Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 25, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | BIOC | ||
Entity Registrant Name | BIOCEPT INC | ||
Entity Central Index Key | 0001044378 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 18,817,076 | ||
Entity Public Float | $ 13,554,726 |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash | $ 3,423,373 | $ 2,146,611 |
Accounts receivable, net | 1,574,325 | 1,193,426 |
Inventories, net | 587,222 | 498,702 |
Prepaid expenses and other current assets | 425,961 | 416,600 |
Total current assets | 6,010,881 | 4,255,339 |
Fixed assets, net | 2,739,422 | 3,123,567 |
Total assets | 8,750,303 | 7,378,906 |
Current liabilities: | ||
Accounts payable | 2,039,718 | 1,269,953 |
Accrued liabilities | 1,928,393 | 1,752,363 |
Supplier financings | 61,226 | |
Current portion of equipment financings | 641,536 | 408,992 |
Current portion of credit facility, net | 1,168,811 | |
Total current liabilities | 4,609,647 | 4,661,345 |
Non-current portion of equipment financings | 985,015 | 1,150,063 |
Non-current portion of deferred rent | 113,122 | 271,464 |
Total liabilities | 5,707,784 | 6,082,872 |
Commitments and contingencies (see Note 16) | ||
Shareholders’ equity: | ||
Preferred stock, $0.0001 par value, 5,000,000 shares authorized; no shares and 4,417 shares issued and outstanding at December 31, 2017 and 2018, respectively. | ||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 1,181,179 shares issued and outstanding at December 31, 2017; 4,629,174 shares issued and outstanding at December 31, 2018. | 463 | 118 |
Additional paid-in capital | 223,499,634 | 196,545,523 |
Accumulated deficit | (220,457,578) | (195,249,607) |
Total shareholders’ equity | 3,042,519 | 1,296,034 |
Total liabilities and shareholders’ equity | $ 8,750,303 | $ 7,378,906 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 4,417 | 0 |
Preferred stock, shares outstanding | 4,417 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 4,629,174 | 1,181,179 |
Common stock, shares outstanding | 4,629,174 | 1,181,179 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Net revenues | $ 3,250,298 | $ 5,068,663 |
Costs and expenses: | ||
Cost of revenues | 10,051,735 | 9,345,122 |
Research and development expenses | 4,468,572 | 3,364,747 |
General and administrative expenses | 7,074,024 | 7,189,529 |
Sales and marketing expenses | 5,914,706 | 6,343,971 |
Total costs and expenses | 27,509,037 | 26,243,369 |
Loss from operations | (24,258,739) | (21,174,706) |
Other income/(expense): | ||
Interest expense, net | (310,976) | (482,623) |
Other income | 51,216 | |
Total other income/(expense): | (310,976) | (431,407) |
Loss before income taxes | (24,569,715) | (21,606,113) |
Income tax expense | (1,886) | (7,624) |
Net loss and comprehensive loss | (24,571,601) | (21,613,737) |
Deemed dividend related to warrants down round provision | (636,370) | |
Net loss attributable to common shareholders | $ (25,207,971) | $ (21,613,737) |
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||
Basic | 2,798,243 | 916,599 |
Diluted | 2,798,243 | 916,599 |
Net loss per common share: | ||
Basic | $ (9.01) | $ (23.58) |
Diluted | $ (9.01) | $ (23.58) |
Statements of Shareholders' Equ
Statements of Shareholders' Equity - USD ($) | Total | March 2017 Registered Direct Offering [Member] | August 2017 Private Placement [Member] | December 2017 Registered Direct Offering [Member] | January 2018 Financing Transaction [Member] | August 2018 Rights Offering [Member] | September 2018 Registered Direct Offering [Member] | Prefunded Warrants [Member] | Common Stock [Member] | Common Stock [Member]March 2017 Registered Direct Offering [Member] | Common Stock [Member]August 2017 Private Placement [Member] | Common Stock [Member]December 2017 Registered Direct Offering [Member] | Common Stock [Member]January 2018 Financing Transaction [Member] | Common Stock [Member]September 2018 Registered Direct Offering [Member] | Common Stock [Member]Prefunded Warrants [Member] | SeriesA Convertible Preferred Stock [Member] | SeriesA Convertible Preferred Stock [Member]August 2018 Rights Offering [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]March 2017 Registered Direct Offering [Member] | Additional Paid-in Capital [Member]August 2017 Private Placement [Member] | Additional Paid-in Capital [Member]December 2017 Registered Direct Offering [Member] | Additional Paid-in Capital [Member]January 2018 Financing Transaction [Member] | Additional Paid-in Capital [Member]August 2018 Rights Offering [Member] | Additional Paid-in Capital [Member]September 2018 Registered Direct Offering [Member] | Additional Paid-in Capital [Member]Prefunded Warrants [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2016 | $ 658,661 | $ 58 | $ 174,294,473 | $ (173,635,870) | ||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2016 | 583,313 | |||||||||||||||||||||||||
Net loss | (4,432,707) | |||||||||||||||||||||||||
Ending balance at Mar. 31, 2017 | 10,418,069 | |||||||||||||||||||||||||
Beginning balance at Dec. 31, 2016 | 658,661 | $ 58 | 174,294,473 | (173,635,870) | ||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2016 | 583,313 | |||||||||||||||||||||||||
Stock-based compensation expense | 1,247,481 | 1,247,481 | ||||||||||||||||||||||||
Shares issued for restricted stock units, shares | 5,194 | |||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 7,498,535 | $ 23 | 7,498,512 | |||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 227,228 | |||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 8,559,959 | $ 2,023,939 | $ 2,921,196 | $ 15 | $ 5 | $ 16 | $ 8,559,944 | $ 2,023,934 | $ 2,921,180 | |||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 144,000 | 48,889 | 164,167 | |||||||||||||||||||||||
Fractional shares issued upon one-for-thirty reverse stock split | $ 1 | (1) | ||||||||||||||||||||||||
Fractional shares issued upon one-for-thirty reverse stock split, shares | 8,388 | |||||||||||||||||||||||||
Net loss | (21,613,737) | (21,613,737) | ||||||||||||||||||||||||
Ending balance at Dec. 31, 2017 | 1,296,034 | $ 118 | 196,545,523 | (195,249,607) | ||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2017 | 1,181,179 | |||||||||||||||||||||||||
Beginning balance at Mar. 31, 2017 | 10,418,069 | |||||||||||||||||||||||||
Net loss | (5,693,151) | |||||||||||||||||||||||||
Ending balance at Jun. 30, 2017 | 7,342,257 | |||||||||||||||||||||||||
Net loss | (5,821,306) | |||||||||||||||||||||||||
Ending balance at Sep. 30, 2017 | 4,026,079 | |||||||||||||||||||||||||
Net loss | (5,666,573) | |||||||||||||||||||||||||
Ending balance at Dec. 31, 2017 | 1,296,034 | $ 118 | 196,545,523 | (195,249,607) | ||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2017 | 1,181,179 | |||||||||||||||||||||||||
Net loss | (6,356,404) | |||||||||||||||||||||||||
Ending balance at Mar. 31, 2018 | 8,507,714 | |||||||||||||||||||||||||
Beginning balance at Dec. 31, 2017 | 1,296,034 | $ 118 | 196,545,523 | (195,249,607) | ||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2017 | 1,181,179 | |||||||||||||||||||||||||
Stock-based compensation expense | 623,412 | 623,412 | ||||||||||||||||||||||||
Shares issued for restricted stock units | $ 1 | (1) | ||||||||||||||||||||||||
Shares issued for restricted stock units, shares | 5,833 | |||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | $ 1,200 | $ 12 | $ 1,188 | |||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 120,000 | |||||||||||||||||||||||||
Deemed dividends related warrants downround provision | 636,370 | 636,370 | (636,370) | |||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 13,342,819 | $ 10,097,862 | $ 2,252,793 | $ 110 | $ 64 | $ 1 | $ 13,342,709 | $ 10,097,861 | $ 2,252,729 | |||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 1,095,153 | 642,438 | 11,587 | |||||||||||||||||||||||
Shares issued upon conversion of preferred stock | $ 158 | $ (1) | (157) | |||||||||||||||||||||||
Shares issued upon conversion of preferred stock, shares | 1,584,571 | (7,170) | ||||||||||||||||||||||||
Net loss | (24,571,601) | (24,571,601) | ||||||||||||||||||||||||
Ending balance at Dec. 31, 2018 | 3,042,519 | $ 463 | 223,499,634 | (220,457,578) | ||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2018 | 4,629,174 | 4,417 | ||||||||||||||||||||||||
Beginning balance at Mar. 31, 2018 | 8,507,714 | |||||||||||||||||||||||||
Net loss | (6,153,101) | |||||||||||||||||||||||||
Ending balance at Jun. 30, 2018 | 2,527,568 | |||||||||||||||||||||||||
Deemed dividends related warrants downround provision | 636,370 | |||||||||||||||||||||||||
Net loss | (6,047,784) | |||||||||||||||||||||||||
Ending balance at Sep. 30, 2018 | 8,938,408 | |||||||||||||||||||||||||
Net loss | (6,014,312) | |||||||||||||||||||||||||
Ending balance at Dec. 31, 2018 | $ 3,042,519 | $ 463 | $ 223,499,634 | $ (220,457,578) | ||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2018 | 4,629,174 | 4,417 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash Flows from Operating Activities | ||
Net loss | $ (24,571,601) | $ (21,613,737) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 800,905 | 575,717 |
Inventory reserve | (38,499) | (50,532) |
Stock-based compensation | 623,412 | 1,247,481 |
Non-cash interest expense related to credit facility and other financing activities | 29,426 | 45,788 |
Increase/(decrease) in cash resulting from changes in: | ||
Accounts receivable, net | (380,899) | (1,064,457) |
Inventory | (50,021) | 100,875 |
Prepaid expenses and other current assets | 488,505 | 518,863 |
Accounts payable | 601,872 | 349,932 |
Accrued liabilities | 460,972 | 236,927 |
Accrued interest | (202,609) | 78,649 |
Deferred rent | (116,681) | (76,232) |
Net cash used in operating activities | (22,355,218) | (19,650,726) |
Cash Flows from Investing Activities: | ||
Purchases of fixed assets | (145,253) | (1,400,180) |
Net cash used in investing activities | (145,253) | (1,400,180) |
Cash Flows from Financing Activities: | ||
Net proceeds from issuance of common stock and warrants | 25,693,474 | 13,505,094 |
Proceeds from exercise of common stock warrants | 1,200 | 7,498,535 |
Net proceeds from sale-leaseback transaction | 150,848 | |
Payments on equipment financings | (160,381) | (166,348) |
Payments on supplier and other third-party financings | (559,092) | (465,279) |
Payments on credit facility | (1,197,968) | (1,934,665) |
Net cash provided by financing activities | 23,777,233 | 18,588,185 |
Net increase/(decrease) in Cash | 1,276,762 | (2,462,721) |
Cash at Beginning of Period | 2,146,611 | 4,609,332 |
Cash at End of Period | 3,423,373 | 2,146,611 |
Cash paid during the period for: | ||
Interest | 605,485 | 358,471 |
Income taxes | $ 4,517 | $ 5,273 |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Financed insurance premium through third party financing | $ 488,000 | $ 451,000 | ||||||
Cancelled insurance premiums previously financed through third-parties, remaining principal outstanding balance | 0 | |||||||
Fixed assets purchased under capital lease obligations | 279,000 | 719,000 | ||||||
Fixed assets with an aggregate net book value | 34,000 | |||||||
Purchases of fixed assets | $ 25,000 | $ 31,000 | ||||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 8,208 | 47,821 | 72,000 | |||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 45 | $ 75 | $ 3.16 | ||
Unregistered warrants to purchase common stock, period | 5 years | 5 years | 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 | $ 100,000 | $ 1,500,000 | $ 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 | $ 428,000 | $ 176,000 | $ 728,000 | ||
Class of warrant or rights, first exercisable date | Jun. 5, 2018 | |||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | |||||||
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 | 1,584,571 | |||||||
Deemed dividend related to warrants down round provision | $ 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] | ||||||||
Exercise price of unregistered warrants | $ 15 | |||||||
Class of warrant or rights, first exercisable date | Mar. 24, 2019 | |||||||
Class of warrant or rights, expiration date | Mar. 24, 2024 | |||||||
Class of warrant or rights, term | 5 years | |||||||
Aggregate warrants sold under right offering | 2,549,140 | |||||||
Series A Preferred Stock [Member] | ||||||||
Aggregate shares sold under right offering | 11,587 | |||||||
Shares converted | 7,170 | |||||||
Maximum [Member] | ||||||||
Issuance of unregistered warrants to purchase shares of common stock | 1,095,153 | |||||||
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 | |||||||
Maximum [Member] | Warrants [Member] | ||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 |
The Company and Business Activi
The Company and Business Activities | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
The Company and Business Activities | 1. The Company and Business Activities The Company was founded in California in May 1997 and 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, Empower TC, provides the unique ability for pathologists to participate in the interpretation of liquid biopsy results and is available to pathology practices and hospital systems throughout the United States. Further, sales to laboratory supply distributors of commenced in June 2018, 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. In July 2013, the Company effected a reincorporation to Delaware by merging itself with and into Biocept, Inc., a Delaware corporation, which had been formed to be and was a wholly-owned subsidiary of the Company since July 23, 2013. |
Liquidity and Going Concern Unc
Liquidity and Going Concern Uncertainty | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Liquidity and Going Concern Uncertainty | 2. Liquidity and Going Concern Uncertainty As of December 31, 2018, cash totaled $3.4 million and the Company had an accumulated deficit of $220.5 million. For the years ended December 31, 2017 and 2018, the Company incurred net losses of $21.6 million and $24.6 million, respectively. At December 31, 2018, the Company had aggregate net interest-bearing indebtedness of $1.6 million of which $642,000 was due within one year, whereas at December 31, 2017, the Company had aggregate net interest-bearing indebtedness of approximately $3.1 million, of which approximately $2.0 million was due within one year, in addition to approximately $2.7 million of other non-interest-bearing current liabilities. Additionally, 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, under which approximately $341,000 remained outstanding at December 31, 2018 (see Note 16). These factors raise substantial doubt about the Company’s ability to continue as a going concern for the one-year period following the date that these financial statements were issued. The accompanying financial statements and notes have been prepared assuming that the Company will continue as a going concern. The accompanying 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. 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. In May 2015, the SEC declared effective a shelf registration statement filed by the Company, which expired in May 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 its public float was less than $75 million. Pursuant to an exclusive placement agent agreement dated April 25, 2016 between the Company and H.C. Wainwright & Co., LLC, or Wainwright, and a securities purchase agreement dated April 29, 2016 between the Company and the purchasers’ signatory thereto, the Company received approximately $4.3 million of net cash proceeds upon the sale of its common stock and warrants to purchase its common stock. Subsequent to the closing of this offering on May 4, 2016, no warrants sold in this offering have been exercised, with approximately $4.5 million in gross warrant proceeds remaining outstanding and available to be exercised at $117.00 per share until their expiration in May 2021. 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. In a concurrent private placement, the Company sold unregistered warrants to purchase up to an aggregate of 72,000 shares of its common stock that closed concurrently with the offering common stock sold pursuant to this shelf registration statement, of which none have been subsequently exercised. All warrants sold in this offering have a per share exercise price of $75.00 and expire on October 1, 2022. The closing of the sale of these securities to the purchasers occurred on March 31, 2017, when the Company received approximately $8.6 million of net cash proceeds. Pursuant to an exclusive placement agent agreement dated December 5, 2017 between the Company and Dawson James Securities, Inc. as lead placement agent, and WestPark Capital as co-placement agent, a securities purchase agreement for a registered direct offering of 164,166 shares of the Company’s common stock was effected under this registration statement at a per share price of $20.40. The placement agent was issued a warrant to purchase 8,208 shares of common stock at an exercise price of $25.50 per share, which was first exercisable on June 5, 2018 and expires on December 5, 2022. The closing of the sale of these securities occurred on December 8, 2017, when the Company received approximately $2.9 million of net cash proceeds. Pursuant to a common stock and warrant purchase agreement dated August 9, 2017, the Company received net cash proceeds of approximately $2.0 million as a result of the sale of its common stock and warrants. 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 $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. On January 30, 2018, the Company received net cash proceeds of approximately $13.3 million as a result of the closing of a follow-on public offering. 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 $3.16 per share, subject to down round adjustment, until their expiration in January 2023. 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 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 $10.1 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. 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. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to purchase one share of the Company’s common stock for each share and pre-funded warrant purchased for cash in the offering. All warrants issued in this offering initially had an exercise price of $3.16 per share, are exercisable upon the six-month anniversary of issuance and expire five years from such date. On January 18, 2019, the Company completed an offering of 990,000 shares of the Company’s common stock pursuant to a shelf-registration on Form S-3 that became effective in May 2018. The shares were sold at a purchase price of $2.25 per share and the net proceeds to the Company from this offering were approximately $2.0 million, after deducting expenses related to the offering including dealer-manager fees and expenses. On February 12, 2019, the Company received net cash proceeds of approximately $6.8 million as a result of the closing of a follow-on public offering of 6,250,000 shares of its common stock and warrants to purchase up to an aggregate of 6,250,000 shares of its common stock at a combined offering price of $1.20 per unit. All warrants sold in this offering have an exercise price of $1.20 per share, are exercisable immediately and expire five years from the date of issuance. In addition, the Company granted warrants to purchase up to an aggregate of 937,500 shares of the Company’s common stock in connection with the partial exercise of the over-allotment option granted to the underwriters. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of warrants sold in this offering. On March 11, 2019, the underwriters exercised their overallotment option for 538,867 shares of the Company’s common stock related to the February 12, 2019 follow-on offering, purchasing shares at $1.20 for net cash proceeds of approximately $601,000. On March 19, 2019, the Company received net cash proceeds of approximately $7.5 million as a result of completing a registered direct offering of 5,950,000 shares at a negotiated purchase price of $1.37 per share. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to purchase one share of the Company’s common stock for each share purchased for cash in the offering. All warrants issued in this offering have an exercise price of $1.25 per share, are exercisable immediately upon issuance and expire 5.5 years following the date of issuance. 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, 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and are prepared on the basis that the Company will continue as a going concern (see Note 2). The accompanying 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. 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 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, which was not affected by the one-for-thirty reverse stock split. Going Concern The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim financial statements are issued (see Note 2). Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by management. Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates these estimates and judgments, including those related to accounts receivable, inventories, long-lived assets, income taxes, revenues, stock-based compensation, and the determination of the Company’s ability to continue as a going concern. The Company bases its estimates on various assumptions that it believes are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. 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. Commencing on March 31, 2017, the Company began to recognize 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. • Once 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 amount of variable consideration using the most likely amount approach to estimating variable consideration for third-party payers, including direct patient bills, whereby the estimated reimbursement for services are established by payment histories on CPT codes for each payer, or similar payer types. When no payment history is available, the value of the account is estimated at Medicare rates, with additional other payer-specific reserves taken as appropriate. Collection periods for billings on commercial revenues range from less than 30 days to several months, depending on the contracted or non-contracted nature of the payer, among other variables. The estimates of amounts that will ultimately be realized from commercial diagnostic services for non-contracted payers require significant judgment by management. 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 year ended December 31, 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 years ended December 31, 2017 and 2018, disaggregated by source and nature, are as follows: For the year ended December 31, 2017 2018 Net revenues from contracted payers* $ 2,074,596 $ 1,348,383 Net revenues from non-contracted payers 2,721,717 1,703,179 Development services revenues 272,350 198,736 Total net revenues $ 5,068,663 $ 3,250,298 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the year ended December 31, 2017 2018 Net commercial revenues recognized upon delivery $ 3,570,337 $ 3,051,562 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total net revenues $ 5,068,663 $ 3,250,298 The amount of nonrecurring net revenue recorded during the year ended December 31, 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 $843,000, and the corresponding decrease in net loss per common share was $0.90. 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 $1,139,000 during the year ended December 31, 2017, and the corresponding decrease in net loss per common share was $1.20, respectively. For the year ended December 31, 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 composition of the Company’s gross and net revenues recognized during the years ended December 31, 2017 and 2018 is as follows: For the year ended December 31, 2017 2018 Commercial revenues recognized upon delivery $ 15,685,069 $ 12,505,149 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total gross revenues 17,183,395 12,703,885 Provisions for contractual discounts (5,805,787 ) (3,937,993 ) Provisions for aged non-patient receivables (735,709 ) (326,137 ) Provisions for estimated patient receivables (169,479 ) (66,470 ) Provisions for other payer-specific sales allowances (5,403,757 ) (5,122,987 ) Net revenues $ 5,068,663 $ 3,250,298 A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2018 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2017 Upon Delivery Adjudication 2018 Accounts receivable, gross $ 6,937,063 $ 12,835,371 $ (11,889,832 ) $ 7,882,602 Reserve for contractual discounts (1,974,849 ) (3,214,615 ) 3,011,989 (2,177,475 ) Reserve for aged non-patient receivables (452,088 ) (994,542 ) 880,682 (565,948 ) Reserve for estimated patient receivables (88,120 ) (135,955 ) 208,598 (15,477 ) Reserve for other payer-specific sales allowances (3,228,580 ) (5,239,961 ) 4,919,164 (3,549,377 ) Accounts receivable, net $ 1,193,426 $ 3,250,298 $ (2,869,399 ) $ 1,574,325 Cash The Company places its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation, or FDIC. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company has not experienced any losses in its cash and believes they are not exposed to any significant credit risk. Fair Value Measurements The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximate their estimated fair values due to the short-term maturities of these financial instruments. See Note 5 for further details about the inputs and assumptions used to determine fair value measurements. Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. 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 a large number of 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 years ended December 31, 2017 and 2018 were as follows: For the year ended December 31, 2017 2018 Medicare and Medicare Advantage 39 % 39 % Blue Cross Blue Shield 19 % 11 % United Healthcare 12 % 17 % 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 2018 were as follows: For the year ended December 31, 2017 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 17 % United Healthcare 15 % 15 % The Company operates in one reportable business segment and historically has derived most revenues only from within the United States. Certain components used in the Company’s current or planned products are currently sourced from one supplier, for which alternative suppliers exist but the Company has not validated the product(s) of such alternative supplier(s), and substitutes for these components may not be obtained easily or may require substantial design or manufacturing modifications. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined by the average cost method. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. At the point of loss recognition, a new cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. In addition, the Company records a liability for firm, non-cancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities in excess of the Company’s future demand forecasts consistent with its valuation of excess and obsolete inventory. Fixed Assets Fixed assets consist of machinery and equipment, furniture and fixtures, computer equipment and software, leasehold improvements, financed equipment and construction in-process. Fixed assets are stated at cost less accumulated depreciation and amortization. Additions, improvements, and major renewals are capitalized. Maintenance, repairs, and minor renewals are expensed as incurred. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the life of the lease or the asset, whichever is shorter. Depreciation and amortization expense for the years ended December 31, 2017 and 2018 was approximately $576,000 and $801,000, respectively. Upon sale or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation or amortization with any gain or loss recorded to the statement of operations and comprehensive loss. Fixed assets are reviewed for impairment whenever changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in the estimates of future cash flows to determine recoverability of these assets. If the assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss. Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees and directors based on their grant date fair values. The Company estimates the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, while the fair value of restricted stock unit awards, or RSUs, is determined by the Company’s stock price on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In addition, the Company estimates forfeitures at the time of grant and revises these estimates in subsequent periods if actual forfeitures differ from those estimates (see Note 10). The Company determines the fair value of the stock-based compensation awards granted as either the fair value of the consideration received, or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards are recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods based on the fair value of the options at the end of each period. Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based compensation expense is calculated using the Company’s best estimates, which involves inherent uncertainties, and the application of management’s judgment. Significant estimates include the expected life of the stock option, stock price volatility and risk-free interest rate. Research and Development Research and development costs are expensed as incurred. The amounts expensed in the years ended December 31, 2017 and 2018 were approximately $3,365,000 and $4,469,000, respectively, which includes salaries of research and development personnel. Income Taxes The Company provides for income taxes utilizing the liability method. Under the liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits. Tax rate changes are reflected in the computation of the income tax provision during the period such changes are enacted. Deferred tax assets are reduced by a valuation allowance when, in management’s opinion, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company’s valuation allowance is based on available evidence, including its current year operating loss, evaluation of positive and negative evidence with respect to certain specific deferred tax assets including evaluation sources of future taxable income to support the realization of the deferred tax assets. The Company has established a full valuation allowance on the deferred tax assets as of December 31, 2017 and 2018, and therefore has not recognized any income tax benefit or expense in the periods presented. A tax benefit from uncertain tax positions may be recognized by the Company when it is more-likely-than-not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. The Company recognizes interest and/or penalties related to income tax matters in income tax expense. There is no accrual for interest or penalties for income taxes on the balance sheets at December 31, 2017 and 2018, and the Company has not recognized interest and/or penalties in the statements of operations and comprehensive loss for the years ended December 31, 2017 and 2018. Recent Accounting Pronouncements 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. Early adoption of the instrument-specific credit risk amendment is permitted. 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 the Company will elect the optional transition method to account for the impact of the adoption with a cumulative-effect adjustment in the period of adoption and will not restate prior periods. The Company expects to elect certain practical expedients permitted under the transition guidance. The Company will record a right-of-use asset and liability upon adoption of the guidance. The Company is currently finalizing its review of contracts and may identify additional embedded leases and additional amounts to be recorded . 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. Early adoption is permitted. 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. Certain applications of this guidance are permitted for early adoption. 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 adopted this guidance for the fiscal year beginning on January 1, 2019 and determined that the adoption of this guidance not 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 adopted this guidance for the fiscal year beginning on January 1, 2019 and determined that the adoption of this guidance will not 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 |
Sales of Equity Securities
Sales of Equity Securities | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Sales of Equity Securities | 4. 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. All warrants sold in this offering have a per share exercise price of $75.00 and expire on October 1, 2022. 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 5). 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, an offering of 48,888 shares of the Company’s common stock and warrants 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. All warrants sold in this offering have a per share exercise price of $45.00, are exercisable immediately and expire five years from the date of issuance. The estimated grant date fair value of this warrant of approximately $1.5 million was recorded as an offset to additional paid-in capital upon the closing of this offering (see Note 5). On January 30, 2018, the Company received net cash proceeds of approximately $13.3 million as a result of 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. All warrants sold in this offering have an exercise price of $3.16 per share, which is subject to down round adjustment, an aggregate estimated grant date fair value of $9.7 million (see Note 4) 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 our 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 our public float is less than $75 million. On August 13, 2018, the Company completed a rights offering. 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 our common stock at an exercise price of $4.53 per share, resulting in net proceeds to the Company of approximately $10.1 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. On September 20, 2018, the Company completed an offering of 642,438 shares of the Company’s common stock and prefunded 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. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to purchase one share of the Company’s common stock for each share and pre-funded warrant purchased for cash in the offering. All warrants issued in this offering have an exercise price of $3.16 per share, are exercisable upon the six-month anniversary of issuance and expire five years from such date. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The estimated nonrecurring fair value measurements associated with fixed asset purchases recorded as equipment financing obligations totaling approximately $719,000 and $279,000 during the years ended December 31, 2017 and 2018, respectively, were based on information provided by vendors, which involved the use of significant unobservable Level 3 inputs. The estimated fair value of the terms of the credit facility entered into with Oxford Finance LLC in April 2014, or the April 2014 Credit Facility, at December 31, 2017 and 2018 approximated its carrying value, which was determined using a discounted cash flow analysis. The analysis considered interest rates of instruments with similar maturity dates, which involved the use of significant unobservable Level 3 inputs. Other Fair Value Measurement As of the closing of the Company’s March 31, 2017 offering, the estimated grant date fair value of $39.30 per share associated with the warrants to purchase up to 72,000 shares of common stock issued in this offering, or a total of approximately $2.8 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 63.90 Exercise price $ 75.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.93 % Expected life (in years) 5.00 Expected volatility 80.0 % As of the closing of the Company’s August 9, 2017 offering, the estimated grant date fair value of $30.90 per share associated with the warrant to purchase up to 47,821 shares of common stock issued in this offering, or a total of approximately $1.5 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 41.70 Exercise price $ 45.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.81 % Expected life (in years) 5.00 Expected volatility 100.0 % As of the closing of the Company’s December 8, 2017 offering, the estimated grant date fair value of $15.60 per share associated with the warrant to purchase up to 8,208 shares of common stock issued to the placement agent in this offering, or a total of approximately $0.1 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 22.20 Exercise price $ 25.50 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.09 % Expected life (in years) 4.50 Expected volatility 100.0 % 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 $3.16 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 at issuance 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 $ 15.00 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. On November 28, 2018, the pre-funded warrants were exercised for total proceeds of approximately $1,200. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Details | 6. Balance Sheet Details The following provides certain balance sheet details: December 31, December 31, 2017 2018 Fixed Assets Machinery and equipment $ 2,841,388 $ 2,818,583 Furniture and office equipment 147,976 157,391 Computer equipment and software 1,637,034 1,437,408 Leasehold improvements 553,529 570,173 Financed equipment 2,294,762 2,573,955 Construction in process 2,975 116,640 7,477,664 7,674,150 Less accumulated depreciation and amortization (4,354,097 ) (4,934,728 ) Total fixed assets, net $ 3,123,567 $ 2,739,422 Accrued Liabilities Accrued interest $ 326,602 $ - Accrued payroll 224,813 255,426 Accrued vacation 474,953 535,682 Accrued bonuses 375,000 712,574 Accrued sales commissions 104,509 62,767 Current portion of deferred rent 116,681 158,342 Accrued other 129,805 203,602 Total accrued liabilities $ 1,752,363 $ 1,928,393 |
April 2014 Credit Facility
April 2014 Credit Facility | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
April 2014 Credit Facility | 7. 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 the entry 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 are amortized to interest expense utilizing the effective interest method over the underlying term of the loan, with total unamortized discounts of approximately $33,000 at December 31, 2017. The effective annual interest rate associated with the April 2014 Credit Facility was 13.87% at December 31, 2017. As of December 31, 2017, total remaining principal payments of approximately $1,201,000 were due and such principal balance was paid during the year ended December 31, 2018 with no outstanding principal balance remaining at December 31, 2018. |
Equipment Financings
Equipment Financings | 12 Months Ended |
Dec. 31, 2018 | |
Capital Lease Obligations [Abstract] | |
Equipment Financings | 8. 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 5 to 7 years. The total gross value of fixed assets capitalized under such financing arrangements was approximately $2,295,000 and $2,574,000 at December 31, 2017 and 2018, respectively. Total accumulated depreciation related to financed equipment was approximately $759,000 and $1,135,000 at December 31, 2017 and 2018, respectively, and total depreciation expense was approximately $234,000 and $376,000, at December 31, 2017 and 2018, respectively. Fixed asset purchases totaling approximately $719,000 and $279,000 during the years ended December 31, 2017 and 2018, respectively, were recorded as equipment financings. On September 15, 2017, and as amended on October 17, 2017, the Company executed an equipment financing commitment with a third-party lender for total proceeds to the Company of approximately $151,000, which was funded by the lender on November 2, 2017. Under the terms of the amended equipment financing agreement, which was accounted for as a sale-leaseback transaction, fixed assets previously purchased by the Company with aggregate gross and net book values of approximately $167,000 and $162,000, respectively, were granted as a security interest to the third-party lender, with the principal balance plus interest to be repaid in 36 monthly installments of $4,884 totaling approximately $176,000 through October 2020. During the year ended December 31, 2017, certain machinery and equipment with aggregate gross, accumulated depreciation, and net book values of approximately $189,000, $155,000 and $34,000, respectively, were exchanged with a lender as partial payment on an outstanding equipment financing obligation balance. 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 and accrued 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 December 31, 2018: Maintenance Minimum and Sales Tax Lease Obligation Payments Payments 2019 $ 670,896 $ 91,285 2020 551,610 72,635 2021 305,006 51,473 2022 264,600 60,832 Thereafter 310,932 45,710 Total payments 2,103,044 321,935 Less amount representing interest 476,493 - Present value of payments $ 1,626,551 $ 321,935 The aggregate weighted average effective annual interest rate related to the equipment financings was 13.51% and 12.53% at December 31, 2017 and 2018, respectively, and the maturity dates on such outstanding arrangements range from June 2018 to September 2024. During the years ended December 31, 2017 and 2018, total interest expense related to equipment financings of $171,000 and $237,000, respectively, was recorded to the Company’s statement of operations and comprehensive loss. At December 31, 2018, the present value of minimum lease payments due within one year was approximately $642,000. On January 26, 2018, the Company executed a lease agreement with a third-party lender to finance approximately $250,000 of planned fixed asset purchases. Under the terms of the lease agreement, the lease commencement and repayment occurs once the Company has financed equipment purchases for the full amount available under the lease agreement. During the fourth quarter of 2018, the lease agreement was amended to increase the amount available under the lease to a total available cost of $332,000. During 2018, equipment with a total cost of $332,000 was purchased under the lease and the lease term commenced on December 1, 2018. Under the term of the lease, the Company is required to make 22 payments of $15,274 per month during the term of the agreement. Prior to lease commencement in December 2018, the Company paid pro-rated equipment rental charges for equipment financed under this lease totaling approximately $124,000. |
Supplier Financings
Supplier Financings | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Supplier Financings | 9. Supplier Financings In 2017 and 2018, the Company obtained third-party financing for certain business insurance premiums. The 2017 and 2018 financings bore interest at rates ranging from 4.40% to 6.20% per annum, and all financings were due within one year. The balances due under these annual financing arrangements were approximately $61,000 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 10. 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 December 31, 2018, 124,211 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 December 31, 2018, under all plans, a total of 264,098 non-inducement shares were authorized for issuance, 95,258 shares had been issued with 79,300 non-inducement stock options and restricted stock units, or RSUs, underlying outstanding awards, and 168,840 non-inducement shares were available for grant. As of December 31, 2018, 118,368 inducement shares had been issued under the 2013 Plan, with 117,534 inducement stock options and RSUs underlying outstanding awards and 0 inducement shares available for grant. Stock Options Non-performance options granted under either plan vest over a maximum period of four years and expire ten years from the date of grant. Non-performance options generally vest either (i) over four years, 25% on the one-year anniversary of the date of grant and monthly thereafter for the remaining three years; or (ii) over four years, monthly vesting beginning month-one after the grant and monthly thereafter. The fair value of stock options is determined on the date of grant using the Black-Scholes valuation model. For non-performance awards, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for performance awards is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. The determination of the fair value of stock options is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables. The volatility assumption is based on a combination of the historical volatility of the Company’s common stock and the volatilities of similar companies over a period of time equal to the expected term of the stock options. The volatilities of similar companies are used in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the Company’s common stock equal to the expected term. The expected term of employee stock options represents the weighted-average period the stock options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’ vesting terms and remaining contractual life and employees’ expected exercise and post-vesting employment termination behavior. The risk-free interest rate assumption is based upon observed interest rates on the grant date appropriate for the term of the employee stock options. The dividend yield assumption is based on the expectation of no future dividend payouts by the Company. The assumptions used in the Black-Scholes pricing model for options granted during the years ended December 31, 2017 and 2018 are as follows: 2017 2018 Stock and exercise prices $20.82 - $63.90 $0.86 - $6.00 Expected dividend yield 0.00% 0.00% Discount rate-bond equivalent yield 1.79% – 2.27% 2.50% - 3.02% Expected life (in years) 5.12 – 6.09 4.00 - 5.96 Expected volatility 70.0% – 90.0% 100% - 120% Using the assumptions described above, with stock and exercise prices being equal on date of grant, the weighted-average estimated fair value of options granted in 2017 and 2018 were approximately $1.02 and $1.75 per share, respectively. A summary of stock option activity for the years ended December 31, 2017 and 2018 is as follows: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term in Years Outstanding at December 31, 2016 29,888 $ 264.00 8.5 Granted 58,501 $ 44.70 Exercised — — Cancelled/forfeited/expired (6,746 ) $ 143.10 Outstanding at December 31, 2017 81,643 $ 113.68 8.8 Granted 142,587 $ 2.20 Exercised — — Cancelled/forfeited/expired (28,410 ) $ 57.96 Outstanding at December 31, 2018 195,820 $ 41.41 9.2 Vested and unvested expected to vest, December 31, 2018 183,136 $ 44.02 9.1 The intrinsic values of options outstanding, options exercisable, and options vested and unvested expected to vest at December 31, 2017 and 2018 were each zero. On July 25, 2016, the Company entered into an employment agreement with its new Chief Financial Officer, Senior Vice President of Operations and Secretary, or CFO. Pursuant to the terms of this employment agreement, on July 29, 2016 the CFO was granted inducement stock option awards with an exercise price of $58.50 per share to purchase up to (i) 2,222 shares of the Company’s common stock with an estimated grant date fair value of $43.50 per share, 25% of which vested on the one-year anniversary of the commencement of the CFO’s employment with the Company, and remainder of which will vest in equal monthly installments over the following three years, and (ii) 1,111 shares of the Company’s common stock with an estimated grant date fair value of $37.80 per share, which vested upon the Company’s achievement of specified corporate goals for 2016 and the consummation of a specified financing transaction. During the year ended December 31, 2017, 546 shares of the performance option award granted on July 29, 2016 were declared vested by the Company’s Board of Directors, and the remaining 565 shares underlying this award were forfeited. 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 has 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 2,500 performance stock options were forfeited by December 31, 2017. Each performance stock option granted on July 31, 2017 has an exercise price of $41.70 per share and an estimated grant date fair value of $24.90 per share. Each of the performance stock options granted during the year ended December 31, 2017 were subject to continuing service with vesting as 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. Subsequent to the year ended December 31, 2017, 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 The fair value of RSUs awarded under either plan is determined by the closing price of the Company’s common stock on the date of grant. For non-performance RSUs, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for RSUs is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. A summary of RSU activity during 2017 and 2018 is as follows: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2016 5,808 $ 80.40 Granted 11,666 $ 45.00 Vested and issued (5,194 ) $ 58.80 Forfeited (250 ) $ 63.60 Outstanding at December 31, 2017 12,030 $ 56.10 Granted — $ — Vested and issued (5,835 ) $ 45.00 Forfeited (5,835 ) $ 45.00 Outstanding at December 31, 2018 360 $ 415.80 Vested and unvested expected to vest, December 31, 2018 360 $ 415.80 At December 31, 2018, the intrinsic value of RSUs outstanding and RSUs unvested and expected to vest were approximately $300. Of the 360 RSUs outstanding at December 31, 2018, all were fully vested. The RSUs granted during the year ended December 31, 2016 vested fully on the one year anniversary of the date of grant and were subject to continuing service by the holders of such RSUs. At December 31, 2017, the intrinsic values of RSUs outstanding and RSUs unvested and expected to vest were approximately $250,000 and $129,000, respectively. 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 certain other executive officers. Each RSU granted on May 31, 2017 has a grant date fair value of $45.00 per share. Vesting of the time-based RSUs granted on May 31, 2017 is subject to continuing service and occurred on the one year anniversary of the vesting commencement date, or May 2, 2018, while the performance RSUs were subject to continuous service and vesting was as 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. Subsequent to the year ended December 31, 2017, 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 5,833 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 statement of operations during the periods presented: Years Ended December 31, 2017 2018 Stock Options Cost of revenues $ 142,400 $ 46,708 Research and development expenses 143,300 133,525 General and administrative expenses 575,741 300,433 Sales and marketing expenses 68,381 78,321 Total expenses related to stock options 929,822 558,987 RSUs Cost of revenues 48,745 (18,802 ) Research and development expenses 55,941 13,576 General and administrative expenses 160,937 54,302 Sales and marketing expenses 52,036 15,349 Total stock-based compensation $ 1,247,481 $ 623,412 Stock-based compensation expense was recorded net of estimated forfeitures of 0% - 8% per annum during the years ended December 31, 2017 and 2018. As of December 31, 2018, total unrecognized share-based compensation expense related to unvested stock options and RSUs, adjusted for estimated forfeitures, was approximately $667,000, and such amount expected to be recognized over a weighted-average period of approximately 2.13 years. |
Common Stock Warrants Outstandi
Common Stock Warrants Outstanding | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Common Stock Warrants Outstanding | 11. Common A summary of equity-classified common stock warrant activity, for warrants other than those underlying unexercised overallotment option warrants, during 2017 and 2018 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2016 387,395 $ 57.90 4.6 Issued 128,029 $ 60.62 Exercised (227,228 ) $ 33.00 Expired — $ — Outstanding at December 31, 2017 288,196 $ 78.86 4.0 Issued 4,526,661 $ 3.85 Exercised (120,000 ) $ 0.01 Expired — $ — Outstanding at December 31, 2018 4,694,927 $ 8.55 4.4 All warrants outstanding at December 31, 2018 are exercisable, except for the 762,438 warrants issued on September 24, 2018, which were first exercisable on March 24, 2019 and expire on March 24, 2024. The intrinsic value of equity-classified common stock warrants outstanding at December 31, 2018 was zero. On January 30, 2018, the Company issued warrants to purchase up to an aggregate of 1,095,153 shares of its common stock, which had an exercise price of $15.00 per share are exercisable immediately and expire five years from the date of issuance |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 12. 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 years ended December 31, 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. Therefore, 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 year ended December 31, 2017 2018 Preferred warrants outstanding (number of common stock equivalents) 17 17 Common warrants outstanding 288,196 4,694,927 RSUs outstanding 12,030 360 Convertible preferred stock outstanding (number of common stock equivalents) — 976,157 Common options outstanding 81,643 195,820 Total anti-dilutive common share equivalents 381,886 5,867,281 |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2018 | |
Postemployment Benefits [Abstract] | |
401(k) Plan | 13. 401(k) Plan The Company sponsors a 401(k) savings plan for all eligible employees. The Company may make discretionary matching contributions to the plan to be allocated to employee accounts based upon employee deferrals and compensation. During the years ended December 31, 2017 and 2018, the Company made $90,000 and approximately $215,000, respectively, in matching contributions into the savings plan. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes On December 22, 2017, the President of the United States signed into law new legislation, or the Act, that significantly revises the Internal Revenue Code of 1986, as amended, or the Code. The Act amends the Code to reduce tax rates and modify policies, credits, and deductions for individuals and businesses. On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act which, among a broad range of tax reform measures, reduced the U.S. corporate tax rate from 35% to a flat 21% effective January 1, 2018. The reduction in the U.S. corporate tax rate required the Company to remeasure the federal portion of deferred tax assets and liabilities at December 31, 2017 to the enacted tax rate expected to apply when the temporary differences are to be realized. The Company provisionally recorded $2.6 million of expense related, offset by a full valuation allowance, for the remeasurement of its deferred tax assets and liabilities. As of December 31, 2018, the Company completed its accounting for the tax effects of the enactment of the 2017 Act which resulted in immaterial adjustments to provisional estimates, offset by a full valuation allowance. For the years ended December 31, 2017 and 2018, the provision for income taxes was calculated as follows: For the year ended December 31, 2017 2018 Current: Federal $ — $ — State 7,624 1,886 Total 7,624 1,886 Deferred Federal — — State — — Total — — Provision for income tax $ 7,624 $ 1,886 The following table reconciles income taxes computed at the federal statutory rate and the Company’s provision for income taxes: For the year ended December 31, 2017 2018 Income tax at statutory rate $ (7,346,079 ) $ (5,159,881 ) Change in federal tax rate 2,621,803 — State liability (411,853 ) (670,015 ) Permanent items 214,313 118,959 Stock compensation 72,696 11,128 Nondeductible interest 15,568 — Expiration of net operating losses 922,307 — Research and development credit (200,379 ) (272,314 ) State rate change (18,026 ) (132,855 ) Estimated section 382 limitation 1,491,942 — Return to provision 365,263 8,386 Other 488,264 19,420 Valuation allowance 1,791,805 6,079,058 Provision for income tax $ 7,624 $ 1,886 Deferred income taxes are provided for temporary differences in recognizing certain income and expense items for financial and tax reporting purposes. The deferred tax assets consisted primarily of the income tax benefits from estimated net operating loss carryforwards, deferred rent, and estimated research and development credits. Valuation allowances have been recorded to fully offset deferred tax assets at December 31, 2017 and 2018, as it is more likely than not that the assets will not be utilized. At December 31, 2018, the Company had estimated federal net operating loss carryforwards of approximately $13.6 million expiring beginning in 2035 and total estimated state net operating loss carryforwards of approximately $24.7 million expiring beginning in 2023. The Company has additional federal net operating losses of $23.6 million generated after 2017, which carry over indefinitely and may generally be used to offset up to 80% of future taxable income. Additionally, at December 31, 2018, the Company had estimated research and development credits of approximately $160,000 and $3,543,000 for federal and California purposes, respectively. The estimated federal research and development tax credits will begin to expire in 2035. The California research and development tax credits do not expire. For the years ended December 31, 2017 and 2018, the Company has evaluated the various tax positions reflected in its income tax returns for both federal and state jurisdictions, to determine if the Company has any uncertain tax positions on the historical tax returns. The Company recognizes the impact of an uncertain tax position on an income tax return at the largest amount that the relevant taxing authority is more-likely-than not to sustain upon audit. The Company does not recognize uncertain income tax positions if they have less than 50 percent likelihood of being sustained. Based on this assessment, the Company believes there are no tax positions for which a liability for unrecognized tax benefits should be recorded as of December 31, 2017 or 2018. The Company is subject to U.S. federal income tax as well as income tax in multiple state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal income tax examinations for 2015 and before, state and local income tax examinations 2014 and before. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where net operating losses were generated and carried forward and make adjustments up to the amount of the net operating loss carry forward amount. The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. Due to the existence of the valuation allowance, future changes in unrecognized tax benefits will not impact the Company’s effective tax rate. The Company is currently not under examination by any taxing authorities and does not believe its unrecognized tax benefits will significantly change in the next twelve months. The tax effects of carryforwards and other temporary differences that give rise to deferred tax assets consist of the following: For the year ended December 31, 2017 2018 Estimated net operating loss carryforward $ 3,699,532 $ 9,229,174 Estimated research and development credits 2,686,665 2,958,710 Accruals and other 2,560,419 2,864,028 Deferred rent 90,866 64,628 9,037,482 15,116,540 Less valuation allowance (9,037,482 ) (15,116,540 ) Net deferred tax assets $ — $ — Utilization of the estimated domestic net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 and 383 of the Code, as well as similar state provisions. These ownership changes may limit the amount of estimated net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders. Since the Company’s formation, the Company has raised capital through the issuance of capital stock on several occasions which on its own or combined with the purchasing stockholders’ subsequent disposition of those shares, likely resulted in such an ownership change, or could result in an ownership change in the future. Upon the occurrence of an ownership change under Section 382 of the Code as outlined above, utilization of the estimated net operating loss and research and development credit carryforwards are subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term, tax-exempt rate, which could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the estimated net operating loss or research and development credit carryforwards before utilization. The Company has not yet completed an analysis to determine whether an ownership change has occurred, however, the Company believes ownership changes likely occurred in each year from 2015 through 2018. As a result, the Company has estimated that the use of its net operating loss is limited and has disclosed in the table above only the amounts it estimates could be used in the future, which remain fully offset by a valuation allowance to reduce the net asset to zero. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. 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 payments totaling approximately $15,000 and $19,000 during the years ended December 31, 2017 and 2018, respectively, from Aegea as reimbursements for shared patent costs under the Cross-License Agreement. 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 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Operating Leases The Company leases office, laboratory, and warehouse space at its San Diego, California facility under a non-cancelable operating lease. The initial lease was for an eight-year term expiring in 2012. In November 2011, the Company extended the lease term through October 31, 2018 and expanded the original premises by 9,849 square feet. Under the amended lease, the landlord delivered the expanded premises in May 2013. In September 2013, the Company extended the lease term through July 31, 2020. The Company records rent expense on a straight-line basis over the life of the lease and records the excess of expense over the amounts paid as deferred rent. During each of the years ended December 31, 2017 and 2018, total rent expense recorded in the Company’s statements of operations and comprehensive loss was approximately $1,272,000. The future minimum lease payments under the amended lease agreement as December 31, 2018 are as follows: 2019 $ 1,430,366 2020 855,136 Thereafter — Total $ 2,285,502 Purchase Commitment 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 December 31, 2018, approximately $341,000 remained outstanding under this purchase commitment. Financed Equipment Maintenance and Sales Tax Obligations During the years ended December 31, 2017 and 2018, total expense recorded in the Company’s statement of operations and comprehensive loss for sales tax and maintenance obligations associated with equipment financing arrangements was approximately $79,000 and $101,000, respectively. At December 31, 2018, approximately $69,000 of such sales tax and maintenance obligations incurred but not paid were recorded in accrued other liabilities in the Company’s balance sheet (see Note 6). Future payments totaling approximately $322,000 for sales tax and maintenance obligations associated with financed equipment were due under equipment financing arrangements at December 31, 2018, which will be expensed as incurred (see Note 8). Legal Proceedings 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 which are expected to have a material adverse effect on its financial condition, results of operations or liquidity. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | 17. Selected Quarterly Financial Data (Unaudited) The following is selected quarterly financial data as of and for the periods ending: First Quarter Second Quarter Third Quarter Fourth Quarter December 31, 2017 Balance sheet data: Cash $ 14,042,388 $ 10,000,155 $ 5,879,025 $ 2,146,611 Total assets 17,933,413 14,653,193 11,120,215 7,378,906 Total non-current liabilities 2,062,544 1,561,520 1,255,939 1,421,527 Total shareholders’ equity 10,418,069 7,342,257 4,026,079 1,296,034 Statement of operations and comprehensive loss data: Net revenues $ 1,683,065 $ 1,278,961 $ 1,111,411 $ 995,226 Cost of revenues 2,129,454 2,368,705 2,487,054 2,359,909 Research and development expenses 757,258 841,991 856,698 908,800 General and administrative expenses 1,906,635 1,798,026 1,834,771 1,650,097 Sales and marketing expenses 1,278,311 1,746,867 1,675,852 1,642,941 Loss from operations (4,388,593 ) (5,476,628 ) (5,742,964 ) (5,566,521 ) Net loss $ (4,432,707 ) $ (5,693,151 ) $ (5,821,306 ) $ (5,666,573 ) Net loss per common share: 1 Basic $ (6.27 ) $ (6.32 ) $ (5.85 ) $ (5.36 ) Diluted $ (6.27 ) $ (6.32 ) $ (5.85 ) $ (5.36 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 707,389 901,007 995,254 1,058,055 Diluted 707,389 901,007 995,254 1,058,055 1 Basic and diluted net loss per common share are computed independently for each of the components and quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. First Quarter Second Quarter Third Quarter Fourth Quarter December 31, 2018 Balance sheet data: Cash $ 9,272,420 $ 2,569,111 $ 8,956,200 $ 3,423,373 Total assets 14,747,827 8,291,310 14,551,892 8,750,303 Total non-current liabilities 1,357,193 1,258,261 1,174,397 1,098,137 Total shareholders’ equity 8,507,714 2,527,568 8,938,408 3,042,519 Statement of operations and comprehensive loss data: Net revenues $ 806,943 $ 822,238 $ 761,591 $ 859,526 Cost of revenues 2,434,886 2,699,671 2,481,916 2,435,262 Research and development expenses 1,070,584 1,019,285 1,089,746 1,288,957 General and administrative expenses 1,938,664 1,708,970 1,793,720 1,632,670 Sales and marketing expenses 1,636,542 1,433,174 1,404,192 1,440,798 Loss from operations (6,273,733 ) (6,038,862 ) (6,007,983 ) (5,938,161 ) Net loss $ (6,356,404 ) $ (6,153,101 ) $ (6,047,784 ) $ (6,014,312 ) Deemed dividend related to warrants down round provision — — (636,370 ) — Net loss attributable to common shareholders $ (6,356,404 ) $ (6,153,101 ) $ (6,684,154 ) $ (6,014,312 ) Net loss per common share: 1 Basic $ (3.33 ) $ (2.70 ) $ (2.42 ) $ (1.43 ) Diluted $ (3.33 ) $ (2.70 ) $ (2.42 ) $ (1.43 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 1,911,282 2,280,115 2,767,440 4,209,221 Diluted 1,911,282 2,280,115 2,759,614 4,209,221 1 Basic and diluted net loss per common share are computed independently for each of the components and quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events On January 18, 2019, the Company completed an offering of 990,000 shares of the Company’s common stock. The shares were sold at a purchase price of $2.25 per share and the net proceeds to the Company from this offering were approximately $2.0 million, after deducting expenses related to the offering including dealer-manager fees and expenses. On February 12, 2019, the Company received net cash proceeds of approximately $6.8 million as a result of the closing of a follow-on public offering of 6,250,000 shares of its common stock and warrants to purchase up to an aggregate of 6,250,000 shares of its common stock at a combined offering price of $1.20 per unit. All warrants sold in this offering have an exercise price of $1.20 per share, are exercisable immediately and expire five years from the date of issuance. In addition, the Company sold warrants to purchase up to an aggregate of 937,500 shares of the Company’s common stock in connection with the partial exercise of the over-allotment option granted to the underwriters. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of warrants sold in this offering. On March 11, 2019, the underwriters exercised their overallotment option for 538,867 shares of the Company’s common stock related to the February 12, 2019 follow-on offering, purchasing shares at $1.20 for net cash proceeds of approximately $601,000. Pursuant to the down round adjustment feature of the January 2018 warrants, the exercise price of these warrants was adjusted to the $1.20 price per share offering price in the February 2019 financing transaction. On March 19, 2019, the Company received net cash proceeds of approximately $7.5 million as a result of completing a registered direct offering of 5,950,000 shares at a negotiated purchase price of $1.37 per share. In addition, in a concurrent private placement, the Company issued to purchasers a warrant to purchase one share of the Company’s common stock for each share purchased for cash in the offering. All warrants issued in this offering have an exercise price of $1.25 per share, are exercisable immediately upon issuance and expire 5.5 years following the date of issuance. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
The Company and Business Activities | 1. The Company and Business Activities The Company was founded in California in May 1997 and 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, Empower TC, provides the unique ability for pathologists to participate in the interpretation of liquid biopsy results and is available to pathology practices and hospital systems throughout the United States. Further, sales to laboratory supply distributors of commenced in June 2018, 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. In July 2013, the Company effected a reincorporation to Delaware by merging itself with and into Biocept, Inc., a Delaware corporation, which had been formed to be and was a wholly-owned subsidiary of the Company since July 23, 2013. |
Basis of Presentation | Basis of Presentation The accompanying financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and are prepared on the basis that the Company will continue as a going concern (see Note 2). The accompanying 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. 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 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, which was not affected by the one-for-thirty reverse stock split. |
Going Concern | Going Concern The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim financial statements are issued (see Note 2). Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by management. |
Use of Estimates | Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates these estimates and judgments, including those related to accounts receivable, inventories, long-lived assets, income taxes, revenues, stock-based compensation, and the determination of the Company’s ability to continue as a going concern. The Company bases its estimates on various assumptions that it believes are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. |
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. Commencing on March 31, 2017, the Company began to recognize 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. • Once 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 amount of variable consideration using the most likely amount approach to estimating variable consideration for third-party payers, including direct patient bills, whereby the estimated reimbursement for services are established by payment histories on CPT codes for each payer, or similar payer types. When no payment history is available, the value of the account is estimated at Medicare rates, with additional other payer-specific reserves taken as appropriate. Collection periods for billings on commercial revenues range from less than 30 days to several months, depending on the contracted or non-contracted nature of the payer, among other variables. The estimates of amounts that will ultimately be realized from commercial diagnostic services for non-contracted payers require significant judgment by management. 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 year ended December 31, 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 years ended December 31, 2017 and 2018, disaggregated by source and nature, are as follows: For the year ended December 31, 2017 2018 Net revenues from contracted payers* $ 2,074,596 $ 1,348,383 Net revenues from non-contracted payers 2,721,717 1,703,179 Development services revenues 272,350 198,736 Total net revenues $ 5,068,663 $ 3,250,298 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the year ended December 31, 2017 2018 Net commercial revenues recognized upon delivery $ 3,570,337 $ 3,051,562 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total net revenues $ 5,068,663 $ 3,250,298 The amount of nonrecurring net revenue recorded during the year ended December 31, 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 $843,000, and the corresponding decrease in net loss per common share was $0.90. 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 $1,139,000 during the year ended December 31, 2017, and the corresponding decrease in net loss per common share was $1.20, respectively. For the year ended December 31, 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 composition of the Company’s gross and net revenues recognized during the years ended December 31, 2017 and 2018 is as follows: For the year ended December 31, 2017 2018 Commercial revenues recognized upon delivery $ 15,685,069 $ 12,505,149 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total gross revenues 17,183,395 12,703,885 Provisions for contractual discounts (5,805,787 ) (3,937,993 ) Provisions for aged non-patient receivables (735,709 ) (326,137 ) Provisions for estimated patient receivables (169,479 ) (66,470 ) Provisions for other payer-specific sales allowances (5,403,757 ) (5,122,987 ) Net revenues $ 5,068,663 $ 3,250,298 A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2018 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2017 Upon Delivery Adjudication 2018 Accounts receivable, gross $ 6,937,063 $ 12,835,371 $ (11,889,832 ) $ 7,882,602 Reserve for contractual discounts (1,974,849 ) (3,214,615 ) 3,011,989 (2,177,475 ) Reserve for aged non-patient receivables (452,088 ) (994,542 ) 880,682 (565,948 ) Reserve for estimated patient receivables (88,120 ) (135,955 ) 208,598 (15,477 ) Reserve for other payer-specific sales allowances (3,228,580 ) (5,239,961 ) 4,919,164 (3,549,377 ) Accounts receivable, net $ 1,193,426 $ 3,250,298 $ (2,869,399 ) $ 1,574,325 |
Cash | Cash The Company places its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation, or FDIC. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company has not experienced any losses in its cash and believes they are not exposed to any significant credit risk. |
Fair Value Measurements | Fair Value Measurements The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximate their estimated fair values due to the short-term maturities of these financial instruments. See Note 5 for further details about the inputs and assumptions used to determine fair value measurements. |
Concentration of Risk | Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. 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 a large number of 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 years ended December 31, 2017 and 2018 were as follows: For the year ended December 31, 2017 2018 Medicare and Medicare Advantage 39 % 39 % Blue Cross Blue Shield 19 % 11 % United Healthcare 12 % 17 % 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 2018 were as follows: For the year ended December 31, 2017 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 17 % United Healthcare 15 % 15 % The Company operates in one reportable business segment and historically has derived most revenues only from within the United States. Certain components used in the Company’s current or planned products are currently sourced from one supplier, for which alternative suppliers exist but the Company has not validated the product(s) of such alternative supplier(s), and substitutes for these components may not be obtained easily or may require substantial design or manufacturing modifications. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined by the average cost method. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. At the point of loss recognition, a new cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. In addition, the Company records a liability for firm, non-cancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities in excess of the Company’s future demand forecasts consistent with its valuation of excess and obsolete inventory. |
Fixed Assets | Fixed Assets Fixed assets consist of machinery and equipment, furniture and fixtures, computer equipment and software, leasehold improvements, financed equipment and construction in-process. Fixed assets are stated at cost less accumulated depreciation and amortization. Additions, improvements, and major renewals are capitalized. Maintenance, repairs, and minor renewals are expensed as incurred. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the life of the lease or the asset, whichever is shorter. Depreciation and amortization expense for the years ended December 31, 2017 and 2018 was approximately $576,000 and $801,000, respectively. Upon sale or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation or amortization with any gain or loss recorded to the statement of operations and comprehensive loss. Fixed assets are reviewed for impairment whenever changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in the estimates of future cash flows to determine recoverability of these assets. If the assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss. |
Stock-based Compensation | Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees and directors based on their grant date fair values. The Company estimates the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, while the fair value of restricted stock unit awards, or RSUs, is determined by the Company’s stock price on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In addition, the Company estimates forfeitures at the time of grant and revises these estimates in subsequent periods if actual forfeitures differ from those estimates (see Note 10). The Company determines the fair value of the stock-based compensation awards granted as either the fair value of the consideration received, or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards are recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods based on the fair value of the options at the end of each period. Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based compensation expense is calculated using the Company’s best estimates, which involves inherent uncertainties, and the application of management’s judgment. Significant estimates include the expected life of the stock option, stock price volatility and risk-free interest rate. |
Research and Development | Research and Development Research and development costs are expensed as incurred. The amounts expensed in the years ended December 31, 2017 and 2018 were approximately $3,365,000 and $4,469,000, respectively, which includes salaries of research and development personnel. |
Income Taxes | Income Taxes The Company provides for income taxes utilizing the liability method. Under the liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits. Tax rate changes are reflected in the computation of the income tax provision during the period such changes are enacted. Deferred tax assets are reduced by a valuation allowance when, in management’s opinion, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company’s valuation allowance is based on available evidence, including its current year operating loss, evaluation of positive and negative evidence with respect to certain specific deferred tax assets including evaluation sources of future taxable income to support the realization of the deferred tax assets. The Company has established a full valuation allowance on the deferred tax assets as of December 31, 2017 and 2018, and therefore has not recognized any income tax benefit or expense in the periods presented. A tax benefit from uncertain tax positions may be recognized by the Company when it is more-likely-than-not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. The Company recognizes interest and/or penalties related to income tax matters in income tax expense. There is no accrual for interest or penalties for income taxes on the balance sheets at December 31, 2017 and 2018, and the Company has not recognized interest and/or penalties in the statements of operations and comprehensive loss for the years ended December 31, 2017 and 2018. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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. Early adoption of the instrument-specific credit risk amendment is permitted. 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 the Company will elect the optional transition method to account for the impact of the adoption with a cumulative-effect adjustment in the period of adoption and will not restate prior periods. The Company expects to elect certain practical expedients permitted under the transition guidance. The Company will record a right-of-use asset and liability upon adoption of the guidance. The Company is currently finalizing its review of contracts and may identify additional embedded leases and additional amounts to be recorded . 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. Early adoption is permitted. 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. Certain applications of this guidance are permitted for early adoption. 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 adopted this guidance for the fiscal year beginning on January 1, 2019 and determined that the adoption of this guidance not 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 adopted this guidance for the fiscal year beginning on January 1, 2019 and determined that the adoption of this guidance will not 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. In June 2018, the FASB issued authoritative guidance simplifying the accounting for nonemployee stock-based compensation and largely aligning such compensation with the accounting requirements for employee stock-based awards. For public companies, this guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of guidance on Revenue from Contracts with Customers (Topic 606). The Company adopted this guidance for the fiscal year beginning on January 1, 2019 and determined that the adoption of this guidance will not have a material impact on its financial statements or disclosures. In November 2018, the FASB issued authoritative guidance clarifying the interaction between Collaborative Arrangements (Topic 808) and Revenue from Contracts with Customers (Topic 606) to address diversity in practice related to how companies account for collaborative arrangements. For public companies, this guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Revenue from Contracts with Customers (Topic 606). The Company currently intends to adopt this guidance upon the effective date and does not anticipate that the adoption of this guidance will have a material impact on its financial statements or disclosures. |
Stock Options [Member] | |
Fair Value Measurements | The fair value of stock options is determined on the date of grant using the Black-Scholes valuation model. For non-performance awards, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for performance awards is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. The determination of the fair value of stock options is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables. The volatility assumption is based on a combination of the historical volatility of the Company’s common stock and the volatilities of similar companies over a period of time equal to the expected term of the stock options. The volatilities of similar companies are used in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the Company’s common stock equal to the expected term. The expected term of employee stock options represents the weighted-average period the stock options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’ vesting terms and remaining contractual life and employees’ expected exercise and post-vesting employment termination behavior. The risk-free interest rate assumption is based upon observed interest rates on the grant date appropriate for the term of the employee stock options. The dividend yield assumption is based on the expectation of no future dividend payouts by the Company. |
Restricted Stock [Member] | |
Fair Value Measurements | The fair value of RSUs awarded under either plan is determined by the closing price of the Company’s common stock on the date of grant. For non-performance RSUs, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for RSUs is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 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 years ended December 31, 2017 and 2018, disaggregated by source and nature, are as follows: For the year ended December 31, 2017 2018 Net revenues from contracted payers* $ 2,074,596 $ 1,348,383 Net revenues from non-contracted payers 2,721,717 1,703,179 Development services revenues 272,350 198,736 Total net revenues $ 5,068,663 $ 3,250,298 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. For the year ended December 31, 2017 2018 Net commercial revenues recognized upon delivery $ 3,570,337 $ 3,051,562 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total net revenues $ 5,068,663 $ 3,250,298 |
Composition of Gross and Net Revenues Recognized | The composition of the Company’s gross and net revenues recognized during the years ended December 31, 2017 and 2018 is as follows: For the year ended December 31, 2017 2018 Commercial revenues recognized upon delivery $ 15,685,069 $ 12,505,149 Development services revenues recognized upon delivery 272,350 198,736 Commercial revenues recognized upon cash collection 1,225,976 — Total gross revenues 17,183,395 12,703,885 Provisions for contractual discounts (5,805,787 ) (3,937,993 ) Provisions for aged non-patient receivables (735,709 ) (326,137 ) Provisions for estimated patient receivables (169,479 ) (66,470 ) Provisions for other payer-specific sales allowances (5,403,757 ) (5,122,987 ) Net revenues $ 5,068,663 $ 3,250,298 |
Summary of Activity in Gross and Net Accounts Receivable Balances and Reserves | A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2018 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2017 Upon Delivery Adjudication 2018 Accounts receivable, gross $ 6,937,063 $ 12,835,371 $ (11,889,832 ) $ 7,882,602 Reserve for contractual discounts (1,974,849 ) (3,214,615 ) 3,011,989 (2,177,475 ) Reserve for aged non-patient receivables (452,088 ) (994,542 ) 880,682 (565,948 ) Reserve for estimated patient receivables (88,120 ) (135,955 ) 208,598 (15,477 ) Reserve for other payer-specific sales allowances (3,228,580 ) (5,239,961 ) 4,919,164 (3,549,377 ) Accounts receivable, net $ 1,193,426 $ 3,250,298 $ (2,869,399 ) $ 1,574,325 |
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 years ended December 31, 2017 and 2018 were as follows: For the year ended December 31, 2017 2018 Medicare and Medicare Advantage 39 % 39 % Blue Cross Blue Shield 19 % 11 % United Healthcare 12 % 17 % 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 2018 were as follows: For the year ended December 31, 2017 2018 Blue Cross Blue Shield 27 % 22 % Medicare and Medicare Advantage 21 % 17 % United Healthcare 15 % 15 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Assumptions Used for Determining Fair Values of Common Stock Warrants | As of the closing of the Company’s March 31, 2017 offering, the estimated grant date fair value of $39.30 per share associated with the warrants to purchase up to 72,000 shares of common stock issued in this offering, or a total of approximately $2.8 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 63.90 Exercise price $ 75.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.93 % Expected life (in years) 5.00 Expected volatility 80.0 % As of the closing of the Company’s August 9, 2017 offering, the estimated grant date fair value of $30.90 per share associated with the warrant to purchase up to 47,821 shares of common stock issued in this offering, or a total of approximately $1.5 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 41.70 Exercise price $ 45.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.81 % Expected life (in years) 5.00 Expected volatility 100.0 % As of the closing of the Company’s December 8, 2017 offering, the estimated grant date fair value of $15.60 per share associated with the warrant to purchase up to 8,208 shares of common stock issued to the placement agent in this offering, or a total of approximately $0.1 million, was recorded as an offset to additional paid-in capital, and was estimated using a Black-Scholes valuation model with the following assumptions: Stock price $ 22.20 Exercise price $ 25.50 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.09 % Expected life (in years) 4.50 Expected volatility 100.0 % Beginning stock price $ 10.17 Exercise price $ 15.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.48 % Expected life (in years) 5.00 Expected volatility 99.00 % 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 % 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) | 12 Months Ended |
Dec. 31, 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, December 31, 2017 2018 Fixed Assets Machinery and equipment $ 2,841,388 $ 2,818,583 Furniture and office equipment 147,976 157,391 Computer equipment and software 1,637,034 1,437,408 Leasehold improvements 553,529 570,173 Financed equipment 2,294,762 2,573,955 Construction in process 2,975 116,640 7,477,664 7,674,150 Less accumulated depreciation and amortization (4,354,097 ) (4,934,728 ) Total fixed assets, net $ 3,123,567 $ 2,739,422 Accrued Liabilities Accrued interest $ 326,602 $ - Accrued payroll 224,813 255,426 Accrued vacation 474,953 535,682 Accrued bonuses 375,000 712,574 Accrued sales commissions 104,509 62,767 Current portion of deferred rent 116,681 158,342 Accrued other 129,805 203,602 Total accrued liabilities $ 1,752,363 $ 1,928,393 |
Equipment Financings (Tables)
Equipment Financings (Tables) | 12 Months Ended |
Dec. 31, 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 and accrued 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 December 31, 2018: Maintenance Minimum and Sales Tax Lease Obligation Payments Payments 2019 $ 670,896 $ 91,285 2020 551,610 72,635 2021 305,006 51,473 2022 264,600 60,832 Thereafter 310,932 45,710 Total payments 2,103,044 321,935 Less amount representing interest 476,493 - Present value of payments $ 1,626,551 $ 321,935 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model | The assumptions used in the Black-Scholes pricing model for options granted during the years ended December 31, 2017 and 2018 are as follows: 2017 2018 Stock and exercise prices $20.82 - $63.90 $0.86 - $6.00 Expected dividend yield 0.00% 0.00% Discount rate-bond equivalent yield 1.79% – 2.27% 2.50% - 3.02% Expected life (in years) 5.12 – 6.09 4.00 - 5.96 Expected volatility 70.0% – 90.0% 100% - 120% |
Summary of Stock Option Activity | A summary of stock option activity for the years ended December 31, 2017 and 2018 is as follows: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term in Years Outstanding at December 31, 2016 29,888 $ 264.00 8.5 Granted 58,501 $ 44.70 Exercised — — Cancelled/forfeited/expired (6,746 ) $ 143.10 Outstanding at December 31, 2017 81,643 $ 113.68 8.8 Granted 142,587 $ 2.20 Exercised — — Cancelled/forfeited/expired (28,410 ) $ 57.96 Outstanding at December 31, 2018 195,820 $ 41.41 9.2 Vested and unvested expected to vest, December 31, 2018 183,136 $ 44.02 9.1 |
Summary of RSU Activity | A summary of RSU activity during 2017 and 2018 is as follows: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2016 5,808 $ 80.40 Granted 11,666 $ 45.00 Vested and issued (5,194 ) $ 58.80 Forfeited (250 ) $ 63.60 Outstanding at December 31, 2017 12,030 $ 56.10 Granted — $ — Vested and issued (5,835 ) $ 45.00 Forfeited (5,835 ) $ 45.00 Outstanding at December 31, 2018 360 $ 415.80 Vested and unvested expected to vest, December 31, 2018 360 $ 415.80 |
Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Statement of Operations | The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the statement of operations during the periods presented: Years Ended December 31, 2017 2018 Stock Options Cost of revenues $ 142,400 $ 46,708 Research and development expenses 143,300 133,525 General and administrative expenses 575,741 300,433 Sales and marketing expenses 68,381 78,321 Total expenses related to stock options 929,822 558,987 RSUs Cost of revenues 48,745 (18,802 ) Research and development expenses 55,941 13,576 General and administrative expenses 160,937 54,302 Sales and marketing expenses 52,036 15,349 Total stock-based compensation $ 1,247,481 $ 623,412 |
Common Stock Warrants Outstan_2
Common Stock Warrants Outstanding (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity Classified Warrants [Abstract] | |
Summary of Equity-Classified Common Stock Warrant Activity, for Warrants Other than Underlying Unexercised Overallotment Option Warrants | A summary of equity-classified common stock warrant activity, for warrants other than those underlying unexercised overallotment option warrants, during 2017 and 2018 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2016 387,395 $ 57.90 4.6 Issued 128,029 $ 60.62 Exercised (227,228 ) $ 33.00 Expired — $ — Outstanding at December 31, 2017 288,196 $ 78.86 4.0 Issued 4,526,661 $ 3.85 Exercised (120,000 ) $ 0.01 Expired — $ — Outstanding at December 31, 2018 4,694,927 $ 8.55 4.4 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 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 year ended December 31, 2017 2018 Preferred warrants outstanding (number of common stock equivalents) 17 17 Common warrants outstanding 288,196 4,694,927 RSUs outstanding 12,030 360 Convertible preferred stock outstanding (number of common stock equivalents) — 976,157 Common options outstanding 81,643 195,820 Total anti-dilutive common share equivalents 381,886 5,867,281 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | For the years ended December 31, 2017 and 2018, the provision for income taxes was calculated as follows: For the year ended December 31, 2017 2018 Current: Federal $ — $ — State 7,624 1,886 Total 7,624 1,886 Deferred Federal — — State — — Total — — Provision for income tax $ 7,624 $ 1,886 |
Reconciles of Income Taxes Computed at Federal Statutory Rate and Provision for Income Taxes | The following table reconciles income taxes computed at the federal statutory rate and the Company’s provision for income taxes: For the year ended December 31, 2017 2018 Income tax at statutory rate $ (7,346,079 ) $ (5,159,881 ) Change in federal tax rate 2,621,803 — State liability (411,853 ) (670,015 ) Permanent items 214,313 118,959 Stock compensation 72,696 11,128 Nondeductible interest 15,568 — Expiration of net operating losses 922,307 — Research and development credit (200,379 ) (272,314 ) State rate change (18,026 ) (132,855 ) Estimated section 382 limitation 1,491,942 — Return to provision 365,263 8,386 Other 488,264 19,420 Valuation allowance 1,791,805 6,079,058 Provision for income tax $ 7,624 $ 1,886 |
Summary of Deferred Tax Assets | The tax effects of carryforwards and other temporary differences that give rise to deferred tax assets consist of the following: For the year ended December 31, 2017 2018 Estimated net operating loss carryforward $ 3,699,532 $ 9,229,174 Estimated research and development credits 2,686,665 2,958,710 Accruals and other 2,560,419 2,864,028 Deferred rent 90,866 64,628 9,037,482 15,116,540 Less valuation allowance (9,037,482 ) (15,116,540 ) Net deferred tax assets $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments | The future minimum lease payments under the amended lease agreement as December 31, 2018 are as follows: 2019 $ 1,430,366 2020 855,136 Thereafter — Total $ 2,285,502 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Selected Quarterly Financial Data | The following is selected quarterly financial data as of and for the periods ending: First Quarter Second Quarter Third Quarter Fourth Quarter December 31, 2017 Balance sheet data: Cash $ 14,042,388 $ 10,000,155 $ 5,879,025 $ 2,146,611 Total assets 17,933,413 14,653,193 11,120,215 7,378,906 Total non-current liabilities 2,062,544 1,561,520 1,255,939 1,421,527 Total shareholders’ equity 10,418,069 7,342,257 4,026,079 1,296,034 Statement of operations and comprehensive loss data: Net revenues $ 1,683,065 $ 1,278,961 $ 1,111,411 $ 995,226 Cost of revenues 2,129,454 2,368,705 2,487,054 2,359,909 Research and development expenses 757,258 841,991 856,698 908,800 General and administrative expenses 1,906,635 1,798,026 1,834,771 1,650,097 Sales and marketing expenses 1,278,311 1,746,867 1,675,852 1,642,941 Loss from operations (4,388,593 ) (5,476,628 ) (5,742,964 ) (5,566,521 ) Net loss $ (4,432,707 ) $ (5,693,151 ) $ (5,821,306 ) $ (5,666,573 ) Net loss per common share: 1 Basic $ (6.27 ) $ (6.32 ) $ (5.85 ) $ (5.36 ) Diluted $ (6.27 ) $ (6.32 ) $ (5.85 ) $ (5.36 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 707,389 901,007 995,254 1,058,055 Diluted 707,389 901,007 995,254 1,058,055 1 Basic and diluted net loss per common share are computed independently for each of the components and quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. First Quarter Second Quarter Third Quarter Fourth Quarter December 31, 2018 Balance sheet data: Cash $ 9,272,420 $ 2,569,111 $ 8,956,200 $ 3,423,373 Total assets 14,747,827 8,291,310 14,551,892 8,750,303 Total non-current liabilities 1,357,193 1,258,261 1,174,397 1,098,137 Total shareholders’ equity 8,507,714 2,527,568 8,938,408 3,042,519 Statement of operations and comprehensive loss data: Net revenues $ 806,943 $ 822,238 $ 761,591 $ 859,526 Cost of revenues 2,434,886 2,699,671 2,481,916 2,435,262 Research and development expenses 1,070,584 1,019,285 1,089,746 1,288,957 General and administrative expenses 1,938,664 1,708,970 1,793,720 1,632,670 Sales and marketing expenses 1,636,542 1,433,174 1,404,192 1,440,798 Loss from operations (6,273,733 ) (6,038,862 ) (6,007,983 ) (5,938,161 ) Net loss $ (6,356,404 ) $ (6,153,101 ) $ (6,047,784 ) $ (6,014,312 ) Deemed dividend related to warrants down round provision — — (636,370 ) — Net loss attributable to common shareholders $ (6,356,404 ) $ (6,153,101 ) $ (6,684,154 ) $ (6,014,312 ) Net loss per common share: 1 Basic $ (3.33 ) $ (2.70 ) $ (2.42 ) $ (1.43 ) Diluted $ (3.33 ) $ (2.70 ) $ (2.42 ) $ (1.43 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 1,911,282 2,280,115 2,767,440 4,209,221 Diluted 1,911,282 2,280,115 2,759,614 4,209,221 1 Basic and diluted net loss per common share are computed independently for each of the components and quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. |
Liquidity and Going Concern U_2
Liquidity and Going Concern Uncertainty- Additional Information (Detail) - USD ($) | Mar. 19, 2019 | Mar. 11, 2019 | Feb. 12, 2019 | Jan. 18, 2019 | Nov. 28, 2018 | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 11, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | May 04, 2016 | May 31, 2018 | Feb. 29, 2016 | May 31, 2015 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Cash | $ 14,042,388 | $ 3,423,373 | $ 8,956,200 | $ 2,569,111 | $ 9,272,420 | $ 2,146,611 | $ 5,879,025 | $ 10,000,155 | $ 14,042,388 | $ 3,423,373 | $ 2,146,611 | $ 4,609,332 | ||||||||||||||||
Accumulated deficit | (220,457,578) | (195,249,607) | (220,457,578) | (195,249,607) | ||||||||||||||||||||||||
Net loss | (6,014,312) | $ (6,047,784) | $ (6,153,101) | $ (6,356,404) | (5,666,573) | $ (5,821,306) | $ (5,693,151) | $ (4,432,707) | (24,571,601) | (21,613,737) | ||||||||||||||||||
Aggregate net interest-bearing indebtedness | 1,600,000 | 3,100,000 | 1,600,000 | 3,100,000 | ||||||||||||||||||||||||
Aggregate net interest-bearing indebtedness due within one year | 642,000 | 2,000,000 | 642,000 | 2,000,000 | ||||||||||||||||||||||||
Other non-interest bearing current liabilities | $ 2,700,000 | 2,700,000 | ||||||||||||||||||||||||||
Unconditional purchase commitment aggregate amount | $ 1,062,500 | $ 341,000 | $ 341,000 | |||||||||||||||||||||||||
Unconditional purchase commitment payment terms | Quarterly | |||||||||||||||||||||||||||
Unconditional purchase commitment period | May 31, 2020 | |||||||||||||||||||||||||||
Minimum public float limit for offering | $ 75,000,000 | |||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,000,000 | |||||||||||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 1,200 | $ 7,498,535 | |||||||||||||||||||||||||
Exercisable warrant available price per share expiration period | 2022-08 | |||||||||||||||||||||||||||
Shares issued in offering | 642,438 | |||||||||||||||||||||||||||
Beginning stock price | $ 3.285 | $ 13.50 | ||||||||||||||||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 8,208 | 47,821 | 72,000 | 72,000 | ||||||||||||||||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 45 | $ 45 | $ 75 | $ 3.16 | $ 75 | $ 3.16 | |||||||||||||||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | |||||||||||||||||||||||||||
Class of warrant or rights, first exercisable date | Jun. 5, 2018 | |||||||||||||||||||||||||||
Proceeds from issuance of common stock | $ 2,500,000 | $ 11,600,000 | $ 2,200,000 | |||||||||||||||||||||||||
Aggregate units sold under right offering | 11,587 | |||||||||||||||||||||||||||
Net proceeds from issuance of units, net of issuance expenses | $ 2,200,000 | $ 10,100,000 | ||||||||||||||||||||||||||
Warrant exercisable for share of common stock | 1 | |||||||||||||||||||||||||||
Class of warrant or rights, term | 5 years | 5 years | ||||||||||||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 7,500,000 | $ 2,000,000 | ||||||||||||||||||||||||||
Shares issued in offering | 5,950,000 | 990,000 | ||||||||||||||||||||||||||
Beginning stock price | $ 1.37 | $ 2.25 | ||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 1.25 | $ 1.20 | ||||||||||||||||||||||||||
Warrant exercisable for share of common stock | 1 | |||||||||||||||||||||||||||
Class of warrant or rights, term | 5 years 6 months | |||||||||||||||||||||||||||
Prefunded Warrants [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 1,200 | |||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||
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] | ||||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 15 | |||||||||||||||||||||||||||
Class of warrant or rights, expiration date | Mar. 24, 2024 | |||||||||||||||||||||||||||
Class of warrant or rights, first exercisable date | Mar. 24, 2019 | |||||||||||||||||||||||||||
Aggregate warrants sold under right offering | 2,549,140 | |||||||||||||||||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||||||||||||||||
Roth Capital Partners, LLC, WestPark Capital and Chardan Capital [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Placement agent agreement, effective date | Mar. 28, 2017 | |||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,600,000 | |||||||||||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||||||||||||||||
Shares issued in offering | 144,000 | |||||||||||||||||||||||||||
Beginning stock price | $ 64.50 | $ 64.50 | ||||||||||||||||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 72,000 | 72,000 | ||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 75 | $ 75 | ||||||||||||||||||||||||||
Class of warrant or rights, expiration date | Oct. 1, 2022 | |||||||||||||||||||||||||||
Dawson James Securities, Inc and WestPark Capital [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Placement agent agreement, effective date | Dec. 5, 2017 | |||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,900,000 | |||||||||||||||||||||||||||
Shares issued in offering | 164,166 | |||||||||||||||||||||||||||
Beginning stock price | $ 20.40 | |||||||||||||||||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 8,208 | |||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 25.50 | |||||||||||||||||||||||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | |||||||||||||||||||||||||||
Class of warrant or rights, first exercisable date | Jun. 5, 2018 | |||||||||||||||||||||||||||
Shelf Registration Statement [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Shelf registration statement expiration period | May 31, 2021 | May 31, 2018 | ||||||||||||||||||||||||||
Minimum public float limit for offering | $ 75,000,000 | $ 75,000,000 | ||||||||||||||||||||||||||
Placement agent agreement, effective date | Apr. 25, 2016 | |||||||||||||||||||||||||||
Securities purchase agreement, effective date | Apr. 29, 2016 | |||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 4,300,000 | |||||||||||||||||||||||||||
Proceeds from exercise of common stock warrants | 0 | |||||||||||||||||||||||||||
Proceeds from gross exercise of common stock warrants outstanding | $ 4,500,000 | |||||||||||||||||||||||||||
Exercisable warrant available price per share | $ 117 | |||||||||||||||||||||||||||
Exercisable warrant available price per share expiration period | 2021-05 | |||||||||||||||||||||||||||
Follow-on Public Offering [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
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 | $ 3.16 | |||||||||||||||||||||||||||
Exercisable warrant available price per share expiration period | 2023-01 | |||||||||||||||||||||||||||
Beginning stock price | $ 13.50 | |||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 3.16 | $ 4.53 | $ 3.16 | |||||||||||||||||||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | |||||||||||||||||||||||||
Follow-on Public Offering [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 601,000 | $ 6,800,000 | ||||||||||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||||||||||||||||
Shares issued in offering | 6,250,000 | |||||||||||||||||||||||||||
Beginning stock price | $ 1.20 | $ 1.20 | ||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 1.20 | |||||||||||||||||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||||||||||||||||
Purchase of common stock by underwriters to cover overallotments, number of shares | 538,867 | |||||||||||||||||||||||||||
Follow-on Public Offering [Member] | Warrants [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Shares issued in offering | 6,250,000 | |||||||||||||||||||||||||||
Private Placement [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Exercise price of unregistered warrants | $ 3.16 | |||||||||||||||||||||||||||
Warrant exercisable for share of common stock | 1 | |||||||||||||||||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||||||||||||||||
Over-allotment Option [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 937,500 | |||||||||||||||||||||||||||
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 unregistered warrants to purchase shares of common stock | 1,095,153 | |||||||||||||||||||||||||||
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] | Warrants [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | |||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||
Maximum [Member] | Follow-on Public Offering [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 6,250,000 | |||||||||||||||||||||||||||
Maximum [Member] | Over-allotment Option [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 937,500 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Jul. 06, 2018shares | Dec. 31, 2018USD ($)shares | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($)shares | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)Segmentshares | Dec. 31, 2017USD ($)$ / sharesshares |
Summary Of Significant Accounting Policies [Line Items] | |||||||||||
Stockholders equity reverse stock split ratio | 0.03 | ||||||||||
Common stock, shares authorized | shares | 150,000,000 | 150,000,000 | 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 | $ 843,000 | ||||||||||
Increase (decrease) in net income (loss) per common share on nonrecurring net revenue | $ / shares | $ (0.90) | ||||||||||
Net revenue recorded in excess of commercial cash collections | $ 1,139,000 | ||||||||||
Increase decrease in net income (loss) per common share | $ / shares | $ (1.20) | ||||||||||
Number of reportable segments | Segment | 1 | ||||||||||
Number of suppliers | one supplier | ||||||||||
Depreciation and amortization expense | $ 800,905 | $ 575,717 | |||||||||
Research and development expenses | $ 1,288,957 | $ 1,089,746 | $ 1,019,285 | $ 1,070,584 | $ 908,800 | $ 856,698 | $ 841,991 | $ 757,258 | 4,468,572 | 3,364,747 | |
Accrual for interest or penalties for income taxes | $ 0 | $ 0 | 0 | 0 | |||||||
Interest or penalties expense on income taxes | $ 0 | $ 0 | |||||||||
Minimum [Member] | |||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||
Estimated useful life of assets | 3 years | ||||||||||
Maximum [Member] | |||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||
Estimated useful life of assets | 7 years | ||||||||||
ASC 606 [Member] | |||||||||||
Summary Of Significant Accounting Policies [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] | |||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||
Amortization period | 1 year |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Composition of Net Revenues Recognized Disaggregated by Source (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | ||
Revenue Recognition [Abstract] | |||||||||||
Net revenues from contracted payers | [1] | $ 1,348,383 | $ 2,074,596 | ||||||||
Net revenues from non-contracted payers | 1,703,179 | 2,721,717 | |||||||||
Development services revenues | 198,736 | 272,350 | |||||||||
Total net revenues | $ 859,526 | $ 761,591 | $ 822,238 | $ 806,943 | $ 995,226 | $ 1,111,411 | $ 1,278,961 | $ 1,683,065 | $ 3,250,298 | $ 5,068,663 | |
[1] | Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed and miscellaneous income from CEE-Sure blood collection tubes. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Composition of Net Revenues Recognized Disaggregated by Nature (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue Recognition [Abstract] | ||||||||||
Net commercial revenues recognized upon delivery | $ 3,051,562 | $ 3,570,337 | ||||||||
Development services revenues recognized upon delivery | 198,736 | 272,350 | ||||||||
Commercial revenues recognized upon cash collection | 1,225,976 | |||||||||
Total net revenues | $ 859,526 | $ 761,591 | $ 822,238 | $ 806,943 | $ 995,226 | $ 1,111,411 | $ 1,278,961 | $ 1,683,065 | $ 3,250,298 | $ 5,068,663 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Composition of Gross and Net Revenues Recognized (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue Recognition [Abstract] | ||||||||||
Commercial revenues recognized upon delivery | $ 12,505,149 | $ 15,685,069 | ||||||||
Development services revenues recognized upon delivery | 198,736 | 272,350 | ||||||||
Commercial revenues recognized upon cash collection | 1,225,976 | |||||||||
Total gross revenues | 12,703,885 | 17,183,395 | ||||||||
Provisions for contractual discounts | (3,937,993) | (5,805,787) | ||||||||
Provisions for aged non-patient receivables | (326,137) | (735,709) | ||||||||
Provisions for estimated patient receivables | (66,470) | (169,479) | ||||||||
Provisions for other payer-specific sales allowances | (5,122,987) | (5,403,757) | ||||||||
Total net revenues | $ 859,526 | $ 761,591 | $ 822,238 | $ 806,943 | $ 995,226 | $ 1,111,411 | $ 1,278,961 | $ 1,683,065 | $ 3,250,298 | $ 5,068,663 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Activity in Gross and Net Accounts Receivable Balances and Reserves (Detail) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | $ 1,193,426 |
Amounts Recognized Upon Delivery | 3,250,298 |
Settlements Upon Adjudication | (2,869,399) |
Gross and net accounts receivable, Ending Balance | 1,574,325 |
Accounts Receivable Gross [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | 6,937,063 |
Amounts Recognized Upon Delivery | 12,835,371 |
Settlements Upon Adjudication | (11,889,832) |
Gross and net accounts receivable, Ending Balance | 7,882,602 |
Reserve for Contractual Discounts [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | (1,974,849) |
Amounts Recognized Upon Delivery | (3,214,615) |
Settlements Upon Adjudication | 3,011,989 |
Gross and net accounts receivable, Ending Balance | (2,177,475) |
Reserve for Aged Non-patient Receivables [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | (452,088) |
Amounts Recognized Upon Delivery | (994,542) |
Settlements Upon Adjudication | 880,682 |
Gross and net accounts receivable, Ending Balance | (565,948) |
Reserve for Estimated Patient Receivables [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | (88,120) |
Amounts Recognized Upon Delivery | (135,955) |
Settlements Upon Adjudication | 208,598 |
Gross and net accounts receivable, Ending Balance | (15,477) |
Reserve for Other Payer-specific Sales Allowances [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Gross and net accounts receivable, Beginning Balance | (3,228,580) |
Amounts Recognized Upon Delivery | (5,239,961) |
Settlements Upon Adjudication | 4,919,164 |
Gross and net accounts receivable, Ending Balance | $ (3,549,377) |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Customer Concentration Risk [Member] | Net Revenues [Member] | Medicare and Medicare Advantage [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 39.00% | 39.00% |
Customer Concentration Risk [Member] | Net Revenues [Member] | Blue Cross Blue Shield [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 11.00% | 19.00% |
Customer Concentration Risk [Member] | Net Revenues [Member] | United Healthcare [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 17.00% | 12.00% |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Medicare and Medicare Advantage [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 17.00% | 21.00% |
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] | United Healthcare [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 15.00% | 15.00% |
Sales of Equity Securities - Ad
Sales of Equity Securities - Additional Information (Detail) - USD ($) | Nov. 28, 2018 | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 11, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | May 04, 2016 | May 31, 2018 | May 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 |
Class Of Stock [Line Items] | ||||||||||||||
Shelf registration statement expiration period | May 21, 2018 | |||||||||||||
Minimum public float limit for offering | $ 75,000,000 | |||||||||||||
Public offering, number of shares issued | 642,438 | |||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 8,208 | 47,821 | 72,000 | |||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 1,200 | $ 7,498,535 | |||||||||||
Beginning 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 | $ 100,000 | $ 1,500,000 | $ 2,800,000 | ||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 45 | $ 45 | $ 75 | $ 3.16 | |||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | |||||||||||||
Net cash proceeds from sale of securities | $ 2,000,000 | |||||||||||||
Proceeds from issuance of common stock | 2,500,000 | $ 11,600,000 | $ 2,200,000 | |||||||||||
Class of warrant or rights, term | 5 years | 5 years | ||||||||||||
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 | |||||||||||||
Net proceeds from issuance of units, net of issuance expenses | $ 2,200,000 | $ 10,100,000 | ||||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||
Public offering, number of common stock and warrants issued | 642,438 | 1,095,153 | ||||||||||||
Prefunded Warrants [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 1,200 | |||||||||||||
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] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Exercise price of unregistered warrants | $ 15 | |||||||||||||
Class of warrant or rights, expiration date | Mar. 24, 2024 | |||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||
Aggregate warrants sold under right offering | 2,549,140 | |||||||||||||
Series A Preferred Stock [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Public offering, number of shares issued | 11,587 | |||||||||||||
Preferred stock stated value per share | $ 1,000 | |||||||||||||
Ally Bridge [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||
Beginning stock price | $ 45 | |||||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 1,500,000 | |||||||||||||
Exercise price of unregistered warrants | $ 45 | |||||||||||||
Net cash proceeds from sale of securities | $ 2,000,000 | |||||||||||||
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 | |||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||
Common stock issuance costs | $ 200,000 | |||||||||||||
Roth Capital Partners, LLC, WestPark Capital and Chardan Capital [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Placement agent agreement, effective date | Mar. 28, 2017 | |||||||||||||
Public offering, number of shares issued | 144,000 | |||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 72,000 | |||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||
Beginning stock price | $ 64.50 | |||||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 2,800,000 | |||||||||||||
Exercise price of unregistered 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 | |||||||||||||
Dawson James Securities, Inc and WestPark Capital [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Placement agent agreement, effective date | Dec. 5, 2017 | |||||||||||||
Public offering, number of shares issued | 164,166 | |||||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 8,208 | |||||||||||||
Beginning stock price | $ 20.40 | |||||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 100,000 | |||||||||||||
Exercise price of unregistered 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 unregistered warrants to purchase shares of common stock | 1,095,153 | |||||||||||||
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 | |||||||||||||
Maximum [Member] | Warrants [Member] | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | |||||||||||||
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 | ||||||||||||
Placement agent agreement, effective date | Apr. 25, 2016 | |||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||
Net cash proceeds from sale of securities | $ 4,300,000 | |||||||||||||
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 | ||||||||||||
Beginning stock price | $ 13.50 | |||||||||||||
Issuance of warrants to purchase shares of common stock, grant date fair value | $ 9,700,000 | |||||||||||||
Exercise price of unregistered warrants | $ 3.16 | $ 4.53 | $ 3.16 | |||||||||||
Cost directly associated with offering | $ 1,400,000 | |||||||||||||
Net cash proceeds from sale of securities | $ 13,300,000 | |||||||||||||
Private offering, number of common stock and warrants issued | 1,095,153 | |||||||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | |||||||||||
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 unregistered warrants | $ 3.16 | |||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||
Warrant exercisable for share of common stock | 1 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | Nov. 28, 2018 | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 11, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||||
Fixed asset purchases as equipment financings obligations | $ 279,000 | $ 719,000 | |||||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 2,000,000 | $ 8,400,000 | $ 9,700,000 | $ 100,000 | $ 1,500,000 | $ 2,800,000 | |||||
Issuance of unregistered warrants to purchase shares of common stock | 762,438 | 2,549,140 | 8,208 | 47,821 | 72,000 | ||||||
Estimated grant date fair value of warrants | $ 2.57 | $ 3.30 | $ 8.82 | $ 15.60 | $ 30.90 | $ 39.30 | |||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 45 | $ 45 | $ 75 | $ 3.16 | ||||
Class of warrant or rights, term | 5 years | 5 years | |||||||||
Common stock warrants outstanding, intrinsic value | $ 0 | ||||||||||
Proceeds from exercise of common stock warrants | $ 0 | 1,200 | 7,498,535 | ||||||||
Prefunded Warrants [Member] | |||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||||
Exercise price of unregistered warrants | $ 3.275 | ||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||
Common stock warrants outstanding, intrinsic value | $ 350,000 | ||||||||||
Proceeds from exercise of common stock warrants | $ 1,200 | ||||||||||
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 unregistered warrants | $ 3.16 | $ 4.53 | $ 3.16 | ||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | ||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 0 | |||||||||
Maximum [Member] | |||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||||
Issuance of unregistered warrants to purchase shares of common stock | 1,095,153 | ||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||||
Maximum [Member] | Prefunded Warrants [Member] | |||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||||
Issuance of warrants to purchase shares of common stock | 120,000 | ||||||||||
Maximum [Member] | Follow-on Public Offering [Member] | |||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||||
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 | $ 279,000 | $ 719,000 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions Used for Determining Fair Values of Common Stock Warrants (Detail) | Dec. 31, 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 | |
March 31, 2017 Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 63.90 | ||
March 31, 2017 Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 75 | ||
March 31, 2017 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
March 31, 2017 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0.0193 | ||
March 31, 2017 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years | ||
March 31, 2017 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0.800 | ||
August 9, 2017 Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 41.70 | ||
August 9, 2017 Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 45 | ||
August 9, 2017 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
August 9, 2017 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0.0181 | ||
August 9, 2017 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years | ||
August 9, 2017 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 1 | ||
December 8, 2017 Offering [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Beginning stock price | $ 22.20 | ||
December 8, 2017 Offering [Member] | Exercise Price [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 25.50 | ||
December 8, 2017 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
December 8, 2017 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0.0209 | ||
December 8, 2017 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 4 years 6 months | ||
December 8, 2017 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 1 | ||
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] | |||
Exercise price | 15 | ||
January 30, 2018 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
January 30, 2018 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 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] | |||
Exercise price | 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] | |||
Exercise price | 4.53 | ||
August 13, 2018 Rights Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
August 13, 2018 Rights Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 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] | |||
Exercise price | 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] | |||
Exercise price | 3.16 | ||
September 20, 2018 Offering [Member] | Expected Dividend Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 0 | ||
September 20, 2018 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 2.77 | ||
September 20, 2018 Offering [Member] | Expected Life [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Expected life (in years) | 5 years | ||
September 20, 2018 Offering [Member] | Expected Volatility [Member] | |||
Warrant Fair Value Black Scholes Method [Line Items] | |||
Exercise price | 130.7 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Fixed Assets and Accrued Liabilities (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fixed Assets | ||
Machinery and equipment | $ 2,818,583 | $ 2,841,388 |
Furniture and office equipment | 157,391 | 147,976 |
Computer equipment and software | 1,437,408 | 1,637,034 |
Leasehold improvements | 570,173 | 553,529 |
Financed equipment | 2,573,955 | 2,294,762 |
Construction in process | 116,640 | 2,975 |
Total fixed assets, gross | 7,674,150 | 7,477,664 |
Less accumulated depreciation and amortization | (4,934,728) | (4,354,097) |
Total fixed assets, net | 2,739,422 | 3,123,567 |
Accrued Liabilities | ||
Accrued interest | 326,602 | |
Accrued payroll | 255,426 | 224,813 |
Accrued vacation | 535,682 | 474,953 |
Accrued bonuses | 712,574 | 375,000 |
Accrued sales commissions | 62,767 | 104,509 |
Current portion of deferred rent | 158,342 | 116,681 |
Accrued other | 203,602 | 129,805 |
Total accrued liabilities | $ 1,928,393 | $ 1,752,363 |
April 2014 Credit Facility - Ad
April 2014 Credit Facility - Additional Information (Detail) - USD ($) | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Aug. 09, 2017 | Mar. 31, 2017 | Apr. 30, 2014 | Dec. 31, 2018 | Dec. 31, 2014 | Dec. 31, 2017 | Aug. 11, 2017 |
Line of Credit Facility [Line Items] | |||||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 45 | $ 75 | $ 3.16 | $ 45 | ||||
Warrant term | 5 years | 5 years | 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 | $ 100,000 | $ 1,500,000 | $ 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 discounts | $ 33,000 | ||||||||||
Effective annual interest rate | 13.87% | ||||||||||
Total remaining principal payments due during fiscal year ending December 31, 2018 | $ 1,201,000 | ||||||||||
Remaining outstanding principal payment | $ 0 | ||||||||||
Total remaining principal payment paid | $ 1,201,000 |
Equipment Financings - Addition
Equipment Financings - Additional Information (Detail) | Jan. 26, 2018USD ($)Payment | Nov. 02, 2017USD ($) | Oct. 17, 2017USD ($)mo | Dec. 31, 2018USD ($) | Nov. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Capital Leased Assets [Line Items] | |||||||
Financed equipment | $ 2,573,955 | $ 2,573,955 | $ 2,294,762 | ||||
Accumulated depreciation related to financed equipment | 1,135,000 | 1,135,000 | 759,000 | ||||
Fixed asset purchases as equipment financings | 279,000 | 719,000 | |||||
Total proceeds from equipment financing commitment | 150,848 | ||||||
Machinery and equipment | 2,818,583 | 2,818,583 | 2,841,388 | ||||
Machinery and equipment, accumulated depreciation | 4,934,728 | $ 4,934,728 | $ 4,354,097 | ||||
Equipment financings aggregate weighted average effective annual interest rate | 12.53% | 13.51% | |||||
Equipment financings maturity date on outstanding arrangements range, Start | 2018-06 | ||||||
Equipment financings maturity date on outstanding arrangements range, End | 2024-09 | ||||||
Interest expense to equipment financings | $ 310,976 | $ 482,623 | |||||
Present value of minimum lease payment due within one year | 642,000 | 642,000 | |||||
Fixed asset purchases | $ 250,000 | 145,253 | 1,400,180 | ||||
Number of lease payments | Payment | 22 | ||||||
Lease payments per month | $ 15,274 | ||||||
Equipment purchases | $ 332,000 | 332,000 | |||||
Rental charges | 1,272,000 | 1,272,000 | |||||
Equipment Financings [Member] | |||||||
Capital Leased Assets [Line Items] | |||||||
Depreciation expense related to financed equipment | 376,000 | 234,000 | |||||
Total proceeds from equipment financing commitment | $ 151,000 | ||||||
Sale-leaseback transaction, aggregate gross value of fixed assets | $ 167,000 | ||||||
Sale-leaseback transaction, net book value of fixed assets | $ 162,000 | ||||||
Sale-leaseback transaction, frequency of payments | monthly | ||||||
Sale-leaseback transaction, number of installments payments | mo | 36 | ||||||
Sale-leaseback transaction, montly installments of principal and interest payments | $ 4,884 | ||||||
Sale-leaseback transaction, total amount to be repaid | $ 176,000 | ||||||
Sale-leaseback transaction, commitment period | 2020-10 | ||||||
Interest expense to equipment financings | $ 237,000 | 171,000 | |||||
Rental charges | $ 124,000 | ||||||
Machinery and Equipment [Member] | |||||||
Capital Leased Assets [Line Items] | |||||||
Machinery and equipment | 189,000 | ||||||
Machinery and equipment, accumulated depreciation | 155,000 | ||||||
Machinery and equipment, net book values | $ 34,000 | ||||||
Minimum [Member] | |||||||
Capital Leased Assets [Line Items] | |||||||
Financed equipment useful life | 3 years | ||||||
Minimum [Member] | Equipment Financings [Member] | |||||||
Capital Leased Assets [Line Items] | |||||||
Financed equipment useful life | 5 years | ||||||
Maximum [Member] | |||||||
Capital Leased Assets [Line Items] | |||||||
Financed equipment useful life | 7 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) | Dec. 31, 2018USD ($) |
Capital Lease Obligations [Abstract] | |
2019 | $ 670,896 |
2020 | 551,610 |
2021 | 305,006 |
2022 | 264,600 |
Thereafter | 310,932 |
Total payments | 2,103,044 |
Less amount representing interest | 476,493 |
Present value of payments | 1,626,551 |
2019 | 91,285 |
2020 | 72,635 |
2021 | 51,473 |
2022 | 60,832 |
Thereafter | 45,710 |
Total payments | 321,935 |
Present value of payments | $ 321,935 |
Supplier Financings - Additiona
Supplier Financings - Additional Information (Detail) - Financing Agreements With Supplier [Member] - Laboratory Software [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | ||
Financing agreement, due period | 1 year | |
Remaining balance under financing agreement | $ 61,000 | $ 0 |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.40% | 4.40% |
Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 6.20% | 6.20% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jun. 28, 2018shares | Jul. 31, 2017$ / shares | May 31, 2017$ / sharesshares | Jul. 29, 2016$ / sharesshares | Jul. 25, 2016$ / sharesshares | Mar. 28, 2018shares | Dec. 31, 2018USD ($)Plan$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016$ / sharesshares | Jul. 06, 2017shares | May 02, 2017shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of equity incentive plans | Plan | 2 | ||||||||||
Total Shares Outstanding | 195,820 | 81,643 | 29,888 | ||||||||
Weighted average exercise price per share | $ / shares | $ 2.20 | $ 44.70 | |||||||||
Number of shares remaining forfeited | 28,410 | 6,746 | |||||||||
Number of Shares, Granted | 142,587 | 58,501 | |||||||||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 1 month 17 days | ||||||||||
Maximum [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Estimated forfeitures rate | 8.00% | 8.00% | |||||||||
Minimum [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Estimated forfeitures rate | 0.00% | 0.00% | |||||||||
Stock Options [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 10 years | ||||||||||
Option awards assumptions, method used | Black-Scholes pricing model | ||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 1.75 | $ 1.02 | |||||||||
Intrinsic value of options outstanding | $ | $ 0 | $ 0 | |||||||||
Intrinsic value of options exercisable | $ | 0 | 0 | |||||||||
Intrinsic value of options vested and unvested expected to vest | $ | $ 0 | 0 | |||||||||
Stock Options [Member] | Maximum [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 4 years | ||||||||||
Employee Stock Option One [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Time period for vesting grants in installments on monthly basis | monthly thereafter for the remaining three years | ||||||||||
Employee Stock Option Two [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Stock options vesting term | monthly vesting beginning month-one after the grant and monthly thereafter | ||||||||||
RSUs [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Vesting period | 1 year | ||||||||||
Intrinsic value shares, RSUs outstanding | $ | $ 300,000,000 | $ 250,000 | |||||||||
Intrinsic value amount, RSUs unvested and vested expected to vest | $ | $ 300,000,000 | ||||||||||
RSUs outstanding | 360 | 12,030 | 5,808 | ||||||||
Intrinsic value amount, RSUs unvested and vested expected to vest | $ | $ 129,000 | ||||||||||
Issuance of restricted stock units | 11,666 | ||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 415.80 | $ 56.10 | $ 80.40 | ||||||||
Total RSUs forfeited | 5,835 | 250 | |||||||||
Stock Options and RSUs [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Unrecognized share-based compensation expense, stock options | $ | $ 667,000 | ||||||||||
Options Vesting on One Year Anniversary [Member] | Stock Options [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Percentage of Overall Stock Grant Subject to Vesting | 25.00% | ||||||||||
2013 Equity Incentive Plan [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total stock options and RSUs authorized | 124,211 | ||||||||||
2013 Equity Incentive Plan [Member] | Chief Financial Officer [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Weighted average exercise price per share | $ / shares | $ 58.50 | ||||||||||
Number of shares remaining forfeited | 565 | ||||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options Granted on July 29 2016 [Member] | Chief Financial Officer [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Stock options vested | 546 | ||||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 24.90 | $ 29.70 | |||||||||
Weighted average exercise price per share | $ / shares | $ 41.70 | $ 45 | |||||||||
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} | Employees and Executive Officers [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Common stock, shares authorized | 18,333 | ||||||||||
Stock options vested | 0 | ||||||||||
Number of shares remaining forfeited | 20,750 | ||||||||||
2013 Equity Incentive Plan [Member] | Performance Stock Options [Member} | Employees [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Common stock, shares authorized | 2,500 | ||||||||||
Number of shares remaining forfeited | 2,500 | ||||||||||
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 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] | |||||||||||
Vesting period | 1 year | ||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 45 | ||||||||||
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] | 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] | Time-Based RSUs [Member] | Other Executive Officers [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] | |||||||||||
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] | 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] | Other Executive Officers [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Issuance of restricted stock units | 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] | |||||||||||
Number of vested shares issued | 0 | ||||||||||
Total RSUs forfeited | 5,833 | ||||||||||
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 | ||||||||||
Increase in number of shares of common stock authorized for issuance | 146,666 | ||||||||||
Stock options and RSUs issued | 95,258 | ||||||||||
Total Shares Outstanding | 79,300 | ||||||||||
Common stock, shares authorized | 168,840 | ||||||||||
2013 Equity Incentive Plan [Member] | Inducement shares [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Stock options and RSUs issued | 118,368 | ||||||||||
Total Shares Outstanding | 117,534 | ||||||||||
Common stock, shares authorized | 0 | ||||||||||
2013 Equity Incentive Plan [Member] | Options Vesting on One Year Anniversary [Member] | Chief Financial Officer [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total stock options and RSUs authorized | 2,222 | ||||||||||
Vesting period | 1 year | ||||||||||
Percentage of Overall Stock Grant Subject to Vesting | 25.00% | ||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 43.50 | ||||||||||
Stock option units remaining vesting period on Equal monthly basis | 3 years | ||||||||||
2013 Equity Incentive Plan [Member] | Options Vesting on Performance Achievement [Member] | Chief Financial Officer [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total stock options and RSUs authorized | 1,111 | ||||||||||
Weighted-average estimated fair value of options granted | $ / shares | $ 37.80 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
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 | $ 0.86 | $ 20.82 |
Discount rate-bond equivalent yield | 2.50% | 1.79% |
Expected life (in years) | 4 years | 5 years 1 month 13 days |
Expected volatility | 100.00% | 70.00% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock and exercise prices | $ 6 | $ 63.90 |
Discount rate-bond equivalent yield | 3.02% | 2.27% |
Expected life (in years) | 5 years 11 months 15 days | 6 years 1 month 2 days |
Expected volatility | 120.00% | 90.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Shares Outstanding, Beginning Balance | 81,643 | 29,888 | |
Number of Shares, Granted | 142,587 | 58,501 | |
Number of Shares, Cancelled/forfeited/expired | (28,410) | (6,746) | |
Number of Shares Outstanding, Ending Balance | 195,820 | 81,643 | 29,888 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | 183,136 | ||
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 113.68 | $ 264 | |
Weighted Average Exercise Price Per Share, Granted | 2.20 | 44.70 | |
Weighted Average Exercise Price Per Share, Cancelled/forfeited/expired | 57.96 | 143.10 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | 41.41 | $ 113.68 | $ 264 |
Weighted Average Exercise Price Per Share, Vested and unvested expected to vest, Ending Balance | $ 44.02 | ||
Weighted Average Remaining Contractual Term in Years, Outstanding | 9 years 2 months 12 days | 8 years 9 months 18 days | 8 years 6 months |
Weighted Average Remaining Contractual Term in Years, Vested and unvested expected to vest | 9 years 1 month 6 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Detail) - RSUs [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares Outstanding, Beginning Balance | 12,030 | 5,808 |
Number of Shares, Granted | 11,666 | |
Number of share, Vested and issued | (5,835) | (5,194) |
Number of share, Forfeited | (5,835) | (250) |
Number of Shares Outstanding, Ending Balance | 360 | 12,030 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | 360 | |
Weighted Average Grand Date Fair Value, Outstanding, Beginning Balance | $ 56.10 | $ 80.40 |
Weighted Average Grand Date Fair Value, Granted | 45 | |
Weighted Average Grand Date Fair Value,Vested and issued | 45 | 58.80 |
Weighted Average Grand Date Fair Value, Forfeited | 45 | 63.60 |
Weighted Average Grand Date Fair Value, Outstanding, Ending Balance | 415.80 | $ 56.10 |
Weighted Average Grant Date Fair Value, Vested and unvested expected to vest, Ending Balance | $ 415.80 |
Stock-Based Compensation - Effe
Stock-Based Compensation - Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Statement of Operations (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | $ 558,987 | $ 929,822 |
Stock Options [Member] | Cost of revenues [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 46,708 | 142,400 |
Stock Options [Member] | Research and Development Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 133,525 | 143,300 |
Stock Options [Member] | General and Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 300,433 | 575,741 |
Stock Options [Member] | Sales and Marketing Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 78,321 | 68,381 |
RSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 623,412 | 1,247,481 |
RSUs [Member] | Cost of revenues [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | (18,802) | 48,745 |
RSUs [Member] | Research and Development Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 13,576 | 55,941 |
RSUs [Member] | General and Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 54,302 | 160,937 |
RSUs [Member] | Sales and Marketing Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | $ 15,349 | $ 52,036 |
Common Stock Warrants Outstan_3
Common Stock Warrants Outstanding - Summary of Equity-Classified Common Stock Warrant Activity, for Warrants Other than Underlying Unexercised Overallotment Option Warrants (Detail) - Warrants [Member] - $ / shares | Sep. 24, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Class Of Warrant Or Right [Line Items] | ||||
Number of Shares, Outstanding, Beginning Balance | 288,196 | 387,395 | ||
Number of Shares, Issued | 762,438 | 4,526,661 | 128,029 | |
Number of Shares, Exercised | (120,000) | (227,228) | ||
Number of Shares, Outstanding, Ending Balance | 4,694,927 | 288,196 | 387,395 | |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 78.86 | $ 57.90 | ||
Weighted Average Exercise Price Per Share, Issued | 3.85 | 60.62 | ||
Weighted Average Exercise Price Per Share, Exercised | 0.01 | 33 | ||
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | $ 8.55 | $ 78.86 | $ 57.90 | |
Average Remaining Contractual Term (in years) | 4 years 4 months 24 days | 4 years | 4 years 7 months 6 days |
Common Stock Warrants Outstan_4
Common Stock Warrants Outstanding - Additional Information (Detail) - USD ($) | Sep. 24, 2018 | Aug. 13, 2018 | Jan. 30, 2018 | Dec. 08, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 11, 2017 | Aug. 09, 2017 | Mar. 31, 2017 |
Class Of Warrant Or Right [Line Items] | |||||||||
Class of warrant or rights, first exercisable date | Jun. 5, 2018 | ||||||||
Class of warrant or rights, expiration date | Dec. 5, 2022 | ||||||||
Common stock warrants outstanding, intrinsic value | $ 0 | ||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 25.50 | $ 3.16 | $ 45 | $ 45 | $ 75 | ||
Class of warrant or rights, term | 5 years | 5 years | |||||||
Maximum [Member] | |||||||||
Class Of Warrant Or Right [Line Items] | |||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | ||||||||
Warrants [Member] | |||||||||
Class Of Warrant Or Right [Line Items] | |||||||||
Warrants issued | 762,438 | 4,526,661 | 128,029 | ||||||
Class of warrant or rights, first exercisable date | Mar. 24, 2019 | ||||||||
Class of warrant or rights, expiration date | Mar. 24, 2024 | ||||||||
Exercise price of unregistered warrants | $ 15 | ||||||||
Class of warrant or rights, term | 5 years | ||||||||
Warrants [Member] | Maximum [Member] | |||||||||
Class Of Warrant Or Right [Line Items] | |||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 |
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 | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 5,867,281 | 381,886 |
Warrants Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 4,694,927 | 288,196 |
RSUs Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 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 |
Convertible Preferred Stock Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 976,157 | |
Common Options Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 195,820 | 81,643 |
401(k) Plan - Additional Inform
401(k) Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Postemployment Benefits [Abstract] | ||
Employer's matching contributions to 401(k) plan | $ 215,000 | $ 90,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Contingency [Line Items] | ||
Corporate tax rate | 21.00% | 35.00% |
Decrease in net deferred tax assets | $ 2,600,000 | |
Deferred tax benefit or expense | $ 2,600,000 | |
Percent of uncertain income tax positions recognized | 50.00% | 50.00% |
Liability for unrecognized tax benefits | $ 0 | $ 0 |
Percentage of change in ownership | 50.00% | |
Period of change in ownership | 3 years | |
Federal [Member] | ||
Income Tax Contingency [Line Items] | ||
Net operating loss carryforwards | $ 13,600,000 | |
Net operating loss carryforwards, expiration year | expiring beginning in 2035 | |
Additional net operating loss carryforwards | $ 23,600,000 | |
Federal [Member] | Maximum [Member] | ||
Income Tax Contingency [Line Items] | ||
Percentage of future taxable income offset by operating loss carryforwards | 80.00% | |
Federal [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Contingency [Line Items] | ||
Research and development tax credits | $ 160,000 | |
Income tax research and development expiration year | begin to expire in 2035 | |
California [Member] | ||
Income Tax Contingency [Line Items] | ||
Net operating loss carryforwards | $ 24,700,000 | |
Net operating loss carryforwards, expiration year | expiring beginning in 2023 | |
California [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Contingency [Line Items] | ||
Research and development tax credits | $ 3,543,000 |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision for Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current: | ||
State | $ 1,886 | $ 7,624 |
Total | 1,886 | 7,624 |
Deferred | ||
Provision for income tax | $ 1,886 | $ 7,624 |
Income Taxes - Reconciles of In
Income Taxes - Reconciles of Income Taxes Computed at Federal Statutory Rate and Provision for Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Income tax at statutory rate | $ (5,159,881) | $ (7,346,079) |
Change in federal tax rate | 2,621,803 | |
State liability | (670,015) | (411,853) |
Permanent items | 118,959 | 214,313 |
Stock compensation | 11,128 | 72,696 |
Nondeductible interest | 15,568 | |
Expiration of net operating losses | 922,307 | |
Research and development credit | (272,314) | (200,379) |
State rate change | (132,855) | (18,026) |
Estimated section 382 limitation | 1,491,942 | |
Return to provision | 8,386 | 365,263 |
Other | 19,420 | 488,264 |
Valuation allowance | 6,079,058 | 1,791,805 |
Provision for income tax | $ 1,886 | $ 7,624 |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Estimated net operating loss carryforward | $ 9,229,174 | $ 3,699,532 |
Estimated research and development credits | 2,958,710 | 2,686,665 |
Accruals and other | 2,864,028 | 2,560,419 |
Deferred rent | 64,628 | 90,866 |
Gross deferred tax assets | 15,116,540 | 9,037,482 |
Less valuation allowance | $ (15,116,540) | $ (9,037,482) |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | Feb. 01, 2017 | Mar. 31, 2015 | Dec. 31, 2018USD ($)ft² | Dec. 31, 2017USD ($) | Nov. 30, 2011ft² |
Related Party Transaction [Line Items] | |||||
Lease expiration date | Jul. 31, 2020 | ||||
San Diego California Facility [Member] | |||||
Related Party Transaction [Line Items] | |||||
Leased facility, expansion of original premises | ft² | 9,849 | ||||
Lease expiration date | Mar. 31, 2017 | Oct. 31, 2018 | |||
Rental income | $ 0 | $ 51,000 | |||
Aegea Biotechnologies, Inc [Member] | |||||
Related Party Transaction [Line Items] | |||||
Reimbursement for shared patent costs | $ 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 | ||||
Lease agreement date of commencement | Mar. 30, 2015 | ||||
Leased facility, rent expense per month | $ 12,804 | ||||
Lease facility, refundable security deposit amount | 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 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Feb. 01, 2017 | Feb. 29, 2016USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2012 | Nov. 30, 2011ft² |
Loss Contingencies [Line Items] | ||||||
Lease expiration date | Jul. 31, 2020 | |||||
Total rent expense | $ 1,272,000 | $ 1,272,000 | ||||
Unconditional purchase commitment aggregate amount | $ 1,062,500 | $ 341,000 | ||||
Unconditional purchase commitment payment terms | Quarterly | |||||
Unconditional purchase commitment period | May 31, 2020 | |||||
Total expense for sales tax and maintenance obligations | $ 101,000 | $ 79,000 | ||||
Sales tax and maintenance obligations incurred but not paid | 91,285 | |||||
Total payments for future sales tax and maintenance obligations | 321,935 | |||||
Accrued Other Liabilities [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Sales tax and maintenance obligations incurred but not paid | $ 69,000 | |||||
Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Unconditional purchase commitment, quarterly payment amount | $ 62,500 | |||||
San Diego California Facility [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Initial lease term | 8 years | |||||
Lease expiration date | Mar. 31, 2017 | Oct. 31, 2018 | ||||
Leased facility, expansion of original premises | ft² | 9,849 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Detail) | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 1,430,366 |
2020 | 855,136 |
Total | $ 2,285,502 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Summary of Selected Quarterly Financial Data (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||||||
Sep. 30, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |||||||||
Balance sheet data: | ||||||||||||||||||||
Cash | $ 8,956,200 | $ 3,423,373 | $ 8,956,200 | $ 2,569,111 | $ 9,272,420 | $ 2,146,611 | $ 5,879,025 | $ 10,000,155 | $ 14,042,388 | $ 3,423,373 | $ 2,146,611 | $ 4,609,332 | ||||||||
Total assets | 14,551,892 | 8,750,303 | 14,551,892 | 8,291,310 | 14,747,827 | 7,378,906 | 11,120,215 | 14,653,193 | 17,933,413 | 8,750,303 | 7,378,906 | |||||||||
Total non-current liabilities | 1,174,397 | 1,098,137 | 1,174,397 | 1,258,261 | 1,357,193 | 1,421,527 | 1,255,939 | 1,561,520 | 2,062,544 | 1,098,137 | 1,421,527 | |||||||||
Total shareholders’ equity | 8,938,408 | 3,042,519 | 8,938,408 | 2,527,568 | 8,507,714 | 1,296,034 | 4,026,079 | 7,342,257 | 10,418,069 | 3,042,519 | 1,296,034 | $ 658,661 | ||||||||
Statement of operations and comprehensive loss data: | ||||||||||||||||||||
Net revenues | 859,526 | 761,591 | 822,238 | 806,943 | 995,226 | 1,111,411 | 1,278,961 | 1,683,065 | 3,250,298 | 5,068,663 | ||||||||||
Cost of revenues | 2,435,262 | 2,481,916 | 2,699,671 | 2,434,886 | 2,359,909 | 2,487,054 | 2,368,705 | 2,129,454 | 10,051,735 | 9,345,122 | ||||||||||
Research and development expenses | 1,288,957 | 1,089,746 | 1,019,285 | 1,070,584 | 908,800 | 856,698 | 841,991 | 757,258 | 4,468,572 | 3,364,747 | ||||||||||
General and administrative expenses | 1,632,670 | 1,793,720 | 1,708,970 | 1,938,664 | 1,650,097 | 1,834,771 | 1,798,026 | 1,906,635 | 7,074,024 | 7,189,529 | ||||||||||
Sales and marketing expenses | 1,440,798 | 1,404,192 | 1,433,174 | 1,636,542 | 1,642,941 | 1,675,852 | 1,746,867 | 1,278,311 | 5,914,706 | 6,343,971 | ||||||||||
Loss from operations | (5,938,161) | (6,007,983) | (6,038,862) | (6,273,733) | (5,566,521) | (5,742,964) | (5,476,628) | (4,388,593) | (24,258,739) | (21,174,706) | ||||||||||
Net loss | (6,014,312) | (6,047,784) | (6,153,101) | (6,356,404) | $ (5,666,573) | $ (5,821,306) | $ (5,693,151) | $ (4,432,707) | (24,571,601) | (21,613,737) | ||||||||||
Deemed dividend related to warrants down round provision | $ (636,000) | (636,370) | (636,370) | |||||||||||||||||
Net loss attributable to common shareholders | $ (6,014,312) | $ (6,684,154) | $ (6,153,101) | $ (6,356,404) | $ (25,207,971) | $ (21,613,737) | ||||||||||||||
Net loss per common share: | ||||||||||||||||||||
Basic | $ (1.43) | [1] | $ (2.42) | [1] | $ (2.70) | [1] | $ (3.33) | [1] | $ (5.36) | [1] | $ (5.85) | [1] | $ (6.32) | [1] | $ (6.27) | [1] | $ (9.01) | $ (23.58) | ||
Diluted | $ (1.43) | [1] | $ (2.42) | [1] | $ (2.70) | [1] | $ (3.33) | [1] | $ (5.36) | [1] | $ (5.85) | [1] | $ (6.32) | [1] | $ (6.27) | [1] | $ (9.01) | $ (23.58) | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||||||||||||||||||||
Basic | 4,209,221 | 2,767,440 | 2,280,115 | 1,911,282 | 1,058,055 | 995,254 | 901,007 | 707,389 | 2,798,243 | 916,599 | ||||||||||
Diluted | 4,209,221 | 2,759,614 | 2,280,115 | 1,911,282 | 1,058,055 | 995,254 | 901,007 | 707,389 | 2,798,243 | 916,599 | ||||||||||
[1] | Basic and diluted net loss per common share are computed independently for each of the components and quarters presented. Therefore, the sum of quarterly basic and diluted per share information may not equal annual basic and diluted net loss per common share. |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Mar. 19, 2019 | Mar. 11, 2019 | Feb. 12, 2019 | Jan. 18, 2019 | Sep. 20, 2018 | Aug. 13, 2018 | Jan. 31, 2018 | Jan. 30, 2018 | Aug. 11, 2017 | Aug. 09, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 08, 2017 | Mar. 31, 2017 |
Subsequent Event [Line Items] | ||||||||||||||
Shares issued in offering | 642,438 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,000,000 | |||||||||||||
Beginning stock price | $ 3.285 | $ 13.50 | ||||||||||||
Exercise price of unregistered warrants | $ 4.53 | $ 3.16 | $ 45 | $ 45 | $ 3.16 | $ 25.50 | $ 75 | |||||||
Class of warrant or rights, term | 5 years | 5 years | ||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 1,200 | $ 7,498,535 | |||||||||||
Warrant exercisable for share of common stock | 1 | |||||||||||||
Follow-on Public Offering [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 13,300,000 | |||||||||||||
Beginning stock price | $ 13.50 | |||||||||||||
Exercise price of unregistered warrants | $ 3.16 | $ 4.53 | $ 3.16 | |||||||||||
Class of warrant or rights, term | 5 years | 5 years | 5 years | |||||||||||
Proceeds from exercise of common stock warrants | $ 0 | $ 0 | ||||||||||||
Subsequent Event [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Shares issued in offering | 5,950,000 | 990,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 7,500,000 | $ 2,000,000 | ||||||||||||
Beginning stock price | $ 1.37 | $ 2.25 | ||||||||||||
Exercise price of unregistered warrants | $ 1.25 | $ 1.20 | ||||||||||||
Class of warrant or rights, term | 5 years 6 months | |||||||||||||
Warrant exercisable for share of common stock | 1 | |||||||||||||
Subsequent Event [Member] | Follow-on Public Offering [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Shares issued in offering | 6,250,000 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 601,000 | $ 6,800,000 | ||||||||||||
Beginning stock price | $ 1.20 | $ 1.20 | ||||||||||||
Exercise price of unregistered warrants | $ 1.20 | |||||||||||||
Class of warrant or rights, term | 5 years | |||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | |||||||||||||
Purchase of common stock by underwriters to cover overallotments, number of shares | 538,867 | |||||||||||||
Subsequent Event [Member] | Over-allotment Option [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 937,500 | |||||||||||||
Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Shares issued in offering | 990,000 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,000,000 | |||||||||||||
Beginning stock price | $ 2.25 | |||||||||||||
Maximum [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | |||||||||||||
Maximum [Member] | Follow-on Public Offering [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 1,095,153 | |||||||||||||
Maximum [Member] | Subsequent Event [Member] | Follow-on Public Offering [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 6,250,000 | |||||||||||||
Maximum [Member] | Subsequent Event [Member] | Over-allotment Option [Member] | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 937,500 |