Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 03, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
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 | 51,556,436 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 211,683 | $ 4,117,324 |
Accounts receivable, net | 411,762 | 542,420 |
Inventory, net | 578,903 | 692,368 |
Prepaid expenses and other current assets | 423,477 | 329,646 |
Total current assets | 1,625,825 | 5,681,758 |
Property and equipment, net | 784,333 | 800,723 |
Deferred offering costs | 179,150 | 0 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 1,487,090 | 1,620,998 |
Other noncurrent assets | 313,828 | 279,752 |
Total assets | 4,991,040 | 8,984,045 |
Current liabilities | ||
Accounts payable | 2,907,190 | 2,232,563 |
Accrued compensation and benefits | 798,069 | 578,480 |
Accrued liabilities | 972,632 | 1,215,283 |
Deferred revenue | 37,760 | 37,397 |
Short-term notes payable | 629,702 | 1,023,815 |
Current maturities of long-term capital lease obligation | 168,831 | 184,399 |
Total current liabilities | 5,514,184 | 5,271,937 |
Deferred rent | 347,648 | 398,084 |
Warrant liability | 89,291 | 0 |
Note payable | 904,475 | 0 |
Long-term capital lease obligation and other noncurrent liabilities | 273,208 | 146,543 |
Total liabilities | 7,128,806 | 5,816,564 |
Commitments (Note 8) | ||
Stockholders' (deficit) equity | ||
Common stock, $0.01 par value; 200,000,000 shares authorized; 29,365,741 and 25,304,270 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 293,657 | 253,042 |
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 0 | 0 |
Additional paid-in capital | 140,047,090 | 136,199,382 |
Accumulated other comprehensive (loss)/income | (1,415) | 6,176 |
Accumulated deficit | (142,477,098) | (133,291,119) |
Total stockholders’ (deficit) equity | (2,137,766) | 3,167,481 |
Total liabilities and stockholders’ (deficit) equity | $ 4,991,040 | $ 8,984,045 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 29,365,741 | 25,304,270 |
Common stock, shares outstanding | 29,365,741 | 25,304,270 |
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, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenue | ||||
Product sales | $ 681,127 | $ 1,028,146 | $ 1,415,629 | $ 1,975,365 |
Laboratory services | 15,850 | 29,674 | 31,955 | 159,094 |
Collaboration revenue | 6,233 | 125,000 | 27,397 | 125,000 |
Total revenue | 703,210 | 1,182,820 | 1,474,981 | 2,259,459 |
Operating expenses | ||||
Cost of products sold | 392,791 | 337,020 | 817,741 | 682,987 |
Cost of services | 78,763 | 161,222 | 178,996 | 476,931 |
Research and development | 1,762,234 | 2,333,584 | 3,884,749 | 4,287,013 |
General and administrative | 1,750,018 | 1,777,054 | 3,719,234 | 3,315,100 |
Sales and marketing | 909,402 | 1,588,553 | 2,014,988 | 2,987,988 |
Total operating expenses | 4,893,208 | 6,197,433 | 10,615,708 | 11,750,019 |
Operating loss | (4,189,998) | (5,014,613) | (9,140,727) | (9,490,560) |
Other expense | ||||
Interest and other income/(expense) | 22 | (3,874) | 43 | (3,699) |
Interest expense | (53,813) | (26,649) | (83,657) | (68,383) |
Foreign currency transaction gains/(losses) | 8,998 | (7,766) | 11,618 | 3,562 |
Changes in fair value of warrant and conversion option liabilities | 26,744 | 0 | 26,744 | 0 |
Total other expense | (18,049) | (38,289) | (45,252) | (68,520) |
Loss before income taxes | (4,208,047) | (5,052,902) | (9,185,979) | (9,559,080) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (4,208,047) | (5,052,902) | (9,185,979) | (9,559,080) |
Preferred stock dividends and beneficial conversion | 0 | (332,550) | 0 | (332,550) |
Net loss available to common stockholders | $ (4,208,047) | $ (5,385,452) | $ (9,185,979) | $ (9,891,630) |
Net loss per common share - basic and diluted | $ (0.15) | $ (0.37) | $ (0.34) | $ (0.74) |
Weighted average shares outstanding - basic and diluted | 28,210,657 | 14,522,097 | 27,161,931 | 13,545,519 |
Net loss | $ (4,208,047) | $ (5,052,902) | $ (9,185,979) | $ (9,559,080) |
Other comprehensive (loss)/income - foreign currency translation | (3,834) | 1,498 | (7,591) | 387 |
Comprehensive loss | $ (4,211,881) | $ (5,051,404) | $ (9,193,570) | $ (9,558,693) |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Cash flows from operating activities | ||
Net loss | $ (9,185,979) | $ (9,559,080) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 324,412 | 329,969 |
Loss on disposal of property and equipment | 0 | 6,308 |
Noncash interest expense | 19,498 | 2,083 |
Share-based compensation | 454,712 | 527,896 |
Change in fair value of warrant and conversion option liabilities | (26,744) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 130,658 | (191,394) |
Inventory | 113,465 | (18,028) |
Other assets | 81,926 | 41,286 |
Accounts payable | 674,627 | (385,024) |
Accrued compensation and other liabilities | (248,372) | (93,999) |
Deferred revenue | 363 | 54,842 |
Net cash used in operating activities | (7,661,434) | (9,285,141) |
Cash flows from investing activities | ||
Purchases of property and equipment (net of proceeds on disposals) | (174,113) | (49,817) |
Net cash used in investing activities | (174,113) | (49,817) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 3,426,050 | 0 |
Proceeds from issuance of promissory notes, net of issuance costs | 664,461 | 204,895 |
Proceeds from private offering of common stock, preferred stock and warrants, net of issuance costs | 0 | 9,460,749 |
Proceeds from exercise of stock options and warrants | 7,560 | 23,512 |
Payments on debt | (53,047) | (25,328) |
Payments on capital lease obligations | (108,095) | (121,170) |
Net cash provided by financing activities | 3,936,929 | 9,542,658 |
Effects of exchange rates on cash | (7,023) | 3,103 |
Net (decrease)/increase in cash and cash equivalents | (3,905,641) | 210,803 |
Cash and cash equivalents at beginning of period | 4,117,324 | 7,814,220 |
Cash and cash equivalents at end of period | 211,683 | 8,025,023 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 36,131 | 28,777 |
Supplemental disclosures of noncash investing and financing activities: | ||
Unpaid deferred offering costs | $ 179,150 | $ 0 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | Note 1 – Organization OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. References in this report to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland and Woburn, Massachusetts. The Company also has operations in Copenhagen, Denmark. 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 our 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 our Acuitas Rapid Test for complicated urinary tract infection in development, the QuickFISH family of 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 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 its informatics systems are the Acuitas Lighthouse Knowledgebase, a proprietary data warehouse of genomic data matched with antibiotic susceptibility information for bacterial pathogens and its Acuitas Lighthouse informatics, which can be 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, 2017 | |
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 financing arrangements and has raised funds in 2017 and 2016, including: • On May 31, 2017, the Company entered into a Note Purchase Agreement with jVen Capital, LLC, a Delaware limited liability company ("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). 0,845 shares with an exercise price of $0.78 per share, and warrants to acquire 158,730 shares with an exercise price of $0.69 per share . As of June 30, 2017, the Company had drawn down on the first of three Bridge Financing Notes, with $1,000,000 remaining capacity available. The Company drew down on the second • As a condition to the receipt of the bridge financing, the Company issued the Second Amended & Restated Senior Secured Promissory Note (the “MGHIF Note”) to Merck Global Health Innovation Fund, LLC (“MGHIF”) • In September 2016, the Company entered into a 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. Pursuant to the Sales Agreement, Cowen may sell the shares of the Company’s 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 of 1933, as amended (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, 2017, the Company has sold an aggregate of approximately 7.7 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $7.8 million, and gross proceeds of $8.4 million. As of June 30, 2017, remaining availability under the at the market offering is $3.1 million. During the three months ended June 30, 2017, the Company has sold approximately 2.0 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $1.3 million, and gross proceeds of $1.4 million. During the six months ended June 30, 2017, the Company has sold approximately 4.0 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $3.4 million, and gross proceeds of $3.6 million. • In May and June 2016, the Company offered and sold units in a private offering to members of management and employees and to accredited investors, including MGHIF and jVen Capital Holders of the non-voting convertible preferred stock subsequently converted all 2,309,428 shares of preferred stock into 2,309,428 shares of common stock. The stock purchase warrants issued as part of the units are exercisable at a price of $1.3125 per share beginning 90 days after closing for five years, expiring on May 18, 2021. 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 on hand, including the $8.7 million of net proceeds from the sale of common stock and warrants in July 2017 described in Note 11 “Subsequent events,” will be sufficient to fund operations into the first quarter of 2018. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the first quarter of 2018, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2017 | |
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 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 condensed, consolidated financial statements be read in conjunction with the 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, 2016 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but do not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited interim 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 One of the Company’s subsidiaries is located in Copenhagen, Denmark and uses the Danish Krone as its functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at June 30, 2017 and December 31, 2016. 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 condensed consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments and other liabilities measured at fair value on a recurring basis, beneficial conversion features of convertible debt, 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, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. Cash and cash equivalents The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limits of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At June 30, 2017 and December 31, 2016, 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 condensed consolidated balance sheets. Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $24,783 and $26,716 as of June 30, 2017 and December 31, 2016, respectively. No individual customer represented in excess of 10% of revenues for the three months ended June 30, 2017. Revenue earned from two customers represented 10% and 11%, respectively, of total revenues for the three months ended June 30, 2016. No individual customer represented in excess of 10% of revenues for the six months ended June 30, 2017. Revenue earned from one customer represented 10% of total revenues for the six months ended June 30, 2016. At June 30, 2017, no individual customer represented in excess of 10% of total accounts receivable. At June 30, 2016, accounts receivable from one customer represented 20% of the total accounts receivable. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or market and consist of the following: June 30, 2017 December 31, 2016 Raw materials and supplies $ 329,904 $ 479,479 Work-in process 48,185 27,422 Finished goods 200,814 185,467 Total $ 578,903 $ 692,368 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 $148,160 and $704,516 at June 30, 2017 and December 31, 2016, respectively. The primary driver of the decrease in the inventory reserves for obsolescence and expirations is the disposal of legacy Argus Whole Genome Mapping Systems and the portion of the reagents and supplies used for Argus consumable kits. All items disposed in the six months ended June 30, 2017 related to Argus were fully reserved for as of December 31, 2016. Long-lived assets Property and equipment Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2017 and 2016, the Company determined that its property and equipment was not impaired. Intangible assets and goodwill Intangible assets and goodwill as of June 30, 2017 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, 2017 and December 31, 2016: June 30, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and trade names $ 461,000 $ (90,627 ) $ 370,373 $ (67,575 ) $ 393,425 Developed technology 458,000 (128,610 ) 329,390 (95,898 ) 362,102 Customer relationships 1,094,000 (306,673 ) 787,327 (228,529 ) 865,471 $ 2,013,000 $ (525,910 ) $ 1,487,090 $ (392,002 ) $ 1,620,998 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks was 10 years, developed technology was 7 years, and customer relationships was 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, 2017 and 2016. Total amortization expense of intangible assets was $133,908 for each of the six months ended June 30, 2017 and 2016, respectively. The Company estimates amortization expense related to intangible assets will be $268,000 per year for each of the next five years. 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, 2017 and 2016, 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, 2017 and December 31, 2016 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. Revenue recognition The Company recognizes revenue primarily from sales of its products and services when the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred; the selling price is fixed or determinable; and collectability is reasonably assured. At times, the Company sells products and services, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. Amounts billed to customers for shipping and handling are included in revenue when the related product or service revenue is recognized. Shipping and handling costs are included in cost of products sold. Revenue from sales of QuickFISH, PNA FISH and XpressFISH diagnostic test products Revenue is recognized upon shipment to the customer. Revenue from providing laboratory services The Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to the customer. Revenue from funded software development arrangements The Company’s funded software development arrangements generally consist of multiple elements. Total arrangement consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. When funded software development arrangements include substantive research and development milestones, revenue is recognized for each such milestone when the milestone is achieved and is due and collectible. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement of the milestone. Revenue from license arrangements The Company recognizes revenue from licenses of its technologies over the applicable license term. Revenue from sales of the reagents and supplies used for Argus consumable kits Revenue is recognized for sales of the reagents and supplies used for Argus consumable kits upon shipment to the customer. 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 $151.0 million at December 31, 2016. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 14.3 million shares and 16.3 million shares as of June 30, 2017 and 2016, respectively. The number of anti-dilutive shares stated above excludes shares related to the possible conversion of convertible debt and convertible preferred stock related to the Bridge Financing Note described in Note 6 “Debt” which was subsequently repaid in July 2017. Recent accounting pronouncements In May 2014, the FASB issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, with early adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify the implementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April 2016, the FASB issued guidance to clarify the identification of performance obligations and licensing arrangements. In May 2016, the FASB issued guidance addressing the presentation of sales and other similar taxes collected from customers, providing clarification of the collectability criterion assessment, as well as clarifying certain transition requirements. The Company has identified its major revenue streams and it plans on completing formal contract reviews in the second half of 2017. While the Company continues to assess all of the potential impacts of these ASUs, the Company does not expect the implementation of these ASUs to have a significant impact on the Company’s results of operations, financial position and cash flows. The Company will assess the disclosure requirements prescribed by these ASUs in the second half of 2017 and it may be required to expand its disclosures. The Company will assess the method of adoption in the second half of 2017 . In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standard is effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company adopted this guidance effective January 1, 2017 on a prospective basis. The adoption of this new guidance did not have a material impact on the Company’s consolidated financial statements. 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. The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its results of operations, financial position, or cash flows. |
2015 MGHIF financing
2015 MGHIF financing | 6 Months Ended |
Jun. 30, 2017 | |
Common Stock And Note Purchase Agreement [Abstract] | |
2015 MGHIF financing | Note 4 – 2015 MGHIF financing In July 2015, in connection with the Merger, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 1,136,364 shares of common stock of the Company at $4.40 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the “MGHIF Note”) in the principal amount of $1.0 million with a two-year maturity date from the date of issuance. The Company’s obligations under the MGHIF Note are secured by a lien on all of the Company’s assets. Under the Purchase Agreement, MGHIF has the right to participate in future securities offerings made by the Company. 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. The Company incurred issuance costs of approximately $50,000 related to the financing. Approximately $8,000 of the issuance costs were deferred as debt issuance costs and netted against notes payable in the accompanying condensed consolidated balance sheets is a result of the Company’s adoption of the new accounting guidance in 2016, and are being amortized as interest expense over the life of the MGHIF Note. The remaining $42,000 of issuance costs were charged to additional paid-in capital. On June 6, 2017, 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 of the MGHIF Note, 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 327,995 shares of its common stock to MGHIF The amendment of the MGHIF Note was treated as a debt modification and as such the issuance date fair value of the warrants is deferred and amortized as incremental interest expense over the term of MGHIF Note. The warrants are classified as mark to market liabilities under ASC 480, Distinguishing Liabilities from Equity The estimated fair value of the MGHIF Note is $1.0 million as of June 30, 2017 and December 31, 2016 which approximates carry value given the short time lapse since modification, prevailing interest rates and maturity date |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 5 - Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - defined as observable inputs such as quoted prices in active markets; • Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and • Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. For the six months ended June 30, 2017, 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 Company accounts for the conversion option embedded in the Bridge Financing Notes as a mark-to-market derivative financial instrument. The Company determines the fair value of the embedded conversion option liability using a probability-weighted expected return method. Using this method, level 3 unobservable inputs include the probability of default, the probability of a qualified financing, the probability of conversion, the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates, among other inputs. The 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 three and six months ended June 30, 2017: Description Balance at December 31, 2016 Established in 2017 Changes in Fair Value Reclassified to Equity Balance at June 30, 2017 Embedded conversion option liability $ — $ 4,500 $ — $ — $ 4,500 Warrant liability $ — $ 116,035 $ (26,744 ) $ — $ 89,291 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, 2017 and 2016. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 - Debt As of June 30, 2017, the Company’s outstanding short-term debt consisted of the $0.5 million of Bridge Financing Notes (see discussion in Note 2 “Liquidity and management’s plans), net of discounts and offering costs, along with a financing arrangement for the Company’s insurance with a note balance of approximately $ The Company has 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 are reflected in earnings during the period of change. 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. As of June 30, 2017, the Company had drawn down on the first of three Bridge Financing Notes, with $1,000,000 remaining capacity available. The Company drew down on the second Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $53,813 and $26,649 for the three months ended June 30, 2017 and 2016, respectively. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $83,657 and $68,383 for the six months ended June 30, 2017 and 2016, respectively. |
Stockholders' equity
Stockholders' equity | 6 Months Ended |
Jun. 30, 2017 | |
Stockholders Equity Note [Abstract] | |
Stockholders' equity | Note 7 - Stockholders’ equity As of June 30, 2017, the Company has 200,000,000 shares of authorized common stock and 29,365,741 issued and outstanding, and 10,000,000 authorized preferred shares, of which none were issued or outstanding. In September 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company 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, 2017, the Company has sold an aggregate of approximately 7.7 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $7.8 million, and gross proceeds of $8.4 million. As of June 30, 2017, remaining availability under the at the market offering is $3.1 million. During the three months ended June 30, 2017, the Company has sold approximately 2.0 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $1.3 million, and gross proceeds of $1.4 million. During the six months ended June 30, 2017, the Company has sold approximately 4.0 million shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $3.4 million, and gross proceeds of $3.6 million. In May and June 2016, the Company offered and sold units in a private offering to members of management and employees and to accredited investors, including MGHIF and jVen Capital, each unit consisting of either (i) one share of common stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to the Company, after deducting offering commissions and expenses was $9.5 million. Pursuant to the private placement the Company issued 6,744,127 shares of common stock, 2,309,428 of Series A non-voting convertible preferred stock and stock purchase warrants to acquire an additional 6,790,169 shares of common stock. Under the purchase agreement, the Company granted registration rights to the investors in the private financing. Each share of Series A non-voting convertible preferred stock was convertible at the option of the holder in whole or in part and from time to time into one share of common stock, was entitled to dividends on an “as converted basis” when and if dividends are issued to common stockholders, and would have participated in liquidation on a pari passu The Company filed a registration statement on Form S-3 on June 13, 2016 to register for resale by the investors, from time to time, of the shares of common stock acquired, or underlying the warrants issued, in the private offering. On July 20, 2016, the registration statement was declared effective by the SEC. 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) 1,355,000 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, 2017, 1,275,950 shares remain available for issuance under the 2015 Plan, which includes 1,012,171 shares automatically added to the 2015 Plan on January 1, 2017. On April 28, 2016, the Board of Directors of the Company made a stock option award to Evan Jones, the Company’s Chief Executive Officer (“CEO”) and Chairman of the Board. The non-qualified stock option award to acquire 766,500 shares of common stock represented approximately 6% of outstanding shares of common stock as of the date of the award. The stock option grant has an exercise price of $1.35 per share, a ten-year term and a vesting schedule of 25% vesting of the award on the first annual anniversary of the date of grant and then 6.25% vesting each quarter thereafter over three additional years. The plan under which the award was made incorporates by reference the provisions of the Company’s 2015 Plan applicable to stock option awards. The stock option award was contingent on receipt of stockholder approval, as the award was made outside of the Company’s stockholder-approved incentive plans. The stockholders approved the stock option award at the Company’s Annual Meeting of Stockholders held on June 22, 2016. For the three and six months ended June 30, 2017 and 2016, the Company recognized stock compensation expense as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Cost of services $ 2,145 $ 696 $ 3,968 $ 5,008 Research and development 52,777 73,204 110,555 135,422 General and administrative 160,419 177,025 312,895 349,128 Sales and marketing (6,034 ) 15,474 27,294 38,338 $ 209,307 $ 266,399 $ 454,712 $ 527,896 No income tax benefit for stock-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, 2017, the Company granted stock options to acquire 146,000 shares of common stock at a weighted average exercise price of $0.73 per share and a weighted average grant date fair value of $0.34 per share. 303,047 options were forfeited during the three months ended June 30, 2017 at a weighted average exercise price of $1.46 per share. During the six months ended June 30, 2017, the Company granted stock options to acquire 869,600 shares of common stock at a weighted average exercise price of $0.98 per share and a weighted average grant date fair value of $0.51 per share. 307,910 options were forfeited during the six months ended June 30, 2017 at a weighted average exercise price of $1.47 per share. The Company had total stock options to acquire 3,340,224 shares of common stock outstanding at June 30, 2017. Restricted stock units During the three months ended June 30, 2017, the Company granted restricted stock units to acquire 26,500 shares of common stock, with a weighted average grant date fair value of $0.63. In the fourth quarter of 2015, the Company granted restricted stock units to acquire 75,000 shares of common stock, with a weighted average grant date fair value of $1.70 per share, 45,250 shares of which remain outstanding as of June 30, 2017. No restricted stock units vested and no restricted stock units were forfeited during the three and six months ended June 30, 2017. Stock purchase warrants At June 30, 2017 and December 31, 2016, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration June 30, 2017 December 31, 2016 August 2007 $ 7.91 August 2017 8,921 8,921 March 2008 $ 790.54 March 2018 46 46 November 2009 $ 7.91 November 2019 6,674 6,674 January 2010 $ 7.91 January 2020 6,674 6,674 March 2010 $ 7.91 March 2020 1,277 1,277 November 2011 $ 7.91 November 2021 5,213 5,213 December 2011 $ 7.91 December 2021 664 664 March 2012 $ 109.90 March 2019 4,125 4,125 February 2015 $ 6.60 February 2025 225,011 225,011 May 2015 $ 6.60 May 2020 3,457,750 3,457,750 May 2016 $ 1.31 May 2021 4,739,348 4,739,348 June 2016 $ 1.31 May 2021 2,050,821 2,050,821 June 2017 $ 0.78 June 2022 398,418 — 10,904,942 10,506,524 The warrants listed above were issued in connection with various debt, equity or development contract agreements. |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | Note 8 - Commitments Operating leases The Company leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. The Company also 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. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis. Rent expense under the Company’s facility operating leases for the three months ended June 30, 2017 and 2016 was $238,703 and $248,345, respectively. Rent expense under the Company’s facility operating leases for the six months ended June 30, 2017 and 2016 was $471,539 and $502,389, 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. The Company expects these actions to reduce operating expenses by 25-30 percent by the fourth quarter of 2017. The restructuring plans anticipate that the Company will consolidate operations for FDA-cleared and CE marked products and research and development activities for the Acuitas Rapid Test in Gaithersburg, Maryland, and reduce the size of its commercial organization while the Company works to complete the development of its Acuitas Rapid Test and Acuitas Lighthouse Knowledgebase products and services in development. There were approximately $128,000 of one-time termination benefits that were recognized during the three and six months ended June 30, 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 period end dates range from the end of August to the end of December 2017. The Company expects to incur total retention expense of approximately $63,000 of which approximately $13,000 was incurred during the three and six months ended June 30, 2017. The future minimum lease payments for the Woburn facility were approximately $2 million as of June 30, 2017. 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 Q1 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 preliminary sublease pursuit activities. We do not believe there will be significant additional costs related to restructuring outside of what is described herein. |
License agreements, research co
License agreements, research collaborations and development agreements | 6 Months Ended |
Jun. 30, 2017 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 9 - License agreements, research collaborations and development agreements The Company is a party to one license agreement to acquire certain patent rights and technologies In June 2016, the Company entered into a license agreement with Hitachi High-Technologies Corporation (“Hitachi”), pursuant to which it resolved various matters with respect to previously delivered milestones under the technology development agreement and provided a development license and commercial products license to certain technology. The license agreement contains non-contingent multiple elements (the licenses) that the Company determined did not have stand alone value, and a contingent substantive milestone. The licenses are treated as a single unit of accounting and the Company will recognize the revenue associated with that unit of accounting over the applicable license period. During the three and six months ended June 30, 2017, the Company recognized $6,233 and $12,397, respectively, of revenue related to the license agreement. |
Related party transactions
Related party transactions | 6 Months Ended |
Jun. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related party transactions | Note 10 - Related party transactions In March 2014, the Company entered into a supply agreement with Fluidigm Corporation (“Fluidigm”) under which Fluidigm supplies the Company with its microfluidic test platform for use in manufacturing the Acuitas MDRO Gene Test. The Company’s CEO and Chairman of the Board of Directors is a director of Fluidigm. On July 12, 2015, the Company entered into a letter agreement (the “Fluidigm Agreement”) with Fluidigm to expand the companies’ existing relationship to include collaborating on the development of test kits and custom analytic instruments for identification, screening and surveillance testing of MDROs. The Fluidigm Agreement also expands the existing Supply Agreement between the Company and Fluidigm, and provides for expansion of the gene targets and organisms to be tested on the Company’s existing CLIA lab-based tests, the Acuitas MDRO Gene Test and the Acuitas Resistome Test, using Fluidigm technologies and products. Additionally, Fluidigm has agreed not to develop or directly collaborate with any third party to develop an FDA approved or CE-marked diagnostic test for the purpose of detecting resistance genes for identified MDROs if the Company meets certain minimum purchase commitments and other requirements. The initial term of the Fluidigm Agreement is five years. Both parties have the ability to extend the term for an additional five years. Under the expanded Supply Agreement, the term was extended until March 17, 2018, and the Company has the right to extend the term of the Supply Agreement for up to two additional three-year terms. The Company paid $0 and $66,865 related to these agreements in the three months ended June 30, 2017 and 2016, respectively. The Company paid $44,721 and $160,089 related to these agreements in the six months ended June 30, 2017 and 2016, respectively. Under the Supply Agreement with Fluidigm, the Company had inventory purchases of $45,758 and $0 in the three months ended June 30, 2017 and 2016, respectively. Under the Supply Agreement with Fluidigm, the Company had inventory purchases of $90,479 and $67,775 in the six months ended June 30, 2017 and 2016, respectively. In addition, the Company has several capital lease arrangements for laboratory equipment manufactured by Fluidigm. The Company paid $30,254 and $45,106 related to the leased equipment in the three months ended June 30, 2017 and 2016, respectively. The Company paid $60,517 and $90,212 related to the leased equipment in the six months ended June 30, 2017 and 2016, respectively. In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp., a wholly-owned subsidiary of Merck Co. & Inc. (“Merck”), an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $146,177 of procurement costs which have been recognized as research and development expense, including $54,774 and $113,907 in the three and six months ended June 30, 2017, respectively. |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent events | Note 11 – Subsequent events On July 18, 2017 the Company closed a 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 $8.7 million (the “July 2017 Public Offering”). jVen Capital was one of the investors included in the offering. Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. Approximately $1 million of the gross proceeds was used to repay the outstanding Bridge Financing Notes in July, 2017. Four million pre-funded warrants were exercised in July 2017. As discussed in Note 2 “Liquidity and management’s plans,” 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. The interest rate on each Bridge Financing Notes 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). 0,845 shares with an exercise price of $0.78 per share, and warrants to acquire 158,730 shares with an exercise price of $0.69 per share . As of June 30, 2017, the Company had drawn down on the first of three Bridge Financing Notes, with $1,000,000 remaining capacity available. The Company drew down on the second |
Summary of significant accoun17
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
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 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 condensed, consolidated financial statements be read in conjunction with the 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, 2016 consolidated balance sheet included herein was derived from the audited consolidated financial statements, but do not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited interim 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 One of the Company’s subsidiaries is located in Copenhagen, Denmark and uses the Danish Krone as its functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at June 30, 2017 and December 31, 2016. 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 condensed consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments and other liabilities measured at fair value on a recurring basis, beneficial conversion features of convertible debt, 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, inventory, prepaid expenses, other current assets, accounts payable and accrued expenses, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (“FDIC”) insured limits of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. At June 30, 2017 and December 31, 2016, 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 condensed consolidated balance sheets. |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $24,783 and $26,716 as of June 30, 2017 and December 31, 2016, respectively. No individual customer represented in excess of 10% of revenues for the three months ended June 30, 2017. Revenue earned from two customers represented 10% and 11%, respectively, of total revenues for the three months ended June 30, 2016. No individual customer represented in excess of 10% of revenues for the six months ended June 30, 2017. Revenue earned from one customer represented 10% of total revenues for the six months ended June 30, 2016. At June 30, 2017, no individual customer represented in excess of 10% of total accounts receivable. At June 30, 2016, accounts receivable from one customer represented 20% of the total accounts receivable. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or market and consist of the following: June 30, 2017 December 31, 2016 Raw materials and supplies $ 329,904 $ 479,479 Work-in process 48,185 27,422 Finished goods 200,814 185,467 Total $ 578,903 $ 692,368 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 $148,160 and $704,516 at June 30, 2017 and December 31, 2016, respectively. The primary driver of the decrease in the inventory reserves for obsolescence and expirations is the disposal of legacy Argus Whole Genome Mapping Systems and the portion of the reagents and supplies used for Argus consumable kits. All items disposed in the six months ended June 30, 2017 related to Argus were fully reserved for as of December 31, 2016. |
Property and equipment | Property and equipment Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and six months ended June 30, 2017 and 2016, 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, 2017 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, 2017 and December 31, 2016: June 30, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and trade names $ 461,000 $ (90,627 ) $ 370,373 $ (67,575 ) $ 393,425 Developed technology 458,000 (128,610 ) 329,390 (95,898 ) 362,102 Customer relationships 1,094,000 (306,673 ) 787,327 (228,529 ) 865,471 $ 2,013,000 $ (525,910 ) $ 1,487,090 $ (392,002 ) $ 1,620,998 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks was 10 years, developed technology was 7 years, and customer relationships was 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, 2017 and 2016. Total amortization expense of intangible assets was $133,908 for each of the six months ended June 30, 2017 and 2016, respectively. The Company estimates amortization expense related to intangible assets will be $268,000 per year for each of the next five years. 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, 2017 and 2016, 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, 2017 and December 31, 2016 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. |
Revenue recognition | Revenue recognition The Company recognizes revenue primarily from sales of its products and services when the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred; the selling price is fixed or determinable; and collectability is reasonably assured. At times, the Company sells products and services, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. Amounts billed to customers for shipping and handling are included in revenue when the related product or service revenue is recognized. Shipping and handling costs are included in cost of products sold. Revenue from sales of QuickFISH, PNA FISH and XpressFISH diagnostic test products Revenue is recognized upon shipment to the customer. Revenue from providing laboratory services The Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to the customer. Revenue from funded software development arrangements The Company’s funded software development arrangements generally consist of multiple elements. Total arrangement consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. When funded software development arrangements include substantive research and development milestones, revenue is recognized for each such milestone when the milestone is achieved and is due and collectible. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement of the milestone. Revenue from license arrangements The Company recognizes revenue from licenses of its technologies over the applicable license term. Revenue from sales of the reagents and supplies used for Argus consumable kits Revenue is recognized for sales of the reagents and supplies used for Argus consumable kits upon shipment to the customer. |
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 $151.0 million at December 31, 2016. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 14.3 million shares and 16.3 million shares as of June 30, 2017 and 2016, respectively. The number of anti-dilutive shares stated above excludes shares related to the possible conversion of convertible debt and convertible preferred stock related to the Bridge Financing Note described in Note 6 “Debt” which was subsequently repaid in July 2017. |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the FASB issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, with early adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify the implementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April 2016, the FASB issued guidance to clarify the identification of performance obligations and licensing arrangements. In May 2016, the FASB issued guidance addressing the presentation of sales and other similar taxes collected from customers, providing clarification of the collectability criterion assessment, as well as clarifying certain transition requirements. The Company has identified its major revenue streams and it plans on completing formal contract reviews in the second half of 2017. While the Company continues to assess all of the potential impacts of these ASUs, the Company does not expect the implementation of these ASUs to have a significant impact on the Company’s results of operations, financial position and cash flows. The Company will assess the disclosure requirements prescribed by these ASUs in the second half of 2017 and it may be required to expand its disclosures. The Company will assess the method of adoption in the second half of 2017 . In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standard is effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company adopted this guidance effective January 1, 2017 on a prospective basis. The adoption of this new guidance did not have a material impact on the Company’s consolidated financial statements. 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. The Company has evaluated all other issued and unadopted Accounting Standards Updates 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 accoun18
Summary of significant accounting policies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or market and consist of the following: June 30, 2017 December 31, 2016 Raw materials and supplies $ 329,904 $ 479,479 Work-in process 48,185 27,422 Finished goods 200,814 185,467 Total $ 578,903 $ 692,368 |
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, 2017 and December 31, 2016 June 30, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and trade names $ 461,000 $ (90,627 ) $ 370,373 $ (67,575 ) $ 393,425 Developed technology 458,000 (128,610 ) 329,390 (95,898 ) 362,102 Customer relationships 1,094,000 (306,673 ) 787,327 (228,529 ) 865,471 $ 2,013,000 $ (525,910 ) $ 1,487,090 $ (392,002 ) $ 1,620,998 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 three and six months ended June 30, 2017: Description Balance at December 31, 2016 Established in 2017 Changes in Fair Value Reclassified to Equity Balance at June 30, 2017 Embedded conversion option liability $ — $ 4,500 $ — $ — $ 4,500 Warrant liability $ — $ 116,035 $ (26,744 ) $ — $ 89,291 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Stockholders Equity Note [Abstract] | |
Schedule of Company Recognized Stock Compensation Expense | For the three and six months ended June 30, 2017 and 2016, the Company recognized stock compensation expense as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Cost of services $ 2,145 $ 696 $ 3,968 $ 5,008 Research and development 52,777 73,204 110,555 135,422 General and administrative 160,419 177,025 312,895 349,128 Sales and marketing (6,034 ) 15,474 27,294 38,338 $ 209,307 $ 266,399 $ 454,712 $ 527,896 |
Schedule of Warrants to Purchase Shares of Common Stock | Stock purchase warrants At June 30, 2017 and December 31, 2016, the following warrants to purchase shares of common stock were outstanding: Outstanding at Issuance Exercise Price Expiration June 30, 2017 December 31, 2016 August 2007 $ 7.91 August 2017 8,921 8,921 March 2008 $ 790.54 March 2018 46 46 November 2009 $ 7.91 November 2019 6,674 6,674 January 2010 $ 7.91 January 2020 6,674 6,674 March 2010 $ 7.91 March 2020 1,277 1,277 November 2011 $ 7.91 November 2021 5,213 5,213 December 2011 $ 7.91 December 2021 664 664 March 2012 $ 109.90 March 2019 4,125 4,125 February 2015 $ 6.60 February 2025 225,011 225,011 May 2015 $ 6.60 May 2020 3,457,750 3,457,750 May 2016 $ 1.31 May 2021 4,739,348 4,739,348 June 2016 $ 1.31 May 2021 2,050,821 2,050,821 June 2017 $ 0.78 June 2022 398,418 — 10,904,942 10,506,524 |
Organization - Additional Infor
Organization - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2017Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating business segment | 1 |
Liquidity and Management's Pl22
Liquidity and Management's Plans - Additional Information (Details) - USD ($) | Jul. 18, 2017 | Jun. 30, 2017 | Jun. 28, 2017 | Jun. 30, 2017 | May 31, 2017 | Sep. 30, 2016 | Jun. 30, 2016 | May 31, 2016 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Jul. 31, 2017 |
Conversion Of Stock [Line Items] | |||||||||||||
Net proceeds from sale of common stock | $ 3,426,050 | $ 0 | |||||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | $ 0 | $ 9,460,749 | ||||||||||
May 2016 Warrant [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.3125 | $ 1.3125 | |||||||||||
Warrant expiration period | 5 years | 5 years | |||||||||||
Expiration date of warrants issued | May 18, 2021 | ||||||||||||
June 2016 Warrant [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | ||||||
Warrant expiration period | 5 years | 5 years | |||||||||||
Expiration date of warrants issued | May 18, 2021 | ||||||||||||
Private Placement [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 6,790,169 | 6,790,169 | 6,790,169 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.14 | $ 1.14 | $ 1.14 | ||||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | ||||||||||||
Sale of stock, description of transaction | (i) one share of common stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. | ||||||||||||
July 2017 Public Offering [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. | ||||||||||||
Second Amended and Restated MGHIF Financing Agreement [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Interest rate | 10.00% | ||||||||||||
Maturity date | Jul. 14, 2017 | ||||||||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||||||||
Percentage of warrants to purchase common stock shares on outstanding pricnipal and accrued interest on issuance date | 20.00% | ||||||||||||
Common Stock [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Conversion of stock, shares issued | 2,309,428 | ||||||||||||
Common Stock [Member] | Private Placement [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | 6,744,127 | ||||||||||||
Non-voting Convertible Preferred Stock [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Conversion of stock, shares converted | 2,309,428 | ||||||||||||
Non-voting Convertible Preferred Stock [Member] | Private Placement [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | 2,309,428 | ||||||||||||
Bridge Financing Notes [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Remaining capacity available under financing | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | |||||||||
Subsequent Event [Member] | July 2017 Public Offering [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.425 | ||||||||||||
Stock issued during period, shares, new issues | 18,164,195 | ||||||||||||
Net proceeds from sale of common stock and warrants | $ 8,700,000 | ||||||||||||
Note Purchase Agreement [Member] | Bridge Financing Notes [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Interest rate | 10.00% | ||||||||||||
Maturity date | Sep. 30, 2017 | ||||||||||||
Remaining capacity available under financing | 1,000,000 | 1,000,000 | 1,000,000 | $ 1,000,000 | |||||||||
Note Purchase Agreement [Member] | Bridge Financing Notes [Member] | Maximum [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | $ 1,500,000 | ||||||||||||
Note Purchase Agreement [Member] | Bridge Financing Note One [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||
Note Purchase Agreement [Member] | Bridge Financing Note Two [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||
Note Purchase Agreement [Member] | Bridge Financing Note Three [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||
Note Purchase Agreement [Member] | Qualified Financing [Member] | Minimum [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Net proceeds from equity or debt financing | $ 5,000,000 | ||||||||||||
Note Purchase Agreement [Member] | Subsequent Event [Member] | Bridge Financing Notes [Member] | Stock Purchase Warrants [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 140,845 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.78 | ||||||||||||
Note Purchase Agreement [Member] | Subsequent Event [Member] | Bridge Financing Notes [Member] | Warrants [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 158,730 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.69 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Bridge Financing Notes [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Interest rate | 10.00% | ||||||||||||
Maturity date | Sep. 30, 2017 | ||||||||||||
Remaining capacity available under financing | 1,000,000 | $ 1,000,000 | 1,000,000 | $ 1,000,000 | |||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Bridge Financing Notes [Member] | Maximum [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | $ 1,500,000 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Bridge Financing Note One [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Bridge Financing Note Two [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Bridge Financing Note Three [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate principal amount | $ 500,000 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Qualified Financing [Member] | Minimum [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Net proceeds from equity or debt financing | 5,000,000 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Subsequent Event [Member] | Bridge Financing Notes [Member] | Stock Purchase Warrants [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 140,845 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.78 | ||||||||||||
Delaware Limited Liability Company [Member] | Note Purchase Agreement [Member] | Subsequent Event [Member] | Bridge Financing Notes [Member] | Warrants [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 158,730 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.69 | ||||||||||||
Cowen and Company, LLC [Member] | Sales Agreement [Member] | At the Market Offering [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | ||||||||||||
Maximum commission percentage on gross proceeds | 3.00% | ||||||||||||
Net proceeds from sale of common stock | 7,800,000 | 1,300,000 | 3,400,000 | ||||||||||
Gross proceeds from sale of common stock | 8,400,000 | $ 1,400,000 | $ 3,600,000 | ||||||||||
Remaining availability under at the market offering | $ 3,100,000 | $ 3,100,000 | |||||||||||
Cowen and Company, LLC [Member] | Sales Agreement [Member] | Maximum [Member] | At the Market Offering [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | ||||||||||||
Cowen and Company, LLC [Member] | Sales Agreement [Member] | Common Stock [Member] | At the Market Offering [Member] | |||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | 7,700,000 | 2,000,000 | 4,000,000 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017USD ($)Customer | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)SegmentCustomershares | Jun. 30, 2016USD ($)shares | Dec. 31, 2016USD ($) | |
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 | 243,380 | 243,380 | $ 243,380 | ||
Allowance for doubtful accounts receivable | $ 24,783 | $ 24,783 | 26,716 | ||
Number of individual customers accounting for more than 10% of revenue | Customer | 0 | 0 | |||
Number of individual customers accounting for more than 10% of accounts receivable | Customer | 0 | 0 | |||
Inventory valuation reserves | $ 148,160 | $ 148,160 | 704,516 | ||
Amortization of intangible assets | 66,954 | $ 66,954 | 133,908 | $ 133,908 | |
Finite-lived intangible assets, amortization expense, next twelve months | 268,000 | 268,000 | |||
Finite-lived intangible assets, amortization expense, 2019 | 268,000 | 268,000 | |||
Finite-lived intangible assets, amortization expense, 2020 | 268,000 | 268,000 | |||
Finite-lived intangible assets, amortization expense, 2021 | 268,000 | 268,000 | |||
Finite-lived intangible assets, amortization expense, 2022 | 268,000 | 268,000 | |||
Impairment of finite-lived intangible assets | 0 | $ 0 | 0 | $ 0 | |
Goodwill | $ 600,814 | $ 600,814 | 600,814 | ||
Operating loss carryforwards | $ 151,000,000 | ||||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 14.3 | 16.3 | |||
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 | ||||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Customer One [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 10.00% | 10.00% | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 11.00% | ||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | |||||
Significant Accounting Policies [Line Items] | |||||
Concentration Risk, Percentage | 20.00% | ||||
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 Accoun24
Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Inventories | ||
Raw materials and supplies | $ 329,904 | $ 479,479 |
Work-in process | 48,185 | 27,422 |
Finished goods | 200,814 | 185,467 |
Total | $ 578,903 | $ 692,368 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Jun. 30, 2017 | Dec. 31, 2016 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (525,910) | (392,002) |
Net Balance | 1,487,090 | 1,620,998 |
Trademarks and Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (90,627) | (67,575) |
Net Balance | 370,373 | 393,425 |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (128,610) | (95,898) |
Net Balance | 329,390 | 362,102 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (306,673) | (228,529) |
Net Balance | $ 787,327 | $ 865,471 |
2015 MGHIF Financing - Addition
2015 MGHIF Financing - Additional Information (Details) - USD ($) | Jun. 06, 2017 | Jul. 31, 2015 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 |
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,426,050 | $ 0 | |||||
Fair value adjustment of warrants | $ (26,744) | $ 0 | (26,744) | $ 0 | |||
MGHIF Financing Agreement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 1,136,364 | ||||||
Shares issued, price per share | $ 4.40 | ||||||
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 | ||||||
Fees related to common stock and debt transaction | 50,000 | ||||||
Deferred debt issuance costs | 8,000 | ||||||
Adjustments to additional paid in capital, stock issued, issuance costs | $ 42,000 | ||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||
Estimated fair value of debt | $ 1,000,000 | 1,000,000 | $ 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% | ||||||
Warrant expiration period | 5 years | ||||||
Issuance of common stock warrants to purchase | 327,995 | ||||||
Warrants first exercisable period after issuance date | 6 months | ||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.78 | ||||||
Percentage of warrant exercise price on common stock closing price on date of issuance | 110.00% | ||||||
Amended and Restated MGHIF Financing Agreement [Member] | Black-Scholes Model [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Fair value adjustment of warrants | $ 100,000 |
Fair value measurements (Detail
Fair value measurements (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
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) | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Embedded Conversion Option Liability [Member] | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | $ 0 |
Established in 2017 | 4,500 |
Reclassified to Equity | 0 |
Balance at the end of the period | 4,500 |
Warrant Liability [Member] | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | 0 |
Established in 2017 | 116,035 |
Changes in Fair Value | (26,744) |
Reclassified to Equity | 0 |
Balance at the end of the period | $ 89,291 |
Debt (Details Textual)
Debt (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||||
Short-term debt | $ 629,702 | $ 629,702 | $ 1,023,815 | ||
Interest expense, debt | 53,813 | $ 26,649 | 83,657 | $ 68,383 | |
Due in 2017 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 500,000 | 500,000 | |||
Due in 2018 [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, annual principal payment | 1,000,000 | 1,000,000 | |||
MGHIF Financing Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Long-term debt, outstanding | 1,000,000 | 1,000,000 | $ 1,000,000 | ||
Bridge Financing Note [Member] | |||||
Debt Instrument [Line Items] | |||||
Short-term debt | 500,000 | 500,000 | |||
Notes Payable, Other Payables [Member] | |||||
Debt Instrument [Line Items] | |||||
Short-term debt | 200,000 | 200,000 | |||
Bridge Financing Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Remaining capacity available under financing | $ 1,000,000 | $ 1,000,000 |
Stockholders' equity (Details T
Stockholders' equity (Details Textual) - USD ($) | Jun. 30, 2017 | Apr. 28, 2016 | Jan. 01, 2016 | Jun. 30, 2017 | May 31, 2017 | Sep. 30, 2016 | Jun. 30, 2016 | May 31, 2016 | Jun. 30, 2016 | Jun. 30, 2017 | Dec. 31, 2015 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | |||||||||
Common stock, shares issued | 29,365,741 | 29,365,741 | 29,365,741 | 29,365,741 | 25,304,270 | |||||||||
Common stock, shares outstanding | 29,365,741 | 29,365,741 | 29,365,741 | 29,365,741 | 25,304,270 | |||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||
Preferred stock, shares issued | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | 0 | 0 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,426,050 | $ 0 | ||||||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | 0 | $ 9,460,749 | |||||||||||
Convertible preferred stock, beneficial conversion feature recognized as deemed dividend | $ 332,550 | |||||||||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, gross | 146,000 | 869,600 | ||||||||||||
Share-based compensation, tax benefit from compensation expense | $ 0 | |||||||||||||
Share-based compensation arrangements by share-based payment award, options, grants in Period, weighted average exercise price | $ 0.73 | $ 0.98 | ||||||||||||
Share-based compensation arrangement by share-based payment award, options, forfeitures in period | 303,047 | 307,910 | ||||||||||||
Share-based compensation arrangements by share-based payment award, options, forfeitures in period, weighted average exercise price | $ 1.46 | $ 1.47 | ||||||||||||
Stock options | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value | $ 0.34 | $ 0.51 | ||||||||||||
Share-based compensation arrangement by share-based payment award, options, outstanding, number | 3,340,224 | 3,340,224 | 3,340,224 | 3,340,224 | ||||||||||
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, grants in period | 26,500 | 75,000 | ||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period, weighted average grant date fair value | $ 0.63 | $ 1.70 | ||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding | 45,250 | 45,250 | 45,250 | 45,250 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period | 0 | 0 | ||||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period | 0 | 0 | ||||||||||||
Chief Executive Officer [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, gross | 766,500 | |||||||||||||
Percentage of total outstanding shares of common stock | 6.00% | |||||||||||||
Share based compensation arrangements by share based payment award options grants in period exercise price | $ 1.35 | |||||||||||||
Share based compensation arrangements by share based payment award contractual term | 10 years | |||||||||||||
Chief Executive Officer [Member] | Share-based Compensation Award, Tranche One [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting rights, percentage | 25.00% | |||||||||||||
Chief Executive Officer [Member] | Share-based Compensation Award, Tranche Two [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, award vesting rights, percentage | 6.25% | |||||||||||||
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 | 1,355,000 | 1,355,000 | 1,355,000 | 1,355,000 | ||||||||||
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 | 1,275,950 | 1,275,950 | 1,275,950 | 1,275,950 | ||||||||||
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 authorized | 1,012,171 | |||||||||||||
May 2016 Warrant [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.3125 | $ 1.3125 | ||||||||||||
Warrant expiration period | 5 years | 5 years | ||||||||||||
Expiration date of warrants issued | May 18, 2021 | |||||||||||||
June 2016 Warrant [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | $ 1.3125 | |||||||
Warrant expiration period | 5 years | 5 years | ||||||||||||
Expiration date of warrants issued | May 18, 2021 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Conversion of stock, shares issued | 2,309,428 | |||||||||||||
Non-voting Convertible Preferred Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Conversion of stock, shares converted | 2,309,428 | |||||||||||||
Private Placement [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 | 0.75 | 0.75 | 0.75 | |||||||||||
Class of warrant or right, number of securities called by warrants or rights | 6,790,169 | 6,790,169 | 6,790,169 | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.14 | $ 1.14 | $ 1.14 | |||||||||||
Sale of stock, description of transaction | (i) one share of common stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. | |||||||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | |||||||||||||
Private Placement [Member] | Common Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued during period, shares, new issues | 6,744,127 | |||||||||||||
Private Placement [Member] | Non-voting Convertible Preferred Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued during period, shares, new issues | 2,309,428 | |||||||||||||
Cowen and Company, LLC [Member] | At the Market Offering [Member] | Sales Agreement [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | |||||||||||||
Maximum commission percentage on gross proceeds | 3.00% | |||||||||||||
Remaining availability under at the market offering | $ 3,100,000 | $ 3,100,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 7,800,000 | $ 1,300,000 | $ 3,400,000 | |||||||||||
Gross proceeds from sale of common stock | $ 8,400,000 | $ 1,400,000 | $ 3,600,000 | |||||||||||
Cowen and Company, LLC [Member] | At the Market Offering [Member] | Sales Agreement [Member] | Common Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock issued during period, shares, new issues | 7,700,000 | 2,000,000 | 4,000,000 | |||||||||||
Maximum [Member] | Cowen and Company, LLC [Member] | At the Market Offering [Member] | Sales Agreement [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 |
Stockholders' equity - Company
Stockholders' equity - Company Recognized Stock Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ 209,307 | $ 266,399 | $ 454,712 | $ 527,896 |
Cost of Services [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 2,145 | 696 | 3,968 | 5,008 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 52,777 | 73,204 | 110,555 | 135,422 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 160,419 | 177,025 | 312,895 | 349,128 |
Sales and Marketing [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ (6,034) | $ 15,474 | $ 27,294 | $ 38,338 |
Stockholders' equity - Warrants
Stockholders' equity - Warrants to Purchase Shares of Common Stock (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 10,904,942 | 10,506,524 |
August 2007 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2017-08 | |
Shares of Common Stock Subject to Warrants | 8,921 | 8,921 |
March 2008 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 790.54 | |
Expiration | 2018-03 | |
Shares of Common Stock Subject to Warrants | 46 | 46 |
November 2009 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2019-11 | |
Shares of Common Stock Subject to Warrants | 6,674 | 6,674 |
January 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2020-01 | |
Shares of Common Stock Subject to Warrants | 6,674 | 6,674 |
March 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2020-03 | |
Shares of Common Stock Subject to Warrants | 1,277 | 1,277 |
November 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2021-11 | |
Shares of Common Stock Subject to Warrants | 5,213 | 5,213 |
December 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2021-12 | |
Shares of Common Stock Subject to Warrants | 664 | 664 |
March 2012 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 109.90 | |
Expiration | 2019-03 | |
Shares of Common Stock Subject to Warrants | 4,125 | 4,125 |
February 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 6.60 | |
Expiration | 2025-02 | |
Shares of Common Stock Subject to Warrants | 225,011 | 225,011 |
May 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 6.60 | |
Expiration | 2020-05 | |
Shares of Common Stock Subject to Warrants | 3,457,750 | 3,457,750 |
May 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 1.31 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 4,739,348 | 4,739,348 |
June 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 1.31 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 2,050,821 | 2,050,821 |
June 2017 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 0.78 | |
Expiration | 2022-06 | |
Shares of Common Stock Subject to Warrants | 398,418 |
Commitments (Details Textual)
Commitments (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Dec. 31, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Other Commitments [Line Items] | |||||
Operating lease description | The Company leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. The Company also 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. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis. | ||||
Operating leases, rent expense, net, total | $ 238,703 | $ 248,345 | $ 471,539 | $ 502,389 | |
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 | 128,000 | $ 128,000 | |||
Expected retention expense | 63,000 | ||||
Retention expense incurred | 13,000 | $ 13,000 | |||
Designated service period of employees, description | The service period end dates range from the end of August to the end of December 2017 | ||||
Scenario, Forecast [Member] | Minimum [Member] | |||||
Other Commitments [Line Items] | |||||
Expected reduction in operating expenses percentage | 25.00% | ||||
Scenario, Forecast [Member] | Maximum [Member] | |||||
Other Commitments [Line Items] | |||||
Expected reduction in operating expenses percentage | 30.00% | ||||
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 | ||||
Facility in Woburn, Massachusetts [Member] | |||||
Other Commitments [Line Items] | |||||
Future minimum operating lease payments | $ 2,000,000 | $ 2,000,000 |
License agreements, research 34
License agreements, research collaborations and development agreements (Details Textual) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017USD ($)Agreement | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)Agreement | Jun. 30, 2016USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||
Royalty expense | $ 62,941 | $ 75,948 | $ 132,186 | $ 145,802 |
Annual future minimum royalty payments due | 250,000 | 250,000 | ||
Collaborations revenue | 6,233 | $ 125,000 | 27,397 | $ 125,000 |
License Agreement with Hitachi [Member] | ||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||
Collaborations revenue | $ 6,233 | $ 12,397 | ||
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 | 8 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Oct. 31, 2016 | |
Merck Sharp & Dohme Corp [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Research and development agreement description | Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. | |||||
Maximum required amount to expend for procurement of materials | $ 175,000 | |||||
Merck Sharp & Dohme Corp [Member] | Research and Development Expense [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Procurement costs recognized | $ 54,774 | $ 113,907 | $ 146,177 | |||
Fluidigm Corporation Supply Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Contractual agreement period | 5 years | |||||
Additional contractual agreement period | 5 years | |||||
Contractual agreement maturity date | Mar. 17, 2018 | |||||
Contractual agreement description | The initial term of the Fluidigm Agreement is five years. Both parties have the ability to extend the term for an additional five years. Under the expanded Supply Agreement, the term was extended until March 17, 2018, and the Company has the right to extend the term of the Supply Agreement for up to two additional three-year terms. | |||||
Related party transaction, expenses from transactions with related party | 0 | $ 66,865 | $ 44,721 | $ 160,089 | ||
Related party transaction, purchases from related party | 45,758 | 0 | 90,479 | 67,775 | ||
Payments to acquire equipment on lease | $ 30,254 | $ 45,106 | $ 60,517 | $ 90,212 |
Subsequent events (Details Text
Subsequent events (Details Textual) - USD ($) | Jul. 18, 2017 | Jul. 31, 2017 | May 31, 2017 | Jun. 30, 2017 |
Bridge Financing Notes [Member] | ||||
Subsequent Event [Line Items] | ||||
Remaining capacity available under financing | $ 1,000,000 | |||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 10.00% | |||
Maturity date | Sep. 30, 2017 | |||
Remaining capacity available under financing | $ 1,000,000 | |||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | Maximum [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate principal amount | $ 1,500,000 | |||
Bridge Financing Note One [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate principal amount | 500,000 | |||
Bridge Financing Note Two [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate principal amount | 500,000 | |||
Bridge Financing Note Three [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Aggregate principal amount | 500,000 | |||
Qualified Financing [Member] | Note Purchase Agreement [Member] | Minimum [Member] | ||||
Subsequent Event [Line Items] | ||||
Net proceeds from equity or debt financing | $ 5,000,000 | |||
Stock Purchase Warrants [Member] | Bridge Financing Notes [Member] | Subsequent Event [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Class of warrant or right, exercise price of warrants or rights | $ 0.78 | |||
Class of warrant or right, number of securities called by warrants or rights | 140,845 | |||
Warrants [Member] | Bridge Financing Notes [Member] | Subsequent Event [Member] | Note Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Class of warrant or right, exercise price of warrants or rights | $ 0.69 | |||
Class of warrant or right, number of securities called by warrants or rights | 158,730 | |||
July 2017 Public Offering [Member] | ||||
Subsequent Event [Line Items] | ||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase one share of common stock at an exercise price of $0.425 per share. | |||
July 2017 Public Offering [Member] | Subsequent Event [Member] | ||||
Subsequent Event [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 | $ 8,700,000 | |||
Class of warrant or right, exercise price of warrants or rights | $ 0.425 | |||
Warrants exercisable period | 5 years | |||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Repayment of outstanding debt | $ 1,000,000 | |||
July 2017 Public Offering [Member] | Pre-funded Units [Member] | Subsequent Event [Member] | ||||
Subsequent Event [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] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | |||
Warrants exercised | 4,000,000 |