Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 07, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | BIOC | |
Entity Registrant Name | BIOCEPT INC | |
Entity Central Index Key | 1,044,378 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 4,061,428 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash | $ 8,956,200 | $ 2,146,611 |
Accounts receivable, net | 1,476,454 | 1,193,426 |
Inventories, net | 581,498 | 498,702 |
Prepaid expenses and other current assets | 636,746 | 416,600 |
Total current assets | 11,650,898 | 4,255,339 |
Fixed assets, net | 2,900,994 | 3,123,567 |
Total assets | 14,551,892 | 7,378,906 |
Current liabilities: | ||
Accounts payable | 1,792,541 | 1,269,953 |
Accrued liabilities | 1,953,970 | 1,425,761 |
Supplier financings | 120,802 | 61,226 |
Interest payable | 326,602 | |
Current portion of equipment financings | 571,774 | 408,992 |
Credit facility, net | 1,168,811 | |
Total current liabilities | 4,439,087 | 4,661,345 |
Non-current portion of equipment financings | 1,016,352 | 1,150,063 |
Non-current portion of deferred rent | 158,045 | 271,464 |
Total liabilities | 5,613,484 | 6,082,872 |
Commitments and contingencies (see Note 11) | ||
Shareholders’ equity: | ||
Preferred stock, $0.0001 par value, 5,000,000 authorized; zero and 11,587 shares issued and outstanding at December 31, 2017 and September 30, 2018. | 1 | |
Common stock, $0.0001 par value, 150,000,000 authorized; 1,181,179 issued and outstanding at December 31, 2017; 3,937,226 issued and outstanding at September 30, 2018. | 394 | 3,518 |
Additional paid-in capital | 223,382,018 | 196,542,123 |
Accumulated deficit | (214,444,005) | (195,249,607) |
Total shareholders’ equity | 8,938,408 | 1,296,034 |
Total liabilities and shareholders’ equity | $ 14,551,892 | $ 7,378,906 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 11,587 | 0 |
Preferred stock, shares outstanding | 11,587 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 3,937,226 | 1,181,179 |
Common stock, shares outstanding | 3,937,226 | 1,181,179 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Net revenues | $ 761,591 | $ 1,111,411 | $ 2,390,772 | $ 4,073,437 |
Costs and expenses: | ||||
Cost of revenues | 2,481,916 | 2,487,054 | 7,616,473 | 6,985,213 |
Research and development expenses | 1,089,746 | 856,698 | 3,179,612 | 2,455,947 |
General and administrative expenses | 1,793,720 | 1,834,771 | 5,441,354 | 5,539,432 |
Sales and marketing expenses | 1,404,192 | 1,675,852 | 4,473,908 | 4,701,030 |
Total costs and expenses | 6,769,574 | 6,854,375 | 20,711,347 | 19,681,622 |
Loss from operations | (6,007,983) | (5,742,964) | (18,320,575) | (15,608,185) |
Other income/ (expense): | ||||
Interest expense | (63,764) | (88,269) | (230,677) | (385,172) |
Other income | 23,963 | 12,804 | (6,037) | 51,216 |
Total other income/ (expense): | (39,801) | (75,465) | (236,714) | (333,956) |
Loss before income taxes | (6,047,784) | (5,818,429) | (18,557,289) | (15,942,141) |
Income tax expense | (2,877) | (739) | (5,023) | |
Net loss and comprehensive loss | (6,047,784) | (5,821,306) | (18,558,028) | (15,947,164) |
Deemed dividend related to warrants down round provision | (636,370) | (636,370) | ||
Net loss attributable to common shareholders | $ (6,684,154) | $ (5,821,306) | $ (19,194,398) | $ (15,947,164) |
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||||
Basic | 2,767,440 | 986,865 | 2,322,749 | 860,539 |
Diluted | 2,759,614 | 986,865 | 2,320,111 | 860,539 |
Net loss per common share: | ||||
Basic | $ (2.42) | $ (5.90) | $ (8.26) | $ (18.53) |
Diluted | $ (2.42) | $ (5.90) | $ (8.27) | $ (18.53) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash Flows from Operating Activities | ||
Net loss | $ (18,558,028) | $ (15,947,164) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 580,366 | 394,708 |
Inventory reserve | (92,488) | (22,431) |
Stock-based compensation | 511,929 | 1,232,149 |
Non-cash interest expense related to credit facility and other financing activities | 29,425 | 23,983 |
Increase/(decrease) in cash resulting from changes in: | ||
Accounts receivable, net | (283,028) | (1,004,403) |
Inventory | 9,692 | (203,630) |
Prepaid expenses and other current assets | 277,720 | 431,355 |
Accounts payable | 413,662 | 508,176 |
Accrued liabilities | 497,119 | 671,407 |
Accrued interest | (241,034) | 71,417 |
Deferred rent | (82,329) | (52,143) |
Net cash used in operating activities | (16,936,994) | (13,896,576) |
Cash Flows from Investing Activities: | ||
Purchases of fixed assets | (145,253) | (1,055,549) |
Net cash used in investing activities | (145,253) | (1,055,549) |
Cash Flows from Financing Activities: | ||
Net proceeds from issuance of common stock and warrants | 25,688,205 | 10,583,898 |
Proceeds from exercise of common stock warrants | 0 | 7,498,535 |
Payments on equipment financings | (160,111) | (109,811) |
Payments on supplier and other third-party financings | (438,290) | (314,270) |
Payments on credit facility | (1,197,968) | (1,436,534) |
Net cash provided by financing activities | 23,891,836 | 16,221,818 |
Net increase in Cash | 6,809,589 | 1,269,693 |
Cash at Beginning of Period | 2,146,611 | 4,609,332 |
Cash at End of Period | 8,956,200 | 5,879,025 |
Cash paid during the period for: | ||
Interest | 379,587 | 285,260 |
Income taxes | $ 739 | $ 5,023 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 30, 2018 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Cancelled insurance premiums previously financed through third-parties, remaining principal outstanding balance | $ 31,000 | |||||||||
Financed insurance premium through third party financing | 488,000 | $ 360,000 | ||||||||
Fixed assets purchased under capital lease obligations | 270,000 | 363,000 | ||||||||
Purchases of fixed assets | $ 55,000 | $ 205,000 | $ 31,000 | $ 58,000 | ||||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 1,095,153 | 72,000 | ||||||
Exercise price of unregistered warrants | $ 4.53 | $ 4.53 | $ 75 | |||||||
Unregistered warrants to purchase common stock, period | 5 years | |||||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 2,000,000 | $ 8,400,000 | $ 9,700,000 | $ 2,800,000 | ||||||
Offering fees and costs recorded within common stock issuance costs as an offset to additional paid in capital | $ 300,000 | $ 1,400,000 | $ 1,400,000 | $ 728,000 | ||||||
Public offering, number of common stock and warrants issued | 642,438 | 1,095,153 | ||||||||
Stock price | $ 3.285 | $ 13.50 | ||||||||
Class of warrant or rights, term | 5 years | 5 years | ||||||||
Aggregate units sold under right offering | 11,587 | |||||||||
Aggregate shares sold under right offering | 642,438 | |||||||||
Warrant exercisable for share of common stock | 1 | |||||||||
Gross proceeds from offering | $ 2,500,000 | $ 11,600,000 | ||||||||
Preferred stock converted to shares of common stock | 1,012,622 | 1,012,622 | 1,012,622 | |||||||
Deemed dividend related to warrants down round provision | $ 636,000 | $ 636,370 | $ 636,370 | |||||||
Private Placement [Member] | ||||||||||
Exercise price of unregistered warrants | $ 3.16 | |||||||||
Class of warrant or rights, term | 5 years | |||||||||
Warrant exercisable for share of common stock | 1 | |||||||||
Prefunded Warrants [Member] | ||||||||||
Exercise price of unregistered warrants | $ 3.275 | |||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | |||||||||
Change in exercise price of warrants | $ 0.01 | |||||||||
Warrants [Member] | ||||||||||
Aggregate warrants sold under right offering | 2,549,140 | |||||||||
Series A Preferred Stock [Member] | ||||||||||
Aggregate shares sold under right offering | 11,587 | |||||||||
Shares converted | 4,582 | |||||||||
Maximum [Member] | ||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | |||||||||
Maximum [Member] | Prefunded Warrants [Member] | ||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 |
The Company, Business Activitie
The Company, Business Activities and Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
The Company, Business Activities and Basis of Presentation | 1. The Company, Business Activities and Basis of Presentation The Company and Business Activities The Company was founded in California in May 1997 and effected a reincorporation to Delaware in July 2013. The Company is an early stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or liquid biopsy. The Company’s current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy at diagnosis, progression or for monitoring in order to identify specific resistance mechanisms. Sometimes traditional procedures, such as surgical tissue biopsies, result in tumor tissue that is insufficient and/or unable to provide the molecular subtype information necessary for clinical decisions. The Company’s assays, performed on blood, have the potential to provide more contemporaneous information on the characteristics of a patient’s disease when compared with tissue biopsy and radiographic imaging. Additionally, commencing in October 2017, the Company’s pathology partnership program, branded as Empower TC TM The Company operates a clinical laboratory that is CLIA-certified (under the Clinical Laboratory Improvement Amendment of 1988) and CAP-accredited (by the College of American Pathologists), and manufactures cell enrichment and extraction microfluidic channels, related equipment and certain reagents to perform the Company’s diagnostic assays in a facility located in San Diego, California. CLIA certification and accreditation are required before any clinical laboratory may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, treatment of disease, or assessment of health. The assays the Company offers are classified as laboratory developed tests under the CLIA regulations. Basis of Presentation The accompanying unaudited condensed financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and on the basis that the Company will continue as a going concern (see Note 2). The accompanying unaudited condensed financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. The unaudited condensed financial statements included in this Form 10-Q have been prepared in accordance with the U.S. Securities and Exchange Commission, or SEC, instructions for Quarterly Reports on Form 10-Q. Accordingly, the condensed financial statements are unaudited and do not contain all the information required by GAAP to be included in a full set of financial statements. The balance sheet at December 31, 2017 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for a complete set of financial statements. The audited financial statements for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission, or SEC, with our Annual Report on Form 10-K on March 28, 2018 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year. On July 6, 2018, the Company’s stockholders approved, and the Company filed, an amendment to the Company’s Certificate of Amendment of Certificate of Incorporation to effect a one-for-thirty reverse stock split of the Company’s outstanding common stock. As such, all references to share and per share amounts in these unaudited condensed financial statements and accompanying notes have been retroactively restated to reflect the one-for-thirty reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 shares Certain prior period balances have been reclassified to conform to the current period presentation. Revenue Recognition and Accounts Receivable The Company's commercial revenues are generated from diagnostic services provided to patient’s physicians and billed to third-party insurance payers such as managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or copayments that may be due. Through December 31, 2017, the Company recognized revenue in accordance with the provisions of Accounting Standards Codification, or ASC, 954-605, Health Care Entities—Revenue Recognition, which required that four basic criteria must be met prior to recognition of revenue: (1) persuasive evidence of an arrangement existed; (2) delivery had occurred and title and the risks and rewards of ownership had been transferred to the client or services had been rendered; (3) the price was fixed or determinable; and (4) collectability was reasonably assured. Commencing on March 31, 2017, the Company recognized commercial revenue related to billings for assays delivered and billed to Medicare and other third-party payers on an accrual basis when amounts that will ultimately be realized can be estimated upon delivery, whereby prior to March 31, 2017, the Company recognized revenues for its commercial diagnostic services on a cash basis as collected because the amounts ultimately expected to be received could not be estimated upon delivery due to insufficient collection history experience. Commencing on January 1, 2018, the Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, which requires that an entity recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted the provisions of ASC 606 using the modified retrospective application method applied to all contracts, which did not impact amounts previously reported by the Company, nor did it require a cumulative effect adjustment upon adoption, as the Company’s method of recognizing revenue under ASC 606 was analogous to the method utilized immediately prior to adoption. Accordingly, there is no need for the Company to disclose the amount by which each financial statement line item was affected as a result of applying the new standard and an explanation of significant changes. Contracts For its commercial revenues, while the Company markets directly to physicians, its customer is the patient. Patients do not enter into direct agreements with the Company that commit either them to pay any portion of the cost of the tests if they have not met their annual deductible limit under their insurance policy, if any, or if their insurance otherwise declines to reimburse the Company. Accordingly, the Company establishes a contract with a commercial patient in accordance with other customary business practices, as follows: • Approval of a contract is established via the order and accession, which are submitted by the patient’s physician. • The Company is obligated to perform its diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable payer are obligated to reimburse the Company for services rendered based on the patient’s insurance benefits. • Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with CMS and applicable reimbursement contracts established between the Company and payers, unless the patient is a self-pay patient, whereby the Company bills the patient directly after the services are provided. • On ce the Company delivers a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as the Company is legally able to collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance benefit status. • Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues recorded to the extent that it is probable that a significant reversal will not occur. The Company’s development services revenues are supported by contractual agreements and generated from assay development services provided to entities, as well as certain other diagnostic services provided to physicians, and revenues are recognized upon delivery of the performance obligations in the contract. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service, or a bundle of goods or services, to the customer. For its commercial and development services revenues, the Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the delivery of a patient’s assay result(s) to the ordering physician or entity. The duration of time between accession receipt and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks. Accordingly, the Company elected the practical expedient and therefore, does not disclose the value of unsatisfied performance obligations. Transaction Price The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may include fixed amounts, variable amounts, or both. The Company’s gross commercial revenues billed, and corresponding gross accounts receivable, are subject to estimated deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and corresponding amounts estimated to be subsequently collected and is deemed to be variable although the variability is not explicitly stated in any contract. Rather, the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim denials. The Company estimates the The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is recognized up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a customer, it will account for the change as an increase in the estimate of the transaction price in the period identified as an increase to revenue. Similarly, if the Company subsequently determines that the amount it expects to collect from a customer is less than it originally estimated, it will generally account for the change as a decrease in the estimate of the transaction price as a decrease to revenue, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from changes in transaction prices was not significant during the three and nine months ended September 30, 2018. Allocate Transaction Price For the Company’s commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a customer. For the Company’s development services revenues, the contracted transaction price is allocated to each single performance obligation contained in a contract with a customer as performed. Point-in-time Recognition The Company’s single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is delivered to the patient’s ordering physician or entity. The Company considers this date to be the time at which the patient obtains control of the promised diagnostic assay service. Contract Balances The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in the Company’s condensed balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2017 and 2018, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net revenues from contracted payers* $ 422,136 $ 325,097 $ 1,655,287 $ 1,019,857 Net revenues from non-contracted payers 621,881 373,018 2,206,414 1,211,309 Development services revenues 67,394 63,476 211,736 159,606 Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net commercial revenues recognized upon delivery $ 941,783 $ 698,115 $ 2,703,424 $ 2,231,166 Development services revenues recognized upon delivery 67,394 63,476 211,736 159,606 Commercial revenues recognized upon cash collection 102,234 — 1,158,277 — Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 The amount of nonrecurring net revenue recorded during the three and nine months ended September 30, 2017, had the Company commenced recognizing revenue for commercial diagnostic services upon delivery on or prior to December 31, 2016 instead of on March 31, 2017, was $102,000 and $839,000, respectively, and the corresponding decrease in net loss per common share was $0.10 and $0.97, respectively. The incremental net revenue and decrease in loss from operations as a result of recognizing revenue on an accrual basis commencing on March 31, 2017, or the total amount of net revenue recorded in excess of the amount of commercial cash collections, was $125,000 and $1,158,000 during the three and nine months ended September 30, 2017, respectively, and the corresponding decrease in net loss per common share was $0.13 and $1.35, respectively. For the nine months ended September 30, 2018 all revenues were recognized on an accrual basis. Concentrations of credit risk with respect to revenues are primarily limited to geographies to which the Company provides a significant volume of its services, and to specific third-party payers of the Company’s services such as Medicare, insurance companies, and other third-party payers. The Company’s client base consists of many geographically dispersed clients diversified across various customer types. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2017 and 2018 were as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Medicare and Medicare Advantage 45 % 40 % 41 % 39 % Blue Cross Blue Shield 16 % 9 % 17 % 14 % United Healthcare 14 % 6 % 12 % 15 % The Company's third-party payers that represent more than 10% of total net accounts receivable, and their related net accounts receivable balance as a percentage of total net accounts receivable, at December 31, 2017 and September 30, 2018 were as follows: December 31, 2017 September 30, 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 18 % United Healthcare 15 % 11 % Recent Accounting Pronouncements In May 2014, and as subsequently updated and amended from time to time, the Financial Accounting Standards Board, or FASB, issued authoritative guidance that requires entities to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, and may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of adoption. The Company adopted the new standard for the fiscal year beginning January 1, 2018 using the modified retrospective application method, which did not have a material impact on its financial statements or disclosures. In January 2016, the FASB issued authoritative guidance requiring, among other things, that certain equity investments be measured at fair value with changes in fair value recognized in net income, that financial assets and financial liabilities be presented separately by measurement category and form of financial asset on the balance sheet or the accompanying notes to the financial statements, that the prior requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet be eliminated, and that a reporting organization is to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the organization has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company adopted this guidance for the fiscal year beginning on January 1, 2018, which did not have a material impact on its financial statements or disclosures. In February 2016, the FASB issued authoritative guidance requiring, among other things, that entities recognize the assets and liabilities arising from leases on the balance sheet under revised criteria, while the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria in the previous leases guidance. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. This guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company anticipates that the adoption of this guidance will materially affect its statement of financial position and will require changes to its processes. The Company expects to adopt this guidance for the reporting period beginning on January 1, 2019 and has not yet made a decision on the method of adoption with respect to the optional practical expedients. In August 2016, the FASB issued authoritative guidance clarifying the classification of certain cash receipts and cash payments in the statement of cash flows. This guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, on a retrospective transition method to each period presented. The Company adopted this guidance for the reporting period beginning January 1, 2018, which did not have a material impact on its financial statements or disclosures. In January 2017, the FASB issued authoritative guidance clarifying the definition of a business when evaluating transactions involving acquisitions or disposals of assets or businesses. This guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted this guidance for the reporting period beginning January 1, 2018, which did not have a material impact on its financial statements or disclosures. In July 2017, the FASB issued authoritative guidance changing the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features, whereby a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock, and also clarifying existing disclosure requirements for equity-classified instruments. This guidance is effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company early adopted this guidance for the fiscal year beginning on January 1, 2018, which did not have a material impact on its financial statements or disclosures upon adoption, but did result in equity classification for the warrants issued on January 30, 2018, whereby liability classification may have occurred in the absence of the adoption of this guidance due to the existence of a down round feature associated with the exercise price of the warrants, which would have resulted in material impacts to the Company’s financial statements and disclosures. In August 2017, the FASB issued authoritative guidance that expands and refines hedge accounting for both nonfinancial and financial risk components and align the recognition and presentation of the effects of the hedging instrument and the hedged item in the financial statements. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early application is permitted. The Company currently intends to adopt this guidance for the fiscal year beginning on January 1, 2019 and does not anticipate that the adoption of this guidance will have a material impact on its financial statements or disclosures because the Company does not currently hold any financial instruments accounted for as a hedging activity. In February 2018, the FASB issued authoritative guidance allowing a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from a tax bill, “H.R.1, An Act to Provide for Reconciliation Pursuant to Titles II and V of the Concurrent Resolution on the Budget for Fiscal Year 2018,” or the Tax Cuts and Jobs Act, enacted on December 22, 2017. These amendments eliminate the stranded tax effects resulting from the Tax Cuts and Jobs Act. However, because these amendments only relate to the reclassification of the income tax effects of the Tax Cuts and Jobs Act, the underlying guidance that requires that the effect of a change in tax laws or rates be included in income from continuing operations is not affected. This guidance also requires certain disclosures about stranded tax effects. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The Company currently intends to adopt this guidance for the fiscal year beginning on January 1, 2019 and does not anticipate that the adoption of this guidance will have a material impact on its financial statements or disclosures because the Company does not currently maintain any stranded tax effects in accumulated other comprehensive income. In February 2018, the FASB issued authoritative guidance concerning certain fair value option liabilities, equity securities without a readily determinable fair value, and certain equity investments. This guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years beginning after June 15, 2018. Public entities with fiscal years beginning between December 15, 2017 and June 15, 2018 are not required to adopt these amendments until the interim period beginning after June 15, 2018. The Company adopted this guidance for the interim period beginning on July 1, 2018, which did not have a material impact on its financial statements or disclosures because the Company did not hold any fair value option liabilities, equity securities without a readily determinable fair value, or equity investments. |
Liquidity and Going Concern Unc
Liquidity and Going Concern Uncertainty | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Liquidity and Going Concern Uncertainty | 2. Liquidity and Going Concern Uncertainty As of September 30, 2018, cash totaled $9.0 million and the Company had an accumulated deficit of $214.4 million. While the Company is currently in the commercialization stage of operations, the Company has not yet achieved profitability and anticipates that it will continue to incur net losses for the foreseeable future. Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred stock, proceeds from the exercise of warrants to purchase common stock, proceeds from the issuance of debt, and revenues from laboratory services. The Company’s principal uses of cash have included cash used in operations, payments relating to purchases of property and equipment and repayments of borrowings. The Company expects that the principal uses of cash in the future will be for continuing operations, hiring of sales and marketing personnel and increased sales and marketing activities, funding of research and development, capital expenditures, and general working capital requirements. The Company expects that, as revenues grow, sales and marketing and research and development expenses will continue to grow, albeit at a slower rate and, as a result, the Company will need to generate significant growth in net revenues to achieve and sustain income from operations. On September 20, 2018, the Company completed an offering of 642,438 shares of the Company’s common stock and pre-funded warrants to purchase up to an aggregate of 120,000 shares of its common stock. The shares were sold at a purchase price of $3.285 per share and the pre-funded warrants were sold at a purchase price of $3.275 per pre-funded warrant which represents the per share purchase price for the shares less the $0.01 per share exercise price for each such pre-funded warrant. The net proceeds to the Company from the offering were approximately $2.2 million, after deducting expenses related to the offering including dealer-manager fees and expenses, and excluding any proceeds received upon exercise of any warrants On August 13, 2018, the Company completed a rights offering pursuant to an effective registration statement. Pursuant to the rights offering, the Company sold an aggregate of 11,587 units consisting of an aggregate of 11,587 shares of Series A Preferred Stock and 2,549,140 warrants, with each warrant exercisable for one share of its common stock at an exercise price of $4.53 per share, resulting in net proceeds to the Company of approximately $10.2 million, after deducting expenses relating to the rights offering, including dealer-manager fees and expenses, and excluding any proceeds received upon exercise of any warrants. In May 2018, the SEC declared effective a shelf registration statement filed by the Company, which expires in May 2021. The shelf registration statement allows the Company to issue any combination of its common stock, preferred stock, debt securities and warrants from time to time for an aggregate initial offering price of up to $50 million, subject to certain limitations for so long as its public float is less than $75 million. On January 30, 2018, the Company received net cash proceeds of approximately $13.3 million from the closing of a follow-on public offering of 1,095,153 shares of its common stock and warrants to purchase up to an aggregate of 1,095,153 shares of its common stock at a combined offering price of $13.50 per unit. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of warrants sold in this offering, with approximately $16.4 million in gross warrant proceeds remaining outstanding and available to be exercised at $4.53 per share, which is subject to down round adjustment, until their expiration in January 2023. Pursuant to a common stock and warrant purchase agreement dated August 9, 2017 between the Company and Ally Bridge LB Healthcare Master Fund Limited, or Ally Bridge, the Company received net cash proceeds of approximately $2.0 million from the sale of its common stock and warrants. Subsequent to the closing of this offering, no additional cash proceeds had been received from the exercise of warrants sold in this offering, with approximately $2.2 million in gross warrant proceeds remaining outstanding and available to be exercised at $45.00 per share until their expiration in August 2022. Management’s Plan to Continue as a Going Concern In order to continue as a going concern, the Company will need, among other things, additional capital resources. Until the Company can generate significant cash from operations, including assay revenues, management’s plans to obtain such resources for the Company include proceeds from offerings of the Company’s equity securities or debt, cash received from the exercise of outstanding common stock warrants, or transactions involving product development, technology licensing or collaboration. Management can provide no assurances that any sources of a sufficient amount of financing will be available to the Company on favorable terms, if at all. |
Sales of Equity Securities
Sales of Equity Securities | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Sales of Equity Securities | 3. Sales of Equity Securities In May 2015, the SEC declared effective a shelf registration statement filed by the Company, which expired on May 21, 2018. The shelf registration statement allowed the Company to issue any combination of its common stock, preferred stock, debt securities and warrants from time to time for an aggregate initial offering price of up to $50 million, subject to certain limitations for so long as the Company’s public float was less than $75 million. Pursuant to an exclusive placement agent agreement dated March 28, 2017 between the Company and Roth Capital Partners, LLC as lead placement agent, and WestPark Capital and Chardan Capital as co-placement agents, a securities purchase agreement for an offering of 144,000 shares of the Company’s common stock was effected under this registration statement at a per share price of $64.50, which closed on March 31, 2017. In a concurrent private placement, the Company sold unregistered warrants to purchase up to an aggregate of 72,000 shares of the Company’s common stock that closed concurrently with the March 2017 offering of common stock sold pursuant the shelf registration statement, of which none have been subsequently exercised. The warrants sold in this offering have a per share exercise price of $75.00, expire on October 1, 2022, and had an aggregate estimated fair value of approximately $2.8 million. Pursuant to an exclusive placement agent agreement dated March 28, 2017 between the Company and Roth Capital Partners, LLC as lead placement agent, and WestPark Capital and Chardan Capital as co-placement agents, a securities purchase agreement for a second offering of 144,000 shares of the Company’s common stock was effected under this registration statement at per share price of $64.50, which closed on March 31, 2017. In a concurrent private placement, the Company sold unregistered warrants to purchase up to an aggregate of 72,000 shares of the Company’s common stock that closed concurrently with the March 2017 offering of common stock sold pursuant the shelf registration statement. All warrants sold in this offering have a per share exercise price of $75.00, are exercisable beginning on the six-month anniversary of the date of issuance and expire five years from the date first exercisable. The estimated grant date fair value of these warrants of approximately $2.8 million was recorded as an offset to additional paid-in capital upon the closing of this offering (see Note 4). At the closing of these sales on March 31, 2017, the Company received, after deducting $0.7 million of costs directly associated with the offering that were recorded as an offset to additional paid-in capital under applicable accounting guidance, approximately $8.6 million of net cash proceeds. The specific terms of additional future offerings, if any, under this shelf registration statement would be established at the time of such offerings. Pursuant to a common stock and warrant purchase agreement dated August 9, 2017 between the Company and Ally Bridge, an offering of 48,888 shares of the Company’s common stock and a warrant to purchase up to an aggregate of 47,821 shares of common stock was effected at a combined offering price of $45.00 per unit for total gross proceeds to the Company of $2.2 million. The warrant sold in this offering has an exercise price of $45.00 per share, an estimated grant date fair value of approximately $1.5 million, and expires five years from the date of issuance. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of the warrant sold in this offering. As such, the total increase in capital from the sale of the common stock and warrant has been approximately $2.0 million after deducting $0.2 million of associated costs incurred, which were offset against these proceeds under applicable accounting guidance. On January 30, 2018, the Company received net cash proceeds of approximately $13.3 million from the closing of a follow-on public offering of 1,095,153 shares of its common stock and warrants to purchase up to an aggregate of 1,095,153 shares of its common stock at a combined offering price of $13.50 per unit, with $1.4 million of costs directly associated with the offering recorded as an offset to additional paid-in capital under applicable accounting guidance. The warrants sold in this offering have an exercise price of $4.53 per share, which is subject to down round adjustment, an aggregate estimated grant date fair value of $9.7 million (see Note 4) and expire five years from the date of issuance. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of warrants sold in this offering. On August 13 , 2018, the Company received net cash proceeds of approximately $10.2 million from closing a rights offering pursuant to its effective registration statement on Form S-1, selling an aggregate of 11,587 units consisting of an aggregate of 11,587 shares of Series A Preferred Stock and 2,549,140 warrants. The warrants are exercisable for one share of our common stock at an exercise price of $4.53 per share, On September 20, 2018, the Company completed an offering of 642,438 shares of the Company’s common stock and pre-funded warrants to purchase up to an aggregate of 120,000 shares of its common stock. The shares were sold at a purchase price of $3.285 per share and the pre-funded warrants were sold at a purchase price of $3.275 per pre-funded warrant which represents the per share purchase price for the shares less the $0.01 per share exercise price for each such pre-funded warrant. The net proceeds to the Company from this offering were approximately $2.2 million, after deducting expenses related to the offering including dealer-manager fees and expenses, and excluding any proceeds received upon exercise of any warrants |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement The estimated nonrecurring fair value measurements associated with fixed asset purchases recorded as equipment financing obligations totaling approximately $274,000 during the nine months ended September 30, 2018 were based on information provided by vendors, which involved the use of significant unobservable Level 3 inputs. Other Fair Value Measurements As of the closing of the Company’s January 30, 2018 offering, the grant date fair value of the warrants issued to purchase up to 1,095,153 shares of common stock were estimated to be approximately $8.82 per share, or a total of approximately $9.7 million. The warrants sold in this offering have an exercise price of $4.53 per share, which is subject to down round adjustment, and expire five years from the date of issuance. The fair value of the warrants was estimated using a Monte Carlo simulation valuation model using Geometric Brownian Motion, incorporating anticipated future financing events, with the following assumptions: Beginning stock price $ 10.17 Exercise price $ 4.53 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.48 % Expected life (in years) 5.00 Expected volatility 99.00 % As of the closing of the Company’s August 13, 2018 rights offering, the grant date fair value of the warrants issued to purchase up to 2,549,140 shares of common stock were estimated to be approximately $3.30 per share, or a total of approximately $8.4 million. The warrants sold in this offering have an exercise price of $4.53 per share and expire five years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions: Beginning stock price $ 3.89 Exercise price $ 4.53 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.75 % Expected life (in years) 5.00 Expected volatility 128.69 % As of the closing of the Company’s September 20, 2018 offering, the grant date fair value of the warrants issued to purchase up to 762,438 shares of common stock were estimated to be approximately $2.57 per share, or a total of approximately $2.0 million. The warrants sold in this offering have an exercise price of $3.16 per share, and expire five years from the initial exercise date, which is the six month anniversary of the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions: Beginning stock price $ 2.92 Exercise price $ 3.16 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.77 % Expected life (in years) 5.50 Expected volatility 130.7 % Also, included in the September 20, 2018 offering the Company issued 120,000 pre-funded warrants. The pre-funded warrants had an intrinsic value of $350,000. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Details | 5. Balance Sheet Details The following provides certain balance sheet details: December 31, September 30, 2017 2018 Fixed Assets Machinery and equipment $ 2,841,388 $ 2,810,226 Furniture and office equipment 147,976 157,391 Computer equipment and software 1,637,034 1,430,669 Leasehold improvements 553,529 570,174 Financed equipment 2,294,762 2,526,081 Construction in process 2,975 128,377 Total fixed assets, gross 7,477,664 7,622,918 Less accumulated depreciation and amortization (4,354,097 ) (4,721,924 ) Total fixed assets, net $ 3,123,567 $ 2,900,994 Accrued Liabilities Accrued payroll 224,813 387,162 Accrued vacation 474,953 470,473 Accrued bonuses 375,000 804,281 Accrued sales commissions 104,509 42,168 Current portion of deferred rent 116,681 147,771 Accrued other 129,805 102,115 Total accrued liabilities $ 1,425,761 $ 1,953,970 Depreciation expense for the nine-month period ended September 30, 2017 was $394,708 and for the nine months ended September 30, 2018 was $580,366. Depreciation expense for the three months ended September 30, 2017 was $159,552 and for the three-month period ended September 30, 2018 was $223,194. |
April 2014 Credit Facility
April 2014 Credit Facility | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
April 2014 Credit Facility | 6. April 2014 Credit Facility On April 30, 2014, the Company received net cash proceeds of approximately $4,898,000 pursuant to the execution of the April 2014 Credit Facility. Upon entering into the April 2014 Credit Facility, the Company was required to pay the lender a facility fee of $50,000 in conjunction with the funding of the term loan. The April 2014 Credit Facility was secured by substantially all of the Company’s personal property other than its intellectual property. The term loan under the April 2014 Credit Facility bore interest at an annual rate of 7.95%. The Company was required to make interest-only payments on the term loan through August 1, 2015. The outstanding term loan under the April 2014 Credit Facility began amortizing at the end of the applicable interest-only period, with monthly payments of principal and interest being made by the Company to the lender in consecutive monthly installments following such interest-only period. The term loan under the April 2014 Credit Facility matured on July 1, 2018. Under the original terms of the underlying agreement, the Company was also required to make a final payment to the lender equal to 5.5% of the original principal amount of the term loan funded. A warrant to purchase up to 588 shares of the Company’s common stock at an exercise price of $424.80 per share with a term of 10 years was issued to Oxford Finance LLC on April 30, 2014. Issuance costs of approximately $102,000 associated with the term loan under the April 2014 Credit Facility were recorded as a discount to outstanding debt as of the closing date, resulting in net proceeds of approximately $4,898,000. The estimated fair value of the warrant issued of approximately $233,000 was also recorded as a discount to outstanding debt as of the closing date. The discounts and other issuance costs were amortized to interest expense utilizing the effective interest method over the underlying term of the loan, with a total unamortized discount of approximately $33,000 at December 31, 2017. The effective annual interest rate associated with the April 2014 Credit Facility was 13.87% at both December 31, 2017 and June 30, 2018. A principal payment of approximately $175,000 remained outstanding at June 30, 2018 and was paid on July 1, 2018. |
Equipment Financings
Equipment Financings | 9 Months Ended |
Sep. 30, 2018 | |
Capital Lease Obligations [Abstract] | |
Equipment Financings | 7. Equipment Financings The Company leases certain laboratory equipment under arrangements accounted for as capital leases and classified as equipment financings. The financed equipment is depreciated on a straight-line basis over periods ranging from approximately 3 to 7 years. The total gross value of fixed assets capitalized under such financing arrangements was approximately $2,295,000 and $2,526,000 at December 31, 2017 and September 30, 2018, respectively. Total accumulated depreciation related to financed equipment was approximately $759,000 and $1,030,000 at December 31, 2017 and September 30, 2018, respectively. Total depreciation expense related to financed equipment during the three months ended September 30, 2017 and 2018 was approximately $52,000 and $115,000, respectively, and was approximately $160,000 and $271,000 during the nine months ended September 30, 2017 and 2018, respectively. The following schedule sets forth the remaining future minimum lease payments outstanding under financed equipment arrangements, as well as corresponding remaining sales tax and maintenance obligation payments that are expensed as incurred and due within each respective year ending December 31, as well as the present value of the total amount of the remaining minimum lease payments, as of September 30, 2018: Maintenance Minimum and Sales Tax Lease Obligation Payments Payments 2018 (remaining three months) $ 154,538 $ 30,237 2019 613,448 88,599 2020 464,152 67,752 2021 303,228 53,252 2022 262,974 53,493 Thereafter 262,952 40,641 Total payments 2,061,292 333,974 Less amount representing interest (473,166 ) — Present value of payments $ 1,588,126 $ 333,974 The aggregate weighted average effective annual interest rate associated with equipment financings was 13.51% and 12.53% at December 31, 2017 and September 30, 2018, respectively, and the maturity dates on such outstanding arrangements range from February 2019 to September 2024. During the three months ended September 30, 2017 and 2018, total interest expense related to equipment financings of approximately $38,000 and $60,000, respectively, was recorded to the Company’s unaudited condensed statements of operations and comprehensive loss, and approximately $118,000 and $168,000 was recorded during the nine months ended September 30, 2017 and 2018, respectively. At September 30, 2018, the present value of minimum lease payments due within one year was approximately $572,000. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans The Company maintains two equity incentive plans: The Amended and Restated 2013 Equity Incentive Plan, or the 2013 Plan, and the 2007 Equity Incentive Plan, or the 2007 Plan. The 2013 Plan includes a provision that shares available for grant under the Company’s 2007 Plan become available for issuance under the 2013 Plan and are no longer available for issuance under the 2007 Plan. At the Company’s annual meeting of stockholders held on June 28, 2018, the Company’s stockholders approved amendments to the 2013 Plan, which included an increase in the number of non-inducement shares of common stock authorized for issuance under the 2013 Plan by 146,666 shares. As of September 30, 2018, 59,511 shares of the Company’s common stock were authorized exclusively for the issuance of stock awards to employees who have not previously been an employee or director of the Company, except following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company, as defined under applicable Nasdaq Listing Rules. As of September 30, 2018, under all plans, a total of 264,098 non-inducement shares were authorized for issuance, 69,449 shares had been issued with 57,863 non-inducement stock options and restricted stock units, or RSUs, underlying outstanding awards, and 194,649 non-inducement shares were available for grant. As of September 30, 2018, 60,268 inducement shares had been issued under the 2013 Plan, with 59,434 inducement stock options and RSUs underlying outstanding awards and 0 inducement shares available for grant. Stock Options A summary of stock option activity for the nine months ended September 30, 2018 is as follows: Weighted Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2017 81,482 $ 113.68 8.80 Granted 58,994 $ 2.96 7.43 Exercised — — Cancelled/forfeited/expired (25,835 ) $ 45.83 8.68 Outstanding at September 30, 2018 114,641 $ 72.02 8.79 Vested and unvested expected to vest at September 30, 2018 112,280 $ 73.23 8.77 The intrinsic values of options outstanding, options exercisable, and options vested and unvested expected to vest at December 31, 2017 and September 30, 2018 were each approximately zero. The assumptions used in the Black-Scholes pricing model for stock options granted during the three and nine months ended September 30, 2018 were as follows: Stock and exercise prices $2.75 - $6.00 Expected dividend yield 0.00% Discount rate-bond equivalent yield 2.73% – 2.97% Expected life (in years) 5.00 – 5.96 Expected volatility 100% - 120% On May 2, 2017, the Company’s Board of Directors approved the issuance of an aggregate of 18,333 performance stock options to be granted on May 31, 2017 to certain of the Company’s employees and all of its executive officers pursuant to the 2013 Plan, of which 6,666 performance stock options were granted to the Company’s CEO, 3,333 performance stock options were granted to its CFO, and 2,500 performance stock options were granted to each of its Chief Scientific Officer and Senior Medical Director. Each performance stock option granted on May 31, 2017 had an exercise price of $45.00 per share and an estimated grant date fair value of $29.70 per share. On July 6, 2017, the Company’s Compensation Committee of the Board of Directors approved the issuance of an aggregate of 2,500 performance stock options to be granted on July 31, 2017 to certain of the Company’s employees pursuant to the 2013 Plan, of which 83 performance stock options were forfeited by December 31, 2017. Each performance stock option granted on July 31, 2017 had an exercise price of $41.70 per share and an estimated grant date fair value of $24.90 per share. The vesting of each of the performance stock options granted during the year ended December 31, 2017 was to be determined by the Company’s Board of Directors or Compensation Committee of the Board of Directors upon the Company’s achievement of specified corporate goals for 2017. During the nine months ended September 30, 2018, none of the performance option awards granted during the year ended December 31, 2017 were declared vested by the Company’s Compensation Committee of the Board of Directors, and the 20,750 shares underlying the remaining outstanding performance stock option awards at December 31, 2017 were forfeited. Restricted Stock A summary of RSU activity for the nine months ended September 30, 2018 is as follows: Weighted Number of Average Grant Shares Date Fair Value Outstanding at December 31, 2017 12,026 $ 56.10 Granted — — Vested and issued (5,833 ) $ 45.00 Forfeited (5,833 ) $ 45.00 Outstanding at September 30, 2018 360 $ 415.80 Vested and unvested expected to vest at September 30, 2018 360 $ 415.80 At September 30, 2018, the intrinsic values of RSUs outstanding and RSUs unvested and expected to vest were each approximately $1,000. Of the 360 RSUs outstanding at September 30, 2018, all were fully vested. On May 2, 2017, the Company’s Board of Directors approved the issuance of an aggregate of 5,833 time-based RSUs and 5,833 performance RSUs to be granted on May 31, 2017 to certain of the Company’s employees and all of its executive officers pursuant to the 2013 Plan, of which 1,666 time-based RSUs and 833 performance RSUs were granted to its CEO, and 833 time-based RSUs and 833 performance RSUs were granted to each of its CFO, Chief Scientific Officer, and Senior Medical Director. Each RSU granted on May 31, 2017 had a grant date fair value of $45.00 per share. Vesting of the time-based RSUs granted on May 31, 2017 occurred on the one-year anniversary of the vesting commencement date, or May 2, 2018, while vesting of the performance RSUs was to be determined by the Company’s Board of Directors or its Compensation Committee of the Board of Directors upon the achievement of specified corporate goals for 2017. During the nine months ended September 30, 2018, none of the performance RSUs granted on May 31, 2017 were declared vested by the Company’s Compensation Committee of the Board of Directors, and the 1,666 shares underlying these awards were forfeited. Stock-based Compensation Expense The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the unaudited condensed statements of operations and comprehensive loss during the periods presented: For the three months ended For the nine months ended September 30, September 30, 2017 2018 2017 2018 Stock Options Cost of revenues $ 59,720 $ 10,150 $ 133,105 $ 37,150 Research and development expenses 53,405 30,247 121,834 103,267 General and administrative expenses 178,671 57,162 528,406 243,593 Sales and marketing expenses 40,181 15,440 100,327 63,494 Total expenses related to stock options 331,977 112,999 883,672 447,504 RSUs Cost of revenues 20,417 - 58,717 (18,802 ) Research and development expenses 20,418 - 57,490 13,576 General and administrative expenses 74,521 - 160,927 54,303 Sales and marketing expenses 28,355 - 71,343 15,348 Total stock-based compensation $ 475,688 $ 112,999 $ 1,232,149 $ 511,929 Stock-based compensation expense was recorded net of estimated forfeitures of 0% - 8% per annum during each of the three and nine months ended September 30, 2017 and 2018. As of September 30, 2018, total unrecognized share-based compensation expense related to unvested stock options and RSUs, adjusted for estimated forfeitures, was approximately $900,474 and is expected to be recognized over a weighted-average period of approximately 2.4 years. |
Common Stock Warrants Outstandi
Common Stock Warrants Outstanding | 9 Months Ended |
Sep. 30, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Common Stock Warrants Outstanding | 9. Common Stock Warrants Outstanding A summary of equity-classified common stock warrant activity for the nine months ended September 30, 2018 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2017 288,196 $ 78.86 4.0 Issued 4,406,731 $ 3.95 Exercised — — Expired — — Outstanding at September 30, 2018 4,814,927 $ 5.44 4.7 |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 10. Net Loss per Common Share Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted-average common shares outstanding during the period. Because there is a net loss attributable to common shareholders for the three and nine months ended September 30, 2017 and 2018, the outstanding RSUs, warrants, and common stock options have been excluded from the calculation of diluted loss per common share because their effect would be anti-dilutive. Based on review of the applicable guidance, the 120,000 prefunded warrants that were issued in the September 20, 2018 registered direct offering with an exercise price of $0.01 are considered common stock equivalents and are included in the calculation of basic and diluted loss per share. In other periods presented, the weighted-average shares used to calculate both basic and diluted loss per share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the periods presented, as they would be anti-dilutive: For the three and nine months ended September 30, 2017 2018 Preferred warrants outstanding (number of common stock equivalents) 17 17 Common warrants outstanding 280,058 4,814,927 RSUs outstanding 12,030 360 Common options outstanding 82,810 114,641 Total anti-dilutive common share equivalents 374,915 4,929,945 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies In the normal course of business, the Company may be involved in legal proceedings or threatened legal proceedings. The Company is not party to any legal proceedings or aware of any threatened legal proceedings that are expected to have a material adverse effect on its financial condition, results of operations or liquidity. In February 2016, the Company signed a firm, non-cancelable, and unconditional commitment in an aggregate amount of $1,062,500 with a vendor to purchase certain inventory items, payable in minimum quarterly amounts of $62,500 through May 2020. At September 30, 2018, a balance of approximately $404,000 remained outstanding under this purchase commitment. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12. Related Party Transactions A member of the Company’s management is the controlling person of Aegea Biotechnologies, Inc., or Aegea. On September 2, 2012, the Company entered into an Assignment and Exclusive Cross-License Agreement, or the Cross-License Agreement, with Aegea. The Company received a payment of approximately $15,000 during the year ended December 31, 2017, as well as a payment of approximately $19,000 during the nine months ended September 30, 2018, from Aegea as reimbursements for shared patent costs under the Cross-License Agreement. There were no payments received on this arrangement during the quarter ended September 30, 2018. Pursuant to a sublease agreement dated March 30, 2015, the Company subleased 9,849 square feet, plus free use of an additional area, of its San Diego facility to an entity affiliated with the Company’s non-executive Chairman for $12,804 per month, with a refundable security deposit of $12,804 received from the subtenant. The initial term of the sublease expired on July 31, 2015 and was subject to renewal on a month-to-month basis thereafter. On February 1, 2017, the Company received notice from the subtenant terminating the sublease effective March 31, 2017. During the year ended December 31, 2017, the total amount of the $12,804 security deposit previously received from the subtenant was applied against approximately $16,000 in additional rents owed as a result of the subtenant continuing to occupy the subleased areas beyond March 31, 2017, and the balance of approximately $3,200 due to the Company was waived. A total of approximately $51,000 and $51,000 in rental income was recorded to other income/(expense) in the Company’s statement of operations and comprehensive loss during the nine months ended September 30, 2017 and the year ended December 31, 2017, respectively. There was no income or expense recorded in the three and nine months ended September 30, 2018 related to this sublease. |
The Company, Business Activit_2
The Company, Business Activities and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
The Company and Business Activities | The Company and Business Activities The Company was founded in California in May 1997 and effected a reincorporation to Delaware in July 2013. The Company is an early stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or liquid biopsy. The Company’s current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy at diagnosis, progression or for monitoring in order to identify specific resistance mechanisms. Sometimes traditional procedures, such as surgical tissue biopsies, result in tumor tissue that is insufficient and/or unable to provide the molecular subtype information necessary for clinical decisions. The Company’s assays, performed on blood, have the potential to provide more contemporaneous information on the characteristics of a patient’s disease when compared with tissue biopsy and radiographic imaging. Additionally, commencing in October 2017, the Company’s pathology partnership program, branded as Empower TC TM The Company operates a clinical laboratory that is CLIA-certified (under the Clinical Laboratory Improvement Amendment of 1988) and CAP-accredited (by the College of American Pathologists), and manufactures cell enrichment and extraction microfluidic channels, related equipment and certain reagents to perform the Company’s diagnostic assays in a facility located in San Diego, California. CLIA certification and accreditation are required before any clinical laboratory may perform testing on human specimens for the purpose of obtaining information for the diagnosis, prevention, treatment of disease, or assessment of health. The assays the Company offers are classified as laboratory developed tests under the CLIA regulations. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and on the basis that the Company will continue as a going concern (see Note 2). The accompanying unaudited condensed financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. The unaudited condensed financial statements included in this Form 10-Q have been prepared in accordance with the U.S. Securities and Exchange Commission, or SEC, instructions for Quarterly Reports on Form 10-Q. Accordingly, the condensed financial statements are unaudited and do not contain all the information required by GAAP to be included in a full set of financial statements. The balance sheet at December 31, 2017 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for a complete set of financial statements. The audited financial statements for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission, or SEC, with our Annual Report on Form 10-K on March 28, 2018 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year. On July 6, 2018, the Company’s stockholders approved, and the Company filed, an amendment to the Company’s Certificate of Amendment of Certificate of Incorporation to effect a one-for-thirty reverse stock split of the Company’s outstanding common stock. As such, all references to share and per share amounts in these unaudited condensed financial statements and accompanying notes have been retroactively restated to reflect the one-for-thirty reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 shares Certain prior period balances have been reclassified to conform to the current period presentation. |
Revenue Recognition and Accounts Receivable | Revenue Recognition and Accounts Receivable The Company's commercial revenues are generated from diagnostic services provided to patient’s physicians and billed to third-party insurance payers such as managed care organizations, Medicare and Medicaid and patients for any deductibles, coinsurance or copayments that may be due. Through December 31, 2017, the Company recognized revenue in accordance with the provisions of Accounting Standards Codification, or ASC, 954-605, Health Care Entities—Revenue Recognition, which required that four basic criteria must be met prior to recognition of revenue: (1) persuasive evidence of an arrangement existed; (2) delivery had occurred and title and the risks and rewards of ownership had been transferred to the client or services had been rendered; (3) the price was fixed or determinable; and (4) collectability was reasonably assured. Commencing on March 31, 2017, the Company recognized commercial revenue related to billings for assays delivered and billed to Medicare and other third-party payers on an accrual basis when amounts that will ultimately be realized can be estimated upon delivery, whereby prior to March 31, 2017, the Company recognized revenues for its commercial diagnostic services on a cash basis as collected because the amounts ultimately expected to be received could not be estimated upon delivery due to insufficient collection history experience. Commencing on January 1, 2018, the Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers, or ASC 606, which requires that an entity recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted the provisions of ASC 606 using the modified retrospective application method applied to all contracts, which did not impact amounts previously reported by the Company, nor did it require a cumulative effect adjustment upon adoption, as the Company’s method of recognizing revenue under ASC 606 was analogous to the method utilized immediately prior to adoption. Accordingly, there is no need for the Company to disclose the amount by which each financial statement line item was affected as a result of applying the new standard and an explanation of significant changes. Contracts For its commercial revenues, while the Company markets directly to physicians, its customer is the patient. Patients do not enter into direct agreements with the Company that commit either them to pay any portion of the cost of the tests if they have not met their annual deductible limit under their insurance policy, if any, or if their insurance otherwise declines to reimburse the Company. Accordingly, the Company establishes a contract with a commercial patient in accordance with other customary business practices, as follows: • Approval of a contract is established via the order and accession, which are submitted by the patient’s physician. • The Company is obligated to perform its diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable payer are obligated to reimburse the Company for services rendered based on the patient’s insurance benefits. • Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with CMS and applicable reimbursement contracts established between the Company and payers, unless the patient is a self-pay patient, whereby the Company bills the patient directly after the services are provided. • On ce the Company delivers a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as the Company is legally able to collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance benefit status. • Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues recorded to the extent that it is probable that a significant reversal will not occur. The Company’s development services revenues are supported by contractual agreements and generated from assay development services provided to entities, as well as certain other diagnostic services provided to physicians, and revenues are recognized upon delivery of the performance obligations in the contract. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service, or a bundle of goods or services, to the customer. For its commercial and development services revenues, the Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the delivery of a patient’s assay result(s) to the ordering physician or entity. The duration of time between accession receipt and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks. Accordingly, the Company elected the practical expedient and therefore, does not disclose the value of unsatisfied performance obligations. Transaction Price The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may include fixed amounts, variable amounts, or both. The Company’s gross commercial revenues billed, and corresponding gross accounts receivable, are subject to estimated deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and corresponding amounts estimated to be subsequently collected and is deemed to be variable although the variability is not explicitly stated in any contract. Rather, the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim denials. The Company estimates the The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is recognized up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a customer, it will account for the change as an increase in the estimate of the transaction price in the period identified as an increase to revenue. Similarly, if the Company subsequently determines that the amount it expects to collect from a customer is less than it originally estimated, it will generally account for the change as a decrease in the estimate of the transaction price as a decrease to revenue, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from changes in transaction prices was not significant during the three and nine months ended September 30, 2018. Allocate Transaction Price For the Company’s commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a customer. For the Company’s development services revenues, the contracted transaction price is allocated to each single performance obligation contained in a contract with a customer as performed. Point-in-time Recognition The Company’s single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is delivered to the patient’s ordering physician or entity. The Company considers this date to be the time at which the patient obtains control of the promised diagnostic assay service. Contract Balances The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in the Company’s condensed balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2017 and 2018, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net revenues from contracted payers* $ 422,136 $ 325,097 $ 1,655,287 $ 1,019,857 Net revenues from non-contracted payers 621,881 373,018 2,206,414 1,211,309 Development services revenues 67,394 63,476 211,736 159,606 Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net commercial revenues recognized upon delivery $ 941,783 $ 698,115 $ 2,703,424 $ 2,231,166 Development services revenues recognized upon delivery 67,394 63,476 211,736 159,606 Commercial revenues recognized upon cash collection 102,234 — 1,158,277 — Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 The amount of nonrecurring net revenue recorded during the three and nine months ended September 30, 2017, had the Company commenced recognizing revenue for commercial diagnostic services upon delivery on or prior to December 31, 2016 instead of on March 31, 2017, was $102,000 and $839,000, respectively, and the corresponding decrease in net loss per common share was $0.10 and $0.97, respectively. The incremental net revenue and decrease in loss from operations as a result of recognizing revenue on an accrual basis commencing on March 31, 2017, or the total amount of net revenue recorded in excess of the amount of commercial cash collections, was $125,000 and $1,158,000 during the three and nine months ended September 30, 2017, respectively, and the corresponding decrease in net loss per common share was $0.13 and $1.35, respectively. For the nine months ended September 30, 2018 all revenues were recognized on an accrual basis. |
Concentration of Risk | Concentrations of credit risk with respect to revenues are primarily limited to geographies to which the Company provides a significant volume of its services, and to specific third-party payers of the Company’s services such as Medicare, insurance companies, and other third-party payers. The Company’s client base consists of many geographically dispersed clients diversified across various customer types. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2017 and 2018 were as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Medicare and Medicare Advantage 45 % 40 % 41 % 39 % Blue Cross Blue Shield 16 % 9 % 17 % 14 % United Healthcare 14 % 6 % 12 % 15 % The Company's third-party payers that represent more than 10% of total net accounts receivable, and their related net accounts receivable balance as a percentage of total net accounts receivable, at December 31, 2017 and September 30, 2018 were as follows: December 31, 2017 September 30, 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 18 % United Healthcare 15 % 11 % |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, and as subsequently updated and amended from time to time, the Financial Accounting Standards Board, or FASB, issued authoritative guidance that requires entities to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, and may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of adoption. The Company adopted the new standard for the fiscal year beginning January 1, 2018 using the modified retrospective application method, which did not have a material impact on its financial statements or disclosures. In January 2016, the FASB issued authoritative guidance requiring, among other things, that certain equity investments be measured at fair value with changes in fair value recognized in net income, that financial assets and financial liabilities be presented separately by measurement category and form of financial asset on the balance sheet or the accompanying notes to the financial statements, that the prior requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet be eliminated, and that a reporting organization is to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the organization has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company adopted this guidance for the fiscal year beginning on January 1, 2018, which did not have a material impact on its financial statements or disclosures. In February 2016, the FASB issued authoritative guidance requiring, among other things, that entities recognize the assets and liabilities arising from leases on the balance sheet under revised criteria, while the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria in the previous leases guidance. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. This guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company anticipates that the adoption of this guidance will materially affect its statement of financial position and will require changes to its processes. The Company expects to adopt this guidance for the reporting period beginning on January 1, 2019 and has not yet made a decision on the method of adoption with respect to the optional practical expedients. In August 2016, the FASB issued authoritative guidance clarifying the classification of certain cash receipts and cash payments in the statement of cash flows. This guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, on a retrospective transition method to each period presented. The Company adopted this guidance for the reporting period beginning January 1, 2018, which did not have a material impact on its financial statements or disclosures. In January 2017, the FASB issued authoritative guidance clarifying the definition of a business when evaluating transactions involving acquisitions or disposals of assets or businesses. This guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted this guidance for the reporting period beginning January 1, 2018, which did not have a material impact on its financial statements or disclosures. In July 2017, the FASB issued authoritative guidance changing the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features, whereby a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock, and also clarifying existing disclosure requirements for equity-classified instruments. This guidance is effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company early adopted this guidance for the fiscal year beginning on January 1, 2018, which did not have a material impact on its financial statements or disclosures upon adoption, but did result in equity classification for the warrants issued on January 30, 2018, whereby liability classification may have occurred in the absence of the adoption of this guidance due to the existence of a down round feature associated with the exercise price of the warrants, which would have resulted in material impacts to the Company’s financial statements and disclosures. In August 2017, the FASB issued authoritative guidance that expands and refines hedge accounting for both nonfinancial and financial risk components and align the recognition and presentation of the effects of the hedging instrument and the hedged item in the financial statements. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early application is permitted. The Company currently intends to adopt this guidance for the fiscal year beginning on January 1, 2019 and does not anticipate that the adoption of this guidance will have a material impact on its financial statements or disclosures because the Company does not currently hold any financial instruments accounted for as a hedging activity. In February 2018, the FASB issued authoritative guidance allowing a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from a tax bill, “H.R.1, An Act to Provide for Reconciliation Pursuant to Titles II and V of the Concurrent Resolution on the Budget for Fiscal Year 2018,” or the Tax Cuts and Jobs Act, enacted on December 22, 2017. These amendments eliminate the stranded tax effects resulting from the Tax Cuts and Jobs Act. However, because these amendments only relate to the reclassification of the income tax effects of the Tax Cuts and Jobs Act, the underlying guidance that requires that the effect of a change in tax laws or rates be included in income from continuing operations is not affected. This guidance also requires certain disclosures about stranded tax effects. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The Company currently intends to adopt this guidance for the fiscal year beginning on January 1, 2019 and does not anticipate that the adoption of this guidance will have a material impact on its financial statements or disclosures because the Company does not currently maintain any stranded tax effects in accumulated other comprehensive income. In February 2018, the FASB issued authoritative guidance concerning certain fair value option liabilities, equity securities without a readily determinable fair value, and certain equity investments. This guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years beginning after June 15, 2018. Public entities with fiscal years beginning between December 15, 2017 and June 15, 2018 are not required to adopt these amendments until the interim period beginning after June 15, 2018. The Company adopted this guidance for the interim period beginning on July 1, 2018, which did not have a material impact on its financial statements or disclosures because the Company did not hold any fair value option liabilities, equity securities without a readily determinable fair value, or equity investments. |
The Company, Business Activit_3
The Company, Business Activities and Basis of Presentation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Composition of Net Revenues Recognized Disaggregated by Source and Nature | The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2017 and 2018, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net revenues from contracted payers* $ 422,136 $ 325,097 $ 1,655,287 $ 1,019,857 Net revenues from non-contracted payers 621,881 373,018 2,206,414 1,211,309 Development services revenues 67,394 63,476 211,736 159,606 Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Net commercial revenues recognized upon delivery $ 941,783 $ 698,115 $ 2,703,424 $ 2,231,166 Development services revenues recognized upon delivery 67,394 63,476 211,736 159,606 Commercial revenues recognized upon cash collection 102,234 — 1,158,277 — Total net revenues $ 1,111,411 $ 761,591 $ 4,073,437 $ 2,390,772 |
Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage | The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2017 and 2018 were as follows: For the three months ended September 30, For the nine months ended September 30, 2017 2018 2017 2018 Medicare and Medicare Advantage 45 % 40 % 41 % 39 % Blue Cross Blue Shield 16 % 9 % 17 % 14 % United Healthcare 14 % 6 % 12 % 15 % The Company's third-party payers that represent more than 10% of total net accounts receivable, and their related net accounts receivable balance as a percentage of total net accounts receivable, at December 31, 2017 and September 30, 2018 were as follows: December 31, 2017 September 30, 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 18 % United Healthcare 15 % 11 % |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Assumptions Used for Determining Fair Values of Common Stock Warrants | The fair value of the warrants was estimated using a Monte Carlo simulation valuation model using Geometric Brownian Motion, incorporating anticipated future financing events, with the following assumptions: Beginning stock price $ 10.17 Exercise price $ 4.53 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.48 % Expected life (in years) 5.00 Expected volatility 99.00 % The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions: Beginning stock price $ 3.89 Exercise price $ 4.53 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.75 % Expected life (in years) 5.00 Expected volatility 128.69 % The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions: Beginning stock price $ 2.92 Exercise price $ 3.16 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.77 % Expected life (in years) 5.50 Expected volatility 130.7 % |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Fixed Assets and Accrued Liabilities | The following provides certain balance sheet details: December 31, September 30, 2017 2018 Fixed Assets Machinery and equipment $ 2,841,388 $ 2,810,226 Furniture and office equipment 147,976 157,391 Computer equipment and software 1,637,034 1,430,669 Leasehold improvements 553,529 570,174 Financed equipment 2,294,762 2,526,081 Construction in process 2,975 128,377 Total fixed assets, gross 7,477,664 7,622,918 Less accumulated depreciation and amortization (4,354,097 ) (4,721,924 ) Total fixed assets, net $ 3,123,567 $ 2,900,994 Accrued Liabilities Accrued payroll 224,813 387,162 Accrued vacation 474,953 470,473 Accrued bonuses 375,000 804,281 Accrued sales commissions 104,509 42,168 Current portion of deferred rent 116,681 147,771 Accrued other 129,805 102,115 Total accrued liabilities $ 1,425,761 $ 1,953,970 |
Equipment Financings (Tables)
Equipment Financings (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Capital Lease Obligations [Abstract] | |
Schedule of Remaining Future Minimum Lease Payments for Financed Equipment Obligations | The following schedule sets forth the remaining future minimum lease payments outstanding under financed equipment arrangements, as well as corresponding remaining sales tax and maintenance obligation payments that are expensed as incurred and due within each respective year ending December 31, as well as the present value of the total amount of the remaining minimum lease payments, as of September 30, 2018: Maintenance Minimum and Sales Tax Lease Obligation Payments Payments 2018 (remaining three months) $ 154,538 $ 30,237 2019 613,448 88,599 2020 464,152 67,752 2021 303,228 53,252 2022 262,974 53,493 Thereafter 262,952 40,641 Total payments 2,061,292 333,974 Less amount representing interest (473,166 ) — Present value of payments $ 1,588,126 $ 333,974 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | A summary of stock option activity for the nine months ended September 30, 2018 is as follows: Weighted Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2017 81,482 $ 113.68 8.80 Granted 58,994 $ 2.96 7.43 Exercised — — Cancelled/forfeited/expired (25,835 ) $ 45.83 8.68 Outstanding at September 30, 2018 114,641 $ 72.02 8.79 Vested and unvested expected to vest at September 30, 2018 112,280 $ 73.23 8.77 |
Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model | The assumptions used in the Black-Scholes pricing model for stock options granted during the three and nine months ended September 30, 2018 were as follows: Stock and exercise prices $2.75 - $6.00 Expected dividend yield 0.00% Discount rate-bond equivalent yield 2.73% – 2.97% Expected life (in years) 5.00 – 5.96 Expected volatility 100% - 120% |
Summary of RSU Activity | A summary of RSU activity for the nine months ended September 30, 2018 is as follows: Weighted Number of Average Grant Shares Date Fair Value Outstanding at December 31, 2017 12,026 $ 56.10 Granted — — Vested and issued (5,833 ) $ 45.00 Forfeited (5,833 ) $ 45.00 Outstanding at September 30, 2018 360 $ 415.80 Vested and unvested expected to vest at September 30, 2018 360 $ 415.80 |
Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Condensed Statement of Operations and Comprehensive Loss | The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the unaudited condensed statements of operations and comprehensive loss during the periods presented: For the three months ended For the nine months ended September 30, September 30, 2017 2018 2017 2018 Stock Options Cost of revenues $ 59,720 $ 10,150 $ 133,105 $ 37,150 Research and development expenses 53,405 30,247 121,834 103,267 General and administrative expenses 178,671 57,162 528,406 243,593 Sales and marketing expenses 40,181 15,440 100,327 63,494 Total expenses related to stock options 331,977 112,999 883,672 447,504 RSUs Cost of revenues 20,417 - 58,717 (18,802 ) Research and development expenses 20,418 - 57,490 13,576 General and administrative expenses 74,521 - 160,927 54,303 Sales and marketing expenses 28,355 - 71,343 15,348 Total stock-based compensation $ 475,688 $ 112,999 $ 1,232,149 $ 511,929 |
Common Stock Warrants Outstan_2
Common Stock Warrants Outstanding (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Equity Classified Warrants [Abstract] | |
Summary of Equity-Classified Common Stock Warrant Activity | A summary of equity-classified common stock warrant activity for the nine months ended September 30, 2018 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2017 288,196 $ 78.86 4.0 Issued 4,406,731 $ 3.95 Exercised — — Expired — — Outstanding at September 30, 2018 4,814,927 $ 5.44 4.7 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Securities Excluded from Computations of Diluted Weighted-Average Shares | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the periods presented, as they would be anti-dilutive: For the three and nine months ended September 30, 2017 2018 Preferred warrants outstanding (number of common stock equivalents) 17 17 Common warrants outstanding 280,058 4,814,927 RSUs outstanding 12,030 360 Common options outstanding 82,810 114,641 Total anti-dilutive common share equivalents 374,915 4,929,945 |
The Company, Business Activit_4
The Company, Business Activities and Basis of Presentation - Additional Information (Detail) | Jul. 06, 2018shares | Sep. 30, 2017USD ($)$ / shares | Sep. 30, 2018shares | Sep. 30, 2017USD ($)$ / shares | Dec. 31, 2017shares |
The Company Business Activities And Basis Of Presentation [Line Items] | |||||
Stockholders equity reverse stock split ratio | 0.03 | ||||
Common stock, shares authorized | shares | 150,000,000 | 150,000,000 | 150,000,000 | ||
Description of reverse stock split | On July 6, 2018, the Company’s stockholders approved, and the Company filed, an amendment to the Company’s Certificate of Amendment of Certificate of Incorporation to effect a one-for-thirty reverse stock split of the Company’s outstanding common stock. | ||||
Nonrecurring net revenue recognized on accrual basis associated with cases delivered | $ | $ 102,000 | $ 839,000 | |||
Increase (decrease) in net income (loss) per common share on nonrecurring net revenue | $ / shares | $ (0.10) | $ (0.97) | |||
Net revenue recorded in excess of commercial cash collections | $ | $ 125,000 | $ 1,158,000 | |||
Increase decrease in net income (loss) per common share | $ / shares | $ (0.13) | $ (1.35) | |||
ASC 606 [Member] | |||||
The Company Business Activities And Basis Of Presentation [Line Items] | |||||
Performance obligation, description of timing | The duration of time between accession receipt and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks. | ||||
Practical expedient, description | The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. | ||||
ASC 606 [Member] | Maximum [Member] | Sales and Marketing Expenses [Member] | |||||
The Company Business Activities And Basis Of Presentation [Line Items] | |||||
Amortization period | 1 year |
The Company, Business Activit_5
The Company, Business Activities and Basis of Presentation - Composition of Net Revenues Recognized Disaggregated by Source (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | ||
Revenue Recognition [Abstract] | |||||
Net revenues from contracted payers | [1] | $ 325,097 | $ 422,136 | $ 1,019,857 | $ 1,655,287 |
Net revenues from non-contracted payers | 373,018 | 621,881 | 1,211,309 | 2,206,414 | |
Development services revenues | 63,476 | 67,394 | 159,606 | 211,736 | |
Total net revenues | $ 761,591 | $ 1,111,411 | $ 2,390,772 | $ 4,073,437 | |
[1] | Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. |
The Company, Business Activit_6
The Company, Business Activities and Basis of Presentation - Composition of Net Revenues Recognized Disaggregated by Nature (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue Recognition [Abstract] | ||||
Net commercial revenues recognized upon delivery | $ 698,115 | $ 941,783 | $ 2,231,166 | $ 2,703,424 |
Development services revenues recognized upon delivery | 63,476 | 67,394 | 159,606 | 211,736 |
Commercial revenues recognized upon cash collection | 102,234 | 1,158,277 | ||
Total net revenues | $ 761,591 | $ 1,111,411 | $ 2,390,772 | $ 4,073,437 |
The Company, Business Activit_7
The Company, Business Activities and Basis of Presentation - Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Customer Concentration Risk [Member] | Net Revenues [Member] | Blue Cross Blue Shield [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 9.00% | 16.00% | 14.00% | 17.00% | |
Customer Concentration Risk [Member] | Net Revenues [Member] | Medicare and Medicare Advantage [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 40.00% | 45.00% | 39.00% | 41.00% | |
Customer Concentration Risk [Member] | Net Revenues [Member] | United Healthcare [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 6.00% | 14.00% | 15.00% | 12.00% | |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Blue Cross Blue Shield [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 22.00% | 27.00% | |||
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Medicare and Medicare Advantage [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 18.00% | 21.00% | |||
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | United Healthcare [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 11.00% | 15.00% |
Liquidity and Going Concern U_2
Liquidity and Going Concern Uncertainty- Additional Information (Detail) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Aug. 09, 2017 | May 31, 2018 | Feb. 29, 2016 | May 31, 2015 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 |
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Cash | $ 8,956,200 | $ 5,879,025 | $ 8,956,200 | $ 5,879,025 | $ 2,146,611 | $ 4,609,332 | |||||||||
Accumulated deficit | (214,444,005) | (214,444,005) | $ (195,249,607) | ||||||||||||
Net loss | (6,047,784) | (5,821,306) | (18,558,028) | (15,947,164) | |||||||||||
Unconditional purchase commitment aggregate amount | $ 1,062,500 | 404,000 | $ 404,000 | ||||||||||||
Unconditional purchase commitment payment terms | Quarterly | ||||||||||||||
Unconditional purchase commitment period | May 31, 2020 | ||||||||||||||
Shelf registration statement expiration period | May 21, 2018 | ||||||||||||||
Public offering, number of common stock and warrants issued | 642,438 | 1,095,153 | |||||||||||||
Stock price | $ 3.285 | $ 13.50 | |||||||||||||
Exercise price of warrants | $ 4.53 | $ 4.53 | $ 75 | ||||||||||||
Net proceeds from issuance of units, net of issuance expenses | $ 2,200,000 | $ 10,200,000 | |||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||
Class of warrant or rights, term | 5 years | 5 years | |||||||||||||
Aggregate units sold under right offering | 11,587 | ||||||||||||||
Shares issued in offering | 642,438 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,200,000 | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 0 | 7,498,535 | ||||||||||||
Proceeds from issuance of common stock | $ 2,500,000 | $ 11,600,000 | |||||||||||||
Ally Bridge [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Issuance of warrants to purchase shares of common stock | 47,821 | ||||||||||||||
Stock price | $ 45 | ||||||||||||||
Exercise price of warrants | $ 45 | ||||||||||||||
Class of warrant or rights, term | 5 years | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,000,000 | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | ||||||||||||||
Exercisable warrant available price per share expiration period | 2022-08 | ||||||||||||||
Proceeds from issuance of common stock | $ 2,200,000 | ||||||||||||||
Prefunded Warrants [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||||||
Exercise price of warrants | $ 3.275 | ||||||||||||||
Change in exercise price of warrants | 0.01 | ||||||||||||||
Series A Preferred Stock [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Shares issued in offering | 11,587 | ||||||||||||||
Warrants [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Aggregate warrants sold under right offering | 2,549,140 | ||||||||||||||
Shelf Registration Statement [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Shelf registration statement expiration period | May 31, 2021 | ||||||||||||||
Minimum public float limit for offering | $ 75,000,000 | $ 75,000,000 | |||||||||||||
Private Placement [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Exercise price of warrants | $ 3.16 | ||||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||
Class of warrant or rights, term | 5 years | ||||||||||||||
Follow-on Public Offering [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Public offering, number of common stock and warrants issued | 1,095,153 | ||||||||||||||
Stock price | $ 13.50 | ||||||||||||||
Exercise price of warrants | $ 3.16 | $ 4.53 | $ 4.53 | ||||||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 13,300,000 | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | 0 | |||||||||||||
Proceeds from gross exercise of common stock warrants outstanding | $ 16,400,000 | ||||||||||||||
Exercisable warrant available price per share | $ 4.53 | ||||||||||||||
Exercisable warrant available price per share expiration period | 2023-01 | ||||||||||||||
April 2014 Credit Facility [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Aggregate net interest-bearing indebtedness | 1,700,000 | 3,300,000 | 1,700,000 | 3,300,000 | |||||||||||
Aggregate net interest-bearing indebtedness due within one year | $ 693,000 | $ 2,400,000 | $ 693,000 | $ 2,400,000 | |||||||||||
Minimum [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Unconditional purchase commitment, quarterly payment amount | $ 62,500 | ||||||||||||||
Maximum [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||||||||
Maximum [Member] | Prefunded Warrants [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||||||
Maximum [Member] | Shelf Registration Statement [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Aggregate offering price | $ 50,000,000 | $ 50,000,000 | |||||||||||||
Maximum [Member] | Follow-on Public Offering [Member] | |||||||||||||||
Liquidity And Managements Plans [Line Items] | |||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 |
Sales of Equity Securities - Ad
Sales of Equity Securities - Additional Information (Detail) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | May 31, 2018 | May 31, 2015 | Sep. 30, 2018 | Sep. 30, 2017 |
Class Of Stock [Line Items] | |||||||||||
Shelf registration statement expiration period | May 21, 2018 | ||||||||||
Shares issued in offering | 642,438 | ||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 1,095,153 | 72,000 | |||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 0 | $ 7,498,535 | ||||||||
Stock price | $ 3.285 | $ 13.50 | |||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 2,000,000 | $ 8,400,000 | $ 9,700,000 | $ 2,800,000 | |||||||
Exercise price of warrants | $ 4.53 | $ 4.53 | $ 75 | ||||||||
Net cash proceeds from sale of securities | 2,200,000 | ||||||||||
Class of warrant or rights, term | 5 years | 5 years | |||||||||
Proceeds from issuance of common stock | 2,500,000 | $ 11,600,000 | |||||||||
Net proceeds from issuance of units, net of issuance expenses | $ 2,200,000 | $ 10,200,000 | |||||||||
Aggregate units sold under right offering | 11,587 | ||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||
Series A Preferred Stock convertible to common stock, conversion price | $ 4.53 | ||||||||||
Prefunded Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 3.275 | ||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||
Change in exercise price of warrants | $ 0.01 | ||||||||||
Series A Preferred Stock [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Shares issued in offering | 11,587 | ||||||||||
Ally Bridge [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from exercise of common stock warrants | $ 0 | ||||||||||
Stock price | $ 45 | ||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 1,500,000 | ||||||||||
Exercise price of warrants | $ 45 | ||||||||||
Net cash proceeds from sale of securities | $ 2,000,000 | ||||||||||
Class of warrant or rights, term | 5 years | ||||||||||
Private offering, number of common stock and warrants issued | 48,888 | ||||||||||
Issuance of warrants to purchase shares of common stock | 47,821 | ||||||||||
Proceeds from issuance of common stock | $ 2,200,000 | ||||||||||
Common stock issuance costs | $ 200,000 | ||||||||||
Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Aggregate warrants sold under right offering | 2,549,140 | ||||||||||
Roth Capital Partners, LLC, WestPark Capital and Chardan Capital [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Placement agent agreement, effective date | Mar. 28, 2017 | ||||||||||
Shares issued in offering | 144,000 | ||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 72,000 | ||||||||||
Proceeds from exercise of common stock warrants | $ 0 | ||||||||||
Stock price | $ 64.50 | ||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 2,800,000 | ||||||||||
Exercise price of warrants | $ 75 | ||||||||||
Class of warrant or rights, expiration date | Oct. 1, 2022 | ||||||||||
Cost directly associated with offering | $ 700,000 | ||||||||||
Net cash proceeds from sale of securities | $ 8,600,000 | ||||||||||
Roth Capital Partners, LLC, WestPark Capital and Chardan Capital [Member] | Second Offering [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Placement agent agreement, effective date | Mar. 28, 2017 | ||||||||||
Shares issued in offering | 144,000 | ||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 72,000 | ||||||||||
Stock price | $ 64.50 | ||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 2,800,000 | ||||||||||
Exercise price of warrants | $ 75 | ||||||||||
Cost directly associated with offering | $ 700,000 | ||||||||||
Net cash proceeds from sale of securities | $ 8,600,000 | ||||||||||
Class of warrant or rights, term | 5 years | ||||||||||
Dawson James Securities, Inc and WestPark Capital [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Placement agent agreement, effective date | Dec. 5, 2017 | ||||||||||
Shares issued in offering | 164,166 | ||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 8,208 | ||||||||||
Stock price | $ 20.40 | ||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 100,000 | ||||||||||
Exercise price of warrants | $ 25.50 | ||||||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | ||||||||||
Cost directly associated with offering | $ 400,000 | ||||||||||
Net cash proceeds from sale of securities | $ 2,900,000 | ||||||||||
Maximum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||||
Maximum [Member] | Prefunded Warrants [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||
Shelf Registration Statement [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Shelf registration statement expiration period | May 31, 2021 | ||||||||||
Minimum public float limit for offering | $ 75,000,000 | $ 75,000,000 | |||||||||
Shelf Registration Statement [Member] | Maximum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Aggregate offering price | $ 50,000,000 | $ 50,000,000 | |||||||||
Follow-on Public Offering [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 0 | |||||||||
Stock price | $ 13.50 | ||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 9,700,000 | ||||||||||
Exercise price of warrants | $ 3.16 | $ 4.53 | $ 4.53 | ||||||||
Cost directly associated with offering | $ 1,400,000 | ||||||||||
Net cash proceeds from sale of securities | $ 13,300,000 | ||||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | ||||||||
Private offering, number of common stock and warrants issued | 1,095,153 | ||||||||||
Follow-on Public Offering [Member] | Maximum [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||||
Private Placement [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 3.16 | ||||||||||
Class of warrant or rights, term | 5 years | ||||||||||
Warrant exercisable for share of common stock | 1 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Detail) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 30, 2018 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Fixed asset purchases as equipment financings obligations | $ 270,000 | $ 363,000 | ||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 2,000,000 | $ 8,400,000 | $ 9,700,000 | $ 2,800,000 | ||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 1,095,153 | 72,000 | ||
Estimated grant date fair value of warrants | $ 2.57 | $ 3.30 | $ 8.82 | |||
Exercise price of warrants | $ 4.53 | $ 4.53 | $ 75 | |||
Class of warrant or rights, term | 5 years | 5 years | ||||
Prefunded Warrants [Member] | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Exercise price of warrants | $ 3.275 | |||||
Issuance of warrants to purchase shares of common stock | 120,000 | |||||
Common stock warrants outstanding, intrinsic value | $ 350,000 | |||||
Follow-on Public Offering [Member] | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 9,700,000 | |||||
Exercise price of warrants | $ 3.16 | $ 4.53 | $ 4.53 | |||
Class of warrant or rights, term | 5 years | 5 years | 5 years | |||
Estimated Fair Value Measurements, Nonrecurring [Member] | Level 3 Inputs [Member] | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Fixed asset purchases as equipment financings obligations | $ 274,000 |
Fair Value Measurement - Assump
Fair Value Measurement - Assumptions Used for Determining Fair Values of Common Stock Warrants (Detail) | Sep. 30, 2018$ / shares | Sep. 20, 2018$ / shares | Jan. 30, 2018$ / shares |
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 3.285 | $ 13.50 | |
January 30, 2018 Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 10.17 | ||
January 30, 2018 Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 4.53 | ||
January 30, 2018 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 0 | ||
January 30, 2018 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 2.48 | ||
January 30, 2018 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years | ||
January 30, 2018 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 99 | ||
August 13, 2018 Rights Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 3.89 | ||
August 13, 2018 Rights Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 4.53 | ||
August 13, 2018 Rights Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 0 | ||
August 13, 2018 Rights Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 2.75 | ||
August 13, 2018 Rights Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years | ||
August 13, 2018 Rights Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 128.69 | ||
September 20, 2018 Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 2.92 | ||
September 20, 2018 Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 3.16 | ||
September 20, 2018 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 0 | ||
September 20, 2018 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 2.77 | ||
September 20, 2018 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years 6 months | ||
September 20, 2018 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Fair value measurement input | 130.7 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Fixed Assets and Accrued Liabilities (Detail) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Fixed Assets | ||
Machinery and equipment | $ 2,810,226 | $ 2,841,388 |
Furniture and office equipment | 157,391 | 147,976 |
Computer equipment and software | 1,430,669 | 1,637,034 |
Leasehold improvements | 570,174 | 553,529 |
Financed equipment | 2,526,081 | 2,294,762 |
Construction in process | 128,377 | 2,975 |
Total fixed assets, gross | 7,622,918 | 7,477,664 |
Less accumulated depreciation and amortization | (4,721,924) | (4,354,097) |
Total fixed assets, net | 2,900,994 | 3,123,567 |
Accrued Liabilities | ||
Accrued payroll | 387,162 | 224,813 |
Accrued vacation | 470,473 | 474,953 |
Accrued bonuses | 804,281 | 375,000 |
Accrued sales commissions | 42,168 | 104,509 |
Current portion of deferred rent | 147,771 | 116,681 |
Accrued other | 102,115 | 129,805 |
Total accrued liabilities | $ 1,953,970 | $ 1,425,761 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||||
Depreciation expense | $ 223,194 | $ 159,552 | $ 580,366 | $ 394,708 |
April 2014 Credit Facility - Ad
April 2014 Credit Facility - Additional Information (Detail) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jul. 01, 2018 | Jan. 30, 2018 | Mar. 31, 2017 | Apr. 30, 2014 | Dec. 31, 2014 | Jun. 30, 2018 | Dec. 31, 2017 |
Line of Credit Facility [Line Items] | |||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 4.53 | $ 75 | ||||||
Warrant term | 5 years | ||||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 2,000,000 | $ 8,400,000 | $ 9,700,000 | $ 2,800,000 | |||||
Remaining outstanding principal payment | $ 1,168,811 | ||||||||
Oxford Finance LLC [Member] | Common Stock [Member] | |||||||||
Line of Credit Facility [Line Items] | |||||||||
Warrant issued to lender | 588 | ||||||||
Exercise price of unregistered warrants | $ 424.80 | ||||||||
Warrant term | 10 years | ||||||||
Oxford Finance LLC [Member] | First Term Loan [Member] | |||||||||
Line of Credit Facility [Line Items] | |||||||||
Net cash proceeds on term loan | $ 4,898,000 | ||||||||
Line of Credit Facility fees amount payable | $ 50,000 | ||||||||
Line of Credit Facility, interest rate during period | 7.95% | ||||||||
Percentage of final interest payment due at maturity | 5.50% | ||||||||
Issuance costs | $ 102,000 | ||||||||
Net proceeds from credit facility | 4,898,000 | ||||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 233,000 | ||||||||
Unamortized discount | $ 33,000 | ||||||||
Effective annual interest rate | 13.87% | 13.87% | |||||||
Remaining outstanding principal payment | $ 175,000 | ||||||||
Total remaining principal payment paid | $ 175,000 |
Equipment Financings - Addition
Equipment Financings - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Capital Leased Assets [Line Items] | |||||
Financed equipment | $ 2,526,081 | $ 2,526,081 | $ 2,294,762 | ||
Accumulated depreciation related to financed equipment | 1,030,000 | 1,030,000 | $ 759,000 | ||
Depreciation expense related to financed equipment | 223,194 | $ 159,552 | $ 580,366 | $ 394,708 | |
Equipment financings aggregate weighted average effective annual interest rate | 12.53% | 13.51% | |||
Equipment financings maturity date on outstanding arrangements range, Start | 2019-02 | ||||
Equipment financings maturity date on outstanding arrangements range, End | 2024-09 | ||||
Interest expense to equipment financings | 63,764 | 88,269 | $ 230,677 | 385,172 | |
Present value of minimum lease payment due within one year | 572,000 | 572,000 | |||
Equipment Financings [Member] | |||||
Capital Leased Assets [Line Items] | |||||
Depreciation expense related to financed equipment | 115,000 | 52,000 | 271,000 | 160,000 | |
Interest expense to equipment financings | $ 60,000 | $ 38,000 | $ 168,000 | $ 118,000 | |
Minimum [Member] | Equipment Financings [Member] | |||||
Capital Leased Assets [Line Items] | |||||
Financed equipment useful life | 3 years | ||||
Maximum [Member] | Equipment Financings [Member] | |||||
Capital Leased Assets [Line Items] | |||||
Financed equipment useful life | 7 years |
Equipment Financings - Schedule
Equipment Financings - Schedule of Remaining Future Minimum Lease Payments for Financed Equipment Obligations (Detail) | Sep. 30, 2018USD ($) |
Capital Lease Obligations [Abstract] | |
2018 (remaining three months) | $ 154,538 |
2,019 | 613,448 |
2,020 | 464,152 |
2,021 | 303,228 |
2,022 | 262,974 |
Thereafter | 262,952 |
Total payments | 2,061,292 |
Less amount representing interest | (473,166) |
Present value of payments | 1,588,126 |
2018 (remaining three months) | 30,237 |
2,019 | 88,599 |
2,020 | 67,752 |
2,021 | 53,252 |
2,022 | 53,493 |
Thereafter | 40,641 |
Total payments | 333,974 |
Present value of payments | $ 333,974 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jun. 28, 2018shares | Jul. 31, 2017$ / sharesshares | May 31, 2017$ / sharesshares | May 02, 2017shares | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017 | Sep. 30, 2018USD ($)Plan$ / sharesshares | Sep. 30, 2017 | Dec. 31, 2017USD ($)$ / sharesshares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of equity incentive plans | Plan | 2 | ||||||||
Total Shares Outstanding | 114,641 | 114,641 | 81,482 | ||||||
Number of Shares, Granted | 58,994 | ||||||||
Weighted average exercise price per share | $ / shares | $ 2.96 | ||||||||
Number of shares remaining forfeited | 25,835 | ||||||||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 4 months 24 days | ||||||||
Minimum [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Estimated forfeitures rate | 0.00% | 0.00% | 0.00% | 0.00% | |||||
Maximum [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Estimated forfeitures rate | 8.00% | 8.00% | 8.00% | 8.00% | |||||
Stock Options [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Intrinsic value of options outstanding | $ | $ 0 | $ 0 | $ 0 | ||||||
Intrinsic value of options exercisable | $ | 0 | 0 | 0 | ||||||
Intrinsic value of options vested and unvested expected to vest | $ | 0 | 0 | $ 0 | ||||||
RSUs [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Intrinsic value shares, RSUs outstanding | $ | 1,000 | 1,000 | |||||||
Intrinsic value amount, RSUs unvested and vested expected to vest | $ | $ 1,000 | $ 1,000 | |||||||
RSUs outstanding | 360 | 360 | 12,026 | ||||||
Issuance of restricted stock units | 0 | ||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 415.80 | $ 415.80 | $ 56.10 | ||||||
Total RSUs forfeited | 5,833 | ||||||||
Stock Options and RSUs [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Unrecognized share-based compensation expense, stock options | $ | $ 900,474 | $ 900,474 | |||||||
2013 Equity Incentive Plan [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Total stock options and RSUs authorized | 59,511 | 59,511 | |||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Weighted average exercise price per share | $ / shares | $ 41.70 | $ 45 | |||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 24.90 | $ 29.70 | |||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Employees and Executive Officers [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares authorized | 18,333 | ||||||||
Number of shares remaining forfeited | 20,750 | ||||||||
Number of shares vested | 0 | ||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Employees [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 2,500 | ||||||||
Number of shares remaining forfeited | 83 | ||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Chief Executive Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 6,666 | ||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Chief Financial Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 3,333 | ||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Chief Scientific Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 2,500 | ||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Senior Medical Director [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 2,500 | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 45 | ||||||||
Vesting period | 1 year | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | Chief Executive Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 1,666 | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | Chief Financial Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | Chief Scientific Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | Senior Medical Director [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Time-Based RSUs [Member] | Executive Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares authorized | 5,833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 45 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | Chief Executive Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | Chief Financial Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | Chief Scientific Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | Senior Medical Director [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Issuance of restricted stock units | 833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSUs [Member] | Executive Officer [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares authorized | 5,833 | ||||||||
2013 Equity Incentive Plan [Member] | Performance RSU Granted on May 31, 2017 [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vested | 0 | ||||||||
Total RSUs forfeited | 1,666 | ||||||||
2013 Equity Incentive Plan [Member] | Non-inducement Shares [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Total stock options and RSUs authorized | 264,098 | 264,098 | |||||||
Increase in total stock otions and RSUs authorized | 146,666 | ||||||||
Stock options and RSUs issued | 69,449 | ||||||||
Total Shares Outstanding | 57,863 | 57,863 | |||||||
Common stock, shares authorized | 194,649 | 194,649 | |||||||
2013 Equity Incentive Plan [Member] | Inducement shares [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock options and RSUs issued | 60,268 | ||||||||
Total Shares Outstanding | 59,434 | 59,434 | |||||||
Common stock, shares authorized | 0 | 0 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of Shares Outstanding, Beginning Balance | 81,482 | |
Number of Shares, Granted | 58,994 | |
Number of Shares, Cancelled/forfeited/expired | (25,835) | |
Number of Shares Outstanding, Ending Balance | 114,641 | 81,482 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | 112,280 | |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 113.68 | |
Weighted Average Exercise Price Per Share, Granted | 2.96 | |
Weighted Average Exercise Price Per Share, Cancelled/forfeited/expired | 45.83 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | 72.02 | $ 113.68 |
Weighted Average Exercise Price Per Share, Vested and unvested expected to vest, Ending Balance | $ 73.23 | |
Weighted Average Remaining Contractual Term in Years, Outstanding | 8 years 9 months 14 days | 8 years 9 months 18 days |
Weighted Average Remaining Contractual Term in Years, Granted | 7 years 5 months 4 days | |
Weighted Average Remaining Contractual Term in Years, Cancelled/forfeited/expired | 8 years 8 months 4 days | |
Weighted Average Remaining Contractual Term in Years, Vested and unvested expected to vest | 8 years 9 months 7 days |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model (Detail) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018$ / shares | Sep. 30, 2018$ / shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock and exercise prices | $ 2.75 | $ 2.75 |
Discount rate-bond equivalent yield | 2.73% | 2.73% |
Expected life (in years) | 5 years | 5 years |
Expected volatility | 100.00% | 100.00% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock and exercise prices | $ 6 | $ 6 |
Discount rate-bond equivalent yield | 2.97% | 2.97% |
Expected life (in years) | 5 years 11 months 15 days | 5 years 11 months 15 days |
Expected volatility | 120.00% | 120.00% |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Detail) - RSUs [Member] | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Shares Outstanding, Beginning Balance | shares | 12,026 |
Number of Shares, Granted | shares | 0 |
Number of share, Vested and issued | shares | (5,833) |
Number of share, Forfeited | shares | (5,833) |
Number of Shares Outstanding, Ending Balance | shares | 360 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | shares | 360 |
Weighted Average Grant Date Fair Value, Outstanding, Beginning Balance | $ / shares | $ 56.10 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 0 |
Weighted Average Grant Date Fair Value, Vested and issued | $ / shares | 45 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 45 |
Weighted Average Grant Date Fair Value, Outstanding, Ending Balance | $ / shares | 415.80 |
Weighted Average Grant Date Fair Value, Vested and unvested expected to vest, Ending Balance | $ / shares | $ 415.80 |
Stock-Based Compensation - Effe
Stock-Based Compensation - Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Condensed Statement of Operations and Comprehensive Loss (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Stock Options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 112,999 | $ 331,977 | $ 447,504 | $ 883,672 |
Stock Options [Member] | Cost of revenues [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 10,150 | 59,720 | 37,150 | 133,105 |
Stock Options [Member] | Research and Development Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 30,247 | 53,405 | 103,267 | 121,834 |
Stock Options [Member] | General and Administrative Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 57,162 | 178,671 | 243,593 | 528,406 |
Stock Options [Member] | Sales and Marketing Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 15,440 | 40,181 | 63,494 | 100,327 |
RSUs [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 112,999 | 475,688 | 511,929 | 1,232,149 |
RSUs [Member] | Cost of revenues [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 20,417 | (18,802) | 58,717 | |
RSUs [Member] | Research and Development Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 20,418 | 13,576 | 57,490 | |
RSUs [Member] | General and Administrative Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 74,521 | 54,303 | 160,927 | |
RSUs [Member] | Sales and Marketing Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 28,355 | $ 15,348 | $ 71,343 |
Common Stock Warrants Outstan_3
Common Stock Warrants Outstanding - Summary of Equity-Classified Common Stock Warrant Activity (Detail) - Warrants [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Class Of Warrant Or Right [Line Items] | ||
Number of Shares, Outstanding, Beginning Balance | 288,196 | |
Number of Shares, Issued | 4,406,731 | |
Number of Shares, Outstanding, Ending Balance | 4,814,927 | 288,196 |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 78.86 | |
Weighted Average Exercise Price Per Share, Issued | 3.95 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | $ 5.44 | $ 78.86 |
Average Remaining Contractual Term (in years) | 4 years 8 months 12 days | 4 years |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Detail) - Prefunded Warrants [Member] | Sep. 20, 2018$ / sharesshares |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |
Issuance of warrants to purchase shares of common stock | shares | 120,000 |
Change in exercise price of warrants | $ / shares | $ 0.01 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Anti-Dilutive Securities Excluded from Computations of Diluted Weighted-Average Shares (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 4,929,945 | 374,915 | 4,929,945 | 374,915 |
Warrants Outstanding [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 4,814,927 | 280,058 | 4,814,927 | 280,058 |
RSUs Outstanding [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 360 | 12,030 | 360 | 12,030 |
Preferred Warrants Outstanding [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 17 | 17 | 17 | 17 |
Common Options Outstanding [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 114,641 | 82,810 | 114,641 | 82,810 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 9 Months Ended |
Feb. 29, 2016 | Sep. 30, 2018 | |
Loss Contingencies [Line Items] | ||
Unconditional purchase commitment aggregate amount | $ 1,062,500 | $ 404,000 |
Unconditional purchase commitment payment terms | Quarterly | |
Unconditional purchase commitment period | May 31, 2020 | |
Minimum [Member] | ||
Loss Contingencies [Line Items] | ||
Unconditional purchase commitment, quarterly payment amount | $ 62,500 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | Feb. 01, 2017 | Sep. 30, 2018USD ($)ft² | Mar. 31, 2015 | Sep. 30, 2018USD ($)ft² | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) |
San Diego California Facility [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Lease expiration date | Mar. 31, 2017 | |||||
Rental income | $ 0 | $ 0 | $ 51,000 | $ 51,000 | ||
Aegea Biotechnologies, Inc [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Reimbursement for shared patent costs | $ 0 | $ 19,000 | $ 15,000 | |||
Nonexecutive [Member] | San Diego California Facility [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Leased facility, expansion of original premises | ft² | 9,849 | 9,849 | ||||
Lease agreement date of commencement | Mar. 30, 2015 | |||||
Leased facility, rent expense per month | $ 12,804 | |||||
Lease facility, refundable security deposit amount | $ 12,804 | 12,804 | ||||
Lease expiration date | Jul. 31, 2015 | |||||
Lease agreement, amount of security deposit applied against additional rents owed | 16,000 | |||||
Lease agreement, amount of additional rents waived | $ 3,200 |