Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 26, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | OPGEN INC | ||
Entity Central Index Key | 1,293,818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $ 11,102,412 | ||
Trading Symbol | OPGN | ||
Entity Common Stock, Shares Outstanding | 5,289,919 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 1,847,171 | $ 4,117,324 |
Accounts receivable, net | 809,540 | 542,420 |
Inventory, net | 533,425 | 692,368 |
Prepaid expenses and other current assets | 311,644 | 329,646 |
Total current assets | 3,501,780 | 5,681,758 |
Property and equipment, net | 835,537 | 800,723 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 1,353,182 | 1,620,998 |
Other noncurrent assets | 328,601 | 279,752 |
Total assets | 6,619,914 | 8,984,045 |
Current liabilities | ||
Accounts payable | 1,691,712 | 2,232,563 |
Accrued compensation and benefits | 746,924 | 578,480 |
Accrued liabilities | 1,160,714 | 1,215,283 |
Deferred revenue | 24,442 | 37,397 |
Short-term notes payable | 1,010,961 | 1,023,815 |
Current maturities of long-term capital lease obligation | 154,839 | 184,399 |
Total current liabilities | 4,789,592 | 5,271,937 |
Deferred rent | 290,719 | 398,084 |
Warrant liability | 8,453 | 0 |
Long-term capital lease obligation and other noncurrent liabilities | 130,153 | 146,543 |
Total liabilities | 5,218,917 | 5,816,564 |
Commitments (Note 8) | ||
Stockholders' equity | ||
Common stock, $0.01 par value; 200,000,000 shares authorized; 2,265,320 and 1,012,171 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 22,653 | 10,122 |
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 0 | 0 |
Additional paid-in capital | 150,114,671 | 136,442,302 |
Accumulated other comprehensive (loss)/income | (25,900) | 6,176 |
Accumulated deficit | (148,710,427) | (133,291,119) |
Total stockholders’ equity | 1,400,997 | 3,167,481 |
Total liabilities and stockholders’ equity | $ 6,619,914 | $ 8,984,045 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 2,265,320 | 1,012,171 |
Common stock, shares outstanding | 2,265,320 | 1,012,171 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue | ||
Product sales | $ 2,771,869 | $ 3,524,178 |
Laboratory services | 41,960 | 228,904 |
Collaboration revenue | 397,178 | 272,603 |
Total revenue | 3,211,007 | 4,025,685 |
Operating expenses | ||
Cost of products sold | 1,612,838 | 1,658,571 |
Cost of services | 520,338 | 631,333 |
Research and development | 6,883,293 | 8,613,236 |
General and administrative | 6,692,659 | 6,602,608 |
Sales and marketing | 2,767,670 | 5,529,274 |
Total operating expenses | 18,476,798 | 23,035,022 |
Operating loss | (15,265,791) | (19,009,337) |
Other income/(expense) | ||
Interest and other expense | (87,255) | (5,967) |
Interest expense | (233,505) | (143,347) |
Foreign currency transaction gains/(losses) | 23,179 | (8,102) |
Change in fair value of derivative financial instruments | 144,064 | 0 |
Total other expense | (153,517) | (157,416) |
Loss before income taxes | (15,419,308) | (19,166,753) |
Provision for income taxes | 0 | 0 |
Net loss | (15,419,308) | (19,166,753) |
Preferred stock dividends and beneficial conversion | 0 | (332,550) |
Net loss available to common stockholders | $ (15,419,308) | $ (19,499,303) |
Net loss per common share - basic and diluted | $ (9.80) | $ (27.59) |
Weighted average shares outstanding - basic and diluted | 1,573,769 | 706,702 |
Net loss | $ (15,419,308) | $ (19,166,753) |
Other comprehensive (loss)/income - foreign currency translation | (32,076) | 7,235 |
Comprehensive loss | $ (15,451,384) | $ (19,159,518) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Private Offering [Member] | At the Market Offering [Member] | Public Offering [Member] | Common Stock [Member] | Common Stock [Member]Private Offering [Member] | Common Stock [Member]At the Market Offering [Member] | Common Stock [Member]Public Offering [Member] | Preferred Stock [Member] | Preferred Stock [Member]Private Offering [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Private Offering [Member] | Additional Paid-in Capital [Member]At the Market Offering [Member] | Additional Paid-in Capital [Member]Public Offering [Member] | Accumulated Other Comprehensive (Loss) / Income [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2015 | $ 7,491,046 | $ 5,019 | $ 121,611,452 | $ (1,059) | $ (114,124,366) | |||||||||||
Balance (in shares) at Dec. 31, 2015 | 501,907 | |||||||||||||||
Stock option exercises | $ 23,771 | $ 27 | 23,744 | |||||||||||||
Stock option exercises (in shares) | 2,660 | 2,660 | ||||||||||||||
Issuance of units, net of offering costs | $ 9,460,749 | $ 4,405,973 | $ 2,697 | $ 1,448 | $ 23,094 | $ 9,434,958 | $ 4,404,525 | |||||||||
Issuance of units, net of offering costs (in shares) | 269,765 | 144,795 | 2,309,428 | |||||||||||||
Conversion of preferred stock into common shares | $ 0 | $ 924 | $ (23,094) | 22,170 | ||||||||||||
Conversion of preferred stock into common shares (in shares) | 92,377 | (2,309,428) | ||||||||||||||
Issuance of RSUs | (1) | $ 7 | (8) | |||||||||||||
Issuance of RSUs (in shares) | 667 | |||||||||||||||
Stock compensation expense | 945,461 | 945,461 | ||||||||||||||
Foreign currency translation | 7,235 | 7,235 | ||||||||||||||
Net loss | (19,166,753) | (19,166,753) | ||||||||||||||
Balance at Dec. 31, 2016 | 3,167,481 | $ 10,122 | 136,442,302 | 6,176 | (133,291,119) | |||||||||||
Balance (in shares) at Dec. 31, 2016 | 1,012,171 | |||||||||||||||
Stock option exercises | $ 8,180 | $ 12 | 8,168 | |||||||||||||
Stock option exercises (in shares) | 1,167 | 1,167 | ||||||||||||||
Issuance of units, net of offering costs | $ 3,808,836 | $ 8,823,242 | $ 2,272 | $ 10,000 | $ 3,806,564 | $ 8,813,242 | ||||||||||
Issuance of units, net of offering costs (in shares) | 227,216 | 1,000,000 | ||||||||||||||
Issuance of RSUs | $ 60 | (60) | ||||||||||||||
Issuance of RSUs (in shares) | 6,025 | |||||||||||||||
Stock compensation expense | $ 911,398 | 911,398 | ||||||||||||||
Legal settlement in common stock | 109,999 | $ 158 | 109,841 | |||||||||||||
Legal settlement in common stock (in shares) | 15,843 | |||||||||||||||
Vendor payment in common stock | 23,245 | $ 29 | 23,216 | |||||||||||||
Vendor payment in common stock (in shares) | 2,898 | |||||||||||||||
Foreign currency translation | (32,076) | (32,076) | ||||||||||||||
Net loss | (15,419,308) | (15,419,308) | ||||||||||||||
Balance at Dec. 31, 2017 | $ 1,400,997 | $ 22,653 | $ 150,114,671 | $ (25,900) | $ (148,710,427) | |||||||||||
Balance (in shares) at Dec. 31, 2017 | 2,265,320 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities | ||
Net loss | $ (15,419,308) | $ (19,166,753) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 669,088 | 656,047 |
Loss on disposal of property and equipment | 0 | 6,309 |
Noncash interest expense | 185,294 | 4,527 |
Share-based compensation | 911,398 | 945,461 |
Inventory obsolescence | 0 | 113,465 |
Change in fair value of warrant liabilities | (144,064) | 0 |
Unamortized discount on bridge loan at repayment | 85,932 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (260,471) | 136,226 |
Inventory | 161,027 | 20,179 |
Other assets | (315,688) | 263,882 |
Accounts payable | (563,357) | (53,229) |
Accrued compensation and other liabilities | 399,224 | (163,223) |
Deferred revenue | (12,955) | (13,528) |
Net cash used in operating activities | (14,303,880) | (17,250,637) |
Cash flows from investing activities | ||
Purchases of property and equipment (net of proceeds on disposals) | (276,950) | (123,514) |
Net cash used in investing activities | (276,950) | (123,514) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 3,808,836 | 4,405,973 |
Proceeds from issuance of promissory notes, net of issuance costs | 0 | 204,895 |
Proceeds from private offering of common stock, preferred stock and warrants, net of issuance costs | 0 | 9,460,749 |
Proceeds from issuance of units, net of selling costs | 8,754,882 | 0 |
Proceeds from exercise of stock options and warrants | 76,537 | 23,771 |
Proceeds from debt, net of issuance costs | 1,168,222 | 0 |
Payments on debt | (1,255,198) | (178,997) |
Payments on capital lease obligations | (205,085) | (251,701) |
Net cash provided by financing activities | 12,348,194 | 13,664,690 |
Effects of exchange rates on cash | (37,517) | 12,565 |
Net decrease in cash and cash equivalents | (2,270,153) | (3,696,896) |
Cash and cash equivalents at beginning of year | 4,117,324 | 7,814,220 |
Cash and cash equivalents at end of year | 1,847,171 | 4,117,324 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 48,211 | 58,564 |
Supplemental disclosures of noncash investing and financing activities: | ||
Unpaid deferred offering costs | 48,398 | 0 |
Shares issued to settle obligations | 133,245 | 0 |
Issuance of placement agent warrant | $ 93,677 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 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. |
Going Concern and Management_s
Going Concern and Management’s Plans | 12 Months Ended |
Dec. 31, 2017 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management’s Plans | Note 2 - Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor , including: On February 7, 2018, the Company closed a public offering (the “February 2018 Public Offering”) of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. On July 18, 2017, the Company closed a public offering (the “July 2017 Public Offering”) of 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital, LLC (“jVen Capital”) jVen Capital is an affiliate of Evan Jones, the Company’s Chairman of the Board and Chief Executive Officer. In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. 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. 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 Note was ten percent (10%) per annum (subject to increase upon an event of default). The Bridge Financing Notes were prepayable by the Company at any time without penalty, and had a maturity date of September 30, 2017, which could be accelerated upon the closing of a qualified financing (any equity or debt financing that raised net proceeds of $5 million or more). The Bridge Financing Notes were contingently convertible at the option of the holder upon an event of default into shares of the Company’s convertible Series B preferred stock. In connection with the issuance of Bridge Financing Notes, in June and July 2017, the Company issued jVen Capital stock purchase warrants to acquire 5,634 shares with an exercise price of $19.50 per share, and warrants to acquire 6,350 shares with an exercise price of $17.25 per share. The Company drew down on two of three Bridge Financing Notes during June and July, and repaid such outstanding Bridge Financing Notes in full upon the closing of the July 2017 Public Offering. As a condition to the receipt of the bridge financing, the Company issued an amended and restated Senior Secured Promissory Note to Merck Global Health Innovation Fund (“MGHIF”) Merck & Co., Inc. (“Merck”), On September 13, 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 3.0% of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2017, the Company has sold an aggregate of approximately 372 thousand shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.2 million, and gross proceeds of $8.8 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 twenty-fifth of a share of common stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.03 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 269,765 shares of common stock, 2,309,428 of Series A non-voting convertible preferred stock and stock purchase warrants to acquire an additional 271,606 shares of common stock. Under the purchase agreement, the Company granted registration rights to the investors in the private financing. 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 February 2018 Public Offering will be sufficient to fund operations into the first quarter of 2019 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with generally accepted accounting standards in the United States (“U.S. GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. 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 (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2017 and 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 United States dollar. Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments, beneficial conversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates. Fair value of financial instruments All financial instruments classified as current assets and liabilities are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 11. Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. As of December 31, 2017 and 2016, the Company has 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 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 $31,278 and $26,716 as of December 31, 2017 and 2016, respectively. At December 31, 2017, the Company had accounts receivable from one customer which individually represented 41% of total accounts receivable. At December 31, 2016, the Company had accounts receivable from one customer which individually represent 25% of total accounts receivable. For the year ended December 31, 2017, revenue earned from one customer represented 11% of total revenues. No individual customer represented in excess of 10% of revenues for year ended December 31, 2016. 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: December 31, 2017 2016 Raw materials and supplies $ 360,134 $ 479,479 Work-in process 51,233 27,422 Finished goods 122,058 185,467 Total $ 533,425 $ 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 $155,507 and $704,516 at December 31, 2017 and 2016, respectively. Whole Genome Mapping System (“Argus”) Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $401,272 and $388,231 for the years ended December 31, 2017 and 2016, respectively. Property and equipment consisted of the following at December 31, 2017 and 2016: December 31, 2017 2016 Laboratory and manufacturing equipment $ 4,109,367 $ 3,785,133 Office furniture and equipment 700,299 688,952 Computers and network equipment 1,505,651 1,472,144 Leasehold improvements 729,504 662,506 7,044,821 6,608,735 Less accumulated depreciation (6,209,284 ) (5,808,012 ) Property and equipment, net $ 835,537 $ 800,723 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2017 and 2016, the Company determined that its property and equipment was not impaired. Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2017 and 2016 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2017 and 2016: December 31, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (113,679 ) $ 347,321 $ (67,575 ) $ 393,425 Developed technology 458,000 (161,322 ) 296,678 (95,898 ) 362,102 Customer relationships 1,094,000 (384,817 ) 709,183 (228,529 ) 865,471 $ 2,013,000 $ (659,818 ) $ 1,353,182 $ (392,002 ) $ 1,620,998 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $267,816 and $267,816 for the years ended December 31, 2017 and 2016, respectively. Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2018 $ 267,816 2019 267,816 2020 267,816 2021 267,816 2022 165,117 Thereafter 116,801 Total $ 1,353,182 Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the years ended December 31, 2017 and 2016, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During the fourth quarter of 2017, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis as of 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. As of December 31, 2017, the Company determined that its goodwill was not impaired. Deferred rent Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required. 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 and PNA FISH 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. For any non-substantive milestones, the Company recognizes revenue as the underlying services are performed, using a proportional performance method based on inputs (cost to cost method percentage of completion method). 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. Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. 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. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $165,544,893 and $150,950,436 at December 31, 2017 and 2016, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 1.6 million shares and 0.5 million shares as of December 31, 2017 and 2016, respectively Recent accounting pronouncements In May 2014, the FASB issued an Accounting Standards Update (“ASU”) 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 has completed its formal contract review and the Company will adopt this guidance effective January 1, 2018. The Company will adopt this guidance using the modified retrospective method. The adoption of this new guidance will not have a material impact on the Company’s consolidated financial statements. 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 ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
MGHIF Financing
MGHIF Financing | 12 Months Ended |
Dec. 31, 2017 | |
Common Stock And Note Purchase Agreement [Abstract] | |
MGHIF Financing | Note 4 – MGHIF Financing In July 2015, in connection with the Merger, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 45,454 shares of common stock of the Company at $110.00 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the "MGHIF Note") in the principal amount of $1.0 million with a two-year maturity date from the date of issuance. 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 as 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 28, 2017, the MGHIF Note was amended and restated, and the maturity date of the MGHIF Note was extended by one year to July 14, 2018. As consideration for the agreement to extend the maturity date, the Company issued an amended and restated secured promissory note to MGHIF that (1) increased the interest rate to ten percent (10%) per annum and (2) provided for the issuance of common stock warrants to purchase 13,120 shares of its common stock to MGHIF. The warrants issued to MGHIF each have a five year term from issuance, are first exercisable on the date that is six months after the date of issuance and have an exercise price equal to $19.50 which represents 110% of the closing price of the Company's common stock on the date of issuance. The MGHIF Note, as amended and restated 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 the MGHIF Note. The warrants are classified as mark to market liabilities under ASC 480, Distinguishing Liabilities from Equity, 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 defined in the agreement. The warrants had an issuance date fair value of approximately $0.1 million which was calculated using the Black-Scholes model. The estimated fair value of the MGHIF Note was $1.0 million as of December 31, 2017 and 2016 which approximates the carrying value given the short time lapse since modification, prevailing interest rates and maturity date. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Debt | Note 5 – Debt As of December 31, 2017, the Company's outstanding short-term debt consisted of the $1.0 million MGHIF Note, net of discounts and financing costs (see Note 4 " The Company drew down on two of three Bridge Financing Notes (see discussion in Note 2 "Going Concern and Management’s Plans”) during June and July of 2017. The outstanding Bridge Financing Notes were repaid in full subsequent to the closing of the July 2017 Public Offering. The Company accounted for the embedded conversion option granted to jVen Capital in the Bridge Financing Notes as a mark-to-market derivative financial instrument carried at fair value. Changes in fair value of the embedded conversion option are reflected in earnings during the period of change. The embedded conversion option was expensed along with the remaining unamortized discount at the date of the Bridge Financing Notes repayment. The warrants issued to jVen Capital and MGHIF are classified as mark-to-market liabilities under ASC 480 due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $233,505 and $143,347 for the years ended December 31, 2017 and 2016, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | Note 6 - Stockholders’ Equity As of December 31, 2017, the Company has 200,000,000 shares of authorized common shares and 2,265,320 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding. In the July 2017 Public Offering, the Company issued 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital was one of the investors participating in the offering. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. At closing, the outstanding Bridge Financing Notes issued to jVen Capital, were repaid in the principal amount of $1 million plus accrued interest of $6,438. All pre-funded warrants were exercised during the year ended December 31, 2017 In connection with the July 2017 Public Offering, the Company issued to its placement agent 50,000 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $12.50 per share and are exercisable for five years. In September 2017, the Company issued 15,842 shares of its common stock with an aggregate value of $110,000 to settle a dispute related to pre-Merger AdvanDx activities. In October 2017, the Company issued 2,898 shares of its common stock with an aggregate value of $23,245 to a vendor in exchange for consulting services. On September 13, 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 3.0% of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2017, the Company has sold an aggregate of approximately 372 thousand shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.2 million, and gross proceeds of $8.8 million. As of December 31, 2017, remaining availability under the at the market offering is $2.7 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 twenty-fifth of a share of common stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.03 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 269,765 shares of common stock, 2,309,428 of Series A non-voting convertible preferred stock and stock purchase warrants to acquire an additional 271,606 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 twenty-fifth of a 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 basis with common stockholders. The preferred stock was classified as permanent equity. The stock purchase warrants issued as part of the units are exercisable at $32.8125 per share beginning 90 days after closing for five years, expiring on May 18, 2021. The warrants are classified as permanent equity at December 31, 2017. In connection with the issuance of Series A non-voting convertible preferred stock, the Company recognized a beneficial conversion feature of $332,550 as a deemed dividend to the preferred shareholders. Holders of the Series A non-voting convertible preferred stock subsequently converted all 2,309,428 shares of preferred stock into 92,377 shares of common stock. 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 Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 54,200 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2017, 32,411 shares remain available for issuance under the 2015 Plan. For the years ended December 31, 2017 and 2016, the Company recognized stock compensation expense as follows: Year Ended December 31, 2017 2016 Cost of services $ 13,776 $ 6,003 Research and development 237,103 236,341 General and administrative 603,787 599,550 Sales and marketing 56,732 103,567 $ 911,398 $ 945,461 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position. As of December 31, 2017, the Company had unrecognized expense related to its stock options of $1.3 million, which will be recognized over a weighted average period of 8.3 years. A summary of the status of options granted is presented below as of and for the years ended December 31, 2017 and 2016: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2016 86,431 $ 65.00 9.1 $ 1,575,646 Granted 58,546 $ 35.25 Exercised (2,660 ) $ 9.00 $ 79,406 Forfeited (22,868 ) $ 99.75 Expired (343 ) $ 212.25 Outstanding at December 31, 2016 119,106 $ 44.00 8.6 $ 663,298 Granted 58,324 $ 17.58 Exercised (1,167 ) $ 7.01 $ 11,256 Forfeited (24,538 ) $ 36.31 Expired (12,330 ) $ 83.49 Outstanding at December 31, 2017 139,395 $ 31.16 8.3 $ 37,339 Vested and expected to vest 139,395 $ 31.16 8.3 $ 37,339 Exercisable at December 31, 2017 63,365 $ 4.73 7.7 $ 33,575 The total fair value of options vested in the years ended December 31, 2017 and 2016 was $2,086,843 and $1,088,978, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Year Ended December 31, 2017 2016 Annual dividend — — Expected life (in years) 5.25 - 6.25 5.25 - 6.25 Risk free interest rate 1.8 - 2.3% 1.2 - 2.2% Expected volatility 44.2 - 53.0% 42.0 - 49.8% Restricted stock units During the year ended December 31, 2017, the Company granted restricted stock units to acquire 11,175 shares of common stock, with a weighted average grant date fair value of $6.93 per share. 6,025 restricted stock units vested and no restricted stock units were forfeited during the year ended December 31, 2017. Stock purchase warrants At December 31, 2017 and 2016, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2017 2016 August 2007 $ 197.75 August 2017 - 357 March 2008 $ 19,763.50 March 2018 2 2 November 2009 $ 197.75 November 2019 267 267 January 2010 $ 197.75 January 2020 267 267 March 2010 $ 197.75 March 2020 51 51 November 2011 $ 197.75 November 2021 209 209 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,000 9,000 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,574 189,574 June 2016 $ 32.81 May 2021 82,033 82,033 June 2017 $ 19.50 June 2022 18,754 - July 2017 $ 17.25 July 2022 6,349 - July 2017 $ 12.50 July 2022 50,000 - July 2017 $ 10.63 July 2022 1,000,000 - 1,495,008 420,262 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 7 - Income Taxes At December 31, 2017 and 2016, the Company had net deferred tax assets of $49,251,408 and $63,520,548, respectively, primarily consisting of NOL carryforwards, research and experimental (“R&E”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2017 and 2016 have been offset by a valuation allowance of $49,251,408 and $63,520,548, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2017 and 2016 are as follows: December 31, 2017 2016 Deferred tax assets: NOL carryforward $ 46,326,407 $ 60,357,220 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 345,088 448,534 Inventory reserve 45,338 269,708 Depreciation 71,756 117,629 Accruals and other 247,093 333,126 Total deferred tax assets 49,595,161 64,085,696 Valuation allowance (49,251,408 ) (63,520,548 ) Deferred tax liabilities: Intangible assets (343,753 ) (565,148 ) Net deferred tax liability $ — $ — The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2017 2016 Federal income tax benefit at statutory rates 34.0 % 34.0 % State income tax benefit, net of Federal benefit 6.8 % 6.5 % Tax reform impact (134.5 )% 0.0 % Change in valuation allowance 93.0 % (37.3 )% Change in state tax rates and other 0.7 % (3.2 )% 0.0 % 0.0 % The Company has federal NOL carryforwards of $165,544,893 and $150,950,436 at December 31, 2017 and 2016, respectively. The NOL carryforwards begin to expire in 2022. Utilization of the NOL carryforward may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code. There can be no assurance that the NOL carryforward will ever be fully utilized. To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Code of 1986, as amended. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. In December 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act"). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to: (i) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) creating a new limitation on deductible interest expense; and (iv) changing rules related to uses and limitations of net operating carryforwards created in tax years beginning after December 31, 2017; and (v) changing the U.S. federal taxation of earnings of foreign subsidiaries. As a result, the Company believes the most significant impact on its consolidated financial statements will be the reduction of approximately $14.6 million of the deferred tax assets related to net operating losses and other deferred tax assets. Such reduction is offset by a change in the Company’s valuation allowance. Additionally, the Company has a foreign subsidiary. At December 31, 2017 and November 2, 2017, the cumulative earnings and profits of this entity was negative. Accordingly, the Company is not liable for the transition tax on foreign earnings enacted under the Tax Act. The Company has completed the accounting for the impact of the Tax Act as of December 31, 2017 and has recorded no provisional amounts. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 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. During the second quarter of 2015, the Company extended the term of its Gaithersburg, Maryland office lease, effective May 7, 2015, through January 31, 2021, with one additional five-year renewal at the Company’s election. The Company is responsible for all utilities, repairs, insurance, and taxes under this operating lease. Effective July 1, 2015, the Company further modified its lease agreement to add additional leased space to its headquarters. 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 year ended December 31, 2017 and 2016 was $949,244 and $1,000,726, 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. Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2017: Year ending December 31, Capital Leases Operating Leases Total 2018 $ 177,464 $ 1,041,323 $ 1,218,787 2019 85,393 1,054,374 1,139,767 2020 56,981 1,072,748 1,129,729 2021 1,773 482,058 483,830 2022 and thereafter - 35,647 35,647 Total 321,611 $ 3,686,150 $ 4,007,760 Less: amount representing interest (36,619 ) Net present value of future minimum lease payments 284,992 Current maturities (154,839 ) Long-term maturities $ 130,153 Assets under capital leases were included in the following balance sheet categories as of December 31: 2017 2016 Laboratory and manufacturing equipment $ 850,792 $ 560,829 Office furniture and equipment 64,790 64,790 Computers and network equipment 24,350 24,350 Less accumulated amortization (454,471 ) (270,808 ) Capital lease assets, net $ 485,461 $ 379,161 Amortization expense associated with equipment under capital leases for the years ended December 31, 2017 and 2016 was $183,663 and $161,606, respectively, and is included within depreciation and amortization expense in the consolidated statements of operations. 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. There were approximately $121,000 of one-time termination benefits that were recognized during the year ended December 31, 2017 related to the restructuring. The Company does not anticipate any further one-time termination benefits related to the restructuring plan. Retention agreements were issued to certain employees in which retention bonuses are earned and paid upon the completion of a designated service period. The service periods ended in December 2017. The Company incurred total retention expense of approximately $68,000 during the year ended December 31, 2017. The future minimum lease payments for the Woburn facility were approximately $1.8 million as of December 31, 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 the second quarter of 2018. We have not estimated the contract termination costs associated with this lease given that we have not yet reached the cease use date and given that we have only begun sublease pursuit activities. We do not believe there will be significant additional costs related to restructuring outside of what is described herein. |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 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 related to its FISH product line. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. Certain of the agreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized net royalty expense of $257,186 and $290,491 for the years ended December 31, 2017 and 2016, respectively. Annual future minimum royalty fees are $250,000 under these agreements. In September 2017, the Company was awarded a contract from the Centers for Disease Control and Prevention (“CDC”) to develop smartphone-based clinical decision support solutions for antimicrobial stewardship, or AMS, and infection control in low- and middle-income countries. The one-year $860,000 award began September 30, 2017 and funds development and evaluation of cloud-based mobile software. The Company will work with subcontractors Ilúm, LLC, an affiliate of Merck, and Universidad El Bosque (“UEB”) of Bogota, Colombia under this CDC contract. During the year ended December 31, 2017, In June 2016, the Company entered into a license agreement with 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 year ended December 31, 2017, the Company recognized $25,000 of revenue related to the license agreement. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 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 $123,067 related to these agreements in the year ended December 31, 2017. The Company paid $183,713 related to these agreements in the year ended December 31, 2016. Under the agreements with Fluidigm, the Company had purchases of $135,415 in the year ended December 31, 2017. The Company had purchases of $91,399 related to these agreements in the year ended December 31, 2016. In addition, the Company has several capital lease arrangements for laboratory equipment manufactured by Fluidigm. The Company paid $91,882 related to the leased equipment in the year ended December 31, 2017. The Company paid $175,475 related to the leased equipment in the year ended December 31, 2016. In October 2016, the Company entered into an agreement with Merck Sharp & Dohme, a wholly-owned subsidiary of Merck Co. & Inc. (“Merck”), an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $146,177 of procurement costs which have been recognized as research and development expense, including $113,907 and $32,270 during the years ended December 31, 2017 and 2016. In December 2017, we entered into a subcontractor agreement with ILÚM Health Solutions, LLC, an entity created by Merck’s Healthcare Services and Solutions division, whereby ILÚM Health Solutions will provide services to the Company in the performance of the Company’s CDC contract to deploy ILÚM’s commercially-available cloud- and mobile-based software platform for infectious disease management in up to three medical sites in Colombia with the aim of improving antibiotic use in resource-limited settings. During the year ended December 31, 2017, |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 11 – Fair Value Measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - defined as observable inputs such as quoted prices in active markets; • Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and • Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. As part of the Company’s bridge financing and amendment to the MGHIF Note, the Company issued stock purchase warrants that the Company considers to be mark-to-market liabilities due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. The Company determines the fair value of the warrant liabilities using the Black-Scholes option pricing model. Using this model, level 3 unobservable inputs include the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates. The Company originally accounted for the conversion option embedded in the Bridge Financing Notes as a mark-to-market derivative financial instrument. The Company determined the fair value of the embedded conversion option liability using a probability-weighted expected return method. Using this method, level 3 unobservable inputs include the probability of default, the probability of a qualified financing, the probability of conversion, the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates, among other inputs. The fair value of the conversion option was expensed at the time of repayment of the Bridge Financing Notes. The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2017: Description Balance at December 2016 Established in 2017 Change in Fair Value Expensed Balance at December 2017 Embedded conversion option liability $ - $ 4,500 $ - $ (4,500 ) $ - Warrant liability $ - $ 152,517 $ (144,064 ) $ - $ 8,453 Financial assets and liabilities carried at fair value on a non-recurring basis The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-financial assets and liabilities carried at fair value on a recurring basis The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis. Non-financial assets and liabilities carried at fair value on a non-recurring basis The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when they are deemed to be impaired. No such fair value impairment was recognized in the year ended December 31, 2017. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent events | Note 12 – Subsequent events On January 5, 2018, the Company entered into a supply agreement with Life Technologies Corporation. The term of the agreement is three years and the Company must make annual minimum purchases of $100,000 per year. On January 17, 2018, the Board of Directors of the Company approved a one-for-twenty-five reverse stock split. All share and per share information in these consolidated financial statements, except for par value and authorized shares, have been amended to reflect the reverse stock split. In addition, on January 17, 2018, the stockholders of the Company approved an Amendment to the Amended and Restated Certificate of Incorporation to reduce the number of authorized shares of common stock from 200,000,000 to 50,000,000. On February 7, 2018, the Company closed a public offering of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with generally accepted accounting standards in the United States (“U.S. GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. |
Foreign Currency | Foreign Currency One of the Company’s subsidiaries is located in Copenhagen, Denmark and uses the Danish Krone as its functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2017 and 2016. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments, beneficial conversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and 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 All financial instruments classified as current assets and liabilities are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 11. |
Cash and cash equivalents and restricted cash | Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. As of December 31, 2017 and 2016, the Company has 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 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 $31,278 and $26,716 as of December 31, 2017 and 2016, respectively. At December 31, 2017, the Company had accounts receivable from one customer which individually represented 41% of total accounts receivable. At December 31, 2016, the Company had accounts receivable from one customer which individually represent 25% of total accounts receivable. For the year ended December 31, 2017, revenue earned from one customer represented 11% of total revenues. No individual customer represented in excess of 10% of revenues for year ended December 31, 2016. |
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: December 31, 2017 2016 Raw materials and supplies $ 360,134 $ 479,479 Work-in process 51,233 27,422 Finished goods 122,058 185,467 Total $ 533,425 $ 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 $155,507 and $704,516 at December 31, 2017 and 2016, respectively. Whole Genome Mapping System (“Argus”) |
Property and equipment | Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $401,272 and $388,231 for the years ended December 31, 2017 and 2016, respectively. Property and equipment consisted of the following at December 31, 2017 and 2016: December 31, 2017 2016 Laboratory and manufacturing equipment $ 4,109,367 $ 3,785,133 Office furniture and equipment 700,299 688,952 Computers and network equipment 1,505,651 1,472,144 Leasehold improvements 729,504 662,506 7,044,821 6,608,735 Less accumulated depreciation (6,209,284 ) (5,808,012 ) Property and equipment, net $ 835,537 $ 800,723 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 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 December 31, 2017 and 2016 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2017 and 2016: December 31, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (113,679 ) $ 347,321 $ (67,575 ) $ 393,425 Developed technology 458,000 (161,322 ) 296,678 (95,898 ) 362,102 Customer relationships 1,094,000 (384,817 ) 709,183 (228,529 ) 865,471 $ 2,013,000 $ (659,818 ) $ 1,353,182 $ (392,002 ) $ 1,620,998 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $267,816 and $267,816 for the years ended December 31, 2017 and 2016, respectively. Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2018 $ 267,816 2019 267,816 2020 267,816 2021 267,816 2022 165,117 Thereafter 116,801 Total $ 1,353,182 Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the years ended December 31, 2017 and 2016, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During the fourth quarter of 2017, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis as of 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. As of December 31, 2017, the Company determined that its goodwill was not impaired. |
Deferred rent | Deferred rent Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required. |
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 and PNA FISH 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. For any non-substantive milestones, the Company recognizes revenue as the underlying services are performed, using a proportional performance method based on inputs (cost to cost method percentage of completion method). 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. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. |
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. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $165,544,893 and $150,950,436 at December 31, 2017 and 2016, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 1.6 million shares and 0.5 million shares as of December 31, 2017 and 2016, respectively |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the FASB issued an Accounting Standards Update (“ASU”) 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 has completed its formal contract review and the Company will adopt this guidance effective January 1, 2018. The Company will adopt this guidance using the modified retrospective method. The adoption of this new guidance will not have a material impact on the Company’s consolidated financial statements. 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 ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 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: December 31, 2017 2016 Raw materials and supplies $ 360,134 $ 479,479 Work-in process 51,233 27,422 Finished goods 122,058 185,467 Total $ 533,425 $ 692,368 |
Property, Plant and Equipment | Property and equipment consisted of the following at December 31, 2017 and 2016: December 31, 2017 2016 Laboratory and manufacturing equipment $ 4,109,367 $ 3,785,133 Office furniture and equipment 700,299 688,952 Computers and network equipment 1,505,651 1,472,144 Leasehold improvements 729,504 662,506 7,044,821 6,608,735 Less accumulated depreciation (6,209,284 ) (5,808,012 ) Property and equipment, net $ 835,537 $ 800,723 |
Schedule of Finite-Lived Intangible Assets | Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2017 and 2016: December 31, 2017 December 31, 2016 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (113,679 ) $ 347,321 $ (67,575 ) $ 393,425 Developed technology 458,000 (161,322 ) 296,678 (95,898 ) 362,102 Customer relationships 1,094,000 (384,817 ) 709,183 (228,529 ) 865,471 $ 2,013,000 $ (659,818 ) $ 1,353,182 $ (392,002 ) $ 1,620,998 |
Schedule of Expected Amortization of Intangible Assets | Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2018 $ 267,816 2019 267,816 2020 267,816 2021 267,816 2022 165,117 Thereafter 116,801 Total $ 1,353,182 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Stockholders Equity Note [Abstract] | |
Schedule of Company Recognized Stock Compensation Expense | For the years ended December 31, 2017 and 2016, the Company recognized stock compensation expense as follows: Year Ended December 31, 2017 2016 Cost of services $ 13,776 $ 6,003 Research and development 237,103 236,341 General and administrative 603,787 599,550 Sales and marketing 56,732 103,567 $ 911,398 $ 945,461 |
Summary of Status of Options Granted | A summary of the status of options granted is presented below as of and for the years ended December 31, 2017 and 2016: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2016 86,431 $ 65.00 9.1 $ 1,575,646 Granted 58,546 $ 35.25 Exercised (2,660 ) $ 9.00 $ 79,406 Forfeited (22,868 ) $ 99.75 Expired (343 ) $ 212.25 Outstanding at December 31, 2016 119,106 $ 44.00 8.6 $ 663,298 Granted 58,324 $ 17.58 Exercised (1,167 ) $ 7.01 $ 11,256 Forfeited (24,538 ) $ 36.31 Expired (12,330 ) $ 83.49 Outstanding at December 31, 2017 139,395 $ 31.16 8.3 $ 37,339 Vested and expected to vest 139,395 $ 31.16 8.3 $ 37,339 Exercisable at December 31, 2017 63,365 $ 4.73 7.7 $ 33,575 |
Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model | The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Year Ended December 31, 2017 2016 Annual dividend — — Expected life (in years) 5.25 - 6.25 5.25 - 6.25 Risk free interest rate 1.8 - 2.3% 1.2 - 2.2% Expected volatility 44.2 - 53.0% 42.0 - 49.8% |
Schedule of Warrants to Purchase Shares of Common Stock | At December 31, 2017 and 2016, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2017 2016 August 2007 $ 197.75 August 2017 - 357 March 2008 $ 19,763.50 March 2018 2 2 November 2009 $ 197.75 November 2019 267 267 January 2010 $ 197.75 January 2020 267 267 March 2010 $ 197.75 March 2020 51 51 November 2011 $ 197.75 November 2021 209 209 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,000 9,000 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,574 189,574 June 2016 $ 32.81 May 2021 82,033 82,033 June 2017 $ 19.50 June 2022 18,754 - July 2017 $ 17.25 July 2022 6,349 - July 2017 $ 12.50 July 2022 50,000 - July 2017 $ 10.63 July 2022 1,000,000 - 1,495,008 420,262 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Deferred tax assets and liabilities | The Company’s deferred tax assets and liabilities as of December 31, 2017 and 2016 are as follows: December 31, 2017 2016 Deferred tax assets: NOL carryforward $ 46,326,407 $ 60,357,220 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 345,088 448,534 Inventory reserve 45,338 269,708 Depreciation 71,756 117,629 Accruals and other 247,093 333,126 Total deferred tax assets 49,595,161 64,085,696 Valuation allowance (49,251,408 ) (63,520,548 ) Deferred tax liabilities: Intangible assets (343,753 ) (565,148 ) Net deferred tax liability $ — $ — |
Expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) | The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2017 2016 Federal income tax benefit at statutory rates 34.0 % 34.0 % State income tax benefit, net of Federal benefit 6.8 % 6.5 % Tax reform impact (134.5 )% 0.0 % Change in valuation allowance 93.0 % (37.3 )% Change in state tax rates and other 0.7 % (3.2 )% 0.0 % 0.0 % |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments For Capital Leases | Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2017: Year ending December 31, Capital Leases Operating Leases Total 2018 $ 177,464 $ 1,041,323 $ 1,218,787 2019 85,393 1,054,374 1,139,767 2020 56,981 1,072,748 1,129,729 2021 1,773 482,058 483,830 2022 and thereafter - 35,647 35,647 Total 321,611 $ 3,686,150 $ 4,007,760 Less: amount representing interest (36,619 ) Net present value of future minimum lease payments 284,992 Current maturities (154,839 ) Long-term maturities $ 130,153 |
Schedule of Capital Leased Assets | Assets under capital leases were included in the following balance sheet categories as of December 31: 2017 2016 Laboratory and manufacturing equipment $ 850,792 $ 560,829 Office furniture and equipment 64,790 64,790 Computers and network equipment 24,350 24,350 Less accumulated amortization (454,471 ) (270,808 ) Capital lease assets, net $ 485,461 $ 379,161 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 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 year ended December 31, 2017: Description Balance at December 2016 Established in 2017 Change in Fair Value Expensed Balance at December 2017 Embedded conversion option liability $ - $ 4,500 $ - $ (4,500 ) $ - Warrant liability $ - $ 152,517 $ (144,064 ) $ - $ 8,453 |
Organization - Additional Infor
Organization - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2017Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating business segment | 1 |
Going Concern and Management's
Going Concern and Management's Plans - Additional Information (Details) - USD ($) | Feb. 07, 2018 | Dec. 31, 2017 | Jul. 18, 2017 | Jun. 28, 2017 | May 31, 2017 | Sep. 13, 2016 | Jul. 31, 2017 | Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Conversion Of Stock [Line Items] | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,754,882 | $ 0 | ||||||||
Net proceeds from sale of common stock | 3,808,836 | 4,405,973 | ||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | $ 0 | 9,460,749 | |||||||
Merck GHI 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 principal and accrued interest on issuance date | 20.00% | |||||||||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Interest rate | 10.00% | |||||||||
Maturity date | Sep. 30, 2017 | |||||||||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | Maximum [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Aggregate principal amount | $ 1,500,000 | |||||||||
Bridge Financing Note One [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Aggregate principal amount | 500,000 | |||||||||
Bridge Financing Note Two [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Aggregate principal amount | 500,000 | |||||||||
Bridge Financing Note Three [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Aggregate principal amount | $ 500,000 | |||||||||
Qualified Financing [Member] | Note Purchase Agreement [Member] | Minimum [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Net proceeds from equity or debt financing | $ 5,000,000 | |||||||||
July 2017 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 18,164,195 | |||||||||
Shares issued, price per share | $ 0.40 | |||||||||
Gross proceeds from sale of common stock and warrants | $ 10,000,000 | |||||||||
Net proceeds from sale of common stock and warrants | $ 8,800,000 | |||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. | |||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 10.625 | |||||||||
Warrants exercisable period | 5 years | |||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Repayment of outstanding debt | $ 1,000,000 | $ 1,000,000 | ||||||||
At the Market Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, value, new issues | $ 3,808,836 | 4,405,973 | ||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [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 | $ 8,200,000 | 8,200,000 | ||||||||
Gross proceeds from sale of common stock | 8,800,000 | 8,800,000 | ||||||||
Remaining availability under at the market offering | $ 2,700,000 | $ 2,700,000 | ||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | |||||||||
Private Placement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Sale of stock, description of transaction | (i) one twenty-fifth of a share of common stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, at a price of $1.14 per unit. | |||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.03 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.14 | |||||||||
Class of warrant or right, number of securities called by warrants or rights | 271,606 | |||||||||
Stock issued during period, value, new issues | $ 9,460,749 | |||||||||
Proceeds from issuance of private placement net | $ 9,500,000 | |||||||||
Pre-funded Units [Member] | July 2017 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 6,835,805 | |||||||||
Shares issued, price per share | $ 0.39 | |||||||||
Pre-funded Warrants [Member] | July 2017 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.25 | |||||||||
Stock Purchase Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 19.50 | |||||||||
Class of warrant or right, number of securities called by warrants or rights | 5,634 | |||||||||
Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 17.25 | |||||||||
Class of warrant or right, number of securities called by warrants or rights | 6,350 | |||||||||
Common Stock [Member] | At the Market Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 227,216 | 144,795 | ||||||||
Stock issued during period, value, new issues | $ 2,272 | $ 1,448 | ||||||||
Common Stock [Member] | At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 372,000 | 372,000 | ||||||||
Common Stock [Member] | Private Placement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 269,765 | 269,765 | ||||||||
Stock issued during period, value, new issues | $ 2,697 | |||||||||
Non-voting Convertible Preferred Stock [Member] | Private Placement [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 2,309,428 | |||||||||
Subsequent Event [Member] | February 2018 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 2,841,152 | |||||||||
Shares issued, price per share | $ 3.25 | |||||||||
Gross proceeds from sale of common stock and warrants | $ 12,000,000 | |||||||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | |||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. | |||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.5 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.25 | |||||||||
Warrants exercisable period | 5 years | |||||||||
Subsequent Event [Member] | Pre-funded Units [Member] | February 2018 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 851,155 | |||||||||
Shares issued, price per share | $ 3.24 | |||||||||
Subsequent Event [Member] | Pre-funded Warrants [Member] | February 2018 Public Offering [Member] | ||||||||||
Conversion Of Stock [Line Items] | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | Dec. 31, 2017USD ($) | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)Customershares |
Significant Accounting Policies [Line Items] | |||
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 | 31,278 | 31,278 | $ 26,716 |
Number of individual customers accounting for more than 10% of revenue | Customer | 0 | ||
Inventory valuation reserves | $ 155,507 | 155,507 | $ 704,516 |
Depreciation expense | 401,272 | 388,231 | |
Amortization of intangible assets | 267,816 | 267,816 | |
Impairment of finite-lived intangible assets | 0 | $ 0 | |
Impairment of goodwill | $ 0 | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 1.6 | 0.5 | |
Domestic Country [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating loss carryforwards | $ 165,544,893 | $ 165,544,893 | $ 150,950,436 |
Trademarks and Trade Names [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 10 years | ||
Developed Technology [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 7 years | ||
Customer Relationships [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-lived intangible asset, useful life | 7 years | ||
Accounts Receivable [Member] | Customer One [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 41.00% | 25.00% | |
Sales Revenue, Net [Member] | Customer One [Member] | Customer Concentration Risk [Member] | |||
Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 11.00% | ||
Minimum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 30 days | ||
Estimated useful lives of related assets | 3 years | ||
Fair value assumptions, expected term | 6 years 3 months | ||
Maximum [Member] | |||
Significant Accounting Policies [Line Items] | |||
Accounts receivable period due | 60 days | ||
Estimated useful lives of related assets | 5 years | ||
Fair value assumptions, expected term | 10 years |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Inventories | ||
Raw materials and supplies | $ 360,134 | $ 479,479 |
Work-in process | 51,233 | 27,422 |
Finished goods | 122,058 | 185,467 |
Total | $ 533,425 | $ 692,368 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 7,044,821 | $ 6,608,735 |
Less accumulated depreciation | (6,209,284) | (5,808,012) |
Property and equipment, net | 835,537 | 800,723 |
Laboratory and Manufacturing Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 4,109,367 | 3,785,133 |
Office Furniture and Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 700,299 | 688,952 |
Computer Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 1,505,651 | 1,472,144 |
Leasehold Improvements [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 729,504 | $ 662,506 |
Summary of Significant Accoun30
Summary of Significant Accounting Policies - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (659,818) | (392,002) |
Net Balance | 1,353,182 | 1,620,998 |
Trademarks and Tradenames [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (113,679) | (67,575) |
Net Balance | 347,321 | 393,425 |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (161,322) | (95,898) |
Net Balance | 296,678 | 362,102 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (384,817) | (228,529) |
Net Balance | $ 709,183 | $ 865,471 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - Schedule of Expected Amortization of Intangible Assets (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||
2,018 | $ 267,816 | |
2,019 | 267,816 | |
2,020 | 267,816 | |
2,021 | 267,816 | |
2,022 | 165,117 | |
Thereafter | 116,801 | |
Net Balance | $ 1,353,182 | $ 1,620,998 |
MGHIF Financing - Additional In
MGHIF Financing - Additional Information (Details) - USD ($) | Jun. 28, 2017 | Jul. 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 |
Common Stock and Note Purchase Agreement [Line Items] | ||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,808,836 | $ 4,405,973 | ||
Fair value adjustment of warrants | (144,064) | 0 | ||
MGHIF Financing Agreement [Member] | ||||
Common Stock and Note Purchase Agreement [Line Items] | ||||
Stock issued during period, shares, new issues | 45,454 | |||
Shares issued, price per share | $ 110 | |||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | |||
Debt instrument, interest rate, stated percentage | 8.00% | |||
Debt instrument, face amount | $ 1,000,000 | |||
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 | |||
Amended and Restated MGHIF Financing Agreement [Member] | ||||
Common Stock and Note Purchase Agreement [Line Items] | ||||
Debt instrument, interest rate, stated percentage | 10.00% | |||
Debt instrument, extended maturity date | Jul. 14, 2018 | |||
Warrant expiration period | 5 years | |||
Issuance of common stock warrants to purchase | 13,120 | |||
Warrants first exercisable period after issuance date | 6 months | |||
Class of warrant or right, exercise price of warrants or rights | $ 19.50 | |||
Percentage of warrant exercise price on common stock closing price on date of issuance | 110.00% | |||
Estimated fair value of debt | 1,000,000 | $ 1,000,000 | ||
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 |
Debt - Additional Information (
Debt - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2017USD ($)Note | Dec. 31, 2016USD ($) | |
Debt Instrument [Line Items] | ||
Short-term debt | $ 1,010,961 | $ 1,023,815 |
Interest expense, debt | 233,505 | 143,347 |
Due in 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, annual principal payment | 1,100,000 | |
MGHIF Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | 1,000,000 | |
Long-term debt, outstanding | $ 1,000,000 | |
Notes Payable, Other Payables [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | $ 100,000 | |
Bridge Financing Notes [Member] | ||
Debt Instrument [Line Items] | ||
Number of notes | Note | 3 | |
Number of notes drew down | Note | 2 |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - USD ($) | Dec. 31, 2017 | Jul. 18, 2017 | Sep. 13, 2016 | Oct. 31, 2017 | Sep. 30, 2017 | Jul. 31, 2017 | Jun. 30, 2016 | May 31, 2016 | Jun. 30, 2016 | Dec. 31, 2017 | 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 | ||||||||
Common stock, shares issued | 2,265,320 | 2,265,320 | 1,012,171 | ||||||||
Common stock, shares outstanding | 2,265,320 | 2,265,320 | 1,012,171 | ||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | ||||||||
Net proceeds from sale of common stock and warrants | $ 8,754,882 | $ 0 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | 3,808,836 | 4,405,973 | |||||||||
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, tax benefit from compensation expense | 0 | ||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ 1,300,000 | $ 1,300,000 | |||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 8 years 3 months 18 days | ||||||||||
Share-based compensation arrangement by share-based payment award, options, vested in period, fair value | $ 2,086,843 | 1,088,978 | |||||||||
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 | 11,175 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, grants in period, weighted average grant date fair value | $ 6.93 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, vested in period | 6,025 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, forfeited in period | 0 | ||||||||||
Share-based compensation arrangement by share-based payment award, equity instruments other than options, non-vested, outstanding | 5,900 | 5,900 | |||||||||
2015 Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 54,200 | 54,200 | |||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | 32,411 | 32,411 | |||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||||
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 | $ 32.8125 | ||||||||||
Warrant expiration period | 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 | $ 32.8125 | $ 32.8125 | |||||||||
Warrant expiration period | 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 | ||||||||||
Common Stock [Member] | Vendor Consulting Services [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 2,898 | ||||||||||
Stock issued during period, value, new issues | $ 23,245 | ||||||||||
Common Stock [Member] | AdvanDx [Member] | Pre-Merger Dispute Settlement [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 15,842 | ||||||||||
Stock issued during period, value, new issues | $ 110,000 | ||||||||||
Non-voting Convertible Preferred Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Conversion of stock, shares converted | 92,377 | ||||||||||
July 2017 Public Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 18,164,195 | ||||||||||
Shares issued, price per share | $ 0.40 | ||||||||||
Gross proceeds from sale of common stock and warrants | $ 10,000,000 | ||||||||||
Net proceeds from sale of common stock and warrants | $ 8,800,000 | ||||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 10.625 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
July 2017 Public Offering [Member] | Placement Agent [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 12.50 | ||||||||||
Warrants exercisable period | 5 years | ||||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Repayment of principal amount of outstanding debt | $ 1,000,000 | $ 1,000,000 | |||||||||
Repayments of accrued interest on outstanding debt | $ 6,438 | ||||||||||
July 2017 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 6,835,805 | ||||||||||
Shares issued, price per share | $ 0.39 | ||||||||||
July 2017 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.25 | ||||||||||
July 2017 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 50,000 | ||||||||||
At the Market Offering [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, value, new issues | $ 3,808,836 | $ 4,405,973 | |||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | ||||||||||
Maximum commission percentage on gross proceeds | 3.00% | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,200,000 | 8,200,000 | |||||||||
Gross proceeds from sale of common stock | 8,800,000 | 8,800,000 | |||||||||
Remaining availability under at the market offering | $ 2,700,000 | $ 2,700,000 | |||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | ||||||||||
At the Market Offering [Member] | Common Stock [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 227,216 | 144,795 | |||||||||
Stock issued during period, value, new issues | $ 2,272 | $ 1,448 | |||||||||
At the Market Offering [Member] | Common Stock [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock issued during period, shares, new issues | 372,000 | 372,000 | |||||||||
Private Placement [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Sale of stock, description of transaction | (i) one twenty-fifth of a share of common stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase an additional 0.03 shares of common stock, at a price of $1.14 per unit. | ||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.03 | 0.03 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 1.14 | $ 1.14 | |||||||||
Stock issued during period, value, new issues | $ 9,460,749 | ||||||||||
Class of warrant or right, number of securities called by warrants or rights | 271,606 | 271,606 | |||||||||
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 | 269,765 | 269,765 | |||||||||
Stock issued during period, value, new issues | $ 2,697 | ||||||||||
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 |
Stockholders' Equity - Company
Stockholders' Equity - Company Recognized Stock Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 911,398 | $ 945,461 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 13,776 | 6,003 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 237,103 | 236,341 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 603,787 | 599,550 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 56,732 | $ 103,567 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Status of Options Granted (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Stockholders Equity Note [Abstract] | |||
Number of Options, Outstanding Balance | 119,106 | 86,431 | |
Number of Options, Granted | 58,324 | 58,546 | |
Number of Options, Exercised | (1,167) | (2,660) | |
Number of Options, Forfeited | (24,538) | (22,868) | |
Number of Options, Expired | (12,330) | (343) | |
Number of Options, Outstanding Balance | 139,395 | 119,106 | 86,431 |
Number of Options, Vested and expected to vest | 139,395 | ||
Number of Options, Exercisable | 63,365 | ||
Weighted Average Exercise Price, Outstanding Balance | $ 44 | $ 65 | |
Weighted Average Exercise Price, Granted | 17.58 | 35.25 | |
Weighted Average Exercise Price, Exercised | 7.01 | 9 | |
Weighted Average Exercise Price, Forfeited | 36.31 | 99.75 | |
Weighted Average Exercise Price, Expired | 83.49 | 212.25 | |
Weighted Average Exercise Price, Outstanding Balance | 31.16 | $ 44 | $ 65 |
Weighted Average Exercise Price, Vested and expected to vest | 31.16 | ||
Weighted Average Exercise Price, Exercisable | $ 4.73 | ||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 8 years 3 months 18 days | 8 years 7 months 6 days | 9 years 1 month 6 days |
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 8 years 3 months 18 days | ||
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 7 years 8 months 12 days | ||
Aggregate Intrinsic Value, Outstanding | $ 663,298 | $ 1,575,646 | |
Aggregate Intrinsic Value, Exercised | 11,256 | 79,406 | |
Aggregate Intrinsic Value, Outstanding | 37,339 | $ 663,298 | $ 1,575,646 |
Aggregate Intrinsic Value, Vested and expected to vest | 37,339 | ||
Aggregate Intrinsic Value, Exercisable | $ 33,575 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | 0.00% | 0.00% |
Risk free interest rate, minimum | 1.80% | 1.20% |
Risk free interest rate, maximum | 2.30% | 2.20% |
Expected volatility, minimum | 44.20% | 42.00% |
Expected volatility, maximum | 53.00% | 49.80% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 3 months | 5 years 3 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 3 months | 6 years 3 months |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Shares of Common Stock (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 1,495,008 | 420,262 |
August 2007 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2017-08 | |
Shares of Common Stock Subject to Warrants | 357 | |
March 2008 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19,763.50 | |
Expiration | 2018-03 | |
Shares of Common Stock Subject to Warrants | 2 | 2 |
November 2009 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2019-11 | |
Shares of Common Stock Subject to Warrants | 267 | 267 |
January 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-01 | |
Shares of Common Stock Subject to Warrants | 267 | 267 |
March 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-03 | |
Shares of Common Stock Subject to Warrants | 51 | 51 |
November 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-11 | |
Shares of Common Stock Subject to Warrants | 209 | 209 |
December 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-12 | |
Shares of Common Stock Subject to Warrants | 27 | 27 |
March 2012 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 2,747.50 | |
Expiration | 2019-03 | |
Shares of Common Stock Subject to Warrants | 165 | 165 |
February 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2025-02 | |
Shares of Common Stock Subject to Warrants | 9,000 | 9,000 |
May 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2020-05 | |
Shares of Common Stock Subject to Warrants | 138,310 | 138,310 |
May 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 189,574 | 189,574 |
June 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 82,033 | 82,033 |
June 2017 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19.50 | |
Expiration | 2022-06 | |
Shares of Common Stock Subject to Warrants | 18,754 | |
July 2017 [Member] | Exercise Price 17.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 17.25 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 6,349 | |
July 2017 [Member] | Exercise Price 12.50 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 12.50 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 50,000 | |
July 2017 [Member] | Exercise Price 10.63 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 10.63 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 1,000,000 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax [Line Items] | |||
Deferred tax assets, net of valuation allowance, total | $ 49,251,408 | $ 63,520,548 | |
Deferred tax assets, valuation allowance | $ 49,251,408 | $ 63,520,548 | |
U.S. federal corporate tax rate | 34.00% | 34.00% | |
Reduction of deferred tax assets | $ 14,600,000 | ||
Provisional amount | $ 0 | ||
Maximum [Member] | |||
Income Tax [Line Items] | |||
U.S. federal corporate tax rate | 35.00% | ||
Scenario Plan [Member] | |||
Income Tax [Line Items] | |||
U.S. federal corporate tax rate | 21.00% | ||
Domestic Country [Member] | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 165,544,893 | $ 150,950,436 | |
Operating loss carryforwards, expiration terms | begin to expire in 2022. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
NOL carryforward | $ 46,326,407 | $ 60,357,220 |
R&E credit carryforward | 2,559,479 | 2,559,479 |
Share-based compensation | 345,088 | 448,534 |
Inventory reserve | 45,338 | 269,708 |
Depreciation | 71,756 | 117,629 |
Accruals and other | 247,093 | 333,126 |
Total deferred tax assets | 49,595,161 | 64,085,696 |
Valuation allowance | (49,251,408) | (63,520,548) |
Deferred tax liabilities: | ||
Intangible assets | (343,753) | (565,148) |
Net deferred tax liability | $ 0 | $ 0 |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rates | 34.00% | 34.00% |
State income tax benefit, net of Federal benefit | 6.80% | 6.50% |
Tax reform impact | (134.50%) | 0.00% |
Change in valuation allowance | 93.00% | (37.30%) |
Change in state tax rates and other | 0.70% | (3.20%) |
Total | 0.00% | 0.00% |
Commitments (Details Textual)
Commitments (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | |
Other Commitments [Line Items] | |||
Operating lease description | During the second quarter of 2015, the Company extended the term of its Gaithersburg, Maryland office lease, effective May 7, 2015, through January 31, 2021, with one additional five-year renewal at the Company’s election. The Company is responsible for all utilities, repairs, insurance, and taxes under this operating lease. Effective July 1, 2015, the Company further modified its lease agreement to add additional leased space to its headquarters. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis. | ||
Operating leases, rent expense, net, total | $ 949,244 | $ 1,000,726 | |
Capital leases description | The Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. | ||
Capital leases expiration date description | The leases expire at various dates through 2021. | ||
Restructuring benefits recognized | $ 121,000 | ||
Retention expense incurred | 68,000 | ||
Future minimum operating lease payments | $ 3,686,150 | ||
Designated service period of employees, description | The service periods ended in December 2017 | ||
Capital Lease Obligations [Member] | |||
Other Commitments [Line Items] | |||
Capital leases, income statement, amortization expense | $ 183,663 | $ 161,606 | |
Facility in Woburn, Massachusetts [Member] | |||
Other Commitments [Line Items] | |||
Future minimum operating lease payments | $ 1,800,000 | ||
Facility in Woburn, Massachusetts [Member] | AdvanDx [Member] | |||
Other Commitments [Line Items] | |||
Operating leases expiration date | Jan. 30, 2022 | ||
Gaithersburg, Maryland Office Lease [Member] | |||
Other Commitments [Line Items] | |||
Operating leases expiration date | Jan. 31, 2021 | ||
Operating leases additional term | 5 years |
Commitments (Details)
Commitments (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Capital Leases | ||
2,018 | $ 177,464 | |
2,019 | 85,393 | |
2,020 | 56,981 | |
2,021 | 1,773 | |
Total | 321,611 | |
Less: amount representing interest | (36,619) | |
Net present value of future minimum lease payments | 284,992 | |
Current maturities | (154,839) | $ (184,399) |
Long-term maturities | 130,153 | |
Operating Leases | ||
2,018 | 1,041,323 | |
2,019 | 1,054,374 | |
2,020 | 1,072,748 | |
2,021 | 482,058 | |
2022 and thereafter | 35,647 | |
Total | 3,686,150 | |
Total | ||
2,018 | 1,218,787 | |
2,019 | 1,139,767 | |
2,020 | 1,129,729 | |
2,021 | 483,830 | |
2022 and thereafter | 35,647 | |
Total | $ 4,007,760 |
Commitments (Details 1)
Commitments (Details 1) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Loss Contingencies [Line Items] | ||
Less accumulated amortization | $ (454,471) | $ (270,808) |
Capital lease assets, net | 485,461 | 379,161 |
Laboratory and Manufacturing Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | 850,792 | 560,829 |
Office Furniture and Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | 64,790 | 64,790 |
Computers and Network Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | $ 24,350 | $ 24,350 |
License Agreements, Research 45
License Agreements, Research Collaborations and Development Agreements (Details Textual) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($)Agreement | Dec. 31, 2016USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Royalty expense | $ 257,186 | $ 290,491 | |
Annual future minimum royalty payments due | 250,000 | ||
Collaborations revenue | 397,178 | $ 272,603 | |
License Agreement with Hitachi [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Collaborations revenue | 25,000 | ||
CDC [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Number of contract awarded year | 1 year | ||
Revenue related to contract | $ 357,178 | ||
CDC [Member] | Cloud-Based Mobile Software [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Contract awarded value for funds development and evaluation of software | $ 860,000 | ||
FISH Product Line [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Number of license agreements | Agreement | 1 |
Related Party Transactions (Det
Related Party Transactions (Details Textual) - USD ($) | 12 Months Ended | 14 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2017 | Oct. 31, 2016 | |
Related Party Transaction [Line Items] | ||||
Cost of services | $ 520,338 | $ 631,333 | ||
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 | $ 113,907 | 32,270 | $ 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 | $ 123,067 | 183,713 | ||
Related party transaction, purchases from related party | 135,415 | 91,399 | ||
Payments to acquire equipment on lease | 91,882 | $ 175,475 | ||
Subcontractor Agreement | ILÚM Health Solutions, LLC [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cost of services | $ 210,180 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) | 12 Months Ended |
Dec. 31, 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 |
Expensed | (4,500) |
Balance at the end of the period | 0 |
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 | 152,517 |
Change in Fair Value | (144,064) |
Expensed | 0 |
Balance at the end of the period | $ 8,453 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Textual) | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Fair Value on Non-Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Financial assets measured at fair value | $ 0 |
Financial liabilities measured at fair value | 0 |
Impairment of non-financial assets and liabilities at fair value | 0 |
Fair Value on Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Non-financial assets measured at fair value | 0 |
Non-financial liabilities measured at fair value | $ 0 |
Subsequent events (Details Text
Subsequent events (Details Textual) - USD ($) | Feb. 07, 2018 | Jan. 17, 2018 | Jan. 05, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Subsequent Event [Line Items] | |||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | |||
Net proceeds from sale of common stock and warrants | $ 8,754,882 | $ 0 | |||
Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Stock split | On January 17, 2018, the Board of Directors of the Company approved a one-for-twenty-five reverse stock split. All share and per share information in these consolidated financial statements, except for par value and authorized shares, have been amended to reflect the reverse stock split. | ||||
Common stock, shares authorized | 50,000,000 | ||||
Subsequent Event [Member] | February 2018 Public Offering [Member] | |||||
Subsequent Event [Line Items] | |||||
Stock issued during period, shares, new issues | 2,841,152 | ||||
Shares issued, price per share | $ 3.25 | ||||
Gross proceeds from sale of common stock and warrants | $ 12,000,000 | ||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | ||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. | ||||
Class of warrant or right, number of securities called by each warrant or right | 0.5 | ||||
Class of warrant or right, exercise price of warrants or rights | $ 3.25 | ||||
Warrants exercisable period | 5 years | ||||
Subsequent Event [Member] | Pre-funded Units [Member] | February 2018 Public Offering [Member] | |||||
Subsequent Event [Line Items] | |||||
Stock issued during period, shares, new issues | 851,155 | ||||
Shares issued, price per share | $ 3.24 | ||||
Subsequent Event [Member] | Pre-funded Warrants [Member] | February 2018 Public Offering [Member] | |||||
Subsequent Event [Line Items] | |||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||
Subsequent Event [Member] | Life Technologies Corporation Supply Agreement [Member] | |||||
Subsequent Event [Line Items] | |||||
Agreement term | 3 years | ||||
Annual minimum purchases per year | $ 100,000 |