Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 19, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | BIOC | ||
Entity Registrant Name | BIOCEPT INC | ||
Entity Central Index Key | 0001044378 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 13,402,368 | ||
Entity Public Float | $ 93,146,301 | ||
Document Annual 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 | 9955 Mesa Rim Road | ||
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 $.0001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for the 2021 Annual Meeting of Stockholders, to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Form 10-K, are incorporated by reference in Part III, Items 10-14 of this Form 10-K. Except for the portions of the Proxy Statement specifically incorporated by reference in this Form 10-K, the Proxy Statement shall not be deemed to be filed as part hereof. |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 14,367,942 | $ 9,301,406 |
Accounts receivable, net | 14,144,911 | 3,527,078 |
Inventories, net | 1,929,624 | 767,986 |
Prepaid expenses and other current assets | 2,151,527 | 296,127 |
Total current assets | 32,594,004 | 13,892,597 |
Fixed assets, net | 2,317,616 | 1,504,330 |
Lease right-of-use assets - operating | 9,776,349 | 729,330 |
Lease right-of-use assets - finance | 2,337,709 | 1,606,387 |
Other non-current assets | 425,908 | |
Total assets | 47,451,586 | 17,732,644 |
Current liabilities: | ||
Accounts payable | 8,364,858 | 2,011,827 |
Accrued liabilities | 3,165,669 | 1,980,204 |
Current portion of lease liabilities - operating | 842,452 | |
Current portion of lease liabilities - finance | 963,726 | 724,329 |
Total current liabilities | 12,494,253 | 5,558,812 |
Non-current portion of lease liabilities - operating | 9,805,361 | |
Non-current portion of lease liabilities - finance | 1,459,550 | 973,189 |
Total liabilities | 23,759,164 | 6,532,001 |
Commitments and contingencies (see Note 15) | ||
Shareholders’ equity: | ||
Preferred stock, $0.0001 par value, 5,000,000 shares authorized; 2,133 shares and 2,111 shares issued and outstanding at December 31, 2019 and 2020, respectively. | ||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 5,473,848 shares issued and outstanding at December 31, 2019; 13,397,041 shares issued and outstanding at December 31, 2020. | 1,340 | 547 |
Additional paid-in capital | 287,217,949 | 256,917,285 |
Accumulated deficit | (263,526,867) | (245,717,189) |
Total shareholders’ equity | 23,692,422 | 11,200,643 |
Total liabilities and shareholders’ equity | $ 47,451,586 | $ 17,732,644 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 2,111 | 2,133 |
Preferred stock, shares outstanding | 2,111 | 2,133 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 13,397,041 | 5,473,848 |
Common stock, shares outstanding | 13,397,041 | 5,473,848 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Net revenues | $ 27,461,398 | $ 5,528,566 |
Costs and expenses: | ||
Cost of revenues | 21,336,791 | 10,977,520 |
Research and development expenses | 5,220,278 | 4,697,022 |
General and administrative expenses | 9,973,082 | 6,970,120 |
Sales and marketing expenses | 6,399,502 | 5,940,843 |
Total costs and expenses | 42,929,653 | 28,585,505 |
Loss from operations | (15,468,255) | (23,056,939) |
Other income/(expense): | ||
Interest expense, net | (236,540) | (249,984) |
Warrant inducement expense | (2,102,109) | (1,831,116) |
Total other income/(expense): | (2,338,649) | (2,081,100) |
Loss before income taxes | (17,806,904) | (25,138,039) |
Net loss and comprehensive loss | (17,806,904) | (25,138,039) |
Deemed dividend related to warrants down round provision | (2,774) | (121,572) |
Net loss attributable to common shareholders | $ (17,809,678) | $ (25,259,611) |
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||
Basic | 11,845,255 | 2,066,086 |
Diluted | 11,845,255 | 2,066,086 |
Net loss per common share: | ||
Basic | $ (1.50) | $ (12.23) |
Diluted | $ (1.50) | $ (12.23) |
Statements of Shareholders' Equ
Statements of Shareholders' Equity - USD ($) | Total | March 2019 Financing Transaction [Member] | January 2019 Financing Transaction [Member] | April 2020 Financing Transaction [Member] | February 2019 Financing [Member] | January 2019 Financing Transaction Overallotment [Member] | December 2019 Underwritten Offering [Member] | December 2019 Financing Transaction Overallotment [Member] | March 2, 2020 Financing Transaction [Member] | March 4, 2020 Financing Transaction [Member] | Pre-funded Warrants [Member] | Common Stock [Member] | Common Stock [Member]March 2019 Financing Transaction [Member] | Common Stock [Member]January 2019 Financing Transaction [Member] | Common Stock [Member]April 2020 Financing Transaction [Member] | Common Stock [Member]February 2019 Financing [Member] | Common Stock [Member]January 2019 Financing Transaction Overallotment [Member] | Common Stock [Member]December 2019 Underwritten Offering [Member] | Common Stock [Member]December 2019 Financing Transaction Overallotment [Member] | Common Stock [Member]March 2, 2020 Financing Transaction [Member] | Common Stock [Member]March 4, 2020 Financing Transaction [Member] | Common Stock [Member]Cashless Warrants [Member] | Common Stock [Member]Pre-funded Warrants [Member] | SeriesA Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]March 2019 Financing Transaction [Member] | Additional Paid-in Capital [Member]January 2019 Financing Transaction [Member] | Additional Paid-in Capital [Member]April 2020 Financing Transaction [Member] | Additional Paid-in Capital [Member]February 2019 Financing [Member] | Additional Paid-in Capital [Member]January 2019 Financing Transaction Overallotment [Member] | Additional Paid-in Capital [Member]December 2019 Underwritten Offering [Member] | Additional Paid-in Capital [Member]December 2019 Financing Transaction Overallotment [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]Cashless Warrants [Member] | Additional Paid-in Capital [Member]Pre-funded Warrants [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 | 869,579 | 869,579 | |||||||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 4,850,470 | $ 54,000 | $ 41 | $ 71 | $ 54 | 4,850,429 | $ (71) | $ 53,946 | |||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 415,543 | 99,000 | 712,025 | 540,000 | |||||||||||||||||||||||||||||||||
Deemed dividends related warrants downround provision | 121,572 | 121,572 | (121,572) | ||||||||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 7,553,793 | $ 2,032,311 | $ 6,602,735 | $ 592,307 | $ 8,909,852 | $ 60 | $ 10 | $ 63 | $ 5 | $ 192 | $ 7,553,733 | $ 2,032,301 | $ 6,602,672 | $ 592,302 | $ 8,909,660 | ||||||||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 595,000 | 625,000 | 53,887 | 1,920,000 | |||||||||||||||||||||||||||||||||
Warrant inducement expense | 1,831,116 | 1,831,116 | |||||||||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock | $ 5 | (5) | |||||||||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock, shares | 50,476 | (2,284) | |||||||||||||||||||||||||||||||||||
Net loss | (25,138,039) | (25,138,039) | |||||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 940,984 | 940,984 | |||||||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants | 2,401,704 | $ 73 | $ 88 | 2,401,631 | $ (88) | ||||||||||||||||||||||||||||||||
Shares issued upon exercise of common stock warrants, shares | 723,272 | 876,772 | |||||||||||||||||||||||||||||||||||
Costs related to previous financings | (42,430) | (42,430) | |||||||||||||||||||||||||||||||||||
Deemed dividends related warrants downround provision | 2,774 | 2,774 | (2,774) | ||||||||||||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs | $ 9,577,297 | $ 659,958 | $ 8,565,500 | $ 6,093,561 | $ 223 | $ 19 | $ 230 | $ 160 | $ 9,577,074 | $ 659,939 | $ 8,565,270 | $ 6,093,401 | |||||||||||||||||||||||||
Shares and warrants issued, net of issuance costs, shares | 2,230,000 | 192,750 | 2,300,000 | 1,600,000 | |||||||||||||||||||||||||||||||||
Fractional shares adjustment upon one-for-ten reverse stock split, shares | (68) | ||||||||||||||||||||||||||||||||||||
Warrant inducement expense | 2,102,109 | 2,102,109 | |||||||||||||||||||||||||||||||||||
Shares issued upon conversion of preferred stock, shares | 467 | (22) | |||||||||||||||||||||||||||||||||||
Net loss | (17,806,904) | (17,806,904) | |||||||||||||||||||||||||||||||||||
Ending balance at Dec. 31, 2020 | $ 23,692,422 | $ 1,340 | $ 287,217,949 | $ (263,526,867) | |||||||||||||||||||||||||||||||||
Ending balance, shares at Dec. 31, 2020 | 13,397,041 | 2,111 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows from Operating Activities | ||
Net loss | $ (17,806,904) | $ (25,138,039) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,085,234 | 931,655 |
Amortization of right-of-use assets | (84,110) | (158,341) |
Inventory reserve | 244,825 | 14,167 |
Stock-based compensation | 940,984 | 869,579 |
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 | (10,617,833) | (1,952,753) |
Inventory | (1,406,464) | (194,928) |
Prepaid expenses and other current assets | 533,460 | 523,293 |
Other non-current assets | (425,908) | |
Accounts payable | 4,463,722 | 14,838 |
Accrued liabilities | 1,185,465 | 210,152 |
Net cash used in operating activities | (19,787,100) | (23,049,261) |
Cash Flows from Investing Activities: | ||
Purchases of fixed assets | (866,814) | (735,300) |
Net cash used in investing activities | (866,814) | (735,300) |
Cash Flows from Financing Activities: | ||
Net proceeds from issuance of common stock and warrants | 24,193,928 | 25,744,997 |
Proceeds from exercise of common stock warrants | 2,401,704 | 2,513,173 |
Proceeds from warrant exercise inducement, net | 2,337,298 | |
Proceeds from exercise of overallotment warrants | 659,958 | |
Payments on finance leases | (702,588) | (539,415) |
Payments on supplier and other third-party financings | (832,552) | (393,459) |
Net cash provided by financing activities | 25,720,450 | 29,662,594 |
Net increase in Cash | 5,066,536 | 5,878,033 |
Cash at Beginning of Period | 9,301,406 | 3,423,373 |
Cash at End of Period | 14,367,942 | 9,301,406 |
Supplemental Disclosures of Cash Flow Information: | ||
Interest | $ 236,540 | $ 249,984 |
Statements of Cash Flows (Paren
Statements of Cash Flows (Parenthetical) | Dec. 11, 2019USD ($)$ / sharesshares | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)$ / shares | Jan. 01, 2019USD ($) |
Financed insurance premium through third party financing | $ 567,000 | $ 393,000 | ||
Fixed assets purchased under finance lease obligations | 1,428,000 | 632,000 | ||
Purchases of fixed asset | 112,000 | 32,000 | ||
Landlord receivable for accrued leasehold improvement costs | 1,631,000 | |||
Operating lease, right-of-use asset | 9,776,349 | 729,330 | ||
Operating lease liability | 9,805,361 | |||
Lease right-of-use assets | 2,337,709 | $ 1,606,387 | ||
Issuance of warrants to purchase shares of common stock | shares | 192,500 | |||
Exercise price of warrants | $ / shares | $ 4.05 | |||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 6,400,000 | |||
Deemed dividend related to warrants down round provision | 2,774 | $ 121,572 | ||
Offering fees and costs recorded within common stock issuance costs as an offset to additional paid in capital | $ 998,000 | |||
Proceeds From Issuance Of Warrants | 2,337,298 | |||
Pre-funded Warrants [Member] | ||||
Issuance of warrants to purchase shares of common stock | shares | 540,000 | |||
Follow-on Public Offering [Member] | ||||
Exercise price of warrants | $ / shares | $ 4.05 | |||
Class of warrant or rights, term | 5 years | |||
Underwritten Public Offering [Member] | ||||
Proceeds from issuance of common stock, net of issuance costs | $ 8,900,000 | |||
Shares issued in offering | shares | 1,920,000 | |||
Issuance of warrants to purchase shares of common stock | shares | 2,460,000 | |||
Stock price | $ / shares | $ 4.05 | |||
Exercise price of warrants | $ / shares | $ 4.05 | |||
Class of warrant or rights, term | 5 years | |||
Warrant exercisable for share of common stock | shares | 1 | |||
Underwritten Public Offering [Member] | Pre-funded Warrants [Member] | ||||
Issuance of warrants to purchase shares of common stock | shares | 540,000 | |||
Exercise price of warrants | $ / shares | $ 3.95 | |||
Warrant exercisable for share of common stock | shares | 1 | |||
Change in exercise price of warrants | $ / shares | $ 0.10 | |||
Maximum [Member] | Over-allotment Option [Member] | ||||
Shares issued in offering | shares | 369,000 | |||
Maximum [Member] | Over-allotment Option [Member] | Warrant [Member] | ||||
Shares issued in offering | shares | 369,000 | |||
ASC Topic 842 [Member] | ||||
Fixed assets purchased under finance lease obligations | 1,428,000 | $ 632,000 | ||
Operating lease, right-of-use asset | $ 1,900,000 | |||
Operating lease liability | 2,200,000 | |||
Lease right-of-use assets | 1,400,000 | |||
ASC Topic 842 [Member] | Nancy Ridge Road In San Diego California [Member] | ||||
Operating lease, right-of-use asset | 1,930,000 | |||
Operating lease liability | 2,201,000 | |||
ASC Topic 842 [Member] | 9955 Mesa Rim Road in San Diego, California [Member] | ||||
Operating lease, right-of-use asset | 9,776,000 | |||
Operating lease liability | $ 9,805,000 | |||
Property, Plant and Equipment [Member] | ASC Topic 842 [Member] | ||||
Lease right-of-use assets | $ 1,400,000 |
The Company and Business Activi
The Company and Business Activities | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
The Company and Business Activities | 1. The Company and Business Activities The Company was founded in California in May 1997 and is an early stage molecular oncology diagnostics company that develops and commercializes proprietary circulating tumor cell, or CTC, and circulating tumor DNA, or ctDNA, assays utilizing a standard blood sample, or liquid biopsy. The Company’s current and planned assays are intended to provide information to aid healthcare providers to identify specific oncogenic alterations that may qualify a subset of cancer patients for targeted therapy at diagnosis, progression or for monitoring in order to identify specific resistance mechanisms. Sometimes traditional procedures, such as surgical tissue biopsies, result in tumor tissue that is insufficient and/or unable to provide the molecular subtype information necessary for clinical decisions. The Company’s assays, performed on blood, have the potential to provide more contemporaneous information on the characteristics of a patient’s disease when compared with tissue biopsy and radiographic imaging. Additionally, commencing in October 2017, the Company’s pathology partnership program, 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. The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact the Company’s 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. While the Company experienced increased revenue levels in 2020 related to its COVID-19 testing business and has attained net income for the first time in its operating history in the fourth quarter in 2020, these results are not expected to be indicative of future results as the COVID-19 pandemic subsides. |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Liquidity | 2. Liquidity As of December 31, 2020, cash totaled $14.4 million and the Company had an accumulated deficit of $263.5 million. For the years ended December 31, 2019 and 2020, the Company incurred net losses of $25.1 million and $17.8 million, respectively, and had negative cash flows from operations of $23.0 million and $19.8 million, respectively. However, the COVID-19 testing revenue during 2020 and through the first quarter of 2021, has provided the Company with increased levels of cash inflows from operations, and it is expected to continue, albeit at lower and declining levels, throughout at least the next twelve months. As a result, the Company believes that based on its current and planned cash usage, along with current COVID-19 testing revenues, its cash balances will support operations through the first quarter of 2022. As such, the Company determined that it is not probable based on projected cash flows that substantial doubt about the Company’s ability to continue as a going concern exists for the one-year period following the date that the financial statements for the year ended December 31, 2020 were issued. The Company’s determination is based on estimates regarding expected COVID-19 testing volumes, which are uncertain and subject to change as more individuals are expected to be vaccinated and as the pandemic subsides. The Company used all information currently available to make this determination. 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. Based on current cash balances and current and planned cash usage, the Company determined that it is not probable that substantial doubt exists about the Company’s ability to continue as a going concern In order to meet its long-term operating requirements beyond the next twelve months, 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. The Company cannot provide any assurances that such additional funds will be available on reasonable terms, or at all. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and are prepared on the basis that the Company will continue as a going concern (see Note 2). The accompanying financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. On September 3, 2020, pursuant to the approval of the Company’s board of directors, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock using a ratio of one-for-ten. As such, all references to share and per share amounts in these financial statements and accompanying notes have been retroactively restated to reflect the one-for-ten reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 shares, which was not affected by the one-for-ten reverse stock split. Going Concern The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim financial statements are issued (see Note 2). Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by management. Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates these estimates and judgments, including those related to accounts receivable reserves, inventory reserves, long-lived assets, income taxes, including uncertain tax benefits, estimated transaction price for revenues, stock-based compensation, incremental borrowing rate estimates, and the determination of the Company’s ability to continue as a going concern. The Company bases its estimates on various assumptions that it believes are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Though the impact of the COVID-19 pandemic on the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to determine its significant accounting estimates. 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 Center for Medicare & Medicaid Services, or 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 years ended December 31, 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 balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the years ended December 31, 2019 and 2020, disaggregated by source and nature, are as follows: For the year ended December 31, 2019 2020 Net revenues from contracted payers* $ 2,071,961 $ 14,070,173 Net revenues from non-contracted payers 3,044,249 12,793,119 Development services revenues 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. Revenues for the year ended December 31, 2020 included $26.9 million in commercial test revenue, which includes $23.3 million attributable to RT-PCR COVID-19 testing. For the year ended December 31, 2019 2020 Net commercial revenues recognized upon delivery $ 5,116,210 $ 26,863,292 Development services revenues recognized upon delivery 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2019 and 2020 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2018 Upon Delivery Adjudication 2019 Accounts receivable, gross $ 7,882,602 $ 19,001,873 $ (10,030,090 ) $ 16,854,385 Reserve for contractual discounts (2,177,475 ) (12,098,297 ) 10,449,272 (3,826,500 ) Reserve for aged non-patient receivables (565,948 ) (287,832 ) (646,247 ) (1,500,027 ) Reserve for estimated patient receivables (15,477 ) (111,572 ) 121,974 (5,075 ) Reserve for other payer-specific sales allowances (3,549,377 ) (975,606 ) (3,470,722 ) (7,995,705 ) Accounts receivable, net $ 1,574,325 $ 5,528,566 $ (3,575,813 ) $ 3,527,078 Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2019 Upon Delivery Adjudication 2020 Accounts receivable, gross $ 16,854,385 $ 73,644,766 $ (49,474,977 ) $ 41,024,174 Reserve for contractual discounts (3,826,500 ) (44,778,868 ) 24,976,851 (23,628,517 ) Reserve for aged non-patient receivables (1,500,027 ) (2,507,660 ) 3,958,481 (49,206 ) Reserve for estimated patient receivables (5,075 ) (61,118 ) 61,068 (5,125 ) Reserve for other payer-specific sales allowances (7,995,705 ) 1,164,278 3,635,012 (3,196,415 ) Accounts receivable, net $ 3,527,078 $ 27,461,398 $ (16,843,565 ) $ 14,144,911 At December 31, 2019 and 2020, unbilled accounts receivables totaled approximately $29,000 and $4.5 million, respectively. Cash The Company places its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation, or FDIC. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company has not experienced any losses in its cash and believes they are not exposed to any significant credit risk. Fair Value Measurements The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximate their estimated fair values due to the short-term maturities of these financial instruments. See Note 5 for further details about the inputs and assumptions used to determine fair value measurements. Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. Concentrations of credit risk with respect to revenues are primarily limited to geographies to which the Company provides a significant volume of its services, and to specific third-party payers of the Company’s services such as Medicare, insurance companies, and other third-party payers. The Company’s client base consists of a large number of geographically dispersed clients diversified across various customer types. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the years ended December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 38 % 51 % Blue Cross Blue Shield 21 % 20 % 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, as of December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 17 % 35 % Blue Cross Blue Shield 26 % 24 % United Healthcare 12 % 6 % The Company operates in one reportable business segment and historically has derived most revenues only from within the United States. Certain components used in the Company’s current or planned products are currently sourced from one supplier, for which alternative suppliers exist but the Company has not validated the product(s) of such alternative supplier(s), and substitutes for these components may not be obtained easily or may require substantial design or manufacturing modifications. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined by the average cost method. The two primary components of inventory balances are raw materials and subassemblies. Subassemblies are in process raw materials used in our laboratory operations. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. At the point of loss recognition, a new cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. In addition, the Company records a liability for firm, non-cancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities in excess of the Company’s future demand forecasts consistent with its valuation of excess and obsolete inventory. Fixed Assets Fixed assets consist of machinery and equipment, furniture and fixtures, computer equipment and software, leasehold improvements, financed equipment and construction in-process. Fixed assets are stated at cost less accumulated depreciation and amortization. Additions, improvements, and major renewals are capitalized. Maintenance, repairs, and minor renewals are expensed as incurred. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the life of the lease or the asset, whichever is shorter. Depreciation and amortization expense for the years ended December 31, 2019 and 2020 was approximately $932,000 and $1,085,000, respectively. Upon sale or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation or amortization with any gain or loss recorded to the statement of operations and comprehensive loss. Fixed assets are reviewed for impairment whenever changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in the estimates of future cash flows to determine recoverability of these assets. If the assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss. There had been no impairment losses recorded in 2019 and 2020. Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees and directors based on their grant date fair values. The Company estimates the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, while the fair value of restricted stock unit awards, or RSUs, is determined by the Company’s stock price on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In addition, the Company estimates forfeitures at the time of grant and revises these estimates in subsequent periods if actual forfeitures differ from those estimates (see Note 9). The Company determines the fair value of the stock-based compensation awards granted as either the fair value of the consideration received, or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards are recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods based on the fair value of the options at the end of each period. Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based compensation expense is calculated using the Company’s best estimates, which involves inherent uncertainties, and the application of management’s judgment. Significant estimates include the expected life of the stock option, stock price volatility and risk-free interest rate. Research and Development Research and development costs are expensed as incurred. The amounts expensed in the years ended December 31, 2019 and 2020 were approximately $4,697,000 and $5,220,000, respectively, which includes salaries of research and development personnel. Income Taxes The Company provides for income taxes utilizing the liability method. Under the liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits. Tax rate changes are reflected in the computation of the income tax provision during the period such changes are enacted. Deferred tax assets are reduced by a valuation allowance when, in management’s opinion, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company’s valuation allowance is based on available evidence, including its current year operating loss, evaluation of positive and negative evidence with respect to certain specific deferred tax assets including evaluation sources of future taxable income to support the realization of the deferred tax assets. The Company has established a full valuation allowance on the deferred tax assets as of December 31, 2019 and 2020, and therefore has not recognized any income tax benefit or expense in the periods presented. A tax benefit from uncertain tax positions may be recognized by the Company when it is more-likely-than-not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. The Company recognizes interest and/or penalties related to income tax matters in income tax expense. There is no accrual for interest or penalties for income taxes on the balance sheets at December 31, 2019 and 2020, and the Company has not recognized interest and/or penalties in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020. 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. In June 2016, the FASB issued ASU 2016-13, “Credit Losses (Topic 326).” ASU 2016-13 requires that financial assets measured at amortized cost, such as trade receivables and investments, be represented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions, and future expectation for each pool of similar financial asset. The new guidance requires enhanced disclosures related to trade receivables and associated credit losses. In May 2019, the FASB issued ASU No. 2019-05, “Financial Instruments—Credit Losses (Topic 326) Targeted Transition Relief,” which allows for a transition election on certain instruments. The guidance is effective for Small Reporting Companies for fiscal years beginning after December 15, 2022 and interim periods in those fiscal years. In November 2019, the FASB issued ASU No. 2019-11 which amends certain aspects of ASU No. 2016-13, including transition relief for trouble debt restructuring, among other topics. The Company is currently evaluating the impact of this pronouncement on its financial statements. |
Sales of Equity Securities
Sales of Equity Securities | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Sales of Equity Securities | 4. 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. Subsequent to the closing of this offering, no additional cash proceeds have been received from the exercise of warrants sold in this offering. On March 11, 2019, the underwriters exercised their overallotment option for 53,887 shares of the Company’s common stock related to the February 12, 2019 follow-on offering, purchasing shares at $12.00 per share for net cash proceeds of approximately $592,000. On March 19, 2019, the Company received net cash proceeds of approximately $7.6 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 Existing 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 the New Warrants, with such New 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 New Warrants were exercisable upon issuance and terminate on the date that is five-years and six-months following the initial exercise date. The New 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 Agreement were considered inducement warrants and are classified in equity. The fair value of the warrants issued was approximately $1.8 million and the fair value of the inducement warrants was expensed as warrant inducement expense in the accompanying statement of operations for the year ended December 31, 2019. On July 15, 2019, the Company entered into amendments (the “Amendments”) to the Exercise Agreements. Pursuant to the Amendments, the period during which the Exercising Holders may elect to exercise for cash the Existing Warrants in exchange for new warrants to purchase common stock to be issued 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 remainder of 2019. In December 2019, the Company received net cash proceeds from an underwritten offering of approximately $8.9 million from the issuance of 1,920,000 shares of common stock, pre-funded warrants to purchase 540,000 shares of common stock, and warrants to purchase an aggregate of 2,460,000 shares of common stock. Each share was sold together with a common warrant to purchase one share of common stock at a combined price of $4.05 per share of common stock and accompanying warrant. Each pre-funded warrant was sold together with a common warrant to purchase one share of common stock at a combined price of $3.95 per pre-funded warrant and accompanying warrant. Each prefunded warrant had an exercise price of $0.10 per share and was exercisable immediately upon issuance and expired when exercised in full. In addition, underwriters were granted an option to purchase up to an additional 369,000 shares of common stock and/or common warrants. Common warrants issued in this offering have an exercise price of $4.05 per share, are exercisable immediately upon issuance and expire 5 years following the date of issuance. In addition, the common warrants have a cashless exercise provision, pursuant to which holders can exercise the warrant without cash payment for 50% of the number of shares of common stock that would issuable upon exercise of the common warrant if such exercise were by means of a cash exercise rather than a cashless exercise. Pursuant to the cashless exercise provision in the common warrants, 1.4 million common warrants were exercised for 712,250 shares of common stock as of December 31, 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 statement of operations for the year ended December 31, 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 Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 5. Fair Value Measurements The estimated nonrecurring fair value measurements associated with fixed asset purchases recorded as right-of-use asset finance lease obligations totaling approximately $1,428,000 during the year ended December 31, 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 Measurement 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 warrants to purchase up to 154,722 shares of common stock issued in this offering, 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 December 11, 2019 offering, the grant date fair value of the warrants issued to purchase up to 2,652,750 shares of common stock were estimated to be approximately $2.40 per share, or a total of approximately $6.4 million, was recorded as an offset to additional paid-in capital on a relative fair value basis. The warrants sold in this offering are exercisable immediately, have an exercise price of $4.05 per share and expire five years from the date of issuance. The fair value of the warrants was estimated using a Black-Scholes model, incorporating the following assumptions: Beginning stock price $ 2.70 Exercise price $ 4.05 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.64 % Expected life (in years) 5.00 Expected volatility 153.7 % Also, included in the December 11, 2019 offering the Company issued 540,000 pre-funded warrants. The pre-funded warrants had an intrinsic value of $1.4 million, were subsequently fully exercised and are no longer outstanding as of December 31, 2019. 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 | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Component [Abstract] | |
Balance Sheet Details | 6. Balance Sheet Details The following provides certain balance sheet details: December 31, December 31, 2019 2020 Inventories Raw materials $ 630,548 $ 1,235,620 Subassemblies 130,898 691,126 Finished goods 6,540 2,878 $ 767,986 $ 1,929,624 Fixed Assets Machinery and equipment $ 2,857,538 $ 2,974,320 Furniture and office equipment 156,987 156,987 Computer equipment and software 1,552,891 2,428,211 Leasehold improvements 570,173 570,173 Construction in process 625,038 761,221 5,762,627 6,890,912 Less accumulated depreciation and amortization (4,258,297 ) (4,573,296 ) Total fixed assets, net $ 1,504,330 $ 2,317,616 Accrued Liabilities Accrued payroll $ 298,855 $ 452,118 Accrued vacation 622,792 868,557 Accrued bonuses 748,742 1,022,421 Accrued sales commissions 89,562 456,526 Accrued other 220,253 366,047 Total accrued liabilities $ 1,980,204 $ 3,165,669 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 7. 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 5 to 7 years. The total gross value of equipment capitalized under such lease financing arrangements was approximately $3,125,000 and $4,639,000 at December 31, 2019 and 2020, respectively. Total accumulated depreciation related to equipment under finance leases was approximately $1,606,000 and $2,302,000 at December 31, 2019 and 2020, respectively, and total depreciation expense was approximately $454,000 and $696,000, at December 31, 2019 and 2020, respectively. Fixed asset purchases totaling approximately $632,000 and $1,428,000 during the years ended December 31, 2019 and 2020, respectively, were recorded as finance leases. On January 31, 2019, the Company executed a finance lease commitment with a third-party lender for 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, a finance lease commitment was executed with a third-party lender for the 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, a finance lease commitment was executed with a third-party lender for the 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, a finance lease commitment was executed with a third-party lender for the 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 December 2019, two finance lease commitments were executed with third-party lenders. The first with a total principal of $28,000, 60-month term and $597 monthly payments totaling approximately $36,000 over the lease term. The second finance lease had a total principal of $22,000, 48-month lease term and $563 monthly payments totaling approximately $27,000 over the lease term. Both of these transactions were accounted for as finance leases. 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. In October 2020 the Company entered into finance leases for a capitalized amount of $192,000 for laboratory equipment. In November 2020 the Company entered into finance leases for a capitalized amount of $73,000 for laboratory equipment. In December 2020 the Company entered into finance leases for a capitalized amount of $91,000 for laboratory equipment. Operating Lease The Company leases its primary laboratory and office facilities in San Diego, California. In accordance with the ASC 842 guidance, the facility lease is classified as an operating lease. From its inception until December 2020, the Company’s primary facilities were located at 5810 Nancy Ridge Road in San Diego, California (Nancy Ridge Facility). The average monthly cash payment related to the Company’s Nancy Ridge Facility operating lease was approximately $120,000 per month, and the lease term expired on July 31, 2020, but was extended as stated below. The Company recorded a lease right-of-use asset and lease liability related to this lease of $1,930,000 and $2,201,000, respectively, as of January 1, 2019, based on the 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, dated March 31, 2004, relating to the Nancy Ridge Facility. 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 was the then current monthly rate paid by the Company. The Company agreed to pay additional rent and all other charges as set forth in the Lease through the expiration date. 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. In order to allow the Company adequate time to move its operations to its new facility, the Company entered into an additional extension related to the facility extending the lease until December 11, 2020 at the prorated amount of the current rent. On June 1, 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility at 9955 Mesa Rim Road in San Diego, California. The lease commenced on December 1, 2020 and is for a term of 127 months from the commencement date. The lease includes a rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount of base rent of $111,000. In addition, the landlord agreed to pay for certain preapproved leasehold improvement costs through a one-time leasehold improvement allowance of approximately $1,586,000, and an additional leasehold improvement allowance of approximately $1,586,000. The amount of additional leasehold improvement allowance of approximately $1,586,000 is to be paid back to the landlord during the term of the lease by the Company, amortized at an agreed upon annual rate of 7% as an additional rent payment of approximately $18,000 per month. The average monthly cash payment including payment for the additional leasehold improvement allowance for the lease is approximately $140,000 per month with initial monthly lease payments at $128,000 per month. The Company recorded a lease right-of-use asset and lease liability of $9,776,000 and $9,805,000, respectively, as of December 31, 2020, based on the present value of payments and an incremental borrowing rate of 12%. As the Company’s lease did not provide an implicit rate, the Company estimated the incremental borrowing rate based on the credit quality of the Company and by comparing interest rates available in the market for similar borrowings. In addition, the Company recorded $1,631,000 in other current assets related to reimbursable leasehold improvement costs incurred as of December 31, 2020. 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 2020 as follows: December 31, December 31, 2019 2020 Lease right-of-use assets: Operating $ 729,330 $ 9,776,349 Finance 1,606,387 2,337,709 Total $ 2,335,717 $ 12,114,058 The following schedule sets forth the current portion of operating and finance lease liabilities as of December 31, 2019 and 2020: December 31, December 31, 2019 2020 Current portion of lease liability: Operating $ 842,452 $ — Finance 724,329 963,726 Total $ 1,566,781 $ 963,726 The following schedule sets forth the long-term portion of operating and finance lease liabilities as of December 31, 2019 and 2020: December 31, December 31, 2019 2020 Long-term portion of lease liability: Operating $ — $ 9,805,361 Finance 973,189 1,459,550 Total $ 973,189 $ 11,264,911 The following schedule represents the components of lease expense for the years ended December 31, 2019 and 2020: For the years ended December 31, 2019 2020 Lease cost Finance lease cost Amortization of right-of-use assets $ 470,486 $ 694,249 Interest on lease liabilities 249,984 227,517 Operating lease cost 1,272,024 1,411,958 Total $ 1,992,494 $ 2,333,724 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 December 31, 2020: Finance Operating Minimum Maintenance and Minimum Lease Sales Tax Obligation Lease Payments Payments Payments 2021 $ 1,026,710 $ 104,011 $ 788,446 2022 765,006 81,741 1,586,210 2023 626,131 66,230 1,629,025 2024 341,425 46,281 1,671,841 Thereafter 88,402 6,809 11,995,433 Total payments 2,847,674 305,072 17,670,955 Less amount representing interest (424,398 ) — (7,865,594 ) Present value of payments $ 2,423,276 $ 305,072 $ 9,805,361 The following schedule sets forth supplemental cash flow information related to operating and finance leases as of December 31, 2019 and 2020: For the years ended December 31, 2019 2020 Other information Operating cash flows from finance leases $ 249,984 $ 227,517 Operating cash flows from operating leases $ 1,430,366 $ 1,511,907 Financing cash flows from finance leases $ 539,415 $ 702,588 The aggregate weighted average remaining lease term was 3.20 years on finance leases and 10.42 years on operating leases as of December 31, 2020. The aggregate weighted average discount rate was 16.3% on finance leases and 12.0% on operating leases as of December 31, 2020. |
Supplier Financings
Supplier Financings | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Supplier Financings | 8. Supplier Financings In 2019 and 2020, the Company obtained third-party financing for certain business insurance premiums. The 2019 and 2020 financings bore interest at rates ranging from 3.70% to 4.40% per annum, and all financings were due within one year. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 9. 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. In December 2020, the Company’s board of directors approved an increase of 750,000 shares in the inducement shares of common stock authorized for issuance under the 2013 Plan. As of December 31, 2020, 762,421 shares of the Company’s common stock were authorized exclusively for the issuance of stock awards to employees who have not previously been an employee or director of the Company, except following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company, as defined under applicable Nasdaq Listing Rules. As of December 31, 2020, under all plans, a total of 1,036,409 non-inducement shares were authorized for issuance, 988,101 shares had been issued with 993,172 non-inducement stock options and restricted stock units, or RSUs, underlying outstanding awards, and 32,220 non-inducement shares were available for grant. As of December 31, 2020, 761,836 inducement shares were authorized for issuance, 94,872 inducement shares had been issued under the 2013 Plan, with 85,532 inducement stock options and RSUs underlying outstanding awards and 676,220 inducement shares available for grant. Stock Options Non-performance options granted under either plan vest over a maximum period of four years and expire ten years from the date of grant. Non-performance options generally vest either (i) over four years, 25% on the one-year anniversary of the date of grant and monthly thereafter for the remaining three years; or (ii) over four years, monthly vesting beginning month-one after the grant and monthly thereafter. The fair value of stock options is determined on the date of grant using the Black-Scholes valuation model. For non-performance awards, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for performance awards is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. The determination of the fair value of stock options is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables. The volatility assumption is based on a combination of the historical volatility of the Company’s common stock and the volatilities of similar companies over a period of time equal to the expected term of the stock options. The volatilities of similar companies are used in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the Company’s common stock equal to the expected term. The expected term of employee stock options represents the weighted-average period the stock options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’ vesting terms and remaining contractual life and employees’ expected exercise and post-vesting employment termination behavior. The risk-free interest rate assumption is based upon observed interest rates on the grant date appropriate for the term of the employee stock options. The dividend yield assumption is based on the expectation of no future dividend payouts by the Company. The assumptions used in the Black-Scholes pricing model for options granted during the years ended December 31, 2019 and 2020 are as follows: 2019 2020 Stock and exercise prices $2.90 - $10.30 $2.70 - $7.10 Expected dividend yield 0.00% 0.00% Discount rate-bond equivalent yield 1.58% - 2.55% 0.34% - 1.37% Expected life (in years) 4.00 - 5.96 5.00 - 5.96 Expected volatility 128% - 156% 146% - 171% Using the assumptions described above, with stock and exercise prices being equal on date of grant, the weighted-average estimated fair value of options granted in 2019 and 2020 were approximately $9.10 and $4.31 per share, respectively. A summary of stock option activity for the years ended December 31, 2019 and 2020 is as follows: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term in Years Outstanding at December 31, 2018 19,560 $ 414.10 9.20 Granted 267,899 $ 9.10 Exercised — — Cancelled/forfeited/expired (14,041 ) $ 37.00 Outstanding at December 31, 2019 273,418 $ 36.14 9.25 Granted 858,523 $ 4.51 Exercised — — Cancelled/forfeited/expired (53,237 ) $ 22.26 Outstanding at December 31, 2020 1,078,704 $ 11.64 9.36 Vested and unvested expected to vest, December 31, 2020 1,059,534 $ 11.76 9.35 The intrinsic values of options outstanding, options exercisable, and options vested and unvested expected to vest at December 31, 2019 and 2020 were $0 and $4,714, respectively. Restricted Stock The fair value of RSUs awarded under either plan is determined by the closing price of the Company’s common stock on the date of grant. For non-performance RSUs, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for RSUs is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. A summary of RSU activity during 2019 and 2020 is as follows: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2018 36 $ 4,158 Granted — $ — Vested and issued — $ — Forfeited — $ — Outstanding at December 31, 2019 36 $ 4,158 Granted — $ — Vested and issued — $ — Forfeited — $ — Outstanding at December 31, 2020 36 $ 4,158 Vested, December 31, 2020 36 $ 4,158 At December 31, 2020, the intrinsic values of RSUs outstanding was approximately $160. Of the 36 RSUs outstanding at December 31, 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 statement of operations during the periods presented: Years Ended December 31, 2019 2020 Stock Options Cost of revenues $ 77,495 $ 159,710 Research and development expenses 127,844 116,431 General and administrative expenses 517,324 547,712 Sales and marketing expenses 146,916 117,131 Total stock-based compensation $ 869,579 $ 940,984 As of December 31, 2020, total unrecognized share-based compensation expense related to unvested stock options and RSUs, adjusted for estimated forfeitures, was approximately $4,476,000, and such amount is expected to be recognized over a weighted-average period of approximately 2.74 years. |
Common Stock Warrants Outstandi
Common Stock Warrants Outstanding | 12 Months Ended |
Dec. 31, 2020 | |
Equity Classified Warrants [Abstract] | |
Common Stock Warrants Outstanding | 10. Common A summary of equity-classified common stock warrant activity, for warrants other than those underlying unexercised overallotment option warrants, during 2019 and 2020 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2018 469,492 $ 85.50 4.4 Issued 4,118,972 $ 7.00 Exercised (1,839,593 ) $ 12.00 Expired (447 ) $ 9,530.00 Outstanding at December 31, 2019 2,748,424 $ 18.58 4.6 Issued 885,475 $ 3.62 Exercised (2,634,799 ) $ 6.74 Expired (1,933 ) $ 1,404.00 Outstanding at December 31, 2020 997,167 $ 35.48 3.3 All warrants outstanding at December 31, 2019 and 2020 are exercisable. Warrants issued in the February 2019 financing transaction have an expiration date of February 12, 2024, warrants issued in the March 2019 transaction have an expiration date of September 19, 2024, warrants issued in the May 2019 inducement offering have an expiration date of December 2, 2024, warrants issued in the December 2019 have an expiration date of December 11, 2024, and warrants issued in the January 2020 inducement offering have an expiration date of July 10, 2025. The intrinsic value of equity-classified common stock warrants outstanding at December 31, 2019 and 2020 was $0 and $243,000, respectively. |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | 11. Net Loss per Common Share Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted-average common shares outstanding during the period. Because there is a net loss attributable to common shareholders for the years ended December 31, 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 years ended December 31, 2019 2020 Common warrants outstanding 2,748,424 997,167 RSUs outstanding 36 36 Convertible preferred stock outstanding (number of common stock equivalents) 47,139 46,675 Common options outstanding 273,418 1,078,704 Total anti-dilutive common share equivalents 3,069,017 2,122,582 During the course of the preparation of the December 31, 2020 financial statements the Company noted a clerical error related to the presentation of the three months and nine months ended September 30, 2020 weighted average shares outstanding such that the three months and nine months ended September 30, 2020 weighted average shares outstanding were transposed, resulting in an error in the per share calculation for the three months and nine months ended September 30, 2020. The impact of the error is presented in the table below: For the three months ended For the nine months ended September 30, 2020 September 30, 2020 As reported Corrected As reported Corrected (Unaudited) (Unaudited) (Unaudited) (Unaudited) Net loss attributable to common shareholders (4,878,334 ) (4,878,334 ) (19,711,749 ) (19,711,749 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 11,324,289 13,333,427 13,333,427 11,324,289 Diluted 11,324,289 13,333,427 13,333,427 11,324,289 Net loss per common share: Basic $ (0.43 ) $ (0.37 ) $ (1.48 ) $ (1.74 ) Diluted $ (0.43 ) $ (0.37 ) $ (1.48 ) $ (1.74 ) The Company evaluated the error and determined that it was immaterial to the Company's financial statements for the three and nine months ended September 30, 2020. The Company will make the correction to the financial statements for the three and nine months ended September 30, 2020, upon filing the Form 10-Q for the third quarter of 2021 . |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2020 | |
Postemployment Benefits [Abstract] | |
401(k) Plan | 12. 401(k) Plan The Company sponsors a 401(k) savings plan for all eligible employees. The Company may make discretionary matching contributions to the plan to be allocated to employee accounts based upon employee deferrals and compensation. During the years ended December 31, 2019 and 2020, the Company made $228,000 and approximately $250,000, respectively, in matching contributions into the savings plan. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes For the years ended December 31, 2019 and 2020, the provision for income taxes was calculated as follows: For the years ended December 31, 2019 2020 Current: Federal $ — $ — State — — Total — — Deferred Federal — — State — — Total — — Provision for income tax $ — $ — The following table reconciles income taxes computed at the federal statutory rate and the Company’s provision for income taxes: For the years ended December 31, 2019 2020 Income tax at statutory rate $ (5,278,232 ) $ (3,738,797 ) Change in federal tax rate — — State liability (764,997 ) (939,936 ) Permanent items 103,617 100,728 Stock compensation 174,128 94,489 Warrant inducement 384,534 441,443 Expiration of net operating losses 35,487 912,357 Research and development credit (359,765 ) (370,350 ) State rate change 388 (164,229 ) Estimated section 382 limitation 325,046 183 Return to provision (4,296 ) 6,845 Other (83,353 ) (875,362 ) Valuation allowance 5,467,443 4,532,629 Provision for income tax $ — $ — Deferred income taxes are provided for temporary differences in recognizing certain income and expense items for financial and tax reporting purposes. The deferred tax assets consisted primarily of the income tax benefits from estimated net operating loss carryforwards, deferred rent, and estimated research and development credits. Valuation allowances have been recorded to fully offset deferred tax assets at December 31, 2019 and 2020, as it is more likely than not that the assets will not be utilized. At December 31, 2020, the Company had estimated federal net operating loss carryforwards of approximately $75.4 million with $61.5 million net operating losses generated in tax years beginning after December 31, 2017 carrying forward indefinitely and may generally be used to offset up to 80% of future taxable income, and total estimated federal net operating loss carryforwards of approximately $13.9 million which will begin to expire in 2021. The Company has additional state net operating losses of $44.2 million with $3.8 million net operating losses generated after December 31, 2017 carrying forward indefinitely and may generally be used to offset up to 80% of future taxable income. The remaining estimated net operating loss carryforwards of approximately $40.4 million will begin to expire in 2020. For the years ended December 31, 2019 and 2020, the Company has evaluated the various tax positions reflected in its income tax returns for both federal and state jurisdictions, to determine if the Company has any uncertain tax positions on the historical tax returns. The Company recognizes the impact of an uncertain tax position on an income tax return at the largest amount that the relevant taxing authority is more-likely-than not to sustain upon audit. The Company does not recognize uncertain income tax positions if they have less than 50 percent likelihood of being sustained. Based on this assessment, the Company believes there are no tax positions for which a liability for unrecognized tax benefits should be recorded as of December 31, 2019 or 2020. The Company is subject to U.S. federal income tax as well as income tax in multiple state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal income tax examinations for tax years ending on or before December 31, 2015, and state and local income tax examinations for tax periods ending on or before December 31, 2014. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where net operating losses were generated and carried forward and make adjustments up to the amount of the net operating loss carryforward amount. The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. Due to the existence of the valuation allowance, future changes in unrecognized tax benefits will not impact the Company’s effective tax rate. The Company is currently not under examination by any taxing authorities and does not believe its unrecognized tax benefits will significantly change in the next twelve months. The tax effects of carryforwards and other temporary differences that give rise to deferred tax assets consist of the following: For the year ended December 31, 2019 2020 Estimated net operating loss carryforward $ 13,118,923 $ 18,672,696 Estimated research and development credits 3,318,475 3,688,825 Accruals and other 3,246,125 1,824,076 Operating lease liability 205,542 2,394,201 Fixed assets 460,218 659,656 Stock based compensation 829,801 860,310 21,179,084 28,099,764 Right-of-use asset (569,870 ) (2,957,921 ) Gross deferred tax liabilities (569,870 ) (2,957,921 ) Less valuation allowance (20,609,214 ) (25,141,843 ) Net deferred tax assets $ — $ — Utilization of the estimated domestic net operating loss and research and development tax credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Sections 382 and 383 of the Code, as well as similar state provisions. These ownership changes may limit the amount of estimated net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points by value of the outstanding stock of a company by certain stockholders. Since the Company’s formation, the Company has raised capital through the issuance of capital stock on several occasions which on its own or combined with the purchasing stockholders’ subsequent disposition of those shares, likely resulted in such an ownership change, or could result in an ownership change in the future. Upon the occurrence of an ownership change under Sections 382 and 383 of the Code as outlined above, utilization of the estimated net operating loss and research and development credit carryforwards are subject to an annual limitation, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term, tax-exempt rate, which could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the estimated net operating loss or research and development tax credit carryforwards before utilization. The Company has not yet completed an analysis to determine whether an ownership change has occurred, however, the Company believes multiple ownership changes have likely occurred. As a result, the Company has estimated that the use of its net operating loss carryforwards is limited and has disclosed in the table above only the amounts it estimates could be used in the future, which remain fully offset by a valuation allowance to reduce the net asset to zero. On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (CARES Act). The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions which are expected to impact the Company’s financial statements include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company has concluded that the CARES Act did not have a material impact on its financial position, results of operations, or cash flows. On December 27, 2020, the United States enacted the Consolidated Appropriations Act which extended many of the benefits of the CARES Act that were scheduled to expire. The Company evaluated the impact of the Consolidated Appropriations Act on its consolidated financial statements and related disclosures, and concluded that the impact is immaterial. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. 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 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies Purchase Commitment In February 2016, the Company signed a firm, non-cancelable, and unconditional commitment in an aggregate amount of $1,062,500 with a vendor to purchase certain inventory items, payable in minimum quarterly amounts of $62,500 through May 2020. At December 31, 2019 and 2020, approximately $91,000 and $0 remained outstanding under this purchase commitment, respectively. Financed Equipment Maintenance and Sales Tax Obligations During the years ended December 31, 2019 and 2020, total expense recorded in the Company’s statement of operations and comprehensive loss for sales tax and maintenance obligations associated with finance lease arrangements was approximately $122,000 and $129,000, respectively. At December 31, 2019 and 2020, approximately $73,000 and $77,000 of such sales tax and maintenance obligations incurred but not paid were recorded in accrued other liabilities in the Company’s balance sheet (see Note 6). Future payments totaling $305,072 for sales tax and maintenance obligations associated with financed equipment were due under equipment financing arrangements as of December 31, 2020, which will be expensed as incurred (see Note 7). Legal Proceedings In the normal course of business, the Company may be involved in legal proceedings or threatened legal proceedings. The Company is not party to any legal proceedings or aware of any threatened legal proceedings which are expected to have a material adverse effect on its financial condition, results of operations or liquidity. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events On June 1, 2020, the Company entered into a lease for a 39,000 square foot headquarters, manufacturing and laboratory facility at 9955 Mesa Rim Road in San Diego, California. The lease commenced on December 1, 2020 and is for a term of 127 months from the commencement date. The lease includes a rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount of base rent of $111,000. In addition, the lease stipulates an additional two months of lease abatement period in the event that the property is sold within the first six months of the initial lease period. In March 2021, the Company was notified that the original landlord has sold the building, hence the Company anticipates being eligible for an additional two months of rent abatement period. In February 2021, the Company entered into a supply agreement with Aegea Biotechnologies, Inc. for a new PCR-based COVID-19 assay kit designed by Aegea and co-developed by Aegea and the Company. Under the agreement, Aegea will supply the COVID-19 assay kit to the Company for validation in its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent commercialization of a laboratory developed test (LDT). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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. The COVID-19 pandemic continues to evolve, and the extent to which COVID-19 may impact the Company’s 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. While the Company experienced increased revenue levels in 2020 related to its COVID-19 testing business and has attained net income for the first time in its operating history in the fourth quarter in 2020, these results are not expected to be indicative of future results as the COVID-19 pandemic subsides. |
Basis of Presentation | Basis of Presentation The accompanying financial statements and notes are prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP, and are prepared on the basis that the Company will continue as a going concern (see Note 2). The accompanying financial statements and notes do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern. On September 3, 2020, pursuant to the approval of the Company’s board of directors, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock using a ratio of one-for-ten. As such, all references to share and per share amounts in these financial statements and accompanying notes have been retroactively restated to reflect the one-for-ten reverse stock split, except for the authorized number of shares of the Company’s common stock of 150,000,000 shares, which was not affected by the one-for-ten reverse stock split. |
Going Concern | Going Concern The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern, which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim financial statements are issued (see Note 2). Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgment by management. |
Use of Estimates | Use of Estimates The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates these estimates and judgments, including those related to accounts receivable reserves, inventory reserves, long-lived assets, income taxes, including uncertain tax benefits, estimated transaction price for revenues, stock-based compensation, incremental borrowing rate estimates, and the determination of the Company’s ability to continue as a going concern. The Company bases its estimates on various assumptions that it believes are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Though the impact of the COVID-19 pandemic on the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to determine its significant accounting estimates. |
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 Center for Medicare & Medicaid Services, or 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 years ended December 31, 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 balance sheets. Generally, billing occurs subsequent to delivery of a patient’s test result to the ordering physician or entity, resulting in an account receivable. Practical Expedients The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less. The Company expenses sales commissions when incurred because the amortization period is one year or less, which are recorded within sales and marketing expenses. The Company incurs certain other costs that are incurred regardless of whether a contract is obtained. Such costs are primarily related to legal services and patient communications. These costs are expensed as incurred and recorded within general and administrative expenses. Disaggregation of Revenue and Concentration of Risk The composition of the Company’s net revenues recognized during the years ended December 31, 2019 and 2020, disaggregated by source and nature, are as follows: For the year ended December 31, 2019 2020 Net revenues from contracted payers* $ 2,071,961 $ 14,070,173 Net revenues from non-contracted payers 3,044,249 12,793,119 Development services revenues 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. Revenues for the year ended December 31, 2020 included $26.9 million in commercial test revenue, which includes $23.3 million attributable to RT-PCR COVID-19 testing. For the year ended December 31, 2019 2020 Net commercial revenues recognized upon delivery $ 5,116,210 $ 26,863,292 Development services revenues recognized upon delivery 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2019 and 2020 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2018 Upon Delivery Adjudication 2019 Accounts receivable, gross $ 7,882,602 $ 19,001,873 $ (10,030,090 ) $ 16,854,385 Reserve for contractual discounts (2,177,475 ) (12,098,297 ) 10,449,272 (3,826,500 ) Reserve for aged non-patient receivables (565,948 ) (287,832 ) (646,247 ) (1,500,027 ) Reserve for estimated patient receivables (15,477 ) (111,572 ) 121,974 (5,075 ) Reserve for other payer-specific sales allowances (3,549,377 ) (975,606 ) (3,470,722 ) (7,995,705 ) Accounts receivable, net $ 1,574,325 $ 5,528,566 $ (3,575,813 ) $ 3,527,078 Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2019 Upon Delivery Adjudication 2020 Accounts receivable, gross $ 16,854,385 $ 73,644,766 $ (49,474,977 ) $ 41,024,174 Reserve for contractual discounts (3,826,500 ) (44,778,868 ) 24,976,851 (23,628,517 ) Reserve for aged non-patient receivables (1,500,027 ) (2,507,660 ) 3,958,481 (49,206 ) Reserve for estimated patient receivables (5,075 ) (61,118 ) 61,068 (5,125 ) Reserve for other payer-specific sales allowances (7,995,705 ) 1,164,278 3,635,012 (3,196,415 ) Accounts receivable, net $ 3,527,078 $ 27,461,398 $ (16,843,565 ) $ 14,144,911 At December 31, 2019 and 2020, unbilled accounts receivables totaled approximately $29,000 and $4.5 million, respectively. |
Cash | Cash The Company places its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation, or FDIC. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company has not experienced any losses in its cash and believes they are not exposed to any significant credit risk. |
Fair Value Measurements | Fair Value Measurements The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximate their estimated fair values due to the short-term maturities of these financial instruments. See Note 5 for further details about the inputs and assumptions used to determine fair value measurements. |
Concentration of Risk | Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. Concentrations of credit risk with respect to revenues are primarily limited to geographies to which the Company provides a significant volume of its services, and to specific third-party payers of the Company’s services such as Medicare, insurance companies, and other third-party payers. The Company’s client base consists of a large number of geographically dispersed clients diversified across various customer types. The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the years ended December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 38 % 51 % Blue Cross Blue Shield 21 % 20 % 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, as of December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 17 % 35 % Blue Cross Blue Shield 26 % 24 % United Healthcare 12 % 6 % The Company operates in one reportable business segment and historically has derived most revenues only from within the United States. Certain components used in the Company’s current or planned products are currently sourced from one supplier, for which alternative suppliers exist but the Company has not validated the product(s) of such alternative supplier(s), and substitutes for these components may not be obtained easily or may require substantial design or manufacturing modifications. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined by the average cost method. The two primary components of inventory balances are raw materials and subassemblies. Subassemblies are in process raw materials used in our laboratory operations. The Company records adjustments to its inventory for estimated obsolescence or diminution in net realizable value equal to the difference between the cost of the inventory and the estimated net realizable value. At the point of loss recognition, a new cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the restoration or increase in that newly established cost basis. In addition, the Company records a liability for firm, non-cancelable, and unconditional purchase commitments with contract manufacturers and suppliers for quantities in excess of the Company’s future demand forecasts consistent with its valuation of excess and obsolete inventory. |
Fixed Assets | Fixed Assets Fixed assets consist of machinery and equipment, furniture and fixtures, computer equipment and software, leasehold improvements, financed equipment and construction in-process. Fixed assets are stated at cost less accumulated depreciation and amortization. Additions, improvements, and major renewals are capitalized. Maintenance, repairs, and minor renewals are expensed as incurred. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, which range from three to seven years. Leasehold improvements are amortized over the life of the lease or the asset, whichever is shorter. Depreciation and amortization expense for the years ended December 31, 2019 and 2020 was approximately $932,000 and $1,085,000, respectively. Upon sale or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation or amortization with any gain or loss recorded to the statement of operations and comprehensive loss. Fixed assets are reviewed for impairment whenever changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in the estimates of future cash flows to determine recoverability of these assets. If the assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss. There had been no impairment losses recorded in 2019 and 2020. |
Stock-based Compensation | Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees and directors based on their grant date fair values. The Company estimates the fair value of stock option awards on the date of grant using the Black-Scholes option pricing model, while the fair value of restricted stock unit awards, or RSUs, is determined by the Company’s stock price on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In addition, the Company estimates forfeitures at the time of grant and revises these estimates in subsequent periods if actual forfeitures differ from those estimates (see Note 9). The Company determines the fair value of the stock-based compensation awards granted as either the fair value of the consideration received, or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards are recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods based on the fair value of the options at the end of each period. Calculating the fair value of stock-based awards requires the input of highly subjective assumptions into the Black-Scholes valuation model. Stock-based compensation expense is calculated using the Company’s best estimates, which involves inherent uncertainties, and the application of management’s judgment. Significant estimates include the expected life of the stock option, stock price volatility and risk-free interest rate. |
Research and Development | Research and Development Research and development costs are expensed as incurred. The amounts expensed in the years ended December 31, 2019 and 2020 were approximately $4,697,000 and $5,220,000, respectively, which includes salaries of research and development personnel. |
Income Taxes | Income Taxes The Company provides for income taxes utilizing the liability method. Under the liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits. Tax rate changes are reflected in the computation of the income tax provision during the period such changes are enacted. Deferred tax assets are reduced by a valuation allowance when, in management’s opinion, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company’s valuation allowance is based on available evidence, including its current year operating loss, evaluation of positive and negative evidence with respect to certain specific deferred tax assets including evaluation sources of future taxable income to support the realization of the deferred tax assets. The Company has established a full valuation allowance on the deferred tax assets as of December 31, 2019 and 2020, and therefore has not recognized any income tax benefit or expense in the periods presented. A tax benefit from uncertain tax positions may be recognized by the Company when it is more-likely-than-not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. The Company recognizes interest and/or penalties related to income tax matters in income tax expense. There is no accrual for interest or penalties for income taxes on the balance sheets at December 31, 2019 and 2020, and the Company has not recognized interest and/or penalties in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020. |
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. In June 2016, the FASB issued ASU 2016-13, “Credit Losses (Topic 326).” ASU 2016-13 requires that financial assets measured at amortized cost, such as trade receivables and investments, be represented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions, and future expectation for each pool of similar financial asset. The new guidance requires enhanced disclosures related to trade receivables and associated credit losses. In May 2019, the FASB issued ASU No. 2019-05, “Financial Instruments—Credit Losses (Topic 326) Targeted Transition Relief,” which allows for a transition election on certain instruments. The guidance is effective for Small Reporting Companies for fiscal years beginning after December 15, 2022 and interim periods in those fiscal years. In November 2019, the FASB issued ASU No. 2019-11 which amends certain aspects of ASU No. 2016-13, including transition relief for trouble debt restructuring, among other topics. The Company is currently evaluating the impact of this pronouncement on its financial statements. |
Stock Options [Member] | |
Fair Value Measurements | The fair value of stock options is determined on the date of grant using the Black-Scholes valuation model. For non-performance awards, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for performance awards is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. The determination of the fair value of stock options is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables. The volatility assumption is based on a combination of the historical volatility of the Company’s common stock and the volatilities of similar companies over a period of time equal to the expected term of the stock options. The volatilities of similar companies are used in conjunction with the Company’s historical volatility because of the lack of sufficient relevant history for the Company’s common stock equal to the expected term. The expected term of employee stock options represents the weighted-average period the stock options are expected to remain outstanding. The expected term assumption is estimated based primarily on the options’ vesting terms and remaining contractual life and employees’ expected exercise and post-vesting employment termination behavior. The risk-free interest rate assumption is based upon observed interest rates on the grant date appropriate for the term of the employee stock options. The dividend yield assumption is based on the expectation of no future dividend payouts by the Company. |
Restricted Stock [Member] | |
Fair Value Measurements | The fair value of RSUs awarded under either plan is determined by the closing price of the Company’s common stock on the date of grant. For non-performance RSUs, such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line method. The amount and timing of compensation expense recognized for RSUs is based on management’s estimate of the most likely outcome and when the achievement of the performance objectives is probable. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 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 years ended December 31, 2019 and 2020, disaggregated by source and nature, are as follows: For the year ended December 31, 2019 2020 Net revenues from contracted payers* $ 2,071,961 $ 14,070,173 Net revenues from non-contracted payers 3,044,249 12,793,119 Development services revenues 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 *Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. Revenues for the year ended December 31, 2020 included $26.9 million in commercial test revenue, which includes $23.3 million attributable to RT-PCR COVID-19 testing. For the year ended December 31, 2019 2020 Net commercial revenues recognized upon delivery $ 5,116,210 $ 26,863,292 Development services revenues recognized upon delivery 212,344 177,286 Kits and Blood Collection Tubes (BCT) 200,012 420,820 Total net revenues $ 5,528,566 $ 27,461,398 |
Summary of Activity in Gross and Net Accounts Receivable Balances and Reserves | A summary of activity in the Company’s gross and net accounts receivable balances, as well as corresponding reserves, during the year ended December 31, 2019 and 2020 is as follows: Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2018 Upon Delivery Adjudication 2019 Accounts receivable, gross $ 7,882,602 $ 19,001,873 $ (10,030,090 ) $ 16,854,385 Reserve for contractual discounts (2,177,475 ) (12,098,297 ) 10,449,272 (3,826,500 ) Reserve for aged non-patient receivables (565,948 ) (287,832 ) (646,247 ) (1,500,027 ) Reserve for estimated patient receivables (15,477 ) (111,572 ) 121,974 (5,075 ) Reserve for other payer-specific sales allowances (3,549,377 ) (975,606 ) (3,470,722 ) (7,995,705 ) Accounts receivable, net $ 1,574,325 $ 5,528,566 $ (3,575,813 ) $ 3,527,078 Balance at Amounts Settlements Balance at December 31, Recognized Upon December 31, 2019 Upon Delivery Adjudication 2020 Accounts receivable, gross $ 16,854,385 $ 73,644,766 $ (49,474,977 ) $ 41,024,174 Reserve for contractual discounts (3,826,500 ) (44,778,868 ) 24,976,851 (23,628,517 ) Reserve for aged non-patient receivables (1,500,027 ) (2,507,660 ) 3,958,481 (49,206 ) Reserve for estimated patient receivables (5,075 ) (61,118 ) 61,068 (5,125 ) Reserve for other payer-specific sales allowances (7,995,705 ) 1,164,278 3,635,012 (3,196,415 ) Accounts receivable, net $ 3,527,078 $ 27,461,398 $ (16,843,565 ) $ 14,144,911 |
Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage | The Company's third-party payers that represent more than 10% of total net revenues in any period presented, as well as their related net revenue amount as a percentage of total net revenues, during the years ended December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 38 % 51 % Blue Cross Blue Shield 21 % 20 % 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, as of December 31, 2019 and 2020 were as follows: For the year ended December 31, 2019 2020 Medicare and Medicare Advantage/CARES Act 17 % 35 % Blue Cross Blue Shield 26 % 24 % United Healthcare 12 % 6 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 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 $ 2.70 Exercise price $ 4.05 Expected dividend yield 0.00 % Discount rate-bond equivalent yield 1.64 % Expected life (in years) 5.00 Expected volatility 153.7 % 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) | 12 Months Ended |
Dec. 31, 2019 | |
Balance Sheet Component [Abstract] | |
Schedule of Balance Sheet Details | The following provides certain balance sheet details: December 31, December 31, 2019 2020 Inventories Raw materials $ 630,548 $ 1,235,620 Subassemblies 130,898 691,126 Finished goods 6,540 2,878 $ 767,986 $ 1,929,624 Fixed Assets Machinery and equipment $ 2,857,538 $ 2,974,320 Furniture and office equipment 156,987 156,987 Computer equipment and software 1,552,891 2,428,211 Leasehold improvements 570,173 570,173 Construction in process 625,038 761,221 5,762,627 6,890,912 Less accumulated depreciation and amortization (4,258,297 ) (4,573,296 ) Total fixed assets, net $ 1,504,330 $ 2,317,616 Accrued Liabilities Accrued payroll $ 298,855 $ 452,118 Accrued vacation 622,792 868,557 Accrued bonuses 748,742 1,022,421 Accrued sales commissions 89,562 456,526 Accrued other 220,253 366,047 Total accrued liabilities $ 1,980,204 $ 3,165,669 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 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 2020 as follows: December 31, December 31, 2019 2020 Lease right-of-use assets: Operating $ 729,330 $ 9,776,349 Finance 1,606,387 2,337,709 Total $ 2,335,717 $ 12,114,058 |
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 2020: December 31, December 31, 2019 2020 Current portion of lease liability: Operating $ 842,452 $ — Finance 724,329 963,726 Total $ 1,566,781 $ 963,726 |
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 2020: December 31, December 31, 2019 2020 Long-term portion of lease liability: Operating $ — $ 9,805,361 Finance 973,189 1,459,550 Total $ 973,189 $ 11,264,911 |
Schedule of Lease Expenses | The following schedule represents the components of lease expense for the years ended December 31, 2019 and 2020: For the years ended December 31, 2019 2020 Lease cost Finance lease cost Amortization of right-of-use assets $ 470,486 $ 694,249 Interest on lease liabilities 249,984 227,517 Operating lease cost 1,272,024 1,411,958 Total $ 1,992,494 $ 2,333,724 |
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 December 31, 2020: Finance Operating Minimum Maintenance and Minimum Lease Sales Tax Obligation Lease Payments Payments Payments 2021 $ 1,026,710 $ 104,011 $ 788,446 2022 765,006 81,741 1,586,210 2023 626,131 66,230 1,629,025 2024 341,425 46,281 1,671,841 Thereafter 88,402 6,809 11,995,433 Total payments 2,847,674 305,072 17,670,955 Less amount representing interest (424,398 ) — (7,865,594 ) Present value of payments $ 2,423,276 $ 305,072 $ 9,805,361 |
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 December 31, 2019 and 2020: For the years ended December 31, 2019 2020 Other information Operating cash flows from finance leases $ 249,984 $ 227,517 Operating cash flows from operating leases $ 1,430,366 $ 1,511,907 Financing cash flows from finance leases $ 539,415 $ 702,588 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model | The assumptions used in the Black-Scholes pricing model for options granted during the years ended December 31, 2019 and 2020 are as follows: 2019 2020 Stock and exercise prices $2.90 - $10.30 $2.70 - $7.10 Expected dividend yield 0.00% 0.00% Discount rate-bond equivalent yield 1.58% - 2.55% 0.34% - 1.37% Expected life (in years) 4.00 - 5.96 5.00 - 5.96 Expected volatility 128% - 156% 146% - 171% |
Summary of Stock Option Activity | A summary of stock option activity for the years ended December 31, 2019 and 2020 is as follows: Number of Shares Weighted Average Exercise Price Per Share Weighted Average Remaining Contractual Term in Years Outstanding at December 31, 2018 19,560 $ 414.10 9.20 Granted 267,899 $ 9.10 Exercised — — Cancelled/forfeited/expired (14,041 ) $ 37.00 Outstanding at December 31, 2019 273,418 $ 36.14 9.25 Granted 858,523 $ 4.51 Exercised — — Cancelled/forfeited/expired (53,237 ) $ 22.26 Outstanding at December 31, 2020 1,078,704 $ 11.64 9.36 Vested and unvested expected to vest, December 31, 2020 1,059,534 $ 11.76 9.35 |
Summary of RSU Activity | A summary of RSU activity during 2019 and 2020 is as follows: Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2018 36 $ 4,158 Granted — $ — Vested and issued — $ — Forfeited — $ — Outstanding at December 31, 2019 36 $ 4,158 Granted — $ — Vested and issued — $ — Forfeited — $ — Outstanding at December 31, 2020 36 $ 4,158 Vested, December 31, 2020 36 $ 4,158 |
Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Statement of Operations | The following table presents the effects of stock-based compensation related to equity awards to employees and nonemployees on the statement of operations during the periods presented: Years Ended December 31, 2019 2020 Stock Options Cost of revenues $ 77,495 $ 159,710 Research and development expenses 127,844 116,431 General and administrative expenses 517,324 547,712 Sales and marketing expenses 146,916 117,131 Total stock-based compensation $ 869,579 $ 940,984 |
Common Stock Warrants Outstan_2
Common Stock Warrants Outstanding (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity Classified Warrants [Abstract] | |
Summary of Equity-Classified Common Stock Warrant Activity, for Warrants Other than Underlying Unexercised Overallotment Option Warrants | A summary of equity-classified common stock warrant activity, for warrants other than those underlying unexercised overallotment option warrants, during 2019 and 2020 is as follows: Average Weighted Remaining Number of Average Exercise Contractual Shares Price Per Share Term in Years Outstanding at December 31, 2018 469,492 $ 85.50 4.4 Issued 4,118,972 $ 7.00 Exercised (1,839,593 ) $ 12.00 Expired (447 ) $ 9,530.00 Outstanding at December 31, 2019 2,748,424 $ 18.58 4.6 Issued 885,475 $ 3.62 Exercised (2,634,799 ) $ 6.74 Expired (1,933 ) $ 1,404.00 Outstanding at December 31, 2020 997,167 $ 35.48 3.3 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 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 years ended December 31, 2019 2020 Common warrants outstanding 2,748,424 997,167 RSUs outstanding 36 36 Convertible preferred stock outstanding (number of common stock equivalents) 47,139 46,675 Common options outstanding 273,418 1,078,704 Total anti-dilutive common share equivalents 3,069,017 2,122,582 |
Schedule of Impact of Error | The impact of the error is presented in the table below: For the three months ended For the nine months ended September 30, 2020 September 30, 2020 As reported Corrected As reported Corrected (Unaudited) (Unaudited) (Unaudited) (Unaudited) Net loss attributable to common shareholders (4,878,334 ) (4,878,334 ) (19,711,749 ) (19,711,749 ) Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: Basic 11,324,289 13,333,427 13,333,427 11,324,289 Diluted 11,324,289 13,333,427 13,333,427 11,324,289 Net loss per common share: Basic $ (0.43 ) $ (0.37 ) $ (1.48 ) $ (1.74 ) Diluted $ (0.43 ) $ (0.37 ) $ (1.48 ) $ (1.74 ) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | For the years ended December 31, 2019 and 2020, the provision for income taxes was calculated as follows: For the years ended December 31, 2019 2020 Current: Federal $ — $ — State — — Total — — Deferred Federal — — State — — Total — — Provision for income tax $ — $ — |
Reconciles of Income Taxes Computed at Federal Statutory Rate and Provision for Income Taxes | The following table reconciles income taxes computed at the federal statutory rate and the Company’s provision for income taxes: For the years ended December 31, 2019 2020 Income tax at statutory rate $ (5,278,232 ) $ (3,738,797 ) Change in federal tax rate — — State liability (764,997 ) (939,936 ) Permanent items 103,617 100,728 Stock compensation 174,128 94,489 Warrant inducement 384,534 441,443 Expiration of net operating losses 35,487 912,357 Research and development credit (359,765 ) (370,350 ) State rate change 388 (164,229 ) Estimated section 382 limitation 325,046 183 Return to provision (4,296 ) 6,845 Other (83,353 ) (875,362 ) Valuation allowance 5,467,443 4,532,629 Provision for income tax $ — $ — |
Summary of Deferred Tax Assets | The tax effects of carryforwards and other temporary differences that give rise to deferred tax assets consist of the following: For the year ended December 31, 2019 2020 Estimated net operating loss carryforward $ 13,118,923 $ 18,672,696 Estimated research and development credits 3,318,475 3,688,825 Accruals and other 3,246,125 1,824,076 Operating lease liability 205,542 2,394,201 Fixed assets 460,218 659,656 Stock based compensation 829,801 860,310 21,179,084 28,099,764 Right-of-use asset (569,870 ) (2,957,921 ) Gross deferred tax liabilities (569,870 ) (2,957,921 ) Less valuation allowance (20,609,214 ) (25,141,843 ) Net deferred tax assets $ — $ — |
Liquidity - Additional Informat
Liquidity - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash And Cash Equivalents [Abstract] | ||
Cash | $ 14,367,942 | $ 9,301,406 |
Accumulated deficit | (263,526,867) | (245,717,189) |
Net loss | (17,806,904) | (25,138,039) |
Cash flows from operations | (19,787,100) | $ (23,049,261) |
Aggregate net interest-bearing indebtedness | 2,400,000 | |
Other non-interest-bearing current liabilities | 3,200,000 | |
Aggregate net interest-bearing indebtedness due within one year | $ 964,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Sep. 03, 2020shares | Dec. 31, 2020USD ($)Segmentshares | Dec. 31, 2019USD ($)shares |
Summary Of Significant Accounting Policies [Line Items] | |||
Stockholders equity reverse stock split ratio | 0.10 | ||
Common stock, shares authorized | shares | 150,000,000 | 150,000,000 | 150,000,000 |
Description of reverse stock split | On September 3, 2020, pursuant to the approval of the Company’s board of directors, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock using a ratio of one-for-ten. | ||
Net revenues | $ 27,461,398 | $ 5,528,566 | |
Unbilled accounts receivables | $ 4,500,000 | 29,000 | |
Number of reportable segments | Segment | 1 | ||
Number of suppliers | one supplier | ||
Depreciation and amortization expense | $ 1,085,234 | 931,655 | |
Impairment losses | 0 | 0 | |
Research and development expenses | 5,220,278 | 4,697,022 | |
Accrual for interest or penalties for income taxes | 0 | 0 | |
Interest or penalties expense on income taxes | 0 | $ 0 | |
Commercial Test Revenue [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Net revenues | 26,900,000 | ||
Commercial Test Revenue [Member] | RT-PCR COVID-19 Testing [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Net revenues | $ 23,300,000 | ||
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of assets | 3 years | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of assets | 7 years | ||
ASC 606 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Performance obligation, description of timing | The duration of time between accession receipt and delivery of a valid assay result to the ordering physician or entity is typically less than two weeks, 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] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Amortization period | 1 year |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Composition of Net Revenues Recognized Disaggregated by Source (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | ||
Disaggregation Of Revenue [Line Items] | |||
Total net revenues | $ 27,461,398 | $ 5,528,566 | |
Commercial Revenues [Member] | Contracted Payers [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total net revenues | [1] | 14,070,173 | 2,071,961 |
Commercial Revenues [Member] | Non-Contracted Payers [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total net revenues | 12,793,119 | 3,044,249 | |
Development Services Revenues [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total net revenues | 177,286 | 212,344 | |
Kits and Blood Collection Tubes [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total net revenues | $ 420,820 | $ 200,012 | |
[1] | Includes Medicare and Medicare Advantage, as reimbursement amounts are fixed. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Composition of Net Revenues Recognized Disaggregated by Nature (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Total net revenues | $ 27,461,398 | $ 5,528,566 |
Commercial Revenues [Member] | Net Commercial Revenues Recognized Upon Delivery [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Total net revenues | 26,863,292 | 5,116,210 |
Development Services Revenues [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Total net revenues | 177,286 | 212,344 |
Kits and Blood Collection Tubes [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Total net revenues | $ 420,820 | $ 200,012 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Activity in Gross and Net Accounts Receivable Balances and Reserves (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | $ 3,527,078 | $ 1,574,325 |
Amounts Recognized Upon Delivery | 27,461,398 | 5,528,566 |
Settlements Upon Adjudication | (16,843,565) | (3,575,813) |
Gross and net accounts receivable, Ending Balance | 14,144,911 | 3,527,078 |
Accounts Receivable Gross [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | 16,854,385 | 7,882,602 |
Amounts Recognized Upon Delivery | 73,644,766 | 19,001,873 |
Settlements Upon Adjudication | (49,474,977) | (10,030,090) |
Gross and net accounts receivable, Ending Balance | 41,024,174 | 16,854,385 |
Reserve for Contractual Discounts [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | (3,826,500) | (2,177,475) |
Amounts Recognized Upon Delivery | (44,778,868) | (12,098,297) |
Settlements Upon Adjudication | 24,976,851 | 10,449,272 |
Gross and net accounts receivable, Ending Balance | (23,628,517) | (3,826,500) |
Reserve for Aged Non-patient Receivables [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | (1,500,027) | (565,948) |
Amounts Recognized Upon Delivery | (2,507,660) | (287,832) |
Settlements Upon Adjudication | 3,958,481 | (646,247) |
Gross and net accounts receivable, Ending Balance | (49,206) | (1,500,027) |
Reserve for Estimated Patient Receivables [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | (5,075) | (15,477) |
Amounts Recognized Upon Delivery | (61,118) | (111,572) |
Settlements Upon Adjudication | 61,068 | 121,974 |
Gross and net accounts receivable, Ending Balance | (5,125) | (5,075) |
Reserve for Other Payer-specific Sales Allowances [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Gross and net accounts receivable, Beginning Balance | (7,995,705) | (3,549,377) |
Amounts Recognized Upon Delivery | 1,164,278 | (975,606) |
Settlements Upon Adjudication | 3,635,012 | (3,470,722) |
Gross and net accounts receivable, Ending Balance | $ (3,196,415) | $ (7,995,705) |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Third-Party Payers That Represent More Than 10% of Total Net Revenues and Total Net Accounts Receivable and Their Related Percentage (Detail) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Customer Concentration Risk [Member] | Net Revenues [Member] | Blue Cross Blue Shield [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 20.00% | 21.00% |
Customer Concentration Risk [Member] | Net Revenues [Member] | Cares Act [Member] | Medicare and Medicare Advantage [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 51.00% | 38.00% |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Blue Cross Blue Shield [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 24.00% | 26.00% |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | United Healthcare [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 6.00% | 12.00% |
Credit Concentration Risk [Member] | Net Accounts Receivable [Member] | Cares Act [Member] | Medicare and Medicare Advantage [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 35.00% | 17.00% |
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 | Dec. 11, 2019 | 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 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2018 | Jan. 30, 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 | $ 7,600,000 | $ 2,000,000 | ||||||||||||||
Issuance of warrants to purchase shares of common stock | 192,500 | ||||||||||||||||||
Exercise price of warrants | $ 3.495 | $ 12.50 | $ 12 | $ 4.05 | $ 12 | ||||||||||||||
Class of warrant or rights, term | 5 years 6 months | ||||||||||||||||||
Proceeds from exercise of common stock warrants | $ 2,401,704 | $ 2,513,173 | |||||||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||||||
Fair value of warrants issued | $ 1,900,000 | ||||||||||||||||||
Proceeds from exercise of common stock warrants | 2,337,298 | ||||||||||||||||||
Warrant inducement expense | $ 130,000 | $ 60,000 | $ 2,102,109 | $ 1,831,116 | |||||||||||||||
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 | |||||||||||||||||
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 the New Warrants, with such New 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 New Warrants were exercisable upon issuance and terminate on the date that is five-years and six-months following the initial exercise date. | ||||||||||||||||||
Percentage of common stock exercised for exchange of Inducement warrants | 75.00% | 75.00% | |||||||||||||||||
Fair value of warrants issued | $ 1,800,000 | ||||||||||||||||||
Warrants exercisable date | Jul. 31, 2019 | Jul. 15, 2019 | |||||||||||||||||
Pre-funded Warrants [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 540,000 | ||||||||||||||||||
February 2019 March 2019 Warrant Repricing and Exchange Transaction [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Proceeds from exercise of common stock warrants | 2,300,000 | ||||||||||||||||||
Warrant inducement expense | $ 191,000 | ||||||||||||||||||
Warrant [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Stock price | $ 3.495 | $ 4.05 | $ 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 | $ 4.05 | $ 12.50 | $ 12 | |||||||||||||||
Class of warrant or rights, term | 5 years 6 months | 5 years | 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 | 53,887 | ||||||||||||||||||
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 | ||||||||||||||||||
Underwritten Public Offering [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued in offering | 1,920,000 | ||||||||||||||||||
Stock price | $ 4.05 | ||||||||||||||||||
Net cash proceeds from sale of securities | $ 8,900,000 | ||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 2,460,000 | ||||||||||||||||||
Exercise price of warrants | $ 4.05 | ||||||||||||||||||
Class of warrant or rights, term | 5 years | ||||||||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||||||
Underwritten Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 540,000 | ||||||||||||||||||
Exercise price of warrants | $ 3.95 | ||||||||||||||||||
Warrant exercisable for share of common stock | 1 | ||||||||||||||||||
Change in exercise price of warrants | $ 0.10 | ||||||||||||||||||
Underwritten Public Offering [Member] | Cashless Warrants [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 712,250 | ||||||||||||||||||
Percentage of common stock issuable upon exercise of the common warrant without cash payment | 50.00% | ||||||||||||||||||
Number of common warrants exercised | 1,400,000 | ||||||||||||||||||
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] | |||||||||||||||||||
Shares issued in offering | 369,000 | ||||||||||||||||||
Issuance of warrants to purchase shares of common stock | 93,750 | ||||||||||||||||||
Maximum [Member] | Over-allotment Option [Member] | Warrant [Member] | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Shares issued in offering | 369,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | Jan. 10, 2020 | Dec. 11, 2019 | May 30, 2019 | Mar. 19, 2019 | Feb. 12, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 30, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||||
Fixed asset purchases as right-of-use asset finance lease obligations | $ 1,428,000 | $ 632,000 | ||||||||
Estimated grant date fair value of warrants | $ 2.80 | $ 2.40 | $ 11.80 | $ 10.10 | $ 9.50 | |||||
Issuance of unregistered warrants to purchase shares of common stock, grant date fair value | $ 1,900,000 | $ 6,400,000 | $ 1,800,000 | $ 6,000,000 | $ 6,800,000 | |||||
Exercise price of unregistered warrants | $ 3.495 | $ 12.50 | $ 12 | $ 4.05 | $ 12 | |||||
Class of warrant or rights, term | 5 years 6 months | |||||||||
Issuance of warrants to purchase shares of common stock | 192,500 | |||||||||
Common stock warrants outstanding, intrinsic value | 243,000 | $ 0 | ||||||||
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 | 2,102,109 | $ 1,831,116 | ||||||
Pre-funded Warrants [Member] | ||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||||
Issuance of warrants to purchase shares of common stock | 540,000 | |||||||||
Common stock warrants outstanding, intrinsic value | $ 1,400,000 | |||||||||
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 | $ 4.05 | $ 12.50 | $ 12 | ||||||
Class of warrant or rights, term | 5 years 6 months | 5 years | 5 years 6 months | 5 years | ||||||
Warrant Inducement Transaction [Member] | ||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||||
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 | 2,652,750 | 154,722 | 595,000 | 716,500 | |||||
Maximum [Member] | Follow-on Public Offering [Member] | ||||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||||
Issuance of warrants to purchase shares of common stock | 625,000 | |||||||||
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 | $ 1,428,000 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions Used for Determining Fair Values of Common Stock Warrants (Detail) | Dec. 31, 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 | |||||
December 11, 2019 Offering [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Beginning stock price | $ 2.70 | |||||
December 11, 2019 Offering [Member] | Exercise Price [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 4.05 | |||||
December 11, 2019 Offering [Member] | Expected Dividend Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 0 | |||||
December 11, 2019 Offering [Member] | Discount Rate-Bond Equivalent Yield [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 1.64 | |||||
December 11, 2019 Offering [Member] | Expected Life [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Expected life (in years) | 5 years | |||||
December 11, 2019 Offering [Member] | Expected Volatility [Member] | ||||||
Warrant Fair Value Black Scholes Method [Line Items] | ||||||
Measurement input | 153.7 | |||||
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 Balance Sheet Details (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Inventories | ||
Raw materials | $ 1,235,620 | $ 630,548 |
Subassemblies | 691,126 | 130,898 |
Finished goods | 2,878 | 6,540 |
Inventory, Gross | 1,929,624 | 767,986 |
Fixed Assets | ||
Machinery and equipment | 2,974,320 | 2,857,538 |
Furniture and office equipment | 156,987 | 156,987 |
Computer equipment and software | 2,428,211 | 1,552,891 |
Leasehold improvements | 570,173 | 570,173 |
Construction in process | 761,221 | 625,038 |
Total fixed assets, gross | 6,890,912 | 5,762,627 |
Less accumulated depreciation and amortization | (4,573,296) | (4,258,297) |
Total fixed assets, net | 2,317,616 | 1,504,330 |
Accrued Liabilities | ||
Accrued payroll | 452,118 | 298,855 |
Accrued vacation | 868,557 | 622,792 |
Accrued bonuses | 1,022,421 | 748,742 |
Accrued sales commissions | 456,526 | 89,562 |
Accrued other | 366,047 | 220,253 |
Total accrued liabilities | $ 3,165,669 | $ 1,980,204 |
Leases - Additional Information
Leases - Additional Information (Detail) | Jun. 05, 2020USD ($) | Jun. 01, 2020USD ($)ft² | Feb. 01, 2019USD ($) | Jan. 31, 2019USD ($)mo | Dec. 31, 2020USD ($)mo | Nov. 30, 2020USD ($)mo | Oct. 31, 2020USD ($)mo | Sep. 30, 2020USD ($)mo | Jul. 31, 2020USD ($)mo | Jun. 30, 2020USD ($)mo | Apr. 30, 2020USD ($)mo | Mar. 31, 2020USD ($)mo | Feb. 29, 2020USD ($)mo | Dec. 31, 2019USD ($)mo | Sep. 30, 2019USD ($)mo | Aug. 31, 2019USD ($)mo | Jul. 31, 2019USD ($)mo | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) |
Leases [Line Items] | ||||||||||||||||||||
Lease, Practical Expedients, Package [true false] | true | |||||||||||||||||||
Finance lease right-of-use assets | $ 2,337,709 | $ 1,606,387 | $ 2,337,709 | $ 1,606,387 | ||||||||||||||||
Fixed asset purchases recorded as finance leases | 1,428,000 | 632,000 | ||||||||||||||||||
Total amount from finance lease commitment | $ 149,000 | $ 91,000 | $ 73,000 | $ 192,000 | $ 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 | monthly | monthly | monthly | |||||||
Finance lease transaction, number of installments payments | mo | 36 | 36 | 60 | 48 | 60 | 60 | 48 | 60 | 36 | 48 | ||||||||||
Finance lease transaction, monthly installments of principal and interest payments | $ 5,013 | $ 3,002 | $ 1,394 | $ 5,382 | $ 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 | $ 108,000 | $ 84,000 | $ 258,000 | $ 261,000 | $ 166,000 | $ 469,000 | $ 185,000 | $ 14,000 | $ 265,000 | $ 106,000 | $ 297,000 | $ 130,000 | 108,000 | ||||||
Finance lease transaction, commitment period | 2022-02 | 2023-12 | 2025-11 | 2024-10 | 2025-07 | 2025-07 | 2025-06 | 2025-03 | 2024-02 | 2025-01 | 2024-09 | 2022-08 | 2023-05 | |||||||
Operating lease monthly payments | 1,511,907 | 1,430,366 | ||||||||||||||||||
Operating lease, right-of-use asset | $ 9,776,349 | 729,330 | 9,776,349 | 729,330 | ||||||||||||||||
Operating lease liability | $ 9,805,361 | $ 9,805,361 | ||||||||||||||||||
Finance lease, weighted average remaining lease term | 3 years 2 months 12 days | 3 years 2 months 12 days | ||||||||||||||||||
Operating lease, weighted average remaining lease term | 10 years 5 months 1 day | 10 years 5 months 1 day | ||||||||||||||||||
Finance lease, weighted average discount rate, percent | 16.30% | 16.30% | ||||||||||||||||||
Operating lease, weighted average discount rate, percent | 12.00% | 12.00% | ||||||||||||||||||
First Finance Lease [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Total amount from finance lease commitment | $ 28,000 | |||||||||||||||||||
Finance lease transaction, frequency of payments | monthly | |||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 60 | |||||||||||||||||||
Finance lease transaction, monthly installments of principal and interest payments | $ 597 | |||||||||||||||||||
Finance lease transaction, total amount to be repaid | 36,000 | 36,000 | ||||||||||||||||||
Second Finance Lease [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Total amount from finance lease commitment | $ 22,000 | |||||||||||||||||||
Finance lease transaction, frequency of payments | monthly | |||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 48 | |||||||||||||||||||
Finance lease transaction, monthly installments of principal and interest payments | $ 563 | |||||||||||||||||||
Finance lease transaction, total amount to be repaid | 27,000 | 27,000 | ||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 12 | 36 | 48 | |||||||||||||||||
Maximum [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Finance lease transaction, number of installments payments | mo | 60 | 60 | 60 | |||||||||||||||||
ASC Topic 842 [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | true | ||||||||||||||||||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 1, 2019 | Jan. 1, 2019 | ||||||||||||||||||
Finance lease right-of-use assets | $ 1,400,000 | |||||||||||||||||||
Financing equipment gross | $ 4,639,000 | 3,125,000 | $ 4,639,000 | 3,125,000 | ||||||||||||||||
Accumulated depreciation related to equipment under finance leases | 2,302,000 | $ 1,606,000 | 2,302,000 | 1,606,000 | ||||||||||||||||
Total depreciation expense related to equipment under finance leases | 696,000 | 454,000 | ||||||||||||||||||
Fixed asset purchases recorded as finance leases | $ 1,428,000 | $ 632,000 | ||||||||||||||||||
Operating lease, right-of-use asset | 1,900,000 | |||||||||||||||||||
Operating lease liability | 2,200,000 | |||||||||||||||||||
ASC Topic 842 [Member] | Nancy Ridge Road In San Diego California [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
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 | $ 482,000 | 1,930,000 | ||||||||||||||||||
Operating lease liability | $ 482,000 | $ 2,201,000 | ||||||||||||||||||
Operating lease incremental borrowing rate | 4.50% | |||||||||||||||||||
Lessee, operating lease, option to extend | Pursuant to the Amendment, the expiration date of the Lease was extended from July 31, 2020 to November 30, 2020 | |||||||||||||||||||
Lease expire date | Nov. 30, 2020 | |||||||||||||||||||
Lessee, operating lease, existence of option to extend | true | |||||||||||||||||||
Additional extension facility extending the lease | December 11, 2020 | |||||||||||||||||||
ASC Topic 842 [Member] | 9955 Mesa Rim Road in San Diego, California [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Operating lease monthly payments | $ 128,000 | |||||||||||||||||||
Operating lease, right-of-use asset | 9,776,000 | $ 9,776,000 | ||||||||||||||||||
Operating lease liability | $ 9,805,000 | $ 9,805,000 | ||||||||||||||||||
Operating lease incremental borrowing rate | 12.00% | 12.00% | ||||||||||||||||||
Lease agreement | ft² | 39,000 | |||||||||||||||||||
Lease commenced date | Dec. 1, 2020 | |||||||||||||||||||
Lessee, operating lease, term of contract | 127 months | |||||||||||||||||||
Lease term, description | The lease includes a rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount of base rent of $111,000. | |||||||||||||||||||
Rent Expense | $ 111,000 | |||||||||||||||||||
Leasehold improvement allowance | 1,586,000 | |||||||||||||||||||
Additional leasehold improvement allowance | $ 1,586,000 | |||||||||||||||||||
Additional rent payment of percentage | 7.00% | |||||||||||||||||||
Additional rent payment | $ 18,000 | |||||||||||||||||||
Lessee operating lease initial monthly lease payments | $ 140,000 | |||||||||||||||||||
Reimbursable leasehold improvement costs | $ 1,631,000 | $ 1,631,000 | ||||||||||||||||||
ASC Topic 842 [Member] | Minimum [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Financed equipment useful life | 5 years | 5 years | ||||||||||||||||||
ASC Topic 842 [Member] | Maximum [Member] | ||||||||||||||||||||
Leases [Line Items] | ||||||||||||||||||||
Financed equipment useful life | 7 years | 7 years |
Leases - Schedule of Right-Of-U
Leases - Schedule of Right-Of-Use Lease Assets (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Lease right-of-use assets: | ||
Operating | $ 9,776,349 | $ 729,330 |
Finance | 2,337,709 | 1,606,387 |
Total | $ 12,114,058 | $ 2,335,717 |
Leases - Schedule of Current Po
Leases - Schedule of Current Portion of Operating and Finance Lease Liabilities (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current portion of lease liability: | ||
Operating | $ 842,452 | |
Finance | $ 963,726 | 724,329 |
Total | $ 963,726 | $ 1,566,781 |
Leases - Schedule of Long-Term
Leases - Schedule of Long-Term Portion of Operating and Finance Lease Liabilities (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Long-term portion of lease liability: | ||
Operating | $ 9,805,361 | |
Finance | 1,459,550 | $ 973,189 |
Total | $ 11,264,911 | $ 973,189 |
Leases - Schedule of Lease Expe
Leases - Schedule of Lease Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Finance lease cost | ||
Amortization of right-of-use assets | $ 694,249 | $ 470,486 |
Interest on lease liabilities | 227,517 | 249,984 |
Operating lease cost | 1,411,958 | 1,272,024 |
Total | $ 2,333,724 | $ 1,992,494 |
Leases - Schedule of Remaining
Leases - Schedule of Remaining Future Minimum Lease Payments for Finance and Operating Leases (Detail) | Dec. 31, 2020USD ($) |
Financing Lease Minimum Payment Abstract | |
2021 | $ 1,026,710 |
2022 | 765,006 |
2023 | 626,131 |
2024 | 341,425 |
Thereafter | 88,402 |
Total payments | 2,847,674 |
Less amount representing interest | (424,398) |
Present value of payments | 2,423,276 |
Financing Lease Maintenance and Sales Tax Obligation Payments Abstract | |
2021 | 104,011 |
2022 | 81,741 |
2023 | 66,230 |
2024 | 46,281 |
Thereafter | 6,809 |
Total payments | 305,072 |
Present value of payments | 305,072 |
Operating Lease Minimum Payment Abstract | |
2021 | 788,446 |
2022 | 1,586,210 |
2023 | 1,629,025 |
2024 | 1,671,841 |
Thereafter | 11,995,433 |
Total payments | 17,670,955 |
Less amount representing interest | (7,865,594) |
Present value of payments | $ 9,805,361 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Operating and Finance Leases (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Other information | ||
Operating cash flows from finance leases | $ 227,517 | $ 249,984 |
Operating cash flows from operating leases | 1,511,907 | 1,430,366 |
Financing cash flows from finance leases | $ 702,588 | $ 539,415 |
Supplier Financings - Additiona
Supplier Financings - Additional Information (Detail) - Financing Agreements With Supplier [Member] - Laboratory Software [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | ||
Financing agreement, due period | 1 year | 1 year |
Remaining balance under financing agreement | $ 0 | $ 0 |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 3.70% | 3.70% |
Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.40% | 4.40% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | Jun. 05, 2020shares | Dec. 31, 2020USD ($)shares | Dec. 31, 2020USD ($)Plan$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of equity incentive plans | Plan | 2 | ||||
Total Shares Outstanding | 1,078,704 | 1,078,704 | 273,418 | 19,560 | |
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 8 months 26 days | ||||
Stock Options [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 10 years | ||||
Option awards assumptions, method used | Black-Scholes pricing model | ||||
Weighted-average estimated fair value of options granted | $ / shares | $ 4.31 | $ 9.10 | |||
Intrinsic value of options outstanding | $ | $ 4,714 | $ 4,714 | $ 0 | ||
Intrinsic value of options exercisable | $ | 4,714 | 4,714 | 0 | ||
Intrinsic value of options vested and unvested expected to vest | $ | 4,714 | $ 4,714 | $ 0 | ||
Stock Options [Member] | Maximum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Employee Stock Option One [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Time period for vesting grants in installments on monthly basis | monthly thereafter for the remaining three years | ||||
Employee Stock Option Two [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options vesting term | monthly vesting beginning month-one after the grant and monthly thereafter | ||||
RSUs [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Intrinsic value shares, RSUs outstanding | $ | 160 | $ 160 | |||
Intrinsic value amount, RSUs unvested and vested expected to vest | $ | $ 160 | $ 160 | |||
RSUs outstanding | 36 | 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 | $ | $ 4,476,000 | $ 4,476,000 | |||
Options Vesting on One Year Anniversary [Member] | Stock Options [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Percentage of Overall Stock Grant Subject to Vesting | 25.00% | ||||
2013 Equity Incentive Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Total stock options and RSUs authorized | 762,421 | 762,421 | |||
2013 Equity Incentive Plan [Member] | Non-inducement Shares [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Total stock options and RSUs authorized | 1,036,409 | 1,036,409 | |||
Increase in number of shares of common stock authorized for issuance | 730,000 | ||||
Stock options and RSUs issued | 988,101 | ||||
Total Shares Outstanding | 993,172 | 993,172 | |||
Common stock, shares authorized | 32,220 | 32,220 | |||
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 | 761,836 | 761,836 | |||
Increase in number of shares of common stock authorized for issuance | 750,000 | ||||
Stock options and RSUs issued | 94,872 | ||||
Total Shares Outstanding | 85,532 | 85,532 | |||
Common stock, shares authorized | 676,220 | 676,220 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used for Determining Fair Value of Stock Options Under Black-Scholes Pricing Model (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock and exercise prices | $ 2.70 | $ 2.90 |
Discount rate-bond equivalent yield | 0.34% | 1.58% |
Expected life (in years) | 5 years | 4 years |
Expected volatility | 146.00% | 128.00% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock and exercise prices | $ 7.10 | $ 10.30 |
Discount rate-bond equivalent yield | 1.37% | 2.55% |
Expected life (in years) | 5 years 11 months 15 days | 5 years 11 months 15 days |
Expected volatility | 171.00% | 156.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Shares Outstanding, Beginning Balance | 273,418 | 19,560 | |
Number of Shares, Granted | 858,523 | 267,899 | |
Number of Shares, Cancelled/forfeited/expired | (53,237) | (14,041) | |
Number of Shares Outstanding, Ending Balance | 1,078,704 | 273,418 | 19,560 |
Number of Shares, Vested and unvested expected to vest, Ending Balance | 1,059,534 | ||
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 36.14 | $ 414.10 | |
Weighted Average Exercise Price Per Share, Granted | 4.51 | 9.10 | |
Weighted Average Exercise Price Per Share, Cancelled/forfeited/expired | 22.26 | 37 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | 11.64 | $ 36.14 | $ 414.10 |
Weighted Average Exercise Price Per Share, Vested and unvested expected to vest, Ending Balance | $ 11.76 | ||
Weighted Average Remaining Contractual Term in Years, Outstanding | 9 years 4 months 9 days | 9 years 3 months | 9 years 2 months 12 days |
Weighted Average Remaining Contractual Term in Years, Vested and unvested expected to vest | 9 years 4 months 6 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Detail) - RSUs [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares Outstanding, Beginning Balance | 36 | 36 |
Number of Shares, Granted | 0 | 0 |
Number of share, Vested and issued | 0 | 0 |
Number of share, Forfeited | 0 | 0 |
Number of Shares Outstanding, Ending Balance | 36 | 36 |
Number of Shares, Vested | 36 | |
Weighted Average Grand Date Fair Value, Outstanding, Beginning Balance | $ 4,158 | $ 4,158 |
Weighted Average Grand Date Fair Value, Granted | 0 | 0 |
Weighted Average Grand Date Fair Value,Vested and issued | 0 | 0 |
Weighted Average Grand Date Fair Value, Forfeited | 0 | 0 |
Weighted Average Grand Date Fair Value, Outstanding, Ending Balance | 4,158 | $ 4,158 |
Weighted Average Grant Date Fair Value, Vested | $ 4,158 |
Stock-Based Compensation - Effe
Stock-Based Compensation - Effects of Stock-Based Compensation Related to Equity Awards to Employees and Nonemployees on Statement of Operations (Detail) - Stock Options [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | $ 940,984 | $ 869,579 |
Cost of revenues [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 159,710 | 77,495 |
Research and Development Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 116,431 | 127,844 |
General and Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | 547,712 | 517,324 |
Sales and Marketing Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation | $ 117,131 | $ 146,916 |
Common Stock Warrants Outstan_3
Common Stock Warrants Outstanding - Summary of Equity-Classified Common Stock Warrant Activity, for Warrants Other than Underlying Unexercised Overallotment Option Warrants (Detail) - Warrants [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Class Of Warrant Or Right [Line Items] | |||
Number of Shares, Outstanding, Beginning Balance | 2,748,424 | 469,492 | |
Number of Shares, Issued | 885,475 | 4,118,972 | |
Number of Shares, Exercised | (2,634,799) | (1,839,593) | |
Number of Shares, Expired | (1,933) | (447) | |
Number of Shares, Outstanding, Ending Balance | 997,167 | 2,748,424 | 469,492 |
Weighted Average Exercise Price Per Share, Outstanding, Beginning Balance | $ 18.58 | $ 85.50 | |
Weighted Average Exercise Price Per Share, Issued | 3.62 | 7 | |
Weighted Average Exercise Price Per Share, Exercised | 6.74 | 12 | |
Weighted Average Exercise Price Per Share, Expired | 1,404 | 9,530 | |
Weighted Average Exercise Price Per Share, Outstanding, Ending Balance | $ 35.48 | $ 18.58 | $ 85.50 |
Average Remaining Contractual Term (in years) | 3 years 3 months 18 days | 4 years 7 months 6 days | 4 years 4 months 24 days |
Common Stock Warrants Outstan_4
Common Stock Warrants Outstanding - Additional Information (Detail) - USD ($) | 1 Months Ended | |||||
Jan. 31, 2020 | Dec. 31, 2019 | May 31, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Dec. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | ||||||
Common stock warrants outstanding, intrinsic value | $ 0 | $ 243,000 | ||||
Warrants [Member] | February 2019 Financing Transaction [Member] | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Class of warrant or rights, expiration date | Feb. 12, 2024 | |||||
Warrants [Member] | March 2019 Transaction [Member] | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Class of warrant or rights, expiration date | Sep. 19, 2024 | |||||
Warrants [Member] | May 2019 Inducement Offering [Member] | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Class of warrant or rights, expiration date | Dec. 2, 2024 | |||||
Warrants [Member] | December 2019 Underwritten Offering [Member] | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Class of warrant or rights, expiration date | Dec. 11, 2024 | |||||
Warrants [Member] | January 2020 Inducement Offering [Member] | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Class of warrant or rights, expiration date | Jul. 10, 2025 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Anti-Dilutive Securities Excluded from Computations of Diluted Weighted-Average Shares (Detail) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 2,122,582 | 3,069,017 |
Convertible Preferred Stock Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 46,675 | 47,139 |
Common Warrants Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 997,167 | 2,748,424 |
RSUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 36 | 36 |
Common Options Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents | 1,078,704 | 273,418 |
Net Loss per Common Share - S_2
Net Loss per Common Share - Schedule of Impact of Error (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Error Corrections And Prior Period Adjustments Restatement [Line Items] | ||||
Net loss attributable to common shareholders | $ (4,878,334) | $ (19,711,749) | $ (17,809,678) | $ (25,259,611) |
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||||
Basic | 13,333,427 | 11,324,289 | 11,845,255 | 2,066,086 |
Diluted | 13,333,427 | 11,324,289 | 11,845,255 | 2,066,086 |
Net loss per common share: | ||||
Basic | $ (0.37) | $ (1.74) | $ (1.50) | $ (12.23) |
Diluted | $ (0.37) | $ (1.74) | $ (1.50) | $ (12.23) |
As Reported [Member] | ||||
Error Corrections And Prior Period Adjustments Restatement [Line Items] | ||||
Net loss attributable to common shareholders | $ (4,878,334) | $ (19,711,749) | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common shareholders: | ||||
Basic | 11,324,289 | 13,333,427 | ||
Diluted | 11,324,289 | 13,333,427 | ||
Net loss per common share: | ||||
Basic | $ (0.43) | $ (1.48) | ||
Diluted | $ (0.43) | $ (1.48) |
401(k) Plan - Additional Inform
401(k) Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Postemployment Benefits [Abstract] | ||
Employer's matching contributions to 401(k) plan | $ 250,000 | $ 228,000 |
Income Taxes - Reconciles of In
Income Taxes - Reconciles of Income Taxes Computed at Federal Statutory Rate and Provision for Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Income tax at statutory rate | $ (3,738,797) | $ (5,278,232) |
State liability | (939,936) | (764,997) |
Permanent items | 100,728 | 103,617 |
Stock compensation | 94,489 | 174,128 |
Warrant inducement | 441,443 | 384,534 |
Expiration of net operating losses | 912,357 | 35,487 |
Research and development credit | (370,350) | (359,765) |
State rate change | (164,229) | 388 |
Estimated section 382 limitation | 183 | 325,046 |
Return to provision | 6,845 | (4,296) |
Other | (875,362) | (83,353) |
Valuation allowance | $ 4,532,629 | $ 5,467,443 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Contingency [Line Items] | |||
Net operating loss carryforwards | $ 13,900,000 | ||
Net operating loss carryforwards, expiration year | which will begin to expire in 2021 | ||
Percent of uncertain income tax positions recognized | 50.00% | 50.00% | |
Liability for unrecognized tax benefits | $ 0 | $ 0 | |
Percentage of change in ownership | 50.00% | ||
Period of change in ownership | 3 years | ||
Federal [Member] | |||
Income Tax Contingency [Line Items] | |||
Net operating loss carryforwards | $ 75,400,000 | 61,500,000 | |
Net operating loss carryforwards, expiration year | carrying forward indefinitely | ||
Federal [Member] | Maximum [Member] | |||
Income Tax Contingency [Line Items] | |||
Percentage of future taxable income offset by operating loss carryforwards | 80.00% | ||
Federal [Member] | Research Tax Credit Carryforward [Member] | |||
Income Tax Contingency [Line Items] | |||
Research and development tax credits | $ 577,000 | ||
Income tax research and development expiration year | begin to expire in 2021 | ||
California [Member] | |||
Income Tax Contingency [Line Items] | |||
Net operating loss carryforwards, expiration year | will begin to expire in 2020 | ||
Additional net operating loss carryforwards | $ 44,200,000 | $ 40,400,000 | $ 3,800,000 |
California [Member] | Maximum [Member] | |||
Income Tax Contingency [Line Items] | |||
Percentage of future taxable income offset by operating loss carryforwards | 80.00% | ||
California [Member] | Research Tax Credit Carryforward [Member] | |||
Income Tax Contingency [Line Items] | |||
Research and development tax credits | $ 3,900,000 |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Estimated net operating loss carryforward | $ 18,672,696 | $ 13,118,923 |
Estimated research and development credits | 3,688,825 | 3,318,475 |
Accruals and other | 1,824,076 | 3,246,125 |
Operating lease liability | 2,394,201 | 205,542 |
Fixed assets | 659,656 | 460,218 |
Stock based compensation | 860,310 | 829,801 |
Gross deferred tax assets | 28,099,764 | 21,179,084 |
Right-of-use asset | (2,957,921) | (569,870) |
Gross deferred tax liabilities | (2,957,921) | (569,870) |
Less valuation allowance | $ (25,141,843) | $ (20,609,214) |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | Jan. 01, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Related Party Transaction [Line Items] | |||
Revenues | $ 27,461,398 | $ 5,528,566 | |
Development Services Revenues [Member] | |||
Related Party Transaction [Line Items] | |||
Revenues | 177,286 | 212,344 | |
Aegea Biotechnologies, Inc [Member] | |||
Related Party Transaction [Line Items] | |||
Reimbursement for shared patent costs | 36,000 | 26,000 | |
Percentage of royalty on sale of product | 10.00% | ||
Accrued royalty expense | 2,900 | $ 5,000 | |
Accounts receivable | 132,000 | ||
Aegea Biotechnologies, Inc [Member] | Development Services Revenues [Member] | |||
Related Party Transaction [Line Items] | |||
Revenues | $ 239,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |
Feb. 29, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | |
Loss Contingencies [Line Items] | |||
Unconditional purchase commitment aggregate amount | $ 1,062,500 | $ 0 | $ 91,000 |
Unconditional purchase commitment payment terms | Quarterly | ||
Unconditional purchase commitment period | May 31, 2020 | ||
Total expense for sales tax and maintenance obligations | $ 129,000 | 122,000 | |
Total amounts for future sales tax and maintenance obligations | 305,072 | ||
Accrued Other Liabilities [Member] | |||
Loss Contingencies [Line Items] | |||
Sales tax and maintenance obligations incurred but not paid | $ 77,000 | $ 73,000 | |
Minimum [Member] | |||
Loss Contingencies [Line Items] | |||
Unconditional purchase commitment, quarterly payment amount | $ 62,500 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - ASC Topic 842 [Member] - 9955 Mesa Rim Road in San Diego, California [Member] | Mar. 31, 2021 | Jun. 01, 2020USD ($)ft² | Dec. 31, 2020 |
Subsequent Event [Line Items] | |||
Lease agreement | ft² | 39,000 | ||
Lease commenced date | Dec. 1, 2020 | ||
Lessee, operating lease, term of contract | 127 months | ||
Lease term, description | The lease includes a rent abatement period of seven months, from January 2021 through July of 2021, during which period the Company is exempted from paying the amount of base rent of $111,000. | ||
Rent Expense | $ | $ 111,000 | ||
Additional lease abatement period | 2 months | ||
Initial lease period to sold property | 6 months | ||
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Additional rent abatement period | 2 months |