21.0 % 21.0 % Permanent adjustment (1.9 )% (1.4 )% Provision to return adjustment 0.4 % (0.2 )% State income tax benefit, net of Federal benefit 4.4 % (6.4 )% Tax reform impact — — Change in valuation allowance (23.9 )% (13.0 )% Change in state tax rates and other — — 0.0 % 0.0 % |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of ROU Assets and Lease Liabilities | The following table presents the Company’s ROU assets and lease liabilities as of December 31, 2019: Lease Classification December 31, 2019 ROU Assets: Operating $ 1,043,537 Financing 958,590 Total ROU assets $ 2,002,127 Liabilities Current: Operating $ 1,017,414 Finance 579,030 Noncurrent: Operating 547,225 Finance 313,263 Total lease liabilities $ 2,456,932 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of December 31, 2019 by year are as follows: Maturity of Lease Liabilities Operating Finance Total 2020 $ 1,128,294 $ 633,130 $ 1,761,424 2021 536,819 281,914 818,733 2022 40,080 45,374 85,454 2023 — 3,364 3,364 2024 — 280 280 Total lease payments 1,705,193 964,062 2,669,255 Less: imputed interest (140,554 ) (71,769 ) (212,323 ) Present value of lease liabilities $ 1,564,639 $ 892,293 $ 2,456,932 |
Schedule of Consolidated Statement of Operations Classifications of Lease Costs and Other Information | Consolidated statement of operations classifications of lease costs are as follows: Year ended Lease Cost Classification December 31, 2019 Operating Operating expenses $ 869,968 Finance: Amortization Operating expenses 467,319 Interest expense Other expenses 75,018 Total lease costs $ 1,412,305 Other Information Total Weighted average remaining lease term (in years) Operating leases 1.7 Finance leases 1.6 Weighted average discount rate: Operating leases 10.0 % Finance leases 9.3 % |
Schedule of Supplemental Cash Flow Information | Supplemental Cash Flow Information Total Cash paid for amounts included in the measurement of lease liabilities Cash used in operating activities Operating leases $ 869,968 Finance leases $ 75,018 Cash used in financing activities Finance leases $ 535,931 ROU assets obtained in exchange for lease obligations: Finance leases $ 592,014 |
Schedule of Future Minimum Lease Payments | Minimum lease payments for future years as of December 31, 2018 were as follows: Year ending December 31, Total 2019 $ 1,615,679 2020 1,534,204 2021 639,829 2022 40,080 2023 and thereafter — Total $ 3,829,792 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2019: Description Balance at December 31, 2018 Change in Fair Value Balance at December 2019 Warrant liability $ 67 $ (67 ) $ - |
Organization - Additional Infor
Organization - Additional Information (Details) | Sep. 04, 2019USD ($)shares | Aug. 22, 2019 | Jan. 17, 2018shares | Dec. 31, 2019Segmentshares | Dec. 31, 2018shares | Jan. 16, 2018shares |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Number of operating business segment | Segment | 1 | |||||
Stock split | 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 Annual Report have been adjusted to reflect the reverse stock splits. | |||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | ||
Reverse stock split conversion ratio | 0.05 | 0.04 | ||||
Implementation Agreement [Member] | Curetis N.V. [Member] | Curetis GmbH [Member] | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Common stock conversion ratio for consideration on diluted basis reserved for future issuance | 0.0959 | |||||
Implementation Agreement [Member] | Curetis N.V. [Member] | Curetis GmbH [Member] | Common Stock [Member] | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Shares of common stock issuable for consideration | 2,662,564 | |||||
Implementation Agreement [Member] | Minimum [Member] | Curetis N.V. [Member] | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Amount of interim equity financing | $ | $ 10,000,000 |
Going Concern and Management'_2
Going Concern and Management's Plans - Additional Information (Details) - USD ($) | Oct. 28, 2019 | Mar. 29, 2019 | Oct. 22, 2018 | Jul. 30, 2018 | Jul. 14, 2018 | Jun. 11, 2018 | Feb. 06, 2018 | Jul. 31, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 13, 2016 |
Conversion Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,782,509 | $ 3,400,013 | |||||||||
MGHIF Financing Agreement [Member] | |||||||||||
Conversion Of Stock [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 | ||||||||||
Aggregate principal amount | $ 1,000,000 | ||||||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Aggregate principal amount | $ 1,000,000 | ||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||
Revised and extended maturity date for payment, terms | Six semi-annual payments | ||||||||||
Principal payments includes accrued and unpaid interest | $ 166,667 | ||||||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||||||
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 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||||
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 | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 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 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,300,000 | ||||||||||
October 2019 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,109,830 | ||||||||||
Shares issued, price per share | $ 1.99 | ||||||||||
October 2019 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 1 | ||||||||||
Warrants exercised | 2,109,830 | 2,109,830 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||
October 2019 Public Offering [Member] | Pre-funded Common Stock Warrants [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 1 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 2 | ||||||||||
March 2019 Public Offering [Member] | Common Stock [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 | ||||||||||
October 2018 Public Offering [Member] | Common Stock [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 110,000 | ||||||||||
Shares issued, price per share | $ 29 | ||||||||||
Gross proceeds from sale of common stock | $ 3,200,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,800,000 | ||||||||||
Private Placement [Member] | Common Stock [Member] | MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||||||
Conversion Of Stock [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 | ||||||||||
February 2018 Public Offering [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,841,152 | ||||||||||
Shares issued, price per share | $ 3.25 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 12,000,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | ||||||||||
Each unit includes number of common shares apart from warrants | 0.05 | ||||||||||
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 | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.071428571 | ||||||||||
Sale of stock, description of transaction | Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 65 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | ||||||||||
February 2018 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 851,155 | ||||||||||
Shares issued, price per share | $ 3.24 | ||||||||||
February 2018 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.05 | ||||||||||
Warrants exercised | 851,155 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.20 | ||||||||||
February 2018 Public Offering [Member] | Pre-funded Common Stock Warrants [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.071428571 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 65 | ||||||||||
At the Market Offering [Member] | Cowen and Company, LLC [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Common stock sales agreement, maximum amount to be issued | $ 25,000,000 | ||||||||||
Maximum common stock value to be issued under sale agreement initially | $ 11,500,000 | ||||||||||
At the Market Offering [Member] | Common Stock [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 15,912 | ||||||||||
At the Market Offering [Member] | Common Stock [Member] | Cowen and Company, LLC [Member] | Sales Agreement [Member] | |||||||||||
Conversion Of Stock [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 15,912 | ||||||||||
Gross proceeds from sale of common stock | $ 600,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 600,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | 12 Months Ended | ||
Dec. 31, 2019USD ($)Customershares | Dec. 31, 2018USD ($)Customershares | Jan. 01, 2019USD ($) | |
Significant Accounting Policies [Line Items] | |||
Prior period reclassification amount | $ 3,400,000 | ||
FDIC limit of insurable cash | 250,000 | ||
Collateral for letters of credit included in other noncurrent assets | 185,380 | $ 164,720 | |
Allowance for doubtful accounts receivable | $ 20,753 | $ 18,332 | |
Number of individual customers accounting for more than 10% of accounts receivable | Customer | 1 | 1 | |
Number of individual customers accounting for more than 10% of revenue | Customer | 1 | 1 | |
Inventory valuation reserves | $ 92,454 | $ 71,270 | |
Depreciation expense | 186,244 | 463,068 | |
Amortization of intangible assets | 267,816 | 267,816 | |
Impairment of finite-lived intangible assets | 0 | $ 0 | |
Impairment of goodwill | $ 0 | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 5.1 | 0.2 | |
Operating lease right-of-use assets | $ 1,043,537 | $ 0 | $ 2,200,000 |
Operating lease liability | 1,564,639 | $ 2,500,000 | |
Domestic Country [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 188,282,298 | $ 178,163,456 | |
Operating loss carryforwards, expiration terms | begin to expire in 2022 | ||
Trademarks and Tradenames [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 10 years | ||
Developed Technology [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 7 years | ||
Customer Relationships [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 7 years | ||
ASU 2016-02 [Member] | |||
Significant Accounting Policies [Line Items] | |||
Impairment charge | $ 520,759 | ||
Accounts Receivable [Member] | Customer One [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 44.00% | 12.00% | |
Sales Revenue, Net [Member] | Customer One [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 38.00% | 17.00% | |
Minimum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 30 days | ||
Estimated useful lives of related assets | 3 years | ||
Fair value assumptions, expected term | 5 years 3 months | ||
Minimum [Member] | Options [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 6 years 3 months | ||
Maximum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 60 days | ||
Estimated useful lives of related assets | 5 years | ||
Fair value assumptions, expected term | 6 years 3 months | ||
Maximum [Member] | Options [Member] | |||
Significant Accounting Policies [Line Items] | |||
Fair value assumptions, expected term | 10 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Inventories | ||
Raw materials and supplies | $ 315,542 | $ 368,438 |
Work-in process | 35,080 | 58,402 |
Finished goods | 122,408 | 116,907 |
Total | $ 473,030 | $ 543,747 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 6,157,398 | $ 7,796,135 |
Less accumulated depreciation | (6,026,639) | (6,574,308) |
Property and equipment, net | 130,759 | 1,221,827 |
Laboratory and Manufacturing Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 3,310,290 | 4,829,323 |
Office Furniture and Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 631,774 | 700,299 |
Computers and Network Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 1,469,534 | 1,520,713 |
Leasehold Improvements [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 745,800 | $ 745,800 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (1,195,450) | (927,634) |
Net Balance | 817,550 | 1,085,366 |
Trademarks and Tradenames [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (205,887) | (159,783) |
Net Balance | 255,113 | 301,217 |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (292,170) | (226,746) |
Net Balance | 165,830 | 231,254 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (697,393) | (541,105) |
Net Balance | $ 396,607 | $ 552,895 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Expected Amortization of Intangible Assets (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
2020 | $ 267,816 | |
2021 | 267,816 | |
2022 | 165,117 | |
2023 | 46,104 | |
2024 | 46,104 | |
2025 | 24,593 | |
Net Balance | $ 817,550 | $ 1,085,366 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash Cash Equivalents and Restricted Cash (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 2,708,223 | $ 4,572,487 | $ 1,847,171 |
Restricted cash | 185,380 | 164,720 | 243,380 |
Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows | $ 2,893,603 | $ 4,737,207 | $ 2,090,551 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Revenues by Type of Service (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 3,498,614 | $ 2,946,307 |
Product [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 2,168,179 | 2,395,626 |
Laboratory Services [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 5,435 | 34,665 |
Collaboration Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 1,325,000 | $ 516,016 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Summary of Changes in Deferred Revenue (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Revenue Recognition And Deferred Revenue [Abstract] | |
Balance at December 31, 2018 | $ 15,824 |
Revenue recognized in the current period from the amounts in the beginning balance | (6,016) |
Balance at December 31, 2019 | $ 9,808 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) | Dec. 31, 2019USD ($) |
Revenue From Contract With Customer [Abstract] | |
Contract with customers, asset | $ 0 |
Unsatisfied performance obligations related to contracts with customers | $ 0 |
MGHIF Financing - Additional In
MGHIF Financing - Additional Information (Details) - USD ($) | Jul. 30, 2018 | Jul. 14, 2018 | Jun. 11, 2018 | Jun. 28, 2017 | Jul. 31, 2015 | Dec. 31, 2019 | Dec. 31, 2018 |
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,782,509 | $ 3,400,013 | |||||
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, term | 2 years | ||||||
Debt instrument, face amount | $ 1,000,000 | ||||||
Unamortized debt issuance costs | $ 7,000 | ||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Debt instrument, face amount | $ 1,000,000 | ||||||
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 | ||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | Common Stock [Member] | Private Placement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 7,212 | ||||||
Accrued and unpaid interest | $ 285,512 | ||||||
Stock issued during period, accrued and unpaid interest due | $ 285,512 | ||||||
Accrued and unpaid interest due date | Jul. 14, 2018 | ||||||
Amended and Restated MGHIF Financing Agreement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||
Issuance of common stock warrants to purchase | 656 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Short-term debt | $ 373,599 | $ 398,595 |
Interest expense, debt | 187,549 | 191,195 |
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 | |
MGHIF Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | 333,000 | 333,000 |
Long-term debt, outstanding | 329,000 | 660,000 |
Notes Payable, Other Payables [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | $ 40,000 | $ 65,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | Oct. 28, 2019USD ($)$ / sharesshares | Aug. 22, 2019 | Mar. 29, 2019USD ($)$ / sharesshares | Oct. 22, 2018USD ($)$ / sharesshares | Feb. 06, 2018USD ($)$ / sharesshares | Jan. 17, 2018shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Jan. 16, 2018shares | Sep. 13, 2016USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | ||||||
Common stock, shares issued | 5,582,280 | 432,286 | ||||||||
Common stock, shares outstanding | 5,582,280 | 432,286 | ||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, shares issued | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 4,782,509 | $ 3,400,013 | ||||||||
Stock split | 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 Annual Report have been adjusted to reflect the reverse stock splits. | |||||||||
Reverse stock split conversion ratio | 0.05 | 0.04 | ||||||||
Share-based compensation, tax benefit from compensation expense | $ | $ 0 | |||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ | $ 200,000 | |||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 1 year 3 months 18 days | |||||||||
Share-based compensation arrangement by share-based payment award, options, vested in period, fair value | $ | $ 375,789 | $ 930,921 | ||||||||
Restricted Stock Units [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 2 years 3 months 18 days | |||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ | $ 96,000 | |||||||||
2015 Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 2,710 | |||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | |||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 5,784 | |||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | |||||||||
At the Market Offering [Member] | Cowen and Company, LLC [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common stock sales agreement, maximum amount to be issued | $ | $ 25,000,000 | |||||||||
Maximum common stock value to be issued under sale agreement initially | $ | $ 11,500,000 | |||||||||
At the Market Offering [Member] | Common Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 15,912 | |||||||||
At the Market Offering [Member] | Common Stock [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 15,912 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 600,000 | |||||||||
Gross proceeds from sale of common stock | $ | $ 600,000 | |||||||||
February 2018 Public Offering [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 2,841,152 | |||||||||
Shares issued, price per share | $ / shares | $ 3.25 | |||||||||
Gross proceeds from sale of common stock and warrants | $ | $ 12,000,000 | |||||||||
Net proceeds from sale of common stock and warrants | $ | $ 10,700,000 | |||||||||
Sale of stock, description of transaction | Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. | |||||||||
Each unit includes number of common shares apart from warrants | 0.05 | |||||||||
Each unit includes number of common stock warrants apart from common stock | 1 | |||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.071428571 | |||||||||
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 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 65 | |||||||||
Warrants exercisable period | 5 years | |||||||||
February 2018 Public Offering [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 | $ / shares | $ 81.25 | |||||||||
Warrants exercisable period | 5 years | |||||||||
February 2018 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Issuance of common stock warrants to purchase | 9,231 | |||||||||
February 2018 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 | 851,155 | |||||||||
Shares issued, price per share | $ / shares | $ 3.24 | |||||||||
February 2018 Public Offering [Member] | Pre-funded Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.05 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.20 | |||||||||
Warrants exercised | 851,155 | |||||||||
February 2018 Public Offering [Member] | Pre-funded Common Stock Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.071428571 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 65 | |||||||||
October 2018 Public Offering [Member] | Common Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 110,000 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 2,800,000 | |||||||||
Gross proceeds from sale of common stock | $ | $ 3,200,000 | |||||||||
Shares issued, price per share | $ / shares | $ 29 | |||||||||
March 2019 Public Offering [Member] | Common Stock [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 | $ / shares | $ 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 | $ / shares | $ 2 | |||||||||
Gross proceeds from sale of common stock and warrants | $ | $ 9,400,000 | |||||||||
Net proceeds from sale of common stock and warrants | $ | $ 8,300,000 | |||||||||
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 | |||||||||
Each unit includes number of common shares apart from warrants | 1 | |||||||||
Each unit includes number of common stock warrants apart from common stock | 1 | |||||||||
Class of warrant or right, number of securities called by each warrant or right | 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 | |||||||||
Warrants exercisable period | 5 years | |||||||||
October 2019 Public Offering [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 | $ / shares | $ 2.60 | |||||||||
Warrants exercisable period | 5 years | |||||||||
October 2019 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
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 | $ / shares | $ 1.99 | |||||||||
October 2019 Public Offering [Member] | Pre-funded Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 1 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.01 | |||||||||
Warrants exercised | 2,109,830 | 2,109,830 | ||||||||
October 2019 Public Offering [Member] | Pre-funded Common Stock Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 1 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 2 |
Stockholders' Equity - Company
Stockholders' Equity - Company Recognized Stock Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 372,870 | $ 862,281 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 2,781 | 964 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 74,841 | 241,122 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 269,292 | 574,244 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 25,956 | $ 45,951 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Status of Options Granted (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders Equity Note [Abstract] | |||
Number of Options, Outstanding Balance | 10,578 | 6,970 | |
Number of Options, Granted | 0 | 4,790 | |
Number of Options, Exercised | 0 | 0 | |
Number of Options, Forfeited | (302) | (941) | |
Number of Options, Expired | (622) | (241) | |
Number of Options, Outstanding Balance | 9,654 | 10,578 | 6,970 |
Number of Options, Vested and expected to vest | 9,654 | ||
Number of Options, Exercisable | 0 | ||
Weighted Average Exercise Price, Outstanding Balance | $ 411.60 | $ 623.20 | |
Weighted Average Exercise Price, Granted | 0 | 76.80 | |
Weighted Average Exercise Price, Exercised | 0 | 0 | |
Weighted Average Exercise Price, Forfeited | 222.17 | 239.60 | |
Weighted Average Exercise Price, Expired | 269.87 | 1,122.40 | |
Weighted Average Exercise Price, Outstanding Balance | 418.10 | $ 411.60 | $ 623.20 |
Weighted Average Exercise Price, Vested and expected to vest | 418.10 | ||
Weighted Average Exercise Price, Exercisable | $ 0 | ||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 8 years | 7 years 7 months 6 days | 8 years 3 months 18 days |
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 8 years | ||
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 0 years | ||
Aggregate Intrinsic Value, Outstanding | $ 522 | $ 37,339 | |
Aggregate Intrinsic Value, Outstanding | 0 | $ 522 | $ 37,339 |
Aggregate Intrinsic Value, Vested and expected to vest | 0 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | 0.00% | 0.00% |
Risk free interest rate, minimum | 2.50% | |
Risk free interest rate, maximum | 2.90% | |
Expected volatility, minimum | 46.00% | |
Expected volatility, maximum | 49.60% | |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 3 months | |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 3 months |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Status of Restricted Stock Unit Granted (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | ||
Number of Options, Outstanding Balance | 12 | 295 |
Number of Options, Granted | 17,150 | 0 |
Number of Options, Vested | (12) | (283) |
Number of Options, Forfeited | (2,175) | 0 |
Number of Options, Outstanding Balance | 14,975 | 12 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 623.20 | $ 623.20 |
Weighted Average Grant Date Fair Value, Granted | 8.77 | 0 |
Weighted Average Grant Date Fair Value, Vested | 623.20 | 178.60 |
Weighted Average Grant Date Fair Value, Forfeited | 8.80 | 0 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 8.76 | $ 623.20 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Shares of Common Stock (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 5,111,107 | 176,132 |
November 2009 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3,955 | |
Expiration | 2019-11 | |
Shares of Common Stock Subject to Warrants | 17 | |
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 | 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 | 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 |
March 2012 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 54,950 | |
Expiration | 2019-03 | |
Shares of Common Stock Subject to Warrants | 8 | |
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] | Exercise Price 345 [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] | Exercise Price 250 [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] | Exercise Price 212.60 [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] | Exercise Price 81.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 81.25 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 9,232 | 9,232 |
February 2018 [Member] | Exercise Price 65 [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] | Exercise Price 2.00 [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 | 4,700,000 | |
October 2019 [Member] | Exercise Price 2.60 [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 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Deferred tax assets, net before valuation allowance | $ 54,359,488 | $ 52,348,036 | |
Deferred tax assets, valuation allowance | $ 54,359,488 | $ 52,348,036 | |
Maximum percentage of taxable income in which NOLs permitted to deduct | 80.00% | ||
U.S. federal corporate tax rate | 21.00% | 21.00% | |
Toll tax liability | $ 0 | ||
Reduction of deferred tax assets | $ 14,600,000 | ||
Maximum [Member] | |||
Income Tax [Line Items] | |||
U.S. federal corporate tax rate | 35.00% | ||
Domestic Country [Member] | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 188,282,298 | $ 178,163,456 | |
Operating loss carryforwards incurred prior to 2018, expiration terms | begin to expire in 2022 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
NOL carryforward | $ 51,247,762 | $ 49,480,731 |
R&E credit carryforward | 2,559,479 | 2,559,479 |
Share-based compensation | 325,571 | 329,796 |
Inventory reserve | 23,213 | 19,068 |
Depreciation | 1,754 | 0 |
Interest expense | 95,077 | 51,152 |
Accruals and other | 286,692 | 284,662 |
Total deferred tax assets | 54,539,548 | 52,724,888 |
Valuation allowance | (54,359,488) | (52,348,036) |
Deferred tax liabilities: | ||
Intangible assets | (180,060) | (256,011) |
Depreciation | 0 | (120,841) |
Net | $ 0 | $ 0 |
Income Taxes - Expected Income
Income Taxes - Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rates | 21.00% | 21.00% |
Permanent adjustment | (1.90%) | (1.40%) |
Provision to return adjustment | 0.40% | (0.20%) |
State income tax benefit, net of Federal benefit | 4.40% | (6.40%) |
Change in valuation allowance | (23.90%) | (13.00%) |
Total | 0.00% | 0.00% |
Commitments - Additional Inform
Commitments - Additional Information (Details) - QuantStudio 5 Real-Time PCR Systems [Member] - Life Technologies Corporation Supply Agreement [Member] | 12 Months Ended |
Dec. 31, 2019Product | |
Other Commitments [Line Items] | |
Number of products acquired | 24 |
Number of products acquired during period | 9 |
Leases - Schedule of ROU Assets
Leases - Schedule of ROU Assets and Lease Liabilities (Details) - USD ($) | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
ROU Assets: | |||
Operating | $ 1,043,537 | $ 2,200,000 | $ 0 |
Financing | 958,590 | 0 | |
Total ROU assets | 2,002,127 | ||
Current: | |||
Operating | 1,017,414 | 0 | |
Finance | 579,030 | 399,345 | |
Noncurrent: | |||
Operating | 547,225 | 0 | |
Finance | 313,263 | $ 437,189 | |
Total lease liabilities | $ 2,456,932 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) | Dec. 31, 2019 | Jan. 01, 2019 |
Operating | ||
2020 | $ 1,128,294 | |
2021 | 536,819 | |
2022 | 40,080 | |
Total lease payments | 1,705,193 | |
Less: imputed interest | (140,554) | |
Present value of lease liabilities | 1,564,639 | $ 2,500,000 |
Finance | ||
2020 | 633,130 | |
2021 | 281,914 | |
2022 | 45,374 | |
2023 | 3,364 | |
2024 | 280 | |
Total lease payments | 964,062 | |
Less: imputed interest | (71,769) | |
Present value of lease liabilities | 892,293 | |
Total | ||
2020 | 1,761,424 | |
2021 | 818,733 | |
2022 | 85,454 | |
2023 | 3,364 | |
2024 | 280 | |
Total lease payments | 2,669,255 | |
Less: imputed interest | (212,323) | |
Present value of lease liabilities | $ 2,456,932 |
Leases - Schedule of Consolidat
Leases - Schedule of Consolidated Statement of Operations Classifications of Lease Costs (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Lease Cost | |
Total lease costs | $ 1,412,305 |
Operating Expense [Member] | |
Lease Cost | |
Operating | 869,968 |
Amortization | 467,319 |
Other Expense [Member] | |
Lease Cost | |
Interest expense | $ 75,018 |
Leases - Schedule of Other Info
Leases - Schedule of Other Information (Details) | Dec. 31, 2019 |
Weighted average remaining lease term (in years) | |
Operating leases | 1 year 8 months 12 days |
Finance leases | 1 year 7 months 6 days |
Weighted average discount rate: | |
Operating leases | 10.00% |
Finance leases | 9.30% |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash used in operating activities | ||
Operating leases | $ 869,968 | |
Finance leases | 75,018 | |
Cash used in financing activities | ||
Finance leases | 535,931 | $ 292,722 |
ROU assets obtained in exchange for lease obligations: | ||
Finance leases | $ 592,014 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments (Details) | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 1,615,679 |
2020 | 1,534,204 |
2021 | 639,829 |
2022 | 40,080 |
Total | $ 3,829,792 |
License Agreements, Research _2
License Agreements, Research Collaborations and Development Agreements - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2019USD ($)Agreement | Dec. 31, 2018USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Revenue from contract | $ 3,498,614 | $ 2,946,307 |
Royalty expense | 250,000 | 250,000 |
Annual future minimum royalty payments due | 250,000 | |
Collaborations Revenue [Member] | ||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||
Revenue from contract | $ 1,325,000 | $ 516,016 |
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 | $ 1,300,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 12 Months Ended | 39 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2019 | Oct. 31, 2016 | |
Service [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cost of services | $ 720,156 | $ 625,516 | ||
Merck Sharp & Dohme Corp [Member] | ||||
Related Party Transaction [Line Items] | ||||
Research and development agreement description | Under the agreement, Merck 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. Merck 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 | |||
Merck Sharp & Dohme Corp [Member] | Research and Development Expense [Member] | ||||
Related Party Transaction [Line Items] | ||||
Procurement costs recognized | $ 0 | 22,603 | $ 171,646 | |
ILUM Health Solutions, LLC [Member] | Subcontractor Agreement [Member] | Service [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cost of services | $ 0 | $ 329,162 |
Interim Facility - Additional I
Interim Facility - Additional Information (Details) - USD ($) | Nov. 12, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Interim Facility [Line Items] | |||
Interim facility borrowed | $ 2,521,479 | $ 0 | |
Interim Facility [Member] | Curetis GmbH [Member] | |||
Interim Facility [Line Items] | |||
Maximum committed capital lending capacity | $ 4,000,000 | ||
Interest rate | 10.00% | ||
Interim facility borrowed | 2,500,000 | ||
Interest income recognized | $ 23,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Warrant Liability [Member] | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | $ 67 |
Change in Fair Value | (67) |
Balance at the end of the period | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Fair Value on Non-Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Financial assets measured at fair value | $ 0 |
Financial liabilities measured at fair value | 0 |
Impairment of non-financial assets and liabilities at fair value | 0 |
Fair Value on Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Non-financial assets measured at fair value | 0 |
Non-financial liabilities measured at fair value | $ 0 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | Mar. 20, 2020 | Feb. 11, 2020 | Oct. 28, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 18, 2020 | Nov. 12, 2019 |
Subsequent Event [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,782,509 | $ 3,400,013 | |||||
Curetis GmbH [Member] | Interim Facility [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Maximum committed capital lending capacity | $ 4,000,000 | ||||||
Curetis GmbH [Member] | Subsequent Event [Member] | Interim Facility [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Additional borrowing capacity, amount | $ 2,200,000 | ||||||
Maximum committed capital lending capacity | $ 5,000,000 | ||||||
2020 ATM Offering [Member] | Wainwright [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Gross proceeds from sale of common stock | 4,500,000 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,400,000 | ||||||
2020 ATM Offering [Member] | Maximum [Member] | Wainwright [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Common shares available for future issuance amount | $ 15,700,000 | ||||||
2020 ATM Offering [Member] | Common Stock [Member] | Wainwright [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Percentage of commission from gross sales proceeds of any shares sold | 3.00% | ||||||
Issuance of units, net of offering costs (in shares) | 2,383,528 | ||||||
October 2019 Public Offering [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Issuance of units, net of offering costs (in shares) | 2,590,170 | ||||||
Gross proceeds from sale of common stock and warrants | $ 9,400,000 | ||||||
October 2019 Public Offering [Member] | Forecast [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Common warrants outstanding | 629,000 | ||||||
October 2019 Public Offering [Member] | Subsequent Event [Member] | |||||||
Subsequent Event [Line Items] | |||||||
Issuance of units, net of offering costs (in shares) | 4,071,000 | ||||||
Gross proceeds from sale of common stock and warrants | $ 8,100,000 |