Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 03, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | OPGEN INC | |
Entity Central Index Key | 1,293,818 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | OPGN | |
Entity Common Stock, Shares Outstanding | 6,211,277 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 7,428,993 | $ 1,847,171 |
Accounts receivable, net | 516,472 | 809,540 |
Inventory, net | 614,423 | 533,425 |
Prepaid expenses and other current assets | 525,484 | 311,644 |
Total current assets | 9,085,372 | 3,501,780 |
Property and equipment, net | 932,215 | 835,537 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 1,219,274 | 1,353,182 |
Other noncurrent assets | 289,032 | 328,601 |
Total assets | 12,126,707 | 6,619,914 |
Current liabilities | ||
Accounts payable | 1,283,469 | 1,691,712 |
Accrued compensation and benefits | 868,802 | 746,924 |
Accrued liabilities | 1,377,055 | 1,160,714 |
Deferred revenue | 14,122 | 24,442 |
Short-term notes payable | 476,567 | 1,010,961 |
Current maturities of long-term capital lease obligations | 248,305 | 154,839 |
Total current liabilities | 4,268,320 | 4,789,592 |
Deferred rent | 230,122 | 290,719 |
Note payable | 825,911 | |
Warrant liability | 298 | 8,453 |
Long-term capital lease obligations and other noncurrent liabilities | 403,291 | 130,153 |
Total liabilities | 5,727,942 | 5,218,917 |
Commitments (Note 9) | ||
Stockholders’ equity | ||
Common stock, $0.01 par value; 50,000,000 shares authorized; 6,067,039 and 2,265,320 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 60,670 | 22,653 |
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 0 | 0 |
Additional paid-in capital | 161,449,185 | 150,114,671 |
Accumulated other comprehensive loss | (20,366) | (25,900) |
Accumulated deficit | (155,090,724) | (148,710,427) |
Total stockholders’ equity | 6,398,765 | 1,400,997 |
Total liabilities and stockholders’ equity | $ 12,126,707 | $ 6,619,914 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 |
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 | 6,067,039 | 2,265,320 |
Common stock, shares outstanding | 6,067,039 | 2,265,320 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenue | ||||
Total revenue | $ 788,901 | $ 703,210 | $ 1,635,127 | $ 1,474,981 |
Operating expenses | ||||
Research and development | 1,304,388 | 1,762,234 | 2,534,817 | 3,884,749 |
General and administrative | 1,831,063 | 1,750,018 | 3,621,585 | 3,719,234 |
Sales and marketing | 426,297 | 909,402 | 756,070 | 2,014,988 |
Total operating expenses | 4,044,813 | 4,893,208 | 7,906,922 | 10,615,708 |
Operating loss | (3,255,912) | (4,189,998) | (6,271,795) | (9,140,727) |
Other (expense) income | ||||
Interest and other income | 5 | 22 | 5,303 | 43 |
Interest expense | (54,533) | (53,813) | (112,379) | (83,657) |
Foreign currency transaction (losses) gains | (21,762) | 8,998 | (9,581) | 11,618 |
Change in fair value of derivative financial instruments | (11) | 26,744 | 8,155 | 26,744 |
Total other expense | (76,301) | (18,049) | (108,502) | (45,252) |
Loss before income taxes | (3,332,213) | (4,208,047) | (6,380,297) | (9,185,979) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (3,332,213) | (4,208,047) | (6,380,297) | (9,185,979) |
Net loss available to common stockholders | $ (3,332,213) | $ (4,208,047) | $ (6,380,297) | $ (9,185,979) |
Net loss per common share - basic and diluted | $ (0.57) | $ (3.73) | $ (1.29) | $ (8.45) |
Weighted average shares outstanding - basic and diluted | 5,826,947 | 1,128,426 | 4,950,517 | 1,086,477 |
Net loss | $ (3,332,213) | $ (4,208,047) | $ (6,380,297) | $ (9,185,979) |
Other comprehensive gain (loss) - foreign currency translation | 18,113 | (3,834) | 5,534 | (7,591) |
Comprehensive loss | (3,314,100) | (4,211,881) | (6,374,763) | (9,193,570) |
Product [Member] | ||||
Revenue | ||||
Total revenue | 632,525 | 681,127 | 1,266,021 | 1,415,629 |
Operating expenses | ||||
Cost of products and services | 303,663 | 392,791 | 646,495 | 817,741 |
Laboratory Service Revenue [Member] | ||||
Revenue | ||||
Total revenue | 1,100 | 15,850 | 9,790 | 31,955 |
Collaborations Revenue [Member] | ||||
Revenue | ||||
Total revenue | 155,276 | 6,233 | 359,316 | 27,397 |
Service [Member] | ||||
Operating expenses | ||||
Cost of products and services | $ 179,402 | $ 78,763 | $ 347,955 | $ 178,996 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (6,380,297) | $ (9,185,979) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 317,652 | 324,412 |
Noncash interest expense | 94,594 | 19,498 |
Share-based compensation | 452,080 | 454,712 |
Gain on sale of equipment | (5,253) | 0 |
Change in fair value of warrant liabilities | (8,155) | (26,744) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 291,273 | 130,658 |
Inventory | (81,321) | 113,465 |
Other assets | (235,835) | 81,926 |
Accounts payable | (219,565) | 674,627 |
Accrued compensation and other liabilities | 226,611 | (248,372) |
Deferred revenue | (10,320) | 363 |
Net cash used in operating activities | (5,558,536) | (7,661,434) |
Cash flows from investing activities | ||
Purchases of property and equipment | (4,457) | (174,113) |
Proceeds from sale of equipment | 10,440 | 0 |
Net cash provided by (used in) investing activities | 5,983 | (174,113) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 192,322 | 3,426,050 |
Proceeds from issuance of units, net of selling costs | 10,728,132 | 0 |
Proceeds from debt, net of issuance costs | 309,900 | 664,461 |
Proceeds from exercise of stock options | 0 | 7,560 |
Payments on debt | (55,582) | (53,047) |
Payments on capital lease obligations | (107,871) | (108,095) |
Net cash provided by financing activities | 11,066,901 | 3,936,929 |
Effects of exchange rates on cash | 5,584 | (7,023) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 5,519,932 | (3,905,641) |
Cash, cash equivalents and restricted cash at beginning of period | 2,090,551 | 4,360,704 |
Cash, cash equivalents and restricted cash at end of period | 7,610,483 | 455,063 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 17,785 | 36,131 |
Supplemental disclosures of noncash investing and financing activities: | ||
Property and equipment acquired through capital lease | 281,153 | 0 |
Conversion of accounts payable to capital lease | 174,968 | 0 |
Unpaid deferred offering costs | $ 0 | $ 179,150 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2018 | |
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 and its principal operations are in Gaithersburg, Maryland. The Company also has operations in Woburn, Massachusetts, Copenhagen, Denmark, and Bogota, Colombia. The Company operates in one business segment. OpGen is a precision medicine company using 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 offerings combine its Acuitas DNA tests and Acuitas Lighthouse informatics platform for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver its products and services, some in development, to a global network of customers and partners. These include: • Its Acuitas DNA tests provide rapid microbial identification and antibiotic resistance gene information. These products include its Acuitas antimicrobial resistance (“AMR”) Gene Panel u5.47 for complicated urinary tract infections in development as a clinical diagnostic test and available for Research Use Only (“RUO”), the QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures, and its Acuitas Resistome Tests for genetic analysis of hospital surveillance isolates. • Its Acuitas Lighthouse informatics systems, which 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 Company’s 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 Company’s operations are subject to certain risks and uncertainties. The risks include rapid technology changes, the need to manage growth, 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 and commercialize its proprietary technology as well as raise additional capital. |
Liquidity and management's plan
Liquidity and management's plans | 6 Months Ended |
Jun. 30, 2018 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Liquidity and management's plans | Note 2 – Liquidity and management’s plans The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor , including: • 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, will 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 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 share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 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 0.5 share of common stock at an exercise price of $3.25 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 851,155 pre-funded warrants issued in the February 2018 Public Offering have been exercised. • On July 18, 2017, the Company closed a public offering (the “July 2017 Public Offering”) of 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital, LLC (“jVen Capital”) jVen Capital is an affiliate of Evan Jones, the Company’s Chairman of the Board and Chief Executive Officer. • In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. Under the restructuring plan the Company is consolidating its operations, including manufacturing, for its FDA-cleared and CE marked QuickFISH and PNA FISH families of and research and development activities for the Acuitas AMR Gene Panel products and services, in Gaithersburg, Maryland, and reducing the size of its commercial organization while the Company works to complete the development of its Acuitas AMR Gene Panel and Acuitas Lighthouse Knowledgebase products and services in development. • On May 31, 2017, the Company entered into a Note Purchase Agreement with jVen Capital, under which jVen Capital agreed to provide bridge financing in an aggregate principal amount of up to $1,500,000 to the Company in up to three separate tranches of $500,000 (each, a “Bridge Financing Note” and collectively, the “Bridge Financing Notes”). The interest rate on each Bridge Financing Note was ten percent (10%) per annum (subject to increase upon an event of default). The Bridge Financing Notes were prepayable by the Company at any time without penalty, and had a maturity date of September 30, 2017, which could be accelerated upon the closing of a qualified financing (any equity or debt financing that raised net proceeds of $5 million or more). The Bridge Financing Notes were contingently convertible at the option of the holder upon an event of default into shares of the Company’s convertible Series B preferred stock. In connection with the issuance of Bridge Financing Notes, in June and July 2017, the Company issued jVen Capital stock purchase warrants to acquire 5,634 shares with an exercise price of $19.50 per share, and warrants to acquire 6,350 shares with an exercise price of $17.25 per share. The Company drew down on two of three Bridge Financing Notes during June and July 2017, and repaid such outstanding Bridge Financing Notes in full upon the closing of the July 2017 Public Offering. • 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. As of June 30, 2018, the Company sold an aggregate of 476,054 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.4 million, and gross proceeds of $9.0 million. As of June 30, 2018, under the initial sales agreement, the remaining availability under the at the market offering is $2.5 million. During the three and six months ended June 30, 2018, the Company has sold 104,043 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.2 million, and gross proceeds of $0.2 million. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash will be sufficient to fund operations into the first quarter of 2019 |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Note 3 - Summary of significant accounting policies Basis of presentation and consolidation The Company has prepared the accompanying unaudited condensed, consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the following unaudited condensed, consolidated financial statements be read in conjunction with the audited condensed, consolidated financial statements and the notes thereto included in the Company’s latest Annual Report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2017 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but does not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen and its wholly-owned subsidiaries; all intercompany transactions and balances have been eliminated. The Company operates in one business segment. Foreign currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia both 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, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at June 30, 2018 and December 31, 2017. 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 U.S. dollar. Use of estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, share-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates. Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. Cash, cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At June 30, 2018, the Company has funds totaling $181,490, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. At December 31, 2017, the Company had funds totaling $243,380, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying unaudited condensed consolidated balance sheets. Accounts receivable The Company’s accounts receivable result from revenues earned but not yet collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $32,416 and $31,278 as of June 30, 2018 and December 31, 2017, respectively. One individual customer represented in excess of 10% of revenues for the three months ended June 30, 2018. No individual customer represented in excess of 10% of revenues for No individual customer represented in excess of 10% of revenues for At December 31, 2017, no individual customer represented in excess of 10% of total accounts receivable. 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: June 30, 2018 December 31, 2017 Raw materials and supplies $ 409,961 $ 360,134 Work-in process 79,098 51,233 Finished goods 125,364 122,058 Total $ 614,423 $ 533,425 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 $125,738 and $155,507 at June 30, 2018 and December 31, 2017, respectively. Long-lived assets Property and equipment Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2018 and 2017, the Company determined that its property and equipment was not impaired. Intangible assets and goodwill Intangible assets and goodwill as of June 30, 2018 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 June 30, 2018 and December 31, 2017: June 30, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (136,731 ) $ 324,269 $ (113,679 ) $ 347,321 Developed technology 458,000 (194,034 ) 263,966 (161,322 ) 296,678 Customer relationships 1,094,000 (462,961 ) 631,039 (384,817 ) 709,183 $ 2,013,000 $ (793,726 ) $ 1,219,274 $ (659,818 ) $ 1,353,182 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $66,954 for each of the three months ended June 30, 2018 and 2017. Total amortization expense of intangible assets was $133,908 for each of the six months ended June 30, 2018 and 2017. 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 three and six months ended June 30, 2018 and 2017, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid in a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of June 30, 2018 and December 31, 2017 was $600,814. The Company conducts an impairment test of goodwill on an annual basis as of October 1 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. During the three and six months ended June 30, 2018 and 2017, the Company determined that its goodwill was not impaired. Revenue recognition Subsequent to the Adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic 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 to 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. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, and fees paid to consultants and outside service partners. Share-based compensation Share-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $165.5 million at December 31, 2017. 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. On December 22, 2017, the Tax Cuts and Jobs Act (“Tax Legislation”) was enacted into law, which reduced the US federal corporate income tax rate to 21% for tax years beginning after December 31, 2017. As a result of the newly enacted tax rate, the Company adjusted its U.S. deferred tax assets as of December 31, 2017, by applying the new 21% rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $14.6 million. The Tax Legislation also implements a territorial tax system. Under the territorial tax system, in general, the Company’s foreign earnings will no longer be subject to tax in the U.S. As part of the transition to the territorial tax system the Tax Legislation includes a mandatory deemed repatriation of all undistributed foreign earnings that are subject to a U.S. income tax. The Company estimates that the deemed repatriation will not result in any additional U.S. income tax liability as it estimates it currently has no undistributed foreign earnings. 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 3.8 million shares and 0.6 million shares as of June 30, 2018 and 2017, respectively. Recent accounting pronouncements There have been no developments to the Recent Accounting Pronouncements discussion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, including the expected dates of adoption and estimated effects on the Company’s condensed consolidated financial statements, except for the following: In May 2014, the Financial Accounting Standards Board (“FASB”) and International Accounting Standards Board (“IASB”) jointly issued a new revenue recognition standard, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASC 606, using the modified retrospective method. Results for reporting periods beginning subsequent to December 31, 2017 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting policies prior to adoption. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a “portfolio” basis. The adoption of this new guidance did not have a material impact on the Company’s consolidated financial statements. In November 2016, the FASB issued 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 unaudited condensed consolidated balance sheets that sum to the total of the same amounts shown in the unaudited statements of cash flows: June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016 Cash and cash equivalents $ 7,428,993 $ 1,847,171 $ 211,683 $ 4,117,324 Restricted cash 181,490 243,380 243,380 243,380 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 7,610,483 $ 2,090,551 $ 455,063 $ 4,360,704 In February 2016, the FASB issued guidance for the accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the consolidated balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2018 | |
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 Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Product sales $ 632,525 $ 681,127 $ 1,266,021 $ 1,415,629 Laboratory services 1,100 15,850 9,790 31,955 Collaboration revenue 155,276 6,233 359,316 27,397 Total revenue $ 788,901 $ 703,210 $ 1,635,127 $ 1,474,981 Deferred Revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2017 $ 24,442 Revenue recognized in the current period from the amounts in the beginning balance (13,470 ) New deferrals, net of amounts recognized in the current period 3,150 Balance at June 30, 2018 $ 14,122 Contract Assets The Company had contract assets of $51,575 of June 30, 2018, 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 Remaining contract consideration for which revenue has not been recognized due to unsatisfied performance obligations was approximately $157 thousand at June 30, 2018, which the Company expects to recognize over the next six months. |
MGHIF Financing
MGHIF Financing | 6 Months Ended |
Jun. 30, 2018 | |
Common Stock And Note Purchase Agreement [Abstract] | |
MGHIF Financing | Note 5 – MGHIF Financing In July 2015, in connection with the Merger, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 45,454 shares of common stock of the Company at $110.00 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. Also in July 2015, the Company entered into a Registration Rights Agreement with MGHIF and certain stockholders, which will require the Company to register for resale by such holders in the future, such shares of Company common stock that cannot be sold under an exemption from such registration. 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 13,120 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, will be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. The Allonge to the MGHIF Note, was treated as a debt modification and as such the unamortized issuance costs of approximately $7 thousand as of June 11, 2018 is deferred and amortized as incremental expense over the term of the MGHIF Note. |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 6 - Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - defined as observable inputs such as quoted prices in active markets; • Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and • Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the six months ended June 30, 2018, the Company has not transferred any assets between fair value measurement levels. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. As part of the Company’s bridge financing and amendment to the MGHIF Note, the Company issued stock purchase warrants that the Company considers to be mark-to-market liabilities due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. The Company determines the fair value of the warrant liabilities using the Black-Scholes option pricing model. Using this model, level 3 unobservable inputs include the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates. The 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 six months ended June 30, 2018: Description Balance at December 31, 2017 Change in Fair Value Balance at June 30, 2018 Warrant liability $ 8,453 $ (8,155 ) $ 298 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 three and six months ended June 30, 2018 and 2017. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 - Debt As of June 30, 2018, the Company’s outstanding short-term debt consisted of approximately $167 thousand due under the MGHIF Note, as well as, the f inancing arrangements for the Company’s insurance with note balances of approximately $ As of December 31, 2017, the Company’s outstanding short-term debt consisted of the $1.0 million MGHIF Note, net of discounts and financing costs, as well as the financing arrangements for the Company’s insurance with note balances of approximately $0.1 million Total principal payments of $0.3 million are due annually in 2018, 2019, 2020, and 2021. The Company drew down on two of three Bridge Financing Notes (see discussion in Note 2 “Liquidity and management’s plans”) during June and July of 2017. The Company accounted for the embedded conversion option granted to jVen Capital in the Bridge Financing Notes as a mark-to-market derivative financial instrument carried at fair value. Changes in fair value of the embedded conversion option were reflected in earnings during the period of change. The embedded conversion option was expensed along with the remaining unamortized discount at the date of the Bridge Financing Notes repayment. The warrants issued to jVen Capital and MGHIF are classified as mark-to-market liabilities under ASC 480 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. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $54,533 and $53,813 for the three months ended June 30, 2018 and 2017, respectively. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $112,379 and $83,657 for the six months ended June 30, 2018 and 2017, respectively. |
Stockholders' equity
Stockholders' equity | 6 Months Ended |
Jun. 30, 2018 | |
Stockholders Equity Note [Abstract] | |
Stockholders' equity | Note 8 - Stockholders’ equity As of June 30, 2018, the Company has 50,000,000 shares of authorized common stock and 6,067,039 shares issued and outstanding, and 10,000,000 authorized preferred shares, of which none were issued or outstanding. Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 shares. All share amounts and per share prices in this quarterly report have been adjusted to reflect the reverse stock split. 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 share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 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 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. 673,077 pre-funded warrants issued in the February 2018 Public Offering were exercised during the three months ended June 30, 2018. 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the six months ended June 30, 2018. In connection with the February 2018 Public Offering, the Company issued to its placement agent warrants to purchase 184,615 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $4.0625 per share and are exercisable for five years. In the July 2017 Public Offering, the Company issued 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital was one of the investors participating in the offering. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. At closing, the outstanding Bridge Financing Notes issued to jVen Capital, were repaid in the principal amount of $1 million plus accrued interest of $6,438. All pre-funded warrants issued in the July 2017 Public Offering were exercised during the year ended December 31, 2017. In connection with the July 2017 Public Offering, the Company issued to its placement agent warrants to purchase 50,000 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $12.50 per share and are exercisable for five years. In September 2017, the Company issued 15,842 shares of its common stock with an aggregate value of $110,000 to settle a dispute related to pre-Merger AdvanDx activities. In October 2017, the Company issued 2,898 shares of its common stock with an aggregate value of $23,245 to a vendor in exchange for consulting services. In September 2016, the Company entered into the Sales Agreement with 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. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock 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. The Company pays Cowen compensation equal to % of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of June 30, 2018, the Company has sold an aggregate of 476,054 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.4 million, and gross proceeds of $9.0 million. As of June 30, 2018, the remaining availability under the at the market offering is $2.5 million. During the three and six months ended June 30, 2018, the Company has sold 104,043 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.2 million, and gross proceeds of $0.2 million. Stock options In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors could grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Company adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s initial public offering in May 2015. Following the effectiveness of the 2015 Plan, no further grants will be made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 54,200 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of June 30, 2018, 36,409 shares remain available for issuance under the 2015 Plan, which includes 90,612 shares automatically added to the 2015 Plan on January 1, 2018. For the three and six months ended June 30, 2018 and 2017, the Company recognized share-based compensation expense as follows: Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Cost of services $ 1,341 $ 2,145 $ 3,731 $ 3,968 Research and development 61,080 52,777 130,551 110,555 General and administrative 140,158 160,419 292,340 312,895 Sales and marketing 11,311 (6,034 ) 25,458 27,294 $ 213,890 $ 209,307 $ 452,080 $ 454,712 No income tax benefit for share-based compensation arrangements was recognized in the condensed consolidated statements of operations and comprehensive loss due to the Company’s net loss position. During the three months ended June 30, 2018, the Company granted stock options to acquire 10,000 shares of common stock at a weighted average exercise price of $2.30 per share and a weighted average grant date fair value of $1.03 per share. During the three months ended June 30, 2018, 1,372 options were forfeited at a weighted average exercise price of $50.14 per share. During the six months ended June 30, 2018, the Company granted stock options to acquire 95,800 shares of common stock at a weighted average exercise price of $3.84 per share and a weighted average grant date fair value of $1.93 per share. During the six months ended June 30, 2018, 6,216 options were forfeited at a weighted average exercise price of $12.85 per share. The Company had total stock options to acquire 226,008 shares of common stock outstanding at June 30, 2018. Restricted stock units During the six months ended June 30, 2018, 5,400 restricted stock units vested and no restricted stock units were forfeited. The Company had 500 total restricted stock units outstanding at June 30, 2018. Stock purchase warrants At June 30, 2018 and December 31, 2017, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration June 30, 2018 (1) December 31, 2017 (1) March 2008 $ 19,763.50 March 2018 — 2 November 2009 $ 197.75 November 2019 270 270 January 2010 $ 197.75 January 2020 270 270 March 2010 $ 197.75 March 2020 55 55 November 2011 $ 197.75 November 2021 212 212 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,001 9,001 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,577 189,577 June 2016 $ 32.81 May 2021 82,035 82,035 June 2017 $ 19.50 June 2022 18,754 18,754 July 2017 $ 17.25 July 2022 6,350 6,350 July 2017 $ 12.50 July 2022 50,000 50,000 July 2017 $ 10.63 July 2022 1,000,003 1,000,003 February 2018 $ 4.06 February 2023 184,615 — February 2018 $ 3.25 February 2023 1,846,153 — 3,525,797 1,495,031 The warrants listed above were issued in connection with various debt, equity or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on January 17, 2018 were rounded up to the next whole share of common stock on a holder by holder basis. |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | Note 9 - Commitments Operating leases The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires January 31, 2021, with one additional five-year renewal at the Company’s election. Rent expense under the Company’s facility operating leases for the three months ended June 30, 2018 and 2017 was $252,535 and $238,703, respectively. Rent expense under the Company’s facility operating leases for the six months ended June 30, 2018 and 2017 was $502,292 and $471,539, respectively. Capital leases The Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. 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. Restructuring In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. Under the restructuring plan, the Company is consolidating its operations for FDA-cleared and CE marked QuickFISH and PNA FISH products and research and development activities for the Acuitas AMR Gene Panel in Gaithersburg, Maryland, and reducing the size of its commercial organization while the Company works to complete the development of its Acuitas AMR Gene Panel and Acuitas Lighthouse Knowledgebase products and services in development. There were approximately $121,000 of one-time termination benefits that were recognized during the year ended December 31, 2017 related to the restructuring. The Company does not anticipate any further one-time termination benefits related to the restructuring plan. Retention agreements were issued to certain employees in which retention bonuses are earned and paid upon the completion of a designated service period. The service periods ended in December 2017. The Company incurred total retention expense of approximately $68,000 during the year ended December 31, 2017. The future minimum lease payments for the Woburn facility were approximately $1.7 million as of June 30, 2018. A liability for costs that will continue to be incurred under a contract for its remaining term without economic benefit to the entity shall be recognized at the cease-use date. If the contract is an operating lease the fair value of the liability at the cease-use date shall be determined based on the remaining lease rentals, adjusted for the effects of any prepaid or deferred items recognized under the lease, and reduced by estimated sublease rentals that could be reasonably obtained for the property. The Company expects the cease-use date for the Woburn facility to be in the second half of 2018. We have not estimated the contract termination costs associated with this lease given that we have not yet reached the cease-use date and given that we have only begun sublease pursuit activities. We do not believe there will be significant additional costs related to restructuring outside of what is described herein. Supply In June 2017, the Company entered into an agreement with Life Technologies Corporation (“LTC”) to supply the Company with QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of June 30, 2018 the Company has acquired eight QuantStudio 5s including five in the six months ended June 30, 2018. Each QuantStudio 5 costs approximately $42 thousand and each instrument acquired to date has been financed through capital leases. As of June 30, 2018 the Company has committed to acquiring an additional three QuantStudio 5s in the next three months. |
License agreements, research co
License agreements, research collaborations and development agreements | 6 Months Ended |
Jun. 30, 2018 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 10 - License agreements, research collaborations and development agreements The Company is a party to one license agreement to acquire certain patent rights and technologies |
Related party transactions
Related party transactions | 6 Months Ended |
Jun. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related party transactions | Note 11 - Related party transactions In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp. (“MSD”), a wholly-owned subsidiary of Merck, and an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, MSD provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. MSD gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $171,646 of procurement costs which have been recognized as research and development expense. The Company recognized research and development expense of $22,604 and $ in the three months ended June 30, 2018 and 2017, respectively. The Company recognized research and development expense of $22,604 and in the six months ended June 30, 2018 and 2017, respectively. In December 2017, the Company 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 will provide 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. The Company recognized $84,853 and $198,665 of cost of services expense related to the contract in the three and six months ended June 30, 2018, respectively |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent events | Note 12 – Subsequent events On July 30, 2018, the |
Summary of significant accoun18
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation and consolidation | Basis of presentation and consolidation The Company has prepared the accompanying unaudited condensed, consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not misleading. The Company recommends that the following unaudited condensed, consolidated financial statements be read in conjunction with the audited condensed, consolidated financial statements and the notes thereto included in the Company’s latest Annual Report on Form 10-K. In the opinion of management, all adjustments that are necessary for a fair presentation of the Company’s financial position for the periods presented have been reflected. All adjustments are of a normal, recurring nature, unless otherwise stated. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2017 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but does not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements include the accounts of OpGen and its wholly-owned subsidiaries; all intercompany transactions and balances have been eliminated. The Company operates in one business segment. |
Foreign currency | Foreign currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia both 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, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at June 30, 2018 and December 31, 2017. 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 U.S. dollar. |
Use of estimates | Use of estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, share-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates. |
Fair value of financial instruments | Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. |
Cash, cash equivalents and restricted cash | Cash, cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limit of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At June 30, 2018, the Company has funds totaling $181,490, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. At December 31, 2017, the Company had funds totaling $243,380, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying unaudited condensed consolidated balance sheets. |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not yet collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $32,416 and $31,278 as of June 30, 2018 and December 31, 2017, respectively. One individual customer represented in excess of 10% of revenues for the three months ended June 30, 2018. No individual customer represented in excess of 10% of revenues for No individual customer represented in excess of 10% of revenues for At December 31, 2017, no individual customer represented in excess of 10% of total accounts receivable. |
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: June 30, 2018 December 31, 2017 Raw materials and supplies $ 409,961 $ 360,134 Work-in process 79,098 51,233 Finished goods 125,364 122,058 Total $ 614,423 $ 533,425 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 $125,738 and $155,507 at June 30, 2018 and December 31, 2017, respectively. |
Property and equipment | Property and equipment Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2018 and 2017, the Company determined that its property and equipment was not impaired. |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of June 30, 2018 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 June 30, 2018 and December 31, 2017: June 30, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (136,731 ) $ 324,269 $ (113,679 ) $ 347,321 Developed technology 458,000 (194,034 ) 263,966 (161,322 ) 296,678 Customer relationships 1,094,000 (462,961 ) 631,039 (384,817 ) 709,183 $ 2,013,000 $ (793,726 ) $ 1,219,274 $ (659,818 ) $ 1,353,182 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $66,954 for each of the three months ended June 30, 2018 and 2017. Total amortization expense of intangible assets was $133,908 for each of the six months ended June 30, 2018 and 2017. 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 three and six months ended June 30, 2018 and 2017, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, Property, Plant and Equipment Goodwill Goodwill represents the excess of the purchase price paid in a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company’s goodwill balance as of June 30, 2018 and December 31, 2017 was $600,814. The Company conducts an impairment test of goodwill on an annual basis as of October 1 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. During the three and six months ended June 30, 2018 and 2017, the Company determined that its goodwill was not impaired. |
Revenue recognition | Revenue recognition Subsequent to the Adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic 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 to 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. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, and fees paid to consultants and outside service partners. |
Share-based compensation | Share-based compensation Share-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $165.5 million at December 31, 2017. 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. On December 22, 2017, the Tax Cuts and Jobs Act (“Tax Legislation”) was enacted into law, which reduced the US federal corporate income tax rate to 21% for tax years beginning after December 31, 2017. As a result of the newly enacted tax rate, the Company adjusted its U.S. deferred tax assets as of December 31, 2017, by applying the new 21% rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $14.6 million. The Tax Legislation also implements a territorial tax system. Under the territorial tax system, in general, the Company’s foreign earnings will no longer be subject to tax in the U.S. As part of the transition to the territorial tax system the Tax Legislation includes a mandatory deemed repatriation of all undistributed foreign earnings that are subject to a U.S. income tax. The Company estimates that the deemed repatriation will not result in any additional U.S. income tax liability as it estimates it currently has no undistributed foreign earnings. |
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 3.8 million shares and 0.6 million shares as of June 30, 2018 and 2017, respectively. |
Recent accounting pronouncements | Recent accounting pronouncements There have been no developments to the Recent Accounting Pronouncements discussion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, including the expected dates of adoption and estimated effects on the Company’s condensed consolidated financial statements, except for the following: In May 2014, the Financial Accounting Standards Board (“FASB”) and International Accounting Standards Board (“IASB”) jointly issued a new revenue recognition standard, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASC 606, using the modified retrospective method. Results for reporting periods beginning subsequent to December 31, 2017 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting policies prior to adoption. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a “portfolio” basis. The adoption of this new guidance did not have a material impact on the Company’s consolidated financial statements. In November 2016, the FASB issued 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 unaudited condensed consolidated balance sheets that sum to the total of the same amounts shown in the unaudited statements of cash flows: June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016 Cash and cash equivalents $ 7,428,993 $ 1,847,171 $ 211,683 $ 4,117,324 Restricted cash 181,490 243,380 243,380 243,380 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 7,610,483 $ 2,090,551 $ 455,063 $ 4,360,704 In February 2016, the FASB issued guidance for the accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the consolidated balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting 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 accoun19
Summary of significant accounting policies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
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: June 30, 2018 December 31, 2017 Raw materials and supplies $ 409,961 $ 360,134 Work-in process 79,098 51,233 Finished goods 125,364 122,058 Total $ 614,423 $ 533,425 |
Schedule of Finite-Lived Intangible Assets | Finite-lived intangible assets include trademarks, developed technology and customer relationships and consisted of the following as of June 30, 2018 and December 31, 2017 June 30, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (136,731 ) $ 324,269 $ (113,679 ) $ 347,321 Developed technology 458,000 (194,034 ) 263,966 (161,322 ) 296,678 Customer relationships 1,094,000 (462,961 ) 631,039 (384,817 ) 709,183 $ 2,013,000 $ (793,726 ) $ 1,219,274 $ (659,818 ) $ 1,353,182 |
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 unaudited condensed consolidated balance sheets that sum to the total of the same amounts shown in the unaudited statements of cash flows: June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016 Cash and cash equivalents $ 7,428,993 $ 1,847,171 $ 211,683 $ 4,117,324 Restricted cash 181,490 243,380 243,380 243,380 Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows $ 7,610,483 $ 2,090,551 $ 455,063 $ 4,360,704 |
Revenue from Contracts with C20
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
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 Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Product sales $ 632,525 $ 681,127 $ 1,266,021 $ 1,415,629 Laboratory services 1,100 15,850 9,790 31,955 Collaboration revenue 155,276 6,233 359,316 27,397 Total revenue $ 788,901 $ 703,210 $ 1,635,127 $ 1,474,981 |
Summary of Changes in Deferred Revenue | Changes in deferred revenue for the period were as follows: Balance at December 31, 2017 $ 24,442 Revenue recognized in the current period from the amounts in the beginning balance (13,470 ) New deferrals, net of amounts recognized in the current period 3,150 Balance at June 30, 2018 $ 14,122 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
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 six months ended June 30, 2018: Description Balance at December 31, 2017 Change in Fair Value Balance at June 30, 2018 Warrant liability $ 8,453 $ (8,155 ) $ 298 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Stockholders Equity Note [Abstract] | |
Schedule of Company Recognized Stock Compensation Expense | For the three and six months ended June 30, 2018 and 2017, the Company recognized share-based compensation expense as follows: Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Cost of services $ 1,341 $ 2,145 $ 3,731 $ 3,968 Research and development 61,080 52,777 130,551 110,555 General and administrative 140,158 160,419 292,340 312,895 Sales and marketing 11,311 (6,034 ) 25,458 27,294 $ 213,890 $ 209,307 $ 452,080 $ 454,712 |
Schedule of Warrants to Purchase Shares of Common Stock | Stock purchase warrants At June 30, 2018 and December 31, 2017, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration June 30, 2018 (1) December 31, 2017 (1) March 2008 $ 19,763.50 March 2018 — 2 November 2009 $ 197.75 November 2019 270 270 January 2010 $ 197.75 January 2020 270 270 March 2010 $ 197.75 March 2020 55 55 November 2011 $ 197.75 November 2021 212 212 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,001 9,001 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,577 189,577 June 2016 $ 32.81 May 2021 82,035 82,035 June 2017 $ 19.50 June 2022 18,754 18,754 July 2017 $ 17.25 July 2022 6,350 6,350 July 2017 $ 12.50 July 2022 50,000 50,000 July 2017 $ 10.63 July 2022 1,000,003 1,000,003 February 2018 $ 4.06 February 2023 184,615 — February 2018 $ 3.25 February 2023 1,846,153 — 3,525,797 1,495,031 (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on January 17, 2018 were rounded up to the next whole share of common stock on a holder by holder basis. |
Organization - Additional Infor
Organization - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2018Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating business segment | 1 |
Liquidity and Management's Pl24
Liquidity and Management's Plans - Additional Information (Details) - USD ($) | Jul. 14, 2018 | Jun. 11, 2018 | Apr. 19, 2018 | Feb. 06, 2018 | Jul. 18, 2017 | May 31, 2017 | Sep. 13, 2016 | Jul. 31, 2017 | Jun. 30, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 |
Conversion Of Stock [Line Items] | ||||||||||||
Net proceeds from sale of common stock and warrants | $ 10,728,132 | $ 0 | ||||||||||
Net proceeds from sale of common stock | 192,322 | $ 3,426,050 | ||||||||||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Interest rate | 10.00% | |||||||||||
Maturity date | Sep. 30, 2017 | |||||||||||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | Maximum [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate principal amount | $ 1,500,000 | |||||||||||
Bridge Financing Note One [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate principal amount | 500,000 | |||||||||||
Bridge Financing Note Two [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate principal amount | 500,000 | |||||||||||
Bridge Financing Note Three [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate principal amount | $ 500,000 | |||||||||||
Qualified Financing [Member] | Note Purchase Agreement [Member] | Minimum [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Net proceeds from equity or debt financing | $ 5,000,000 | |||||||||||
Merck GHI Financing Agreement [Member] | The Allonge [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate principal amount | $ 1,000,000 | |||||||||||
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 | |||||||||||
Merck GHI Financing Agreement [Member] | The Allonge [Member] | Subsequent Event [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Accrued and unpaid interest | $ 285,512 | |||||||||||
Stock Purchase Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 19.50 | |||||||||||
Class of warrant or right, number of securities called by warrants or rights | 5,634 | |||||||||||
Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 17.25 | |||||||||||
Class of warrant or right, number of securities called by warrants or rights | 6,350 | |||||||||||
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 | |||||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 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 0.5 share of common stock at an exercise price of $3.25 per share. | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.5 | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.25 | |||||||||||
Warrants exercisable period | 5 years | |||||||||||
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, exercise price of warrants or rights | $ 0.01 | |||||||||||
Warrants exercised | 851,155 | 673,077 | 851,155 | |||||||||
July 2017 Public Offering [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Stock issued during period, shares, new issues | 18,164,195 | |||||||||||
Shares issued, price per share | $ 0.40 | |||||||||||
Gross proceeds from sale of common stock and warrants | $ 10,000,000 | |||||||||||
Net proceeds from sale of common stock and warrants | $ 8,800,000 | |||||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 10.63 | |||||||||||
Warrants exercisable period | 5 years | |||||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Repayment of outstanding debt | $ 1,000,000 | $ 1,000,000 | ||||||||||
July 2017 Public Offering [Member] | Pre-funded Units [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Stock issued during period, shares, new issues | 6,835,805 | |||||||||||
Shares issued, price per share | $ 0.39 | |||||||||||
July 2017 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 | 0.04 | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.25 | |||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 9,000,000 | |||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | |||||||||||
Aggregate net proceeds from sale of common stock | 8,400,000 | |||||||||||
Remaining availability under at the market offering | 2,500,000 | |||||||||||
Net proceeds from sale of common stock | $ 200,000 | 200,000 | ||||||||||
Gross proceeds from sale of common stock | $ 200,000 | $ 200,000 | ||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | |||||||||||
At the Market Offering [Member] | Common Stock [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | ||||||||||||
Conversion Of Stock [Line Items] | ||||||||||||
Stock issued during period, shares, new issues | 104,043 | 104,043 | 476,054 | |||||||||
Net proceeds from sale of common stock | $ 200,000 | $ 200,000 | ||||||||||
Gross proceeds from sale of common stock | $ 200,000 | $ 200,000 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018USD ($)Customer | Jun. 30, 2017USD ($)Customer | Jun. 30, 2018USD ($)SegmentCustomershares | Jun. 30, 2017USD ($)Customershares | Dec. 31, 2017USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Number of operating business segment | Segment | 1 | ||||
FDIC limit of insurable cash | $ 250,000 | $ 250,000 | |||
Letters of credit outstanding, amount | 181,490 | 181,490 | $ 243,380 | ||
Allowance for doubtful accounts receivable | $ 32,416 | $ 32,416 | 31,278 | ||
Number of individual customers accounting for more than 10% of revenue | Customer | 1 | 0 | 1 | 0 | |
Number of individual customers accounting for more than 10% of accounts receivable | Customer | 1 | 0 | 1 | 0 | |
Inventory valuation reserves | $ 125,738 | $ 125,738 | 155,507 | ||
Amortization of intangible assets | 66,954 | $ 66,954 | 133,908 | $ 133,908 | |
Impairment of finite-lived intangible assets | 0 | 0 | 0 | 0 | |
Goodwill | 600,814 | 600,814 | 600,814 | ||
Impairment of goodwill | 0 | $ 0 | $ 0 | $ 0 | |
U.S. federal corporate tax rate | 21.00% | ||||
Decrease to deferred tax assets | 14,600,000 | ||||
Undistributed foreign earnings | $ 0 | $ 0 | |||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 3.8 | 0.6 | |||
Domestic Country [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Operating loss carryforwards | $ 165,500,000 | ||||
Operating loss carryforwards, expiration terms | begin to expire in 2022 | ||||
Trademarks and Trade Names [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 | ||||
Accounts Receivable [Member] | Customer One [Member] | Customer Concentration Risk [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration risk, percentage | 10.00% | 10.00% | |||
Minimum [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Accounts receivable period due | 30 days | ||||
Maximum [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Accounts receivable period due | 60 days |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Inventories | ||
Raw materials and supplies | $ 409,961 | $ 360,134 |
Work-in process | 79,098 | 51,233 |
Finished goods | 125,364 | 122,058 |
Total | $ 614,423 | $ 533,425 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (793,726) | (659,818) |
Net Balance | 1,219,274 | 1,353,182 |
Trademarks and Tradenames [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (136,731) | (113,679) |
Net Balance | 324,269 | 347,321 |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (194,034) | (161,322) |
Net Balance | 263,966 | 296,678 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (462,961) | (384,817) |
Net Balance | $ 631,039 | $ 709,183 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash Cash Equivalents and Restricted Cash (Details) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 7,428,993 | $ 1,847,171 | $ 211,683 | $ 4,117,324 |
Restricted cash | 181,490 | 243,380 | 243,380 | 243,380 |
Total cash, cash equivalents and restricted cash in the condensed consolidated statement of cash flows | $ 7,610,483 | $ 2,090,551 | $ 455,063 | $ 4,360,704 |
Revenue from Contracts with C29
Revenue from Contracts with Customers - Schedule of Revenues by Type of Service (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 788,901 | $ 703,210 | $ 1,635,127 | $ 1,474,981 |
Product [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 632,525 | 681,127 | 1,266,021 | 1,415,629 |
Laboratory Services [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 1,100 | 15,850 | 9,790 | 31,955 |
Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 155,276 | $ 6,233 | $ 359,316 | $ 27,397 |
Revenue from Contracts with C30
Revenue from Contracts with Customers - Summary of Changes in Deferred Revenue (Details) | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Revenue Recognition And Deferred Revenue [Abstract] | |
Balance at December 31, 2017 | $ 24,442 |
Revenue recognized in the current period from the amounts in the beginning balance | (13,470) |
New deferrals, net of amounts recognized in the current period | 3,150 |
Balance at June 30, 2018 | $ 14,122 |
Revenue from Contracts with C31
Revenue from Contracts with Customers - Additional Information (Details) | Jun. 30, 2018USD ($) |
Revenue From Contract With Customer [Abstract] | |
Contract with customers, asset | $ 51,575 |
Remaining contract consideration for which revenue has not been recognized due to unsatisfied performance obligations | $ 157,000 |
Remaining contract consideration, expected period to be recognized | 6 months |
MGHIF Financing - Additional In
MGHIF Financing - Additional Information (Details) - USD ($) | Jul. 14, 2018 | Jun. 11, 2018 | Jun. 28, 2017 | Jul. 31, 2015 | Jun. 30, 2018 | Jun. 30, 2017 |
Common Stock and Note Purchase Agreement [Line Items] | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 192,322 | $ 3,426,050 | ||||
MGHIF Financing Agreement [Member] | ||||||
Common Stock and Note Purchase Agreement [Line Items] | ||||||
Stock issued during period, shares, new issues | 45,454 | |||||
Shares issued, price per share | $ 110 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | |||||
Debt instrument, interest rate, stated percentage | 8.00% | |||||
Debt instrument, face amount | $ 1,000,000 | |||||
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 | 13,120 | |||||
Merck GHI Financing Agreement [Member] | ||||||
Common Stock and Note Purchase Agreement [Line Items] | ||||||
Unamortized debt issuance costs | $ 7,000 | |||||
Merck GHI Financing Agreement [Member] | The Allonge [Member] | ||||||
Common Stock and Note Purchase Agreement [Line Items] | ||||||
Debt instrument, face amount | $ 1,000,000 | |||||
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 | |||||
Merck GHI Financing Agreement [Member] | The Allonge [Member] | Subsequent Event [Member] | ||||||
Common Stock and Note Purchase Agreement [Line Items] | ||||||
Accrued and unpaid interest | $ 285,512 |
Fair value measurements (Detail
Fair value measurements (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||
Assets transferred between fair value measurement levels | $ 0 | |||
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 | 0 | ||
Financial liabilities measured at fair value | 0 | 0 | ||
Impairment of non-financial assets and liabilities at fair value | 0 | $ 0 | 0 | $ 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 | 0 | ||
Non-financial liabilities measured at fair value | $ 0 | $ 0 |
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] | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | $ 8,453 |
Change in Fair Value | (8,155) |
Balance at the end of the period | $ 298 |
Debt - Additional Information (
Debt - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)Note | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($) | |
Debt Instrument [Line Items] | |||||
Short-term debt | $ 476,567 | $ 476,567 | $ 1,010,961 | ||
Interest expense, debt | 54,533 | $ 53,813 | 112,379 | $ 83,657 | |
Due in 2018 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 300,000 | 300,000 | |||
Due in 2019 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 300,000 | 300,000 | |||
Due in 2020 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 300,000 | 300,000 | |||
Due in 2021 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 300,000 | 300,000 | |||
MGHIF Financing Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Short-term debt | 167,000 | 167,000 | 1,000,000 | ||
Long-term debt, outstanding | 826,000 | 826,000 | |||
Notes Payable, Other Payables [Member] | |||||
Debt Instrument [Line Items] | |||||
Short-term debt | $ 310,000 | $ 310,000 | $ 100,000 | ||
Bridge Financing Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Number of notes | Note | 3 | ||||
Number of notes drew down | Note | 2 |
Stockholders' equity (Details T
Stockholders' equity (Details Textual) | Apr. 19, 2018shares | Feb. 06, 2018USD ($)$ / sharesshares | Jan. 17, 2018shares | Jan. 01, 2018shares | Jul. 18, 2017USD ($)$ / sharesshares | Sep. 13, 2016USD ($) | Oct. 31, 2017USD ($)shares | Sep. 30, 2017USD ($)shares | Jul. 31, 2017USD ($) | Jun. 30, 2018USD ($)$ / sharesshares | Jun. 30, 2018USD ($)$ / sharesshares | Jun. 30, 2017USD ($) | Jun. 30, 2018shares | Jan. 16, 2018shares | Dec. 31, 2017shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | 50,000,000 | |||||||||
Common stock, shares issued | 6,067,039 | 6,067,039 | 6,067,039 | 2,265,320 | |||||||||||
Common stock, shares outstanding | 6,067,039 | 6,067,039 | 6,067,039 | 2,265,320 | |||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||||
Preferred stock, shares issued | 0 | 0 | 0 | 0 | |||||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | 0 | |||||||||||
Stock split | On January 17, 2018, we filed an amendment to our Amended and Restated Certificate of Incorporation to effect a? reverse stock split of the issued and outstanding shares of our common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of our common stock from 200,000,000 to 50,000,000 shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock split. | ||||||||||||||
Reverse stock split conversion ratio | 0.04 | ||||||||||||||
Net proceeds from sale of common stock and warrants | $ | $ 10,728,132 | $ 0 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | 192,322 | $ 3,426,050 | |||||||||||||
Share-based compensation, tax benefit from compensation expense | $ | $ 0 | ||||||||||||||
Stock options, granted | 10,000 | 95,800 | |||||||||||||
Stock options, granted, weighted average exercise price | $ / shares | $ 2.30 | $ 3.84 | |||||||||||||
Stock options, granted, weighted average grant date fair value | $ / shares | $ 1.03 | $ 1.93 | |||||||||||||
Stock options, forfeited | 1,372 | 6,216 | |||||||||||||
Stock options, forfeited, weighted average exercise price | $ / shares | $ 50.14 | $ 12.85 | |||||||||||||
Stock options, outstanding | 226,008 | 226,008 | 226,008 | ||||||||||||
Restricted Stock Units [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period | 5,400 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period | 0 | ||||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding | 500 | 500 | 500 | ||||||||||||
2015 Plan [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 54,200 | 54,200 | 54,200 | ||||||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 36,409 | 36,409 | 36,409 | ||||||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||||||||
Share-based compensation arrangement by share-based payment award, number of additional shares added | 90,612 | ||||||||||||||
Common Stock [Member] | Vendor Consulting Services [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 2,898 | ||||||||||||||
Stock issued during period, value, new issues | $ | $ 23,245 | ||||||||||||||
Common Stock [Member] | AdvanDx [Member] | Pre-Merger Dispute Settlement [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 15,842 | ||||||||||||||
Stock issued during period, value, new issues | $ | $ 110,000 | ||||||||||||||
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 share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 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 0.5 share of common stock at an exercise price of $3.25 per share. | ||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.5 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 3.25 | ||||||||||||||
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 | $ 4.0625 | ||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||
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, exercise price of warrants or rights | $ / shares | $ 0.01 | ||||||||||||||
Warrants exercised | 851,155 | 673,077 | 851,155 | ||||||||||||
February 2018 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 184,615 | ||||||||||||||
July 2017 Public Offering [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 18,164,195 | ||||||||||||||
Shares issued, price per share | $ / shares | $ 0.40 | ||||||||||||||
Gross proceeds from sale of common stock and warrants | $ | $ 10,000,000 | ||||||||||||||
Net proceeds from sale of common stock and warrants | $ | $ 8,800,000 | ||||||||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.63 per share. | ||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 10.63 | ||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Repayment of principal amount of outstanding debt | $ | $ 1,000,000 | $ 1,000,000 | |||||||||||||
Repayments of accrued interest on outstanding debt | $ | $ 6,438 | ||||||||||||||
July 2017 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 | $ 12.50 | ||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||
July 2017 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 | 6,835,805 | ||||||||||||||
Shares issued, price per share | $ / shares | $ 0.39 | ||||||||||||||
July 2017 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 | 0.04 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.25 | ||||||||||||||
July 2017 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 50,000 | ||||||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock issued during period, value, new issues | $ | $ 11,500,000 | ||||||||||||||
Aggregate gross proceeds from issuance of common stock | $ | $ 9,000,000 | ||||||||||||||
Maximum commission percentage on gross proceeds | 3.00% | ||||||||||||||
Remaining availability under at the market offering | $ | 2,500,000 | ||||||||||||||
Aggregate net proceeds from issuance of common stock | $ | 8,400,000 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 200,000 | 200,000 | |||||||||||||
Gross proceeds from sale of common stock | $ | $ 200,000 | $ 200,000 | |||||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Aggregate gross proceeds from issuance of common stock | $ | $ 25,000,000 | ||||||||||||||
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 | 104,043 | 104,043 | 476,054 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 200,000 | $ 200,000 | |||||||||||||
Gross proceeds from sale of common stock | $ | $ 200,000 | $ 200,000 |
Stockholders' equity - Company
Stockholders' equity - Company Recognized Stock Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ 213,890 | $ 209,307 | $ 452,080 | $ 454,712 |
Cost of Services [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 1,341 | 2,145 | 3,731 | 3,968 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 61,080 | 52,777 | 130,551 | 110,555 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 140,158 | 160,419 | 292,340 | 312,895 |
Sales and Marketing [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ 11,311 | $ (6,034) | $ 25,458 | $ 27,294 |
Stockholders' equity - Warrants
Stockholders' equity - Warrants to Purchase Shares of Common Stock (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 3,525,797 | 1,495,031 |
March 2008 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19,763.50 | |
Expiration | 2018-03 | |
Shares of Common Stock Subject to Warrants | 2 | |
November 2009 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2019-11 | |
Shares of Common Stock Subject to Warrants | 270 | 270 |
January 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-01 | |
Shares of Common Stock Subject to Warrants | 270 | 270 |
March 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-03 | |
Shares of Common Stock Subject to Warrants | 55 | 55 |
November 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-11 | |
Shares of Common Stock Subject to Warrants | 212 | 212 |
December 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-12 | |
Shares of Common Stock Subject to Warrants | 27 | 27 |
March 2012 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 2,747.50 | |
Expiration | 2019-03 | |
Shares of Common Stock Subject to Warrants | 165 | 165 |
February 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2025-02 | |
Shares of Common Stock Subject to Warrants | 9,001 | 9,001 |
May 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2020-05 | |
Shares of Common Stock Subject to Warrants | 138,310 | 138,310 |
May 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 189,577 | 189,577 |
June 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 82,035 | 82,035 |
June 2017 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19.50 | |
Expiration | 2022-06 | |
Shares of Common Stock Subject to Warrants | 18,754 | 18,754 |
July 2017 [Member] | Exercise Price 17.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 17.25 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 6,350 | 6,350 |
July 2017 [Member] | Exercise Price 12.50 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 12.50 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 50,000 | 50,000 |
July 2017 [Member] | Exercise Price 10.63 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 10.63 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 1,000,003 | 1,000,003 |
February 2018 [Member] | Exercise Price 4.06 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 4.06 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 184,615 | |
February 2018 [Member] | Exercise Price 3.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3.25 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 1,846,153 |
Commitments (Details Textual)
Commitments (Details Textual) | Jun. 30, 2018USD ($)Product | Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)Product | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($) |
Other Commitments [Line Items] | ||||||
Operating lease description | The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires January 31, 2021, with one additional five-year renewal at the Company’s election. The Company also leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis. | |||||
Operating leases, rent expense, net, total | $ 252,535 | $ 238,703 | $ 502,292 | $ 471,539 | ||
Capital leases description | The Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. | |||||
Capital leases expiration date description | The leases expire at various dates through 2021. | |||||
Restructuring benefits recognized | $ 121,000 | |||||
Retention expense incurred | $ 68,000 | |||||
Designated service period of employees, description | The service periods ended in December 2017 | |||||
QuantStudio 5 Real-Time PCR Systems [Member] | Life Technologies Corporation Supply Agreement [Member] | ||||||
Other Commitments [Line Items] | ||||||
Number of products acquired | Product | 8 | 5 | ||||
QuantStudio 5 Real-Time PCR Systems [Member] | Life Technologies Corporation Supply Agreement [Member] | Capital Leases [Member] | ||||||
Other Commitments [Line Items] | ||||||
Costs of each product | $ 42,000 | |||||
Facility in Woburn, Massachusetts [Member] | ||||||
Other Commitments [Line Items] | ||||||
Future minimum operating lease payments | $ 1,700,000 | $ 1,700,000 | $ 1,700,000 | |||
Facility in Woburn, Massachusetts [Member] | AdvanDx [Member] | ||||||
Other Commitments [Line Items] | ||||||
Operating leases expiration date | Jan. 30, 2022 | |||||
Gaithersburg, Maryland Office Lease [Member] | ||||||
Other Commitments [Line Items] | ||||||
Operating leases expiration date | Jan. 31, 2021 | |||||
Operating leases additional term | 5 years | 5 years | 5 years |
License agreements, research 40
License agreements, research collaborations and development agreements (Details Textual) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018USD ($)Agreement | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)Agreement | Jun. 30, 2017USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||
Royalty expense | $ 62,500 | $ 62,941 | $ 125,000 | $ 132,186 |
Annual future minimum royalty payments due | $ 250,000 | $ 250,000 | ||
FISH Product Line [Member] | ||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||
Number of license agreements | Agreement | 1 | 1 |
Related party transactions (Det
Related party transactions (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | 20 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Oct. 31, 2016 | |
Service [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Cost of services | $ 179,402 | $ 78,763 | $ 347,955 | $ 178,996 | ||
Merck Sharp & Dohme Corp [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Research and development agreement description | Under the agreement, MSD provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. MSD gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. | |||||
Maximum required amount to expend for procurement of materials | $ 175,000 | |||||
Merck Sharp & Dohme Corp [Member] | Research and Development Expense [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Procurement costs recognized | 22,604 | $ 54,774 | $ 22,604 | $ 113,907 | $ 171,646 | |
ILÚM Health Solutions, LLC [Member] | Subcontractor Agreement | Service [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Cost of services | $ 84,853 | $ 198,665 |
Subsequent events (Details Text
Subsequent events (Details Textual) - MGHIF Financing Agreement [Member] - USD ($) | Jul. 30, 2018 | Jul. 31, 2015 |
Subsequent Event [Line Items] | ||
Stock issued during period, shares, new issues | 45,454 | |
Common Stock [Member] | Private Placement [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Stock issued during period, shares, new issues | 144,238 | |
Stock issued during period, accrued and unpaid interest due | $ 285,512 | |
Accrued and unpaid interest due date | Jul. 14, 2018 |