Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 13, 2020 | Jun. 28, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | HTGM | ||
Entity Registrant Name | HTG Molecular Diagnostics, Inc | ||
Entity Central Index Key | 0001169987 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity File Number | 001-37369 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 86-0912294 | ||
Entity Address, Address Line One | 3430 E. Global Loop | ||
Entity Address, City or Town | Tucson | ||
Entity Address, State or Province | AZ | ||
Entity Address, Postal Zip Code | 85706 | ||
City Area Code | (877) | ||
Local Phone Number | 289-2615 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Entity Common Stock, Shares Outstanding | 58,403,971 | ||
Entity Public Float | $ 46,618,227 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 7,619,748 | $ 8,432,600 |
Short-term investments available-for-sale, at fair value | 25,410,222 | 22,681,049 |
Accounts receivable | 3,164,176 | 5,012,678 |
Inventory, net of allowance of $39,403 at both December 31, 2019 and December 31, 2018 | 1,269,667 | 1,306,609 |
Restricted cash, current | 3,270,247 | |
Prepaid expenses and other | 633,522 | 519,002 |
Total current assets | 41,367,582 | 37,951,938 |
Restricted cash, non-current | 3,270,247 | |
Operating lease right-of-use assets | 1,209,145 | |
Property and equipment, net | 2,240,133 | 2,373,790 |
Other non-current assets | 302,409 | 175,305 |
Total assets | 45,119,269 | 43,771,280 |
Current liabilities: | ||
Accounts payable | 1,662,583 | 1,849,921 |
Accrued liabilities | 1,870,296 | 3,358,465 |
Contract liabilities - current | 426,014 | 332,711 |
NuvoGen obligation - current | 1,152,233 | 1,290,234 |
Convertible note - current, net of debt issuance costs | 2,987,667 | |
Operating lease liabilities - current | 758,932 | |
Other current liabilities | 41,134 | 186,043 |
Total current liabilities | 8,898,859 | 7,017,374 |
NuvoGen obligation - non-current, net of discount | 4,498,777 | 5,702,519 |
Convertible note - non-current, net of debt issuance costs | 2,974,213 | |
MidCap Term Loan payable - net of discount and debt issuance costs | 6,871,545 | 6,704,641 |
Operating lease liabilities - non-current | 636,340 | |
Other non-current liabilities | 244,114 | 280,471 |
Total liabilities | 21,149,635 | 22,679,218 |
Commitments and Contingencies (Note 15) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2019 and December 31, 2018, 58,090,233 shares issued and outstanding at December 31, 2019 and 28,585,449 shares issued and outstanding at December 31, 2018 | 58,090 | 28,585 |
Additional paid-in-capital | 194,234,151 | 172,086,909 |
Accumulated other comprehensive loss | (4,964) | (3,453) |
Accumulated deficit | (170,317,643) | (151,019,979) |
Total stockholders’ equity | 23,969,634 | 21,092,062 |
Total liabilities and stockholders' equity | $ 45,119,269 | $ 43,771,280 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Inventory net allowance | $ 39,403 | $ 39,403 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 58,090,233 | 28,585,449 |
Common stock, shares outstanding | 58,090,233 | 28,585,449 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | ||
Total revenue | $ 19,203,888 | $ 21,503,894 |
Operating expenses: | ||
Cost of product and product-related services revenue | $ 8,911,372 | $ 5,090,475 |
Type of Cost, Good or Service [Extensible List] | htgm:ProductAndProductRelatedServicesMember | htgm:ProductAndProductRelatedServicesMember |
Selling, general and administrative | $ 18,682,396 | $ 19,974,616 |
Research and development | 10,570,225 | 12,598,034 |
Total operating expenses | 38,163,993 | 37,663,125 |
Operating loss | (18,960,105) | (16,159,231) |
Other income (expense): | ||
Interest expense | (957,535) | (901,820) |
Interest income | 623,355 | 715,723 |
Loss on extinguishment of Growth Term Loan | (105,064) | |
Total other income (expense) | (334,180) | (291,161) |
Net loss before income taxes | (19,294,285) | (16,450,392) |
Provision for income taxes | (3,379) | (3,526) |
Net loss | $ (19,297,664) | $ (16,453,918) |
Net loss per share, basic and diluted | $ (0.51) | $ (0.60) |
Shares used in computing net loss per share, basic and diluted | 38,099,687 | 27,523,463 |
Product and Product-related Services | ||
Revenue: | ||
Total revenue | $ 14,632,204 | $ 9,121,390 |
Collaborative Development Services | ||
Revenue: | ||
Total revenue | $ 4,571,684 | $ 12,382,504 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (19,297,664) | $ (16,453,918) |
Other comprehensive income (loss), net of tax effect: | ||
Unrealized gain (loss) on short-term investments | 2,299 | (2,308) |
Foreign currency translation adjustment | (3,810) | (1,145) |
Total other comprehensive loss | (1,511) | (3,453) |
Comprehensive loss | $ (19,299,175) | $ (16,457,371) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) | Total | ATM Offering | 2018 Underwritten Public Offering | Underwritten Public and Private Offerings | Common Stock | Common StockATM Offering | Common Stock2018 Underwritten Public Offering | Common StockUnderwritten Public and Private Offerings | Additional Paid-In Capital | Additional Paid-In CapitalATM Offering | Additional Paid-In Capital2018 Underwritten Public Offering | Additional Paid-In CapitalUnderwritten Public and Private Offerings | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at Dec. 31, 2017 | $ (3,059,537) | $ 13,929 | $ 131,492,595 | $ (134,566,061) | ||||||||||
Balance, shares at Dec. 31, 2017 | 13,929,763 | |||||||||||||
Exercise of stock options | 316,767 | $ 145 | 316,622 | |||||||||||
Exercise of stock options, shares | 144,645 | |||||||||||||
Stock-based compensation expense | 1,887,764 | 1,887,764 | ||||||||||||
Release of restricted stock awards | 291 | $ 291 | ||||||||||||
Release of restricted stock awards, shares | 291,010 | |||||||||||||
Net share settlement of restricted stock award | (150,748) | $ (39) | (150,709) | |||||||||||
Net share settlement of restricted stock award, shares | (38,582) | |||||||||||||
Stock issued under stock purchase plans | $ 199,874 | $ 82 | 199,792 | |||||||||||
Stock issued under stock purchase plans, shares | 2,304 | 82,261 | ||||||||||||
Issuance of common stock | $ 556,706 | $ 37,724,316 | $ 262 | $ 13,915 | $ 556,444 | $ 37,710,401 | ||||||||
Issuance of common stock, shares | 261,352 | 13,915,000 | ||||||||||||
Issuance of common stock warrants in connection with MidCap Term Loan | $ 74,000 | 74,000 | ||||||||||||
Net loss | (16,453,918) | (16,453,918) | ||||||||||||
Unrealized gain (loss) on short-term investments | (2,308) | $ (2,308) | ||||||||||||
Foreign currency translation adjustment | (1,145) | (1,145) | ||||||||||||
Balance at Dec. 31, 2018 | 21,092,062 | $ 28,585 | 172,086,909 | (3,453) | (151,019,979) | |||||||||
Balance, shares at Dec. 31, 2018 | 28,585,449 | |||||||||||||
Exercise of stock options | 120,954 | $ 54 | 120,900 | |||||||||||
Exercise of stock options, shares | 54,256 | |||||||||||||
Stock-based compensation expense | 1,156,486 | 1,156,486 | ||||||||||||
Release of restricted stock awards | 81 | $ 81 | ||||||||||||
Release of restricted stock awards, shares | 81,462 | |||||||||||||
Net share settlement of restricted stock award | (30,904) | $ (17) | (30,887) | |||||||||||
Net share settlement of restricted stock award, shares | (16,927) | |||||||||||||
Stock issued under stock purchase plans | $ 171,190 | $ 88 | 171,102 | |||||||||||
Stock issued under stock purchase plans, shares | 7,500 | 87,456 | ||||||||||||
Issuance of common stock | $ 20,758,940 | $ 29,299 | $ 20,729,641 | |||||||||||
Issuance of common stock, shares | 29,298,537 | |||||||||||||
Net loss | $ (19,297,664) | (19,297,664) | ||||||||||||
Unrealized gain (loss) on short-term investments | 2,299 | 2,299 | ||||||||||||
Foreign currency translation adjustment | (3,810) | (3,810) | ||||||||||||
Balance at Dec. 31, 2019 | $ 23,969,634 | $ 58,090 | $ 194,234,151 | $ (4,964) | $ (170,317,643) | |||||||||
Balance, shares at Dec. 31, 2019 | 58,090,233 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Stockholders Equity [Abstract] | ||
At the market offering, issuance costs | $ 17,000 | |
Public offerings, underwriting discounts, commissions and issuance costs | $ 2,600,000 | |
Public and private offerings, underwriting discounts, commissions and issuance costs | $ 1,700,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | ||
Net loss | $ (19,297,664) | $ (16,453,918) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,259,015 | 1,468,121 |
Accretion of discount on NuvoGen obligation | (13,821) | (12,480) |
Provision for excess inventory | 153,729 | 83,218 |
Amortization of Growth Term Loan discount and issuance costs | 62,951 | |
Loss on extinguishment of Growth Term Loan | 105,064 | |
Write-off of ATM offering costs | 108,883 | |
Amortization of QNAH Convertible Note issuance costs | 13,454 | 13,453 |
Amortization of MidCap Credit Facility discount and issuance costs | 183,002 | 133,963 |
Stock-based compensation expense | 1,156,567 | 1,888,055 |
Employee stock purchase plan expense | 66,238 | 58,959 |
Amortization of operating lease right-of-use assets | 476,789 | |
Amortization of incentive from landlord | (142,000) | |
Accrued interest on available-for-sale securities investments | (325,666) | (412,436) |
Loss on disposal of assets | 9,051 | 8,104 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,848,502 | 1,332,030 |
Inventory | (116,787) | (171,909) |
Prepaid expenses and other | (177,307) | (113,581) |
Deferred offering costs | 2,953 | |
Accounts payable | (155,974) | (150,176) |
Accrued liabilities | (1,440,065) | (447,351) |
Contract liabilities | 188,507 | (426,938) |
Operating lease liabilities | (632,389) | |
Net cash used in operating activities | (16,695,936) | (13,173,918) |
Investing activities | ||
Purchase of property and equipment | (1,103,176) | (949,514) |
Sales, redemptions and maturities of available-for-sale securities | 32,200,000 | 31,700,000 |
Purchase of available-for-sale securities | (34,601,208) | (53,970,921) |
Net cash used in investing activities | (3,504,384) | (23,220,435) |
Financing activities | ||
Proceeds from MidCap Credit Facility | 7,000,000 | |
MidCap Credit Facility lender fees | (422,390) | |
Payments on Growth Term Loan | (1,684,626) | |
Payments for extinguishment of Growth Term Loan | (4,276,988) | |
Proceeds from 2018 underwritten public offering, net of underwriting discounts, commissions and issuance costs of $2.6 million | 37,724,316 | |
Proceeds from 2019 underwritten public and private offerings, net of underwriting discounts, commissions and issuance costs of $1.7 million | 20,758,940 | |
Proceeds from ATM Offering, net | 556,706 | |
Payments on NuvoGen obligation | (1,327,922) | (1,012,122) |
Payments on financing leases | (44,043) | (62,085) |
Proceeds from exercise of stock options | 120,954 | 316,767 |
Taxes paid for net share settlement of restricted stock awards | (30,904) | (150,748) |
Proceeds from shares purchased under stock purchase plans | 104,952 | 140,915 |
Payment of deferred offering costs | (190,173) | |
Net cash provided by financing activities | 19,391,804 | 38,129,745 |
Effect of exchange rates on cash | (4,336) | (1,145) |
(Decrease) increase in cash, cash equivalents and restricted cash | (812,852) | 1,734,247 |
Cash, cash equivalents and restricted cash at beginning of year | 11,702,847 | 9,968,600 |
Cash, cash equivalents and restricted cash at end of year | 10,889,995 | 11,702,847 |
Supplemental disclosure of noncash investing and financing activities | ||
Fixed asset purchases payable and accrued at period end | 8,299 | 39,265 |
Adoption of ASC 842, Leases | 694,352 | |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | 1,005,085 | |
Financing lease right-of-use assets obtained in exchange for financing lease liabilities | 63,406 | |
Equipment purchased through capital leases | 71,709 | |
Carrying value of demonstration units transferred from property and equipment to inventory | 49,245 | |
Debt issuance costs payable and accrued at period end | 59,030 | |
MidCap Term Loan fees and warrant discount | 389,000 | |
Supplemental cash flow information | ||
Cash paid for interest | 686,042 | 553,070 |
Cash paid for taxes | $ 3,379 | $ 3,545 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
2018 Underwritten Public Offering | |
Subsidiary Sale Of Stock [Line Items] | |
Underwriting discounts, commissions and issuance costs | $ 2.6 |
2019 Underwritten Public and Private Offerings | |
Subsidiary Sale Of Stock [Line Items] | |
Underwriting discounts, commissions and issuance costs | $ 1.7 |
Description of Business, Basis
Description of Business, Basis of Presentation and Principles of Consolidation | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation and Principles of Consolidation | Note 1. Description of Business, Basis of Presentation and Principles of Consolidation HTG Molecular Diagnostics, Inc. (the “Company”) is a provider of instruments, reagents and services for molecular profiling applications. The Company derives revenue from sales of its HTG EdgeSeq automation system and integrated next-generation sequencing-based (“NGS-based”) HTG EdgeSeq assays, from services including sample processing and custom research use only (“RUO”) assay development and from collaborative development services. The Company operates in one segment and its customers are located primarily in the United States and Europe. For the year ended December 31, 2019, approximately 34% of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 69% for the year ended December 31, 2018. Approximately 69% and 84% of the sales to customers located outside of the United States resulted from collaborative development services revenue generated through the Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”), with QIAGEN Manchester Limited (“QML”), a wholly owned subsidiary of QIAGEN N.V. (see Note 9), for the years ended December 31, 2019 and 2018, respectively. Basis of Presentation The consolidated financial statements and accompanying notes were prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Principles of Consolidation The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL (“HTG France”), in November 2018. The consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of intercompany transactions and balances as of December 31, 2019 and 2018. Reclassifications Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. Liquidity The Company may need to raise additional capital to fund its operations and service its near and long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If sufficient additional capital is not available as and when needed, the Company may have to delay, scale back or discontinue one or more product development programs, curtail its commercialization activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if the Company defaults under its term loan agreement, its lenders could foreclose on its assets, including some of its cash and cash equivalents, which are held in accounts with other financial institutions. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s significant estimates include revenue recognition, stock-based compensation expense, bonus accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory obsolescence and inventory valuation. Actual results could materially differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with financial institutions, commercial paper, money market instruments and high credit quality corporate debt securities purchased with a term of three months or less. Accounts Receivable Accounts receivable represent valid claims against debtors. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value. Investments The Company classifies its debt securities as available-for-sale, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive loss, net of tax. Realized gains, realized losses and declines in value of securities judged to be other-than-temporary, are included in other income (expense) within the accompanying consolidated statements of operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Interest earned on all securities is included in other income (expense) within the accompanying consolidated statements of operations. Investments in securities with maturities of less than one year, or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments. If the estimated fair value of a security is below its carrying value, the Company evaluates whether it is more likely than not that it will sell the security before its anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. The Company also evaluates whether or not it intends to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition, the Company considers whether credit losses exist for any securities. A credit loss exists if the present value of cash flows expected to be collected is less than the amortized cost basis of the security. Other-than-temporary declines in estimated fair value and credit losses are charged against other income (expense). Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the accompanying consolidated balance sheets that sum to the total of the same such amounts shown in the accompanying consolidated statements of cash flows. December 31, 2019 2018 Cash and cash equivalents $ 7,619,748 $ 8,432,600 Restricted cash, current 3,270,247 — Restricted cash, non-current — 3,270,247 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 10,889,995 $ 11,702,847 In October 2017, the Company received $3.0 million in gross proceeds from, and issued a subordinated convertible promissory note (the “QNAH Convertible Note”) in that principal amount to, QIAGEN North American Holdings, Inc. (“QNAH”). Amounts included in restricted cash represent those required to be set aside in escrow under the terms of the MidCap Term Loan to collateralize the payment that will be due upon maturity of the QNAH Convertible Note (see Note 8). The amounts will be released to the Company upon subsequent delivery of subordination documents for the QNAH Convertible Note to MidCap or conversion of the QNAH Convertible Note. If neither occurs, the amounts will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020) subject to the terms of the MidCap Term Loan including (i) having at least $18.0 million of unrestricted cash and cash equivalents and (ii) there being no default under the MidCap Credit Facility. Fair Value of Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1 – Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates. The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which was determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the MidCap Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt securities with similar terms and risk characteristics. As of December 31, 2019, the estimated aggregate fair value of the QNAH Convertible Note with QNAH is approximately $3.0 million, based on a discounted cash flow approach and utilizing an option pricing model to value the conversion feature, with key assumptions including expected volatility, discount rates, term and risk-free rates. The NuvoGen obligation is an obligation relating to an asset purchase transaction with a then-common stockholder of the Company. As of December 31, 2019, the estimated aggregate fair value of the NuvoGen obligation is approximately $5.1 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. The estimated fair values of the QNAH Convertible Note and the NuvoGen obligation represent Level 3 measurements. Inventory, net Inventory, consisting of raw materials, work in process and finished goods, is stated at the lower of cost (first-in, first-out) or net realizable value. Cost is determined using a standard cost system, whereby the standard costs are updated periodically to reflect current costs and net realizable value represents the lower of replacement cost or estimated net realizable value. The Company reserves or writes down its inventory for estimated obsolescence or inventory in excess of reasonably expected near term sales or unmarketable inventory, in an amount equal to the difference between the cost of inventory and the estimated market value, based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Inventory impairment charges establish a new cost basis for inventory and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable. Equipment that is under evaluation for purchase remains in inventory as the Company maintains title to the equipment throughout the evaluation period. The period of time customers use to evaluate the Company’s equipment generally ranges from 90 to 180 days, and in certain circumstances the evaluation period may need to be extended beyond that period. However, in no case will the evaluation period exceed one year. If the customer has not purchased the equipment or entered into a reagent rental agreement with the Company after evaluating the product for one year, the equipment is returned to the Company or the customer is allowed to continue use of the equipment, in which case the equipment is written off to selling, general and administrative expense in the accompanying consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation as of December 31, 2019 was $79,338 compared to $143,271 as of December 31, 2018. Property and Equipment, net Property and equipment are stated at historical cost and depreciated over their useful lives, which range from three to five years, using the straight-line method. Equipment used in the field is amortized using the straight-line method over the lesser of the period of the related reagent rental or collaborative development services agreement where applicable or the estimated useful life. Leasehold improvements are amortized using the straight-line method over the lesser of the remaining lease term or the estimated useful life. Costs incurred in the development and installation of software for internal use and in the development of the Company’s website are expensed or capitalized, depending on whether they are incurred in the preliminary project stage (expensed), application development stage (capitalized), or post-implementation stage (expensed). Amounts capitalized following project completion are amortized on a straight-line basis over the useful life of the developed asset, which is generally three years. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the 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 group to the estimated undiscounted future cash flows expected to be generated by the asset group. If the carrying amount of an asset group exceeds its estimated future cash flow, an impairment charge is recognized in the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. Although the Company has accumulated losses since inception, the Company believes the future cash flows will be sufficient to exceed the carrying value of the Company’s long-lived assets. There were no impairments of long-lived assets during the years ended December 31, 2019 and 2018. Leases Effective Janu ary 1, 2019, the Company accounts for its leases under Financial Accounting Standards Board (“FASB”), Accounting Standards Codification (“ASC”) 842. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred. Certain leasehold improvements constructed by the landlord of the Company’s Tucson, AZ facilities as an incentive for the Company to extend its leases are included in leasehold improvements in the consolidated balance sheets as of December 31, 2018. The total cost of the improvements constructed by the landlord of $710,000 was capitalized when construction was completed in February 2016 and is being amortized over the remaining term of the lease agreement. The incentive of $710,000 was also recognized as deferred rent and was being amortized over the lease term as a reduction of lease expense. As of December 31, 2018, the remaining unamortized incentive of $295,833 was recognized as deferred rent within other current liabilities and other liabilities, in accordance with ASC Topic 840, Leases The comparative information in these consolidated financial statements has not been restated and continues to be reported under ASC 840. Debt Issuance Costs and Debt Discounts Costs incurred to issue non-revolving debt instruments are recognized as a reduction to the related debt balance in the accompanying consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Costs incurred to issue revolving debt instruments are deferred as an asset in the accompanying consolidated balance sheets and amortized on a straight-line basis to interest expense over the term of the revolving commitment . Deferred Offering Costs Deferred offering costs represent legal and other direct costs related to planned future stock offering transactions. Deferred offering costs of $140,320 included as non-current assets in the accompanying consolidated balance sheets represent legal costs incurred, $81,290 of which were incurred during the year ended December 31, 2019 and $59,030 of which were incurred during the year ended December 31, 2018, by the Company in contemplation of the issuance of additional shares in a future financing transaction. In January 2020, these deferred offering costs were recorded to additional paid in capital, as an offset to proceeds received from the 2019 ATM Offering (see Note 17). Contract Liabilities Contract liabilities represent cash receipts for products or services to be delivered in future periods, including up-front fees received relating to custom RUO assay design and collaborative development services. When products or services are delivered to customers, contract liabilities are recognized as earned. Up-front fees received for custom RUO assay design or collaborative development services are recognized over time based on the costs incurred to date compared to total expected costs as design or development procedures are completed and outputs are produced. Revenue Recognition The Company adopted ASC 606, Revenue from Contracts with Customers For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. The Company has made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected by the Company from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes. See Note 9 for additional discussion of the Company’s revenue recognition policies. Product Warranty The Company generally provides a one-year warranty on its HTG EdgeSeq systems covering the performance of system hardware and software in conformance with customer specifications under normal use and protecting against defects in materials and workmanship. The Company may, at its option, replace, repair or exchange products covered under valid warranty claims. A provision for estimated warranty costs is recognized at the time of sale, through cost of product and product-related services revenue, based upon recent historical experience and other relevant information as it becomes available. The Company continuously assesses the adequacy of its product warranty accrual by reviewing actual claims and adjusts the provision as needed. Warranty accrual is included in accrued liabilities in the accompanying consolidated balance sheets. Research and Development Expenses Research and development expenses represent costs incurred internally for research and development activities and costs incurred externally to fund research activities. These costs include those generated through research and development efforts for the improvement and expansion of the Company’s proprietary technology and product offerings as well as those related to third-party collaborative development agreements, for which related revenue is included in collaborative development services revenue in the accompanying consolidated statements of operations. See for further discussion of the development costs associated with collaborative development services agreements included in research and development expense as compared to cost of revenue in the accompanying consolidated statements of operations. Advertising All costs associated with advertising and promotions are expensed as incurred. Advertising expense was $4,595 and $110,591 for the years ended December 31, 2019 and 2018, respectively, and is included as a component of selling, general and administrative expenses on the accompanying consolidated statements of operations. Stock-based Compensation The Company incurs stock-based compensation expense relating to grants under its equity incentive plans of restricted stock units (“RSUs”) and stock options to employees, consultants and non-employee directors, and stock purchase rights granted under the 2014 Employee Stock Purchase Plan (“ESPP”). The Company recognizes expense for stock-based awards based on the fair value of awards on the date of grant. The fair value of RSUs is based on the quoted market price of the Company’s common stock on the date of grant. The fair value of ESPP rights and stock options granted pursuant to the Company’s equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s stock price and several assumptions, including volatility, expected term, risk-free interest rate, and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. The Company does not estimate the number of awards expected to be forfeited, but instead accounts for such forfeitures as they occur. Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets we have assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that it is “more likely than not” that the assets will not be recovered or there is an insufficient history of operating profits, a valuation allowance is established. We record the valuation allowance in the period we determine that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 2019 and 2018, we have provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote in the near term. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. Foreign Currency Translation and Foreign Currency Transactions The Company has assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than its functional currency. These assets and liabilities are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations. Adjustments resulting from translating foreign functional currency financial statements of the Company’s wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive loss in the accompanying consolidated statements of stockholder’s equity (deficit). Comprehensive Loss Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains and losses on short-term available-for-sale investments and adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in comprehensive loss. Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. Management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. The Company sells its instruments, consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The top three customers accounted for 24%, 22% and 19% of the Company’s revenue for the year ended December 31, 2019, compared with 58%, 10% and 9% for the year ended December 31, 2018. The largest two customers accounted for approximately 29% and 25% of the Company’s net accounts receivable as of December 31, 2019. These accounts receivable primarily relate to sample processing services performed for a biopharmaceutical company customer and work performed under the Company’s Governing Agreement with QML. The largest three customers accounted for approximately 44%, 27%, and 11% of the Company’s net accounts receivable at December 31, 2018. Three vendors accounted for 36%, 10% and 10% of the Company’s accounts payable as of December 31, 2019 primarily related to a strategic marketing study compared to 24%, 14% and 11% of the Company’s accounts payable at December 31, 2018. The Company currently relies on a single supplier to supply a subcomponent used in its HTG EdgeSeq processors. A loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting . In July 2017, the FASB issued ASU 2017-11, Accounting for Certain Financial Instruments with Down Round Features New Accounting Pronouncements The following are new FASB ASUs that had not been adopted by the Company as of December 31, 2019, and are grouped by their respective effective dates: January 1, 2020 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In November 2018, the FASB issued ASU No. 2018-18, which amended ASC 808, Collaborative Arrangements Revenue from Contracts with Customers In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting Entities may apply the provisions of the new standard as of the beginning of the reporting period when the election is made (i.e. as early as the first quarter 2020). Unlike other topics, the provisions of this update are only available until December 31, 2022, when the reference rate replacement activity is expected to have completed. January 1, 2021 In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes January 1, 2023 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 3. Inventory Inventory, net of allowance, consisted of the following as of the date indicated: December 31, 2019 2018 Raw materials $ 872,947 $ 892,631 Work in process 151,351 168,937 Finished goods 284,772 284,444 Total gross inventory 1,309,070 1,346,012 Less inventory allowance $ (39,403 ) (39,403 ) $ 1,269,667 $ 1,306,609 The reserve for shrinkage and excess inventory was $39,403 as of both December 31, 2019 and 2018. For the year ended December 31, 2019, the Company recorded $0 in adjustments to the inventory reserve, compared to a net decrease of $22,739 for the year ended December 31, 2018, to adjust for estimated shrinkage and obsolescence. For the years ended December 31, 2019 and 2018, the Company recorded adjustments to the provision for excess inventory of $153,729 and $83,218, respectively. Adjustments in these periods to the allowance for estimated shrinkage, obsolescence and excess inventory have been included in cost of product and product-related services revenue in the accompanying consolidated statements of operations. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value | Note 4. Fair Value Financial assets and liabilities measured at fair value are classified in their entirety in the fair value hierarchy, based on the lowest level input significant to the fair value measurement. The following table classifies the Company’s financial assets and liabilities measured at fair value on a recurring basis at December 31, 2019 and 2018, respectively, in the fair value hierarchy: December 31, 2019 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 7,217,096 $ — $ — $ 7,217,096 Investments available-for-sale at fair value U.S. Treasury securities 5,961,983 — — 5,961,983 Corporate debt securities — 19,448,239 — 19,448,239 Total $ 13,179,079 $ 19,448,239 $ — $ 32,627,318 December 31, 2018 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 6,923,255 $ 998,400 $ — $ 7,921,655 Investments available-for-sale at fair value U.S. Treasury securities 6,031,515 — — 6,031,515 Corporate debt securities — 16,649,534 — 16,649,534 Total $ 12,954,770 $ 17,647,934 $ — $ 30,602,704 There were no other financial instruments subject to fair value measurement on a recurring basis. Transfers to and from Levels 1, 2 and 3 are recognized at the end of the reporting period. There were no transfers between levels for the years ended December 31, 2019 and 2018. Level 1 instruments include investments in money market funds, U.S. Treasuries and U.S. government agency obligations. These instruments are valued using quoted market prices for identical unrestricted instruments in active markets. The Company defines active markets for debt instruments based on both the average daily trading volume and the number of days with trading activity. Level 2 instruments include corporate debt securities and commercial paper. Valuations of Level 2 instruments can be verified to quoted prices, recent trading activity for identical or similar instruments, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. Consideration is given to the nature of the quotations (e.g. indicative or firm) and the relationship of recent market activity to the prices provided from alternative pricing sources. Fair values of these assets and liabilities are based on prices provided by independent market participants that are based on observable inputs using market-based valuation techniques. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company did not adjust any of the valuations received from these third parties with respect to any of its Level 1 or 2 securities for either of the years ended December 31, 2019 or 2018 and did not have any Level 3 financial assets or liabilities during either of these periods. |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Securities | Note 5. Available-for-Sale Securities The Company’s portfolio of available-for-sale securities consists of U.S. Treasuries and high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities at December 31, 2019 and 2018: December 31, 2019 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 5,962,224 $ 394 $ (635 ) $ 5,961,983 Corporate debt securities 19,448,239 — — 19,448,239 Total available-for-sale securities $ 25,410,463 $ 394 $ (635 ) $ 25,410,222 December 31, 2018 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 6,032,844 $ — $ (1,329 ) $ 6,031,515 Corporate debt securities 16,650,513 — (979 ) 16,649,534 Total available-for-sale securities $ 22,683,357 $ — $ (2,308 ) $ 22,681,049 The net adjustment to unrealized holding gains (losses) on short-term investments, net of tax in other comprehensive income totaled $2,299 and $(2,308) for the years ended December 31, 2019 and 2018, respectively. Contractual maturities of debt investment securities at December 31, 2019 are shown below. Expected maturities will differ from contractual maturities because the issuers of the securities may have the right to prepay obligations without prepayment penalties. Under 1 Year 1 to 2 Years Total U.S. Treasury securities $ 5,961,983 $ — $ 5,961,983 Corporate debt securities 19,448,239 — 19,448,239 Total available-for-sale securities $ 25,410,222 $ — $ 25,410,222 The following table shows the gross unrealized losses and fair values of the Company’s investments that have unrealized losses, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position as of December 31, 2019: Under 1 Year 1 to 2 Years Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 3,956,401 $ (635 ) $ — $ — $ 3,956,401 $ (635 ) Corporate debt securities — — — — — — Total available-for-sale securities with unrealized losses $ 3,956,401 $ (635 ) $ — $ — $ 3,956,401 $ (635 ) For debt securities, the Company determines whether it intends to sell or if it is more likely than not that it will be required to sell impaired securities. This determination considers current and forecasted liquidity requirements, regulatory and capital requirements and securities portfolio management. For all impaired debt securities for which there was no intent or expected requirement to sell, the evaluation considers all available evidence to assess whether it is likely the amortized cost value will be recovered. The Company conducts a regular assessment of its debt securities with unrealized losses to determine whether securities have other-than-temporary impairment considering, among other factors, the nature of the securities, credit rating or financial condition of the issuer, the extent and duration of the unrealized loss, expected cash flows of underlying collateral, market conditions and whether the Company intends to sell or it is more likely than not that the Company will be required to sell the debt securities. The Company did not have any other-than-temporary impairment in its available-for-sale securities at December 31, 2019. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Note 6. Property and Equipment Property and equipment, net consists of the following: December 31, 2019 2018 Furniture & fixtures $ 1,089,371 $ 791,973 Leasehold improvements 1,987,997 1,930,300 Equipment used in manufacturing 2,305,340 2,297,797 Equipment used in research & development 2,134,019 1,456,954 Equipment used in the field 182,762 125,253 Software 374,812 373,683 Construction in progress — 19,246 8,074,301 6,995,206 Less: accumulated depreciation and amortization (5,834,168 ) (4,621,416 ) $ 2,240,133 $ 2,373,790 Depreciation and leasehold improvement amortization expense was $1,259,015 and $1,468,121 for the years ended December 31, 2019 and 2018, respectively. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Liabilities Current [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2019 2018 Accrued employee bonuses $ 900,740 $ 2,150,418 Payroll and employee benefit accruals 469,530 698,969 Accrued professional fees 43,850 60,400 Accrued interest 245,350 156,492 Other accrued liabilities 210,826 292,186 $ 1,870,296 $ 3,358,465 |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt Obligations | Note 8. Debt Obligations. Growth Term Loan In August 2014, the Company entered into a Loan and Security Agreement (the “Growth Term Loan”) with a syndicate of two lending institutions, Oxford Finance LLC and Silicon Valley Bank, which was amended in August 2015 and June 2016. The first tranche of the Growth Term Loan (“Growth Term Loan A”) of $11.0 million was funded in August 2014. The second tranche of $5.0 million (“Growth Term Loan B”) was funded in March 2016. With the August 2015 amendment, the interest-only payment period for the Growth Term Loan was extended until April 1, 2016. Following the interest-only payment period, the Company became obligated to make equal monthly payments of principal and interest amortized over the remaining term of the loan for all funds drawn under the Growth Term Loan. Growth Term Loan A and B bore interest at fixed rates of 8.5% and 8.75% per annum, respectively, and were scheduled to mature in September 2018. The amended agreement also included a prepayment fee of 1% of the principal amount repaid if the Growth Term Loan was repaid after the second anniversary of the August 2015 amendment and prior to maturity. The debt discount was being amortized to interest expense using the effective interest method, over the term of the related Growth Term Loan tranche. The aggregate amortization of debt discount associated with the Growth Term Loan was approximately $0 and $62,951 for the years ended December 31, 2019 and 2018, respectively. Extinguishment of Growth Term Loan upon MidCap Credit Facility Closing In March 2018, the Company repaid all principal and interest amounts outstanding under the Growth Term Loan in an aggregate amount equal to approximately $4.3 million, including collateral agent legal fees and prepayment fees. The repayment was funded with net proceeds from the MidCap Credit Facility (see description of the MidCap Credit Facility below). As a result of the repayment, the Company recorded a loss on extinguishment of the Growth Term Loan of $105,064, including remaining unamortized discounts of $67,272 and prepayment and other Growth Term Loan lender fees in the accompanying consolidated statements of operations for the year ended December 31, 2018. All obligations under the Growth Term Loan were terminated upon extinguishment of the Growth Term Loan. MidCap Credit Facility On March 26, 2018 (the “MidCap Closing Date”), the Company entered into a Credit and Security Agreement (Term Loan) (the “MidCap Term Loan”) and a Credit and Security Agreement (Revolving Loan) (the “MidCap Revolving Loan” and together with the MidCap Term Loan, the “MidCap Credit Facility”) with MidCap Financial Trust, as agent. MidCap Financial Trust subsequently assigned its rights and obligations as agent to MidCap Funding IV Trust. The MidCap Term Loan provided a secured term loan facility in an aggregate principal amount of up to $20.0 million. The Company borrowed the first advance of $7.0 million (“MidCap Tranche 1”) on the MidCap Closing Date. Under the terms of the MidCap Term Loan, the second advance of $13.0 million (“MidCap Tranche 2”) was to be available to the Company on or before September 30, 2019, subject to the Company’s satisfaction of certain conditions described in the MidCap Term Loan, including (a) the Company achieving the first commercial sale of an FDA-approved diagnostic assay utilizing next-generation sequencing under its Governing Agreement with QML, and (b) delivery of subordination documents with respect to the QNAH Convertible Note (or the satisfaction of alternative arrangements as provided in the MidCap Term Loan, as described below). As the Company did not satisfy these conditions, MidCap Tranche 2 was not made available to the Company for borrowing. MidCap Tranche 1 was used to repay in full all outstanding amounts and fees due under the Growth Term Loan. The proceeds remaining from MidCap Tranche 1 are being used for working capital and general corporate purposes. MidCap Tranche 1 bears interest at a floating rate equal to 7.25% per annum, plus the greater of (i) 1.25% or (ii) the one-month LIBOR. As LIBOR is currently scheduled to be phased out in 2021 MidCap Credit Facility Interest on MidCap Tranche 1 is due and payable monthly in arrears and was calculated at a rate of 8.9% for interest accrued as of December 31, 2019. Principal on this term loan advance was payable in 36 equal monthly installments beginning April 1, 2020 until paid in full on March 1, 2023 prior to amendment of the MidCap Credit Facility in February 2020. Prepayments of the term loan under the MidCap Term Loan, in whole or in part, will be subject to early termination fees in an amount equal to 2.0% of principal prepaid if prepayment occurs after the first anniversary of the MidCap Closing Date but on or prior to the second anniversary of the MidCap Closing Date, and 1.0% of principal prepaid if prepayment occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date. In connection with execution of the MidCap Term Loan, the Company paid MidCap a $100,000 origination fee. The MidCap Credit Facility was amended to, amongst other things, extend the interest-only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payable in 25 equal monthly installments beginning March 1, 2021 until paid in full on March 1, 2023 (see Note 17). As such, the principal repayments remaining due under the MidCap Term Loan as of December 31, 2019 have been classified as long-term debt within MidCap Term Loan payable, net of discount and debt issuance costs in the accompanying consolidated balance sheet as of December 31, 2019. The remaining principal repayments due under the MidCap Term Loan, following amendment of this agreement in February 2020, are as follows: 2020 — 2021 2,800,000 2022 3,360,000 2023 840,000 Total MidCap Term Loan payments 7,000,000 Less discount and deferred financing costs (443,455 ) Plus final fee premium 315,000 Total MidCap Term Loan, net $ 6,871,545 Upon termination of the MidCap Term Loan, the Company is required to pay an exit fee equal to 4.50% of the principal amount of all term loans advanced to the Company under the MidCap Term Loan. The MidCap Term Loan also required that the Company deliver subordination documents with respect to the QNAH Convertible Note, or that the QNAH Convertible Note otherwise be converted or prepaid, on or before June 30, 2018, and required the Company to deposit approximately $3.3 million into an escrow account by July 15, 2018 if neither event occurred by such date. As neither event occurred prior to June 30, 2018, the Company deposited approximately $3.3 million into an escrow account on July 11, 2018. Such escrowed funds will be released to the Company upon subsequent delivery of the requisite subordination documents or conversion of the QNAH Convertible Note. If neither delivery of the subordination documents or conversion of the QNAH Convertible Note occurs, such funds will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020), subject to (i) our having at least $18.0 million of unrestricted cash and cash equivalents and (ii) there being no default under the MidCap Credit Facility. The MidCap Revolving Loan provides a secured revolving credit facility in an aggregate principal amount of up to $2.0 million. The Company may request an increase in the total commitments under the MidCap Revolving Loan by up to an additional $8.0 million, subject to agent and lender approval and the satisfaction of certain conditions. Availability of the revolving credit facility under the MidCap Revolving Loan will be based upon a borrowing base formula and periodic borrowing base certifications valuing certain of the Company’s accounts receivable and inventory, as reduced by certain reserves, if any. Further, although the revolving credit facility was made available following establishment of required lockbox arrangements by the Company in June 2018, there were no amounts outstanding under the MidCap Revolving Loan as of either December 31, 2019 or 2018. The proceeds of any loans under the MidCap Revolving Loan may be used for working capital and general corporate purposes. Loans under the MidCap Revolving Loan accrue interest at a floating rate equal to 4.25% per annum, plus the greater of (i) 1.25% or (ii) the one-month LIBOR. Accrued interest on the revolving loans will be paid monthly and revolving loans may be borrowed, repaid and re-borrowed until March 1, 2023, when all outstanding amounts must be repaid. Subject to certain exceptions, termination or permanent reductions of the revolving loan commitment under the MidCap Revolving Loan will be subject to termination fees in an amount equal to 2.0% of the commitment amount terminated or reduced if such termination or reduction occurs after the first anniversary of the MidCap Closing Date but on or prior to the second anniversary of the MidCap Closing Date, and 1.0% of the commitment amount terminated or reduced if such termination or reduction occurs after the second anniversary of the MidCap Closing Date and prior to or on the third anniversary of the MidCap Closing Date. In connection with the MidCap Revolving Loan, the Company is required to pay customary fees, including an origination fee of 0.50% of the original commitment amount at closing (and an equivalent origination fee with respect to any increased commitments at the time of the applicable increase), a monthly unused line fee of 0.50% per annum based upon the average daily unused portion of the revolving credit facility and a monthly collateral management fee of 0.50% per annum based upon the average daily used portion of the revolving credit facility. The Company is also required to maintain a minimum drawn balance of not less 20% of availability under the revolving line. If the Company does not maintain such minimum drawn balance, it is required to pay monthly interest and fees as if an amount equal to 20% of availability had been drawn down under the revolving line. The Company’s obligations under the MidCap Credit Facility are secured by a security interest in substantially all of its assets, including intellectual property. Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the MidCap Credit Facility. The MidCap Credit Facility contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries, if any, to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The MidCap Credit Facility also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, delisting of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, agent and the lenders may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased by 3.0%. In March 2018, the Company granted the lender ten-year warrants to purchase 18,123 shares of the Company’s common stock at $7.73 per share as a result of Tranche 1. The fair value of the warrants on the date of issuance was approximately $74,000, determined using the Black-Scholes option-pricing model, and was recorded as a discount to the MidCap Term Loan. The Company has recognized approximately $443,455 and $610,359 of unamortized debt discount associated with the MidCap Term Loan, resulting from fees and debt issuance costs, in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Amortization of the debt discount associated with the MidCap Term Loan was approximately $166,904 and $121,611 for the years ended December 31, 2019 and 2018, respectively, and was included in interest expense in the accompanying consolidated statements of operations. Unamortized costs incurred in connection with the issuance of the Midcap Revolving Loan of $50,970 and $67, See Note 17 for further information regarding the MidCap Credit Facility. QNAH Convertible Note Agreement In October 2017, the Company issued a subordinated convertible promissory note to QNAH in the principal amount of $3.0 million against receipt of cash proceeds equal to such principal amount. The QNAH Convertible Note bears simple interest at the rate of 3.0% per annum and matures on October 26, 2020 (the “Maturity Date”). Neither interest nor principal payment are due until the Maturity Date, subject to earlier conversion. QNAH may elect to convert all or any portion of the outstanding principal balance of the QNAH Convertible Note and all unpaid accrued interest thereon at any time prior to the Maturity Date into shares of the Company’s common stock at a conversion price of $3.984 per share. Debt issuance costs of $12,333 and $25,787 relating to the QNAH Convertible Note are being presented as a direct reduction of Convertible Note – net of debt issuance costs - current as of December 31, 2019 and of Convertible note – net of debt issuance costs – non-current as of December 31, 2018, respectively. Amortization of the QNAH Convertible Note deferred financing costs was $13,454 and $13,453 for the years ended December 31, 2019 and 2018, respectively. Interest accrued on the QNAH Convertible Note for the years ended December 31, 2019 and 2018 was $188,630 and $98,630, respectively. Both amounts were included in interest expense in the accompanying consolidated statements of operations. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | Note 9. Revenue from Contracts with Customers Revenue from contracts with customers is recognized when, or as, the Company satisfies its performance obligations by delivering the promised goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring the Company’s progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that the Company determines the customer obtains control over the promised good or service deliverable. The amount of revenue recognized reflects the consideration the Company expects to be entitled to in exchange for those promised goods or services ( i.e. Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the years ended December 31, 2019 and 2018 as follows: Years Ended December 31, 2019 2018 Product revenue: Instruments $ 1,436,730 $ 351,885 Consumables 3,010,094 1,964,499 Total product revenue $ 4,446,824 $ 2,316,384 Product-related services revenue: Custom RUO assay design 4,498,088 964,241 RUO sample processing 5,687,292 5,840,765 Total product-related services revenue 10,185,380 6,805,006 Total product and product-related services revenue $ 14,632,204 $ 9,121,390 Because the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations. Sale of instruments and consumables The delivery of each instrument and related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment. The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. The Company’s standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable. Shipping and handling fees charged to the Company’s customers for instruments and consumables shipped are included in the accompanying consolidated statements of operations as part of product and product-related services revenue. Shipping and handling costs for sold products shipped to the Company’s customers are included in the accompanying consolidated statements of operations as part of cost of product and product-related services For sales of consumables in the United States, standard delivery terms are FOB shipping point, unless otherwise specified in the customer contract, reflecting transfer of control to the customer upon shipment. Standard delivery terms for sales to customers outside of the United States are FOB delivery point, unless otherwise specified in the customer contract. The Company has elected the practical expedient to account for shipping and handling as activities to fulfill the promise to transfer the consumables. The Company provides instruments to certain customers under reagent rental agreements. Under these agreements, the Company installs instruments in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. The Company measures progress toward complete satisfaction of its performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. The Company expects to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement. In reagent rental agreements, the Company retains title to the instrument and title is transferred to the customer at no additional charge at the conclusion of the initial arrangement. The cost of the instrument is amortized on a straight-line basis over the term of the arrangement, unless there is no minimum consumable product purchase, in which case the instrument would be expensed as cost of product and product-related services Service Revenue RUO Sample Processing The Company also provides sample preparation and processing services and molecular profiling of retrospective cohorts for its customers through its VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and the Company has the present right to payment. Custom RUO Assay Design and Related Agreements The Company enters into custom RUO assay design agreements that may generate up-front fees and subsequent payments that might be earned upon completion of design process phases. The Company measures progress toward complete satisfaction of its performance obligation to perform custom RUO assay design using an output method based on the costs incurred to date compared to total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay development fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Collaborative Development Services Revenue The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. Collaborative development services revenue for the years ended December 31, 2019 and 2018 was generated through statements of work entered into under the Governing Agreement with QML as discussed below. Years Ended December 31, 2019 2018 Collaborative development services $ 4,571,684 $ 12,382,504 Master Assay Development, Commercialization and Manufacturing Agreement In November 2016, the Company entered into the Governing Agreement, which created the framework for QML and the Company to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly sought companion diagnostic programs with biopharmaceutical companies, with QML entering into sponsor project agreements with interested biopharmaceutical companies for specified projects, and QML and the Company entering into statements of work which set forth the rights and obligations of QML and the Company with respect to each project. In November 2019, the Company elected to terminate the Governing Agreement with QML, effective immediately, as a result of QML’s material breach of the Governing Agreement, including QML’s failure to develop an in vitro diagnostic (“IVD”) version of its GeneReader sequencing platform for development of PDP Assays. The Company’s termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. The Company has determined that SOW One, SOW Two and SOW Three (each defined below) are collaborative arrangements and that QML meets the definition of a customer under ASC 606. Additionally, each SOW is a separate contract with a single performance obligation to provide development services. Under each SOW, QML pays the Company a monthly fee for development work performed by the Company and its subcontractors (collectively, the “Monthly Fee”). The Monthly Fee is based on the employee and materials costs incurred during the month, which is subject to significant variability from period to period and unknown until the costs are incurred. Therefore, the Monthly Fee, which is based on use of hours and costs as a measure of progress, is included in the transaction price and recognized as revenue over time when the costs are incurred, and the Monthly Fee is billed to QML. It is at this time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company and QML also share any net profits resulting from performance of the development work as determined pursuant to the Governing Agreement. Such profit-sharing payment(s) are deemed to be variable consideration using the expected value method and are included in the transaction price upon completion of the respective SOW deliverables, acceptance of corresponding deliverables, and the mutual agreement by QML and the Company on the calculation of net profit, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Because each SOW has an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW. Statement of Work No. One In June 2017, the Company and QML entered into the first statement of work under the Governing Agreement, which has been twice amended in December 2017 and March 2018 (collectively, “SOW One”). SOW One addressed the activities of the Company and QML in support of the development and potential commercialization of a NGS-based companion diagnostic assay that was the subject of a sponsor project agreement between QML and a biopharmaceutical company (“Pharma One”). In May 2018, SOW One was terminated by QML as a result of Pharma One’s termination of the development project. The Company discontinued development activities related to the project following wind down activities completed in the second quarter of 2018. Revenue of $2,397,136, inclusive of SOW One Monthly Fees and $99,394 of SOW One profit-sharing payments was included in the accompanying consolidated statements of operations for the year ended December 31, 2018. Costs relating to development activities conducted by the Company pursuant to SOW One of $1,716,115 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2018. There was no revenue or costs relating to SOW One during the year ended December 31, 2019, and there were no accounts receivable relating to SOW One as of December 31, 2019 or 2018. Statement of Work No. Two In October 2017, the Company and QML entered into the second statement of work under the Governing Agreement (“SOW Two”), which was made effective as of June 2, 2017 (“Onset Date”). The Company and QML amended SOW Two twice in August 2018 and two additional times, in September 2018 and in February 2019. SOW Two addresses development activities conducted by the Company and QML since the Onset Date and those expected to be further conducted by the parties in connection with what is expected to be a multi-stage project leading to the potential development and commercialization of an NGS-based companion diagnostic assay in support of one or more therapeutic development and commercialization programs for a third-party biopharmaceutical company. The initial-phase investigational-use-only (“IUO”) development activities under SOW Two and the first three amendments related to next phases, which include the use of the IUO assay developed in the initial-phase in a retrospective clinical trial and in additional disease indications, have been completed. The fourth amendment of SOW Two, effective as of February 5, 2019, contemplates the use of the IUO assay in multiple biopharmaceutical company clinical trials and additional development activities which could potentially be included in a future companion diagnostic regulatory submission. As of December 31, 2019, development activities agreed upon in the fourth amendment are ongoing and expected to continue into the first half of 2020. Revenue of $2,685,634, inclusive of SOW Two Monthly Fees and $657,000 of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2019. Revenue of $5,988,021, inclusive of SOW Two Monthly Fees and $1,779,827 of SOW Two profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2018. Accounts receivable relating to SOW Two of $171,298 and $1,007,950 remained in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Two of $1,849,088 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2019, compared to $3,625,332 for the year ended December 31, 2018. Statement of Work No. Three In January 2018, the Company and QML entered into a third statement of work under the Governing Agreement (“SOW Three”) and amended SOW Three in September 2018. SOW Three relates to development activities for an NGS-based clinical-trial assay (“SOW Three Project”) in connection with a sponsor project agreement between QML and a pharmaceutical company (“Pharma Three”). Initial assay development activities under SOW Three have been completed, and the first amendment to SOW Three provides for the development of an IUO assay, subsequent retrospective testing of clinical trial samples, design verification and, subject to satisfactory achievement of relevant performance and regulatory milestones, regulatory submissions in the United States and European Union necessary for the commercialization of a companion diagnostic for a corresponding Pharma Three drug. As of December 31, 2019, the Company and QML are on hold pending customer decision as to whether to proceed with next phase contract activities. Revenue of $1,886,050, inclusive of SOW Three Monthly Fees and $720,270 of SOW Three profit-sharing payment has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2019. Revenue of $3,997,346 inclusive of SOW Three Monthly Fees and $355,631 of SOW Three profit-sharing payments has been included in collaborative development services revenue in the accompanying consolidated statements of operations for the year ended December 31, 2018. Accounts receivable relating to SOW Three of $760,274 and $363,869 remained in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Three of $983,603 have been included in research and development expense in the accompanying consolidated statements of operations for the year ended December 31, 2019, compared to $2,667,030 for the year ended December 31, 2018. Contract Liabilities The Company receives up-front payments from customers for custom RUO assay design services, and occasionally for sample processing services. Payments for instrument extended warranty contracts are made in advance as are payments for certain agreed-upon capital purchases required for collaborative development service projects. The Company recognizes such up-front payments as a contract liability. The contract liability is subsequently reduced at the point in time that the data file is delivered for sample processing services or as the Company satisfies its performance obligations over time for RUO assay design, collaborative development and extended warranty services. Contract liabilities of $599,454 and $410,947 were included in contract liabilities – current and other non-current liabilities in the accompanying consolidated balance sheets as of December 31, 2019 and 2018, respectively. Changes in the Company’s contract liabilities were as follows as of the dates indicated: Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2019 $ 116,547 $ 50,000 $ 244,400 $ 410,947 Deferral of revenue 218,802 972,267 529,913 1,720,982 Recognition of deferred revenue (240,201 ) (956,051 ) (336,223 ) (1,532,475 ) Balance at December 31, 2019 $ 95,148 $ 66,216 $ 438,090 $ 599,454 Product Revenue Custom RUO Assay Design Sample Processing Collaborative Development Services Total Contract Liability Balance at January 1, 2018 $ 39,426 $ 197,606 $ 490,536 $ 110,317 $ 837,885 Deferral of revenue 190,703 448,580 197,541 70,918 907,742 Customer deposits 131,864 - - — 131,864 Recognition of deferred revenue (245,446 ) (596,186 ) (443,677 ) (181,235 ) (1,466,544 ) Balance at December 31, 2018 $ 116,547 $ 50,000 $ 244,400 $ — $ 410,947 |
Other Agreements
Other Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Other Agreements [Abstract] | |
Other Agreements | Note 10. Other Agreements NuvoGen Obligation The Company entered into an asset purchase agreement in 2001, as amended, with NuvoGen Research, LLC (“NuvoGen”) to acquire certain intellectual property from NuvoGen. The Company accounted for the transaction as an asset acquisition. However, as the intellectual property was determined to not have an alternative future use, the upfront consideration was expensed. In exchange for the intellectual property, the Company initially paid NuvoGen 5,587 shares of the Company’s common stock, fixed payments of $740,000 over the first two years of the agreement and agreed to make quarterly installment payments to NuvoGen until the total aggregate cash compensation paid to NuvoGen under the agreement equaled $15,000,000. Certain terms of the agreement were amended in November 2003, September 2004, November 2012 and February 2014. Pursuant to the latest amendment to the agreement, the Company is obligated to pay the greater of $400,000 or 6% of annual revenue until the obligation is paid in full. The Company paid yearly fixed fees, in quarterly installments, to NuvoGen of $400,000 as well as revenue-based payments of $927,922 and $612,122 during the years ended December 31, 2019 and 2018, respectively, for the amount by which 6% of revenue exceeded the applicable fixed fee. Additional revenue-based payments of $187,997 and $363,686 were payable as of December 31, 2019 and 2018, respectively. Beginning on January 1, 2019 and continuing until the remaining obligation has been paid in full, interest on the remaining unpaid obligation will accrue and compound annually at a rate of 2.5% per year. Accrued interest on this unpaid obligation is payable on the date that the remaining obligation is paid in full. Minimum payments to be made in 2020 include $187,997 of revenue-based payments payable as of December 31, 2019 and an estimate of additional revenue-based payments to be made throughout the remainder of 2020 relating to revenue generated in the first, second and third quarters of 2020 using actual revenue generated in the same quarters in 2019. Minimum payments for the remaining years include only the minimum payments for each year. Actual payments could be significantly more than provided in the table, to the extent that 6% of the Company’s annual revenue in 2020 and beyond exceeds $400,000: 2020 1,152,233 2021 400,000 2022 400,000 2023 400,000 2024 400,000 2025 and beyond 2,806,466 Total NuvoGen obligation payments 5,558,699 Plus interest accretion 92,311 Total NuvoGen obligation, net $ 5,651,010 The Company has recorded the obligation at the estimated present value of the future payments using a discount rate of 2.5%, the Company’s estimate of its effective borrowing rate for similar obligations. The unamortized debt discount was $(92,311) and $(106,132) at December 31, 2019 and 2018, respectively. Discount accreted during the years ended December 31, 2019 and 2018 was $(13,821), and $(12,480), respectively. Illumina, Inc. Agreement In June 2017, the Company entered into an Amended and Restated Development and Component Supply Agreement with Illumina, Inc. (“Illumina”), effective May 31, 2017 (“Restated Agreement”), which amended and restated the parties’ IVD Test Development and Component Supply Agreement entered into in October 2014 (“Original Agreement”). The Restated Agreement provided for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or DNA profiling tests (“IVD test kits”) for use with Illumina’s MiSeqDx sequencer in the field of diagnostic oncology testing in humans (“Field”). In addition, the Company agreed to pay Illumina a single digit percentage royalty on net sales of any IVD test kits that the Company commercializes pursuant to the Restated Agreement. On April 23, 2019, the Company and Illumina entered into the First Amendment to the Restated Agreement, effective as of April 3, 2019 (the “First Amendment”). The First Amendment expanded the scope of the Field defined in the Restated Agreement to include diagnostic testing in humans for (i) autoimmune disorders and diseases, (ii) cardiovascular disorders and diseases, and (iii) fibrosis disorders and diseases ((i)-(iii) together, the “Other Fields”). The Company and Illumina have continued the development plans that were previously entered into under the Restated Agreement, and the Company may, at its discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld. In addition, Illumina will consider requests for additional development plans for IVD test kits in the Other Fields in good faith, but Illumina may accept or reject such requests in its sole and absolute discretion. Under each development plan, Illumina will provide specified regulatory support and rights, and develop and deliver to the Company an executable version of custom software, which, when deployed on Illumina’s MiSeqDx sequencer, would enable sequencing by the end-user of the subject IVD test kit probe library. Illumina retains ownership of the custom software, subject to the Company’s right to use the custom software in connection with the commercialization of IVD test kits. The Company is required to pay Illumina up to $0.6 million in the aggregate upon achievement of specified regulatory milestones relating to the IVD test kits, though none of these regulatory milestones have been reached through December 31, 2019. As a result of IVD test kit development plans submitted by the Company to Illumina in accordance with the Restated Agreement, the Company paid Illumina $0 and $12,500 Absent earlier termination, the Restated Agreement will expire in May 2027; however, Illumina is no longer obligated to notify the Company of changes in its products that may affect the Company’s IVD test kits after May 31, 2023. The Company may terminate the Restated Agreement at any time upon 90 days’ written notice and may terminate any development plan under the Restated Agreement upon 30 days’ prior written notice. Illumina may terminate the Restated Agreement upon 30 days’ prior written notice if the Company undergoes certain changes of control, subject to a transition period of up to 12 months for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other party’s material breach of the Restated Agreement that remains uncured for 30 days, or upon the other party’s bankruptcy. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Note 11. Leases Operating Leases T he Company leases office space and equipment under agreements classified as operating leases that expire on various dates through 2023. The Company’s most significant active leases as of December 31, 2019 are for office and manufacturing space in Tucson, Arizona, which expire in 2021. The Company also leases a development laboratory space in San Carlos, California, for which the lease term expires in 2023. The Company’s leases do not include any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. Annual rent increases are included in the calculation of the operating lease right-of-use assets. Variable expenses generally represent the Company’s share of the landlord’s operating expenses and are recorded when incurred. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to the rate on the Company’s MidCap Term Loan, as this represents the cost of borrowing for secured loans of similar duration. The Company does not have any operating lease arrangements where it acts as a lessor. The components of lease cost for operating leases were as follows: Year Ended December 31, 2019 Operating leases Operating lease cost $ 618,463 Variable lease cost 131,387 Operating lease expense 749,850 Short-term lease rent expense 1,497 Total rent expense $ 751,347 The table below summarizes other information related to the Company’s operating leases: Year Ended or As of December 31, 2019 Operating cash flows for operating leases $ 770,658 Establishment of operating lease liabilities arising from obtaining right-of-use assets $ 2,038,193 Weighted-average remaining lease term – operating leases 2.3 Weighted-average discount rate – operating leases 9.6 % As of December 31, 2019, remaining maturities of our operating leases, excluding short-term leases, are as follows: 2020 $ 881,300 2021 352,243 2022 281,232 2023 70,848 Total 1,585,623 Less present value discount (190,351 ) Operating lease liabilities, net $ 1,395,272 Prior to the Company’s adoption of ASC 842, rent expense was $583,182 for the year ended December 31, 2018, recorded on a straight-line basis. Lease commitments as presented under ASC 840 as of December 31, 2018 were as follows: 2019 525,745 2020 528,225 2021 53,907 2022 10,768 2023 10,768 2024 and beyond 43,073 $ 1,172,486 Financing Leases The Company has a number of computer and copier equipment leases that are classified as financing leases. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to information received by the Company from bankers regarding estimated current borrowing rates for collateralized loans with similar amount and duration as the leases. Year Ended December 31, 2019 Financing leases Amortization of right-of-use assets $ 46,255 Interest on lease liability 6,859 Total financing lease cost $ 53,114 The table below summarizes other information related to the Company’s financing leases: December 31, 2019 Weighted-average remaining lease term – financing leases 3.7 Weighted-average discount rate – financing leases 9.77 % As of December 31, 2019, remaining maturities of our financing leases are as follows: 2020 $ 50,072 2021 28,355 2022 20,716 2023 18,396 2024 16,080 Total 133,619 Less present value discount (21,811 ) Financing lease liabilities, net $ 111,808 At December 31, 2019 the Company had financing lease liabilities net of discount of $111,808, of which $41,134 was included in other current liabilities and $70,674 was included in other non-current liabilities, and financing right-of-use assets of $108,253, which were included in property and equipment, net, in the accompanying consolidated balance sheet. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Note 12. Net Loss Per Share Basic loss per common share is computed by dividing the net loss allocable to common stockholders by the weighted-average number of shares of common stock or common stock equivalents outstanding. Diluted loss per common share is computed similar to basic loss per share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss per share for the periods presented: Years Ended December 31, 2019 2018 Numerator: Net loss $ (19,297,664 ) $ (16,453,918 ) Denominator: Weighted-average shares outstanding-basic and diluted 38,099,687 27,523,463 Net loss per share, basic and diluted $ (0.51 ) $ (0.60 ) In connection with the Securities Purchase Agreement (see Note 14), the Company issued and sold an aggregate of 5,411,687 pre-funded warrants exercisable for an aggregate of 5,411,687 shares of common stock. The total exercise price of the pre-funded warrants is $0.65 per share, $0.64 of which was pre-funded and paid to the Company upon issuance of the pre-funded warrants. The remaining exercise price of the pre-funded warrants is $0.01 per share. The pre-funded warrants are immediately exercisable and do not expire. As the shares underlying the pre-funded warrants are issuable for nominal consideration of $0.01 per share, they are considered outstanding for purposes of the calculation of loss per share. The following outstanding options, warrants, restricted stock units and debt conversion option were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Years Ended December 31, 2019 2018 Options to purchase common stock 2,904,898 2,047,237 Common stock warrants 236,915 237,846 Restricted stock units 223,745 227,707 QNAH convertible note 800,359 777,769 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2019 | |
Proceeds From Issuance Of Preferred Stock Preference Stock And Warrants [Abstract] | |
Warrants | Note 13. Warrants In connection with certain of its redeemable convertible preferred stock issuances, convertible debt financings and other financing arrangements, the Company has issued warrants for shares of its common stock and various issues of its redeemable convertible preferred stock which have since been converted to common stock warrants. On August 22, 2014, in connection with the Company’s entry into the Growth Term Loan (see Note 8), the Company issued to the two-lender syndicate warrants exercisable for an aggregate of 2,512,562 shares of Series E stock at a price of $0.2189 per share. The warrants provide for cashless exercise at the option of the holders, and contain provisions for the adjustment of the number of shares issuable upon the exercise of the warrant in the event of stock splits, recapitalizations, reclassifications, consolidations or dilutive issuances. In connection with the closing of the IPO in May 2015, the warrants became exercisable for an aggregate of 23,396 shares of common stock at an exercise price of $23.51 per share. The warrants expire by their terms on August 22, 2024, provided that the warrants will be automatically exercised on a cashless basis upon expiration if not previously exercised if the fair market value of a share of the common stock exceeds the per share exercise price. In connection with the funding of Growth Term Loan B, in March 2016 the Company issued Oxford Finance LLC a common stock warrant exercisable for 45,307 shares of common stock at an exercise price of $2.759 per share, and the warrant originally issued to Silicon Valley Bank automatically became exercisable for an additional 5,317 shares of common stock at an exercise price of $23.51 per share in accordance with the terms of the Growth Term Loan. On December 30, 2014, in connection with the Company’s entry into convertible note agreements, the Company agreed to issue warrants (“Convertible Note Warrants”) to the holders exercisable for an aggregate of 9,311,586 shares of Series E Stock at a price of $0.2189 per share, for aggregate consideration of $1,354 on January 15, 2015. The warrants provide for cashless exercise at the option of the holders, and contain provisions for the adjustment of the number of shares issuable upon the exercise of the warrant in the event of stock splits, recapitalizations, reclassifications, consolidations or dilutive issuances. In connection with the closing of the IPO in May 2015, the Convertible Note Warrants became exercisable for an aggregate of 144,772 shares of common stock at the IPO price of $14.00 per share. The Convertible Note Warrants expire by their terms on January 15, 2022. In March 2018, in connection with the entry into the MidCap Term Loan (see Note 8), the Company granted the lender ten-year warrants to purchase 18,123 shares of the Company’s common stock at $7.73 per share as a result of the Company borrowing $7.0 million under MidCap Tranche 1 on the MidCap Closing Date. In September 2019, in connection with the Securities Purchase Agreement (see Note 14), the Company issued and sold an aggregate of 5,411,687 pre-funded warrants exercisable for an aggregate of 5,411,687 shares of common stock. The total exercise price of the pre-funded warrants is $0.65 per share, $0.64 of which was pre-funded and paid to the Company upon issuance of the pre-funded warrants. The remaining exercise price of the pre-funded warrants is $0.01 per share. The pre-funded warrants are immediately exercisable and do not expire. The following table shows the common stock warrants outstanding as of December 31, 2019: Warrant Issuance Date Shares of Common Underlying Warrants Exercise Price/Share Expiration Date August 2014 28,713 $ 23.51 2024 December 2014 144,772 14.00 2022 March 2016 45,307 2.76 2026 March 2018 18,123 7.73 2028 September 2019 5,411,687 0.01 N/A |
Stockholders Equity
Stockholders Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Public Offerings ATM Offering In April 2017, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), as sales agent, pursuant to which the Company had the right to offer and sell, from time to time, through Cantor, shares of the Company’s common stock, par value $0.001 per share, by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), (the “ATM Offering”). In April 2017, the Company also filed a prospectus supplement (File No. 333-216977) with the SEC relating to the offer and sale of up to $20.0 million of common stock in the ATM Offering. In June 2017, the Company filed a first amendment to the prospectus supplement with the SEC to increase the amount of common stock that could be offered and sold in the ATM Offering under the Sales Agreement to $40.0 million in the aggregate, inclusive of the common stock previously sold in the ATM Offering prior to the date of the first amendment. In January 2018, the Company filed a second amendment to the prospectus supplement with the SEC to decrease the amount of common stock that could be offered and sold in the ATM Offering under the Sales Agreement to $23.0 million in the aggregate, inclusive of the common stock sold in the ATM Offering prior to the date of the second amendment. In February 2018, the Company and Cantor mutually agreed to terminate the Sales Agreement. Prior to termination of the Sales Agreement, the Company sold 5,733,314 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $21.1 million, including 0.3 million shares of common stock sold for gross proceeds of $0.6 million during the first quarter ended March 31, 2018. After $0.6 million of sales commissions and $0.2 million of other offering expenses paid by the Company in connection with the ATM Offering, the Company’s aggregate net proceeds from the ATM Offering were approximately $20.2 million. Sales commissions and offering expenses have been recorded as a reduction of proceeds received in arriving at the amounts recorded in additional paid-in capital in the accompanying consolidated balance sheets as of December 31, 2018. 2018 Underwritten Public Offering In January 2018, the Company completed an underwritten public offering of 13,915,000 shares of its common stock at a price of $2.90 per share, including 1,815,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. The Company sold its common stock through an underwriting agreement with Leerink Partners LLC and Cantor as representatives of the underwriters for the offering. The aggregate net proceeds to the Company from the offering were approximately $37.7 million, after deducting the underwriting discounts and commissions and offering expenses. Cowen ATM Offering In March 2019, the Company entered into a Controlled Equity Offering Sales Agreement (“Cowen Sales Agreement”) with Cowen and Company (“Cowen”), as sales agent, pursuant to which the Company has the right to offer and sell, from time to time, through Cowen, shares of the Company’s common stock, having an aggregate offering price of up to $40.0 million, by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act (the “Cowen ATM Offering”) under the Company’s shelf registration statement on Form S-3 (File No. 333-229045). Approximately $0.2 million of costs incurred in connection with the offering were capitalized as deferred offering costs in the Company’s 2019 consolidated balance sheet upon entry into this agreement. As of December 31, 2019, no shares were sold under the Cowen ATM Offering and no shares will be sold under the Cowen ATM Offering as the Company terminated the Cowen Sales Agreement in November 2019. As a result of this termination, the Company wrote off approximately $0.1 million of the previously capitalized deferred offering costs as the Company will not utilize these costs in the sale of shares through the Cowen ATM Offering. The remaining approximately $60,000 of costs capitalized as deferred offering costs in the consolidated balance sheets related to the filing of the Form S-3 were able to be utilized for the 2019 ATM Offering discussed below. 2019 Underwritten Public and Private Offerings Public Offering In September 2019, the Company entered into an underwriting agreement with Cantor (the “2019 Underwriting Agreement”), relating to the issuance and sale in a public offering of 29,298,537 shares of its common stock, including 3,821,548 shares sold pursuant to the full exercise of the underwriter’s option to purchase additional shares. The price to the public in the offering was $0.65 per share and the underwriter agreed to purchase the shares from the Company pursuant to the 2019 Underwriting Agreement at a price of $0.611 per share. The net proceeds to the Company were approximately $17.7 million, after deducting the underwriting discounts and commissions and offering expenses. The offering was made pursuant to the Company’s registration statement on Form S-3 (Registration Statement No. 333‑229045), previously filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on February 11, 2019, and a prospectus supplement and accompanying prospectus thereunder. Securities Purchase Agreement In September 2019, concurrent with the closing of the September 2019 underwritten public offering, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Purchasers”), pursuant to which the Company sold to the Purchasers, in a private placement transaction, an aggregate of 5,411,687 pre-funded warrants to purchase up to an aggregate of 5,411,687 shares of our common stock (“Warrant Shares”), at a price of $0.64 per warrant (which $0.64 price relates to the pre-funded portion of the total $0.65 exercise price per share). Each pre-funded warrant has a remaining exercise price of $0.01 per share and became immediately exercisable upon issuance, subject to certain beneficial ownership limitations. The exercise price of the pre-funded warrants will be subject to adjustment in the event of any stock dividends and splits, recapitalization, reorganization or similar transaction, as described in the pre-funded warrants. The pre-funded warrants are exercisable on a “cashless” basis in certain circumstances. The pre-funded warrants and the Warrant Shares were not registered under the Securities Act and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Company agreed to file a registration statement to register the resale of the Warrant Shares within 30 days following the date of the Closing and to obtain effectiveness of such registration statement within 90 days following the Closing, subject to certain exceptions. Each Purchaser was an “accredited investor” as defined in Rule 501(a) under the Securities Act. Cantor (the “Placement Agent”) acted as the sole placement agent in connection with the private placement of the warrants. Pursuant to a Placement Agency Agreement between us and the Placement Agent, we agreed to pay the Placement Agent a cash fee equal to 6% of the gross proceeds to us from the sale of the pre-funded warrants, and to provide reimbursement for certain out-of-pocket expenses. Upon closing, the Company received approximately $3.1 million in net proceeds from the sale of the pre-funded warrants in the private placement, which does not include proceeds that may be received upon exercise of the pre-funded warrants, after deducting the Placement Agent fee and other expenses. 2019 ATM Offering In November 2019, the Company entered into a Controlled Equity Offering Sales Agreement (the “Cantor Sales Agreement”) with Cantor as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor, shares of the Company’s common stock, par value $0.001 per share, having an aggregate offering price of up to $20.0 million, by any method deemed to be an “at the market offering” as defined by rule 415(a)(4) under the Securities Act (the “2019 ATM Offering”). The shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-229045). The Company is not obligated to sell any shares under the Cantor Sales Agreement. Approximately $81,000 of costs incurred in connection with the offering were capitalized as deferred offering costs in the Company’s consolidated balance sheets upon entry into this agreement in addition to the Form S-3 costs capitalized previously, as discussed in Cowen ATM Offering above, of which $45,000 are reimbursable by Cantor through reduction of commissions earned on shares sold under the Cantor Sales Agreement. The Company is not obligated to sell any shares under the Cantor Sales Agreement and will pay Cantor a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Cantor with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cantor or the Company at any time upon notice to the other party, or by Cantor at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares. There were no shares sold under the Cantor Sales Agreement through December 31, 2019. See Note 17 for further information regarding the 2019 ATM Offering. Common Stock Pursuant to the Company Amended and Restated Certificate of Incorporation, the Company is authorized to issue 200,000,000 shares of common stock at a par value of $0.001 per share. Each share of common stock is entitled to one vote. The shares of common stock have no preemptive or conversion rights, no redemption or sinking fund provisions, no liability for further call or assessment, and are not entitled to cumulative voting rights. Preferred Stock Pursuant to the Company’s certificate of incorporation the Company has been authorized to issue 10,000,000 shares of preferred stock, each having a par value of $0.001. The preferred stock may be issued from time to time in one or more series with the authorization of the Company’s Board of Directors. The Board of Directors can determine voting power for each series issued, as well as designation, preferences, and relative, participating, optional or other rights and such qualifications, limitations or restrictions thereof. Stock-based Compensation The Company incurs stock-based compensation expense relating to the grants under its equity incentive plans of RSUs and stock options to employees, non-employee directors and consultants of the Company and its affiliates and through the ESPP. Equity Incentive Plans The Company initially established the 2001 Stock Option Plan (the “2001 Plan”), which included incentive and nonqualified stock options and restricted stock to be granted to directors, officers, employees, consultants and others. The 2001 Plan terminated, and no further awards were granted under the 2001 Plan upon the effective date of the Company’s 2011 Equity Incentive Plan (the “2011 Plan”). In February 2014, the number of shares reserved under the 2011 Plan was increased to 20% of the total outstanding shares of the Company calculated on a fully diluted basis. The shares reserved under the 2011 Plan were required to be kept at that percentage with each subsequent equity financing. No new equity awards may be granted under the 2011 Plan. In May 2015, 940,112 shares were reserved for issuance under the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), including 14,006 remaining shares reserved under the 2011 Plan. No shares of the Company’s stock available for issuance under the 2014 Plan as of December 31, 2019, other than those reserved for inducement awards, as outlined below. On January 1, 2020, an additional 2,323,609 shares were registered for issuance under the 2014 Plan pursuant to an evergreen provision contained in the 2014 Plan. In May 2019, 200,000 shares were reserved for issuance under the 2014 Plan pursuant to an amendment approved by the Company’s Board of Directors pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules, to be used exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). The Company’s Board of Directors determines the grant date for all awards granted under the 2014 Plan. The option exercise price of stock options and Inducement Awards granted is generally equal to the closing price of the Company’s common stock on the date of grant or on the employee’s hire date for new hire grants. All stock options granted have a ten-year term. The vesting period of stock options, Inducement Awards and RSUs is established by the Board of Directors but typically ranges between one and four years. Amounts recognized in the accompanying consolidated statements of operations with respect to the Company’s equity incentive plans were as follows: Years Ended December 31, 2019 2018 Selling, general and administrative $ 859,653 $ 1,668,227 Research and development 243,804 159,450 Cost of product and product-related services revenue 53,110 60,378 $ 1,156,567 $ 1,888,055 The following table summarizes stock option activity during the two-year period ended December 31, 2019: Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Balance at January 1, 2018 1,517,771 $ 2.97 7.5 $ 67,242 Granted 802,500 3.39 Exercised (144,645 ) 2.19 $ 243,531 Forfeited (66,428 ) 3.24 Expired/Cancelled (61,961 ) 6.52 Balance at December 31, 2018 2,047,237 $ 3.07 7.6 $ 366,007 Granted 1,270,000 1.48 Exercised (54,256 ) 2.23 $ 21,380 Forfeited (161,571 ) 3.29 Expired/Cancelled (196,512 ) 3.23 Balance at December 31, 2019 2,904,898 $ 2.37 8.0 $ 781 Vested and expected to vest at December 31, 2019 2,904,898 2.37 8.0 $ 781 Exercisable at December 31, 2018 1,256,352 2.91 6.5 $ 346,595 Exercisable at December 31, 2019 1,380,865 2.84 6.6 $ 96 The weighted-average fair value of stock options granted was $0.97 and $2.29 for the years ended December 31, 2019 and 2018, respectively. This activity includes 80,000 Inducement Awards granted during the year ended December 31, 2019. No Inducement Awards were granted during the year ended December 31, 2018. As of December 31, 2019, total unrecognized compensation cost related to stock option awards was approximately $1,833,329, which is expected to be recognized over approximately 2.31 years. In June 2018, in connection with the retirement of two employees, the vesting of stock options covering 46,613 shares of common stock was accelerated and the post-termination exercise period for the employees’ options was extended to a one-year period from the termination date. As a result of this modification, the Company recorded incremental stock-based compensation expense of approximately $79,400 for the year ended December 31, 2018. The fair value of each stock option granted has been determined using the Black-Scholes option pricing model. The material factors incorporated in the Black-Scholes model in estimating the fair value of the stock options granted for the periods presented were as follows: 2019 2018 Fair value of common stock on grant date $0.68 - 2.26 $3.26 - 5.06 Risk-free interest rate 1.43% - 2.21% 2.59% - 2.82% Expected volatility 63.9% - 97.1% 79.5% - 85.8% Expected term 5.5 to 6.1 years 5.3 to 5.5 years Expected dividend yield 0% 0% • Expected stock price volatility • Risk-free interest rate • Expected term • Expected dividend yield In preparing its Black-Scholes option-pricing model fair value calculations, the Company does not estimate a forfeiture rate to calculate stock-based compensation. The Company uses judgment in evaluating the expected volatility and expected terms utilized for the Company’s stock-based compensation calculations on a prospective basis. The following table summarizes RSU award activity during the two-year period ended December 31, 2019: Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance at January 1, 2018 26,666 $ 2.78 Granted 492,051 3.63 Released (291,010 ) 3.72 Balance at December 31, 2018 227,707 $ 3.30 Granted 77,500 1.93 Released (81,462 ) 3.31 Balance at December 31, 2019 223,745 $ 2.91 Vested and unissued at December 31, 2019 15,942 $ 3.14 The weighted-average fair value of RSUs granted was $1.93 and $3.63 for the years ended December 31, 2019 and 2018, respectively. As of December 31, 2019, total unrecognized compensation cost related to RSU awards was approximately $555,439, which is expected to be recognized over approximately 2.26 years. Vested and unissued awards at December 31, 2019 represents RSU awards granted on August 16, 2018, January 21, 2019 and September 12, 2019 for which a portion of the awards vested on December 31, 2019, but for which issuance of awards occurred on the next business day, January 2, 2020. 2014 Employee Stock Purchase Plan In April 2015, the Company’s stockholders approved the 2014 Employee Stock Purchase Plan, which became effective in May 2015. Initially, the ESPP authorized the issuance of up to 110,820 shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of the Company’s designated affiliates. The number of shares of common stock reserved for issuance automatically increases on January 1 of each calendar year, from January 1, 2016 to January 1, 2024 by the least of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 195,000 shares, or (iii) a number determined by the Company’s board of directors that is less than (i) and (ii). The ESPP enables participants to contribute up to 15% of such participant’s eligible compensation during a defined period (not to exceed 27 months) to purchase common stock of the Company. The purchase price of common stock under the ESPP is the lesser of: (i) 85% of the fair market value of a share of the Company’s common stock on the first day of an offering or (ii) 85% of the fair market value of the Company’s common stock at the applicable purchase date. Amounts recognized in the accompanying consolidated statements of operations with respect to the ESPP were as follows: Years Ended December 31, 2019 2018 Selling, general and administrative $ 43,615 $ 41,716 Research and development 18,454 12,556 Cost of product and product-related services revenue 4,169 4,687 $ 66,238 $ 58,959 During the year ended December 31, 2019, employees entering the plan at various times throughout the year purchased the following shares at the end of each of the ESPP’s six-month purchase periods: June 2019 December 2019 Number of Shares Price per Share Number of Shares Price per Share ESPP Group: Group A 29,580 $ 1.57 27,449 $ 0.57 Group B 5,828 1.79 5,240 0.57 Group C 4,581 1.79 4,804 0.57 Group D — N/A 2,474 0.57 Total number of shares purchased 39,989 39,967 During the year ended December 31, 2018, employees entering the plan at various times throughout the year purchased the following shares at the end of each of the ESPP’s six-month purchase periods: June 2018 December 2018 Number of Shares Price per Share Number of Shares Price per Share ESPP Group: Group A 39,976 $ 1.57 35,805 $ 1.57 Group B — N/A 4,176 2.81 Total number of shares purchased 39,976 39,981 As of December 31, 2019, approximately 273,111 shares of the Company’s common stock were reserved for future issuance under the ESPP. On January 1, 2020, an additional 195,000 shares were registered for issuance pursuant to an evergreen provision contained in the ESPP. The Company recognizes ESPP expense based on the fair value of the ESPP stock purchase rights, estimated for each six-month purchase period using the Black-Scholes option pricing model. The model requires the Company to make subjective assumptions, including expected stock price volatility, risk free rate of return and estimated life. The fair value of equity-based awards is amortized straight-line over the vesting period of the award. The material factors incorporated in the Black-Scholes model in estimating the fair value of the ESPP awards for the periods presented were as follows: 2019 2018 Fair value of common stock $1.85 - 4.00 $1.85 - 4.00 Risk-free interest rate 1.88% - 2.37% 1.88% - 2.07% Expected volatility 79.5% - 85.8% 83.2% - 85.8% Expected term 0.5 years 0.5 years Expected dividend yield 0% 0% • Fair value of common stock • Expected stock price volatility • Risk-free interest rate • Expected term • Expected dividend yield Stock Purchase Plan In December 2015, the Board of Directors adopted a Stock Purchase Plan (the “Purchase Plan”) which allows directors, any individual deemed by the Board of Directors to be an officer for purposes of Section 16 of the Exchange Act, and anyone designated by the Board of Directors as eligible to participate in the Purchase Plan to purchase shares of the Company’s common stock from the Company at fair market value. The aggregate number of shares of common stock that may be issued under the Purchase Plan shall not exceed 250,000 shares of common stock, and a maximum of 7,500 shares of common stock may be purchased by any one participant on any one purchase date. The Board of Directors or an authorized committee must review and approve each individual request to purchase common stock under the Purchase Plan. Cash received from the sale of common stock by the Company to eligible participants for the year ended December 31, 2019 was $17,250, which resulted in the sale of 7,500 shares of the Company’s common stock at fair market value. Cash received from the sale of common stock by the Company to eligible participants for the year ended December 31, 2018 was $9,997 which resulted in the sale of 2,304 shares of the Company’s common stock at fair market value. As of December 31, 2019, there were 174,871 shares available for issuance under the Purchase Plan. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15. Commitments and Contingencies Legal Matters The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property and product liability. As a result, the Company may be subject to various legal proceedings from time to time. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Any current litigation is considered immaterial and counter claims have been assessed as remote. Employment Agreements The Company has entered into employment agreements or other arrangements with certain named executive officers and various other members of management, which provide salary continuation payments, bonuses and, in certain instances, the acceleration of the vesting of certain equity awards to individuals in the event that the individual is terminated other than for cause, as defined in the applicable agreement. Indemnification Agreements In the course of operating its business, the Company has entered into, and continues to enter into, separate indemnification agreements with the Company’s directors and executive officers, in addition to the indemnification provided for in the Company’s amended and restated bylaws. These agreements may require the Company to indemnify its directors and executive officers for certain expenses incurred in any action or proceeding arising out of their services as one of the Company’s directors or executive officers. Product Warranty The following is a summary of the Company’s general product warranty liability, which is included in accrued liabilities in the accompanying consolidated balance sheets for the years ended December 31, 2019 and 2018: Years Ended December 31, 2019 2018 Beginning balance $ 63,461 $ 37,156 Cost of warranty claims (40,055 ) (2,596 ) Increase in warranty reserve 71,076 28,901 Ending balance $ 94,482 $ 63,461 Defined Contribution Plan In January 2003, the Company established a defined contribution plan (“401(k) Plan”) under section 401(k) of the Internal Revenue Code of 1986, as amended (the “IRC”). All employees who are over the age of 21 and who are expected to work at least 1,000 hours in a calendar year are eligible for participation in the 401(k) Plan upon commencement of employment with the Company. The Company may make discretionary contributions to the 401(k) Plan but has not done so during the years ended December 31, 2019 and 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 16. Income Taxes The Company provides for income taxes based upon management’s estimate of taxable income or loss for each respective period. The Company recognizes an asset or liability for the deferred tax consequences of temporary differences between the tax bases of assets and liabilities and their reported amounts in the financial statements. These temporary differences would result in deductible or taxable amounts in future years, when the reported amounts of the assets are recovered or liabilities are settled, respectively. In each period since inception, the Company has recorded a valuation allowance for the full amount of its net deferred tax assets, as the realization of the net deferred tax assets is uncertain. As a result, the Company has not recorded any federal or state income tax benefit in the accompanying consolidated statements of operations; however, state income tax expense has been recorded for state minimum taxes. The Company periodically reviews its filing positions for all open tax years in all U.S. federal, state and international jurisdictions where the Company is or might be required to file tax returns or other required reports. The Company applies a two-step approach to recognizing and measuring uncertain tax positions. The Company evaluates the tax position for recognition by determining if the weight of available evidence indicates that it is “more likely than not” that the position will be sustained on audit, including resolution of related appeals or litigation process, if any. The term “more likely than not” means a likelihood of more than 50 percent. If the tax position is not more likely than not to be sustained in a court of last resort, the Company may not recognize any of the potential tax benefit associated with the position. The Company recognizes a benefit for a tax position that meets the more likely than not criterion at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon its effective resolution. Unrecognized tax benefits involve management’s judgment regarding the likelihood of the benefit being sustained. The final resolution of uncertain tax positions could result in adjustments to recorded amounts and may affect the Company’s results of operations, financial position and cash flows. As discussed below, the Company has estimated $2,731,015 and $1,538,220 of uncertain tax positions as of December 31, 2019 and 2018, respectively, related to certain tax credit carryforwards. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties at December 31, 2019 or 2018, and has not recognized interest or penalties during the years ended December 31, 2019 and 2018, since there was no reduction in income taxes paid due to uncertain tax positions. Management of the Company believes no significant change to the amount of unrecognized tax benefits will occur within the next 12 months. The following table summarizes loss before income taxes: Years Ended December 31, 2019 2018 U.S. pre-tax loss $ (19,332,809 ) $ (16,406,443 ) Foreign pre-tax gain (loss) 38,524 (43,949 ) Loss before income taxes $ (19,294,285 ) $ (16,450,392 ) The components of income tax expense are as follows: Years Ended December 31, 2019 2018 Current: Federal $ — $ — State 3,379 3,526 Total current income tax expense $ 3,379 $ 3,526 Deferred: Federal $ — $ — State — — Total deferred income tax expense $ — $ — Total income tax expense $ 3,379 $ 3,526 The Company’s actual income tax expense for the years ended December 31, 2019 and 2018 differ from the expected amount computed by applying the statutory federal income tax rate to loss before income taxes as follows: Years Ended December 31, 2019 2018 Computed tax (benefit) at 21% $ (4,051,800 ) $ (3,454,582 ) State taxes, net of federal benefit (881,670 ) (384,035 ) Stock-based compensation 183,167 82,024 Foreign tax rate differential 4,298 (3,158 ) Return to provision 80,668 (31,111 ) Other 51,737 51,598 Research and development tax credit - state (342,320 ) (511,845 ) Research and development tax credit - federal (301,878 ) (506,364 ) Uncertain tax position adjustment for prior periods 650,687 1,029,115 Increase in valuation allowance 4,610,490 3,731,884 $ 3,379 $ 3,526 Deferred tax assets and liabilities comprise the following: Years Ended December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 38,357,970 $ 33,431,082 Research and development credits 3,061,981 3,076,441 Deferred revenue 154,497 86,567 Inventory reserve 10,155 9,645 Fixed assets and intangibles 217,332 223,767 Accrued NuvoGen liability 1,456,435 1,720,335 Accrued expense — 86,034 Lease liability 359,603 — Other 150,134 106,913 Gross deferred tax assets 43,768,107 38,740,784 Valuation allowance (43,350,682 ) (38,740,784 ) Deferred tax assets, net 417,425 — Deferred tax liabilities: Right of use asset 311,633 — Other 105,792 — Total deferred tax liabilities 417,425 — Net deferred tax assets (liabilities) $ — $ — As of December 31, 2019, the Company has estimated federal and state net operating loss (“NOL”) carryforwards of approximately $158,175,977 and $106,182,477 for federal and state income tax purposes, respectively. $121,776,595 of the Company’s federal NOLs are scheduled to expire from 2021 through 2037, while the remaining federal NOLs of $36,399,382 do not expire. The Company’s state NOLs are scheduled to expire from 2027 through 2039. The Company’s federal and state tax credit carryforwards begin expiring in 2021 and 2020, respectively. For financial reporting purposes, valuation allowances of $43,350,682 and $38,740,784 at December 31, 2019 and 2018, respectively, have been established to offset deferred tax assets relating primarily to NOLs and research and development credits. The increase in the valuation allowance of $4,609,898 for the year ended December 31, 2019 was primarily due to increased operating losses. The Company has established a valuation allowance against its entire tax asset. As a result, the Company does not recognize any tax benefit until it is in a taxpaying position or there is no longer negative evidence leading to the conclusion that it is more likely than not that the benefits will not be realized. A reconciliation of the Company’s gross unrecognized tax benefits is as follows: Years Ended December 31, 2019 2018 Balance at beginning of year $ 1,538,220 $ — Increases to prior positions 650,687 $ 1,029,115 Increases for current year positions 542,108 509,105 Balance at end of year $ 2,731,015 $ 1,538,220 As of December 31, 2019, the Company had $2,731,015 of gross unrecognized tax benefits, related to research and experimental tax credits. The Company had no unrecognized tax benefits as of December 31, 2019, which, if recognized, would affect the annual effective tax rate, due to the full valuation allowance on the deferred tax assets. The Company files income tax returns in the United States, Arizona, California, Texas, various other state jurisdictions, and France , |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 17. Subsequent Events 2019 ATM Offering From January 1, 2020 through March 15, 2020, the Company has sold 4,399,062 shares of common stock under the 2019 ATM Offering at then-market prices for total gross proceeds of approximately $2.6 million. After deferred offering costs included as non-current assets in the condensed balance sheets as of December 31, 2019 of approximately $0.1 million and sales commissions owed in connection with the 2019 ATM Offering, the Company’s aggregate net proceeds through March 15, 2020 were approximately $2.5 million. Private Placement Agreement On February 25, 2020, the Company entered into an Exchange and Purchase Agreement (the “Exchange Agreement”) with certain accredited investors (the “Investors”) pursuant to which the Company agreed to (i) issue to the Investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”), in exchange for the Investors surrendering to the Company for cancellation an aggregate of 4,110,000 shares of its common stock (the “Exchange”) and (ii) sell and issue to the Investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $600,030, or $59.00 per share (the “Private Placement”), both of which were completed prior to the end of February 2020. The Series A Preferred have not been registered under the Securities Act or any state securities laws. The Company relied on exemptions from the registration requirements of the Securities Act by virtue of Section 3(a)(9) and Section 4(a)(2) thereof. Each Investor represented that it was acquiring the securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. In February 2020, in connection with the Exchange Agreement and the planned issuance of shares of Series A Preferred pursuant to the Exchange and Private Placement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”). The Series A Certificate of Designation establishes and designates the Series A Preferred and the rights, preferences and privileges thereof. Each share of Series A Preferred is convertible into 100 shares of the Company’s common stock, subject to proportional adjustment and beneficial ownership limitations as provided in the Series A Certificate of Designation. In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Preferred will participate pari passu with any distribution of proceeds to holders of the Company’s common stock. Holders of Series A Preferred are entitled to receive dividends on shares of Series A Preferred equal (on an as converted to common stock basis) to and in the same form as dividends actually paid on the Company’s common stock. Shares of Series A Preferred generally have no voting rights, except as required by law. MidCap Credit Facility On February 26, 2020 (the “Amendment Effective Date”), the Company entered into (i) Amendment No. 2 to its MidCap Term Loan (the “MidCap Term Loan Amendment”), and (ii) Amendment No. 3 to its MidCap Revolving Loan, (the “MidCap Revolving Loan Amendment,” and together with the MidCap Term Loan Amendment, the “Amendments”). The MidCap Term Loan Amendment extends the interest only payments on the term loan advances by an additional 11 months, with principal on each term loan advance payable in 25 equal monthly installments beginning March 1, 2021 until paid in full on March 1, 2023. If the Company achieves a stated revenue milestone for the 12-month period ending on December 31, 2020, the interest-only period will be further extended by an additional four months, with principal on each term loan advance then payable in 21 equal monthly installments beginning July 1, 2021. In addition, both Amendments (i) permit the use of the $3.3 million of escrowed funds previously deposited by the Company for repayment of the QNAH Convertible Note, subject to such repayment not being made before September 1, 2020, the Company having at least $18.0 million of unrestricted cash and cash equivalents and there being no default under the MidCap Term Loan or the MidCap Revolving Loan and (ii) include a grant by the Company of a security interest in its intellectual property, effective as of the Amendment Effective Date. LP Purchase Agreement On March 24, 2020, we entered into a purchase agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, we have the right to sell to Lincoln Park up to $20,000,000 of shares of our common stock (“Purchase Shares”) from time to time over the 36-month term of the LP Purchase Agreement. The purchase price of the Purchase Shares will be based on recent closing prices of our common stock at the time of sale. We issued Lincoln Park an aggregate of 615,384 shares of our common stock as consideration for their purchase commitment pursuant to the LP Purchase Agreement. COVID-19 Pandemic On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report and likewise the full impact of the pandemic on the Company’s financial condition, liquidity, and future results of operations is uncertain. Management is actively monitoring the global situation on its financial condition, liquidity, operations, suppliers, industry and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition or liquidity for fiscal year 2020. While significant uncertainty remains as to the potential impact of the COVID-19 outbreak on the Company’s operations, and on the global economy as a whole, the Company believes it is likely that the COVID-19 outbreak will have a negative impact on the Company’s product and product-related services revenue and collaborative development services revenue in 2020. The Company believes this negative impact will be primarily demand-side driven as its customers experience disruptions in their own businesses from the pandemic. However, it is possible that the COVID-19 pandemic will also impact the Company’s workforce, supply chains or distribution networks or otherwise impact the Company’s ability to conduct sample processing services and custom assay development services and its ability to provide collaborative development services for companion diagnostic development programs. Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of operations, financial position and liquidity in fiscal year 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements and accompanying notes were prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). |
Principles of Consolidation | Principles of Consolidation The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL (“HTG France”), in November 2018. The consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of intercompany transactions and balances as of December 31, 2019 and 2018. |
Reclassifications | Reclassifications Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. |
Liquidity | Liquidity The Company may need to raise additional capital to fund its operations and service its near and long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If sufficient additional capital is not available as and when needed, the Company may have to delay, scale back or discontinue one or more product development programs, curtail its commercialization activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if the Company defaults under its term loan agreement, its lenders could foreclose on its assets, including some of its cash and cash equivalents, which are held in accounts with other financial institutions. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s significant estimates include revenue recognition, stock-based compensation expense, bonus accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory obsolescence and inventory valuation. Actual results could materially differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with financial institutions, commercial paper, money market instruments and high credit quality corporate debt securities purchased with a term of three months or less. |
Accounts Receivable | Accounts Receivable Accounts receivable represent valid claims against debtors. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value. |
Investments | Investments The Company classifies its debt securities as available-for-sale, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive loss, net of tax. Realized gains, realized losses and declines in value of securities judged to be other-than-temporary, are included in other income (expense) within the accompanying consolidated statements of operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Interest earned on all securities is included in other income (expense) within the accompanying consolidated statements of operations. Investments in securities with maturities of less than one year, or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments. If the estimated fair value of a security is below its carrying value, the Company evaluates whether it is more likely than not that it will sell the security before its anticipated recovery in market value and whether evidence indicating that the cost of the investment is recoverable within a reasonable period of time outweighs evidence to the contrary. The Company also evaluates whether or not it intends to sell the investment. If the impairment is considered to be other-than-temporary, the security is written down to its estimated fair value. In addition, the Company considers whether credit losses exist for any securities. A credit loss exists if the present value of cash flows expected to be collected is less than the amortized cost basis of the security. Other-than-temporary declines in estimated fair value and credit losses are charged against other income (expense). |
Restricted Cash | Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the accompanying consolidated balance sheets that sum to the total of the same such amounts shown in the accompanying consolidated statements of cash flows. December 31, 2019 2018 Cash and cash equivalents $ 7,619,748 $ 8,432,600 Restricted cash, current 3,270,247 — Restricted cash, non-current — 3,270,247 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 10,889,995 $ 11,702,847 In October 2017, the Company received $3.0 million in gross proceeds from, and issued a subordinated convertible promissory note (the “QNAH Convertible Note”) in that principal amount to, QIAGEN North American Holdings, Inc. (“QNAH”). Amounts included in restricted cash represent those required to be set aside in escrow under the terms of the MidCap Term Loan to collateralize the payment that will be due upon maturity of the QNAH Convertible Note (see Note 8). The amounts will be released to the Company upon subsequent delivery of subordination documents for the QNAH Convertible Note to MidCap or conversion of the QNAH Convertible Note. If neither occurs, the amounts will be applied by the escrow agent to repay in full the QNAH Convertible Note at maturity (or in connection with a prepayment at the direction of the Company after September 1, 2020) subject to the terms of the MidCap Term Loan including (i) having at least $18.0 million of unrestricted cash and cash equivalents and (ii) there being no default under the MidCap Credit Facility. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1 – Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates. The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which was determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the MidCap Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt securities with similar terms and risk characteristics. As of December 31, 2019, the estimated aggregate fair value of the QNAH Convertible Note with QNAH is approximately $3.0 million, based on a discounted cash flow approach and utilizing an option pricing model to value the conversion feature, with key assumptions including expected volatility, discount rates, term and risk-free rates. The NuvoGen obligation is an obligation relating to an asset purchase transaction with a then-common stockholder of the Company. As of December 31, 2019, the estimated aggregate fair value of the NuvoGen obligation is approximately $5.1 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. The estimated fair values of the QNAH Convertible Note and the NuvoGen obligation represent Level 3 measurements. |
Inventory, net | Inventory, net Inventory, consisting of raw materials, work in process and finished goods, is stated at the lower of cost (first-in, first-out) or net realizable value. Cost is determined using a standard cost system, whereby the standard costs are updated periodically to reflect current costs and net realizable value represents the lower of replacement cost or estimated net realizable value. The Company reserves or writes down its inventory for estimated obsolescence or inventory in excess of reasonably expected near term sales or unmarketable inventory, in an amount equal to the difference between the cost of inventory and the estimated market value, based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Inventory impairment charges establish a new cost basis for inventory and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable. Equipment that is under evaluation for purchase remains in inventory as the Company maintains title to the equipment throughout the evaluation period. The period of time customers use to evaluate the Company’s equipment generally ranges from 90 to 180 days, and in certain circumstances the evaluation period may need to be extended beyond that period. However, in no case will the evaluation period exceed one year. If the customer has not purchased the equipment or entered into a reagent rental agreement with the Company after evaluating the product for one year, the equipment is returned to the Company or the customer is allowed to continue use of the equipment, in which case the equipment is written off to selling, general and administrative expense in the accompanying consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation as of December 31, 2019 was $79,338 compared to $143,271 as of December 31, 2018. |
Property and Equipment, net | Property and Equipment, net Property and equipment are stated at historical cost and depreciated over their useful lives, which range from three to five years, using the straight-line method. Equipment used in the field is amortized using the straight-line method over the lesser of the period of the related reagent rental or collaborative development services agreement where applicable or the estimated useful life. Leasehold improvements are amortized using the straight-line method over the lesser of the remaining lease term or the estimated useful life. Costs incurred in the development and installation of software for internal use and in the development of the Company’s website are expensed or capitalized, depending on whether they are incurred in the preliminary project stage (expensed), application development stage (capitalized), or post-implementation stage (expensed). Amounts capitalized following project completion are amortized on a straight-line basis over the useful life of the developed asset, which is generally three years. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the 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 group to the estimated undiscounted future cash flows expected to be generated by the asset group. If the carrying amount of an asset group exceeds its estimated future cash flow, an impairment charge is recognized in the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. Although the Company has accumulated losses since inception, the Company believes the future cash flows will be sufficient to exceed the carrying value of the Company’s long-lived assets. There were no impairments of long-lived assets during the years ended December 31, 2019 and 2018. |
Leases | Leases Effective Janu ary 1, 2019, the Company accounts for its leases under Financial Accounting Standards Board (“FASB”), Accounting Standards Codification (“ASC”) 842. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred. Certain leasehold improvements constructed by the landlord of the Company’s Tucson, AZ facilities as an incentive for the Company to extend its leases are included in leasehold improvements in the consolidated balance sheets as of December 31, 2018. The total cost of the improvements constructed by the landlord of $710,000 was capitalized when construction was completed in February 2016 and is being amortized over the remaining term of the lease agreement. The incentive of $710,000 was also recognized as deferred rent and was being amortized over the lease term as a reduction of lease expense. As of December 31, 2018, the remaining unamortized incentive of $295,833 was recognized as deferred rent within other current liabilities and other liabilities, in accordance with ASC Topic 840, Leases The comparative information in these consolidated financial statements has not been restated and continues to be reported under ASC 840. |
Debt Issuance Costs and Debt Discounts | Debt Issuance Costs and Debt Discounts Costs incurred to issue non-revolving debt instruments are recognized as a reduction to the related debt balance in the accompanying consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Costs incurred to issue revolving debt instruments are deferred as an asset in the accompanying consolidated balance sheets and amortized on a straight-line basis to interest expense over the term of the revolving commitment . |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs represent legal and other direct costs related to planned future stock offering transactions. Deferred offering costs of $140,320 included as non-current assets in the accompanying consolidated balance sheets represent legal costs incurred, $81,290 of which were incurred during the year ended December 31, 2019 and $59,030 of which were incurred during the year ended December 31, 2018, by the Company in contemplation of the issuance of additional shares in a future financing transaction. In January 2020, these deferred offering costs were recorded to additional paid in capital, as an offset to proceeds received from the 2019 ATM Offering (see Note 17). |
Contract Liabilities | Contract Liabilities Contract liabilities represent cash receipts for products or services to be delivered in future periods, including up-front fees received relating to custom RUO assay design and collaborative development services. When products or services are delivered to customers, contract liabilities are recognized as earned. Up-front fees received for custom RUO assay design or collaborative development services are recognized over time based on the costs incurred to date compared to total expected costs as design or development procedures are completed and outputs are produced. |
Revenue Recognition | Revenue Recognition The Company adopted ASC 606, Revenue from Contracts with Customers For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. The Company has made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected by the Company from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes. See Note 9 for additional discussion of the Company’s revenue recognition policies. |
Product Warranty | Product Warranty The Company generally provides a one-year warranty on its HTG EdgeSeq systems covering the performance of system hardware and software in conformance with customer specifications under normal use and protecting against defects in materials and workmanship. The Company may, at its option, replace, repair or exchange products covered under valid warranty claims. A provision for estimated warranty costs is recognized at the time of sale, through cost of product and product-related services revenue, based upon recent historical experience and other relevant information as it becomes available. The Company continuously assesses the adequacy of its product warranty accrual by reviewing actual claims and adjusts the provision as needed. Warranty accrual is included in accrued liabilities in the accompanying consolidated balance sheets. |
Research and Development Expenses | Research and Development Expenses Research and development expenses represent costs incurred internally for research and development activities and costs incurred externally to fund research activities. These costs include those generated through research and development efforts for the improvement and expansion of the Company’s proprietary technology and product offerings as well as those related to third-party collaborative development agreements, for which related revenue is included in collaborative development services revenue in the accompanying consolidated statements of operations. See for further discussion of the development costs associated with collaborative development services agreements included in research and development expense as compared to cost of revenue in the accompanying consolidated statements of operations. |
Advertising | Advertising All costs associated with advertising and promotions are expensed as incurred. Advertising expense was $4,595 and $110,591 for the years ended December 31, 2019 and 2018, respectively, and is included as a component of selling, general and administrative expenses on the accompanying consolidated statements of operations. |
Stock-based Compensation | Stock-based Compensation The Company incurs stock-based compensation expense relating to grants under its equity incentive plans of restricted stock units (“RSUs”) and stock options to employees, consultants and non-employee directors, and stock purchase rights granted under the 2014 Employee Stock Purchase Plan (“ESPP”). The Company recognizes expense for stock-based awards based on the fair value of awards on the date of grant. The fair value of RSUs is based on the quoted market price of the Company’s common stock on the date of grant. The fair value of ESPP rights and stock options granted pursuant to the Company’s equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s stock price and several assumptions, including volatility, expected term, risk-free interest rate, and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. The Company does not estimate the number of awards expected to be forfeited, but instead accounts for such forfeitures as they occur. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets we have assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that it is “more likely than not” that the assets will not be recovered or there is an insufficient history of operating profits, a valuation allowance is established. We record the valuation allowance in the period we determine that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 2019 and 2018, we have provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote in the near term. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. |
Foreign Currency Translation and Foreign Currency Transactions | Foreign Currency Translation and Foreign Currency Transactions The Company has assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than its functional currency. These assets and liabilities are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations. Adjustments resulting from translating foreign functional currency financial statements of the Company’s wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive loss in the accompanying consolidated statements of stockholder’s equity (deficit). |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains and losses on short-term available-for-sale investments and adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in comprehensive loss. |
Concentration Risks | Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. Management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. The Company sells its instruments, consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The top three customers accounted for 24%, 22% and 19% of the Company’s revenue for the year ended December 31, 2019, compared with 58%, 10% and 9% for the year ended December 31, 2018. The largest two customers accounted for approximately 29% and 25% of the Company’s net accounts receivable as of December 31, 2019. These accounts receivable primarily relate to sample processing services performed for a biopharmaceutical company customer and work performed under the Company’s Governing Agreement with QML. The largest three customers accounted for approximately 44%, 27%, and 11% of the Company’s net accounts receivable at December 31, 2018. Three vendors accounted for 36%, 10% and 10% of the Company’s accounts payable as of December 31, 2019 primarily related to a strategic marketing study compared to 24%, 14% and 11% of the Company’s accounts payable at December 31, 2018. The Company currently relies on a single supplier to supply a subcomponent used in its HTG EdgeSeq processors. A loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue. |
Recently Adopted and New Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting . In July 2017, the FASB issued ASU 2017-11, Accounting for Certain Financial Instruments with Down Round Features New Accounting Pronouncements The following are new FASB ASUs that had not been adopted by the Company as of December 31, 2019, and are grouped by their respective effective dates: January 1, 2020 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement In November 2018, the FASB issued ASU No. 2018-18, which amended ASC 808, Collaborative Arrangements Revenue from Contracts with Customers In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting Entities may apply the provisions of the new standard as of the beginning of the reporting period when the election is made (i.e. as early as the first quarter 2020). Unlike other topics, the provisions of this update are only available until December 31, 2022, when the reference rate replacement activity is expected to have completed. January 1, 2021 In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes January 1, 2023 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the accompanying consolidated balance sheets that sum to the total of the same such amounts shown in the accompanying consolidated statements of cash flows. December 31, 2019 2018 Cash and cash equivalents $ 7,619,748 $ 8,432,600 Restricted cash, current 3,270,247 — Restricted cash, non-current — 3,270,247 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 10,889,995 $ 11,702,847 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, net of allowance, consisted of the following as of the date indicated: December 31, 2019 2018 Raw materials $ 872,947 $ 892,631 Work in process 151,351 168,937 Finished goods 284,772 284,444 Total gross inventory 1,309,070 1,346,012 Less inventory allowance $ (39,403 ) (39,403 ) $ 1,269,667 $ 1,306,609 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table classifies the Company’s financial assets and liabilities measured at fair value on a recurring basis at December 31, 2019 and 2018, respectively, in the fair value hierarchy: December 31, 2019 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 7,217,096 $ — $ — $ 7,217,096 Investments available-for-sale at fair value U.S. Treasury securities 5,961,983 — — 5,961,983 Corporate debt securities — 19,448,239 — 19,448,239 Total $ 13,179,079 $ 19,448,239 $ — $ 32,627,318 December 31, 2018 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 6,923,255 $ 998,400 $ — $ 7,921,655 Investments available-for-sale at fair value U.S. Treasury securities 6,031,515 — — 6,031,515 Corporate debt securities — 16,649,534 — 16,649,534 Total $ 12,954,770 $ 17,647,934 $ — $ 30,602,704 |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Available-for-sale Securities | The Company’s portfolio of available-for-sale securities consists of U.S. Treasuries and high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities at December 31, 2019 and 2018: December 31, 2019 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 5,962,224 $ 394 $ (635 ) $ 5,961,983 Corporate debt securities 19,448,239 — — 19,448,239 Total available-for-sale securities $ 25,410,463 $ 394 $ (635 ) $ 25,410,222 December 31, 2018 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 6,032,844 $ — $ (1,329 ) $ 6,031,515 Corporate debt securities 16,650,513 — (979 ) 16,649,534 Total available-for-sale securities $ 22,683,357 $ — $ (2,308 ) $ 22,681,049 |
Summary of Contractual Maturities of Debt Investment Securities | Contractual maturities of debt investment securities at December 31, 2019 are shown below. Under 1 Year 1 to 2 Years Total U.S. Treasury securities $ 5,961,983 $ — $ 5,961,983 Corporate debt securities 19,448,239 — 19,448,239 Total available-for-sale securities $ 25,410,222 $ — $ 25,410,222 |
Summary of Debt Securities with Unrealized Losses | The following table shows the gross unrealized losses and fair values of the Company’s investments that have unrealized losses, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position as of December 31, 2019: Under 1 Year 1 to 2 Years Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 3,956,401 $ (635 ) $ — $ — $ 3,956,401 $ (635 ) Corporate debt securities — — — — — — Total available-for-sale securities with unrealized losses $ 3,956,401 $ (635 ) $ — $ — $ 3,956,401 $ (635 ) |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment, net consists of the following: December 31, 2019 2018 Furniture & fixtures $ 1,089,371 $ 791,973 Leasehold improvements 1,987,997 1,930,300 Equipment used in manufacturing 2,305,340 2,297,797 Equipment used in research & development 2,134,019 1,456,954 Equipment used in the field 182,762 125,253 Software 374,812 373,683 Construction in progress — 19,246 8,074,301 6,995,206 Less: accumulated depreciation and amortization (5,834,168 ) (4,621,416 ) $ 2,240,133 $ 2,373,790 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Liabilities Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consist of the following: December 31, 2019 2018 Accrued employee bonuses $ 900,740 $ 2,150,418 Payroll and employee benefit accruals 469,530 698,969 Accrued professional fees 43,850 60,400 Accrued interest 245,350 156,492 Other accrued liabilities 210,826 292,186 $ 1,870,296 $ 3,358,465 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Remaining Principal Repayments due Under MidCap Term Loan | The remaining principal repayments due under the MidCap Term Loan, following amendment of this agreement in February 2020, are as follows: 2020 — 2021 2,800,000 2022 3,360,000 2023 840,000 Total MidCap Term Loan payments 7,000,000 Less discount and deferred financing costs (443,455 ) Plus final fee premium 315,000 Total MidCap Term Loan, net $ 6,871,545 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Product and Product-Related Service Revenue from Sale of Instruments and Consumables | Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the years ended December 31, 2019 and 2018 as follows: Years Ended December 31, 2019 2018 Product revenue: Instruments $ 1,436,730 $ 351,885 Consumables 3,010,094 1,964,499 Total product revenue $ 4,446,824 $ 2,316,384 Product-related services revenue: Custom RUO assay design 4,498,088 964,241 RUO sample processing 5,687,292 5,840,765 Total product-related services revenue 10,185,380 6,805,006 Total product and product-related services revenue $ 14,632,204 $ 9,121,390 |
Schedule of Collaborative Development Services | Collaborative Development Services Revenue The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. Collaborative development services revenue for the years ended December 31, 2019 and 2018 was generated through statements of work entered into under the Governing Agreement with QML as discussed below. Years Ended December 31, 2019 2018 Collaborative development services $ 4,571,684 $ 12,382,504 |
Schedule of Changes in Contract Liability | Changes in the Company’s contract liabilities were as follows as of the dates indicated: Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2019 $ 116,547 $ 50,000 $ 244,400 $ 410,947 Deferral of revenue 218,802 972,267 529,913 1,720,982 Recognition of deferred revenue (240,201 ) (956,051 ) (336,223 ) (1,532,475 ) Balance at December 31, 2019 $ 95,148 $ 66,216 $ 438,090 $ 599,454 Product Revenue Custom RUO Assay Design Sample Processing Collaborative Development Services Total Contract Liability Balance at January 1, 2018 $ 39,426 $ 197,606 $ 490,536 $ 110,317 $ 837,885 Deferral of revenue 190,703 448,580 197,541 70,918 907,742 Customer deposits 131,864 - - — 131,864 Recognition of deferred revenue (245,446 ) (596,186 ) (443,677 ) (181,235 ) (1,466,544 ) Balance at December 31, 2018 $ 116,547 $ 50,000 $ 244,400 $ — $ 410,947 |
Other Agreements (Tables)
Other Agreements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Other Agreements [Abstract] | |
Schedule of Remaining Minimum Principal Payments Due | Minimum payments to be made in 2020 include $187,997 of revenue-based payments payable as of December 31, 2019 and an estimate of additional revenue-based payments to be made throughout the remainder of 2020 relating to revenue generated in the first, second and third quarters of 2020 using actual revenue generated in the same quarters in 2019. Minimum payments for the remaining years include only the minimum payments for each year. Actual payments could be significantly more than provided in the table, to the extent that 6% of the Company’s annual revenue in 2020 and beyond exceeds $400,000: 2020 1,152,233 2021 400,000 2022 400,000 2023 400,000 2024 400,000 2025 and beyond 2,806,466 Total NuvoGen obligation payments 5,558,699 Plus interest accretion 92,311 Total NuvoGen obligation, net $ 5,651,010 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Summary of Components of Lease Cost | The components of lease cost for operating leases were as follows: Year Ended December 31, 2019 Operating leases Operating lease cost $ 618,463 Variable lease cost 131,387 Operating lease expense 749,850 Short-term lease rent expense 1,497 Total rent expense $ 751,347 Year Ended December 31, 2019 Financing leases Amortization of right-of-use assets $ 46,255 Interest on lease liability 6,859 Total financing lease cost $ 53,114 |
Schedule of Other Information Related to Operating Leases | The table below summarizes other information related to the Company’s operating leases: Year Ended or As of December 31, 2019 Operating cash flows for operating leases $ 770,658 Establishment of operating lease liabilities arising from obtaining right-of-use assets $ 2,038,193 Weighted-average remaining lease term – operating leases 2.3 Weighted-average discount rate – operating leases 9.6 % |
Summary of Remaining Maturities of Operating Leases, Excluding Short-term Leases | As of December 31, 2019, remaining maturities of our operating leases, excluding short-term leases, are as follows: 2020 $ 881,300 2021 352,243 2022 281,232 2023 70,848 Total 1,585,623 Less present value discount (190,351 ) Operating lease liabilities, net $ 1,395,272 |
Summary of Lease Commitments | Lease commitments as presented under ASC 840 as of December 31, 2018 were as follows: 2019 525,745 2020 528,225 2021 53,907 2022 10,768 2023 10,768 2024 and beyond 43,073 $ 1,172,486 |
Schedule of Other Information Related to Finance Leases | The table below summarizes other information related to the Company’s financing leases: December 31, 2019 Weighted-average remaining lease term – financing leases 3.7 Weighted-average discount rate – financing leases 9.77 % |
Summary of Remaining Maturities of Financing Leases | As of December 31, 2019, remaining maturities of our financing leases are as follows: 2020 $ 50,072 2021 28,355 2022 20,716 2023 18,396 2024 16,080 Total 133,619 Less present value discount (21,811 ) Financing lease liabilities, net $ 111,808 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Reconciliation of Numerator and Denominator Used in Computing Basic and Diluted Net Loss per Share | The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss per share for the periods presented: Years Ended December 31, 2019 2018 Numerator: Net loss $ (19,297,664 ) $ (16,453,918 ) Denominator: Weighted-average shares outstanding-basic and diluted 38,099,687 27,523,463 Net loss per share, basic and diluted $ (0.51 ) $ (0.60 ) |
Outstanding Options, Warrants, Restricted Stock Units and Debt Conversion Option Excluded from Computation of Diluted Net Loss per Share | The following outstanding options, warrants, restricted stock units and debt conversion option were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Years Ended December 31, 2019 2018 Options to purchase common stock 2,904,898 2,047,237 Common stock warrants 236,915 237,846 Restricted stock units 223,745 227,707 QNAH convertible note 800,359 777,769 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Proceeds From Issuance Of Preferred Stock Preference Stock And Warrants [Abstract] | |
Summary of Outstanding Warrants | The following table shows the common stock warrants outstanding as of December 31, 2019: Warrant Issuance Date Shares of Common Underlying Warrants Exercise Price/Share Expiration Date August 2014 28,713 $ 23.51 2024 December 2014 144,772 14.00 2022 March 2016 45,307 2.76 2026 March 2018 18,123 7.73 2028 September 2019 5,411,687 0.01 N/A |
Stockholders Equity (Tables)
Stockholders Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Amounts recognized in the accompanying consolidated statements of operations with respect to the Company’s equity incentive plans were as follows: Years Ended December 31, 2019 2018 Selling, general and administrative $ 859,653 $ 1,668,227 Research and development 243,804 159,450 Cost of product and product-related services revenue 53,110 60,378 $ 1,156,567 $ 1,888,055 |
Summary of Stock Option Plans Activity | The following table summarizes stock option activity during the two-year period ended December 31, 2019: Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Balance at January 1, 2018 1,517,771 $ 2.97 7.5 $ 67,242 Granted 802,500 3.39 Exercised (144,645 ) 2.19 $ 243,531 Forfeited (66,428 ) 3.24 Expired/Cancelled (61,961 ) 6.52 Balance at December 31, 2018 2,047,237 $ 3.07 7.6 $ 366,007 Granted 1,270,000 1.48 Exercised (54,256 ) 2.23 $ 21,380 Forfeited (161,571 ) 3.29 Expired/Cancelled (196,512 ) 3.23 Balance at December 31, 2019 2,904,898 $ 2.37 8.0 $ 781 Vested and expected to vest at December 31, 2019 2,904,898 2.37 8.0 $ 781 Exercisable at December 31, 2018 1,256,352 2.91 6.5 $ 346,595 Exercisable at December 31, 2019 1,380,865 2.84 6.6 $ 96 |
Summary of Material Factors Incorporated in Black-Scholes Model In Estimating Fair Value of Options Granted | The material factors incorporated in the Black-Scholes model in estimating the fair value of the stock options granted for the periods presented were as follows: 2019 2018 Fair value of common stock on grant date $0.68 - 2.26 $3.26 - 5.06 Risk-free interest rate 1.43% - 2.21% 2.59% - 2.82% Expected volatility 63.9% - 97.1% 79.5% - 85.8% Expected term 5.5 to 6.1 years 5.3 to 5.5 years Expected dividend yield 0% 0% |
Summary of Restricted Stock Unit (RSU) Plans Activity | The following table summarizes RSU award activity during the two-year period ended December 31, 2019: Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance at January 1, 2018 26,666 $ 2.78 Granted 492,051 3.63 Released (291,010 ) 3.72 Balance at December 31, 2018 227,707 $ 3.30 Granted 77,500 1.93 Released (81,462 ) 3.31 Balance at December 31, 2019 223,745 $ 2.91 Vested and unissued at December 31, 2019 15,942 $ 3.14 |
Employee Stock Purchase Plan | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Amounts recognized in the accompanying consolidated statements of operations with respect to the ESPP were as follows: Years Ended December 31, 2019 2018 Selling, general and administrative $ 43,615 $ 41,716 Research and development 18,454 12,556 Cost of product and product-related services revenue 4,169 4,687 $ 66,238 $ 58,959 |
Summary of Material Factors Incorporated in Black-Scholes Model In Estimating Fair Value of Options Granted | The material factors incorporated in the Black-Scholes model in estimating the fair value of the ESPP awards for the periods presented were as follows: 2019 2018 Fair value of common stock $1.85 - 4.00 $1.85 - 4.00 Risk-free interest rate 1.88% - 2.37% 1.88% - 2.07% Expected volatility 79.5% - 85.8% 83.2% - 85.8% Expected term 0.5 years 0.5 years Expected dividend yield 0% 0% |
Summary of Shares Purchased under ESPP'S Six Month Purchase Periods | During the year ended December 31, 2019, employees entering the plan at various times throughout the year purchased the following shares at the end of each of the ESPP’s six-month purchase periods: June 2019 December 2019 Number of Shares Price per Share Number of Shares Price per Share ESPP Group: Group A 29,580 $ 1.57 27,449 $ 0.57 Group B 5,828 1.79 5,240 0.57 Group C 4,581 1.79 4,804 0.57 Group D — N/A 2,474 0.57 Total number of shares purchased 39,989 39,967 During the year ended December 31, 2018, employees entering the plan at various times throughout the year purchased the following shares at the end of each of the ESPP’s six-month purchase periods: June 2018 December 2018 Number of Shares Price per Share Number of Shares Price per Share ESPP Group: Group A 39,976 $ 1.57 35,805 $ 1.57 Group B — N/A 4,176 2.81 Total number of shares purchased 39,976 39,981 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Product Warranty Liability | The following is a summary of the Company’s general product warranty liability, which is included in accrued liabilities in the accompanying consolidated balance sheets for the years ended December 31, 2019 and 2018: Years Ended December 31, 2019 2018 Beginning balance $ 63,461 $ 37,156 Cost of warranty claims (40,055 ) (2,596 ) Increase in warranty reserve 71,076 28,901 Ending balance $ 94,482 $ 63,461 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income taxes | The following table summarizes loss before income taxes: Years Ended December 31, 2019 2018 U.S. pre-tax loss $ (19,332,809 ) $ (16,406,443 ) Foreign pre-tax gain (loss) 38,524 (43,949 ) Loss before income taxes $ (19,294,285 ) $ (16,450,392 ) |
Components of Income Tax Expense | The components of income tax expense are as follows: Years Ended December 31, 2019 2018 Current: Federal $ — $ — State 3,379 3,526 Total current income tax expense $ 3,379 $ 3,526 Deferred: Federal $ — $ — State — — Total deferred income tax expense $ — $ — Total income tax expense $ 3,379 $ 3,526 |
Schedule of Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes | The Company’s actual income tax expense for the years ended December 31, 2019 and 2018 differ from the expected amount computed by applying the statutory federal income tax rate to loss before income taxes as follows: Years Ended December 31, 2019 2018 Computed tax (benefit) at 21% $ (4,051,800 ) $ (3,454,582 ) State taxes, net of federal benefit (881,670 ) (384,035 ) Stock-based compensation 183,167 82,024 Foreign tax rate differential 4,298 (3,158 ) Return to provision 80,668 (31,111 ) Other 51,737 51,598 Research and development tax credit - state (342,320 ) (511,845 ) Research and development tax credit - federal (301,878 ) (506,364 ) Uncertain tax position adjustment for prior periods 650,687 1,029,115 Increase in valuation allowance 4,610,490 3,731,884 $ 3,379 $ 3,526 |
Schedule of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities comprise the following: Years Ended December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 38,357,970 $ 33,431,082 Research and development credits 3,061,981 3,076,441 Deferred revenue 154,497 86,567 Inventory reserve 10,155 9,645 Fixed assets and intangibles 217,332 223,767 Accrued NuvoGen liability 1,456,435 1,720,335 Accrued expense — 86,034 Lease liability 359,603 — Other 150,134 106,913 Gross deferred tax assets 43,768,107 38,740,784 Valuation allowance (43,350,682 ) (38,740,784 ) Deferred tax assets, net 417,425 — Deferred tax liabilities: Right of use asset 311,633 — Other 105,792 — Total deferred tax liabilities 417,425 — Net deferred tax assets (liabilities) $ — $ — |
Schedule of Reconciliation of Gross Unrecognized Tax Benefits | A reconciliation of the Company’s gross unrecognized tax benefits is as follows: Years Ended December 31, 2019 2018 Balance at beginning of year $ 1,538,220 $ — Increases to prior positions 650,687 $ 1,029,115 Increases for current year positions 542,108 509,105 Balance at end of year $ 2,731,015 $ 1,538,220 |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Principles of Consolidation - Additional Information (Details) - Segment | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Significant Accounting Policies [Line Items] | ||
Number of operating segments | 1 | |
Sales Revenue, Net | Customer Concentration Risk | Customers Located Outside Of United States | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 34.00% | 69.00% |
Sales Revenue, Net | Customer Concentration Risk | Customers Located Outside Of United States | QIAGEN Manchester Limited | Collaborative Development Services | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 69.00% | 84.00% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2017USD ($) | Dec. 31, 2019USD ($)CustomerVendor | Dec. 31, 2018USD ($)CustomerVendor | Jan. 01, 2019USD ($) | Feb. 29, 2016USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Maturity period of investments | less than one year | ||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||
Finished goods inventory | 284,772 | $ 284,444 | |||
Impairment of Long-lived assets | 0 | 0 | |||
Leasehold improvements | 710,000 | $ 710,000 | |||
Lease incentive, recognized as deferred rent | 295,833 | ||||
Deferred offering costs, current | 140,320 | 59,030 | |||
Legal costs incurred | 81,290 | ||||
Advertising and promotion expense incurred | 4,595 | $ 110,591 | |||
Operating lease right-of-use assets | 1,209,145 | ||||
Operating lease liabilities | $ 1,395,272 | ||||
Supplier Concentration Risk | Accounts Payable | |||||
Significant Accounting Policies [Line Items] | |||||
Number of vendors | Vendor | 3 | 3 | |||
Supplier Concentration Risk | Accounts Payable | Vendor One | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 36.00% | 24.00% | |||
Supplier Concentration Risk | Accounts Payable | Vendor Two | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 10.00% | 14.00% | |||
Supplier Concentration Risk | Accounts Payable | Vendor Three | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 10.00% | 11.00% | |||
Sales Revenue, Net | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Number of customers | Customer | 3 | 3 | |||
Sales Revenue, Net | Customer Concentration Risk | Customer One | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 24.00% | 58.00% | |||
Sales Revenue, Net | Customer Concentration Risk | Customer Two | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 22.00% | 10.00% | |||
Sales Revenue, Net | Customer Concentration Risk | Customer Three | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 19.00% | 9.00% | |||
Accounts Receivable | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Number of customers | Customer | 2 | 3 | |||
Accounts Receivable | Customer Concentration Risk | Customer One | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 29.00% | 44.00% | |||
Accounts Receivable | Customer Concentration Risk | Customer Two | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 25.00% | 27.00% | |||
Accounts Receivable | Customer Concentration Risk | Customer Three | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 11.00% | ||||
Accounting Standards Update 2016-02 | |||||
Significant Accounting Policies [Line Items] | |||||
Lease incentive, recognized as offset to right-of-use asset | $ 295,833 | ||||
Operating lease right-of-use assets | 694,352 | ||||
Operating lease liabilities | 1,033,107 | ||||
Effect on retained earnings | $ 0 | ||||
Decrease in operating lease asset | $ 300,000 | ||||
Software and Software Development Costs | |||||
Significant Accounting Policies [Line Items] | |||||
Long-term asset, estimated life | 3 years | ||||
Minimum | |||||
Significant Accounting Policies [Line Items] | |||||
Period of time customers use to evaluate the Company’s equipment | 90 days | ||||
Long-term asset, estimated life | 3 years | ||||
Maximum | |||||
Significant Accounting Policies [Line Items] | |||||
Period of time customers use to evaluate the Company’s equipment | 180 days | ||||
Long-term asset, estimated life | 5 years | ||||
NuvoGen Asset Purchase Agreement | |||||
Significant Accounting Policies [Line Items] | |||||
Convertible debt, fair value | $ 5,100,000 | ||||
QIAGEN North American Holdings, Inc. | |||||
Significant Accounting Policies [Line Items] | |||||
Convertible debt, fair value | 3,000,000 | ||||
QIAGEN North American Holdings, Inc. | Convertible Promissory Note | |||||
Significant Accounting Policies [Line Items] | |||||
Gross proceeds from issuance of subordinated notes | $ 3,000,000 | ||||
HTG EdgeSeq | |||||
Significant Accounting Policies [Line Items] | |||||
Finished goods inventory | $ 79,338 | $ 143,271 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents | $ 7,619,748 | $ 8,432,600 |
Restricted cash, current | 3,270,247 | |
Restricted cash, non-current | 3,270,247 | |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 10,889,995 | $ 11,702,847 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 872,947 | $ 892,631 |
Work in process | 151,351 | 168,937 |
Finished goods | 284,772 | 284,444 |
Total gross inventory | 1,309,070 | 1,346,012 |
Less inventory allowance | (39,403) | (39,403) |
Inventory, net | $ 1,269,667 | $ 1,306,609 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | ||
Reserve for shrinkage and excess inventory | $ 39,403 | $ 39,403 |
Net change in inventory valuation reserves | 0 | 22,739 |
Provision for excess inventory | $ 153,729 | $ 83,218 |
Fair Value - Financial Assets a
Fair Value - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Asset included in: | ||
Investments available-for-sale at fair value | $ 25,410,222 | $ 22,681,049 |
U.S. Treasury Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 5,961,983 | 6,031,515 |
Corporate Debt Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 19,448,239 | 16,649,534 |
Fair Value, Measurements, Recurring | ||
Asset included in: | ||
Financial Assets | 32,627,318 | 30,602,704 |
Fair Value, Measurements, Recurring | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 7,217,096 | 7,921,655 |
Fair Value, Measurements, Recurring | U.S. Treasury Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 5,961,983 | 6,031,515 |
Fair Value, Measurements, Recurring | Corporate Debt Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 19,448,239 | 16,649,534 |
Fair Value, Measurements, Recurring | Level 1 | ||
Asset included in: | ||
Financial Assets | 13,179,079 | 12,954,770 |
Fair Value, Measurements, Recurring | Level 1 | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 7,217,096 | 6,923,255 |
Fair Value, Measurements, Recurring | Level 1 | U.S. Treasury Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 5,961,983 | 6,031,515 |
Fair Value, Measurements, Recurring | Level 2 | ||
Asset included in: | ||
Financial Assets | 19,448,239 | 17,647,934 |
Fair Value, Measurements, Recurring | Level 2 | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 998,400 | |
Fair Value, Measurements, Recurring | Level 2 | Corporate Debt Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | $ 19,448,239 | $ 16,649,534 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Fair value assets, Level 1 to Level 2 transfers, Amount | $ 0 | $ 0 |
Fair value, assets, Level 2 to Level 1 transfers, Amount | 0 | 0 |
Fair value, liabilities, Level 1 to Level 2 transfers, Amount | 0 | 0 |
Fair value, liabilities, Level 2 to Level 1 transfers, Amount | 0 | 0 |
Fair value, measurement with unobservable inputs reconciliation, recurring basis, asset transfers into Level 3 | 0 | 0 |
Fair value, measurement with unobservable inputs reconciliation, recurring Basis, asset, transfers out of Level 3 | 0 | 0 |
Fair Value, measurement with unobservable inputs reconciliation, liability, transfers into Level 3 | 0 | 0 |
Fair Value, measurement with unobservable inputs reconciliation, liability, transfers out of Level 3 | $ 0 | $ 0 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-sale Securities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 25,410,463 | $ 22,683,357 |
Gross Unrealized Gains | 394 | |
Gross Unrealized Losses | (635) | (2,308) |
Fair Value (Net Carrying Amount) | 25,410,222 | 22,681,049 |
U.S. Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 5,962,224 | 6,032,844 |
Gross Unrealized Gains | 394 | |
Gross Unrealized Losses | (635) | (1,329) |
Fair Value (Net Carrying Amount) | 5,961,983 | 6,031,515 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 19,448,239 | 16,650,513 |
Gross Unrealized Losses | (979) | |
Fair Value (Net Carrying Amount) | $ 19,448,239 | $ 16,649,534 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Unrealized gain on short and long-term investments | $ 2,299 | $ (2,308) |
Other-than-temporary impairment | $ 0 |
Available-for-Sale Securities_3
Available-for-Sale Securities - Summary of Contractual Maturities of Debt Investment Securities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule Of Available For Sale Securities [Line Items] | ||
Under 1 Year | $ 25,410,222 | |
Fair Value (Net Carrying Amount) | 25,410,222 | $ 22,681,049 |
U.S. Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Under 1 Year | 5,961,983 | |
Fair Value (Net Carrying Amount) | 5,961,983 | 6,031,515 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Under 1 Year | 19,448,239 | |
Fair Value (Net Carrying Amount) | $ 19,448,239 | $ 16,649,534 |
Available-for-Sale Securities_4
Available-for-Sale Securities - Summary of Debt Securities with Unrealized Losses (Details) | Dec. 31, 2019USD ($) |
Schedule Of Available For Sale Securities [Line Items] | |
Under 1 Year, Fair Value | $ 3,956,401 |
Under 1 Year, Gross Unrealized Losses | (635) |
Total, Fair Value | 3,956,401 |
Total, Gross Unrealized Losses | (635) |
U.S. Treasury Securities | |
Schedule Of Available For Sale Securities [Line Items] | |
Under 1 Year, Fair Value | 3,956,401 |
Under 1 Year, Gross Unrealized Losses | (635) |
Total, Fair Value | 3,956,401 |
Total, Gross Unrealized Losses | $ (635) |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Abstract] | ||
Furniture & fixtures | $ 1,089,371 | $ 791,973 |
Leasehold improvements | 1,987,997 | 1,930,300 |
Equipment used in manufacturing | 2,305,340 | 2,297,797 |
Equipment used in research & development | 2,134,019 | 1,456,954 |
Equipment used in the field | 182,762 | 125,253 |
Software | 374,812 | 373,683 |
Construction in progress | 19,246 | |
Total property and equipment, gross | 8,074,301 | 6,995,206 |
Less: accumulated depreciation and amortization | (5,834,168) | (4,621,416) |
Property and equipment, net | $ 2,240,133 | $ 2,373,790 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation and leasehold improvement amortization expense | $ 1,259,015 | $ 1,468,121 |
Accrued Liabilities - Summary o
Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued employee bonuses | $ 900,740 | $ 2,150,418 |
Payroll and employee benefit accruals | 469,530 | 698,969 |
Accrued professional fees | 43,850 | 60,400 |
Accrued interest | 245,350 | 156,492 |
Other accrued liabilities | 210,826 | 292,186 |
Total accrued liabilities | $ 1,870,296 | $ 3,358,465 |
Debt Obligations - Additional I
Debt Obligations - Additional Information (Details) | Mar. 26, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($)$ / sharesshares | Oct. 31, 2017USD ($)$ / shares | Mar. 31, 2016USD ($) | Aug. 31, 2014USD ($)Institution | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2016Institution | Jul. 11, 2018USD ($) |
Debt Instrument [Line Items] | |||||||||
Repayment of outstanding principal and interest | $ 4,276,988 | ||||||||
Loss on extinguishment of Growth Term Loan | 105,064 | ||||||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||||||
MidCap Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, amortization expense | 166,904 | 121,611 | |||||||
Credit facility aggregate principal amount | $ 20,000,000 | ||||||||
Line of credit facility second anniversary early termination fee percentage | 2.00% | ||||||||
Line of credit facility third anniversary early termination fee percentage | 1.00% | ||||||||
Origination fee | $ 100,000 | ||||||||
Extend the interest-only payments | 11 months | ||||||||
Line of credit facility termination fee | 4.50% | ||||||||
Amount required to deposit in escrow account | $ 3,300,000 | ||||||||
Escrow deposit | $ 3,300,000 | ||||||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||||||
Credit Facility increase in interest on obligation percentage | 3.00% | ||||||||
Fair value of warrants | $ 74,000 | ||||||||
Unamortized debt discount | 443,455 | 610,359 | |||||||
MidCap Credit Facility | Beginning April 1, 2020 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Line of credit facility, expiration period | 36 months | ||||||||
MidCap Credit Facility | Beginning March 1, 2021 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Line of credit facility, expiration period | 25 months | ||||||||
Line of credit facility, expiration Date | Mar. 1, 2023 | ||||||||
MidCap Credit Facility | MidCap Tranche 1 | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility aggregate principal amount | $ 7,000,000 | $ 7,000,000 | |||||||
Line of credit facility interest rate | 7.25% | ||||||||
Credit facility, basis spread on variable rate | 1.25% | ||||||||
Credit facility, basis spread on variable rate description | one-month LIBOR | ||||||||
Line of credit facility interest rate at the end of the period | 8.90% | ||||||||
Warrants to purchase of common stock expiration year | 10 years | 10 years | |||||||
Warrants to purchase common stock, shares | shares | 18,123 | 18,123 | |||||||
Warrants exercise price | $ / shares | $ 7.73 | $ 7.73 | |||||||
MidCap Credit Facility | MidCap Tranche 2 | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility aggregate principal amount | $ 13,000,000 | ||||||||
Revolving Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility aggregate principal amount | $ 2,000,000 | ||||||||
Line of credit facility interest rate | 4.25% | ||||||||
Credit facility, basis spread on variable rate | 1.25% | ||||||||
Credit facility, basis spread on variable rate description | one-month LIBOR | ||||||||
Line of credit facility second anniversary early termination fee percentage | 2.00% | ||||||||
Line of credit facility third anniversary early termination fee percentage | 1.00% | ||||||||
Credit facility outstanding amount | 0 | 0 | |||||||
Credit facility origination fee percentage | 0.50% | ||||||||
Credit facility, unused line fee percentage | 0.50% | ||||||||
Credit facility collateral management fee percentage | 0.50% | ||||||||
Credit facility minimum drawn balance percentage | 20.00% | ||||||||
Revolving loan cost | 50,970 | 67,068 | |||||||
Amortization of deferred financing costs | 16,098 | 12,352 | |||||||
Revolving Credit Facility | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility additional borrowing capacity | $ 8,000,000 | ||||||||
Growth Term Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of loan lending institutions | Institution | 2 | 2 | |||||||
prepayment fee Percentage | 1.00% | ||||||||
Debt instrument, amortization expense | 0 | 62,951 | |||||||
Repayment of outstanding principal and interest | $ 4,300,000 | ||||||||
Loss on extinguishment of Growth Term Loan | 105,064 | ||||||||
Unamortized discounts | 67,272 | ||||||||
Growth Term Loan A | |||||||||
Debt Instrument [Line Items] | |||||||||
Term loan payable | $ 11,000,000 | ||||||||
Debt instrument, fixed rate | 8.50% | ||||||||
Debt instrument, maturity date | Sep. 30, 2018 | ||||||||
Growth Term Loan B | |||||||||
Debt Instrument [Line Items] | |||||||||
Term loan payable | $ 5,000,000 | ||||||||
Debt instrument, fixed rate | 8.75% | ||||||||
Debt instrument, maturity date | Sep. 30, 2018 | ||||||||
Convertible Promissory Note | QIAGEN North American Holdings, Inc. | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, fixed rate | 3.00% | ||||||||
Debt instrument, maturity date | Oct. 26, 2020 | ||||||||
Amortization of deferred financing costs | 13,454 | 13,453 | |||||||
Cash proceeds from issuance of subordinated notes | $ 3,000,000 | ||||||||
Debt Instrument Convertible Conversion Price1 | $ / shares | $ 3.984 | ||||||||
Debt Issuance Costs, Current, Net | 12,333 | ||||||||
Debt Issuance Costs, Noncurrent, Net | 25,787 | ||||||||
Interest accrued on Convertible Note | $ 188,630 | $ 98,630 |
Debt Obligations - Schedule of
Debt Obligations - Schedule of Remaining Principal Repayments due Under MidCap Term Loan (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Total MidCap Term Loan, net | $ 6,871,545 | $ 6,704,641 |
MidCap Credit Facility | ||
Debt Instrument [Line Items] | ||
2021 | 2,800,000 | |
2022 | 3,360,000 | |
2023 | 840,000 | |
Total MidCap Term Loan payments | 7,000,000 | |
Less discount and deferred financing costs | (443,455) | $ (610,359) |
Plus final fee premium | 315,000 | |
Total MidCap Term Loan, net | $ 6,871,545 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Product and Product-Related Service Revenue from Sale of Instruments and Consumables (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | $ 19,203,888 | $ 21,503,894 |
Product and Product-related Services | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 14,632,204 | 9,121,390 |
HTG EdgeSeq | Instruments | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 1,436,730 | 351,885 |
HTG EdgeSeq | Consumables | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 3,010,094 | 1,964,499 |
HTG EdgeSeq | Product revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 4,446,824 | 2,316,384 |
HTG EdgeSeq | Custom RUO assay design | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 4,498,088 | 964,241 |
HTG EdgeSeq | RUO Sample processing | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 5,687,292 | 5,840,765 |
HTG EdgeSeq | Product-related services revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | 10,185,380 | 6,805,006 |
HTG EdgeSeq | Product and Product-related Services | ||
Disaggregation Of Revenue [Line Items] | ||
Product and product-related services revenue | $ 14,632,204 | $ 9,121,390 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation Of Revenue [Line Items] | |||
Agreements for product and product-related services revenue, description | The Company’s agreements for product and product-related services revenue have an expected duration of one year or less | ||
Service revenue | $ 19,203,888 | $ 21,503,894 | |
Profit sharing payments | 8,911,372 | 5,090,475 | |
Research and development | 10,570,225 | 12,598,034 | |
Accounts receivable | 3,164,176 | 5,012,678 | |
Contract liabilities | 599,454 | 410,947 | $ 837,885 |
Collaborative Development Services | |||
Disaggregation Of Revenue [Line Items] | |||
Service revenue | 4,571,684 | 12,382,504 | |
Contract liabilities | $ 110,317 | ||
SOW One | |||
Disaggregation Of Revenue [Line Items] | |||
Service revenue | 0 | 2,397,136 | |
Profit sharing payments | 99,394 | ||
Research and development | 0 | 1,716,115 | |
Accounts receivable | 0 | 0 | |
SOW Two | |||
Disaggregation Of Revenue [Line Items] | |||
Research and development | 1,849,088 | 3,625,332 | |
Accounts receivable | 171,298 | 1,007,950 | |
SOW Two | Collaborative Development Services | |||
Disaggregation Of Revenue [Line Items] | |||
Service revenue | 2,685,634 | 5,988,021 | |
Profit sharing payments | 657,000 | 1,779,827 | |
SOW Three | |||
Disaggregation Of Revenue [Line Items] | |||
Research and development | 983,603 | 2,667,030 | |
Accounts receivable | 760,274 | 363,869 | |
SOW Three | Collaborative Development Services | |||
Disaggregation Of Revenue [Line Items] | |||
Service revenue | 1,886,050 | 3,997,346 | |
Profit sharing payments | $ 720,270 | $ 355,631 | |
QIAGEN Manchester Limited | |||
Disaggregation Of Revenue [Line Items] | |||
Agreement commencement period | 2016-11 | ||
Minimum | |||
Disaggregation Of Revenue [Line Items] | |||
Customer payment term | 30 days | ||
Maximum | |||
Disaggregation Of Revenue [Line Items] | |||
Customer payment term | 90 days | ||
Maximum | QIAGEN Manchester Limited | |||
Disaggregation Of Revenue [Line Items] | |||
Term of agreement | 1 year |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information1 (Details) | Dec. 31, 2019 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2020-01-01 | |
Disaggregation Of Revenue [Line Items] | |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Collaborative Development Services (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Service revenue | $ 19,203,888 | $ 21,503,894 |
Collaborative Development Services | ||
Disaggregation Of Revenue [Line Items] | ||
Service revenue | $ 4,571,684 | $ 12,382,504 |
Revenue from Contracts with C_7
Revenue from Contracts with Customers - Schedule of Changes in Contract Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | $ 410,947 | $ 837,885 |
Deferral of revenue | 1,720,982 | 907,742 |
Customer deposits | 131,864 | |
Recognition of deferred revenue | (1,532,475) | (1,466,544) |
Ending Balance | 599,454 | 410,947 |
Product Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 116,547 | 39,426 |
Deferral of revenue | 218,802 | 190,703 |
Customer deposits | 131,864 | |
Recognition of deferred revenue | (240,201) | (245,446) |
Ending Balance | 95,148 | 116,547 |
Custom RUO Assay Design | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 50,000 | 197,606 |
Deferral of revenue | 972,267 | 448,580 |
Recognition of deferred revenue | (956,051) | (596,186) |
Ending Balance | 66,216 | 50,000 |
Sample Processing | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 244,400 | 490,536 |
Deferral of revenue | 529,913 | 197,541 |
Recognition of deferred revenue | (336,223) | (443,677) |
Ending Balance | $ 438,090 | 244,400 |
Collaborative Development Services | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 110,317 | |
Deferral of revenue | 70,918 | |
Recognition of deferred revenue | $ (181,235) |
Other Agreements - Additional I
Other Agreements - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) | |
Other Agreements [Line Items] | ||
Upfront consideration paid in exchange of common stock | shares | 5,587 | |
Asset purchase agreement fixed payments paid for first two years | $ 740,000 | |
Asset purchase agreement aggregate cash compensation paid | 15,000,000 | |
Accretion expense | (13,821) | $ (12,480) |
Research and development | $ 10,570,225 | 12,598,034 |
Agreement expiration date | May 31, 2027 | |
Description on termination of agreement | The Company may terminate the Restated Agreement at any time upon 90 days’ written notice and may terminate any development plan under the Restated Agreement upon 30 days’ prior written notice. Illumina may terminate the Restated Agreement upon 30 days’ prior written notice if the Company undergoes certain changes of control, subject to a transition period of up to 12 months for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other party’s material breach of the Restated Agreement that remains uncured for 30 days, or upon the other party’s bankruptcy. | |
Illumina, Inc. Agreement | ||
Other Agreements [Line Items] | ||
Aggregate payment upon achievement of specified regulatory milestones | $ 600,000 | |
Research and development | $ 0 | 12,500 |
Agreement termination notice period | 90 days | |
Development plan agreement termination notice period | 30 days | |
Number of days material breach remains uncured | 30 days | |
Measurement Input, Default Rate [Member] | ||
Other Agreements [Line Items] | ||
Discount rate used to calculate asset purchase obligation | 2.5 | |
NuvoGen Asset Purchase Agreement | ||
Other Agreements [Line Items] | ||
Percentage on annual revenues for cash consideration to be paid | 6.00% | |
Asset purchase agreement yearly fixed fees paid | $ 400,000 | 400,000 |
Accrued revenue-based payments | 927,922 | 612,122 |
Additional revenue based payments payable | $ 187,997 | 363,686 |
Percentage of compounded annual interest on unpaid Obligation | 2.50% | |
NuvoGen | ||
Other Agreements [Line Items] | ||
Convertible notes and related debt discount | $ (92,311) | (106,132) |
Accretion expense | $ (13,821) | $ (12,480) |
Other Agreements - Schedule of
Other Agreements - Schedule of Remaining Minimum Principal Payments Due (Details) - NuvoGen Asset Purchase Agreement | Dec. 31, 2019USD ($) |
Purchase Obligation Fiscal Year Maturity [Line Items] | |
2020 | $ 1,152,233 |
2021 | 400,000 |
2022 | 400,000 |
2023 | 400,000 |
2024 | 400,000 |
2025 and beyond | 2,806,466 |
Total NuvoGen obligation payments | 5,558,699 |
Plus interest accretion | 92,311 |
Total NuvoGen obligation, net | $ 5,651,010 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Lessee Lease Description [Line Items] | ||
Lease expiration year | 2023 | |
Operating lease, description | The Company’s most significant active leases as of December 31, 2019 are for office and manufacturing space in Tucson, Arizona | |
Operating leases, rent expense | $ 583,182 | |
Financing lease liabilities, net of discount | $ 111,808 | |
Financing lease liabilities, current | $ 41,134 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Financing lease liabilities, non current | $ 70,674 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |
Financing leases, right-of-use assets | $ 108,253 | |
Tucson, Arizona | ||
Lessee Lease Description [Line Items] | ||
Lease expiration year | 2021 | |
San Carlos, California | ||
Lessee Lease Description [Line Items] | ||
Lease expiration year | 2023 |
Leases - Summary of Components
Leases - Summary of Components of Lease Cost for Operating Leases (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 618,463 |
Variable lease cost | 131,387 |
Operating lease expense | 749,850 |
Short-term lease rent expense | 1,497 |
Total rent expense | $ 751,347 |
Leases - Summary of Other Infor
Leases - Summary of Other Information Related to Operating Leases (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating cash flows for operating leases | $ 770,658 |
Establishment of operating lease liabilities arising from obtaining right-of-use assets | $ 2,038,193 |
Weighted-average remaining lease term – operating leases | 2 years 3 months 18 days |
Weighted-average discount rate – operating leases | 9.60% |
Leases - Summary of Remaining M
Leases - Summary of Remaining Maturities of Operating Leases, Excluding Short-term Leases (Details) | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 881,300 |
2021 | 352,243 |
2022 | 281,232 |
2023 | 70,848 |
Total | 1,585,623 |
Less present value discount | (190,351) |
Operating lease liabilities, net | $ 1,395,272 |
Leases - Summary of Lease Commi
Leases - Summary of Lease Commitments (Details) | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 525,745 |
2020 | 528,225 |
2021 | 53,907 |
2022 | 10,768 |
2023 | 10,768 |
2024 and beyond | 43,073 |
Total minimum lease payments | $ 1,172,486 |
Leases - Summary of Component_2
Leases - Summary of Components of Lease Cost for Financing Leases (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases [Abstract] | |
Amortization of right-of-use assets | $ 46,255 |
Interest on lease liability | 6,859 |
Total financing lease cost | $ 53,114 |
Leases - Summary of Other Inf_2
Leases - Summary of Other Information Related to Financing Leases (Details) | Dec. 31, 2019 |
Leases [Abstract] | |
Weighted-average remaining lease term – financing leases | 3 years 8 months 12 days |
Weighted-average discount rate – financing leases | 9.77% |
Leases - Summary of Remaining_2
Leases - Summary of Remaining Maturities of Financing Leases (Details) | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 50,072 |
2021 | 28,355 |
2022 | 20,716 |
2023 | 18,396 |
2024 | 16,080 |
Total | 133,619 |
Less present value discount | (21,811) |
Financing lease liabilities, net | $ 111,808 |
Net Loss per Share - Reconcilia
Net Loss per Share - Reconciliation of Numerator and Denominator Used in Computing Basic and Diluted Net Loss per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | ||
Net loss | $ (19,297,664) | $ (16,453,918) |
Denominator: | ||
Weighted-average shares outstanding-basic and diluted | 38,099,687 | 27,523,463 |
Net loss per share, basic and diluted | $ (0.51) | $ (0.60) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - $ / shares | Dec. 31, 2019 | Sep. 30, 2019 |
Pre-funded Warrants | ||
Class Of Warrant Or Right [Line Items] | ||
Exercise price of warrants | $ 0.01 | |
Private Placement | Institutional Accredited Investors | ||
Class Of Warrant Or Right [Line Items] | ||
Exercise price of warrants | $ 0.65 | $ 0.65 |
Private Placement | Institutional Accredited Investors | Pre-funded Warrants | ||
Class Of Warrant Or Right [Line Items] | ||
Issuance of warrants, shares | 5,411,687 | 5,411,687 |
Number of securities called by warrants | 5,411,687 | 5,411,687 |
Exercise price of warrants | $ 0.64 | $ 0.64 |
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ 0.01 | $ 0.01 |
Net Loss per Share - Outstandin
Net Loss per Share - Outstanding Options, Warrants, Restricted Stock Units and Debt Conversion Option Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 2,904,898 | 2,047,237 |
Restricted Stock Units R S U | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 223,745 | 227,707 |
Warrants | Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 236,915 | 237,846 |
QNAH convertible note | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 800,359 | 777,769 |
Warrants - Additional Informati
Warrants - Additional Information (Details) | Mar. 26, 2018USD ($)$ / sharesshares | Jan. 15, 2015USD ($)$ / sharesshares | Mar. 31, 2018USD ($)$ / sharesshares | Aug. 31, 2014Institution | Dec. 31, 2019$ / sharesshares | Dec. 31, 2016Institution | Sep. 30, 2019$ / sharesshares | Mar. 31, 2016$ / sharesshares | May 11, 2015$ / sharesshares | Aug. 22, 2014$ / sharesshares |
MidCap Credit Facility | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Credit facility aggregate principal amount | $ | $ 20,000,000 | |||||||||
MidCap Credit Facility | MidCap Tranche 1 | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 18,123 | 18,123 | ||||||||
Exercise price of warrants | $ 7.73 | $ 7.73 | ||||||||
Warrants to purchase of common stock expiration year | 10 years | 10 years | ||||||||
Credit facility aggregate principal amount | $ | $ 7,000,000 | $ 7,000,000 | ||||||||
Private Placement | Institutional Accredited Investors | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Exercise price of warrants | $ 0.65 | $ 0.65 | ||||||||
Growth Term Loan | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of loan lending institutions | Institution | 2 | 2 | ||||||||
Series E Redeemable Convertible Preferred Stock | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 5,317 | 23,396 | 2,512,562 | |||||||
Exercise price of warrants | $ 23.51 | $ 23.51 | $ 23.51 | $ 0.2189 | ||||||
Warrants expiration date | Aug. 22, 2024 | |||||||||
Common Stock Warrants one | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 45,307 | |||||||||
Exercise price of warrants | $ 2.759 | |||||||||
Convertible Note Warrants | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 9,311,586 | |||||||||
Exercise price of warrants | $ 0.2189 | $ 14 | ||||||||
Warrants expiration date | Jan. 15, 2022 | |||||||||
Aggregate consideration | $ | $ 1,354 | |||||||||
Convertible Note Warrants | IPO | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 144,772 | |||||||||
Exercise price of warrants | $ 14 | |||||||||
Pre-funded Warrants | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Exercise price of warrants | $ 0.01 | |||||||||
Pre-funded Warrants | Private Placement | Institutional Accredited Investors | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Number of securities called by warrants | shares | 5,411,687 | 5,411,687 | ||||||||
Exercise price of warrants | $ 0.64 | $ 0.64 | ||||||||
Issuance of warrants, shares | shares | 5,411,687 | 5,411,687 | ||||||||
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ 0.01 | $ 0.01 |
Warrants -Summary of Outstandin
Warrants -Summary of Outstanding Warrants (Details) - $ / shares | 12 Months Ended | ||||
Dec. 31, 2019 | Mar. 31, 2016 | May 11, 2015 | Jan. 15, 2015 | Aug. 22, 2014 | |
Convertible Note Warrants | |||||
Class Of Warrant Or Right [Line Items] | |||||
Warrant Issuance Date | 2014-12 | ||||
Shares of Common Stock Underlying Warrants | 144,772 | ||||
Exercise Price/Share | $ 14 | $ 0.2189 | |||
Expiration Date | 2022 | ||||
Common Stock Warrants | |||||
Class Of Warrant Or Right [Line Items] | |||||
Warrant Issuance Date | 2016-03 | ||||
Shares of Common Stock Underlying Warrants | 45,307 | ||||
Exercise Price/Share | $ 2.76 | ||||
Expiration Date | 2026 | ||||
Common Stock Tranche one | |||||
Class Of Warrant Or Right [Line Items] | |||||
Warrant Issuance Date | 2018-03 | ||||
Shares of Common Stock Underlying Warrants | 18,123 | ||||
Exercise Price/Share | $ 7.73 | ||||
Expiration Date | 2028 | ||||
Pre-funded Warrants | |||||
Class Of Warrant Or Right [Line Items] | |||||
Warrant Issuance Date | 2019-09 | ||||
Shares of Common Stock Underlying Warrants | 5,411,687 | ||||
Exercise Price/Share | $ 0.01 | ||||
Series E Redeemable Convertible Preferred Stock | |||||
Class Of Warrant Or Right [Line Items] | |||||
Warrant Issuance Date | 2014-08 | ||||
Shares of Common Stock Underlying Warrants | 28,713 | ||||
Exercise Price/Share | $ 23.51 | $ 23.51 | $ 23.51 | $ 0.2189 | |
Expiration Date | 2024 |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Details) - USD ($) | Jan. 01, 2020 | Nov. 30, 2019 | Jun. 30, 2017 | Apr. 30, 2017 | Sep. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jan. 31, 2018 | Feb. 28, 2014 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2015 | May 31, 2019 | Dec. 31, 2017 | May 31, 2015 |
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 5,733,314 | |||||||||||||||
Gross proceeds from issuance of common stock | $ 21,100,000 | |||||||||||||||
Sales commission | 600,000 | |||||||||||||||
Other offering expenses paid | 200,000 | |||||||||||||||
Net proceeds from issuance of common stock | $ 20,200,000 | |||||||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||||||||||
Common stock, voting rights | Each share of common stock is entitled to one vote. | |||||||||||||||
Common stock, conversion features | The shares of common stock have no preemptive or conversion rights, no redemption or sinking fund provisions, no liability for further call or assessment, and are not entitled to cumulative voting rights. | |||||||||||||||
Preferred stock, shares authorized | 10,000,000 | |||||||||||||||
Preferred stock, par value | $ 0.001 | |||||||||||||||
Weighted-average fair value of stock options granted | $ 0.97 | $ 2.29 | ||||||||||||||
Accelerated vesting of stock options | 46,613 | |||||||||||||||
Options extended exercise period | 1 year | |||||||||||||||
Incremental stock-based compensation expense | $ 79,400 | |||||||||||||||
Maximum aggregate number of common stock available purchase under employee stock purchase plan | 250,000 | |||||||||||||||
Maximum number of shares that may be purchased by eligible participants under employee stock purchase plan | 7,500 | |||||||||||||||
Stock issued under employee stock purchase plans | 7,500 | 2,304 | ||||||||||||||
2014 Equity Incentive Plan | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Shares reserved for issuance | 200,000 | 940,112 | ||||||||||||||
Number of shares available for issuance | 0 | 120,000 | ||||||||||||||
Options granted in term | 10 years | |||||||||||||||
2014 Equity Incentive Plan | Subsequent Event | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of additional shares registered for issuance | 2,323,609 | |||||||||||||||
Stock-based Compensation | 2011 Equity Incentive Plan | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Percentage of increase on outstanding shares | 20.00% | |||||||||||||||
Stock option granted | 0 | |||||||||||||||
Employee Stock Option | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Stock option granted | 1,270,000 | 802,500 | ||||||||||||||
Unrecognized compensation expense | $ 1,833,329 | |||||||||||||||
Compensation expense period expected to be recognized | 2 years 3 months 21 days | |||||||||||||||
Options to purchase common stock outstanding | 2,904,898 | 2,047,237 | 1,517,771 | |||||||||||||
Employee Stock Option | 2011 Equity Incentive Plan | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Shares reserved for issuance | 14,006 | |||||||||||||||
Employee Stock Option | Inducement Awards | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Stock option granted | 80,000 | 0 | ||||||||||||||
Restricted Stock Units R S U | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Unrecognized compensation expense | $ 555,439 | |||||||||||||||
Compensation expense period expected to be recognized | 2 years 3 months 3 days | |||||||||||||||
Weighted-average fair value of RSUs granted | $ 1.93 | $ 3.63 | ||||||||||||||
Vested and unissued RSU awards, description | Vested and unissued awards at December 31, 2018 represents RSU awards granted on August 16, 2018 for which the second vesting date was December 31, 2018, but for which issuance of awards occurred on the next business day, January 2, 2019. | |||||||||||||||
Vested and unissued RSU awards granted date | Aug. 16, 2018 | |||||||||||||||
Vested and unissued RSU awards vesting date | Dec. 31, 2019 | |||||||||||||||
Vested and unissued RSU awards issuance date | Jan. 2, 2020 | |||||||||||||||
Restricted Stock Units R S U | Share-based Payment Arrangement, Tranche One | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Vested and unissued RSU awards granted date | Jan. 21, 2019 | |||||||||||||||
Restricted Stock Units R S U | Share-based Payment Arrangement, Tranche Two | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Vested and unissued RSU awards granted date | Sep. 12, 2019 | |||||||||||||||
Maximum | 2014 Equity Incentive Plan | Board Of Directors | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Options exercise period | 4 years | |||||||||||||||
Minimum | 2014 Equity Incentive Plan | Board Of Directors | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Options exercise period | 1 year | |||||||||||||||
Pre-funded Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Exercise price of warrants | $ 0.01 | |||||||||||||||
Underwritten Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock price per share | $ 0.65 | $ 2.90 | ||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 29,298,537 | 13,915,000 | ||||||||||||||
Net proceeds from initial public offering after underwriters' discounts, commissions and offering expenses | $ 17,700,000 | $ 37,700,000 | ||||||||||||||
Over-Allotment Option | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock price per share | $ 0.611 | |||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 3,821,548 | 1,815,000 | ||||||||||||||
Cowen ATM Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock aggregate offering price | $ 40,000,000 | |||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 0 | 0 | ||||||||||||||
Deferred offering costs | $ 200,000 | $ 60,000 | ||||||||||||||
Sales agreement termination, month and year | 2019-11 | |||||||||||||||
Deferred offering costs written off | $ 100,000 | |||||||||||||||
Private Placement | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Resale of warrants, registration statement to file, period following date of closing | 30 days | |||||||||||||||
Warrants to obtain effectiveness of registration statement period following closing date | 90 days | |||||||||||||||
Private Placement | Institutional Accredited Investors | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Exercise price of warrants | $ 0.65 | $ 0.65 | ||||||||||||||
Private Placement | Institutional Accredited Investors | Pre-funded Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of warrants, shares | 5,411,687 | 5,411,687 | ||||||||||||||
Number of securities called by warrants | 5,411,687 | 5,411,687 | ||||||||||||||
Exercise price of warrants | $ 0.64 | $ 0.64 | ||||||||||||||
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ 0.01 | $ 0.01 | ||||||||||||||
Private Placement | Cantor Fitzgerald & Co. | Pre-funded Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Agent cash fee, percentage of gross proceeds from sale of warrants | 6.00% | |||||||||||||||
Net proceeds from sale of warrants | $ 3,100,000 | |||||||||||||||
2014 Employee Stock Purchase Plan | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Percentage of increase on outstanding shares | 1.00% | |||||||||||||||
Shares reserved for issuance | 273,111 | |||||||||||||||
Vested and unissued RSU awards, description | The number of shares of common stock reserved for issuance automatically increases on January 1 of each calendar year, from January 1, 2016 to January 1, 2024 by the least of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 195,000 shares, or (iii) a number determined by the Company’s board of directors that is less than (i) and (ii). | |||||||||||||||
Maximum aggregate number of common stock available purchase under employee stock purchase plan | 110,820 | |||||||||||||||
Common stock issuance offering date | Jan. 1, 2016 | |||||||||||||||
Common stock issuance expiration date | Jan. 1, 2024 | |||||||||||||||
Options to purchase common stock outstanding | 195,000 | |||||||||||||||
Maximum contribution eligible compensation during a period to purchase common stock | 15.00% | |||||||||||||||
Fair market value of company common stock, shares offering price | 85.00% | |||||||||||||||
Fair market value of company common stock, shares purchase price | 85.00% | |||||||||||||||
2014 Employee Stock Purchase Plan | Subsequent Event | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of additional shares registered for issuance | 195,000 | |||||||||||||||
Employee Stock Purchase Plan | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Net proceeds from issuance of common stock | $ 17,250 | $ 9,997 | ||||||||||||||
Number of shares available for issuance | 174,871 | |||||||||||||||
Common Stock | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 300,000 | |||||||||||||||
Gross proceeds from issuance of common stock | $ 600,000 | |||||||||||||||
Stock issued under employee stock purchase plans | 87,456 | 82,261 | ||||||||||||||
Sales Agreement | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock price per share | $ 0.001 | |||||||||||||||
Common stock aggregate offering price | $ 40,000,000 | $ 20,000,000 | $ 23,000,000 | |||||||||||||
Cantor Sales Agreement | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock price per share | $ 0.001 | |||||||||||||||
Issuance of common stock from the ATM Offering, Shares | 0 | |||||||||||||||
Deferred offering costs | $ 81,000 | |||||||||||||||
Reduction of commissions earned on sold shares | 45,000 | |||||||||||||||
Cantor Sales Agreement | Maximum | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock aggregate offering price | $ 20,000,000 | |||||||||||||||
Percentage of commission aggregate gross proceeds from each sale of shares | 3.00% |
Stockholders Equity - Summary o
Stockholders Equity - Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 1,156,567 | $ 1,888,055 |
2014 Employee Stock Purchase Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 66,238 | 58,959 |
Selling, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 859,653 | 1,668,227 |
Selling, General and Administrative | 2014 Employee Stock Purchase Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 43,615 | 41,716 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 243,804 | 159,450 |
Research and Development | 2014 Employee Stock Purchase Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 18,454 | 12,556 |
Cost of Product and Product-related Services Revenue | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 53,110 | 60,378 |
Cost of Product and Product-related Services Revenue | 2014 Employee Stock Purchase Plan | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 4,169 | $ 4,687 |
Stockholders Equity - Summary_2
Stockholders Equity - Summary of Stock Option Plans Activity (Details) - Employee Stock Option - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 2,047,237 | 1,517,771 | |
Number of Shares, Granted | 1,270,000 | 802,500 | |
Number of Shares, Exercised | (54,256) | (144,645) | |
Number of Shares, Forfeited | (161,571) | (66,428) | |
Number of Shares, Expired/Cancelled | (196,512) | (61,961) | |
Number of Shares, Ending Balance | 2,904,898 | 2,047,237 | 1,517,771 |
Number of Shares, Vested and expected to vest | 2,904,898 | ||
Number of Shares, Exercisable | 1,380,865 | 1,256,352 | |
Weighted-Average Exercise Price Per Share, Beginning Balance | $ 3.07 | $ 2.97 | |
Weighted-Average Exercise Price Per Share, Granted | 1.48 | 3.39 | |
Weighted-Average Exercise Price Per Share, Exercised | 2.23 | 2.19 | |
Weighted-Average Exercise Price Per Share, Forfeited | 3.29 | 3.24 | |
Weighted-Average Exercise Price Per Share, Expired/Cancelled | 3.23 | 6.52 | |
Weighted-Average Exercise Price Per Share, Ending Balance | 2.37 | 3.07 | $ 2.97 |
Weighted-Average Exercise Price Per Share, Vested and expected to vest | 2.37 | ||
Weighted-Average Exercise Price Per Share, Exercisable | $ 2.84 | $ 2.91 | |
Weighted-Average Remaining Contractual Life, Outstanding | 8 years | 7 years 7 months 6 days | 7 years 6 months |
Weighted-Average Remaining Contractual Life, Vested and expected to vest | 8 years | ||
Weighted-Average Remaining Contractual Life, Exercisable | 6 years 7 months 6 days | 6 years 6 months | |
Aggregate Intrinsic Value, Balance | $ 781 | $ 366,007 | $ 67,242 |
Aggregate Intrinsic Value, Exercised | 21,380 | 243,531 | |
Aggregate Intrinsic Value, Vested and expected to vest | 781 | ||
Aggregate Intrinsic Value, Exercisable | $ 96 | $ 346,595 |
Stockholders Equity - Summary_3
Stockholders Equity - Summary of Material Factors Incorporated in Black-Scholes Model in Estimating Fair Value of Options Granted (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 1.43% | 2.59% |
Risk-free interest rate, maximum | 2.21% | 2.82% |
Expected volatility, minimum | 63.90% | 79.50% |
Expected volatility, maximum | 97.10% | 85.80% |
Expected dividend yield | 0.00% | 0.00% |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 1.88% | 1.88% |
Risk-free interest rate, maximum | 2.37% | 2.07% |
Expected volatility, minimum | 79.50% | 83.20% |
Expected volatility, maximum | 85.80% | 85.80% |
Expected term | 6 months | 6 months |
Expected dividend yield | 0.00% | 0.00% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term | 5 years 6 months | 5 years 3 months 18 days |
Minimum | Common Stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 0.68 | $ 3.26 |
Minimum | Common Stock | Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 1.85 | $ 1.85 |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term | 6 years 1 month 6 days | 5 years 6 months |
Maximum | Common Stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 2.26 | $ 5.06 |
Maximum | Common Stock | Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 4 | $ 4 |
Stockholders Equity - Summary_4
Stockholders Equity - Summary of Material Factors Incorporated in Black-Scholes Model in Estimating Fair Value of Options Granted (Parenthetical) (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Class Of Stock [Line Items] | |
Expected dividend assumed value | $ 0 |
2014 Employee Stock Purchase Plan | |
Class Of Stock [Line Items] | |
Expected dividend assumed value | $ 0 |
Stockholders Equity - Summary_5
Stockholders Equity - Summary of RSU Award Activity (Details) - Restricted Stock Units R S U - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Restricted Stock Units (RSU) | ||
Beginning Balance | 227,707 | 26,666 |
Granted | 77,500 | 492,051 |
Released | (81,462) | (291,010) |
Ending Balance | 223,745 | 227,707 |
Vested and unissued at December 31, 2019 | 15,942 | |
Weighted Average Grant Date Fair Value Per Share | ||
Beginning Balance | $ 3.30 | $ 2.78 |
Granted | 1.93 | 3.63 |
Released | 3.31 | 3.72 |
Ending Balance | 2.91 | $ 3.30 |
Vested and unissued at December 31, 2019 | $ 3.14 |
Stockholders Equity - Summary_6
Stockholders Equity - Summary of Shares Purchased under ESPP'S Six Month Purchase Periods (Details) - $ / shares | 6 Months Ended | |||
Dec. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | |
Class Of Stock [Line Items] | ||||
Number of Shares | 39,967 | 39,989 | 39,981 | 39,976 |
2014 Employee Stock Purchase Plan Group A | ||||
Class Of Stock [Line Items] | ||||
Number of Shares | 27,449 | 29,580 | 35,805 | 39,976 |
Price per Share | $ 0.57 | $ 1.57 | $ 1.57 | $ 1.57 |
2014 Employee Stock Purchase Plan Group B | ||||
Class Of Stock [Line Items] | ||||
Number of Shares | 5,240 | 5,828 | 4,176 | |
Price per Share | $ 0.57 | $ 1.79 | $ 2.81 | |
2014 Employee Stock Purchase Plan Group C | ||||
Class Of Stock [Line Items] | ||||
Number of Shares | 4,804 | 4,581 | ||
Price per Share | $ 0.57 | $ 1.79 | ||
2014 Employee Stock Purchase Plan Group D | ||||
Class Of Stock [Line Items] | ||||
Number of Shares | 2,474 | |||
Price per Share | $ 0.57 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule Of Product Warranty Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Beginning balance | $ 63,461 | $ 37,156 |
Cost of warranty claims | (40,055) | (2,596) |
Increase in warranty reserve | 71,076 | 28,901 |
Ending balance | $ 94,482 | $ 63,461 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Discretionary contributions company may make | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Line Items] | ||
Income tax examination, likelihood of unfavorable settlement | greater than 50 percent | |
Uncertain tax positions | $ 2,731,015 | $ 1,538,220 |
Accrued interest or penalties | 0 | 0 |
Recognized interest or penalties | 0 | 0 |
Valuation allowance | 43,350,682 | 38,740,784 |
Change in valuation reserve | 4,609,898 | |
Gross unrecognized tax benefits | 2,731,015 | $ 1,538,220 |
Unrecognized tax benefits if recognized would impact effective tax rate | 0 | |
Research and Experimental Tax Credits | ||
Income Tax Disclosure [Line Items] | ||
Gross unrecognized tax benefits | 2,731,015 | |
Federal | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforwards | 158,175,977 | |
State | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforwards | 106,182,477 | |
With Expiration | Federal | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforwards | $ 121,776,595 | |
Beginning Expiration Year | Federal | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforward expiration year | 2021 | |
Tax credit carryforward, expiration year | 2021 | |
Beginning Expiration Year | State | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforward expiration year | 2027 | |
Tax credit carryforward, expiration year | 2020 | |
Ending Expiration Year | Federal | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforward expiration year | 2037 | |
Ending Expiration Year | State | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforward expiration year | 2039 | |
Without Expiration | Federal | ||
Income Tax Disclosure [Line Items] | ||
NOL carryforwards | $ 36,399,382 |
Income Taxes - Summary of Loss
Income Taxes - Summary of Loss Before Income taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
U.S. pre-tax loss | $ (19,332,809) | $ (16,406,443) |
Foreign pre-tax gain (loss) | 38,524 | (43,949) |
Net loss before income taxes | $ (19,294,285) | $ (16,450,392) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Current: | ||
State | $ 3,379 | $ 3,526 |
Total current income tax expense | 3,379 | 3,526 |
Total income tax expense | $ 3,379 | $ 3,526 |
Income Taxes - Difference in Ac
Income Taxes - Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Line Items] | ||
Computed tax (benefit) at 21% | $ (4,051,800) | $ (3,454,582) |
State taxes, net of federal benefit | (881,670) | (384,035) |
Stock-based compensation | 183,167 | 82,024 |
Foreign tax rate differential | 4,298 | (3,158) |
Return to provision | 80,668 | (31,111) |
Other | 51,737 | 51,598 |
Uncertain tax position adjustment for prior periods | 650,687 | 1,029,115 |
Increase in valuation allowance | 4,610,490 | 3,731,884 |
Total income tax expense | 3,379 | 3,526 |
State | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credit | (342,320) | (511,845) |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credit | $ (301,878) | $ (506,364) |
Income Taxes - Difference in _2
Income Taxes - Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes (Parenthetical) (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Statutory federal income tax rate | 21.00% | 21.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 38,357,970 | $ 33,431,082 |
Research and development credits | 3,061,981 | 3,076,441 |
Deferred revenue | 154,497 | 86,567 |
Inventory reserve | 10,155 | 9,645 |
Fixed assets and intangibles | 217,332 | 223,767 |
Accrued liability | 86,034 | |
Lease liability | 359,603 | |
Other | 150,134 | 106,913 |
Gross deferred tax assets | 43,768,107 | 38,740,784 |
Valuation allowance | (43,350,682) | (38,740,784) |
Deferred tax assets, net | 417,425 | |
Deferred tax liabilities: | ||
Right of use asset | 311,633 | |
Other | 105,792 | |
Total deferred tax liabilities | 417,425 | |
NuvoGen | ||
Deferred tax assets: | ||
Accrued liability | $ 1,456,435 | $ 1,720,335 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Gross Unrecognized Tax Benefits (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Balance at beginning of year | $ 1,538,220 | |
Increases to prior positions | 650,687 | $ 1,029,115 |
Increases for current year positions | 542,108 | 509,105 |
Balance at end of year | $ 2,731,015 | $ 1,538,220 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | Feb. 26, 2020 | Feb. 25, 2020 | Mar. 15, 2020 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 26, 2018 |
Subsequent Event [Line Items] | |||||||
Issuance of common stock, shares | 5,733,314 | ||||||
Gross proceeds from issuance of common stock | $ 21,100,000 | ||||||
Net proceeds from issuance of common stock | $ 20,200,000 | ||||||
Common stock, shares outstanding | 58,090,233 | 28,585,449 | |||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||||
MidCap Credit Facility | |||||||
Subsequent Event [Line Items] | |||||||
Debt Instrument, Frequency of Periodic Payment | 25 equal monthly installments | ||||||
Debt instrument frequency of periodic payment if revenue milestone achieved | 21 equal monthly installments | ||||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||||
Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Issuance of common stock, shares | 300,000 | ||||||
Gross proceeds from issuance of common stock | $ 600,000 | ||||||
2019 ATM Offering | Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Deferred offering costs | $ 100,000 | ||||||
Subsequent Event | MidCap Credit Facility | |||||||
Subsequent Event [Line Items] | |||||||
Debt instrument interest only payment period | 11 months | ||||||
Debt instrument interest only payment period if revenue milestone achieved | 4 months | ||||||
Repayment of convertible note by previously deposited escrowed funds | $ 3,300,000 | ||||||
Unrestricted cash and cash equivalents | $ 18,000,000 | ||||||
Subsequent Event | Exchange Agreement | |||||||
Subsequent Event [Line Items] | |||||||
Common stock, shares outstanding | 4,110,000 | ||||||
Conversion of convertible preferred stock into common stock | 100 | ||||||
Subsequent Event | Series A Convertible Preferred Stock | Exchange Agreement | |||||||
Subsequent Event [Line Items] | |||||||
Issuance of common stock, shares | 10,170 | ||||||
Preferred stock, shares issued | 41,100 | ||||||
Preferred stock, par value | $ 0.001 | ||||||
Issuance of common stock | $ 600,030 | ||||||
Stock issued, price per share | $ 59 | ||||||
Subsequent Event | 2019 ATM Offering | |||||||
Subsequent Event [Line Items] | |||||||
Gross proceeds from issuance of common stock | $ 2,600,000 | ||||||
Net proceeds from issuance of common stock | $ 2.5 | ||||||
Subsequent Event | 2019 ATM Offering | Common Stock | |||||||
Subsequent Event [Line Items] | |||||||
Issuance of common stock, shares | 4,399,062 |