Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 06, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | BIOC | |
Entity Registrant Name | BIOCEPT INC | |
Entity Central Index Key | 0001044378 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Interactive Data Current | Yes | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 13,396,748 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-36284 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 80-0943522 | |
Entity Address, Address Line One | 5810 Nancy Ridge Drive | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92121 | |
City Area Code | 858 | |
Local Phone Number | 320-8200 | |
Title of 12(b) Security | Common Stock, par value $.0001 per share | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Security Exchange Name | NASDAQ |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 16,857,941 | $ 9,301,406 |
Accounts receivable, net | 7,954,625 | 3,527,078 |
Inventories, net | 3,315,789 | 767,986 |
Prepaid expenses and other current assets | 697,946 | 296,127 |
Total current assets | 28,826,301 | 13,892,597 |
Fixed assets, net | 1,607,177 | 1,504,330 |
Lease right-of-use assets - operating | 235,369 | 729,330 |
Lease right-of-use assets - finance | 2,135,788 | 1,606,387 |
Total assets | 32,804,635 | 17,732,644 |
Current liabilities: | ||
Accounts payable | 6,123,990 | 2,011,827 |
Accrued liabilities | 2,622,722 | 1,980,204 |
Current portion of lease liabilities - operating | 242,957 | 842,452 |
Current portion of lease liabilities - finance | 914,671 | 724,329 |
Supplier financings | 209,312 | |
Total current liabilities | 10,113,652 | 5,558,812 |
Non-current portion of lease liabilities - finance | 1,337,686 | 973,189 |
Total liabilities | 11,451,338 | 6,532,001 |
Commitments and contingencies (see Note 10) | ||
Shareholders’ equity: | ||
Preferred stock, $0.0001 par value, 5,000,000 authorized; 2,133 shares issued and outstanding at December 31, 2019 and September 30, 2020. | ||
Common stock, $0.0001 par value, 150,000,000 authorized; 5,473,848 issued and outstanding at December 31, 2019; 13,396,570 issued and outstanding at September 30, 2020. | 1,340 | 547 |
Additional paid-in capital | 286,780,895 | 256,917,285 |
Accumulated deficit | (265,428,938) | (245,717,189) |
Total shareholders’ equity | 21,353,297 | 11,200,643 |
Total liabilities and shareholders’ equity | $ 32,804,635 | $ 17,732,644 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 2,133 | 2,133 |
Preferred stock, shares outstanding | 2,133 | 2,133 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 13,396,570 | 5,473,848 |
Common stock, shares outstanding | 13,396,570 | 5,473,848 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Net revenues | $ 6,586,144 | $ 1,529,262 | $ 8,950,160 | $ 3,744,824 |
Costs and expenses: | ||||
Cost of revenues | 5,859,370 | 2,832,735 | 11,323,668 | 8,105,422 |
Research and development expenses | 1,087,741 | 1,163,546 | 3,989,133 | 3,535,116 |
General and administrative expenses | 3,023,337 | 1,700,380 | 6,839,467 | 5,058,525 |
Sales and marketing expenses | 1,434,481 | 1,462,335 | 4,232,867 | 4,451,628 |
Total costs and expenses | 11,404,929 | 7,158,996 | 26,385,135 | 21,150,691 |
Loss from operations | (4,818,785) | (5,629,734) | (17,434,975) | (17,405,867) |
Other income/ (expense): | ||||
Interest expense | (59,549) | (62,028) | (171,891) | (187,575) |
Warrant inducement and other income (expenses) | (2,102,109) | (1,831,116) | ||
Total other income/ (expense): | (59,549) | (62,028) | (2,274,000) | (2,018,691) |
Loss before income taxes | (4,878,334) | (5,691,762) | (19,708,975) | (19,424,558) |
Net loss and comprehensive loss | (4,878,334) | (5,691,762) | (19,708,975) | (19,424,558) |
Deemed dividend related to warrants down round provision | (2,774) | (99,743) | ||
Net loss attributable to common shareholders | $ (4,878,334) | $ (5,691,762) | $ (19,711,749) | $ (19,524,301) |
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||||
Basic | 11,324,289 | 2,301,819 | 13,333,427 | 1,780,727 |
Diluted | 11,324,289 | 2,301,819 | 13,333,427 | 1,780,727 |
Net loss per common share: | ||||
Basic | $ (0.43) | $ (2.47) | $ (1.48) | $ (10.96) |
Diluted | $ (0.43) | $ (2.47) | $ (1.48) | $ (10.96) |
Condensed Statements of Shareho
Condensed Statements of Shareholders' Equity - USD ($) | Total | Cashless Warrants [Member] | January 2019 Financing Transaction [Member] | February 2019 Financing Transaction [Member] | January 2019 Financing Transaction Overallotment [Member] | March 2019 Financing Transaction [Member] | March 2, 2020 Financing Transaction [Member] | March 4, 2020 Financing Transaction [Member] | December 2019 Financing Transaction Overallotment [Member] | April 2020 Financing Transaction [Member] | Common Stock [Member] | Common Stock [Member]Cashless Warrants [Member] | Common Stock [Member]January 2019 Financing Transaction [Member] | Common Stock [Member]February 2019 Financing Transaction [Member] | Common Stock [Member]January 2019 Financing Transaction Overallotment [Member] | Common Stock [Member]March 2019 Financing Transaction [Member] | Common Stock [Member]March 2, 2020 Financing Transaction [Member] | Common Stock [Member]March 4, 2020 Financing Transaction [Member] | Common Stock [Member]December 2019 Financing Transaction Overallotment [Member] | Common Stock [Member]April 2020 Financing Transaction [Member] | SeriesA Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Cashless Warrants [Member] | Additional Paid-in Capital [Member]January 2019 Financing Transaction [Member] | Additional Paid-in Capital [Member]February 2019 Financing Transaction [Member] | Additional Paid-in Capital [Member]January 2019 Financing Transaction Overallotment [Member] | Additional Paid-in Capital [Member]March 2019 Financing Transaction [Member] | Additional Paid-in Capital [Member]March 2, 2020 Financing Transaction [Member] | Additional Paid-in Capital [Member]March 4, 2020 Financing Transaction [Member] | Additional Paid-in Capital [Member]December 2019 Financing Transaction Overallotment [Member] | Additional Paid-in Capital [Member]April 2020 Financing Transaction [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2018 | $ 3,042,519 | $ 46 | $ 223,500,051 | $ (220,457,578) | ||||||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2018 | 462,917 | 4,417 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 102,459 | 102,459 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 4,748 | 4,748 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 598 | |||||||||||||||||||||||||||||||
Deemed dividends related to warrants downround provision | 99,743 | (99,743) | ||||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 2,032,311 | $ 6,602,735 | $ 592,306 | $ 7,553,793 | $ 10 | $ 62 | $ 5 | $ 59 | $ 2,032,301 | $ 6,602,673 | $ 592,301 | $ 7,553,734 | ||||||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 99,000 | 625,000 | 53,886 | 595,000 | ||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock | $ 5 | (5) | ||||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock, shares | 50,343 | (2,278) | ||||||||||||||||||||||||||||||
Net loss | (5,916,787) | (5,916,787) | ||||||||||||||||||||||||||||||
Ending balance at Mar. 31, 2019 | 14,014,084 | $ 187 | 240,488,005 | (226,474,108) | ||||||||||||||||||||||||||||
Ending balance, shares at Mar. 31, 2019 | 1,886,744 | 2,139 | ||||||||||||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | 3,042,519 | $ 46 | 223,500,051 | (220,457,578) | ||||||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2018 | 462,917 | 4,417 | ||||||||||||||||||||||||||||||
Deemed dividends related to warrants downround provision | 99,743 | |||||||||||||||||||||||||||||||
Net loss | (19,424,558) | |||||||||||||||||||||||||||||||
Ending balance at Sep. 30, 2019 | 7,705,458 | $ 228 | 247,687,112 | (239,981,882) | ||||||||||||||||||||||||||||
Ending balance, shares at Sep. 30, 2019 | 2,301,820 | 2,133 | ||||||||||||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | 3,042,519 | $ 46 | 223,500,051 | (220,457,578) | ||||||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2018 | 462,917 | 4,417 | ||||||||||||||||||||||||||||||
Net loss | (25,100,000) | |||||||||||||||||||||||||||||||
Ending balance at Dec. 31, 2019 | 11,200,643 | $ 547 | 256,917,285 | (245,717,189) | ||||||||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2019 | 5,473,848 | 2,133 | ||||||||||||||||||||||||||||||
Beginning balance at Mar. 31, 2019 | 14,014,084 | $ 187 | 240,488,005 | (226,474,108) | ||||||||||||||||||||||||||||
Beginning balance, shares at Mar. 31, 2019 | 1,886,744 | 2,139 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 224,641 | 224,641 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 4,845,722 | $ 41 | 4,845,681 | |||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 414,944 | |||||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock, shares | 132 | (6) | ||||||||||||||||||||||||||||||
Warrant inducement expense | 1,831,116 | 1,831,116 | ||||||||||||||||||||||||||||||
Net loss | (7,816,012) | (7,816,012) | ||||||||||||||||||||||||||||||
Ending balance at Jun. 30, 2019 | 13,099,551 | $ 228 | 247,389,443 | (234,290,120) | ||||||||||||||||||||||||||||
Ending balance, shares at Jun. 30, 2019 | 2,301,820 | 2,133 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 297,669 | 297,669 | ||||||||||||||||||||||||||||||
Net loss | (5,691,762) | (5,691,762) | ||||||||||||||||||||||||||||||
Ending balance at Sep. 30, 2019 | 7,705,458 | $ 228 | 247,687,112 | (239,981,882) | ||||||||||||||||||||||||||||
Ending balance, shares at Sep. 30, 2019 | 2,301,820 | 2,133 | ||||||||||||||||||||||||||||||
Beginning balance at Dec. 31, 2019 | 11,200,643 | $ 547 | 256,917,285 | (245,717,189) | ||||||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2019 | 5,473,848 | 2,133 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 142,964 | 142,964 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 2,306,708 | $ 70 | $ 61 | 2,306,638 | $ (61) | |||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 696,140 | 608,000 | ||||||||||||||||||||||||||||||
Deemed dividends related to warrants downround provision | 2,774 | (2,774) | ||||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 8,565,500 | $ 6,093,561 | $ 659,958 | $ 230 | $ 160 | $ 19 | $ 8,565,270 | $ 6,093,401 | $ 659,939 | |||||||||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 2,300,000 | 1,600,000 | 192,750 | |||||||||||||||||||||||||||||
Warrant inducement expense | 2,102,109 | 2,102,109 | ||||||||||||||||||||||||||||||
Net loss | (8,341,338) | (8,341,338) | ||||||||||||||||||||||||||||||
Ending balance at Mar. 31, 2020 | 22,730,105 | $ 1,087 | 276,790,319 | (254,061,301) | ||||||||||||||||||||||||||||
Ending balance, shares at Mar. 31, 2020 | 10,870,738 | 2,133 | ||||||||||||||||||||||||||||||
Beginning balance at Dec. 31, 2019 | 11,200,643 | $ 547 | 256,917,285 | (245,717,189) | ||||||||||||||||||||||||||||
Beginning balance, shares at Dec. 31, 2019 | 5,473,848 | 2,133 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 876,772 | |||||||||||||||||||||||||||||||
Deemed dividends related to warrants downround provision | 2,774 | |||||||||||||||||||||||||||||||
Net loss | (19,708,975) | |||||||||||||||||||||||||||||||
Ending balance at Sep. 30, 2020 | 21,353,297 | $ 1,340 | 286,780,895 | (265,428,938) | ||||||||||||||||||||||||||||
Ending balance, shares at Sep. 30, 2020 | 13,396,570 | 2,133 | ||||||||||||||||||||||||||||||
Beginning balance at Mar. 31, 2020 | 22,730,105 | $ 1,087 | 276,790,319 | (254,061,301) | ||||||||||||||||||||||||||||
Beginning balance, shares at Mar. 31, 2020 | 10,870,738 | 2,133 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 194,236 | 194,236 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 72,608 | $ 2 | 72,606 | |||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 20,584 | |||||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 9,577,297 | $ 223 | $ 9,577,074 | |||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 2,230,000 | |||||||||||||||||||||||||||||||
Net loss | (6,489,303) | (6,489,303) | ||||||||||||||||||||||||||||||
Ending balance at Jun. 30, 2020 | 26,084,943 | $ 1,312 | 286,634,235 | (260,550,604) | ||||||||||||||||||||||||||||
Ending balance, shares at Jun. 30, 2020 | 13,121,322 | 2,133 | ||||||||||||||||||||||||||||||
Stock-based compensation expense | 166,730 | 166,730 | ||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 22,388 | $ 1 | $ 27 | 22,387 | $ (27) | |||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 6,546 | 268,772 | ||||||||||||||||||||||||||||||
Costs related to previous financings | (42,430) | (42,430) | ||||||||||||||||||||||||||||||
Fractional shares adjustment upon one-for-ten reverse stock split, shares | (70) | |||||||||||||||||||||||||||||||
Net loss | (4,878,334) | (4,878,334) | ||||||||||||||||||||||||||||||
Ending balance at Sep. 30, 2020 | $ 21,353,297 | $ 1,340 | $ 286,780,895 | $ (265,428,938) | ||||||||||||||||||||||||||||
Ending balance, shares at Sep. 30, 2020 | 13,396,570 | 2,133 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash Flows from Operating Activities | ||
Net loss | $ (19,708,975) | $ (19,424,558) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 839,794 | 691,191 |
Amortization of right-of-use assets | (105,534) | (113,419) |
Inventory reserve | 57,350 | 20,277 |
Stock-based compensation | 503,930 | 624,769 |
Warrant inducement expense | 2,102,109 | 1,831,116 |
Gain on disposal of fixed assets | (1,680) | |
Increase/(decrease) in cash resulting from changes in: | ||
Accounts receivable, net | (4,427,547) | (1,287,334) |
Inventory | (2,605,153) | (120,241) |
Prepaid expenses and other current assets | 165,353 | 322,299 |
Accounts payable | 3,853,736 | (198,400) |
Accrued liabilities | 642,516 | 76,932 |
Net cash used in operating activities | (18,684,101) | (17,577,368) |
Cash Flows from Investing Activities: | ||
Purchases of fixed assets | (64,331) | (297,877) |
Net cash used in investing activities | (64,331) | (297,877) |
Cash Flows from Financing Activities: | ||
Net proceeds from issuance of common stock and warrants | 24,193,930 | 16,779,772 |
Proceeds from exercise of common stock warrants | 2,401,704 | 2,513,172 |
Proceeds from warrant exercise inducement, net | 2,337,298 | |
Proceeds from exercise of overallotment warrants | 659,958 | |
Payments on finance leases | (518,190) | (378,389) |
Payments on supplier and other third-party financings | (432,435) | (260,537) |
Net cash provided by financing activities | 26,304,967 | 20,991,316 |
Net increase in Cash | 7,556,535 | 3,116,071 |
Cash at Beginning of Period | 9,301,406 | 3,423,373 |
Cash at End of Period | 16,857,941 | 6,539,444 |
Cash paid during the period for: | ||
Interest | $ 171,891 | $ 187,574 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Financed insurance premium through third party financing | $ 567,000 | $ 393,000 | |||
Fixed assets purchased under finance lease obligations | 1,073,000 | 583,000 | |||
Unpaid fixed assets | 173,000 | 67,000 | $ 32,000 | $ 25,000 | |
Operating lease, right-of-use asset | 235,369 | 729,330 | |||
Operating lease liability | 242,957 | ||||
Lease right-of-use assets | 2,135,788 | $ 1,606,387 | |||
Deemed dividends related to warrants downround provision | 2,774 | 99,743 | |||
Proceeds from exercise of common stock warrants | 2,337,298 | ||||
Proceeds from exercise of common stock warrants | 2,401,704 | $ 2,513,172 | |||
February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | |||||
Proceeds from exercise of common stock warrants | $ 2,300,000 | ||||
Warrant [Member] | |||||
Stock price | $ 3.495 | ||||
ASC Topic 842 [Member] | |||||
Operating lease, right-of-use asset | $ 1,900,000 | ||||
ASC Topic 842 [Member] | San Diego, California [Member] | |||||
Operating lease, right-of-use asset | $ 482,000 | ||||
Operating lease liability | $ 482,000 | ||||
Lessee operating lease option to extend | November 2020 | ||||
Lessee operating lease existence of option to extend | true | ||||
Property, Plant and Equipment [Member] | ASC Topic 842 [Member] | |||||
Lease right-of-use assets | $ 1,400,000 |
The Company, Business Activitie
The Company, Business Activities and Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
The Company, Business Activities and Basis of Presentation | 1. The Company, Business Activities and Basis of Presentation The Company and Business Activities The Company was founded in California in May 1997 and is an early stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or liquid biopsy. The Company’s current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy at diagnosis, progression or for monitoring in order to identify specific resistance mechanisms. Sometimes traditional procedures, such as surgical tissue biopsies, result in tumor tissue that is insufficient and/or unable to provide the molecular subtype information necessary for clinical decisions. The Company’s assays, performed on blood, have the potential to provide more contemporaneous information on the characteristics of a patient’s disease when compared with tissue biopsy and radiographic imaging. Additionally, commencing in October 2017, the Company’s pathology partnership program, branded as Empower TC TM , 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 the Company’s proprietary blood collection tubes commenced in June 2018, which allow for the intact transport of liquid biopsy samples for research use only, or RUO, from regions around the world. 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 The accompanying unaudited condensed financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and on the basis that the Company will continue as a going concern (see Note 2). The accompanying unaudited condensed financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. On September 3, 2020, the Company filed an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a one-for-ten reverse stock split of the shares of common stock outstanding on September 4, 2020. As such, all references to share and per share amounts in these unaudited condensed financial statements and accompanying notes have been retroactively restated to reflect the one-for-ten reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 The unaudited condensed financial statements included in this Form 10-Q have been prepared in accordance with the U.S. Securities and Exchange Commission, or SEC, instructions for Quarterly Reports on Form 10-Q. Accordingly, the condensed financial statements are unaudited and do not contain all the information required by GAAP to be included in a full set of financial statements. The balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for a complete set of financial statements. The audited financial statements for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, with our Annual Report on Form 10-K on March 27, 2020 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year. A novel strain of coronavirus (“ COVID COVID COVID Significant Accounting Policies During the three and nine months ended September 30, 2020, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, except as described in Recent Accounting Pronouncements below. 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. 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. Contracts For its commercial revenues, while the Company markets directly to physicians and other healthcare providers, the Company provides services that benefit the patient. Patients do not typically enter into direct agreements with the Company, however, a patient’s insurance coverage requirements would dictate whether or not any portion of the cost of the tests would be patient responsibility. Accordingly, the Company establishes contracts with commercial insurers in accordance with customary business practices, as follows: • Approval of a contract is established via the order and accession, which are submitted by the patient’s physician. • The Company is obligated to perform its diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable payer are obligated to reimburse the Company for services rendered based on the patient’s insurance benefits. • Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with CMS and applicable reimbursement contracts established between the Company and payers, unless the patient is a self-pay patient, whereby the Company bills the patient directly after the services are provided. • On ce the Company delivers a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as the Company is legally able to collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance benefit status. • Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues recorded to the extent that it is probable that a significant reversal will not occur. The Company’s development services revenues are supported by contractual agreements and generated from assay development services provided to entities, such as pharma or biotech organizations, 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, and for our RT-PCR COVID-19 testing, typically 48 hours or less. Accordingly, the Company elected the practical expedient and therefore, does not disclose the value of unsatisfied performance obligations. Transaction Price The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may include fixed amounts, variable amounts, or both. The Company’s gross commercial revenues billed, and corresponding gross accounts receivable, are subject to estimated deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and corresponding amounts estimated to be subsequently collected, and is deemed to be variable although the variability is not explicitly stated in any contract. Rather, the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim denials. The Company estimates the The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is recognized up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a customer, it will account for the change as an increase in the estimate of the transaction price in the period identified as an increase to revenue. Similarly, if the Company subsequently determines that the amount it expects to collect from a customer is less than it originally estimated, it will generally account for the change as a decrease in the estimate of the transaction price as a decrease to revenue, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from changes in transaction prices was not significant during the three and nine months ended September 30, 2019 and 2020. Further, although the Company believes that its estimate for contractual allowances and other reserves is appropriate, it is possible that the Company will experience an impact on cash collections as a result of the impact of the COVID-19 pandemic. Allocate Transaction Price For the Company’s commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a customer. For the Company’s development services revenues, the contracted transaction price is allocated to each single performance obligation contained in a contract with a customer as performed. Point-in-time Recognition The Company’s single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is delivered to the patient’s ordering physician or entity. The Company considers this date to be the time at which the patient obtains control of the promised diagnostic assay service. Contract Balances The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in the Company’s condensed balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2019 and 2020, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net revenues from contracted payers* $ 476,101 $ 3,219,233 $ 1,447,421 $ 3,981,041 Net revenues from non-contracted payers 956,140 3,166,101 2,080,018 4,562,909 Development services revenues 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net commercial revenues recognized upon delivery $ 1,432,241 $ 6,385,334 $ 3,527,439 $ 8,543,950 Development services revenues recognized upon delivery 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 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. For the nine months ended September 30, 2020, approximately 67% of the Company’s commercial revenue and as of September 30, 2020 61% of the total outstanding accounts receivable is related to RT-PCR COVID-19 testing. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2019 and 2020 were as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Medicare and Medicare Advantage 32 % 32 % 40 % 32 % Blue Cross Blue Shield 25 % 42 % 20 % 38 % 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, 2019 and September 30, 2020 were as follows: December 31, 2019 September 30, 2020 Blue Cross Blue Shield 26 % 36 % Medicare and Medicare Advantage 17 % 11 % United Healthcare 12 % 5 % Recent Accounting Pronouncements 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 adopted this guidance for the fiscal year beginning on January 1, 2020, and determined that the adoption of this guidance does not have a material impact on its financial statements or disclosures. |
Liquidity and Going Concern Unc
Liquidity and Going Concern Uncertainty | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Liquidity and Going Concern Uncertainty | 2. Liquidity and Going Concern Uncertainty As of September 30, 2020, cash totaled $16.9 million and the Company had an accumulated deficit of $265.4 million. While the Company is currently in the commercialization stage of operations, the Company has not yet achieved profitability and anticipates that it will continue to incur net losses and negative cash flows from operations 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. 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. The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. The Company estimates that the COVID-19 pandemic led to an approximate 15 to 25% decline in commercial volume from its core oncology business, and also impacted opportunities for gaining new customers with the closing of many physician offices and labs. The Company is continuing to vigilantly monitor the situation with its primary focus on the health and safety of its employees and clients. The Company launched its RT-PCR COVID-19 testing business during the second quarter of 2020 and received more than 50,000 samples for processing through its RT-PCR technology at its laboratory through September 30, 2020. The Company’s management believes that performing highly accurate RT-PCR testing for COVID-19 will be an important aspect of the Company’s business until the COVID-19 pandemic subsides. During the three and nine months ended September 30, 2020, there was a significant increase in the Company’s net revenues primarily due to substantial RT-PCR COVID-19 testing volumes during that time. If a vaccine for COVID-19 is successfully developed, the Company will likely lose much of the revenue generated by its RT-PCR COVID-19 testing business. In January 2020, the Company issued an aggregate of 692,725 shares of its common stock pursuant to the exercise of certain warrants issued by the Company in February 2019 and March 2019, as part of a warrant repricing and exchange transaction. As part of the warrant repricing and exchange transaction, the Company issued an aggregate of 692,725 new warrants in exchange for the exercise of the February 2019 and March 2019 warrants and received net proceeds of approximately $2.3 million. As a result of the warrant repricing, the exercise price of warrants to purchase an aggregate of 89,657 shares of common stock issued by the Company in January 2018 was adjusted from $4.05 to $3.495 per share. In January 2020, the Company issued 192,750 shares of common stock pursuant to the partial exercise of the underwriters’ overallotment option from the Company’s December 2019 public offering. The net proceeds to the Company from the overallotment closing, was approximately $700,000. On March 2, 2020, the Company received net cash proceeds of approximately $8.6 million from a registered direct offering to certain institutional investors of 2,300,000 shares of common stock at a negotiated purchase price of $4.00 per share. On March 4, 2020, the Company received net cash proceeds of approximately $6.1 million from a registered direct offering to certain institutional investors of 1,600,000 shares of common stock at a negotiated purchase price of $4.10 per share. On April 16, 2020, the Company received net cash proceeds of approximately $9.6 million from a registered direct offering to certain institutional investors of 2,230,000 shares of common stock at a negotiated purchase price of $4.60 per share. Management’s Plan to Continue as a Going Concern In order to continue as a going concern, the Company will need, among other things, additional capital resources. Until the Company can generate significant cash from operations, including assay revenues, management’s plans to obtain such resources for the Company include proceeds from offerings of the Company’s equity securities or debt, cash received from the exercise of outstanding common stock warrants, or transactions involving product development, technology licensing or collaboration. Management can provide no assurances that any sources of a sufficient amount of financing will be available to the Company on favorable terms, if at all. Based on the above, the Company’s management concluded that the going concern uncertainty has not been alleviated and as such, there is substantial doubt about the Company’s ability to continue as a going concern as of the date of this filing. |
Sales of Equity Securities
Sales of Equity Securities | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Sales of Equity Securities | 3. Sales of Equity Securities On January 18, 2019, the Company completed an offering of 99,000 shares of the Company’s common stock. The shares were sold at a purchase price of $22.50 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 $6.6 million as a result of the closing of a follow-on public offering of 625,000 shares of its common stock and warrants to purchase up to an aggregate of 625,000 shares of its common stock at a combined offering price of $12.00 per unit. All warrants sold in this offering have an exercise price of $12.00 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 93,750 shares of the Company’s common stock in connection with the partial exercise of the over-allotment option granted to the underwriters. Upon closing of the transaction, warrants to purchase 91,500 shares were issued pursuant to the placement agents’ partial exercise of their overallotment. Pursuant to the down round adjustment feature of the January 2018 warrants, the exercise price of these warrants was adjusted to the $12.00 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 595,000 shares at a negotiated purchase price of $13.70 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 $12.50 per share, are exercisable immediately upon issuance and expire 5.5 years following the date of issuance. In May 2019, the Company received cash proceeds of approximately $2.5 million from the exercise of 208,647 February 2019 warrants at $12.00 per share. On May 28, 2019, the Company entered into Warrant Exercise Agreements, or the Exercise Agreements, with certain of the holders of its existing warrants, or the Exercising Holders. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that, subject to any applicable beneficial ownership limitations, the Exercising Holders would cash exercise up to 20% of their existing warrants, or the Investor Warrants, into shares of common stock underlying such Investor Warrants, or the Exercised Shares. In order to induce the Exercising Holders to cash exercise the Investor Warrants, the Exercise Agreements provided for the issuance of new warrants, or Inducement Warrants, with such Inducement Warrants to be issued in an amount equal to 75% of the number of Exercised Shares underlying any Investor Warrants that was cash exercised by July 15, 2019. The Inducement Warrants were exercisable upon issuance and terminate on the date that is 5.5 years following the initial exercise date. The Inducement Warrants have an exercise price per share of $13.10. A total of 206,296 Investor Warrants were exercised contemporaneously with the execution of the Exercise Agreements resulting in total proceeds to the Company of $2.3 million, net of investment banking fees. The warrants issued in connection with the Exercise Agreements were considered inducement warrants and are classified in equity. The fair value of the warrants issued was approximately $1.8 million (see valuation assumptions in Note 4). The fair value of the Inducement Warrants of $1.8 million was expensed as warrant inducement expense in the accompanying condensed statements of operations for the three and nine months ended September 30, 2019. On July 15, 2019, the Company entered into amendments, or the Amendments, to the Exercise Agreements. Pursuant to the Amendments, the period during which the Exercising Holders may elect to exercise for cash the Investor Warrants in exchange for Inducement Warrants in an amount equal to 75% of the number of shares of common stock exercised under the Existing Warrants was extended from July 15, 2019 to July 31, 2019. There were no additional warrants exercised under the Amendments during the second or third quarter of 2019. In January 2020, the Company issued an aggregate of 692,725 shares of its common stock pursuant to the exercise of certain warrants issued by the Company in February 2019 and March 2019, as part of a warrant repricing and exchange transaction. As part of the warrant repricing and exchange transaction, the Company issued an aggregate of 692,725 new warrants in exchange for the exercise of the February 2019 and March 2019 warrants and received net proceeds of approximately $2.3 million. As a result of the warrant repricing, the exercise price of warrants to purchase an aggregate of 89,657 shares of common stock issued by the Company in January 2018 was adjusted from $4.05 to $3.495 per share. In January 2020, the Company issued 192,750 shares of common stock pursuant to the partial exercise of the underwriters’ overallotment option from the Company’s December 2019 public offering. The net proceeds to the Company from the overallotment closing, was approximately $700,000. The warrants issued in connection with the warrant repricing and exchange transaction were considered inducement warrants and are classified in equity. In addition, the modification expense associated with the change in fair value due to the repricing of February and March 2019 warrants is recorded as inducement expense, which was approximately $191,000. The fair value of the warrants issued was approximately $1.9 million. The fair value of the inducement warrants and warrant modification of $2.1 million was expensed as warrant inducement expense in the accompanying condensed statements of operations for the nine months ended September 30, 2020. On March 2, 2020, the Company sold and issued 2,300,000 shares of its common stock at a negotiated purchase price of $4.00 per share in a registered direct offering and received net cash proceeds of approximately $8.6 million after deducting placement agent fees and other expenses. On March 4, 2020, the Company sold and issued 1,600,000 shares of its common stock at a negotiated purchase price of $4.10 per share in a registered direct offering and received net cash proceeds of approximately $6.1 million after deducting placement agent fees and other expenses. On April 16, 2020, the Company sold and issued 2,230,000 shares of its common stock at a negotiated purchase price of $4.60 per share in a registered direct offering and received net cash proceeds of approximately $9.6 million after deducting placement agent fees and other expenses. |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement The estimated nonrecurring fair value measurements associated with fixed asset purchases recorded as right-of-use asset finance lease obligations totaling approximately $1,073,000 during the nine months ended September 30, 2020 were calculated as the present value of the lease payments based on contractual payment amounts and estimated market rates. Upon adoption of guidance in ASC Topic 842 Leases, the estimated fair value of the right-of-use operating lease asset was recorded based on the present value of future lease payments based on contractual payment amounts and estimated market rates in effect. Other Fair Value Measurements As of the closing of the Company’s February 12, 2019 offering, the estimated grant date fair value of approximately $9.50 per share associated with the warrants to purchase up to 716,500 shares of common stock issued in this offering, or a total of approximately $6.8 million, was recorded as an offset to additional paid-in capital on a relative fair value basis. All warrants sold in this offering have an exercise price of $12.00 per share, are exercisable immediately and expire five years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model with the following assumptions: Beginning stock price $ 10.50 Exercise price $ 12.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.49 % Expected life (in years) 5.00 Expected volatility 147.7 % As of the closing of the Company’s March 19, 2019 offering, the estimated grant date fair value of approximately $10.10 per share associated with the warrants to purchase up to 595,000 shares of common stock issued in this offering, or a total of approximately $6.0 million, was recorded as an offset to additional paid-in capital on a relative fair value basis. All warrants sold in this offering have an exercise price of $12.50 per share, are exercisable immediately and expire 5.5 years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model with the following assumptions: Beginning stock price $ 11.20 Exercise price $ 12.50 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.44 % Expected life (in years) 5.50 Expected volatility 140.0 % As of the closing of the Company’s May 30, 2019 warrant inducement transaction, the estimated grant date fair value of approximately $11.80 per share associated with the Inducement Warrants to purchase up to 154,722 shares of common stock issued in this transaction, or a total of approximately $1.8 million, was recorded as a warrant inducement expense with an offset to additional paid-in capital. All warrants issued in this warrant inducement transaction have an exercise price of $13.10 per share, are exercisable immediately and expire 5.5 years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model with the following assumptions: Beginning stock price $ 12.90 Exercise price $ 13.10 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.05 % Expected life (in years) 5.50 Expected volatility 145.9 % As of the closing of the Company’s January 2020 warrant repricing and exchange transaction, the estimated grant date fair value of approximately $2.80 per share associated with the warrants to purchase up to 692,725 shares of common stock issued in the transaction, or a total of approximately $1.9 million, was recorded as a warrant inducement expense with an offset to additional paid-in capital. All warrants issued in this warrant inducement transaction have an exercise price of $3.495 per share, became exercisable beginning 6 months from issuance and expire 5.5 years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model with the following assumptions: Beginning stock price $ 3.00 Exercise price $ 3.495 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.66 % Expected life (in years) 5.50 Expected volatility 150.33 % In addition to the inducement warrants issued in the Company’s January 2020 warrant repricing and exchange transaction, the Company adjusted the exercise prices of the February 2019 and March 2019 warrants from $12.00 and $12.50, respectively, to $3.495 to induce exercise of these warrants. This price modification triggered the requirement for modification accounting of these warrants. Based on the applicable guidance, the modification required the Company to value the modified February 2019 and March 2019 warrants immediately prior to the modification of the exercise price and immediately following the modification and record the difference between the resulting two values as warrant inducement expense. The estimated fair value prior to modification of the February 2019 and March 2019 warrants was approximately $2.70 per share, whereas the estimated fair value of the February 2019 warrants increased to $2.90 due to the adjustment of the exercise price, and the estimated fair value of the March 2019 warrants increased to $3.00 per share. There were 216,725 February 2019 warrants and 476,000 March 2019 warrants eligible for this price modification and the resulting modification expense recorded as warrant inducement expenses were $60,000 and $130,000, respectively. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Component [Abstract] | |
Balance Sheet Details | 5. Balance Sheet Details The following provides certain balance sheet details: December 31, September 30, 2019 2020 Fixed Assets Machinery and equipment $ 2,857,538 $ 2,900,943 Furniture and office equipment 156,987 156,987 Computer equipment and software 1,552,891 1,552,891 Leasehold improvements 570,173 570,173 Construction in process 625,038 907,435 Total fixed assets, gross 5,762,627 6,088,429 Less accumulated depreciation and amortization (4,258,297 ) (4,481,252 ) Total fixed assets, net $ 1,504,330 $ 1,607,177 Accrued Liabilities Accrued payroll 298,855 666,735 Accrued vacation 622,792 857,385 Accrued bonuses 748,742 708,281 Accrued sales commissions 89,562 159,775 Accrued other 220,253 230,546 Total accrued liabilities $ 1,980,204 $ 2,622,722 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Leases | 6. Leases Effective January 1, 2019, the Company adopted US GAAP accounting rules in ASC Topic 842, Leases (ASC 842), using the modified retrospective method. The Company elected to follow the package of practical expedients provided under the transition guidance within ASC 842, and accordingly, did not reassess whether any expired or existing contracts are or contain leases, did not reassess expired or existing leases, and did not reassess initial direct costs for any existing leases. Upon adoption, the Company recorded an operating lease right-of-use asset and an operating lease liability on the balance sheet. In addition, assets under equipment leases previously classified as capital leases within Property, Plant and Equipment on the Company’s balance sheet were reclassified to finance lease right-of-use assets upon adoption of the guidance. Right-of-use assets and obligations were recognized based on the present value of remaining lease payments over the lease term. As the Company’s operating lease does not provide an implicit rate, an estimated incremental borrowing rate was used based on the information available at the adoption date in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Variable lease costs such as common area costs and other operating costs are expensed as incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Finance Leases The Company leases certain laboratory equipment under arrangements previously accounted for as capital leases, classified on the Company’s balance sheet as fixed assets and related lease liabilities and depreciated on a straight-line basis over the lease term. Upon adoption of ASC 842, leased equipment previously classified as fixed assets totaling $1.4 million in net book value were reclassified to lease right-of-use assets in accordance with the guidance. The equipment under finance leases is depreciated on a straight-line basis over periods ranging from approximately 3 to 7 years. The total gross value of equipment capitalized under such lease arrangements was approximately $3,125,000 and $4,284,000 at December 31, 2019 and September 30, 2020, respectively. Total accumulated depreciation related to equipment under finance leases was approximately $1,606,000 and $2,148,000 at December 31, 2019 and September 30, 2020, respectively. Total depreciation expense related to equipment under finance leases during the three months ended September 30, 2019 and 2020 was approximately $134,000 and $267,000, respectively, and during the nine months ended September 30, 2019 and 2020 was approximately $365,000 and $541,000, respectively. On January 31, 2019, the Company executed an equipment financing commitment with a third-party lender for a total amount of approximately $149,000, which was funded by the lender on February 1, 2019. Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be repaid in full after 36 monthly installments of $5,013 totaling approximately $180,000 through February 2022. In July 2019, an equipment financing commitment was executed with a third-party lender for a total amount of approximately $100,000, which was accounted for as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 48 monthly installments of $2,706 totaling approximately $130,000 through May 2023. In August 2019, an equipment financing commitment was executed with a third-party lender for a total amount of approximately $245,000, which was accounted for as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 36 monthly installments of $8,253 totaling approximately $297,000 through August 2022. In September 2019, an additional equipment financing commitment was executed with a third-party lender for a total additional amount of approximately $89,000, which was accounted for as a finance lease transaction with the principal balance plus interest for the equipment to be repaid in full after 60 monthly installments of $1,770 totaling approximately $106,000 through September 2024. In February 2020, the Company entered into finance leases for a total capitalized amount of $197,000 for three pieces of equipment . Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be repaid in full in installments ranging from 48 to 60 monthly installments of $4,532 totaling approximately $265,000 through January 2025. In addition, in March 2020, the Company entered into a finance lease for a capitalized amount of $11,000 for an additional piece of equipment. Under the term of the equipment financing agreement, the principal amount plus interest are to be repaid in 48 monthly installments of $288 totaling approximately $14,000 through February 2024. In April 2020, the Company entered into finance leases for a capitalized amount of $161,000 for laboratory testing equipment and manufacturing tooling. Under the terms of the equipment financing agreement, which was accounted for as a finance lease transaction, the principal balance plus interest for the equipment are to be repaid in full in 60 monthly installments of $3,337 totaling approximately $185,000 through March 2025. In June 2020 the Company entered into finance leases for a capitalized amount of $334,000 for equipment and laboratory management software. In July 2020 the Company entered into finance leases for a capitalized amount of $143,000 for computer infrastructure equipment and implementation. In September 2020 the Company entered into finance leases for a capitalized amount of $226,000 for laboratory equipment. Operating Lease The Company leases its primary laboratory and office facilities in San Diego, California. This lease is classified as an operating lease in accordance with the ASC 842 guidance. The average monthly cash payment for the operating lease is approximately $120,000 per month, the lease term ended on July 31, 2020, but was extended as stated below. The Company recorded a lease right-of-use asset and lease liability of $1,930,000 and $2,201,000, respectively, as of January 1, 2019, based on present value of payments and an incremental borrowing rate of 4.5%. On June 5, 2020, the Company entered into a fifth amendment (the “Amendment”) to its lease agreement with ARE-SC Region No. 18, LLC, dated March 31, 2004, relating to its current facility in San Diego, California. Pursuant to the Amendment, the expiration date of the Lease was extended from July 31, 2020 to November 30, 2020. The monthly base rent during the extended term will be the current monthly rate paid by the Company. The Company will also pay additional rent and all other charges as set forth in the Lease through the expiration date. During the nine months ended September 30, 2020, pursuant to the extension of the expiration date of the lease, the Company recorded an additional lease right-of-use asset and lease liability of $482,000. On June 1, 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility in San Diego, California. The lease is anticipated to commence on December 1, 2020 and is for a term of 127 months from the commencement date. The average monthly cash payment for the lease is approximately $128,000 per month with initial monthly lease payments at $111,000 per month. In addition, the Company reviews agreements at inception to determine if they include a lease, and when they do, uses its incremental borrowing rate or implicit interest rate to determine the present value of the future lease payments. The following schedule sets forth the components of right-of-use lease assets as of December 31, 2019 and September 30, 2020 as follows: December 31, September 30, 2019 2020 Lease right-of-use assets: Operating $ 729,330 $ 235,369 Finance 1,606,387 2,135,788 Total $ 2,335,717 $ 2,371,157 The following schedule sets forth the current portion of operating and finance lease liabilities as of December 31, 2019 and September 30, 2020: December 31, September 30, 2019 2020 Current portion of lease liability: Operating $ 842,452 242,957 Finance 724,329 914,671 Total $ 1,566,781 $ 1,157,628 The following schedule sets forth the long-term portion of operating and finance lease liabilities as of December 31, 2019 and September 30, 2020: December 31, September 30, 2019 2020 Long-term portion of lease liability: Operating $ — $ — Finance 973,189 1,337,686 Total $ 973,189 $ 1,337,686 The following schedule represents the components of lease expense for the three and nine months ended September 30, 2019 and 2020: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Lease cost Finance lease cost Amortization of right-of-use assets $ 134,472 $ 266,747 $ 364,401 $ 540,853 Interest on lease liabilities 62,026 56,372 187,574 164,044 Operating lease cost 318,005 357,914 954,015 993,924 Total $ 514,503 $ 681,033 $ 1,505,990 $ 1,698,821 The following schedule sets forth the remaining future minimum lease payments outstanding under finance and operating leases, as well as corresponding remaining sales tax and maintenance obligation payments that are expensed as incurred and due within each respective year ending December 31, as well as the present value of the total amount of the remaining minimum lease payments, as of September 30, 2020: Finance Operating Minimum Maintenance and Minimum Lease Sales Tax Obligation Lease Payments Payments Payments 2020 (remaining) $ 280,813 28,630 244,324 2021 915,374 95,381 — 2022 656,100 73,301 — 2023 515,473 57,603 — Thereafter 323,474 45,081 — Total payments 2,691,234 299,996 244,324 Less amount representing interest (438,877 ) — (1,367 ) Present value of payments $ 2,252,357 $ 299,996 $ 242,957 The following schedule sets forth supplemental cash flow information related to operating and finance leases as of September 30, 2020: For the nine months ended September 30, 2019 2020 Other information Operating cash flows from financing leases $ 187,574 $ 164,044 Operating cash flows from operating leases $ 1,067,437 $ 1,099,460 Financing cash flows from finance leases $ 378,389 $ 518,190 The aggregate weighted average remaining lease term was 3.26 years on finance leases and 0.17 years on operating leases as of September 30, 2020. The aggregate weighted average discount rate was 16.45% on finance leases and 4.5% on operating leases as of September 30, 2020. During the nine months ended September 30, 2020, the Company added $1,073,000 of right of use assets in exchange for finance lease liabilities. In addition, upon adoption of the accounting guidance in ASC 842, $1.4 million of net machinery and equipment was reclassified to lease right-of-use assets related to assets under finance leases and $1.9 million of right-of-use facility lease was recorded under operating lease. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 7. 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 5, 2020, 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 730,000 shares. As of September 30, 2020, under all plans, a total of 1,036,409 non-inducement shares were authorized for issuance, 258,625 shares had been issued with 254,356 non-inducement stock options and restricted stock units, or RSUs, underlying outstanding awards, and 777,784 non-inducement shares were available for grant. As of September 30, 2020, 11,836 inducement shares were authorized for issuance, 11,836 inducement shares had been issued under the 2013 Plan, with 2,412 inducement stock options and RSUs underlying outstanding awards and 9,340 inducement shares available for grant. Stock Options A summary of stock option activity for the nine months ended September 30, 2020 is as follows: Weighted Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2019 273,406 $ 36.14 9.25 Granted 13,870 $ 5.23 Exercised — — Cancelled/forfeited/expired (32,920 ) $ 16.09 Outstanding at September 30, 2020 254,356 $ 37.04 8.50 Vested and unvested expected to vest at September 30, 2020 250,368 $ 37.48 8.50 The intrinsic values of options outstanding, options exercisable, and options vested and unvested expected to vest at December 31, 2019 and September 30, 2020 were each zero. The assumptions used in the Black-Scholes pricing model for stock options granted during the nine months ended September 30, 2020 were as follows: Stock and exercise prices $2.70 - $7.10 Expected dividend yield 0.00% Discount rate-bond equivalent yield 0.38% – 1.37% Expected life (in years) 5.00 – 5.96 Expected volatility 146.1% - 171.1% Restricted Stock A summary of RSU activity for the nine months ended September 30, 2020 is as follows: Weighted Number of Average Grant Shares Date Fair Value Outstanding at December 31, 2019 36 $ 4,158 Granted — — Vested and issued — — Forfeited — — Outstanding at September 30, 2020 36 $ 4,158 Vested and unvested expected to vest at September 30, 2020 36 $ 4,158 At September 30, 2020, the intrinsic values of RSUs outstanding and RSUs unvested and expected to vest were each approximately $100. Of the 36 RSUs outstanding at September 30, 2020, all were fully vested. Stock-based Compensation Expense The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the unaudited condensed statements of operations and comprehensive loss during the periods presented: For the three months ended For the nine months ended September 30, September 30, 2019 2020 2019 2020 Stock Options Cost of revenues $ 29,405 $ 25,352 $ 54,625 $ 78,917 Research and development expenses 37,626 25,397 102,742 78,914 General and administrative expenses 168,484 92,472 361,102 290,231 Sales and marketing expenses 62,154 23,509 106,300 55,868 Total expenses related to stock options $ 297,669 $ 166,730 $ 624,769 $ 503,930 Stock-based compensation expense was recorded net of estimated forfeitures of 0% - 8% per annum during each of the three and nine months ended September 30, 2019 and 2020. As of September 30, 2020, total unrecognized share-based compensation expense related to unvested stock options and RSUs, adjusted for estimated forfeitures, was $1,425,133 and is expected to be recognized over a weighted-average period of approximately 2.51 years. |
Common Stock Warrants Outstandi
Common Stock Warrants Outstanding | 9 Months Ended |
Sep. 30, 2020 | |
Equity Classified Warrants [Abstract] | |
Common Stock Warrants Outstanding | 8. Common Stock Warrants Outstanding A summary of equity-classified common stock warrant activity for the nine months ended September 30, 2020 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2019 2,748,424 $ 18.58 4.6 Issued 885,475 $ 3.62 Exercised (2,634,795 ) 6.74 Expired (1,933 ) 1,404.00 Outstanding at September 30, 2020 997,171 $ 35.48 3.6 During the nine months ended September 30, 2020, holders have exercised their warrants in cashless exercise transactions for 876,772 shares of the Company’s common stock. All warrants outstanding at September 30, 2020 are exercisable. The intrinsic value of equity-classified common stock warrants outstanding at September 30, 2020 was zero. |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 9. Net Loss per Common Share Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted-average common shares outstanding during the period. Because there is a net loss attributable to common shareholders for the three and nine months ended September 30, 2019 and 2020, 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 three and nine months ended September 30, 2019 2020 Preferred warrants outstanding (number of common stock equivalents) — — Common warrants outstanding 1,519,724 997,171 RSUs outstanding 36 36 Convertible preferred stock outstanding (number of common stock equivalents) 47,139 47,139 Common options outstanding 279,765 254,356 Total anti-dilutive common share equivalents 1,846,664 1,298,702 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies In the normal course of business, the Company may be involved in legal proceedings or threatened legal proceedings. The Company is not party to any legal proceedings or aware of any threatened legal proceedings that are expected to have a material adverse effect on its financial condition, results of operations or liquidity. During the three months ended September 30, 2019 and 2020, total expense recorded in the Company’s unaudited condensed statements of operations and comprehensive loss for sales tax and maintenance obligations associated with equipment financing arrangements was approximately $35,000 and $29,000, respectively, with approximately $82,000 and $111,000 recorded during the nine months ended September 30, 2019 and 2020, respectively. At December 31, 2019 and September 30, 2020, approximately $73,000 and $77,000, respectively, 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 5). Future amounts totaling $299,996 for sales tax and maintenance obligations associated with financed equipment were due under equipment financing arrangements at September 30, 2020, which will be expensed as incurred (see Note 6). |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. 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 $19,000 and $26,000 during the years ended December 31, 2018 and 2019, respectively, from Aegea as reimbursements for shared patent costs under the Cross-License Agreement. On December 11, 2019, the Company entered into a First Amendment to Assignment and Exclusive Cross-License Agreement with Aegea pursuant to which the Company obtained a royalty bearing license for a certain patent. The Company agreed to pay Aegea, effective January 1, 2019, a royalty of 10% on the Company’s sale of research use only, or RUO, and import research use only reagents and kits in the field of oncology, where the sample types are tissue, whole blood, bone marrow, cerebrospinal fluid or derivatives of any of the foregoing. As of December 31, 2019 and September 30, 2020, the Company has accrued approximately $7,500 and $5,000 for royalty expenses, respectively, related to this arrangement. On June 3, 2020, the Company announced entering into a development agreement with Aegea focused on the co-development by Biocept and Aegea of a highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus. Pursuant to the agreement, the Company will receive compensation for development services performed based on time and materials expended. During the three and nine months ended September 30, 2020, the Company recorded development service revenues of approximately $107,000 and $109,000, respectively, and had approximately $72,000 accounts receivable due from Aegea as of September 30, 2020, related to this agreement. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events On October 1, 2020, the Company’s Board of Directors approved the issuance of an aggregate of 722,568 options to be granted to the Company’s employees and executives. The options granted have an exercise price of $4.50 per share and vest monthly over a three-year period from the grant date. |
The Company, Business Activit_2
The Company, Business Activities and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
The Company and Business Activities | 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, branded as Empower TC TM , 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 the Company’s proprietary blood collection tubes commenced in June 2018, which allow for the intact transport of liquid biopsy samples for research use only, or RUO, from regions around the world. 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 unaudited condensed financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and on the basis that the Company will continue as a going concern (see Note 2). The accompanying unaudited condensed financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. On September 3, 2020, the Company filed an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a one-for-ten reverse stock split of the shares of common stock outstanding on September 4, 2020. As such, all references to share and per share amounts in these unaudited condensed financial statements and accompanying notes have been retroactively restated to reflect the one-for-ten reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 The unaudited condensed financial statements included in this Form 10-Q have been prepared in accordance with the U.S. Securities and Exchange Commission, or SEC, instructions for Quarterly Reports on Form 10-Q. Accordingly, the condensed financial statements are unaudited and do not contain all the information required by GAAP to be included in a full set of financial statements. The balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for a complete set of financial statements. The audited financial statements for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, with our Annual Report on Form 10-K on March 27, 2020 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in this Form 10-Q. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results of operations for the entire year. A novel strain of coronavirus (“ COVID COVID COVID |
Significant Accounting Policies | Significant Accounting Policies During the three and nine months ended September 30, 2020, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, except as described in Recent Accounting Pronouncements below. |
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. 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. Contracts For its commercial revenues, while the Company markets directly to physicians and other healthcare providers, the Company provides services that benefit the patient. Patients do not typically enter into direct agreements with the Company, however, a patient’s insurance coverage requirements would dictate whether or not any portion of the cost of the tests would be patient responsibility. Accordingly, the Company establishes contracts with commercial insurers in accordance with customary business practices, as follows: • Approval of a contract is established via the order and accession, which are submitted by the patient’s physician. • The Company is obligated to perform its diagnostic services upon receipt of a sample from a physician, and the patient and/or applicable payer are obligated to reimburse the Company for services rendered based on the patient’s insurance benefits. • Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with CMS and applicable reimbursement contracts established between the Company and payers, unless the patient is a self-pay patient, whereby the Company bills the patient directly after the services are provided. • On ce the Company delivers a patient’s assay result to the ordering physician, the contract with a patient has commercial substance, as the Company is legally able to collect payment and bill an insurer and/or patient, regardless of payer contract status or patient insurance benefit status. • Consideration associated with commercial revenues is considered variable and constrained until fully adjudicated, with net revenues recorded to the extent that it is probable that a significant reversal will not occur. The Company’s development services revenues are supported by contractual agreements and generated from assay development services provided to entities, such as pharma or biotech organizations, 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, and for our RT-PCR COVID-19 testing, typically 48 hours or less. Accordingly, the Company elected the practical expedient and therefore, does not disclose the value of unsatisfied performance obligations. Transaction Price The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties, such as sales taxes. The consideration expected from a contract with a customer may include fixed amounts, variable amounts, or both. The Company’s gross commercial revenues billed, and corresponding gross accounts receivable, are subject to estimated deductions for such allowances and reserves to arrive at reported net revenues, which relate to differences between amounts billed and corresponding amounts estimated to be subsequently collected, and is deemed to be variable although the variability is not explicitly stated in any contract. Rather, the implied variability is due to several factors, such as the payment history or lack thereof for third-party payers, reimbursement rate changes for contracted and non-contracted payers, any patient co-payments, deductibles or compliance incentives, the existence of secondary payers and claim denials. The Company estimates the The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. Revenue is recognized up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in the estimate of variable consideration and are included in the period in which such revisions are made. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a customer, it will account for the change as an increase in the estimate of the transaction price in the period identified as an increase to revenue. Similarly, if the Company subsequently determines that the amount it expects to collect from a customer is less than it originally estimated, it will generally account for the change as a decrease in the estimate of the transaction price as a decrease to revenue, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. Revenue recognized from changes in transaction prices was not significant during the three and nine months ended September 30, 2019 and 2020. Further, although the Company believes that its estimate for contractual allowances and other reserves is appropriate, it is possible that the Company will experience an impact on cash collections as a result of the impact of the COVID-19 pandemic. Allocate Transaction Price For the Company’s commercial revenues, the entire transaction price is allocated to the single performance obligation contained in a contract with a customer. For the Company’s development services revenues, the contracted transaction price is allocated to each single performance obligation contained in a contract with a customer as performed. Point-in-time Recognition The Company’s single performance obligation is satisfied at a point in time, and that point in time is defined as the date a patient’s successful assay result is delivered to the patient’s ordering physician or entity. The Company considers this date to be the time at which the patient obtains control of the promised diagnostic assay service. Contract Balances The timing of revenue recognition, billings and cash collections results in accounts receivable recorded in the Company’s condensed balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2019 and 2020, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net revenues from contracted payers* $ 476,101 $ 3,219,233 $ 1,447,421 $ 3,981,041 Net revenues from non-contracted payers 956,140 3,166,101 2,080,018 4,562,909 Development services revenues 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net commercial revenues recognized upon delivery $ 1,432,241 $ 6,385,334 $ 3,527,439 $ 8,543,950 Development services revenues recognized upon delivery 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 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. For the nine months ended September 30, 2020, approximately 67% of the Company’s commercial revenue and as of September 30, 2020 61% of the total outstanding accounts receivable is related to RT-PCR COVID-19 testing. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2019 and 2020 were as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Medicare and Medicare Advantage 32 % 32 % 40 % 32 % Blue Cross Blue Shield 25 % 42 % 20 % 38 % 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, 2019 and September 30, 2020 were as follows: December 31, 2019 September 30, 2020 Blue Cross Blue Shield 26 % 36 % Medicare and Medicare Advantage 17 % 11 % United Healthcare 12 % 5 % |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 adopted this guidance for the fiscal year beginning on January 1, 2020, and determined that the adoption of this guidance does not have a material impact on its financial statements or disclosures. |
The Company, Business Activit_3
The Company, Business Activities and Basis of Presentation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Composition of Net Revenues Recognized Disaggregated by Source and Nature | The composition of the Company’s net revenues recognized during the three and nine months ended September 30, 2019 and 2020, disaggregated by source and nature, are as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net revenues from contracted payers* $ 476,101 $ 3,219,233 $ 1,447,421 $ 3,981,041 Net revenues from non-contracted payers 956,140 3,166,101 2,080,018 4,562,909 Development services revenues 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Net commercial revenues recognized upon delivery $ 1,432,241 $ 6,385,334 $ 3,527,439 $ 8,543,950 Development services revenues recognized upon delivery 37,981 46,500 125,169 145,282 Kits and Blood Collection Tubes (BCT) and other revenues 59,040 154,310 92,216 260,928 Total net revenues $ 1,529,262 $ 6,586,144 $ 3,744,824 $ 8,950,160 |
Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage | The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the three and nine months ended September 30, 2019 and 2020 were as follows: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Medicare and Medicare Advantage 32 % 32 % 40 % 32 % Blue Cross Blue Shield 25 % 42 % 20 % 38 % 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, 2019 and September 30, 2020 were as follows: December 31, 2019 September 30, 2020 Blue Cross Blue Shield 26 % 36 % Medicare and Medicare Advantage 17 % 11 % United Healthcare 12 % 5 % |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Assumptions Used for Determining Fair Values of Common Stock Warrants | The fair value of the warrants was estimated using a Black-Scholes model with the following assumptions: Beginning stock price $ 10.50 Exercise price $ 12.00 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.49 % Expected life (in years) 5.00 Expected volatility 147.7 % Beginning stock price $ 11.20 Exercise price $ 12.50 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.44 % Expected life (in years) 5.50 Expected volatility 140.0 % Beginning stock price $ 12.90 Exercise price $ 13.10 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 2.05 % Expected life (in years) 5.50 Expected volatility 145.9 % Beginning stock price $ 3.00 Exercise price $ 3.495 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.66 % Expected life (in years) 5.50 Expected volatility 150.33 % |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Component [Abstract] | |
Schedule of Fixed Assets and Accrued Liabilities | The following provides certain balance sheet details: December 31, September 30, 2019 2020 Fixed Assets Machinery and equipment $ 2,857,538 $ 2,900,943 Furniture and office equipment 156,987 156,987 Computer equipment and software 1,552,891 1,552,891 Leasehold improvements 570,173 570,173 Construction in process 625,038 907,435 Total fixed assets, gross 5,762,627 6,088,429 Less accumulated depreciation and amortization (4,258,297 ) (4,481,252 ) Total fixed assets, net $ 1,504,330 $ 1,607,177 Accrued Liabilities Accrued payroll 298,855 666,735 Accrued vacation 622,792 857,385 Accrued bonuses 748,742 708,281 Accrued sales commissions 89,562 159,775 Accrued other 220,253 230,546 Total accrued liabilities $ 1,980,204 $ 2,622,722 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Schedule of Right-Of-Use Lease Assets | The following schedule sets forth the components of right-of-use lease assets as of December 31, 2019 and September 30, 2020 as follows: December 31, September 30, 2019 2020 Lease right-of-use assets: Operating $ 729,330 $ 235,369 Finance 1,606,387 2,135,788 Total $ 2,335,717 $ 2,371,157 |
Schedule of Current Portion of Operating and Finance Lease Liabilities | The following schedule sets forth the current portion of operating and finance lease liabilities as of December 31, 2019 and September 30, 2020: December 31, September 30, 2019 2020 Current portion of lease liability: Operating $ 842,452 242,957 Finance 724,329 914,671 Total $ 1,566,781 $ 1,157,628 |
Schedule of Long-Term Portion of Operating and Finance Lease Liabilities | The following schedule sets forth the long-term portion of operating and finance lease liabilities as of December 31, 2019 and September 30, 2020: December 31, September 30, 2019 2020 Long-term portion of lease liability: Operating $ — $ — Finance 973,189 1,337,686 Total $ 973,189 $ 1,337,686 |
Schedule of Lease Expenses | The following schedule represents the components of lease expense for the three and nine months ended September 30, 2019 and 2020: For the three months ended September 30, For the nine months ended September 30, 2019 2020 2019 2020 Lease cost Finance lease cost Amortization of right-of-use assets $ 134,472 $ 266,747 $ 364,401 $ 540,853 Interest on lease liabilities 62,026 56,372 187,574 164,044 Operating lease cost 318,005 357,914 954,015 993,924 Total $ 514,503 $ 681,033 $ 1,505,990 $ 1,698,821 |
Schedule of Remaining Future Minimum Lease Payments for Finance and Operating Leases | The following schedule sets forth the remaining future minimum lease payments outstanding under finance and operating leases, as well as corresponding remaining sales tax and maintenance obligation payments that are expensed as incurred and due within each respective year ending December 31, as well as the present value of the total amount of the remaining minimum lease payments, as of September 30, 2020: Finance Operating Minimum Maintenance and Minimum Lease Sales Tax Obligation Lease Payments Payments Payments 2020 (remaining) $ 280,813 28,630 244,324 2021 915,374 95,381 — 2022 656,100 73,301 — 2023 515,473 57,603 — Thereafter 323,474 45,081 — Total payments 2,691,234 299,996 244,324 Less amount representing interest (438,877 ) — (1,367 ) Present value of payments $ 2,252,357 $ 299,996 $ 242,957 |
Supplemental Cash Flow Information Related to Operating and Finance Leases | The following schedule sets forth supplemental cash flow information related to operating and finance leases as of September 30, 2020: For the nine months ended September 30, 2019 2020 Other information Operating cash flows from financing leases $ 187,574 $ 164,044 Operating cash flows from operating leases $ 1,067,437 $ 1,099,460 Financing cash flows from finance leases $ 378,389 $ 518,190 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | A summary of stock option activity for the nine months ended September 30, 2020 is as follows: Weighted Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2019 273,406 $ 36.14 9.25 Granted 13,870 $ 5.23 Exercised — — Cancelled/forfeited/expired (32,920 ) $ 16.09 Outstanding at September 30, 2020 254,356 $ 37.04 8.50 Vested and unvested expected to vest at September 30, 2020 250,368 $ 37.48 8.50 |
Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model | The assumptions used in the Black-Scholes pricing model for stock options granted during the nine months ended September 30, 2020 were as follows: Stock and exercise prices $2.70 - $7.10 Expected dividend yield 0.00% Discount rate-bond equivalent yield 0.38% – 1.37% Expected life (in years) 5.00 – 5.96 Expected volatility 146.1% - 171.1% |
Summary of RSU Activity | A summary of RSU activity for the nine months ended September 30, 2020 is as follows: Weighted Number of Average Grant Shares Date Fair Value Outstanding at December 31, 2019 36 $ 4,158 Granted — — Vested and issued — — Forfeited — — Outstanding at September 30, 2020 36 $ 4,158 Vested and unvested expected to vest at September 30, 2020 36 $ 4,158 |
Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Condensed Statement of Operations and Comprehensive Loss | The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the unaudited condensed statements of operations and comprehensive loss during the periods presented: For the three months ended For the nine months ended September 30, September 30, 2019 2020 2019 2020 Stock Options Cost of revenues $ 29,405 $ 25,352 $ 54,625 $ 78,917 Research and development expenses 37,626 25,397 102,742 78,914 General and administrative expenses 168,484 92,472 361,102 290,231 Sales and marketing expenses 62,154 23,509 106,300 55,868 Total expenses related to stock options $ 297,669 $ 166,730 $ 624,769 $ 503,930 |
Common Stock Warrants Outstan_2
Common Stock Warrants Outstanding (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity Classified Warrants [Abstract] | |
Summary of Equity-Classified Common Stock Warrant Activity | A summary of equity-classified common stock warrant activity for the nine months ended September 30, 2020 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2019 2,748,424 $ 18.58 4.6 Issued 885,475 $ 3.62 Exercised (2,634,795 ) 6.74 Expired (1,933 ) 1,404.00 Outstanding at September 30, 2020 997,171 $ 35.48 3.6 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-Dilutive Securities Excluded from Computations of Diluted Weighted-Average Shares | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the periods presented, as they would be anti-dilutive: For the three and nine months ended September 30, 2019 2020 Preferred warrants outstanding (number of common stock equivalents) — — Common warrants outstanding 1,519,724 997,171 RSUs outstanding 36 36 Convertible preferred stock outstanding (number of common stock equivalents) 47,139 47,139 Common options outstanding 279,765 254,356 Total anti-dilutive common share equivalents 1,846,664 1,298,702 |
The Company, Business Activit_4
The Company, Business Activities and Basis of Presentation - Additional Information (Detail) | Sep. 03, 2020shares | Sep. 30, 2020shares | Dec. 31, 2019shares |
The Company Business Activities And Basis Of Presentation [Line Items] | |||
Stockholders equity reverse stock split ratio | 0.10 | ||
Common stock, shares authorized | 150,000,000 | 150,000,000 | 150,000,000 |
Description of reverse stock split | On September 3, 2020, the Company filed an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a one-for-ten reverse stock split of the shares of common stock outstanding on September 4, 2020. | ||
Customer Concentration Risk [Member] | Commercial Revenues [Member] | |||
The Company Business Activities And Basis Of Presentation [Line Items] | |||
Concentration risk percentage | 67.00% | ||
Credit Concentration Risk [Member] | Accounts Receivable [Member] | |||
The Company Business Activities And Basis Of Presentation [Line Items] | |||
Concentration risk percentage | 61.00% | ||
ASC 606 [Member] | |||
The Company Business Activities And Basis Of Presentation [Line Items] | |||
Performance obligation, description of timing | The duration of time between accession receipt and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks, and for our RT-PCR COVID-19 testing, typically 48 hours or less. | ||
Practical expedient, description | The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. | ||
ASC 606 [Member] | Maximum [Member] | Sales and Marketing Expenses [Member] | |||
The Company Business Activities And Basis Of Presentation [Line Items] | |||
Amortization period | 1 year |
The Company, Business Activit_5
The Company, Business Activities and Basis of Presentation - Composition of Net Revenues Recognized Disaggregated by Source (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | ||
Disaggregation Of Revenue [Line Items] | |||||
Total net revenues | $ 6,586,144 | $ 1,529,262 | $ 8,950,160 | $ 3,744,824 | |
Commercial Revenues [Member] | Contracted Payers [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total net revenues | [1] | 3,219,233 | 476,101 | 3,981,041 | 1,447,421 |
Commercial Revenues [Member] | Non-Contracted Payers [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total net revenues | 3,166,101 | 956,140 | 4,562,909 | 2,080,018 | |
Development Services Revenues [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total net revenues | 46,500 | 37,981 | 145,282 | 125,169 | |
Kits and Blood Collection Tubes and Other Revenues [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total net revenues | $ 154,310 | $ 59,040 | $ 260,928 | $ 92,216 | |
[1] | Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. |
The Company, Business Activit_6
The Company, Business Activities and Basis of Presentation - Composition of Net Revenues Recognized Disaggregated by Nature (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
The Company Business Activities And Basis Of Presentation [Line Items] | ||||
Total net revenues | $ 6,586,144 | $ 1,529,262 | $ 8,950,160 | $ 3,744,824 |
Commercial Revenues [Member] | Net Commercial Revenues Recognized Upon Delivery [Member] | ||||
The Company Business Activities And Basis Of Presentation [Line Items] | ||||
Total net revenues | 6,385,334 | 1,432,241 | 8,543,950 | 3,527,439 |
Development Services Revenues [Member] | ||||
The Company Business Activities And Basis Of Presentation [Line Items] | ||||
Total net revenues | 46,500 | 37,981 | 145,282 | 125,169 |
Kits and Blood Collection Tubes and Other Revenues [Member] | ||||
The Company Business Activities And Basis Of Presentation [Line Items] | ||||
Total net revenues | $ 154,310 | $ 59,040 | $ 260,928 | $ 92,216 |
The Company, Business Activit_7
The Company, Business Activities and Basis of Presentation - Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Customer Concentration Risk [Member] | Net Revenues [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 67.00% | ||||
Customer Concentration Risk [Member] | Net Revenues [Member] | Medicare and Medicare Advantage [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 32.00% | 32.00% | 32.00% | 40.00% | |
Customer Concentration Risk [Member] | Net Revenues [Member] | Blue Cross Blue Shield [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 42.00% | 25.00% | 38.00% | 20.00% | |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 61.00% | ||||
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Medicare and Medicare Advantage [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 11.00% | 17.00% | |||
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Blue Cross Blue Shield [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 36.00% | 26.00% | |||
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | United Healthcare [Member] | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 5.00% | 12.00% |
Liquidity and Going Concern U_2
Liquidity and Going Concern Uncertainty - Additional Information (Detail) | Apr. 16, 2020USD ($)$ / sharesshares | Mar. 04, 2020USD ($)$ / sharesshares | Mar. 02, 2020USD ($)$ / sharesshares | Mar. 19, 2019USD ($)$ / sharesshares | Feb. 12, 2019shares | Jan. 18, 2019USD ($)$ / sharesshares | Jan. 31, 2020USD ($)$ / sharesshares | May 31, 2019USD ($) | Sep. 30, 2020USD ($)$ / shares | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2020USD ($)Sample$ / shares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Jan. 31, 2018$ / sharesshares |
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Cash | $ 16,857,941 | $ 16,857,941 | $ 9,301,406 | |||||||||||||||
Accumulated deficit | (265,428,938) | (265,428,938) | (245,717,189) | |||||||||||||||
Net loss | (4,878,334) | $ (6,489,303) | $ (8,341,338) | $ (5,691,762) | $ (7,816,012) | $ (5,916,787) | (19,708,975) | $ (19,424,558) | $ (25,100,000) | |||||||||
Aggregate net interest-bearing indebtedness | 2,300,000 | 2,300,000 | ||||||||||||||||
Aggregate net interest-bearing indebtedness due within one year | 915,000 | 915,000 | ||||||||||||||||
Other non-interest bearing current liabilities | $ 2,800,000 | 2,800,000 | ||||||||||||||||
Proceeds from exercise of common stock warrants | 2,337,298 | |||||||||||||||||
Stock price | $ / shares | $ 4.60 | $ 4.10 | $ 4 | $ 13.70 | $ 22.50 | |||||||||||||
Shares issued in offering | shares | 2,230,000 | 1,600,000 | 2,300,000 | 595,000 | 99,000 | |||||||||||||
Proceeds from exercise of common stock warrants | $ 2,401,704 | $ 2,513,172 | ||||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 9,600,000 | $ 6,100,000 | $ 8,600,000 | $ 7,500,000 | $ 2,000,000 | |||||||||||||
Warrant [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Issuance of warrants to purchase shares of common stock | shares | 89,657 | |||||||||||||||||
Stock price | $ / shares | $ 3.495 | $ 3.495 | $ 3.495 | $ 4.05 | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,500,000 | |||||||||||||||||
Warrant [Member] | Over-allotment Option [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Shares issued in offering | shares | 91,500 | 192,750 | ||||||||||||||||
Proceeds from exercise of common stock warrants | $ 700,000 | |||||||||||||||||
February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,300,000 | $ 2,300,000 | ||||||||||||||||
February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | Warrant [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Issuance of warrants to purchase shares of common stock | shares | 692,725 | 692,725 | ||||||||||||||||
Minimum [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
CARES ACT of 2020 percentage of estimated decrease in commercial volume | 15.00% | |||||||||||||||||
Number of samples for processing of covid testing | Sample | 50,000 | |||||||||||||||||
Maximum [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
CARES ACT of 2020 percentage of estimated decrease in commercial volume | 25.00% | |||||||||||||||||
Maximum [Member] | Over-allotment Option [Member] | ||||||||||||||||||
Liquidity And Managements Plans [Line Items] | ||||||||||||||||||
Issuance of warrants to purchase shares of common stock | shares | 93,750 |
Sales of Equity Securities - Ad
Sales of Equity Securities - Additional Information (Detail) - USD ($) | Apr. 16, 2020 | Mar. 04, 2020 | Mar. 02, 2020 | Jan. 10, 2020 | Jul. 15, 2019 | May 28, 2019 | Mar. 19, 2019 | Mar. 11, 2019 | Feb. 12, 2019 | Jan. 18, 2019 | Jan. 31, 2020 | May 31, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Jan. 31, 2018 |
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued in offering | 2,230,000 | 1,600,000 | 2,300,000 | 595,000 | 99,000 | ||||||||||||||
Stock price | $ 4.60 | $ 4.10 | $ 4 | $ 13.70 | $ 22.50 | ||||||||||||||
Net cash proceeds from sale of securities | $ 9,600,000 | $ 6,100,000 | $ 8,600,000 | $ 7,500,000 | $ 2,000,000 | ||||||||||||||
Exercise price of warrants | $ 3.495 | $ 12.50 | $ 12 | $ 12 | |||||||||||||||
Class of warrant or rights, term | 5 years 6 months | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,401,704 | $ 2,513,172 | |||||||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||||||
Fair value of warrants issued | $ 1,900,000 | ||||||||||||||||||
Warrant inducement expense | $ 130,000 | $ 60,000 | $ 1,800,000 | 2,100,000 | 1,800,000 | ||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,337,298 | ||||||||||||||||||
Investor Warrants [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 13.10 | ||||||||||||||||||
Class of warrant or rights, term | 5 years 6 months | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,300,000 | ||||||||||||||||||
Number of warrant exercised | 206,296 | 0 | 0 | ||||||||||||||||
Cash exercise of warrants description | In order to induce the Exercising Holders to cash exercise the Investor Warrants, the Exercise Agreements provided for the issuance of new warrants, or Inducement Warrants, with such Inducement Warrants to be issued in an amount equal to 75% of the number of Exercised Shares underlying any Investor Warrants that was cash exercised by July 15, 2019. The Inducement Warrants were exercisable upon issuance and terminate on the date that is 5.5 years following the initial exercise date. | ||||||||||||||||||
Fair value of warrants issued | $ 1,800,000 | ||||||||||||||||||
Percentage of common stock exercised for exchange of Inducement warrants | 75.00% | ||||||||||||||||||
Warrants exercisable date | Jul. 31, 2019 | Jul. 15, 2019 | |||||||||||||||||
February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrant inducement expense | 191,000 | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,300,000 | $ 2,300,000 | |||||||||||||||||
Warrant [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Stock price | $ 3.495 | $ 3.495 | $ 4.05 | ||||||||||||||||
Issuance of warrants to purchase shares of common stock | 89,657 | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,500,000 | ||||||||||||||||||
Number of warrant exercised | 208,647 | ||||||||||||||||||
Warrant [Member] | February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 692,725 | 692,725 | |||||||||||||||||
Follow-on Public Offering [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued in offering | 625,000 | ||||||||||||||||||
Stock price | $ 12 | $ 12 | |||||||||||||||||
Net cash proceeds from sale of securities | $ 592,000 | $ 6,600,000 | |||||||||||||||||
Private offering, number of common stock and warrants issued | 625,000 | ||||||||||||||||||
Exercise price of warrants | $ 3.495 | $ 12.50 | $ 12 | ||||||||||||||||
Class of warrant or rights, term | 5 years 6 months | 5 years 6 months | 5 years | ||||||||||||||||
Proceeds from exercise of common stock warrants | $ 0 | ||||||||||||||||||
Purchase of common stock by underwriters to cover overallotments, number of shares | 53,886 | ||||||||||||||||||
Over-allotment Option [Member] | Warrant [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued in offering | 91,500 | 192,750 | |||||||||||||||||
Proceeds from exercise of common stock warrants | $ 700,000 | ||||||||||||||||||
Maximum [Member] | Investor Warrants [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Warrants exercisable percentage | 20.00% | ||||||||||||||||||
Maximum [Member] | Follow-on Public Offering [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 625,000 | ||||||||||||||||||
Maximum [Member] | Over-allotment Option [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 93,750 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Detail) - USD ($) | Jan. 10, 2020 | May 30, 2019 | Mar. 19, 2019 | Feb. 12, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||
Fixed asset purchases as right-of-use asset finance lease obligations | $ 1,073,000 | $ 583,000 | |||||||
Estimated grant date fair value of warrants | $ 2.80 | $ 10.10 | $ 9.50 | ||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 1,900,000 | $ 6,000,000 | $ 6,800,000 | ||||||
Exercise price of unregistered warrants | $ 3.495 | $ 12.50 | $ 12 | $ 12 | |||||
Class of warrant or rights, term | 5 years 6 months | ||||||||
Adjusted exercise price of warrants | $ 12.50 | 12 | |||||||
Estimated fair value of warrants | 2.70 | 2.70 | |||||||
Estimated fair value of warrants increased | $ 3 | $ 2.90 | |||||||
Warrants eligible for price modification | 476,000 | 216,725 | |||||||
Warrant inducement expense | $ 130,000 | $ 60,000 | $ 1,800,000 | 2,100,000 | $ 1,800,000 | ||||
Follow-on Public Offering [Member] | |||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||
Exercise price of unregistered warrants | $ 3.495 | $ 12.50 | $ 12 | ||||||
Class of warrant or rights, term | 5 years 6 months | 5 years 6 months | 5 years | ||||||
Warrant Inducement Transaction [Member] | |||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||
Estimated grant date fair value of warrants | $ 11.80 | ||||||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 1,800,000 | ||||||||
Exercise price of unregistered warrants | $ 13.10 | ||||||||
Class of warrant or rights, term | 5 years 6 months | ||||||||
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 | 692,725 | 595,000 | 716,500 | ||||||
Maximum [Member] | Warrant Inducement Transaction [Member] | |||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||||||
Issuance of unregistered warrants to purchase shares of common stock | 154,722 | ||||||||
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 right-of-use asset finance lease obligations | $ 1,073,000 |
Fair Value Measurement - Assump
Fair Value Measurement - Assumptions Used for Determining Fair Values of Common Stock Warrants (Detail) | Sep. 30, 2020$ / shares | Apr. 16, 2020$ / shares | Mar. 04, 2020$ / shares | Mar. 02, 2020$ / shares | Mar. 19, 2019$ / shares | Jan. 18, 2019$ / shares |
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 4.60 | $ 4.10 | $ 4 | $ 13.70 | $ 22.50 | |
February 12, 2019 Offering [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 10.50 | |||||
February 12, 2019 Offering [Member] | Exercise Price [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 12 | |||||
February 12, 2019 Offering [Member] | Expected Dividend Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 0 | |||||
February 12, 2019 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 2.49 | |||||
February 12, 2019 Offering [Member] | Expected Life [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Expected life (in years) | 5 years | |||||
February 12, 2019 Offering [Member] | Expected Volatility [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 147.7 | |||||
March 19, 2019 Offering [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 11.20 | |||||
March 19, 2019 Offering [Member] | Exercise Price [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 12.50 | |||||
March 19, 2019 Offering [Member] | Expected Dividend Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 0 | |||||
March 19, 2019 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 2.44 | |||||
March 19, 2019 Offering [Member] | Expected Life [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Expected life (in years) | 5 years 6 months | |||||
March 19, 2019 Offering [Member] | Expected Volatility [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 140 | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 12.90 | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | Exercise Price [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 13.10 | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | Expected Dividend Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 0 | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | Discount Rate-Bond Equivalent Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 2.05 | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | Expected Life [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Expected life (in years) | 5 years 6 months | |||||
May 30, 2019 Warrant Inducement Transaction [Member] | Expected Volatility [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 145.9 | |||||
September 20, 2018 Offering [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 3 | |||||
September 20, 2018 Offering [Member] | Exercise Price [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 3.495 | |||||
September 20, 2018 Offering [Member] | Expected Dividend Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 0 | |||||
September 20, 2018 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 1.66 | |||||
September 20, 2018 Offering [Member] | Expected Life [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Expected life (in years) | 5 years 6 months | |||||
September 20, 2018 Offering [Member] | Expected Volatility [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 150.33 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Fixed Assets and Accrued Liabilities (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Fixed Assets | ||
Machinery and equipment | $ 2,900,943 | $ 2,857,538 |
Furniture and office equipment | 156,987 | 156,987 |
Computer equipment and software | 1,552,891 | 1,552,891 |
Leasehold improvements | 570,173 | 570,173 |
Construction in process | 907,435 | 625,038 |
Total fixed assets, gross | 6,088,429 | 5,762,627 |
Less accumulated depreciation and amortization | (4,481,252) | (4,258,297) |
Total fixed assets, net | 1,607,177 | 1,504,330 |
Accrued Liabilities | ||
Accrued payroll | 666,735 | 298,855 |
Accrued vacation | 857,385 | 622,792 |
Accrued bonuses | 708,281 | 748,742 |
Accrued sales commissions | 159,775 | 89,562 |
Accrued other | 230,546 | 220,253 |
Total accrued liabilities | $ 2,622,722 | $ 1,980,204 |
Leases - Additional Information
Leases - Additional Information (Detail) | Jun. 05, 2020 | Jun. 01, 2020USD ($)ft² | Feb. 01, 2019USD ($) | Jan. 31, 2019USD ($)mo | Sep. 30, 2020USD ($)mo | Jul. 31, 2020USD ($)mo | Jun. 30, 2020USD ($)mo | Apr. 30, 2020USD ($)mo | Mar. 31, 2020USD ($)mo | Feb. 29, 2020USD ($)mo | Sep. 30, 2019USD ($)mo | Aug. 31, 2019USD ($)mo | Jul. 31, 2019USD ($)mo | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) |
Leases [Line Items] | |||||||||||||||||||
Finance lease right-of-use assets | $ 2,135,788 | $ 2,135,788 | $ 2,135,788 | $ 1,606,387 | |||||||||||||||
Total amount from equipment financing commitment | $ 149,000 | $ 226,000 | $ 143,000 | $ 334,000 | $ 161,000 | $ 11,000 | $ 197,000 | $ 89,000 | $ 245,000 | $ 100,000 | |||||||||
Finance lease transaction, frequency of payments | monthly | monthly | monthly | monthly | monthly | monthly | monthly | monthly | monthly | monthly | |||||||||
Finance lease transaction, number of installments payments | mo | 36 | 60 | 60 | 48 | 60 | 36 | 48 | ||||||||||||
Finance lease transaction, monthly installments of principal and interest payments | $ 5,013 | $ 16,427 | $ 2,772 | $ 8,966 | $ 3,337 | $ 288 | $ 4,532 | $ 1,770 | $ 8,253 | $ 2,706 | |||||||||
Finance lease transaction, total amount to be repaid | $ 180,000 | $ 261,000 | $ 166,000 | $ 469,000 | $ 185,000 | $ 14,000 | $ 265,000 | $ 106,000 | $ 297,000 | $ 130,000 | 261,000 | $ 106,000 | 261,000 | $ 106,000 | |||||
Finance lease transaction, commitment period | 2022-02 | 2025-07 | 2025-07 | 2025-06 | 2025-03 | 2024-02 | 2025-01 | 2024-09 | 2022-08 | 2023-05 | |||||||||
Operating lease monthly payments | 1,099,460 | 1,067,437 | |||||||||||||||||
Operating lease, right-of-use asset | $ 235,369 | 235,369 | 235,369 | 729,330 | |||||||||||||||
Operating lease liability | $ 242,957 | $ 242,957 | $ 242,957 | ||||||||||||||||
Finance lease, weighted average remaining lease term | 3 years 3 months 4 days | 3 years 3 months 4 days | 3 years 3 months 4 days | ||||||||||||||||
Operating lease, weighted average remaining lease term | 2 months 1 day | 2 months 1 day | 2 months 1 day | ||||||||||||||||
Finance lease, weighted average discount rate, percent | 16.45% | 16.45% | 16.45% | ||||||||||||||||
Operating lease, weighted average discount rate, percent | 4.50% | 4.50% | 4.50% | ||||||||||||||||
Right of use assets in exchange for finance lease liabilities | $ 1,073,000 | ||||||||||||||||||
ASC Topic 842 [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Finance lease right-of-use assets | $ 1,400,000 | ||||||||||||||||||
Financed equipment gross | $ 4,284,000 | $ 4,284,000 | 4,284,000 | 3,125,000 | |||||||||||||||
Accumulated depreciation related to equipment under finance leases | 2,148,000 | 2,148,000 | 2,148,000 | $ 1,606,000 | |||||||||||||||
Depreciation expense related to equipment under finance leases | 267,000 | $ 134,000 | $ 541,000 | $ 365,000 | |||||||||||||||
Operating lease transaction, frequency of payments | monthly cash payment | ||||||||||||||||||
Operating lease monthly payments | $ 120,000 | ||||||||||||||||||
Operating lease term | Jul. 31, 2020 | ||||||||||||||||||
Operating lease, right-of-use asset | 1,900,000 | 1,900,000 | $ 1,900,000 | 1,930,000 | |||||||||||||||
Operating lease liability | $ 2,201,000 | ||||||||||||||||||
Operating lease incremental borrowing rate | 4.50% | ||||||||||||||||||
ASC Topic 842 [Member] | Net Machinery and Equipment [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Finance lease right-of-use assets | 1,400,000 | 1,400,000 | 1,400,000 | $ 1,400,000 | |||||||||||||||
ASC Topic 842 [Member] | San Diego, California [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Operating lease monthly payments | $ 128,000 | ||||||||||||||||||
Operating lease, right-of-use asset | 482,000 | 482,000 | 482,000 | ||||||||||||||||
Operating lease liability | $ 482,000 | $ 482,000 | $ 482,000 | ||||||||||||||||
Lessee, operating lease, option to extend | November 30, 2020 | ||||||||||||||||||
Lessee, operating lease, existence of option to extend | true | ||||||||||||||||||
Lease agreement | ft² | 39,000 | ||||||||||||||||||
Lessee, operating lease, term of contract | 127 months | ||||||||||||||||||
Initial monthly lease payments | $ 111,000 | ||||||||||||||||||
Minimum [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 12 | 36 | 48 | ||||||||||||||||
Minimum [Member] | ASC Topic 842 [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Financed equipment useful life | 3 years | 3 years | 3 years | ||||||||||||||||
Maximum [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 60 | 60 | 60 | ||||||||||||||||
Maximum [Member] | ASC Topic 842 [Member] | |||||||||||||||||||
Leases [Line Items] | |||||||||||||||||||
Financed equipment useful life | 7 years | 7 years | 7 years |
Leases - Schedule of Right-Of-U
Leases - Schedule of Right-Of-Use Lease Assets (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Lease right-of-use assets: | ||
Operating | $ 235,369 | $ 729,330 |
Finance | 2,135,788 | 1,606,387 |
Total | $ 2,371,157 | $ 2,335,717 |
Leases - Schedule of Current Po
Leases - Schedule of Current Portion of Operating and Finance Lease Liabilities (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current portion of lease liability: | ||
Operating | $ 242,957 | $ 842,452 |
Finance | 914,671 | 724,329 |
Total | $ 1,157,628 | $ 1,566,781 |
Leases - Schedule of Long-Term
Leases - Schedule of Long-Term Portion of Operating and Finance Lease Liabilities (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Long-term portion of lease liability: | ||
Finance | $ 1,337,686 | $ 973,189 |
Total | $ 1,337,686 | $ 973,189 |
Leases - Schedule of Lease Expe
Leases - Schedule of Lease Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Finance lease cost | ||||
Amortization of right-of-use assets | $ 266,747 | $ 134,472 | $ 540,853 | $ 364,401 |
Interest on lease liabilities | 56,372 | 62,026 | 164,044 | 187,574 |
Operating lease cost | 357,914 | 318,005 | 993,924 | 954,015 |
Total | $ 681,033 | $ 514,503 | $ 1,698,821 | $ 1,505,990 |
Leases - Schedule of Remaining
Leases - Schedule of Remaining Future Minimum Lease Payments for Finance and Operating Leases (Detail) | Sep. 30, 2020USD ($) |
Financing Lease Minimum Payment Abstract | |
2020 (remaining) | $ 280,813 |
2021 | 915,374 |
2022 | 656,100 |
2023 | 515,473 |
Thereafter | 323,474 |
Total payments | 2,691,234 |
Less amount representing interest | (438,877) |
Present value of payments | 2,252,357 |
Financing Lease Maintenance and Sales Tax Obligation Payments Abstract | |
2020 (remaining) | 28,630 |
2021 | 95,381 |
2022 | 73,301 |
2023 | 57,603 |
Thereafter | 45,081 |
Total payments | 299,996 |
Present value of payments | 299,996 |
Operating Lease Minimum Payment Abstract | |
2020 (remaining) | 244,324 |
Total payments | 244,324 |
Less amount representing interest | (1,367) |
Present value of payments | $ 242,957 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Operating and Finance Leases (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Other information | ||
Operating cash flows from financing leases | $ 164,044 | $ 187,574 |
Operating cash flows from operating leases | 1,099,460 | 1,067,437 |
Financing cash flows from finance leases | $ 518,190 | $ 378,389 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jun. 05, 2020shares | Sep. 30, 2020USD ($)shares | Sep. 30, 2019 | Sep. 30, 2020USD ($)Planshares | Sep. 30, 2019 | Dec. 31, 2019USD ($)shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of equity incentive plans | Plan | 2 | |||||
Total Shares Outstanding | 254,356 | 254,356 | 273,406 | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 6 months 3 days | |||||
Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Estimated forfeitures rate | 0.00% | 0.00% | 0.00% | 0.00% | ||
Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Estimated forfeitures rate | 8.00% | 8.00% | 8.00% | 8.00% | ||
Stock Options [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Intrinsic value of options outstanding | $ | $ 0 | $ 0 | $ 0 | |||
Intrinsic value of options exercisable | $ | 0 | 0 | 0 | |||
Intrinsic value of options vested and unvested expected to vest | $ | 0 | 0 | $ 0 | |||
RSUs [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Intrinsic value shares, RSUs outstanding | $ | 100 | 100 | ||||
Intrinsic value amount, RSUs unvested and vested expected to vest | $ | $ 100 | $ 100 | ||||
RSUs outstanding | 36 | 36 | 36 | |||
Stock Options and RSUs [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized share-based compensation expense, stock options | $ | $ 1,425,133 | $ 1,425,133 | ||||
2013 Equity Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total stock options and RSUs authorized | 12,421 | 12,421 | ||||
2013 Equity Incentive Plan [Member] | Non-inducement Shares [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Increase in number of shares of common stock authorized for issuance | 730,000 | |||||
Total stock options and RSUs authorized | 1,036,409 | 1,036,409 | ||||
Stock options and RSUs issued | 258,625 | |||||
Total Shares Outstanding | 254,356 | 254,356 | ||||
Common stock, shares authorized | 777,784 | 777,784 | ||||
2013 Equity Incentive Plan [Member] | Inducement shares [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total stock options and RSUs authorized | 11,836 | 11,836 | ||||
Stock options and RSUs issued | 11,836 | |||||
Total Shares Outstanding | 2,412 | 2,412 | ||||
Common stock, shares authorized | 9,340 | 9,340 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of Shares Outstanding, Beginning Balance | 273,406 | |
Number of Shares, Granted | 13,870 | |
Number of Shares, Cancelled/forfeited/expired | (32,920) | |
Number of Shares Outstanding, Ending Balance | 254,356 | 273,406 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | 250,368 | |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 36.14 | |
Weighted Average Exercise Price Per Share, Granted | 5.23 | |
Weighted Average Exercise Price Per Share, Cancelled/forfeited/expired | 16.09 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | 37.04 | $ 36.14 |
Weighted Average Exercise Price Per Share, Vested and unvested expected to vest, Ending Balance | $ 37.48 | |
Weighted Average Remaining Contractual Term in Years, Outstanding | 8 years 6 months | 9 years 3 months |
Weighted Average Remaining Contractual Term in Years, Vested and unvested expected to vest | 8 years 6 months |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model (Detail) | 9 Months Ended |
Sep. 30, 2020$ / shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Expected dividend yield | 0.00% |
Expected volatility, Minimum | 146.10% |
Expected volatility, Maximum | 171.10% |
Minimum [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock and exercise prices | $ 2.70 |
Discount rate-bond equivalent yield | 0.38% |
Expected life (in years) | 5 years |
Maximum [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock and exercise prices | $ 7.10 |
Discount rate-bond equivalent yield | 1.37% |
Expected life (in years) | 5 years 11 months 15 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Detail) - RSUs [Member] | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of Shares Outstanding, Beginning Balance | shares | 36 |
Number of Shares, Granted | shares | 0 |
Number of share, Vested and issued | shares | 0 |
Number of share, Forfeited | shares | 0 |
Number of Shares Outstanding, Ending Balance | shares | 36 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | shares | 36 |
Weighted Average Grant Date Fair Value, Outstanding, Beginning Balance | $ / shares | $ 4,158 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 0 |
Weighted Average Grant Date Fair Value, Vested and issued | $ / shares | 0 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 0 |
Weighted Average Grant Date Fair Value, Outstanding, Ending Balance | $ / shares | 4,158 |
Weighted Average Grant Date Fair Value, Vested and unvested expected to vest, Ending Balance | $ / shares | $ 4,158 |
Stock-Based Compensation - Effe
Stock-Based Compensation - Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Condensed Statement of Operations and Comprehensive Loss (Detail) - Stock Options [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 166,730 | $ 297,669 | $ 503,930 | $ 624,769 |
Cost of revenues [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 25,352 | 29,405 | 78,917 | 54,625 |
Research and Development Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 25,397 | 37,626 | 78,914 | 102,742 |
General and Administrative Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 92,472 | 168,484 | 290,231 | 361,102 |
Sales and Marketing Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 23,509 | $ 62,154 | $ 55,868 | $ 106,300 |
Common Stock Warrants Outstan_3
Common Stock Warrants Outstanding - Summary of Equity-Classified Common Stock Warrant Activity (Detail) - Warrants [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Class Of Warrant Or Right [Line Items] | ||
Number of Shares, Outstanding, Beginning Balance | 2,748,424 | |
Number of Shares, Issued | 885,475 | |
Number of Shares, Exercised | (2,634,795) | |
Number of Shares, Expired | (1,933) | |
Number of Shares, Outstanding, Ending Balance | 997,171 | 2,748,424 |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 18.58 | |
Weighted Average Exercise Price Per Share, Issued | 3.62 | |
Weighted Average Exercise Price Per Share, Exercised | 6.74 | |
Weighted Average Exercise Price Per Share, Expired | 1,404 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | $ 35.48 | $ 18.58 |
Average Remaining Contractual Term (in years) | 3 years 7 months 6 days | 4 years 7 months 6 days |
Common Stock Warrants Outstan_4
Common Stock Warrants Outstanding - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2020USD ($)shares | |
Class Of Warrant Or Right [Line Items] | |
Common stock warrants outstanding, intrinsic value | $ | $ 0 |
Cashless Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares issued upon exercise of common stock warrants, shares | shares | 876,772 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Anti-Dilutive Securities Excluded from Computations of Diluted Weighted-Average Shares (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 1,298,702 | 1,846,664 | 1,298,702 | 1,846,664 |
Common Warrants Outstanding [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 997,171 | 1,519,724 | 997,171 | 1,519,724 |
RSUs [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 36 | 36 | 36 | 36 |
Common Options Outstanding [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 254,356 | 279,765 | 254,356 | 279,765 |
Convertible Preferred Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents | 47,139 | 47,139 | 47,139 | 47,139 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Loss Contingencies [Line Items] | |||||
Total expense for sales tax and maintenance obligations | $ 29,000 | $ 35,000 | $ 111,000 | $ 82,000 | |
Total amounts for future sales tax and maintenance obligations | 299,996 | 299,996 | |||
Accrued Other Liabilities [Member] | |||||
Loss Contingencies [Line Items] | |||||
Sales tax and maintenance obligations incurred but not paid | $ 77,000 | $ 77,000 | $ 73,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | Jan. 01, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Related Party Transaction [Line Items] | |||||||
Revenues | $ 6,586,144 | $ 1,529,262 | $ 8,950,160 | $ 3,744,824 | |||
Development Services Revenues [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenues | 46,500 | $ 37,981 | 145,282 | $ 125,169 | |||
Aegea Biotechnologies, Inc [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Reimbursement for shared patent costs | $ 26,000 | $ 19,000 | |||||
Percentage of royalty on sale of product | 10.00% | ||||||
Accrued royalty expense | 5,000 | 5,000 | $ 7,500 | ||||
Accounts receivable | 72,000 | 72,000 | |||||
Aegea Biotechnologies, Inc [Member] | Development Services Revenues [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenues | $ 107,000 | $ 109,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - $ / shares | Oct. 01, 2020 | Sep. 30, 2020 |
Subsequent Event [Line Items] | ||
Exercise price | $ 5.23 | |
Employees and Executives [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Number of shares options to be granted | 722,568 | |
Exercise price | $ 4.50 | |
vesting period | 3 years |