Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 17, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
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 | $ 39.9 | ||
Trading Symbol | OPGN | ||
Entity Common Stock, Shares Outstanding | 12,574,303 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets | ||
Cash and cash equivalents | $ 7,814,220 | $ 749,517 |
Accounts receivable, net | 678,646 | 503,983 |
Inventory, net | 826,012 | 369,742 |
Prepaid expenses and other current assets | 572,489 | 90,233 |
Total current assets | 9,891,367 | 1,713,475 |
Property and equipment, net | 1,074,710 | 587,956 |
Deferred IPO issuance costs | 0 | 296,041 |
Intangible assets, net | 1,888,814 | 0 |
Goodwill | 637,528 | 0 |
Other noncurrent assets | 270,327 | 57,459 |
Total assets | 13,762,746 | 2,654,931 |
Current liabilities | ||
Accounts payable | 2,285,792 | 1,160,081 |
Accrued compensation and benefits | 1,081,270 | 423,099 |
Deferred rent, current portion | 303,719 | 26,000 |
Accrued liabilities | 920,286 | 967,657 |
Deferred revenue | 50,925 | 339,171 |
Short-term notes payable | 0 | 1,505,000 |
Current maturities of long-term capital lease obligations | 251,800 | 100,499 |
Short term convertible notes, net of discounts | 0 | 1,500,000 |
Total current liabilities | 4,893,792 | 6,021,507 |
Long-term capital lease obligations and other liabilities | 377,908 | 134,149 |
Notes payable | 1,000,000 | 0 |
Total liabilities | $ 6,271,700 | 6,155,656 |
Commitments and contingencies (Note 10) | ||
Redeemable convertible preferred stock | ||
Total redeemable convertible preferred stock | $ 0 | 4,564,899 |
Stockholders' equity (deficit) | ||
Common stock, $.01 par value; 200,000,000 shares authorized; 12,547,684 and 493,178 shares issued and outstanding at December 31, 2015 and 2014, respectively | 125,477 | 4,932 |
Additional paid-in capital | 121,490,994 | 88,701,737 |
Accumulated other comprehensive loss | (1,059) | 0 |
Accumulated deficit | (114,124,366) | (96,772,293) |
Total stockholders' equity (deficit) | 7,491,046 | (8,065,624) |
Total liabilities, preferred stock and stockholders’ equity (deficit) | 13,762,746 | 2,654,931 |
Series A Redeemable Convertible Preferred Stock | ||
Redeemable convertible preferred stock | ||
Total redeemable convertible preferred stock | $ 0 | $ 4,564,899 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
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 | 12,547,684 | 493,178 |
Common stock, shares outstanding | 12,547,684 | 493,178 |
Series A Redeemable Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0 | $ 0.01 |
Preferred stock, shares authorized | 0 | 6,000,000 |
Preferred stock, shares issued | 0 | 3,999,864 |
Preferred stock, shares outstanding | 0 | 3,999,864 |
Preferred stock, liquidation preference | $ 0 | $ 7,999,728 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue | ||
Product sales | $ 2,701,142 | $ 1,236,349 |
Laboratory services | 120,476 | 478,909 |
Collaborations revenue | 336,102 | 2,411,120 |
Total revenue | 3,157,720 | 4,126,378 |
Operating expenses | ||
Costs of products sold | 1,179,771 | 425,541 |
Costs of services | 367,802 | 526,196 |
Research and development | 6,002,941 | 4,368,302 |
General and administrative | 5,834,642 | 2,312,935 |
Sales and marketing | 4,305,444 | 2,058,085 |
Transaction expenses | 526,283 | 0 |
Total operating expenses | 18,216,883 | 9,691,059 |
Operating loss | (15,059,163) | (5,564,681) |
Other income (expense) | ||
Interest and other income | 26,657 | 156 |
Interest expense | (1,801,320) | (111,345) |
Change in fair value of derivative financial instruments and other | (647,342) | 4,400 |
Total other income (expense) | (2,422,005) | (106,789) |
Loss before income taxes | (17,481,168) | (5,671,470) |
Income tax benefit | (129,095) | 0 |
Net loss | (17,352,073) | (5,671,470) |
Accretion of Series A preferred stock | (243,762) | (627,133) |
Net loss available to common stockholders | $ (17,595,835) | $ (6,298,603) |
Net loss per common share - basic and diluted (in dollars per share) | $ (2.20) | $ (16.25) |
Weighted average shares outstanding - basic and diluted (in shares) | 7,980,995 | 387,590 |
Net loss | $ (17,352,073) | $ (5,671,470) |
Other comprehensive loss - foreign currency translation | (1,059) | 0 |
Comprehensive loss | $ (17,353,132) | $ (5,671,470) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2013 | $ (1,831,441) | $ 3,625 | $ 89,265,757 | $ 0 | $ (91,100,823) |
Balance (in shares) at Dec. 31, 2013 | 362,537 | ||||
Stock option exercises | $ 8 | $ 0 | 8 | 0 | 0 |
Stock option exercises (in shares) | 1 | 1 | |||
Restricted stock unit exercises | $ 0 | $ 1,307 | (1,307) | 0 | 0 |
Restricted stock unit exercises (in shares) | 130,640 | ||||
Common shares issued in business combination | 0 | ||||
Stock compensation expense | 64,412 | $ 0 | 64,412 | 0 | 0 |
Accretion of Series A preferred stock | (627,133) | 0 | (627,133) | 0 | 0 |
Net loss | (5,671,470) | 0 | 0 | 0 | (5,671,470) |
Balance at Dec. 31, 2014 | (8,065,624) | $ 4,932 | 88,701,737 | 0 | (96,772,293) |
Balance (in shares) at Dec. 31, 2014 | 493,178 | ||||
Stock option exercises | $ 2,303 | $ 114 | 2,189 | 0 | 0 |
Stock option exercises (in shares) | 11,472 | 11,472 | |||
Beneficial conversion feature | $ 1,427,667 | $ 0 | 1,427,667 | 0 | 0 |
Reclassification of warrant liability to equity | 719,675 | 0 | 719,675 | 0 | 0 |
Conversion of preferred stock into common shares | 7,804,172 | $ 73,749 | 7,730,423 | 0 | 0 |
Conversion of preferred stock into common shares (in shares) | 7,374,852 | ||||
Demand notes tendered for IPO Units | 2,100,000 | $ 3,500 | 2,096,500 | 0 | 0 |
Demand notes tendered for IPO Units (in shares) | 350,000 | ||||
Issuance of IPO units, net of offering costs | 12,129,133 | $ 25,000 | 12,104,133 | 0 | 0 |
Issuance of IPO units, net of offering costs (in shares) | 2,500,000 | ||||
Additional IPO issuance costs | (58,566) | (58,566) | 0 | 0 | |
Common shares issued in business combination | 2,584,090 | $ 6,818 | 2,577,272 | 0 | 0 |
Common shares issued in business combination (in shares) | 681,818 | ||||
Common shares issued in financing | 5,000,002 | $ 11,364 | 4,988,638 | 0 | 0 |
Common shares issued in financing (in shares) | 1,136,364 | ||||
Stock compensation expense | 1,445,088 | $ 0 | 1,445,088 | 0 | 0 |
Accretion of Series A preferred stock | (243,762) | 0 | (243,762) | 0 | 0 |
Foreign currency translation | (1,059) | 0 | 0 | (1,059) | 0 |
Net loss | (17,352,073) | 0 | 0 | 0 | (17,352,073) |
Balance at Dec. 31, 2015 | $ 7,491,046 | $ 125,477 | $ 121,490,994 | $ (1,059) | $ (114,124,366) |
Balance (in shares) at Dec. 31, 2015 | 12,547,684 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities | ||
Net loss | $ (17,352,073) | $ (5,671,470) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 624,653 | 573,918 |
Non-cash interest expense including beneficial conversion | 1,598,312 | 84,168 |
Bad debt expense | 0 | 4,000 |
Recovery of bad debt | 0 | (8,400) |
Deferred tax benefit | (129,095) | 0 |
Stock compensation expense | 1,445,088 | 64,412 |
Inventory obsolescence expense | 0 | 21,877 |
Change in fair value of derivative financial instruments | 647,342 | 0 |
Other non-cash items | 24,010 | 14,681 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 359,298 | (257,686) |
Inventory | 424,505 | (215,906) |
Other assets | (319,305) | 76,554 |
Accounts payable | 196,444 | 198,177 |
Accrued compensation and other liabilities | (1,508,937) | (99,310) |
Deferred revenue | (288,246) | (170,557) |
Net cash used in operating activities | (14,278,004) | (5,385,542) |
Cash flows from investing activities | ||
Cash acquired in business combination | 1,367,211 | 0 |
Purchases of property and equipment | (185,296) | (39,537) |
Net cash provided by (used in) investing activities | 1,181,915 | (39,537) |
Cash flows from financing activities | ||
Proceeds from issuance of preferred stock, net of issuance costs | 0 | 1,937,902 |
Proceeds from issuance of common stock, net of issuance costs | 17,366,620 | 0 |
Proceeds from issuance of convertible notes, net of issuance costs | 1,388,815 | 1,472,386 |
Proceeds from issuance of promissory notes, net of issuance costs | 1,741,667 | 1,488,229 |
Proceeds from exercise of stock options and warrants | 2,293 | 8 |
Payments on debt | (155,000) | (5,000) |
Payments on capital lease obligations | (175,317) | (105,881) |
Deferred IPO issuance costs | 0 | (13,393) |
Net cash provided by financing activities | 20,169,078 | 4,774,251 |
Effects of exchange rates on cash | (8,286) | 0 |
Net increase (decrease) in cash and cash equivalents | 7,072,989 | (650,828) |
Cash and cash equivalents at beginning of year | 749,517 | 1,400,345 |
Cash and cash equivalents at end of year | 7,814,220 | 749,517 |
Supplemental disclosure of cash flow information | ||
Cash paid during the year for interest | 194,288 | 32,296 |
Supplemental disclosure of noncash investing and financing activities: | ||
Common stock issued for business combination | 2,584,090 | 0 |
Acquisition of equipment purchased through capital leases and leasehold improvement allowances | 580,477 | 0 |
Deferred and accrued IPO issuance costs | 0 | 282,648 |
Convertible Debt [Member] | ||
Supplemental disclosure of noncash investing and financing activities: | ||
Debt Conversion, Converted Instrument, Amount | 300,000 | 0 |
IPO [Member] | ||
Supplemental disclosure of noncash investing and financing activities: | ||
Debt Conversion, Converted Instrument, Amount | 2,100,000 | 0 |
Series A Preferred Stock [Member] | ||
Supplemental disclosure of noncash investing and financing activities: | ||
Debt Conversion, Converted Instrument, Amount | 3,000,000 | 0 |
Conversion of Series A preferred stock into common shares | $ 8,183,661 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 – Organization OpGen, Inc. (“OpGen” of the “Company”) was incorporated in Delaware in 2001. On July 14, 2015, OpGen completed the strategic acquisition (the “Merger”) of AdvanDx, Inc. and its wholly owned subsidiary AdvanDx A/S (collectively, “AdvanDx”) (see Note 4). Pursuant to the terms of a merger agreement, Velox Acquisition Corp., OpGen’s wholly owned subsidiary formed for the express purpose of effecting the Merger, merged with and into AdvanDx, Inc. with AdvanDx, Inc. surviving as OpGen’s wholly owned subsidiary (see Note 4). OpGen, AdvanDx, Inc. and AdvanDx A/S are collectively referred to hereinafter as the “Company.” 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 combat infectious disease. OpGen is developing molecular information solutions to combat infectious disease in global healthcare settings, helping to guide clinicians with more rapid information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms. The Company’s proprietary DNA tests and bioinformatics address the rising threat of antibiotic resistance by helping physicians and healthcare providers optimize patient care decisions and protect the hospital biome through customized screening and surveillance solutions. The Company’s molecular information solution combines Acuitas® DNA tests, Acuitas Lighthouse™ bioinformatics, CLIA lab services for MDRO surveillance, and a proprietary data warehouse including genomic data matched with antibiotic susceptibility information for microbes and patient information from healthcare providers. The Company is working to deliver our molecular information solution to a global network of customers and partners. The Acuitas DNA tests provide rapid microbial ID, and antibiotic resistance gene information. These products include the QuickFISH® family of FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures, the MDRO Gene Test to detect, type, track, and trend antibiotic resistant organisms in real-time and our rapid antibiotic resistance test in development. 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, 2015 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management’s Plans | The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements. The Company raised significant funds in 2015, including: · $ 0.8 0.3 0.2 · $ 1.5 · $ 12.1 · $ 6.0 On May 8, 2015, OpGen completed its IPO pursuant to which it offered and sold 2,850,000 6.00 17.1 2.1 350,000 12.1 422,500 7,374,852 In July 2015, the Company raised $ 6.0 1,136,364 4.40 1.0 The Company’s current operating assumptions, which include management’s best estimate of future revenue and operating expenses, indicate that current cash on hand will be sufficient to fund operations into the second quarter of 2016. In the event the Company is unable to successfully raise additional capital in 2016, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing, or pursue other strategic alternatives which may include licensing and/or partnering arrangements or mergers and acquisitions. The consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies 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. Certain prior period information has been reclassified to conform to the current period presentation. AdvanDx A/S is located in Copenhagen, Denmark and uses the Danish Kroner 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 other comprehensive loss, a component of stockholder's equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at December 31, 2015. 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. 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, and the recoverability of long-lived assets. Actual results could differ from those estimates. 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. Debt is reflective of fair value based on instruments with similar terms available to the Company. For additional fair value disclosures, see Note 13. 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 At December 31, 2015, the Company has funds totaling $ 243,380 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 60 15,596 79,697 At December 31, 2015, the Company had accounts receivable from one customer which individually represented 25 79 15 64 Inventory December 31, 2015 2014 Raw Materials and supplies $ 362,526 $ 40,749 Work-in-process 150,369 135,625 Finished goods 313,117 193,368 Total inventory $ 826,012 $ 369,742 Inventory includes the Argus Whole Genome Mapping Systems, reagents and supplies used for Argus consumable kits, reagents and components for Quick 591,051 867,816 Intangible assets and goodwill Intangible assets as of December 31, 2015 were acquired as part of the Merger, and consist of definite-lived intangible assets and goodwill. Intangible assets acquired in prior years were fully amortized as of December 31, 2014. Definite-lived intangible assets 10 7 7 Cost Accumulated Net balance at Trademarks and tradenames $ 461,000 $ (21,471) $ 439,529 Developed technology 458,000 (30,474) 427,526 Customer relationships 1,094,000 (72,241) 1,021,759 Balance $ 2,013,000 $ (124,186) $ 1,888,814 Total amortization expense of intangible assets was $ 124,186 57,594 268,000 Definite-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 years ended December 31, 2015 and 2014, the Company determined that its definite-lived intangible assets were not impaired. Goodwill Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. As a result of the Merger and subsequent measurement period adjustments (see Note 4), the Company recognized goodwill of $ 637,528 The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During year ended December 31, 2015, the Company determined that its goodwill was not impaired. 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 $ 500,467 516,324 December 31, 2015 2014 Laboratory equipment $ 3,734,044 $ 2,304,615 Office furniture and equipment 701,557 691,032 Computers 1,563,177 1,169,910 Leasehold improvements 659,949 245,558 6,658,727 4,411,115 Less accumulated depreciation (5,584,017) (3,823,159) Property and equipment, net $ 1,074,710 $ 587,956 In 2012, the Company began to provide Argus™ Whole Genome Systems under its Argus Reagent Rental Program to customers, in which the Company retains title without requiring customers to purchase the equipment or enter into an equipment lease or rental contract. The costs associated with these instruments are capitalized and charged to sales and marketing on a straight-line basis over the estimated useful life of the instrument, which is approximately four years. During the years ended December 31, 2015 and 2014, sales and marketing expenses related to these costs were approximately $ 175,000 101,000 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, 2015 and 2014, the Company determined that its property and equipment was not impaired. 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. All shares of Series A redeemable convertible preferred stock (“Series A Preferred Stock”) (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt (see Note 6)), were converted into 7,374,852 Prior to the IPO, the carrying value of the Series A Preferred Stock was increased by the accretion of related discounts, issuance costs and accrued but unpaid dividends so that the carrying amount would equal the redemption amount at the dates the stock becomes redeemable. At December 31, 2014, the Company had 3,999,864 70 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 sales. Revenue from sales of the Argus System When an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is delivered to the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are considered inconsequential and are combined with the Argus System as one unit of accounting. When an Argus System is sold with the Genome Builder software in a multiple-element arrangement, total arrangement consideration is allocated to the Argus System and to the Genome Builder software based on their relative selling prices. Selling prices are determined based on sales of similar systems to similar customers and, where no sales have occurred, on management’s best estimate of the expected selling price relative to similar products. Revenue related to the Argus System is recognized when it is delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered to the customer. Revenue from sales of QuickFISH, PNA FISH and XpressFISH diagnostic test products Revenue is recognized upon shipment to the customer. Sales are recorded net of accruals for estimated rebates, discounts and other deductions and returns. Revenue from sales of Genome Builder Software and consumables (on a stand-alone basis) Revenue is recognized for Genome Builder Software and for consumables, when sold on a standalone basis, upon delivery to the customer. Revenue from extended warranty service contracts The Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to be incurred over that same period. 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. 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 payments are recognized at fair value. The fair value of share-based payments 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. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. 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 believes that it is appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors include: (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 6.25 Expected forfeiture rate The forfeiture rate is the estimated percentage of options granted that is expected to be forfeited or canceled on an annual basis before becoming fully vested. The Company estimates the forfeiture rate based on turnover data with further consideration given to the class of the employees to whom the options were granted. The estimated fair value of equity instruments issued to nonemployees are recorded at fair value on the earlier of the performance commitment date or the date the services required are completed. 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 The Company had federal net operating loss (“NOL”) carryforwards of $ 90,297,000 76,268,000 Basic loss per share is computed by dividing net loss available to common shareholders 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 shareholders 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) restricted stock units (in 2014), (iii) stock purchase warrants, and (iv) prior to the IPO, convertible preferred stock and convertible debt, exercisable or exchangeable into common stock which have been excluded from the computation of diluted loss per share, was 6.0 5.9 In May 2014, the Financial Accounting Standards Board (“FASB”), issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue arising from contracts with customers. The standard is effective for the Company’s reporting year beginning January 1, 2018 and early adoption is permitted starting January 1, 2017. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raise substantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) requires an evaluation every reporting period, interim periods included, 3) provides principles for considering the mitigating effect of management’s plans to alleviate the substantial doubt, 4) requires certain disclosures if the substantial doubt is alleviated as a result of management’s plans, 5) requires an express statement, as well as other disclosures, if the substantial doubt is not alleviated, and 6) requires an assessment period of one year from the date the financial statements are issued. The standard is effective for the Company’s reporting year beginning January 1, 2017 and early adoption is permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as a direct reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its 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 is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In September 2015, the FASB issued accounting guidance to simplify the accounting for measurement period adjustments resulting from business combinations. Under the guidance, an acquirer will be required to recognize adjustments to provisional amounts identified during the measurement period in the reporting period in which the adjustments are determined. The guidance requires an entity to present separately on the face of the income statement or disclose in the notes to the financial statements the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date. The Company adopted this new guidance in the fourth quarter of 2015; see Note 4 for the impact of adoption. In February 2016, the FASB issued accounting guidance which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018 but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its consolidated financial statements and related disclosures. The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its financial position, results of operations, or cash flows. |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Business Combination | Note 4 – Business Combination On July 14, 2015, the Company acquired 100% of the capital stock of AdvanDx in the Merger in a taxable transaction. AdvanDx researches, develops and markets advanced in vitro Pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), Velox Acquisition Corp. merged with and into AdvanDx, Inc. with AdvanDx, Inc. surviving as a wholly owned subsidiary of the Company in accordance with the General Corporation Law of the State of Delaware. Under the terms of the Merger Agreement, the merger consideration consisted of an aggregate 681,818 2.6 The Company accounted for its acquisition of AdvanDx by recording all tangible and intangible assets acquired and liabilities assumed at their estimated fair values on the acquisition date, with the remaining unallocated purchase price recorded as goodwill. The fair value assigned to identifiable intangible assets acquired was determined using an income approach for trade names and customer relationships, and a cost approach for technology. The fair values are preliminary, are based on the Company’s estimates and may be adjusted from time to time, but no later than July 13, 2016, as better information becomes available. The Company received carryover tax basis in the acquired assets and liabilities and no tax basis in the intangible assets (including goodwill) established on the acquisition date. As a result, the Company recognized deferred tax assets related to foreign taxing jurisdictions of $ 4.3 0.1 Total purchase price - fair value of common stock issued $ 2,584,090 Fair value of tangible assets acquired: Cash $ 1,367,211 Receivables 536,406 Inventory 881,273 Property and equipment 245,479 Other assets 359,587 Fair value of identifable intangible assets acquired: Customer relationships 1,094,000 Developed technology 458,000 Trademarks and tradenames 461,000 Fair value of goodwill 637,528 Deferred tax liabilities, net 129,095 Fair value of liabilities assumed 3,327,299 $ 2,584,090 The total consideration paid in the acquisition exceeded the estimated fair value of the tangible and identifiable intangible assets acquired and liabilities assumed, resulting in approximately $ 0.6 0.5 1.7 Adjustments to Purchase Accounting Estimates In the fourth quarter of 2015, the Company adopted new accounting guidance with respect to the accounting for measurement period adjustments resulting from business combinations. Under the new guidance, the Company is required to recognize adjustments to provisional amounts identified during the measurement period in the reporting period in which the adjustments are determined and disclose the portion of the amount recorded in current-period losses by line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date. In the third quarter of 2015, the Company allocated the total purchase consideration to the assets and liabilities acquired from AdvanDx, based on provisional estimated fair value of those acquired assets and liabilities. As previously Adjusted reported (1) Adjustment amount Accounts receivable $ 557,112 $ (20,706) $ 536,406 Inventory 1,073,855 (192,582) 881,273 Property and equipment 250,636 (5,157) 245,479 Liabilities 3,329,058 (1,759) 3,327,299 Deferred tax liabilities - 129,095 129,095 Goodwill 291,747 345,781 637,528 Provision (benefit) for income taxes 1,662 (130,757) (129,095) (1) As reported on Form 10-Q for the quarter ended September 30, 2015 In the provisional amounts recorded in the third quarter, the Company had anticipated that it would receive “stepped-up” tax bases in the acquired assets and liabilities as a result of making an election under section 338 of the U.S. Internal Revenue Code. In the fourth quarter of 2015, after further tax analysis, the Company decided that it would not make the 338 election and, as such, the Company will receive “carry-over” tax bases in the assets and liabilities acquired. The change in tax treatment resulted in a reduction of the Company’s deferred tax asset valuation allowance in the U.S. taxing jurisdiction that existed prior to the acquisition. Pro Forma Disclosures (unaudited) The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Merger had been completed as of January 1, 2014. Pro forma information primarily reflects adjustments relating to (i) elimination of the interest on AdvanDx’s outstanding debt, and (ii) the amortization of intangibles acquired. Unaudited pro forma results Year Ended December 31, 2015 2014 Revenues $ 5,231,844 $ 8,904,244 Net loss $ (20,751,552) $ (14,520,497) Net loss per share $ (2.52) $ (6.87) |
Merck GHI Financing
Merck GHI Financing | 12 Months Ended |
Dec. 31, 2015 | |
Common Stock and Note Purchase Agreement [Abstract] | |
Merck GHI Financing | Note 5 – Merck GHI Financing On July 14, 2015, as a condition to the Merger, the Company entered into a Common Stock and Note Purchase Agreement (the “Purchase Agreement”) with Merck GHI, pursuant to which Merck GHI purchased 1,136,364 4.40 5.0 8 1.0 The Company incurred issuance costs of approximately $ 50,000 8,000 42,000 |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2015 | |
Preferred Stock, Number of Shares, Par Value and Other Disclosures [Abstract] | |
Redeemable Convertible Preferred Stock | Note 6 - Redeemable Convertible Preferred Stock All shares of Series A Preferred Stock (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt) were converted into 7,374,852 3,999,864 The Company issued 1,999,864 1.00 1,999,864 1,405,096 1,405,096 594,904 594,904 62,098 3,999,864 3,999,864 Shares Amount Balance at December 31, 2013 1,999,864 $ 1,999,864 February 2014 Issuance 1,405,096 1,361,469 April 2014 Issuance 594,904 576,433 2014 Accretion - 627,133 Balance at December 31, 2014 3,999,864 4,564,899 2015 Accretion - 243,762 2015 Conversions (3,999,864) (4,808,661) Balance at December 31, 2015 - $ - The Series A Preferred Stock had the right to receive non-cumulative dividends, at a rate of 8 The holders of Series A Preferred Stock had the right to convert such shares, at their option and at any time, into shares of common stock at the then-applicable conversion rate, as defined. The initial conversion rate was one common share for each preferred share, which may be adjusted for specified dilutive transactions. Beginning in December 2019, the Company may have been obligated to redeem shares of Series A Preferred Stock, if requested, by holders of at least 70 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 – Debt All the Company’s outstanding demand notes and convertible notes were exchanged for units in the Company’s IPO or otherwise were converted into Series A Preferred Stock and subsequently converted into shares of common stock in connection with the IPO. A short-term 8 150,000 1.0 8 December 31, 2015 2014 Convertible notes $ - $ 1,500,000 Demand promissory notes - 1,500,000 Long term promissory notes 1,000,000 5,000 $ 1,000,000 $ 3,005,000 The long-term promissory notes are due in July 2017 (see Note 5). In 2009, the Company entered into loan agreements with the Department of Business and Economic Development, a principal department of the State of Maryland, and Montgomery County, Maryland. Under the terms of the agreements, the State of Maryland and Montgomery County loaned the Company $ 100,000 10,000 3 75,000 100,000 11,811 Demand notes In the fourth quarter of 2014 and first quarter of 2015, the Company raised a total of $ 2.3 0.3 350,000 8 2014 convertible debt In July, August and September 2014, the Company raised $ 1.5 1,500,000 8 2015 convertible debt In February and March 2015, the Company raised $ 1.5 8 1,875,000 1.25 1.00 1.00 The conversion option embedded in the convertible notes was determined to contain beneficial conversion features, resulting in the bifurcation of those features as an equity instrument (resulting in an additional debt discount) at issuance. After allocation of the gross proceeds to the detachable stock purchase warrants (discussed below) and beneficial conversion feature, the total debt discount recognized was equal to the face value of the 2015 convertible notes. Upon conversion in May 2015, the remaining unamortized beneficial conversion feature of approximately $ 1.5 71,421 The 2015 convertible note holders also received detachable stock purchase warrants exercisable for 225,011 110 0.7 Total interest expense on all debt instruments was $ 1.8 0.1 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Deficit | Note 8 - Stockholders’ Equity As of December 31, 2015, the Company has 200,000,000 12,547,684 10,000,000 On May 8, 2015, the Company completed its IPO pursuant to which the Company offered and sold 2,850,000 6.00 17.1 2.1 350,000 2.9 12.1 422,500 4,225 7,374,852 The stock purchase warrants issued as part of the units (including over-allotment option) are exercisable for 3,272,500 6.60 May 8, 2020 185,250 In July 2015, the Company issued 1,136,364 5.0 Stock options In 2002, the Company adopted the 2002 Stock Option and Restricted Stock Plan (the “2002 Plan”), pursuant to which the Company’s Board of Directors could grant either incentive stock options or non-qualified stock options, shares of restricted stock, shares of unrestricted common stock, and other share-based awards to officers and employees. In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors 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 Company adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants will be made under the 2002 Plan or 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Internal Revenue Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 1,355,000 4 233,562 For the years ended December 31, 2015 and 2014, the Company recorded $ 1.4 0.1 Year Ended December 31, 2015 2014 Research and development $ 240,739 $ 5,234 General and administrative 619,899 55,802 Sales and marketing 584,450 3,376 $ 1,445,088 $ 64,412 During 2015 and 2014, the Company granted stock options to acquire 1,961,637 401,053 2.68 0.05 2.80 0.03 3.4 1.57 Weighted- Weighted- Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding at January 1, 2014 20,956 8.1 $ - Granted 401,053 $ 0.05 Exercised (1) $ 7.91 $ - Forfeited (17,736) $ 40.34 Outstanding at December 31, 2014 404,272 $ 1.13 9.3 $ - Granted 1,961,637 $ 2.68 Exercised (11,472) $ 0.20 $ 19,519 Forfeited (193,657) $ 0.55 Outstanding at December 31, 2015 2,160,780 $ 2.60 9.1 $ 1,575,646 Exercisable at December 31, 2015 432,340 $ 1.36 8.6 $ 632,052 Vested and expected to vest 2,138,606 $ 2.60 9.1 $ 1,555,185 The weighted-average grant-date fair value for the option awards granted during the years ended December 31, 2015 and 2014 was $2.80 and $0.03, respectively. The total fair value of options vested in the years ended December 31, 2015 and 2014, was $ 1,140,079 47,331 Year Ended December 31, 2015 2014 Annual dividend - - Expected life (in years) 5.5-6.25 6.25 Risk free interest rate 1.46-1.9 % 1.84-2.02 % Expected volatility 47.7-65.0 % 60.0 % On October 23, 2014, the Company’s Board of Directors approved grants of stock options to acquire approximately 825,000 Restricted stock units In March 2014, the Company awarded restricted stock units to acquire 130,640 130,640 75,000 1.70 Stock purchase warrants At December 31, 2015 and 2014, Outstanding at December 31, Exercise Issuance Price Expiration 2015 2014 August 2007 $ 7.91 August 2017 8,921 8,921 March 2008 $ 790.54 March 2018 46 46 November 2009 $ 7.91 November 2019 6,674 6,674 January 2010 $ 7.91 January 2020 6,674 6,674 March 2010 $ 7.91 March 2020 1,277 1,277 November 2011 $ 7.91 November 2021 5,213 5,213 December 2011 $ 7.91 December 2021 664 664 March 2012 $ 109.90 March 2019 4,125 4,125 February 2015 $ 6.60 February 2025 225,011 - May 2015 $ 6.60 May 2020 3,457,750 - 3,716,355 33,594 The warrants listed above were issued in connection with various debt, preferred stock or development contract agreements. The warrants issued in February 2015 were initially classified as a liability since the exercise price was variable. The exercise price became fixed as a result of the Company’s IPO and, as such, the warrant liability was marked to fair value at that time and reclassified to equity (see Note 13). |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 9 - Income Taxes At December 31, 2015 and 2014, the Company had net deferred tax assets of $ 41,554,045 31,505,287 41,545,045 31,505,287 December 31, 2015 2014 Deferred tax assets: NOL carryforward $ 38,797,762 $ 28,704,237 R&E credit carryforward 1,994,478 1,894,478 Share-based compensation 383,153 144,742 Inventory reserve 226,299 334,578 Depreciation 313,714 246,233 Accruals and other 495,640 185,702 Total deferred tax assets 42,211,046 31,509,970 Valuation allowance (41,554,045) (31,505,287) Deferred tax liabilities: Intangible assets (657,001) - Fixed assets - (4,683) Net deferred tax liability $ - $ - 2015 2014 Federal income tax benefit at statutory rates 35.0 % 34.0 % State income tax benefit, net of Federal benefit 3.3 % 3.6 % Change in valuation allowance (33.1) % (51.1) % Change in state tax rates and other (4.5) % 13.5 % 0.7 % 0.0 % Additionally, despite the NOL carryforwards, the Company may have future tax liability due to alternative minimum tax or state tax requirements. The Company has federal NOL carryforwards of $ 90,297,225 76,267,809 begin to expire in 2022. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 10 - Commitments Operating leases During the second quarter 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. The Company also leases a facility in Woburn, Massachusetts under an operating lease that expires in January 2017, and provides the Company with options to extend the lease beyond the current expiration date. 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 years ended December 31, 2015 and 2014, was $ 1,027,174 883,155 Capital leases The Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2020. The leases require monthly principal and interest payments. Capital Operating Year ending December 31, Leases Leases Total 2016 $ 294,141 $ 870,484 $ 1,164,625 2017 204,354 633,480 837,834 2018 109,272 568,410 677,682 2019 21,266 - 21,266 2020 and thereafter 19,494 - 19,494 Total $ 648,527 $ 2,072,374 $ 2,720,901 Less: amount representing interest (70,255) Net present value of future minimum lease payments $ 578,272 Current maturities (251,800) Long-term maturities $ 326,472 2015 2014 Laboratory equipment $ 803,500 $ 364,471 Office furniture 89,140 - Computers 153,693 153,693 Less accumulated amortization (402,066) (245,030) Capital lease assets, net $ 644,267 $ 273,134 Amortization expense associated with equipment under capital leases for the years ended December 31, 2015 and 2014 was $ 157,036 122,411 Registration and other shareholder rights In connection with the Merger and the investment transactions (see Notes 4 and 5), the Company also entered into a Registration Rights Agreement with the AdvanDx stockholders receiving Merger Consideration and with Merck GHI, pursuant to which the investors were granted certain demand registration rights and piggyback registration rights in connection with subsequent registered offerings of the Company’s common stock. Merck GHI also received rights to participate on a pro-rata basis in future securities offerings by the Company. On December 18, 2013, the Company entered into the Third Amended and Restated Investors’ Rights Agreement (the “Investors’ Rights Agreement”) with investors acquiring promissory notes convertible into shares of the Company's Series A Preferred Stock. Following the IPO, the holders of 20% or more of such shares of common stock subject to the Investors’ Rights Agreement have demand registration rights and piggyback registration rights in connection with subsequent registered offerings of the Company’s common stock. |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 2015 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 11 - License Agreements, Research Collaborations and Development Agreements The Company is a party to three license agreements to acquire certain patent rights and technologies. 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 $ 205,147 97,134 270,000 In September 2013, the Company entered into a technology development agreement in which the Company would receive fixed milestone payments for meeting development milestones under the agreement. Since the milestones are substantive, the Company recognizes revenue in the periods in which the substantive milestones are achieved. In addition, the Company received an upfront payment of $ 250,000 336,102 2,411,120 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related party transactions | Note 12 – Related Party Transactions In March 2014, the Company entered into a supply agreement with Fluidigm Corporation, or 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 of the Company, 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 resistome 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 is 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 incurred and paid $ 370,539 138,339 In addition, the Company has several capital lease arrangements for laboratory equipment manufactured by Fluidigm. The Company paid $ 119,919 59,412 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 13 – 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. Prior to its IPO, certain stock purchase warrants contained cash settlement features and, accordingly, the Company considered them to be derivative financial instruments and accounted for them at fair value using level 3 inputs. As a result of the Company’s IPO and elimination of the cash settlement features pursuant to their terms, those stock purchase warrants were reclassified to equity. For periods prior to the IPO, the Company determined the fair value of these derivative liabilities using a hybrid valuation method that consisted of a probability weighted expected return method that values the Company’s equity securities assuming various possible future economic outcomes while using an option pricing method (that treated all equity linked instruments as call options on the Company’s equity value with exercise prices based on the liquidation preference of the Series A Preferred Stock ) to estimate the allocation of value within one or more of the scenarios. Using this hybrid method, unobservable inputs included the Company’s equity value, the exercise price for each option value, expected timing of possible economic outcomes such as initial public offering, risk free interest rates and stock price volatility. Balance at Balance at December Established Change in Reclassified December Description 31, 2014 in 2015 Fair Value to Equity 31, 2015 Derivative warrant liability $ - $ 72,333 $ 647,342 $ (719,675) $ - 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 2015 and 2014. See Note 4 for a discussion of the fair value of assets acquired and liabilities assumed in the Merger. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
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. Certain prior period information has been reclassified to conform to the current period presentation. |
Foreign Currency | Foreign Currency AdvanDx A/S is located in Copenhagen, Denmark and uses the Danish Kroner 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 other comprehensive loss, a component of stockholder's equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at December 31, 2015. 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, and the recoverability 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. Debt is reflective of fair value based on instruments with similar terms available to the Company. For additional fair value disclosures, see Note 13. |
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 At December 31, 2015, the Company has funds totaling $ 243,380 |
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 60 15,596 79,697 At December 31, 2015, the Company had accounts receivable from one customer which individually represented 25 79 15 64 |
Inventory | Inventory December 31, 2015 2014 Raw Materials and supplies $ 362,526 $ 40,749 Work-in-process 150,369 135,625 Finished goods 313,117 193,368 Total inventory $ 826,012 $ 369,742 Inventory includes the Argus Whole Genome Mapping Systems, reagents and supplies used for Argus consumable kits, reagents and components for Quick 591,051 867,816 |
Intangible assets and goodwill | Intangible assets as of December 31, 2015 were acquired as part of the Merger, and consist of definite-lived intangible assets and goodwill. Intangible assets acquired in prior years were fully amortized as of December 31, 2014. Definite-lived intangible assets 10 7 7 Cost Accumulated Net balance at Trademarks and tradenames $ 461,000 $ (21,471) $ 439,529 Developed technology 458,000 (30,474) 427,526 Customer relationships 1,094,000 (72,241) 1,021,759 Balance $ 2,013,000 $ (124,186) $ 1,888,814 Total amortization expense of intangible assets was $ 124,186 57,594 268,000 Definite-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 years ended December 31, 2015 and 2014, the Company determined that its definite-lived intangible assets were not impaired. Goodwill Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. As a result of the Merger and subsequent measurement period adjustments (see Note 4), the Company recognized goodwill of $ 637,528 The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. During year ended December 31, 2015, the Company determined that its goodwill was not impaired. |
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 $ 500,467 516,324 December 31, 2015 2014 Laboratory equipment $ 3,734,044 $ 2,304,615 Office furniture and equipment 701,557 691,032 Computers 1,563,177 1,169,910 Leasehold improvements 659,949 245,558 6,658,727 4,411,115 Less accumulated depreciation (5,584,017) (3,823,159) Property and equipment, net $ 1,074,710 $ 587,956 In 2012, the Company began to provide Argus™ Whole Genome Systems under its Argus Reagent Rental Program to customers, in which the Company retains title without requiring customers to purchase the equipment or enter into an equipment lease or rental contract. The costs associated with these instruments are capitalized and charged to sales and marketing on a straight-line basis over the estimated useful life of the instrument, which is approximately four years. During the years ended December 31, 2015 and 2014, sales and marketing expenses related to these costs were approximately $ 175,000 101,000 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, 2015 and 2014, the Company determined that its property and equipment 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. |
Redeemable convertible preferred stock | Redeemable convertible preferred stock All shares of Series A redeemable convertible preferred stock (“Series A Preferred Stock”) (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt (see Note 6)), were converted into 7,374,852 Prior to the IPO, the carrying value of the Series A Preferred Stock was increased by the accretion of related discounts, issuance costs and accrued but unpaid dividends so that the carrying amount would equal the redemption amount at the dates the stock becomes redeemable. At December 31, 2014, the Company had 3,999,864 70 |
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 sales. Revenue from sales of the Argus System When an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is delivered to the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are considered inconsequential and are combined with the Argus System as one unit of accounting. When an Argus System is sold with the Genome Builder software in a multiple-element arrangement, total arrangement consideration is allocated to the Argus System and to the Genome Builder software based on their relative selling prices. Selling prices are determined based on sales of similar systems to similar customers and, where no sales have occurred, on management’s best estimate of the expected selling price relative to similar products. Revenue related to the Argus System is recognized when it is delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered to the customer. Revenue from sales of QuickFISH, PNA FISH and XpressFISH diagnostic test products Revenue is recognized upon shipment to the customer. Sales are recorded net of accruals for estimated rebates, discounts and other deductions and returns. Revenue from sales of Genome Builder Software and consumables (on a stand-alone basis) Revenue is recognized for Genome Builder Software and for consumables, when sold on a standalone basis, upon delivery to the customer. Revenue from extended warranty service contracts The Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to be incurred over that same period. 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. |
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 payments are recognized at fair value. The fair value of share-based payments 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. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. 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 believes that it is appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors include: (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 6.25 Expected forfeiture rate The forfeiture rate is the estimated percentage of options granted that is expected to be forfeited or canceled on an annual basis before becoming fully vested. The Company estimates the forfeiture rate based on turnover data with further consideration given to the class of the employees to whom the options were granted. The estimated fair value of equity instruments issued to nonemployees are recorded at fair value on the earlier of the performance commitment date or the date the services required are completed. |
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 The Company had federal net operating loss (“NOL”) carryforwards of $ 90,297,000 76,268,000 |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common shareholders 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 shareholders 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) restricted stock units (in 2014), (iii) stock purchase warrants, and (iv) prior to the IPO, convertible preferred stock and convertible debt, exercisable or exchangeable into common stock which have been excluded from the computation of diluted loss per share, was 6.0 5.9 |
Recent accounting pronouncements | In May 2014, the Financial Accounting Standards Board (“FASB”), issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue arising from contracts with customers. The standard is effective for the Company’s reporting year beginning January 1, 2018 and early adoption is permitted starting January 1, 2017. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raise substantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) requires an evaluation every reporting period, interim periods included, 3) provides principles for considering the mitigating effect of management’s plans to alleviate the substantial doubt, 4) requires certain disclosures if the substantial doubt is alleviated as a result of management’s plans, 5) requires an express statement, as well as other disclosures, if the substantial doubt is not alleviated, and 6) requires an assessment period of one year from the date the financial statements are issued. The standard is effective for the Company’s reporting year beginning January 1, 2017 and early adoption is permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as a direct reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its 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 is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidated financial statements. In September 2015, the FASB issued accounting guidance to simplify the accounting for measurement period adjustments resulting from business combinations. Under the guidance, an acquirer will be required to recognize adjustments to provisional amounts identified during the measurement period in the reporting period in which the adjustments are determined. The guidance requires an entity to present separately on the face of the income statement or disclose in the notes to the financial statements the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date. The Company adopted this new guidance in the fourth quarter of 2015; see Note 4 for the impact of adoption. In February 2016, the FASB issued accounting guidance which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018 but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its consolidated financial statements and related disclosures. The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its financial position, results of operations, or cash flows. |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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, 2015 2014 Raw Materials and supplies $ 362,526 $ 40,749 Work-in-process 150,369 135,625 Finished goods 313,117 193,368 Total inventory $ 826,012 $ 369,742 |
Schedule of Finite-Lived Intangible Assets | 10 7 7 Cost Accumulated Net balance at Trademarks and tradenames $ 461,000 $ (21,471) $ 439,529 Developed technology 458,000 (30,474) 427,526 Customer relationships 1,094,000 (72,241) 1,021,759 Balance $ 2,013,000 $ (124,186) $ 1,888,814 |
Property, Plant and Equipment | Property and equipment consisted of the following at December 31, 2015 and 2014: December 31, 2015 2014 Laboratory equipment $ 3,734,044 $ 2,304,615 Office furniture and equipment 701,557 691,032 Computers 1,563,177 1,169,910 Leasehold improvements 659,949 245,558 6,658,727 4,411,115 Less accumulated depreciation (5,584,017) (3,823,159) Property and equipment, net $ 1,074,710 $ 587,956 |
Business Combination (Tables)
Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Business Combinations [Abstract] | |
Schedule of preliminary allocation of the purchase price | Total purchase price - fair value of common stock issued $ 2,584,090 Fair value of tangible assets acquired: Cash $ 1,367,211 Receivables 536,406 Inventory 881,273 Property and equipment 245,479 Other assets 359,587 Fair value of identifable intangible assets acquired: Customer relationships 1,094,000 Developed technology 458,000 Trademarks and tradenames 461,000 Fair value of goodwill 637,528 Deferred tax liabilities, net 129,095 Fair value of liabilities assumed 3,327,299 $ 2,584,090 |
Schedule Of Provisional Estimated Fair Values | During the fourth quarter of 2015, as a result of obtaining new information about facts and circumstances that existed as of the acquisition date, the Company adjusted the provisional estimated fair values, as follows: As previously Adjusted reported (1) Adjustment amount Accounts receivable $ 557,112 $ (20,706) $ 536,406 Inventory 1,073,855 (192,582) 881,273 Property and equipment 250,636 (5,157) 245,479 Liabilities 3,329,058 (1,759) 3,327,299 Deferred tax liabilities - 129,095 129,095 Goodwill 291,747 345,781 637,528 Provision (benefit) for income taxes 1,662 (130,757) (129,095) (1) As reported on Form 10-Q for the quarter ended September 30, 2015 |
Schedule of unaudited pro forma financial information | The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2014 or that may be obtained in the future: Unaudited pro forma results Year Ended December 31, 2015 2014 Revenues $ 5,231,844 $ 8,904,244 Net loss $ (20,751,552) $ (14,520,497) Net loss per share $ (2.52) $ (6.87) |
Redeemable Convertible Prefer23
Redeemable Convertible Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Preferred Stock, Number of Shares, Par Value and Other Disclosures [Abstract] | |
Schedule of changes in the Series A Preferred Stock | Shares Amount Balance at December 31, 2013 1,999,864 $ 1,999,864 February 2014 Issuance 1,405,096 1,361,469 April 2014 Issuance 594,904 576,433 2014 Accretion - 627,133 Balance at December 31, 2014 3,999,864 4,564,899 2015 Accretion - 243,762 2015 Conversions (3,999,864) (4,808,661) Balance at December 31, 2015 - $ - |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Schedule of debt outstanding | As of December 31, 2015 and 2014, the Company has a total debt outstanding as follows: December 31, 2015 2014 Convertible notes $ - $ 1,500,000 Demand promissory notes - 1,500,000 Long term promissory notes 1,000,000 5,000 $ 1,000,000 $ 3,005,000 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Schedule of allocation of share-based compensation expense | The allocation of share-based compensation expense by operating expenses is as follows: Year Ended December 31, 2015 2014 Research and development $ 240,739 $ 5,234 General and administrative 619,899 55,802 Sales and marketing 584,450 3,376 $ 1,445,088 $ 64,412 |
Schedule of share-based compensation, options granted | A summary of the status of options granted under the plan is presented below as of and for the years ended December 31, 2015 and 2014: Weighted- Weighted- Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding at January 1, 2014 20,956 8.1 $ - Granted 401,053 $ 0.05 Exercised (1) $ 7.91 $ - Forfeited (17,736) $ 40.34 Outstanding at December 31, 2014 404,272 $ 1.13 9.3 $ - Granted 1,961,637 $ 2.68 Exercised (11,472) $ 0.20 $ 19,519 Forfeited (193,657) $ 0.55 Outstanding at December 31, 2015 2,160,780 $ 2.60 9.1 $ 1,575,646 Exercisable at December 31, 2015 432,340 $ 1.36 8.6 $ 632,052 Vested and expected to vest 2,138,606 $ 2.60 9.1 $ 1,555,185 |
Schedule of share-based payment award, Stock Options granted, fair value | 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, 2015 2014 Annual dividend - - Expected life (in years) 5.5-6.25 6.25 Risk free interest rate 1.46-1.9 % 1.84-2.02 % Expected volatility 47.7-65.0 % 60.0 % |
Schedule of warrants to purchase shares of common stock | the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Exercise Issuance Price Expiration 2015 2014 August 2007 $ 7.91 August 2017 8,921 8,921 March 2008 $ 790.54 March 2018 46 46 November 2009 $ 7.91 November 2019 6,674 6,674 January 2010 $ 7.91 January 2020 6,674 6,674 March 2010 $ 7.91 March 2020 1,277 1,277 November 2011 $ 7.91 November 2021 5,213 5,213 December 2011 $ 7.91 December 2021 664 664 March 2012 $ 109.90 March 2019 4,125 4,125 February 2015 $ 6.60 February 2025 225,011 - May 2015 $ 6.60 May 2020 3,457,750 - 3,716,355 33,594 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Deferred tax assets and liabilities | The Company’s deferred tax assets and liabilities as of December 31, 2015 and 2014 are as follows: December 31, 2015 2014 Deferred tax assets: NOL carryforward $ 38,797,762 $ 28,704,237 R&E credit carryforward 1,994,478 1,894,478 Share-based compensation 383,153 144,742 Inventory reserve 226,299 334,578 Depreciation 313,714 246,233 Accruals and other 495,640 185,702 Total deferred tax assets 42,211,046 31,509,970 Valuation allowance (41,554,045) (31,505,287) Deferred tax liabilities: Intangible assets (657,001) - Fixed assets - (4,683) 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: 2015 2014 Federal income tax benefit at statutory rates 35.0 % 34.0 % State income tax benefit, net of Federal benefit 3.3 % 3.6 % Change in valuation allowance (33.1) % (51.1) % Change in state tax rates and other (4.5) % 13.5 % 0.7 % 0.0 % |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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, 2015: Capital Operating Year ending December 31, Leases Leases Total 2016 $ 294,141 $ 870,484 $ 1,164,625 2017 204,354 633,480 837,834 2018 109,272 568,410 677,682 2019 21,266 - 21,266 2020 and thereafter 19,494 - 19,494 Total $ 648,527 $ 2,072,374 $ 2,720,901 Less: amount representing interest (70,255) Net present value of future minimum lease payments $ 578,272 Current maturities (251,800) Long-term maturities $ 326,472 |
Schedule of Capital Leased Assets | Assets under capital leases were included in the following balance sheet categories as of December 31: 2015 2014 Laboratory equipment $ 803,500 $ 364,471 Office furniture 89,140 - Computers 153,693 153,693 Less accumulated amortization (402,066) (245,030) Capital lease assets, net $ 644,267 $ 273,134 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value, liabilities measured on recurring basis | The following tables set 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, 2015: Balance at Balance at December Established Change in Reclassified December Description 31, 2014 in 2015 Fair Value to Equity 31, 2015 Derivative warrant liability $ - $ 72,333 $ 647,342 $ (719,675) $ - |
Going Concern and Management'29
Going Concern and Management's Plans (Details Textual) - USD ($) | Jul. 14, 2015 | May. 08, 2015 | Jul. 31, 2015 | May. 31, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Conversion of Stock [Line Items] | |||||||||
Proceeds from Convertible Debt | $ 1,388,815 | $ 1,472,386 | |||||||
Proceeds from Notes Payable | $ 1,741,667 | 1,488,229 | |||||||
Units Of Stock And Warrants Issued During Period Shares Initial Public Offering | 2,850,000 | ||||||||
Stock And Warrants Issued During Period Shares Initial Public Offering Purchase Price Per Unit | $ 6 | ||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | $ 12,100,000 | ||||||||
Debt Conversion, Original Debt, Amount | 2,100,000 | ||||||||
Conversion of Stock, Shares Issued | 7,374,852 | ||||||||
Proceeds from Issuance Initial Public Offering | $ 17,100,000 | ||||||||
Merck Global Health Innovation Fund LLC | |||||||||
Conversion of Stock [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | ||||||||
Common Stock | |||||||||
Conversion of Stock [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 2,500,000 | ||||||||
Warrants Issued During Period On Exercise Of Over Allotment Option Shares | 422,500 | ||||||||
Shares Issued, Price Per Share | $ 6 | ||||||||
Common Stock | Merck Global Health Innovation Fund LLC | |||||||||
Conversion of Stock [Line Items] | |||||||||
Proceeds From Issuance Of Shares And Debt | $ 6,000,000 | ||||||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | ||||||||
Shares Issued, Price Per Share | $ 4.40 | ||||||||
Initial public offering | |||||||||
Conversion of Stock [Line Items] | |||||||||
Debt Conversion, Converted Instrument, Amount | $ 2,100,000 | $ 0 | |||||||
Debt Conversion, Converted Instrument, Shares Issued | 350,000 | 1,875,000 | |||||||
Proceeds from Issuance Initial Public Offering | $ 12,100,000 | ||||||||
Initial public offering | Common Stock | |||||||||
Conversion of Stock [Line Items] | |||||||||
Debt Conversion, Converted Instrument, Shares Issued | 350,000 | ||||||||
Convertible Notes Payable | |||||||||
Conversion of Stock [Line Items] | |||||||||
Proceeds from Convertible Debt | $ 1,500,000 | ||||||||
Short-term Demand Notes | |||||||||
Conversion of Stock [Line Items] | |||||||||
Proceeds from Notes Payable | $ 2,300,000 | 800,000 | |||||||
Repayments of Notes Payable | $ 200,000 | ||||||||
Debt Conversion, Converted Instrument, Amount | $ 300,000 | ||||||||
Promissory Note | Merck Global Health Innovation Fund LLC | |||||||||
Conversion of Stock [Line Items] | |||||||||
Debt Instrument, Face Amount | $ 1,000,000 | ||||||||
Promissory Note | Common Stock | Merck Global Health Innovation Fund LLC | |||||||||
Conversion of Stock [Line Items] | |||||||||
Proceeds From Issuance Of Common Stock And Notes Payable | $ 6,000,000 |
Summary of Significant Accoun30
Summary of Significant Accounting Policies (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Inventories | ||
Raw materials and supplies | $ 362,526 | $ 40,749 |
Work-in process | 150,369 | 135,625 |
Finished goods | 313,117 | 193,368 |
Total inventory | $ 826,012 | $ 369,742 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies (Details 1) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Significant Accounting Policies [Line Items] | ||
Cost | $ 2,013,000 | |
Accumulated Amortization | (124,186) | |
Net balance at December 31, 2015 | 1,888,814 | $ 0 |
Trademarks and tradenames | ||
Significant Accounting Policies [Line Items] | ||
Cost | 461,000 | |
Accumulated Amortization | (21,471) | |
Net balance at December 31, 2015 | 439,529 | |
Developed technology | ||
Significant Accounting Policies [Line Items] | ||
Cost | 458,000 | |
Accumulated Amortization | (30,474) | |
Net balance at December 31, 2015 | 427,526 | |
Customer relationships | ||
Significant Accounting Policies [Line Items] | ||
Cost | 1,094,000 | |
Accumulated Amortization | (72,241) | |
Net balance at December 31, 2015 | $ 1,021,759 |
Summary of Significant Accoun32
Summary of Significant Accounting Policies (Details 2) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 6,658,727 | $ 4,411,115 |
Less accumulated depreciation | (5,584,017) | (3,823,159) |
Property and equipment, net | 1,074,710 | 587,956 |
Laboratory equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 3,734,044 | 2,304,615 |
Office furniture and equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 701,557 | 691,032 |
Computer equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 1,563,177 | 1,169,910 |
Leasehold improvements [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 659,949 | $ 245,558 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | May. 08, 2015 | |
Significant Accounting Policies [Line Items] | |||
Allowance for Doubtful Accounts Receivable | $ 15,596 | $ 79,697 | |
Inventory Valuation Reserves | 591,051 | 867,816 | |
Operating Loss Carryforwards | $ 90,297,000 | $ 76,268,000 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,000,000 | 5,900,000 | |
Cash, FDIC Insured Amount | $ 250,000 | ||
Income Tax Expense (Benefit) | (129,095) | $ 0 | |
Goodwill | 637,528 | 0 | |
Letters of Credit Outstanding, Amount | 243,380 | ||
Amortization of Intangible Assets | 124,186 | 57,594 | |
Depreciation, Total | 500,467 | 516,324 | |
Selling and Marketing Expense | 4,305,444 | 2,058,085 | |
Finite-Lived Intangible Assets, Amortization Expense, Next Twelve Months | 268,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Year Two | 268,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Year Three | 268,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Year Four | 268,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Year Five | $ 268,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||
Equipment [Member] | |||
Significant Accounting Policies [Line Items] | |||
Selling and Marketing Expense | $ 175,000 | $ 101,000 | |
Developed Technology Rights [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 | ||
Trademarks [Member] | |||
Significant Accounting Policies [Line Items] | |||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||
Common Stock [Member] | |||
Significant Accounting Policies [Line Items] | |||
Convertible Preferred Stock, Shares Issued upon Conversion | 7,374,852 | 7,374,852 | |
Series A Convertible Redeemable Preferred Stock | |||
Significant Accounting Policies [Line Items] | |||
Temporary Equity Redemption Request Of Minimum Percentage Of Holders Of Outstanding Preferred Stock Required | 70.00% | ||
Temporary Equity, Shares Outstanding | 0 | 3,999,864 | |
Accounts Receivable | Customer One | |||
Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 25.00% | 79.00% | |
Accounts Receivable | Customer Two | |||
Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 15.00% | ||
Sales Revenue, Net [Member] | Hitachi High - Technologies Corporation | |||
Significant Accounting Policies [Line Items] | |||
Concentration Risk, Percentage | 11.00% | 64.00% | |
Maximum | |||
Significant Accounting Policies [Line Items] | |||
Accounts Receivable Period Due | 60 days | ||
Fair Value Assumptions, Expected Term | 10 years | ||
Minimum | |||
Significant Accounting Policies [Line Items] | |||
Accounts Receivable Period Due | 30 days | ||
Fair Value Assumptions, Expected Term | 6 years 3 months |
Business Combination (Details)
Business Combination (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Fair value of identifiable intangible assets acquired: | ||
Fair value of goodwill | $ 637,528 | $ 0 |
AdvanDx [Member] | ||
Business Acquisition [Line Items] | ||
Total purchase price - fair value of common stock issued | 2,584,090 | |
Fair value of tangible assets acquired: | ||
Cash | 1,367,211 | |
Receivables | 536,406 | |
Inventory | 881,273 | |
Property and equipment | 245,479 | |
Other assets | 359,587 | |
Fair value of identifiable intangible assets acquired: | ||
Customer relationships | 1,094,000 | |
Developed technology | 458,000 | |
Trademarks and tradenames | 461,000 | |
Fair value of goodwill | 637,528 | |
Deferred tax liabilities, net | 129,095 | |
Fair value of liabilities assumed | 3,327,299 | |
Total acquisition purchase price Allocation | $ 2,584,090 |
Business Combination (Details 1
Business Combination (Details 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Goodwill | $ 637,528 | $ 0 | |
Provision (benefit) for income taxes | (129,095) | $ 0 | |
AdvanDx [Member] | |||
Accounts receivable | 536,406 | ||
Inventory | 881,273 | ||
Property and equipment | 245,479 | ||
Liabilities | 3,327,299 | ||
Deferred tax liabilities | 129,095 | ||
Goodwill | 637,528 | ||
Provision (benefit) for income taxes | (129,095) | ||
Scenario, Previously Reported [Member] | |||
Accounts receivable | [1] | 557,112 | |
Inventory | [1] | 1,073,855 | |
Property and equipment | [1] | 250,636 | |
Liabilities | [1] | 3,329,058 | |
Deferred tax liabilities | [1] | 0 | |
Goodwill | [1] | 291,747 | |
Provision (benefit) for income taxes | [1] | 1,662 | |
Scenario, Adjustment [Member] | |||
Accounts receivable | (20,706) | ||
Inventory | (192,582) | ||
Property and equipment | (5,157) | ||
Liabilities | (1,759) | ||
Deferred tax liabilities | 129,095 | ||
Goodwill | 345,781 | ||
Provision (benefit) for income taxes | $ (130,757) | ||
[1] | As reported on Form 10-Q for the quarter ended September 30, 2015 |
Business Combination (Details 2
Business Combination (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Business Acquisition, Pro Forma Information | ||
Revenues | $ 5,231,844 | $ 8,904,244 |
Net loss | $ (20,751,552) | $ (14,520,497) |
Net loss per share | $ (2.52) | $ (6.87) |
Business Combination (Details T
Business Combination (Details Textual) - USD ($) | Jul. 14, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Business Acquisition [Line Items] | |||
Goodwill | $ 637,528 | $ 0 | |
Payments of Merger Related Costs, Financing Activities | 500,000 | ||
Deferred Tax Assets, Tax Credit Carryforwards, Foreign | 4,300,000 | ||
Deferred Tax Liabilities, Net, Total | $ 100,000 | ||
AdvanDx [Member] | |||
Business Acquisition [Line Items] | |||
Goodwill | 637,528 | ||
Business Combination, Separately Recognized Transactions, Revenues and Gains Recognized | 1,700,000 | ||
Net Income Loss Generated by Acquired Entity Post Acquisition Date | $ (2,100,000) | ||
AdvanDx [Member] | Equity Issued in Business Combination [Member] | |||
Business Acquisition [Line Items] | |||
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares | 681,818 | ||
Equity Issued in Business Combination, Fair Value Disclosure | $ 2,600,000 |
Merck GHI Financing (Details Te
Merck GHI Financing (Details Textual) - USD ($) | Jul. 14, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Jul. 31, 2015 |
Common Stock and Note Purchase Agreement [Line Items] | ||||
Proceeds from Issuance of Common Stock | $ 17,366,620 | $ 0 | ||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 58,566 | |||
Merck GHI Financing Agreement [Member] | ||||
Common Stock and Note Purchase Agreement [Line Items] | ||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | |||
Shares Issued, Price Per Share | $ 4.40 | |||
Proceeds from Issuance of Common Stock | $ 5,000,000 | |||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 8.00% | ||
Debt Instrument, Face Amount | $ 1,000,000 | |||
Fees Related to Common Stock and Debt Transaction | 50,000 | |||
Payments of Debt Issuance Costs | 8,000 | |||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 42,000 |
Redeemable Convertible Prefer39
Redeemable Convertible Preferred Stock (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2014 | Feb. 28, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Conversions | $ (7,804,172) | ||||
Series A Preferred Stock [Member] | |||||
Balance (in shares) | 3,999,864 | 1,999,864 | |||
Balance | $ 4,564,899 | $ 1,999,864 | |||
Issuance (In shares) | 594,904 | 1,405,096 | 1,999,864 | ||
Issuance | $ 576,433 | $ 1,361,469 | |||
Accretion | $ 243,762 | $ 627,133 | |||
Conversions (In shares) | (3,999,864) | ||||
Conversions | $ (4,808,661) | ||||
Balance (In shares) | 0 | 3,999,864 | |||
Balance | $ 0 | $ 4,564,899 |
Redeemable Convertible Prefer40
Redeemable Convertible Preferred Stock (Details Textual) - USD ($) | May. 08, 2015 | Apr. 30, 2014 | Feb. 28, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 |
Class of Stock [Line Items] | ||||||
Debt Conversion, Original Debt, Amount | $ 2,100,000 | |||||
Conversion of Stock, Shares Issued | 7,374,852 | |||||
Series A Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Temporary Equity, Shares Issued | 594,904 | 1,405,096 | 1,999,864 | |||
Temporary Equity, Par or Stated Value Per Share | $ 1 | |||||
Debt Conversion, Original Debt, Amount | $ 1,999,864 | |||||
Proceeds from Issuance of Convertible Preferred Stock | $ 594,904 | $ 1,405,096 | ||||
Temporary Equity, Shares Outstanding | 1,999,864 | 0 | 3,999,864 | |||
Temporary Equity Shares Outstanding Convertible Into Common Stock Number | 3,999,864 | |||||
Preferred Stock, Dividend Rate, Percentage | 8.00% | |||||
Temporary Equity Redemption Request Of Minimum Percentage Of Holders Of Outstanding Preferred Stock Required | 70.00% | |||||
Payment of Financing and Stock Issuance Costs, Total | $ 62,098 |
Debt (Details)
Debt (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Debt Instrument [Line Items] | ||
Debt, Long-term and Short-term, Combined Amount, Total | $ 1,000,000 | $ 3,005,000 |
Convertible notes | ||
Debt Instrument [Line Items] | ||
Convertible notes | 0 | 1,500,000 |
Demand promissory notes | ||
Debt Instrument [Line Items] | ||
Short-term Debt | 0 | 1,500,000 |
Long term promissory notes | ||
Debt Instrument [Line Items] | ||
Long-term Debt | $ 1,000,000 | $ 5,000 |
Debt (Details Textual)
Debt (Details Textual) | May. 08, 2015USD ($)shares | Jul. 31, 2015USD ($) | May. 31, 2015USD ($)shares | Jun. 30, 2013USD ($) | Mar. 31, 2015USD ($)$ / shares | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($)$ / shares | Sep. 30, 2014USD ($) | Mar. 31, 2015USD ($)$ / shares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | Jul. 14, 2015USD ($) | Dec. 31, 2009USD ($) |
Debt Instrument [Line Items] | |||||||||||||
Proceeds from Notes Payable | $ 1,741,667 | $ 1,488,229 | |||||||||||
Proceeds from Convertible Debt | 1,388,815 | 1,472,386 | |||||||||||
Interest Expense, Debt | $ 1,500,000 | 1,800,000 | 100,000 | ||||||||||
Amortization of Financing Costs | 71,421 | ||||||||||||
Repayments of Debt | 155,000 | 5,000 | |||||||||||
Merck GHI Financing Agreement [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 8.00% | |||||||||||
Proceeds from Other Short-term Debt | $ 1,000,000 | ||||||||||||
Debt Instrument, Face Amount | $ 1,000,000 | ||||||||||||
Repayments of Debt | $ 150,000 | ||||||||||||
Department of Business and Economic Development Agreement [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Face Amount | $ 100,000 | ||||||||||||
Repayments of Debt | 75,000 | ||||||||||||
Interest Payable | $ 11,811 | ||||||||||||
Loan From Department Of Business And Economic Development, Maryland [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% | ||||||||||||
Debt Instrument, Face Amount | $ 100,000 | ||||||||||||
Loan From Department Of Business And Economic Development, Montgomery County [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Face Amount | $ 10,000 | ||||||||||||
IPO [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Conversion, Converted Instrument, Amount | $ 2,100,000 | 0 | |||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 350,000 | 1,875,000 | |||||||||||
Interest Expense, Debt | $ 1,500,000 | ||||||||||||
Common Stock Percent | 110.00% | ||||||||||||
IPO [Member] | Common Stock [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 350,000 | ||||||||||||
2014 Convertible Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | ||||||||||||
Proceeds from Convertible Debt | $ 1,500,000 | ||||||||||||
2015 Convertible Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 0.00% | 8.00% | 8.00% | |||||||||
Proceeds from Other Short-term Debt | $ 1,500,000 | ||||||||||||
Fair Value Adjustment of Warrants | $ 700,000 | ||||||||||||
2015 Convertible Notes | Common Stock [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 225,011 | ||||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 1 | $ 1 | $ 1 | ||||||||||
2015 Convertible Notes | Pre IPO | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Convertible, Conversion Ratio | 1.25 | ||||||||||||
2015 Convertible Notes | Post IPO | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt Instrument, Convertible, Conversion Ratio | 1 | ||||||||||||
Short-term Demand Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from Notes Payable | $ 2,300,000 | $ 800,000 | |||||||||||
Debt Conversion, Converted Instrument, Amount | $ 300,000 | ||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 1,445,088 | $ 64,412 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 240,739 | 5,234 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 619,899 | 55,802 |
Sales and marketing | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 584,450 | $ 3,376 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Options, Outstanding Balance | 404,272 | 20,956 | |
Number of Options, Granted | 1,961,637 | 401,053 | |
Number of Options, Exercised | (11,472) | (1) | |
Number of Options, Forfeited | (193,657) | (17,736) | |
Number of Options, Outstanding Balance | 2,160,780 | 404,272 | 20,956 |
Number of Options, Exercisable | 432,340 | ||
Number of Options, Vested and expected to vest | 2,138,606 | ||
Weighted Average Exercise Price, Outstanding Balance | $ 1.13 | ||
Weighted Average Exercise Price, Granted | 2.68 | $ 0.05 | |
Weighted Average Exercise Price, Exercised | 0.20 | 7.91 | |
Weighted Average Exercise Price, Forfeited | 0.55 | 40.34 | |
Weighted Average Exercise Price, Outstanding Balance | 2.60 | $ 1.13 | |
Weighted Average Exercise Price, Exercisable | 1.36 | ||
Weighted Average Exercise Price, Vested and expected to vest | $ 2.60 | ||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 9 years 1 month 6 days | 9 years 3 months 18 days | 8 years 1 month 6 days |
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 8 years 7 months 6 days | ||
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 9 years 1 month 6 days | ||
Aggregate Intrinsic Value, Outstanding | $ 0 | $ 0 | |
Aggregate Intrinsic Value, Exercised | 19,519 | 0 | |
Aggregate Intrinsic Value, Outstanding | 1,575,646 | $ 0 | $ 0 |
Aggregate Intrinsic Value, Exercisable | 632,052 | ||
Aggregate Intrinsic Value, Vested and expected to vest | $ 1,555,185 |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | 0.00% | 0.00% |
Expected life (in years) | 6 years 3 months | |
Risk free interest rate, minimum | 1.46% | 1.84% |
Risk free interest rate, maximum | 1.90% | 2.02% |
Expected volatility, minimum | 47.70% | |
Expected volatility, maximum | 65.00% | |
Expected volatility | 60.00% | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 6 months | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 3 months |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding | 3,716,355 | 33,594 |
August 2,007 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2017-08 | |
Outstanding | 8,921 | 8,921 |
March 2,008 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 790.54 | |
Expiration | 2018-03 | |
Outstanding | 46 | 46 |
November 2,009 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2019-11 | |
Outstanding | 6,674 | 6,674 |
January 2,010 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2020-01 | |
Outstanding | 6,674 | 6,674 |
March 2,010 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2020-03 | |
Outstanding | 1,277 | 1,277 |
November 2,011 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2021-11 | |
Outstanding | 5,213 | 5,213 |
December 2,011 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 7.91 | |
Expiration | 2021-12 | |
Outstanding | 664 | 664 |
March 2,012 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 109.90 | |
Expiration | 2019-03 | |
Outstanding | 4,125 | 4,125 |
February 2,015 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 6.60 | |
Expiration | 2025-02 | |
Outstanding | 225,011 | 0 |
May 2,015 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 6.60 | |
Expiration | 2020-05 | |
Outstanding | 3,457,750 | 0 |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - USD ($) | Jul. 14, 2015 | May. 08, 2015 | Jul. 31, 2015 | May. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Oct. 23, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Allocated Share-based Compensation Expense | $ 1,445,088 | $ 64,412 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 1,961,637 | 401,053 | |||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2.68 | $ 0.05 | |||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 58,566 | ||||||||
Proceeds from Issuance of Warrants | $ 4,225 | ||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Gross | 17,100,000 | ||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | $ 12,100,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 1,140,079 | $ 47,331 | |||||||
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||||||
Common Stock, Shares, Issued | 12,547,684 | 12,547,684 | 493,178 | ||||||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 3,400,000 | $ 3,400,000 | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 6 months 25 days | ||||||||
Common Stock, Shares, Outstanding | 12,547,684 | 12,547,684 | 493,178 | ||||||
Proceeds from Issuance of Common Stock | $ 17,366,620 | $ 0 | |||||||
Merck Global Health Innovation Fund LLC [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | ||||||||
Over-Allotment Option [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,272,500 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.60 | ||||||||
Expiration Date of Warrants Issued | May 8, 2020 | ||||||||
IPO [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Debt Conversion, Converted Instrument, Amount | $ 2,100,000 | $ 0 | |||||||
Debt Conversion, Converted Instrument, Shares Issued | 350,000 | 1,875,000 | |||||||
Demand Notes Payable [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Debt Conversion, Converted Instrument, Amount | $ 2,100,000 | ||||||||
2002 plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 825,000 | ||||||||
2015 Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,355,000 | 1,355,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 233,562 | 233,562 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Common stock Percentage | 4.00% | ||||||||
Stock options | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.80 | $ 0.03 | |||||||
Restricted stock units | |||||||||
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 | 130,640 | 75,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.70 | ||||||||
Common Stock [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 2,500,000 | ||||||||
Stock and Warrants Issued in Conjunction with Initial Public Offering | 2,850,000 | ||||||||
Offering Price Per Unit | $ 6 | ||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 2,900,000 | ||||||||
Warrants Issued During Period On Exercise Of Over Allotment Option Shares | 422,500 | ||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 7,374,852 | 7,374,852 | 7,374,852 | ||||||
Shares Of Stock Issued For Restricted Stock Unit Exercises | 130,640 | ||||||||
Common Stock [Member] | Merck Global Health Innovation Fund LLC [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | ||||||||
Offering Price Per Unit | $ 4.40 | ||||||||
Proceeds from Issuance of Common Stock | $ 5,000,000 | ||||||||
Common Stock [Member] | Over-Allotment Option [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 185,250 | ||||||||
Common Stock [Member] | IPO [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Debt Conversion, Converted Instrument, Shares Issued | 350,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
NOL carryforward | $ 38,797,762 | $ 28,704,237 |
R&E credit carryforward | 1,994,478 | 1,894,478 |
Share-based compensation | 383,153 | 144,742 |
Inventory reserve | 226,299 | 334,578 |
Depreciation | 313,714 | 246,233 |
Accruals and other | 495,640 | 185,702 |
Total deferred tax assets | 42,211,046 | 31,509,970 |
Valuation allowance | (41,554,045) | (31,505,287) |
Deferred tax liabilities: | ||
Intangible assets | (657,001) | 0 |
Fixed assets | 0 | (4,683) |
Net deferred tax liability | $ 0 | $ 0 |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax [Line Items] | ||
Federal income tax benefit at statutory rates | 35.00% | 34.00% |
State income tax benefit, net of Federal benefit | 3.30% | 3.60% |
Change in valuation allowance | (33.10%) | (51.10%) |
Change in state tax rates and other | (4.50%) | 13.50% |
Total | 0.70% | 0.00% |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax [Line Items] | ||
Deferred Tax Assets, Net of Valuation Allowance, Total | $ 41,554,045 | $ 31,505,287 |
Deferred Tax Assets, Valuation Allowance | 41,554,045 | 31,505,287 |
Operating Loss Carryforwards | 90,297,000 | 76,268,000 |
Domestic Tax Authority [Member] | ||
Income Tax [Line Items] | ||
Operating Loss Carryforwards | $ 90,297,225 | $ 76,267,809 |
Operating Loss Carry forwards, Expiration Terms | begin to expire in 2022. |
Commitments (Details)
Commitments (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Capital Leases | ||
2,016 | $ 294,141 | |
2,017 | 204,354 | |
2,018 | 109,272 | |
2,019 | 21,266 | |
2020 and thereafter | 19,494 | |
Total | 648,527 | |
Less: amount representing interest | (70,255) | |
Net present value of future minimum lease payments | 578,272 | |
Current maturities | 251,800 | $ 100,499 |
Long-term maturities | 377,908 | $ 134,149 |
Operating Leases | ||
2,016 | 870,484 | |
2,017 | 633,480 | |
2,018 | 568,410 | |
2,019 | 0 | |
2020 and thereafter | 0 | |
Total | 2,072,374 | |
Total | ||
2,016 | 1,164,625 | |
2,017 | 837,834 | |
2,018 | 677,682 | |
2,019 | 21,266 | |
2020 and thereafter | 19,494 | |
Total | $ 2,720,901 |
Commitments (Details 1)
Commitments (Details 1) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Loss Contingencies [Line Items] | ||
Less accumulated amortization | $ (402,066) | $ (245,030) |
Capital lease assets, net | 644,267 | 273,134 |
Laboratory Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital Leased Assets Gross | 803,500 | 364,471 |
Office Furniture [Member] | ||
Loss Contingencies [Line Items] | ||
Capital Leased Assets Gross | 89,140 | 0 |
Computer [Member] | ||
Loss Contingencies [Line Items] | ||
Capital Leased Assets Gross | $ 153,693 | $ 153,693 |
Commitments (Details Textual)
Commitments (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Loss Contingencies [Line Items] | ||
Operating Leases, Rent Expense, Net, Total | $ 1,027,174 | $ 883,155 |
Capital Lease Obligations [Member] | ||
Loss Contingencies [Line Items] | ||
Capital Leases, Income Statement, Amortization Expense | $ 157,036 | $ 122,411 |
License Agreements, Research 54
License Agreements, Research Collaborations and Development Agreements (Details Textual) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2013USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Future Minimum Royalty Payments Due | $ 270,000 | ||
License Upfront Payment Received | $ 250,000 | ||
Royalty (Income) Expense | 205,147 | $ 97,134 | |
Licenses Revenue | $ 336,102 | $ 2,411,120 | |
Number Of License Agreements | 3 |
Related Party Transactions (Det
Related Party Transactions (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Related Party Transaction [Line Items] | ||
Related Party Transaction, Expenses from Transactions with Related Party | $ 370,539 | $ 138,339 |
Payments to Acquire Equipment on Lease | $ 119,919 | $ 59,412 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Warrant | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the begining of the period | $ 0 |
Established in 2015 | 72,333 |
Change in Fair Value | 647,342 |
Reclassified to Equity | (719,675) |
Balance at the end of the period | $ 0 |