Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 09, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001439725 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-39659 | ||
Entity Registrant Name | Biodesix, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-3986492 | ||
Entity Address, Address Line One | 2970 Wilderness Place | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, City or Town | Boulder | ||
Entity Address, State or Province | CO | ||
Entity Address, Postal Zip Code | 80301 | ||
City Area Code | 303 | ||
Local Phone Number | 417-0500 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
ICFR Auditor Attestation Flag | false | ||
Trading Symbol | BDSX | ||
Security Exchange Name | NASDAQ | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Voluntary Filers | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 31,307,853 | ||
Entity Public Float | $ 196.5 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Denver, CO | ||
Auditor Firm ID | 185 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the Company’s definitive Proxy Statement for its 2022 Annual Meeting of Shareholders are to be incorporated by reference into Part III, as specifically set forth in Part III.) |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 32,712 | $ 62,126 |
Accounts receivable, net of allowance for doubtful accounts of $158 and $180 | 3,656 | 15,304 |
Other current assets | 7,245 | 8,710 |
Total current assets | 43,613 | 86,140 |
Non‑current assets | ||
Property and equipment, net | 4,179 | 3,178 |
Intangible assets, net | 11,617 | 13,260 |
Goodwill | 15,031 | 15,031 |
Other long-term assets | 1,657 | 3,461 |
Total non‑current assets | 32,484 | 34,930 |
Total assets | 76,097 | 121,070 |
Current liabilities | ||
Accounts payable | 1,662 | 8,964 |
Accrued liabilities | 7,665 | 7,789 |
Deferred revenue | 1,850 | 3,532 |
Current portion of contingent consideration | 17,764 | |
Current portion of notes payable | 19 | 11,840 |
Total current liabilities | 28,960 | 32,125 |
Non‑current liabilities | ||
Long-term notes payable, net of current portion | 9,993 | 15,926 |
Contingent consideration | 16,028 | 29,932 |
Other long-term liabilities | 1,389 | 1,921 |
Total non‑current liabilities | 27,410 | 47,779 |
Total liabilities | 56,370 | 79,904 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value, 5,000,000 authorized; 0 (2021 and 2020) issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 authorized; 30,789,649 (2021) and 26,561,504 (2020) shares issued and outstanding | 31 | 27 |
Additional paid‑in capital | 321,669 | 299,953 |
Accumulated deficit | (301,973) | (258,814) |
Total stockholders' equity | 19,727 | 41,166 |
Total liabilities and stockholders' equity | $ 76,097 | $ 121,070 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable | $ 158 | $ 180 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 5,000,000 | 5,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, authorized | 200,000,000 | 200,000,000 |
Common stock, issued | 30,789,649 | 26,561,504 |
Common stock, outstanding | 30,789,649 | 26,561,504 |
Statements of Operations
Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Revenues | $ 54,506 | $ 45,557 |
Operating expenses: | ||
Direct costs and expenses | 30,518 | 21,998 |
Research and development | 12,789 | 10,818 |
Sales, marketing, general and administrative | 50,517 | 34,857 |
Change in fair value of contingent consideration | 1,622 | 818 |
Total operating expenses | 95,446 | 68,491 |
Loss from operations | (40,940) | (22,934) |
Other (expense) income: | ||
Interest expense | (4,508) | (7,604) |
Change in fair value of warrant liability | (1,252) | |
Gain on debt extinguishments, net | 2,298 | |
Other (expense) income, net | 9 | 440 |
Total other expense | (2,219) | (8,416) |
Net loss | $ (43,159) | $ (31,350) |
Net loss per share, basic and diluted | $ (1.58) | $ (6.48) |
Weighted-average shares outstanding, basic and diluted | 27,365 | 4,838 |
Statements of Convertible Prefe
Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balances at Dec. 31, 2019 | $ (225,139) | $ 1 | $ 2,324 | $ (227,464) | |
Temporary Equity Balance, Shares at Dec. 31, 2019 | 118,766,000 | ||||
Temporary Equity Balance at Dec. 31, 2019 | $ 193,959 | ||||
Common Stock Balance, Shares at Dec. 31, 2019 | 255,000 | ||||
Issuance of common stock | 63,757 | $ 4 | 63,753 | ||
Issuance of common stock, shares | 4,000,000 | ||||
Conversion of preferred stock into common stock upon initial public offering | 193,959 | $ (193,959) | $ 20 | 193,939 | |
Conversion of preferred stock into common stock upon initial public offering, shares | (118,766,000) | 20,091,000 | |||
Conversion of convertible debt into common stock upon initial public offering | 26,616 | $ 2 | 26,614 | ||
Conversion of convertible debt into common stock upon initial public offering, shares | 1,848,000 | ||||
Reclassification of preferred stock warrant liability and put option into additional paid-in capital upon initial public offering | 8,274 | 8,274 | |||
Exercise of stock options | 1,340 | 1,340 | |||
Exercise of stock options, shares | 368,000 | ||||
Stock‑based compensation | 3,709 | 3,709 | |||
Net loss | (31,350) | (31,350) | |||
Balances at Dec. 31, 2020 | 41,166 | $ 27 | 299,953 | (258,814) | |
Common Stock Balance, Shares at Dec. 31, 2020 | 26,562,000 | ||||
Issuance of common stock | 15,679 | $ 4 | 15,675 | ||
Issuance of common stock, shares | 3,757,000 | ||||
Issuance of common stock under employee stock purchase plan | 328 | 328 | |||
Issuance of common stock under employee stock purchase plan, Shares | 43,000 | ||||
Exercise of stock options | $ 769 | 769 | |||
Exercise of stock options, shares | 408 | 428,000 | |||
Stock‑based compensation | $ 4,944 | 4,944 | |||
Net loss | (43,159) | (43,159) | |||
Balances at Dec. 31, 2021 | $ 19,727 | $ 31 | $ 321,669 | $ (301,973) | |
Common Stock Balance, Shares at Dec. 31, 2021 | 30,790,000 |
Statements of Convertible Pre_2
Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Stockholders Equity [Abstract] | ||
Discounts and commission | $ 664 | $ 5,040 |
Direct offering costs | $ 3,203 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (43,159) | $ (31,350) |
Adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities | ||
Depreciation and amortization | 3,178 | 2,903 |
Amortization of convertible notes debt discount | 4,389 | |
Gain on debt extinguishments, net | (2,298) | |
Stock‑based compensation expense | 4,944 | 3,709 |
Change in fair value of warrant liability | 1,252 | |
Change in contingent consideration | 1,622 | 818 |
Provision for doubtful accounts | 193 | 296 |
Accrued interest, amortization of debt issuance costs and other | 2,706 | 1,418 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 11,454 | (10,308) |
Other current assets | 1,369 | (6,588) |
Other long-term assets and liabilities | 875 | (1,808) |
Accounts payable and other accrued liabilities | (7,425) | 11,654 |
Deferred revenue | (1,682) | 2,249 |
Net cash and cash equivalents and restricted cash used in operating activities | (28,223) | (21,366) |
Cash flows from investing activities | ||
Purchase of property and equipment | (2,241) | (1,945) |
Patent costs and intangible asset acquisition, net | (306) | (232) |
Payments to acquire Oncimmune assets | (750) | |
Net cash and cash equivalents and restricted cash used in investing activities | (2,547) | (2,927) |
Cash flows from financing activities | ||
Proceeds from initial public offering | 72,000 | |
Proceeds from the issuance of common stock | 16,343 | |
Proceeds from issuance of common stock under employee stock purchase plan | 328 | |
Proceeds from exercise of stock options | 769 | 1,340 |
Proceeds from issuances of convertible notes payable | 12,955 | |
Proceeds from term loan and notes payable | 30,078 | 3,085 |
Repayment of term loan and notes payable | (45,428) | |
Payment of debt issuance costs | (164) | |
Equity financing costs | (664) | (8,243) |
Other | (6) | |
Net cash and cash equivalents and restricted cash provided by financing activities | 1,262 | 81,131 |
Net increase (decrease) in cash and cash equivalents and restricted cash | (29,508) | 56,838 |
Cash, cash equivalents, and restricted cash ‑ beginning of period | 62,306 | 5,468 |
Cash, cash equivalents, and restricted cash ‑ end of period | 32,798 | 62,306 |
Supplemental cash flow information | ||
Conversion of preferred stock into common stock | 193,959 | |
Conversion of convertible notes and accrued interest into common stock | 26,616 | |
Reclassification of put option liability to additional paid-in capital | 6,650 | |
Value of put option recorded at issuance of convertible debt payable | 3,389 | |
Cash paid for interest | 1,676 | 1,844 |
Reclassification of warrant liability to additional paid-in capital | $ 1,624 | |
Non-cash debt issuance costs included in Accrued liabilities | $ 15 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization And Description Of Business [Abstract] | |
Organization and Description of Business | Note 1 – Organization and Description of Business Biodesix, Inc. (the “Company”, “Biodesix”, “we” “us” and “our”), formerly Elston Technologies, Inc., was incorporated in Delaware in 2005. The Company’s headquarters are in Colorado, with laboratories in Colorado and Kansas. The Company conducts all of its operations within a single legal entity. Biodesix is a data-driven diagnostic solutions company leveraging state of the art technologies with its proprietary artificial intelligence platform to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in lung disease. In addition to diagnostic tests, the Company provides biopharmaceutical companies with services that include diagnostic research, clinical trial testing, and the discovery, development, and commercialization of companion diagnostics. The Company performs its blood-based diagnostic tests in its laboratory facilities, which are located in Boulder, Colorado and De Soto, Kansas. In May 2020, the Federal Drug Administration (FDA) granted Emergency Use Authorization (EUA) of the Bio-Rad SARS-CoV-2 Droplet Digital polymerase chain reaction (ddPCR) test to detect Coronavirus Disease 2019 (COVID-19) infection. In April 2020, the FDA authorized the Platelia SARS-CoV-2 Total Ab test to detect COVID-19 antibodies. Medical products that are granted an EUA are only permitted to commercialize their products under the terms and conditions provided in the authorization. The FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, if the conditions for the issuance of the EUA are no longer met, or if other circumstances make revocation appropriate to protect the public health or safety. Blood-Based Lung Tests The Company offers five blood-based lung cancer tests across the lung cancer continuum of care: Diagnosis • Nodify XL2® and Nodify CDT ® tests, together marketed as part of our Nodify Lung ® Nodule Risk Assessment testing strategy, assess the risk of lung cancer to help identify the most appropriate treatment pathway. We believe we are the only company to offer two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules. Treatment & Monitoring • GeneStrat ddPCR® and VeriStrat® tests, marketed as part of our new IQLung testing strategy, are used following diagnosis of lung cancer to measure the presence of mutations in the tumor and the state of the patient’s immune system to establish the patient’s prognosis and help guide treatment decisions. The GeneStrat ddPCR tumor profiling test and the VeriStrat immune profiling test have a 36-hour average turnaround time, providing physicians with timely results to facilitate treatment decisions. • GeneStrat NGS (NGS) test, our 72-hour blood-based NGS test, was launched in November 2021 to a select group of physicians, with national launch in January 2022. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced-stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner. The GeneStrat NGS test is marketed as part of the new IQ Lung testing strategy with the GeneStrat ddPCR and VeriStrat tests. COVID-19 Tests We operate and have commercialized the Biodesix WorkSafe testing program, under which the Company offers three SARS-CoV-2 tests: • Bio-Rad SARS-CoV-2 ddPCR test, which is authorized by the FDA to be performed by Clinical Laboratory Improvement Amendments (CLIA) authorized laboratories that perform high complexity tests. The ddPCR test is designed to detect the presence of infection by the SARS-CoV-2 virus. • Platelia SARS-CoV-2 Total Ab test, which is an antibody test, authorized by the FDA, intended for detecting a B-cell immune response to SARS-CoV-2, indicating recent or prior infection. • cPass SARS-CoV-2 Neutralization Antibody test , which is the first blood-based surrogate neutralizing antibody test with FDA EUA and uses ELISA technology to qualitatively detect circulating neutralizing antibodies to the receptor binding domain (RBD) in the spike protein of SARS-CoV-2 that are produced in response to vaccination or a previous SARS-CoV-2 infection. This test was commercially introduced during the second quarter 2021 in partnership with GenScript Biotech Corporation. These tests under the Biodesix WorkSafe testing program are utilized by healthcare providers, including hospitals and nursing homes, and are also offered to businesses and educational systems to assist in their back-to-work or back-to-school strategies, a crucial element of restarting economic activity. In developing the Company's products, the Company has built or gained access to unique biorepositories, proprietary technology, and bioinformatics methods that it believes are important to the development of new targeted therapies, determining clinical trial eligibility and guiding treatment selection. The Company’s testing services are made available through its clinical laboratories. Initial Public Offering On October 27, 2020, the Company completed its initial public offering (IPO), in which it issued and sold 4,000,000 shares of its common stock at a public offering price of $ 18.00 per share. The Company received net proceeds of $ 63.8 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. In addition, in connection with the IPO, all shares of the Company’s then-outstanding convertible preferred stock and convertible notes payable were automatically converted into 21,939,025 shares of common stock, and all then outstanding warrants to purchase the Company’s Series G convertible preferred stock were automatically converted into warrants to purchase 103,326 shares of the Company’s common stock. At-the-Money Offering |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation and Estimates The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; the estimation of the fair value of goodwill and other intangible assets; fair value of stock options; income tax uncertainties, including a valuation allowance for deferred tax assets; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recognized revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. Certain prior period amounts have been reclassified to conform to the current period presentation. During March 2020, a global pandemic was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus (COVID-19). The COVID-19 pandemic negatively affected, and we expect will continue to negatively affect, our lung diagnostic testing-related revenue and our clinical studies. As of December 31, 2021, we maintained cash and cash equivalents of $ 32.7 million and we have $ 10 million in principal balance outstanding on our 2021 Term Loan. We have incurred significant losses since inception and, as a result, we have funded our operations to date primarily through the sale of common stock in our IPO in October 2020, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which include lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources and needs and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-K in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our 2021 Term Loan (see Note 8 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our 2021 Term Loan during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balance. We have taken steps to improve our liquidity through raising debt and equity capital during 2021, amendments to our 2021 Term Loan and have also undertaken several proactive measures to mitigate the financial and operational impacts of the COVID-19 pandemic through the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. In addition, we have entered into negotiation with certain creditors to modify existing terms of arrangement to delay near term cash requirements and extend the period of payments; however, those negotiations are not final at this time and may not result in final agreement. To maintain an adequate amount of available liquidity and execute our current operating plan, we will need to continue to raise additional funds from external sources, such as through the issuance of equity or debt securities; however, we have not secured such funding at the time of this filing and any such financing activities are subject to market conditions. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. Our current operating plan, which is in part determined based on our most recent historical actual results and trends, along with the items noted above, raises substantial doubt about the Company’s ability to continue as a going concern. Our audited financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments that might be necessary should we be unable to continue as a going concern. Segment Reporting The Company has a single operating segment focused on providing diagnostic testing services to customers. All of the Company’s revenue and long-lived assets were derived or located in the United States for the years ended December 31, 2021 and 2020 . Revenue Recognition The Company generates revenues from (i) diagnostic tests and (ii) assay development and testing services (services revenue). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company determines the transaction price related to its blood-based lung diagnostic test contracts using a portfolio approach by considering the nature of the payer and historical price concessions granted to groups of customers. The transaction price associated with COVID-19 testing arrangements are determined on the basis of the individual contract with each customer. Services revenue consists of various types of tests or other scientific services for a purpose as defined by any individual customer, which are often larger biopharmaceutical companies, as defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or achievement of contractual milestone(s) as defined in the customer agreements. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach as discussed above. In determining the amount to accrue for a delivered test, the Company considers factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and the Company, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. Variable consideration, if any, is estimated based on an analysis of historical experience and adjusted as better estimates become available. These estimates require significant judgment by management. The Company also provides services to patients with whom the Company does not have contracts as defined in Financial Accounting Standards Board (FASB) Accounting Standards Codification 606 (ASC 606). The Company recognizes revenue for these patients when contracts, as defined in ASC 606, are established at the amount of consideration to which it expects to be entitled, or when the Company receives substantially all of the consideration subsequent to satisfaction and delivery of the performance obligations. Deferred revenue consists of payments received for research, development, and testing services fees received prior to the completion of performance of these tests and services. See Note 11 — Revenue and Accounts Receivable Credit Concentration for additional information. Direct Costs and Expenses The components of our cost of diagnostic tests and testing services consist of cost of materials, direct labor, including bonus, benefit and stock-based compensation, depreciation of laboratory equipment, rent costs, amortization of leasehold improvements and information technology costs associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing of license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. Costs associated with performing tests are expensed as the test is processed regardless of whether and when revenue is recognized with respect to that test. Research and Development Expenses Research and development expenses include external and internal costs incurred to develop our technology, collect clinical samples, and conduct clinical studies to develop and support our products. External costs consist primarily of payments to clinical trial sites, sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, process development and clinical development activities. Internal costs consist primarily of salaries and benefits, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated facility occupancy and information technology costs . The Company estimates and accrues its expenses resulting from its obligations under contracts with vendors and consultants in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payments that do not match the periods over which materials or services are provided under such contracts. The Company’s estimates depend on the timeliness and accuracy of the data provided by consultants and vendors regarding the status of each activity. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information received. Research and development costs are expensed as incurred. Sales, Marketing, General and Administrative Expenses Selling expenses consist primarily of costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel, and stock-based compensation, as well as marketing and educational activities and allocated overhead expenses. Sales, marketing, general and administrative expenses also include costs for our marketing and sales organizations, and other functions including finance, legal, human resources, and information technology. These expenses consist principally of salaries, bonuses, employee benefits, travel, stock-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and allocated overhead expenses. Concentrations of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial institutions with which it holds cash. Periodically throughout the year, the Company has maintained balances in various operating accounts in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. Several of the components of the Company's sample collection kit and test reagents, and certain test systems and related test kits are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of December 31, 2021 and 2020, see Note 11 – Revenue and Accounts Receivable Credit Concentration . Cash and Cash Equivalents Cash equivalents consist of short-term, highly-liquid instruments with an original maturity of three months or less from the date of purchase. Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit card and a letter of credit related to an operating lease agreement. As of December 31, 2021 and 2020 , the Company had $ 0.1 million and $ 0.2 million restricted cash, respectively, which was included in ‘Other current assets’ in the accompanying balance sheets. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are stated at the amount management expects to collect from customers based on their outstanding invoices. Management reviews accounts receivable quarterly to determine if any receivable will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value based on historical experience, customer creditworthiness, facts, and circumstances specific to outstanding balances, and payment terms. Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to 'Direct costs and expenses'. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and were $ 2.9 million and $ 3.2 million as of December 31, 2021 and 2020 , respectively. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years . Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations in the period realized. Long-lived assets to be held and used are evaluated for impairment when events or circumstances indicate the carrying value of a long-lived asset or asset group is less than the undiscounted cash flows from the use and eventual disposition over its remaining useful life. The Company assesses recoverability by comparing the sum or projected undiscounted cash flows from the use and eventual disposition of the asset or asset group to its carrying value, and records an impairment loss if the carrying value is greater than the undiscounted future cash flows. There were no impairments for the years ended December 31, 2021 and 2020 . Intangible Assets Intangible assets primarily consist of intangible assets acquired as part of business combinations, external costs associated with patent applications that are probable of future economic benefits, and trademark costs. Finite-lived intangibles are stated at cost, net of accumulated amortization. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 9 to 10 years, based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. Trademarks are considered indefinite lived and are not amortized. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate a reduction to fair value below their carrying amounts. There were no impairments for the years ended December 31, 2021 and 2020 . Goodwill Goodwill represents the excess of purchase price over amounts allocated to acquired assets and liabilities assumed in business combinations. The carrying value of goodwill is evaluated for impairment at least annually or more frequently when events or circumstances occur indicate a potential for impairment. The annual impairment test is performed on the last day of our fourth quarter. Prior to performing a quantitative evaluation, an assessment of qualitative factors may be performed to determine whether it is more likely than not that the fair value of the reporting unit exceeds its carrying value. In the event the Company determines that it is more likely than not the carrying value of our single reporting unit is higher than its estimated fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. Through December 31, 2021 , there were no accumulated impairment losses. Fair Value of Financial Instruments U.S. GAAP for fair value establishes a hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach, and cost approach). We utilize a combination of market and income approaches to value our financial instruments. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. Fair value measurements are categorized within the fair value hierarchy based upon the lowest level of the most significant inputs used to determine fair value. The three levels of the hierarchy and the related inputs are as follows: Level Inputs 1 Unadjusted quoted prices in active markets for identical assets and liabilities. 2 Unadjusted quoted prices in active markets for similar assets and liabilities; Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or Inputs other than quoted prices that are observable for the asset or liability. 3 Unobservable inputs for the asset or liability. The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. Contingent Consideration In connection with the purchase transaction with Integrated Diagnostics, Inc. (Indi), the Company recorded contingent consideration for amounts potentially payable to Indi’s shareholder upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value through the date the gross margin target was met is recorded as operating expenses in the statements of operations. Subsequent changes to the contingent consideration following the achievement of the gross margin target are recorded as ‘Interest expense’ in the statements of operations resulting from the passage of time and fixed payment schedule. The significant unobservable inputs used in the measurement of fair value include the probability of successful achievement of the specified product gross margin targets, the period in which the targets were expected to be achieved, and discount rates which ranged from 11 % to 13.5 %. As a result of the achievement of the gross margin target, the only significant unobservable input used in the measurement of fair value includes the discount rate since all other inputs became fixed and determinable. Significant increases or decreases in the discount rate would result in a significantly higher or lower fair value measurement. Warrant Liability Prior to the completion of the Company’s IPO in October 2020, certain warrants issued to purchase convertible preferred stock were classified as liabilities with changes in the estimated fair value of these liabilities recognized in our results of operations. Upon completion of the Company’s IPO in October 2020, the warrants were automatically converted to warrants to purchase common stock. Accordingly, the warrants were remeasured to an estimate of fair value and recognized in our results of operations and then reclassified to additional paid-in capital. Put Option Liability During 2020 and 2019, the Company issued convertible debt with terms that provided for a conversion rate to the convertible debtholders that was more favorable than the price that other investors would pay for common stock in certain situations, including the completion of an IPO. As a result, the convertible debt is a financial instrument that was bifurcated into two instruments, a debt obligation and a put option liability, which represented the estimated fair value of the favorable conversion rate. The estimated fair value of the put option liability was separated from the convertible debt at inception and reported as a liability and debt discount, and amortized to interest expense. As a result of our IPO, the convertible debt was automatically converted to common stock and the put option liability was remeasured to an estimate of fair value and recognized in our results of operations and then reclassified to additional paid-in capital. Share‑Based Compensation Stock Options The Company grants service condition and performance condition stock options. Stock options are granted with exercise prices equal to the fair market value of our common stock on the date of grant. The grant date fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model, which requires the use of assumptions, including the expected term of the option, expected volatility of our stock price, expected dividend yield, and the risk-free interest rate, among others. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. These assumptions involve inherent uncertainties including market conditions and employee behavior that are generally outside of the Company’s control. Service condition stock options are expensed based on the grant date fair value of the awards using the straight-line method over the requisite service period. Performance-condition stock options vest based on achievement of multiple weighted performance goals, certification of performance achievement by the Compensation Committee of the Board of Directors, and continued service. For performance-condition stock options, compensation expense is updated for our expected performance level against performance goals at the end of each reporting period, which involves judgment as to achievement of certain performance metrics. Restricted Stock Units (RSUs) The Company grants service-condition RSUs. As a result of our IPO, the grant date fair values of these RSUs are based on the closing market price of our common stock on the grant date. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. The service-condition RSUs vest based on continued service with compensation expense recognized on a straight-line basis over the requisite service period. See Note 12 — Share-Based Compensation for additional information related to share-based compensation. Net Loss per Common Share Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding for the period, if dilutive, using the treasury stock method. Potentially dilutive securities consisting of options to purchase common stock, warrants to purchase common stock, RSUs and shares subject to purchase under our employee stock purchase plan were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. Until the Company’s IPO in October 2020, basic and diluted net loss attributable to common stockholders per share was calculated using the two-class method. The net loss was attributable entirely to common stockholders because the participating securities did not have a contractual obligation to share in the Company’s losses. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2021 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | Note 3 – Recent Accounting Pronouncements Recently Issued Accounting Standards Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02 , Leases (ASC Topic 842). The new guidance maintains two classifications of leases: finance leases, which replace capital leases, and operating leases. Lessees will need to recognize a right-of-use asset and a lease liability on the balance sheet for those leases previously classified as operating leases under the old guidance. The liability will be equal to the present value of lease payments. The asset will be based on the liability, subject to adjustment, such as for direct costs. The accounting standard will be effective for the Company beginning January 1, 2022. Based on our current analysis we expect the adoption to result in the recognition of approximately $ 1.5 million of right of use assets and associated lease liabilities, inclusive of both lease and non-lease components, in our balance sheet and do not expect any material impact to our statement of operations or statement of cash flows. We are implementing new processes and internal controls over lease recognition, which will ultimately assist in the application of the new lease standard. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. This ASU requires measurement and recognition of expected credit losses for financial assets. This guidance will become effective for the Company beginning January 1, 2023 with early adoption permitted. The Company is currently evaluating this guidance and assessing the overall impact on its financial statements. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value | Note 4 - Fair Value Recurring Fair Value Measurements Our borrowing instruments are recorded at their carrying values in the balance sheets, which may differ from their respective fair values. The fair values of outstanding borrowings, which are classified as Level 2, approximate their carrying values as of December 31, 2021 and 2020, based on interest rates currently available for similar borrowings and were (in thousands): As of December 31, 2021 2020 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 10,012 $ 10,012 $ 27,766 $ 27,766 The financial liabilities that are measured and recorded at estimated fair value on a recurring basis consist of our contingent consideration associated with our acquisition of Indi, and prior to the completion of our IPO in October 2020, the warrant liability, put option liability and contingent value rights granted to certain holders of our convertible preferred stock and debt instruments, which were accounted for as liabilities and remeasured through our statements of operations. The table below presents the reported fair values of contingent consideration, which is classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): As of December 31, Description 2021 2020 Current portion of contingent consideration $ 17,764 $ — Contingent consideration 16,028 29,932 Total contingent consideration $ 33,792 $ 29,932 The following table presents the changes in contingent consideration for the year ended December 31, 2021 (in thousands): Year Ended Level 3 Rollforward December 31, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 2,238 Ending balances - December 31, 2021 $ 33,792 The following table presents the changes in these financial liabilities for the year ended December 31, 2020 (in thousands): For the Year Ended December 31, 2020 Level 3 Rollforward Contingent Put Warrant Contingent Beginning balances - January 1, 2020 $ 29,114 $ 3,261 $ 372 $ 60 Additions — 3,389 — — Changes in fair value 818 — 1,252 ( 60 ) Reclassified to additional paid-in capital — ( 6,650 ) ( 1,624 ) — Ending balances - December 31, 2020 $ 29,932 $ — $ — $ — Contingent Consideration In connection with the acquisition of Indi in 2018, the Company recorded contingent consideration for amounts contingently payable to Indi's selling shareholders pursuant to the terms of the asset purchase agreement (Indi APA). The contingent consideration arrangement requires additional consideration to be paid by the Company to Indi upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. Under the terms of the agreement, when the gross margin target was met the Company was required to issue 2,520,108 shares of common stock. For the six months following the achievement of the gross margin target, Indi had the option to require the Company to redeem these common shares for $ 37.0 million in cash over eight equal quarterly installments. If Indi elected to not exercise its option, the Company had 12 months to repurchase the common stock in two equal and consecutive quarterly cash installments totaling $ 37.0 million. The Company met the gross margin target of $ 2.0 million for three consecutive months during the three months ended June 30, 2021. The Company entered into an amendment to the original agreement in August 2021 in which all parties agreed to forgo the issuance of common stock and agreed that the Company will in lieu thereof make six quarterly installments of approximately $ 4.6 million beginning in January 2022 and a final payment of approximately $ 9.3 million in July 2023 for a total of $ 37.0 million. The aggregate amount of payments owed by the Company under this amendment is the same as if Indi had exercised the put right or the Company had exercised the call right provided for in the original agreement. Our ability to make these payments are subject to consent from our lender under the 2021 Term Loan and related amendments (see Note 8 - Debt ). We obtained consent and subsequently made the first milestone payment of $ 4.6 million in January 2022 and we are in discussions with our lender to obtain consents for future payments. The significant unobservable inputs used in the measurement of fair value include the probability of successful achievement of the specified product gross margin targets, the period in which the targets were expected to be achieved, and discount rates which ranged from 11 % to 13.5 %. As a result of the achievement of the gross margin target, the only significant unobservable input used in the measurement of fair value includes the discount rate since all other inputs became fixed and determinable. Significant increases or decreases in the discount rate would result in a significantly higher or lower fair value measurement. Contingent consideration expected to be paid in the next twelve months is recorded in the balance sheets as ‘Current portion of contingent consideration’ while the remaining amount to be paid is recorded as ‘Contingent consideration’ within non-current liabilities. The net change to contingent consideration through the date the gross margin target was met is recorded as operating expenses in the statements of operations. Subsequent changes to the contingent consideration following the achievement of the gross margin target are recorded as ‘Interest expense’ in the statements of operations resulting from the passage of time and fixed payment schedule. The net change to contingent consideration recorded as operating expenses during the years ended December 31, 2021 and 2020 was a loss of $ 1.6 million and $ 0.8 million, respectively. The amount recorded as ‘Interest expense’ during the year ended December 31, 2021 was $ 2.2 million. Put Option Liability The put option liability was valued based on the calculated returns as a result of the various discounts included in the Company’s convertible notes payable and the related probability assessments of the various settlement scenarios. During 2020, the Company recognized an addition to the put option liability of $ 3.4 million in connection with a favorable conversion rate granted to holders of issued convertible debt. The put option liability was settled upon the closing of the Company’s IPO in October 2020 and reclassified to additional paid-in capital. Warrant Liability In connection with entering into the 2018 Notes, the Company issued to the lender a warrant to purchase 613,333 shares of Series G convertible preferred stock, at an exercise price of $ 0.75 per share, subject to adjustment upon specified dilutive issuances. The warrant was immediately exercisable upon issuance and expires on February 23, 2028 . The estimated fair value of the warrant on the issuance date of $ 0.3 million was recorded as a debt discount and as a preferred stock warrant liability. Through the effective date of the Company’s IPO, the Series G warrants were remeasured to an estimate of fair value using a Black Scholes pricing model. As a result of the Company’s IPO, the preferred stock warrants were automatically converted to warrants to purchase 103,326 shares of common stock with a weighted average exercise price of $ 4.46 and were also transferred to additional paid-in capital. During 2020, the Company recorded an increase in the value of the warrant liability of $ 1.3 million. Contingent Value Rights In addition to the shares of Series F Preferred Stock that were issued in January 2016, investors who purchased more than their pro‑rata amount in the financing described above received a calculated number of contingent value rights (CVRs). In connection with the Series F financing, the Company issued 3,999 CVRs originally valued at $ 0.5 million. One CVR represents 0.00375 % of the Company’s interest in the drug ficlatuzumab. The initial estimated value of the CVRs were recorded as a liability and as a reduction to the Series F proceeds. Upon receipt by the Company or a milestone, royalty, or any other type of payment from the Company’s ownership rights in the drug, the Company was required to make a cash payment to the CVR holders equal to 15 % of net proceeds, as defined. In September 2020, the Company exercised its opt-out right with AVEO Oncology (AVEO) for the payment of 50 % of development and regulatory costs for ficlatuzumab. As a result, the CVRs were settled effective December 2, 2020. See Note 15 – Commitments and Contingencies for a discussion of the Co-Development Agreement with AVEO. Non-Financial Assets and Liabilities Our non-financial assets, which primarily consist of property and equipment, goodwill, and other intangible assets, are not required to be carried at fair value on a recurring basis and are reported at carrying value. There were no changes to the valuation methods during the periods presented. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Note 5 – Property and Equipment Property and equipment consist of the following (in thousands): As of December 31, 2021 2020 Lab equipment $ 6,784 $ 5,730 Leasehold improvements 2,339 1,845 Computer equipment 700 871 Furniture and fixtures 391 424 Software 600 651 Vehicles 97 — Construction in process 17 381 10,928 9,902 Less accumulated depreciation ( 6,749 ) ( 6,724 ) Total property and equipment, net $ 4,179 $ 3,178 Depreciation expense related to pr operty and equipment was: Year Ended December 31, 2021 2020 Direct costs and expenses $ 614 $ 361 Selling, marketing, general and administrative 614 478 Total $ 1,228 $ 839 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Note 6 – Goodwill and Intangible Assets Intangible assets, excluding goodwill, consist of the following (in thousands): December 31, 2021 December 31, 2020 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,755 $ ( 566 ) $ 1,189 $ 1,474 $ ( 494 ) $ 980 Purchased technology 16,900 ( 6,572 ) 10,328 16,900 ( 4,694 ) 12,206 Intangible assets not subject to Trademarks 100 — 100 74 — 74 Total $ 18,755 $ ( 7,138 ) $ 11,617 $ 18,448 $ ( 5,188 ) $ 13,260 Amortization expense related to definite-lived intangible assets was (in thousands): Year Ended December 31, 2021 2020 Direct costs and expenses $ 5 $ 13 Sales, marketing, general and administrative 1,945 2,051 Total $ 1,950 $ 2,064 Future estimated amortization expense of intangible assets is (in thousands): As of 2022 $ 1,975 2023 1,969 2024 1,959 2025 1,954 2026 1,941 2027 and thereafter 1,719 Total $ 11,517 |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Note 7 – Accrued Liabilities Accrued liabilities consist of the following (in thousands): As of December 31, 2021 2020 Compensation related accruals $ 4,029 $ 3,975 Accrued clinical trial expense 870 715 Other expenses 2,766 3,099 Total accrued liabilities $ 7,665 $ 7,789 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 8 – Debt Our long-term debt consists of notes payable associated with our 2021 Term Loan, 2018 Notes and Paycheck Protection Program, each of which is described in further detail below. Long-term notes payable were as follows (in thousands): As of December 31, 2021 2020 2021 Term Loan $ 10,000 $ — 2018 Notes — 24,972 Paycheck Protection Program — 3,107 Other 75 — Unamortized debt discount and debt issuance costs ( 63 ) ( 313 ) 10,012 27,766 Less: current maturities 19 11,840 Long-term notes payable $ 9,993 $ 15,926 2021 Term Loan On March 19, 2021 (Effective Date), the Company entered into a Loan and Security Agreement (the 2021 Term Loan) by and between Silicon Valley Bank (SVB or Lender) and the Company, as borrower, whereby subject to the terms and conditions of the 2021 Term Loan, SVB advanced to the Company an original principal amount of $ 30 million. The 2021 Term Loan provides for an “interest-only” period from the Effective Date through February 28, 2023, with interest due and payable monthly on the first calendar day of each month. However, the Company achieved a revenue milestone of at least $ 65 million on a trailing twelve-month basis during the three months ended March 31, 2021 which automatically extended the interest-only period through February 28, 2024. Beginning on the first calendar day of the month following the end of the interest-only period, the 2021 Term Loan shall be payable in (i) consecutive equal installments of principal through March 1, 2026, plus (ii) monthly payments of accrued interest. The principal amount outstanding under the 2021 Term Loan shall accrue interest at a floating per annum rate equal to the greater of (i) 2.00% above the prime rate, or (ii) 5.25%, which interest, in each case, shall be payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate shall be effective on the effective date of any change to the prime rate. The Company’s final payment, due at maturity on March 1, 2026 , shall include all outstanding principal and accrued and unpaid interest, lender fees and expenses, of which the majority will include a final payment of $ 2.7 million, and all other sums, if any, that shall have become due and payable hereunder with respect to the 2021 Term Loan. The $ 2.7 million final payment will be amortized as interest expense over the term of the 2021 Term Loan. The Company has the option to prepay, prior to maturity, the total outstanding principal amount plus accrued and unpaid interest, subject to a prepayment penalty of 3 % of the principal amount if paid prior to the first anniversary of the Effective Date, 2 % of the principal amount if paid on or after the first anniversary but prior to the second anniversary of the Effective Date, 1 % of the principal amount if paid on or after the second anniversary but prior to October 19, 2025, and 0 % thereafter. The Company granted the Lender a security interest in substantially all of the Company’s assets. The 2021 Term Loan requires the Company to comply with a minimum liquidity ratio covenant (as defined) by the 2021 Term Loan of not less than 0.95 to 1.00, and has a trailing six month rolling minimum revenue requirement of not less than 70 % of the Company’s projected revenue performed at the end of each reporting p eriod. On September 30, 2021, we entered into the Consent and First Amendment to Loan and Security Agreement (First Amendment) to, among other things, amend our 2021 Term Loan to eliminate the revenue covenant for the period ended September 30, 2021 and modify the revenue covenant threshold for the three month period ended December 31, 2021. In addition, we agreed to establish a restricted cash collateral account for $ 15 million for the benefit of our lender if the balance of our cash and cash equivalents declines below $ 40 million. On December 31, 2021, we entered into the Consent and Second Amendment to Loan and Security Agreement (Second Amendment) to, among other things, amend our 2021 Term Loan and First Amendment to obtain consent for the $ 4.6 million January 2022 milestone payment under the Indi APA, repay $ 20 million in outstanding principal on December 31, 2021, waive the $ 600,000 prepayment fee on the $ 20 million Term Loan repayment , and waive the minimum revenue covenant as of December 31, 2021 and modify the minimum revenue requirement to not less 75 % for the three months ended March 31, 2022 and not less than 75 % on a trailing six month rolling basis for each quarter thereafter of the Company’s projected revenue performed at the end of each reporting period . The Lender agreed to apply the full amount of funds previously established within the restricted cash collateral account to partially prepay the $ 20 million in outstanding principal, thereby eliminating the restricted cash collateral account. The Company recorded a loss on extinguishment of $ 0.1 million resulting from the write-off of debt issuance costs associated with the $ 20 million repayment of our 2021 Term Loan. The 2021 Term Loan contains certain covenants limiting the ability of the Company to, among other things, incur future debt, transfer assets except for the ordinary course of business, make acquisitions, pay dividends or make other certain restricted payments, or sell assets, subject to certain exceptions, without the prior written consent of the Lender. Failure to comply with the covenants and loan requirements may result in an event of default. As of December 31, 2021 , the Company was in compliance with all restrictive and financial covenants associated with its borrowings. In the event of a default, including, among other things, our failure to make any payment when due or our failure to comply with any covenant under the 2021 Term Loan, the Lender may elect to declare all amounts outstanding to be immediately due and payable, and may proceed against the collateral granted to them to secure such indebtedness, including a royalty-free license or other right to use all of our intellectual property without charge. 2018 Notes In February 2018, the Company issued long-term debt of $ 23.0 million to Innovatus Life Sciences Lending Fund (Innovatus or Lender) (the 2018 Notes). Innovatus is also a holder of the Company’s common stock. At the time of issuance, the Company paid a facility fee of $ 0.2 million and issued a warrant to Innovatus, with an initial estimated fair value of $ 0.3 million, for the purchase of 613,333 shares of Series G preferred stock. The facility fee and the estimated warrant fair value were recorded as debt discount and is amortized to interest expense over the term of the 2018 Notes. The 2018 Notes bore annual interest at 10 %, of which 7.5 % was payable in cash, with the remaining 2.5 % added to principal through December 31, 2020. Total interest added to principal was $ 1.7 million as of March 31, 2021 and December 31, 2020. On March 19, 2021, in connection with entering into the 2021 Term Loan agreement with SVB, the Company repaid all outstanding principal, accrued and unpaid interest, and prepayment fees in the amount of $ 25.9 million due under the 2018 Notes and contemporaneously terminated the related Loan and Security Agreement, dated as of February 23, 2018, as amended, between Innovatus and the Company. As a result of the extinguishment of the 2018 Notes, the Company recognized a loss on debt extinguishment of $ 0.7 million during the three months ended March 31, 2021. Paycheck Protection Program Note Payable In April 2020, the Company entered into a loan pursuant to the Paycheck Protection Program under the CARES Act, as administered by the U.S. Small Business Administration (the SBA). The loan, in the principal amount of $ 3.1 million (the PPP Loan), was disbursed by JPMorgan Chase Bank (JPM) pursuant to a Paycheck Protection Program Promissory Note and Agreement (the Note and Agreement). The PPP Loan had a maturity date on the two-year anniversary of the funding date, April 2022, and included a fixed rate of 1.00 % per annum. Monthly principal and interest payments, less the amount of any potential forgiveness (as discussed below), were scheduled to commence in September 2021. The Company did not provide any collateral or guarantees in connection with the PPP Loan, nor did the Company pay any facility charge to obtain the PPP Loan. The Note and Agreement contained customary events of default, including those relating to failure to make payment, bankruptcy, breaches of representations and material adverse effects. All or a portion of the PPP Loan may be forgiven by the SBA upon application by the Company. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, and covered utilities during the eight-week period beginning on the approval date of the PPP Loan. For purposes of the CARES Act, payroll costs exclude compensation of an individual employee earning more than $ 100,000 , prorated annually. Not more than 40 % of the forgiven amount may be for non-payroll costs. Forgiveness is reduced if full-time headcount declines, or if salaries and wages for employees with salaries of $ 100,000 or less annually are reduced by more than 25 %. During the second quarter of 2021, the Company determined that it would apply for forgiveness under the SBA’s Loan Forgiveness program, a change from its previous intent to repay. Subsequently, in July 2021 the Company applied for loan forgiveness and on August 17, 2021, the Company received legal release and formal notification that the PPP Loan was forgiven in full. During the three months ended September 30, 2021, the Company reduced the ‘Current portion of notes payable’ and recorded a gain on extinguishment in the statements of operations for the $ 3.1 million forgiven. Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of 2022 $ 19 2023 15 2024 4,017 2025 4,818 2026 1,206 2027 and thereafter — Total $ 10,075 |
Warrants to Purchase Convertibl
Warrants to Purchase Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants to Purchase Convertible Preferred Stock | Note 9 – Warrants to Pur chase Convertible Preferred Stock The Company issued warrants to purchase shares of convertible preferred stock in conjunction with the sale of certain of the convertible preferred shares and issuance of debt. Through the closing of the Company’s IPO, the preferred warrants were classified as liabilities with estimated fair value remeasured at each reporting date reported within in the accompanying statements of operations. The following table presents the activity for convertible preferred stock warrants (in thousands, except weighted average exercise price): Series E Series G (1) Warrants Weighted Warrants Weighted Outstanding ‑ January 1, 2020 925 $ 5.00 613 $ 0.75 Granted — — — — Forfeited/canceled ( 925 ) ( 5.00 ) — — Exercised — — — — Reclassification of warrant liability to additional paid-in capital — — ( 613 ) ( 0.75 ) Outstanding ‑ December 31, 2020 — $ — $ — $ — The warrants to purchase Series E convertible preferred stock were not exercised and expired during the three months ended June 2020. (1) On October 27, 2020, all convertible preferred stock converted to common stock at the completion of our IPO, and as a consequence, the warrants to purchase Series G convertible preferred stock were converted to 103,326 warrants to purchase common stock at $ 4.46 per share, which have an expiration date of February 23, 2028 . All common stock warrants remain outstanding as of December 31, 2021. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Equity | Note 10 – Equity Common Stock The Company’s Restated Certificate of Incorporation authorizes the Company to issue up to 200,000,000 shares of common stock with a par value of $ 0.001 per share. The holder of each share of common stock is entitled to one vote per share. The common shareholders are entitled to dividends whenever funds and assets are legally available and when and if declared by the Board of Directors. The Company is currently subject to restrictions on the payment of dividends (see Note 8 - Debt ) and no dividends have been declared as of December 31, 2021. On October 27, 2020, the Company issued and sold 4,000,000 shares of common stock in a registered IPO at a price to the public of $ 18.00 per share. The net proceeds to the Company were approximately $ 63.8 million, after deducting underwriting discounts and commissions of $ 5.0 million and direct offering expenses of approximately $ 3.2 million. On December 30, 2021, the Company raised approximately $ 16.3 million in gross proceeds from the sale of 3,756,994 common shares at a public offering price of $ 4.35 per share in an at-the-market offering. The Company received net proceeds of $ 15.7 million, after deducting underwriting discounts and commissions and offering expenses payable of approximately $ 0.7 million. Preferred Stock The Company’s Restated Certificate of Incorporation authorizes the Company to issue up to 5,000,000 shares of preferred stock with a par value of $ 0.001 per share. As of December 31, 2021 and 2020 , no shares of preferred stock were issued or outstanding. |
Revenue and Accounts Receivable
Revenue and Accounts Receivable Credit Concentration | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue and Accounts Receivable Credit Concentration | Note 11 – Revenue and Accounts Receivable Credit Concentration We derive our revenue from two primary sources: (i) providing diagnostic testing in the clinical setting (Diagnostic Tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, clinical trial testing, development and testing services generally provided outside the clinical setting and governed by individual contracts with third parties as well as development and commercialization of companion diagnostics (Services). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company conducts diagnostic tests and delivers the completed test results to the prescribing physician or patient, as applicable. The fees for diagnostic tests are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. The Company determines the transaction price related to its diagnostic test contracts by considering the nature of the payer, historical price concessions granted to groups of customers, and its historical collection experience using a portfolio approach. The Company recognizes revenues for diagnostic tests upon delivery of the tests to the physicians requesting the tests or patient, as applicable. Services revenue consists of on-market tests, pipeline tests, custom diagnostic testing, and other scientific services for a purpose as defined by any individual customer, which is often with biopharmaceutical companies. The performance obligations and related revenue for these sales is defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). Revenues consisted of the following (in thousands): Year Ended December 31, 2021 2020 Diagnostic tests $ 48,937 $ 40,919 Services 5,569 4,638 Total revenue $ 54,506 $ 45,557 Deferred Revenue Deferred Revenue consists of cash payments from customers received in advance of delivery. As test results are delivered, the Company recognizes the deferred revenue in ‘Revenues’ in the statements of operations. Of the $ 3.5 million in ‘Deferred Revenue’ recorded in the balance sheet as of December 31, 2020 , $ 3.0 million was recognized in revenues. During the year ended December 31, 2021 $ 1.4 million was added to 'Deferred revenue' for up-front cash payments received for which revenue recognition criteria have not been met. The 'Deferred revenue' of $ 1.9 million recorded in the balance sheet as of December 31, 2021 is expected to be recognized in revenues over the next twelve months as test results are delivered and services are performed. As of December 31, 2021 and 2020 , the Company had $ 0.8 million and $ 1.4 million in non-current deferred revenue, respectively, recorded within ‘Other long-term liabilities’ in the balance sheets which represent amounts to be recognized in excess of twelve months from the respective balance sheet date. The Company’s customers in excess of 10% of total revenue, and their related revenue as a percentage of total revenue were as follows: Year Ended December 31, 2021 2020 The Big Ten Conference 40 % 30 % Centura Healthcare 5 % 17 % In addition to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for 18 % and 17 % of the Company’s total revenue for the years ended December 31, 2021 and 2020, respectively. The Company is subject to credit risk from its accounts receivable related to services provided to its customers. The Company does not perform evaluations of customers' financial condition and does not require collateral. The Company’s third-party payors and other customers in excess of 10% of accounts receivable, and their related accounts receivable as a percentage of total accounts receivable were as follows: As of December 31, 2021 2020 Medicare 30 % 6 % Janssen Research and Development, LLC 14 % 5 % LabCorp DD (formerly Covance) 11 % 2 % The Big Ten Conference — % 35 % Centura Healthcare — % 24 % |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation | Note 12 – Share Based Compensation Predecessor 2016 and 2006 Equity Incentive Plans Under the 2006 Equity Incentive Plan (2006 Plan), the Company was authorized to grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards and RSUs. No additional awards may be granted under the 2006 Plan. In February 2016, the Company adopted the 2016 Equity Incentive Plan (2016 Plan) as a successor to and continuation of the prior 2006 Plan. The 2016 Plan provided for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock awards to directors, employees, and consultant . Awards granted under the 2016 Plan or the 2006 Plan that were unallocated, expired or otherwise terminated, or were forfeited, cancelled, or repurchased by the Company, became available for future issuance under the 2016 Plan. In addition, shares subject to an award were withheld to satisfy a participant’s tax withholding obligations, or were reacquired by the Company as consideration for the exercise or purchase price of a stock award also became available for future issuance under the 2016 Incentive Plan. No additional awards may be granted under the 2016 Plan. 2020 Equity Incentive Plan Effective upon the closing of our IPO, the Company’s Board of Directors approved the 2020 Equity Incentive Plan (2020 Plan), which replaced the 2016 Plan. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs, performance awards and other stock awards. Officers, directors, employees, consultants, agents, and independent contractors who provide services to the Company may receive awards. The terms of all awards are governed by an agreement between the Company and the recipients, as administered and approved by the Compensation Committee of the Board of Directors. Any awards that expire or are forfeited under the 2016 Plan or 2006 Plan become available for issuance under the 2020 Plan. The number of shares reserved for issuance under the 20 20 Plan is 1,893,395 , plus an annual increase added on the first day of each calendar year, beginning with the calendar year ending December 31, 2022, and continuing until, and including, the calendar year ending December 31, 2030. The annual increase will be equal to the lesser of (i) 4 % of the number of shares of our common stock issued and outstanding as of December 31st of the immediately preceding calendar year and (ii) such lesser amount determined by the Board of Directors. Up to 1,893,395 sh ares of our common stock that may be issued under the 2020 Plan may be issued in satisfaction of incentive stock option awards. To the extent an equity award granted under the 2020 Plan (other than any substitute award) or granted under any other equity plan maintained by us under which awards are outstanding as of the effective date of the 2020 Plan (the Prior Plans) expires or otherwise terminates without having been exercised or paid in full, or is settled in cash, the shares subject to such award will become available for future grant under the 2020 Plan. In addition, to the extent shares subject to an award are withheld to satisfy a participant’s tax withholding obligation upon the exercise or settlement of such award (other than any substitute award) or to pay the exercise price of a stock option granted under the 2020 Plan or a Prior Plan, such shares will become available for future grant under the 2020 Plan. The total number of shares available for grant under all Plans was 630,685 at December 31, 2021. Employee Stock Purchase Plan Effective with our IPO in October 2020, the Company’s Board of Directors and its stockholders approved the Company’s Employee Stock Purchase Plan (ESPP). A total of 338,106 shares of our common stock have been reserved for issuance under the ESPP. The maximum number of shares of our common stock available under the ESPP will automatically increase on the first trading day of each calendar year by an amount equal to the lesser of (i) 1 % of the shares of our common stock issued and outstanding on December 31st of the immediately preceding calendar year, and (ii) an amount determined by our Board of Directors. Subject to any plan limitations, the ESPP allows eligible employees to contribute, normally through payroll deductions, up to 15 % of their earnings for the purchase of the Company’s common stock at a discounted price per share. The price at which common stock is purchased under the ESPP is equal to 85 % of the fair market value of the Company’s common stock on the first or last day of the offering period, whichever is lower. No employee may participate in an offering period if the employee owns 5% or more of the total combined voting power or value of the Company’s stock. The initial offering period was from January 1, 2021 through August 31, 2021. On a go-forward basis, the ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. As of December 31, 2021 , 42,855 shares have been issued under the ESPP leaving 295,251 shares remaining for future issuance. Description of Awards Granted The Company has granted incentive stock options, non-statutory stock options, performance-based stock options, and RSUs. Incentive stock options, which may only be issued to employees, are granted at an exercise price per share equal to the closing market price of the Company’s common stock on the grant date, and vest over time as determined by the Compensation Committee, provided that the term of the options may not exceed ten years from the date of grant. Accelerated vesting may occur in the event of an optionee's death, disability, or other events. Non-statutory stock options, which may be issued to employees, non-employees and directors, are granted at an exercise price per share equal to the closing market price of the Company’s common stock on the grant date, and vest over time as determined by the Compensation Committee, provided that the term of the options may not exceed ten years from the date of grant. Accelerated vesting may occur in the event of an optionee's death, disability, or other events. Performance-based stock options are typically granted on an annual basis and consist of a performance-based and service-based component. The performance targets and vesting conditions for performance-condition options are based on achievement of recognized revenue targets. Performance-based options vest in three equal annual installments beginning one year after the grant date , pending certification of performance achievement by the Compensation Committee and continued service. The fair value of performance-condition awards is based on the closing market price of the Company’s common stock on the grant date. On January 1, 2019, the Company granted 168,466 performance-condition options, with an exercise price of $ 0.77 per share and a term of ten years . During the year ended December 31, 2021 and 2020, the performance-conditions w ere met and 56,156 opti ons and 56,155 options, respectively, vested. During the year ended December 31, 2019, the performance-conditions were not met and 56,155 options were forfeited. RSUs and the related terms and conditions are awarded at the discretion of the Compensation Committee. RSU holders have a contractual right to receive a share of common stock when vested. RSUs vest over time as determined by the Compensation Committee. RSU agreements may provide for accelerated vesting in the event of a stock unit holder's death, disability, or retirement or other events. Our Compensation Committee may grant other stock awards that are based on or related to shares of our common stock, such as awards of shares of common stock granted as bonus and not subject to any vesting conditions, deferred stock units, stock purchase rights, and shares of our common stock issued in lieu of our obligations to pay cash under any compensatory plan or arrangement. To date, t he Company has granted service-condition RSUs. Bonus-To-Options Program The Company also has a Bonus-to-Options Program (the “Bonus Option Program”), is separate from predecessor Plans and was initially adopted by the Board of Directors in 2008, and subsequently amended and restated in 2010, 2011 and 2015. For fiscal year 2022, the Bonus Option Program is subject to the shares reserved under the 2020 Plan. The Bonus Option Program, which is limited to participation of the Chief Executive Officer, direct reports to the Chief Executive Officer and Vice Presidents of the Company, allows participants who so elect to convert all or a portion of their annual cash bonus into fully vested, non-qualified stock options to purchase shares of common stock (Bonus Options). The exercise price for the options under the Bonus Option Program equals the then current price for the shares of the common stock as of the grant date, as disclosed below under “ Fair Value of Common Stock ”. Bonus Options issued must be exercised within a ten-year term. The Company recorded the following activity related to the Bonus Option Program during the year ended December 31, 2021 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Weighted Weighted Aggregate Outstanding ‑ January 1, 2021 173 $ 11.11 4.9 $ 1,723 Granted 266 20.67 — — Forfeited/canceled ( 46 ) 20.03 — — Exercised ( 20 ) 7.69 — — Outstanding ‑ December 31, 2021 373 $ 17.00 7.5 $ 76 Exercisable ‑ December 31, 2021 373 $ 17.00 7.5 $ 76 The Company recorded $ 0.8 million and $ 3.4 million during the years ended December 31, 2021 and 2020, respectively, associated with the estimate of options to be delivered to eligible participants under the Bonus Option Program and which were granted in February 2022 and 2021 by the Compensation Committee of the Board of Directors. In determining the amount of stock compensation to recognize under the Bonus Option Program, the Company estimates the bonus attainment for the year and determines the expected number of options to be delivered to eligible participants. A Black-Scholes option pricing model is used to determine the estimated fair value of the expected number of options to be delivered to eligible participants. The key elements in determining the estimated fair value include assumptions for volatility, the risk-free interest rate, expected dividends and strike price, utilizing the measurement date closing stock price until the grants are authorized. Share-Based Compensation Expense Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Year Ended December 31, 2021 2020 Direct costs and expenses $ 49 $ — Research and development 572 589 Sales, marketing, general and administrative 4,323 3,120 Total $ 4,944 $ 3,709 The unrecognized remaining share-based compensation expense for options and RSUs was approximately $ 7.8 million as of December 31, 2021 , and is expected to be amortized to expense over the next 3.8 years. Stock Options Stock option activity during the year ended December 31, 2021, excluding the Bonus Option Program described above, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Weighted Weighted Aggregate Outstanding - January 1, 2021 2,321 $ 1.82 7.4 $ 42,580 Granted 1,190 17.87 — — Forfeited/canceled ( 225 ) 7.22 — — Exercised ( 408 ) 1.51 — — Outstanding ‑ December 31, 2021 2,878 $ 8.08 7.7 $ 6,288 Exercisable ‑ December 31, 2021 1,428 $ 5.02 6.7 $ 3,849 Fair Value of Common Stock Prior to the Company’s IPO, the fair value of the Company’s common stock underlying the stock options was determined by the Board of Directors with assistance from management and, in part, on input from an independent third-party valuation firm. The Board of Directors determined the fair value of common stock by considering a number of objective and subjective factors, including valuations of comparable companies, sales of convertible preferred stock, operating and financial performance, the lack of liquidity of the Company’s common stock and the general and industry-specific economic outlook. Subsequent to the Company’s IPO, the fair value of the Company’s common stock is determined based on its closing market price on the date of grant. The estimated grant date fair value of stock options was calculated using the Black-Scholes option-pricing model, based on the following assumptions: • Expected Term : The expected term represents the period that the options granted are expected to be outstanding using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). • Expected Volatility : The Company uses an average historical stock price of selected comparable companies over the expected term of the awards as the Company does not have sufficient trading history for its common stock. • Risk-Free Interest Rate : The Company uses the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. • Expected Dividend Yield : The Company is currently subject to restrictions on the payment of dividends (see Note 8 - Debt ) and no dividends have been declared as of December 31, 2021 and 2020. The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero. The fair value of each option grant was estimated on the grant date with the following weighted average assumptions for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Expected term (in years) 6.01 5.73 Expected volatility 68.5 % 77.0 % Risk‑free rate 0.79 % 0.34 % Expected dividend yield — % — % Restricted Stock Units During the year ended December 31, 2021 , the Company granted 71,707 service-condition RSUs. As of December 31, 2021 , there were 150,811 RSUs outstanding, with a weighted average grant date fair value of $ 5.30 per share. |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Note 13 – Net Loss per Common Share Basic earnings per share (EPS) excludes dilution and is computed by dividing net loss attributable to the Company’s stockholders by the weighted-average shares outstanding during the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised, resulting in the issuance of shares of common stock that would then share in the earnings or losses of the Company. In connection with the acquisition of Indi in 2018, the Company recorded contingent consideration (See Note 4 – Fair Value ) for amounts contingently payable to Indi's selling shareholders pursuant to the terms of the asset purchase agreement. The contingent consideration arrangement requires additional consideration to be paid by the Company to Indi upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. If the gross margin target was met, the Company was required to issue 2,520,108 shares of common stock. The Company met the gross margin target of $ 2.0 million for three consecutive months during the three months ended June 30, 2021. In August 2021, the Company entered into an amendment of the original agreement in which all parties agreed to forgo the issuance of common stock. As a result of the achievement of the gross margin target, the Company included the 2,520,108 shares of common stock in the calculation of weighted-average shares outstanding used in computing basic and diluted net loss per share from the date the gross margin target was met until the amendment was executed. These shares are not included in the statements of convertible preferred stock and stockholders' equity (deficit) or shares issued and outstanding in the accompanying balance sheets. Basic and diluted loss per share for the years ended December 31, 2021 and 2020 were (in thousands, except per share amounts): Year Ended December 31, 2021 2020 Numerator Net loss attributable to common stockholders $ ( 43,159 ) $ ( 31,350 ) Denominator Weighted-average shares outstanding used 27,365 4,838 Net loss per share, basic and diluted $ ( 1.58 ) $ ( 6.48 ) The potentially dilutive securities as of December 31, 2021 and 2020 primarily represent the shares subject to future issuance under stock options awards, warrants, RSUs, and shares subject to purchase under our employee stock purchase plan and would be subject to the treasury stock method when dilutive the terms of which are described in further detail in Note 12 – Share Based Compensation . The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Year Ended December 31, 2021 2020 Options to purchase common stock 3,251 2,495 Shares committed under ESPP 30 — Warrants 103 103 Restricted stock units 151 79 Total 3,535 2,677 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 14 - Income Taxes Since inception, the Company has incurred net taxable losses, and accordingly, no current provision for income taxes has been recorded. The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate 21 % 21 % State income taxes, net of federal benefit 5 2 Research and developments credits 1 ( 1 ) Permanent items ( 1 ) ( 6 ) Change in valuation allowance ( 26 ) ( 16 ) Effective income tax rate — % — % The tax effects of temporary differences that give rise to significant portions of the deferred income tax assets and liabilities are as follows (in thousands): As of December 31, 2021 2020 Deferred Tax Assets: Net operating loss carryforwards $ 61,874 $ 53,128 Research and development tax credits 3,372 2,860 Interest expense limitation 554 — Property and equipment 215 279 Stock-based compensation 1,977 865 Accruals and reserves 1,618 1,406 Total 69,610 58,538 Valuation allowance ( 67,457 ) ( 56,083 ) Total deferred tax assets after valuation allowance 2,153 2,455 Deferred Tax Liabilities: Intangible assets ( 2,153 ) ( 2,455 ) Total deferred tax liabilities ( 2,153 ) ( 2,455 ) Net deferred tax assets and liabilities $ — $ — At December 31, 2021 , the Company had $ 267.1 million and $ 4.2 million of federal net operating loss and research and experimentation tax carryforwards, respectively, which are set to expire beginning in 2026 . The Internal Revenue Code contains provisions that may limit the net operating loss carryovers available to be used in any year if certain events occur, including significant changes in ownership interest. In assessing the realizability of its deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. As the Company does not have any historical taxable income, projections of future taxable income over the periods in which the deferred tax assets are deductible, and after consideration of the history of operating losses, the Company does not believe it is more likely than not that it will realize the benefits of net deferred tax assets and, accordingly, has established a valuation allowance equal to 100 % of net deferred tax assets. The valuation allowance increased by $ 11.4 million during 2021 and $ 7.0 million during 2020. During 2021, the Company determined that it now has uncertain tax positions related to its U.S. research and development credits. As of December 31, 2021 and 2020 , there was no accrued interest related to uncertain tax positions. The Company does not believe it is reasonably possible that its unrecognized tax benefits will significantly change in the next twelve months. A reconciliation of beginning and ending balances for unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2021 2020 Balance at January 1 $ 715 $ — Additions for tax positions related to the current year 128 106 Additions for tax positions related to prior years — 609 Reductions for tax positions related to prior years — — Reductions related to settlements — — Reductions related to a lapse of statute — — Balance at December 31 $ 843 $ 715 The Company monitors proposed and issued tax law, regulations, and cases to determine the potential impact of uncertain income tax positions. At December 31, 2021 , the Company had not identified any potential subsequent events that would have a material impact on unrecognized income tax benefits within the next twelve months. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15 – Commitments and Contingencies Leases The Company leases facilities under non‑cancelable operating leases. Rent expense was $ 1.2 million and $ 1.7 million for the years ended December 31, 2021 and 2020, respectively. Future minimum lease payments, which do not include amounts for common area maintenance, insurance, or taxes, for operating lease obligations are as follows (in thousands): As of 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 Co‑Development Agreement In April 2014 and amended in October 2016, the Company entered into a worldwide agreement with AVEO to develop and commercialize AVEO's hepatocyte growth factor inhibitory antibody ficlatuzumab with the Company's proprietary companion diagnostic test, BDX004, a version of the Company’s serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non‑small cell lung cancer (NSCLC). Under the terms of the agreement, AVEO will conduct a proof‑of‑concept (POC) clinical study of ficlatuzumab for NSCLC in which BDX004 will be used to select clinical trial subjects (the NSCLC POC Trial). Under the agreement, the Company and AVEO would share equally in the costs of the NSCLC POC Trial, and each would be responsible for 50 % of development and regulatory costs associated with all future clinical trials agreed upon by the Company and AVEO. The Company and AVEO continue to conduct POC clinical trials of ficlatuzumab in combination with BDX004. In September 2020, the Company exercised its opt-out right with AVEO for the payment of 50 % of development and regulatory costs for ficlatuzumab effective December 2, 2020 (the Effective Date). In September 2021, AVEO announced that the FDA has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma. In November 2021 AVEO also announced plans to initiate a potential registrational Phase 3 clinical trial for ficlatuzumab in the first half of 2023. The Company has $ 0.1 million in remaining obligations related to the AVEO agreement as of December 31, 2021 . Following the Effective Date, the Company is entitled to a 10 % royalty of net sales of ficlatuzumab and 25 % of license income generated from the licensing of ficlatuzumab from AVEO. There were no expenses related to this agreement for the year ended December 31, 2021 . Expenses related to this agreement for the year ended December 31, 2020 were approximately $ 0.9 million. License Agreement In August 2019, we entered into a non-exclusive license agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) (the Bio-Rad License). Under the terms of the Bio-Rad License, the Company received a non-exclusive license, without the right to grant sublicenses, to utilize certain of Bio-Rad’s intellectual property, machinery, materials, reagents, supplies and know-how necessary for the performance of Droplet Digital PCR (ddPCR) in cancer detection testing for third parties in the United States. The Company also agreed to purchase all of the necessary supplies and reagents for such testing exclusively from Bio-Rad, pursuant to a separately executed supply agreement (the Supply Agreement) with Bio-Rad. As further consideration for the non-exclusive license, the Company agreed to pay a royalty of 2.5 % on the net revenue received for the performance of such ddPCR testing collected from third parties. On May 24, 2021, the Company entered into the First Amendment to the Non-Exclusive License Agreement with Bio-Rad which amended the Bio-Rad License such that, effective May 1, 2021, the Company will no longer pay a royalty of 2.5 % on the net revenue received for the performance of such ddPCR testing collected from third parties. The Bio-Rad License expires in August 2024 . Either party may terminate for the other’s uncured material breach or bankruptcy events. Bio-Rad may terminate the Bio-Rad License if the Company does not purchase licensed products under the Supply Agreement for a consecutive twelve-month period or for any material breach by us of the Supply Agreement. Royalty expense under the Bio-Rad License was not significant for the year ended December 31, 2021 and $ 0.1 million for the year ended December 31, 2020. On May 13, 2021 (Effective Date), we reached agreement with CellCarta Biosciences Inc. (formerly Caprion Biosciences, Inc.) (the CellCarta License) on a new royalty bearing license agreement for the Nodify XL2 test. The parties agreed to terminate all prior agreements and replace with this new arrangement, which has a 1 % fee on net sales made from the first commercial sale of the Nodify XL2 test to the Effective Date as an upfront make-good payment covering past royalties due and a royalty rate of 0.675 % on future Nodify XL2 test net sales worldwide for 15 years from the first commercial sale, ending in 2034 . Royalty expense under the CellCarta License for the year ended December 31, 2021 was $ 0.1 million. As part of the acquisition of Oncimmune, the Company entered into several agreements to govern the relationship between the parties. The Company agreed to a license agreement and royalty payment related to an acquired diagnostic test of 8 % of recognized revenue for non-screen tests up to an annual minimum volume and 5 % thereafter, with an escalating minimum through the first four years of sales . Royalty expenses of $ 0.7 million and $ 0.3 million were incurred for the years ended December 31, 2021 and 2020, respectively. Litigation, Claims and Assessments From time to time, we may become involved in legal proceedings or investigations which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. In September 2021, we reached a settlement agreement with the plaintiffs, which received preliminary approval from the Circuit Court of the City of St. Louis, State of Missouri (the Court) on November 10 th , regarding a dispute involving the Telephone Consumer Protection Act (TCPA). On January 31, 2022, the Court approved the final settlement payment to third parties of approximately $ 210,000 which was accrued as a legal contingency during the year ended December 31, 2021. We are not presently a party to any other legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 16 – Subsequent Events Common Stock Purchase Agreement On March 7, 2022 (the Effective Date), the Company entered into a purchase agreement, dated as of March 7, 2022 with Lincoln Park Capital Fund, LLC, an Illinois limited liability company (Lincoln Park), pursuant to which Lincoln Park has committed to purchase up to $ 50.0 million of the Company's common stock (the Purchase Agreement). Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 50.0 million of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the Effective Date. The number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is 50,000 shares, but that amount may be increased up to 100,000 shares, depending upon the market price of the Company’s common stock at the time of sale and subject to a maximum limit of $ 1.5 million per regular purchase. The purchase price per share for each such regular purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale as computed under the Purchase Agreement. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases. Under applicable rules of the Nasdaq Capital Market, in no event may the Company issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.20 per share, such that issuances and sales of the common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable Nasda q rules. Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if doing so would result in Lincoln Park beneficially owning more than 9.99 % of its common stock. Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds, if any, under the Purchase Agreement will depend on the frequency and prices at which the Company sells shares of its common stock to Lincoln Park. The Company intends to use any net proceeds from the sale of its common stock to Lincoln Park to advance its growth strategy and for general corporate purposes. On the Effective Date, the Company issued 184,275 shares of common stock to Lincoln Park as a commitment fee and, upon the available amount being reduced to an amount equal to or less than $ 20.0 million, the Company will be required to issue 61,426 shares (collectively, the Commitment Shares). The Purchase Agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the common stock. Although the Company has agreed to reimburse Lincoln Park for a limited portion of the fees it incurred in connection with the Purchase Agreement, the Company did not pay any additional amounts to reimburse or otherwise compensate Lincoln Park in connection with the transaction, other than the issuance of the Commitment Shares. Centennial Valley Properties I, LLC Lease Agreement On March 11, 2022, the Company entered into a Lease Agreement (the Lease) with Centennial Valley Properties I, LLC, a Colorado limited liability company (the Landlord) for office and laboratory space located at 919 West Dillion Road; Louisville, Colorado (the Leased Premises). The purpose of the Lease is to replace the Company’s current leased premises at 2970 Wilderness Place, Suite 100 in Boulder, Colorado and the Company intends to move its corporate headquarters to the Leased Premises by mid-2023. T he initial term of the Lease wi ll extend twelve years (the Initial Term) from the commencement date, which is the earlier of: (i) the Company conducting revenue generating business (as defined in the Lease), or (ii) April 1, 2023 (the Commencement Date), unless earlier terminated in accordance with the Lease. The Company has two renewal options to extend the term of the Lease for an additional seven or ten year terms for each renewal. Under the Lease, the Company will lease approximately 79,980 square feet at the Leased Premises. The Company will pay base rent over the life of the Lease beginning at approximately $ 227,000 per month and escalating, based on fixed escalation provisions, to $ 326,000 per month, plus certain operating expenses and taxes. The Company's obligation to pay base rent shall be abated, commencing as of the Commencement Date and ending on and including the date that is 12 months after the Commencement Date (the Abated Rent Period). Further, the Company's obligation to pay base rent with respect to a portion of the area of the Lease Premises equal to 19,980 square feet shall be abated (the Partial Abated Rent), commencing as of the day after the end of the Abated Rent Period and ending on and including the date that is 24 months after the Commencement Date (the Partial Abated Rent Period). Pursuant to a work letter entered by the parties in connection with the Lease, the Landlord will contribute an aggregate of $ 18.8 million toward the cost of construction and improvements for the Leased Premises and the Company exercised its option for an additional tenant improvement allowance of up to $ 25.00 per rentable square foot (the Extra Allowance Amount). The Company will repay the Extra Allowance Amount actually funded by the Landlord in equal monthly payments with an interest rate of 6 % per year over the Initial Term excluding any part of the Abated Rent Period or Partial Abated Rent Period, which shall start to accrue on the date that the Landlord first disburses the Extra Allowance Amount. The Lease includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature, including maintaining a $ 5.0 million letter of credit (subject to contingent reduction over the term of the lease) to secure the performance of the Company’s obligations under the Lease. The $ 5.0 million letter of credit has to be cash collateralized by the Company through a restricted cash account for the benefit of the Landlord. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Initial Public Offering ("IPO") | Initial Public Offering On October 27, 2020, the Company completed its initial public offering (IPO), in which it issued and sold 4,000,000 shares of its common stock at a public offering price of $ 18.00 per share. The Company received net proceeds of $ 63.8 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. In addition, in connection with the IPO, all shares of the Company’s then-outstanding convertible preferred stock and convertible notes payable were automatically converted into 21,939,025 shares of common stock, and all then outstanding warrants to purchase the Company’s Series G convertible preferred stock were automatically converted into warrants to purchase 103,326 shares of the Company’s common stock. |
Basis of Presentation and Estimates | Basis of Presentation and Estimates The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; the estimation of the fair value of goodwill and other intangible assets; fair value of stock options; income tax uncertainties, including a valuation allowance for deferred tax assets; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recognized revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. Certain prior period amounts have been reclassified to conform to the current period presentation. During March 2020, a global pandemic was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus (COVID-19). The COVID-19 pandemic negatively affected, and we expect will continue to negatively affect, our lung diagnostic testing-related revenue and our clinical studies. As of December 31, 2021, we maintained cash and cash equivalents of $ 32.7 million and we have $ 10 million in principal balance outstanding on our 2021 Term Loan. We have incurred significant losses since inception and, as a result, we have funded our operations to date primarily through the sale of common stock in our IPO in October 2020, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which include lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources and needs and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-K in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our 2021 Term Loan (see Note 8 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our 2021 Term Loan during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balance. We have taken steps to improve our liquidity through raising debt and equity capital during 2021, amendments to our 2021 Term Loan and have also undertaken several proactive measures to mitigate the financial and operational impacts of the COVID-19 pandemic through the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. In addition, we have entered into negotiation with certain creditors to modify existing terms of arrangement to delay near term cash requirements and extend the period of payments; however, those negotiations are not final at this time and may not result in final agreement. To maintain an adequate amount of available liquidity and execute our current operating plan, we will need to continue to raise additional funds from external sources, such as through the issuance of equity or debt securities; however, we have not secured such funding at the time of this filing and any such financing activities are subject to market conditions. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. Our current operating plan, which is in part determined based on our most recent historical actual results and trends, along with the items noted above, raises substantial doubt about the Company’s ability to continue as a going concern. Our audited financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments that might be necessary should we be unable to continue as a going concern. |
Segment Reporting | Segment Reporting The Company has a single operating segment focused on providing diagnostic testing services to customers. All of the Company’s revenue and long-lived assets were derived or located in the United States for the years ended December 31, 2021 and 2020 . |
Revenue Recognition | Revenue Recognition The Company generates revenues from (i) diagnostic tests and (ii) assay development and testing services (services revenue). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company determines the transaction price related to its blood-based lung diagnostic test contracts using a portfolio approach by considering the nature of the payer and historical price concessions granted to groups of customers. The transaction price associated with COVID-19 testing arrangements are determined on the basis of the individual contract with each customer. Services revenue consists of various types of tests or other scientific services for a purpose as defined by any individual customer, which are often larger biopharmaceutical companies, as defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or achievement of contractual milestone(s) as defined in the customer agreements. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach as discussed above. In determining the amount to accrue for a delivered test, the Company considers factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and the Company, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. Variable consideration, if any, is estimated based on an analysis of historical experience and adjusted as better estimates become available. These estimates require significant judgment by management. The Company also provides services to patients with whom the Company does not have contracts as defined in Financial Accounting Standards Board (FASB) Accounting Standards Codification 606 (ASC 606). The Company recognizes revenue for these patients when contracts, as defined in ASC 606, are established at the amount of consideration to which it expects to be entitled, or when the Company receives substantially all of the consideration subsequent to satisfaction and delivery of the performance obligations. Deferred revenue consists of payments received for research, development, and testing services fees received prior to the completion of performance of these tests and services. See Note 11 — Revenue and Accounts Receivable Credit Concentration for additional information. |
Direct Costs and Expenses | Direct Costs and Expenses The components of our cost of diagnostic tests and testing services consist of cost of materials, direct labor, including bonus, benefit and stock-based compensation, depreciation of laboratory equipment, rent costs, amortization of leasehold improvements and information technology costs associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing of license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. Costs associated with performing tests are expensed as the test is processed regardless of whether and when revenue is recognized with respect to that test. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include external and internal costs incurred to develop our technology, collect clinical samples, and conduct clinical studies to develop and support our products. External costs consist primarily of payments to clinical trial sites, sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, process development and clinical development activities. Internal costs consist primarily of salaries and benefits, reagents and supplies used in research and development laboratory work, infrastructure expenses, including allocated facility occupancy and information technology costs . The Company estimates and accrues its expenses resulting from its obligations under contracts with vendors and consultants in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payments that do not match the periods over which materials or services are provided under such contracts. The Company’s estimates depend on the timeliness and accuracy of the data provided by consultants and vendors regarding the status of each activity. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information received. Research and development costs are expensed as incurred. |
Sales, Marketing, General and Administrative Expenses | Sales, Marketing, General and Administrative Expenses Selling expenses consist primarily of costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel, and stock-based compensation, as well as marketing and educational activities and allocated overhead expenses. Sales, marketing, general and administrative expenses also include costs for our marketing and sales organizations, and other functions including finance, legal, human resources, and information technology. These expenses consist principally of salaries, bonuses, employee benefits, travel, stock-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and allocated overhead expenses. |
Concentrations of Credit Risk and Other Uncertainties | Concentrations of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial institutions with which it holds cash. Periodically throughout the year, the Company has maintained balances in various operating accounts in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. Several of the components of the Company's sample collection kit and test reagents, and certain test systems and related test kits are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of December 31, 2021 and 2020, see Note 11 – Revenue and Accounts Receivable Credit Concentration . |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash equivalents consist of short-term, highly-liquid instruments with an original maturity of three months or less from the date of purchase. |
Restricted Cash | Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit card and a letter of credit related to an operating lease agreement. As of December 31, 2021 and 2020 , the Company had $ 0.1 million and $ 0.2 million restricted cash, respectively, which was included in ‘Other current assets’ in the accompanying balance sheets. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are stated at the amount management expects to collect from customers based on their outstanding invoices. Management reviews accounts receivable quarterly to determine if any receivable will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value based on historical experience, customer creditworthiness, facts, and circumstances specific to outstanding balances, and payment terms. |
Inventory | Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to 'Direct costs and expenses'. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and were $ 2.9 million and $ 3.2 million as of December 31, 2021 and 2020 , respectively. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years . Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations in the period realized. Long-lived assets to be held and used are evaluated for impairment when events or circumstances indicate the carrying value of a long-lived asset or asset group is less than the undiscounted cash flows from the use and eventual disposition over its remaining useful life. The Company assesses recoverability by comparing the sum or projected undiscounted cash flows from the use and eventual disposition of the asset or asset group to its carrying value, and records an impairment loss if the carrying value is greater than the undiscounted future cash flows. There were no impairments for the years ended December 31, 2021 and 2020 . |
Intangible Assets | Intangible Assets Intangible assets primarily consist of intangible assets acquired as part of business combinations, external costs associated with patent applications that are probable of future economic benefits, and trademark costs. Finite-lived intangibles are stated at cost, net of accumulated amortization. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 9 to 10 years, based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. Trademarks are considered indefinite lived and are not amortized. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate a reduction to fair value below their carrying amounts. There were no impairments for the years ended December 31, 2021 and 2020 . |
Goodwill | Goodwill Goodwill represents the excess of purchase price over amounts allocated to acquired assets and liabilities assumed in business combinations. The carrying value of goodwill is evaluated for impairment at least annually or more frequently when events or circumstances occur indicate a potential for impairment. The annual impairment test is performed on the last day of our fourth quarter. Prior to performing a quantitative evaluation, an assessment of qualitative factors may be performed to determine whether it is more likely than not that the fair value of the reporting unit exceeds its carrying value. In the event the Company determines that it is more likely than not the carrying value of our single reporting unit is higher than its estimated fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. Through December 31, 2021 , there were no accumulated impairment losses. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments U.S. GAAP for fair value establishes a hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach, and cost approach). We utilize a combination of market and income approaches to value our financial instruments. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. Fair value measurements are categorized within the fair value hierarchy based upon the lowest level of the most significant inputs used to determine fair value. The three levels of the hierarchy and the related inputs are as follows: Level Inputs 1 Unadjusted quoted prices in active markets for identical assets and liabilities. 2 Unadjusted quoted prices in active markets for similar assets and liabilities; Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or Inputs other than quoted prices that are observable for the asset or liability. 3 Unobservable inputs for the asset or liability. The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. |
Contingent Consideration | Contingent Consideration In connection with the purchase transaction with Integrated Diagnostics, Inc. (Indi), the Company recorded contingent consideration for amounts potentially payable to Indi’s shareholder upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value through the date the gross margin target was met is recorded as operating expenses in the statements of operations. Subsequent changes to the contingent consideration following the achievement of the gross margin target are recorded as ‘Interest expense’ in the statements of operations resulting from the passage of time and fixed payment schedule. The significant unobservable inputs used in the measurement of fair value include the probability of successful achievement of the specified product gross margin targets, the period in which the targets were expected to be achieved, and discount rates which ranged from 11 % to 13.5 %. As a result of the achievement of the gross margin target, the only significant unobservable input used in the measurement of fair value includes the discount rate since all other inputs became fixed and determinable. Significant increases or decreases in the discount rate would result in a significantly higher or lower fair value measurement. |
Warrant Liability | Warrant Liability Prior to the completion of the Company’s IPO in October 2020, certain warrants issued to purchase convertible preferred stock were classified as liabilities with changes in the estimated fair value of these liabilities recognized in our results of operations. Upon completion of the Company’s IPO in October 2020, the warrants were automatically converted to warrants to purchase common stock. Accordingly, the warrants were remeasured to an estimate of fair value and recognized in our results of operations and then reclassified to additional paid-in capital. |
Put Option Liability | Put Option Liability During 2020 and 2019, the Company issued convertible debt with terms that provided for a conversion rate to the convertible debtholders that was more favorable than the price that other investors would pay for common stock in certain situations, including the completion of an IPO. As a result, the convertible debt is a financial instrument that was bifurcated into two instruments, a debt obligation and a put option liability, which represented the estimated fair value of the favorable conversion rate. The estimated fair value of the put option liability was separated from the convertible debt at inception and reported as a liability and debt discount, and amortized to interest expense. As a result of our IPO, the convertible debt was automatically converted to common stock and the put option liability was remeasured to an estimate of fair value and recognized in our results of operations and then reclassified to additional paid-in capital. |
Share-Based Compensation | Share‑Based Compensation Stock Options The Company grants service condition and performance condition stock options. Stock options are granted with exercise prices equal to the fair market value of our common stock on the date of grant. The grant date fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model, which requires the use of assumptions, including the expected term of the option, expected volatility of our stock price, expected dividend yield, and the risk-free interest rate, among others. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. These assumptions involve inherent uncertainties including market conditions and employee behavior that are generally outside of the Company’s control. Service condition stock options are expensed based on the grant date fair value of the awards using the straight-line method over the requisite service period. Performance-condition stock options vest based on achievement of multiple weighted performance goals, certification of performance achievement by the Compensation Committee of the Board of Directors, and continued service. For performance-condition stock options, compensation expense is updated for our expected performance level against performance goals at the end of each reporting period, which involves judgment as to achievement of certain performance metrics. Restricted Stock Units (RSUs) The Company grants service-condition RSUs. As a result of our IPO, the grant date fair values of these RSUs are based on the closing market price of our common stock on the grant date. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. The service-condition RSUs vest based on continued service with compensation expense recognized on a straight-line basis over the requisite service period. See Note 12 — Share-Based Compensation for additional information related to share-based compensation. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding for the period, if dilutive, using the treasury stock method. Potentially dilutive securities consisting of options to purchase common stock, warrants to purchase common stock, RSUs and shares subject to purchase under our employee stock purchase plan were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. Until the Company’s IPO in October 2020, basic and diluted net loss attributable to common stockholders per share was calculated using the two-class method. The net loss was attributable entirely to common stockholders because the participating securities did not have a contractual obligation to share in the Company’s losses. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented. |
Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02 , Leases (ASC Topic 842). The new guidance maintains two classifications of leases: finance leases, which replace capital leases, and operating leases. Lessees will need to recognize a right-of-use asset and a lease liability on the balance sheet for those leases previously classified as operating leases under the old guidance. The liability will be equal to the present value of lease payments. The asset will be based on the liability, subject to adjustment, such as for direct costs. The accounting standard will be effective for the Company beginning January 1, 2022. Based on our current analysis we expect the adoption to result in the recognition of approximately $ 1.5 million of right of use assets and associated lease liabilities, inclusive of both lease and non-lease components, in our balance sheet and do not expect any material impact to our statement of operations or statement of cash flows. We are implementing new processes and internal controls over lease recognition, which will ultimately assist in the application of the new lease standard. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. This ASU requires measurement and recognition of expected credit losses for financial assets. This guidance will become effective for the Company beginning January 1, 2023 with early adoption permitted. The Company is currently evaluating this guidance and assessing the overall impact on its financial statements. |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Outstanding Borrowings | The fair values of outstanding borrowings, which are classified as Level 2, approximate their carrying values as of December 31, 2021 and 2020, based on interest rates currently available for similar borrowings and were (in thousands): As of December 31, 2021 2020 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 10,012 $ 10,012 $ 27,766 $ 27,766 |
Schedule of Reported Fair values of Contingent Consideration | The table below presents the reported fair values of contingent consideration, which is classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): As of December 31, Description 2021 2020 Current portion of contingent consideration $ 17,764 $ — Contingent consideration 16,028 29,932 Total contingent consideration $ 33,792 $ 29,932 |
Schedule of Changes in Contingent Consideration and Financial Liabilities | The following table presents the changes in contingent consideration for the year ended December 31, 2021 (in thousands): Year Ended Level 3 Rollforward December 31, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 2,238 Ending balances - December 31, 2021 $ 33,792 The following table presents the changes in these financial liabilities for the year ended December 31, 2020 (in thousands): For the Year Ended December 31, 2020 Level 3 Rollforward Contingent Put Warrant Contingent Beginning balances - January 1, 2020 $ 29,114 $ 3,261 $ 372 $ 60 Additions — 3,389 — — Changes in fair value 818 — 1,252 ( 60 ) Reclassified to additional paid-in capital — ( 6,650 ) ( 1,624 ) — Ending balances - December 31, 2020 $ 29,932 $ — $ — $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): As of December 31, 2021 2020 Lab equipment $ 6,784 $ 5,730 Leasehold improvements 2,339 1,845 Computer equipment 700 871 Furniture and fixtures 391 424 Software 600 651 Vehicles 97 — Construction in process 17 381 10,928 9,902 Less accumulated depreciation ( 6,749 ) ( 6,724 ) Total property and equipment, net $ 4,179 $ 3,178 |
Schedule of Depreciation Expense Related to Property and Equipment | Depreciation expense related to pr operty and equipment was: Year Ended December 31, 2021 2020 Direct costs and expenses $ 614 $ 361 Selling, marketing, general and administrative 614 478 Total $ 1,228 $ 839 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets, Excluding Goodwill | Intangible assets, excluding goodwill, consist of the following (in thousands): December 31, 2021 December 31, 2020 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,755 $ ( 566 ) $ 1,189 $ 1,474 $ ( 494 ) $ 980 Purchased technology 16,900 ( 6,572 ) 10,328 16,900 ( 4,694 ) 12,206 Intangible assets not subject to Trademarks 100 — 100 74 — 74 Total $ 18,755 $ ( 7,138 ) $ 11,617 $ 18,448 $ ( 5,188 ) $ 13,260 |
Schedule of Amortization Expense Related to Definite-Lived Intangible Assets | Amortization expense related to definite-lived intangible assets was (in thousands): Year Ended December 31, 2021 2020 Direct costs and expenses $ 5 $ 13 Sales, marketing, general and administrative 1,945 2,051 Total $ 1,950 $ 2,064 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): As of December 31, 2021 2020 Compensation related accruals $ 4,029 $ 3,975 Accrued clinical trial expense 870 715 Other expenses 2,766 3,099 Total accrued liabilities $ 7,665 $ 7,789 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Notes Payable | Long-term notes payable were as follows (in thousands): As of December 31, 2021 2020 2021 Term Loan $ 10,000 $ — 2018 Notes — 24,972 Paycheck Protection Program — 3,107 Other 75 — Unamortized debt discount and debt issuance costs ( 63 ) ( 313 ) 10,012 27,766 Less: current maturities 19 11,840 Long-term notes payable $ 9,993 $ 15,926 |
Scheduled Principal Repayments (Maturities) of Long-term Obligations | Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of 2022 $ 19 2023 15 2024 4,017 2025 4,818 2026 1,206 2027 and thereafter — Total $ 10,075 |
Warrants to Purchase Converti_2
Warrants to Purchase Convertible Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Summary of Activity for Convertible Preferred Stock Warrants | The following table presents the activity for convertible preferred stock warrants (in thousands, except weighted average exercise price): Series E Series G (1) Warrants Weighted Warrants Weighted Outstanding ‑ January 1, 2020 925 $ 5.00 613 $ 0.75 Granted — — — — Forfeited/canceled ( 925 ) ( 5.00 ) — — Exercised — — — — Reclassification of warrant liability to additional paid-in capital — — ( 613 ) ( 0.75 ) Outstanding ‑ December 31, 2020 — $ — $ — $ — (1) On October 27, 2020, all convertible preferred stock converted to common stock at the completion of our IPO, and as a consequence, the warrants to purchase Series G convertible preferred stock were converted to 103,326 warrants to purchase common stock at $ 4.46 per share, which have an expiration date of February 23, 2028 . All common stock warrants remain outstanding as of December 31, 2021. |
Revenue and Accounts Receivab_2
Revenue and Accounts Receivable Credit Concentration (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Summary of Revenue | Revenues consisted of the following (in thousands): Year Ended December 31, 2021 2020 Diagnostic tests $ 48,937 $ 40,919 Services 5,569 4,638 Total revenue $ 54,506 $ 45,557 |
Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers | The Company’s customers in excess of 10% of total revenue, and their related revenue as a percentage of total revenue were as follows: Year Ended December 31, 2021 2020 The Big Ten Conference 40 % 30 % Centura Healthcare 5 % 17 % The Company’s third-party payors and other customers in excess of 10% of accounts receivable, and their related accounts receivable as a percentage of total accounts receivable were as follows: As of December 31, 2021 2020 Medicare 30 % 6 % Janssen Research and Development, LLC 14 % 5 % LabCorp DD (formerly Covance) 11 % 2 % The Big Ten Conference — % 35 % Centura Healthcare — % 24 % |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Pre-tax Share-based Compensation Expense | Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Year Ended December 31, 2021 2020 Direct costs and expenses $ 49 $ — Research and development 572 589 Sales, marketing, general and administrative 4,323 3,120 Total $ 4,944 $ 3,709 |
Summary of Stock Option Activity | Stock option activity during the year ended December 31, 2021, excluding the Bonus Option Program described above, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Weighted Weighted Aggregate Outstanding - January 1, 2021 2,321 $ 1.82 7.4 $ 42,580 Granted 1,190 17.87 — — Forfeited/canceled ( 225 ) 7.22 — — Exercised ( 408 ) 1.51 — — Outstanding ‑ December 31, 2021 2,878 $ 8.08 7.7 $ 6,288 Exercisable ‑ December 31, 2021 1,428 $ 5.02 6.7 $ 3,849 |
Summary of Weighted Average Assumptions | The fair value of each option grant was estimated on the grant date with the following weighted average assumptions for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Expected term (in years) 6.01 5.73 Expected volatility 68.5 % 77.0 % Risk‑free rate 0.79 % 0.34 % Expected dividend yield — % — % |
Bonus-To-Options Program | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Option Activity | The Company recorded the following activity related to the Bonus Option Program during the year ended December 31, 2021 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Weighted Weighted Aggregate Outstanding ‑ January 1, 2021 173 $ 11.11 4.9 $ 1,723 Granted 266 20.67 — — Forfeited/canceled ( 46 ) 20.03 — — Exercised ( 20 ) 7.69 — — Outstanding ‑ December 31, 2021 373 $ 17.00 7.5 $ 76 Exercisable ‑ December 31, 2021 373 $ 17.00 7.5 $ 76 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted loss per share for the years ended December 31, 2021 and 2020 were (in thousands, except per share amounts): Year Ended December 31, 2021 2020 Numerator Net loss attributable to common stockholders $ ( 43,159 ) $ ( 31,350 ) Denominator Weighted-average shares outstanding used 27,365 4,838 Net loss per share, basic and diluted $ ( 1.58 ) $ ( 6.48 ) |
Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders | The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Year Ended December 31, 2021 2020 Options to purchase common stock 3,251 2,495 Shares committed under ESPP 30 — Warrants 103 103 Restricted stock units 151 79 Total 3,535 2,677 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate 21 % 21 % State income taxes, net of federal benefit 5 2 Research and developments credits 1 ( 1 ) Permanent items ( 1 ) ( 6 ) Change in valuation allowance ( 26 ) ( 16 ) Effective income tax rate — % — % |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred income tax assets and liabilities are as follows (in thousands): As of December 31, 2021 2020 Deferred Tax Assets: Net operating loss carryforwards $ 61,874 $ 53,128 Research and development tax credits 3,372 2,860 Interest expense limitation 554 — Property and equipment 215 279 Stock-based compensation 1,977 865 Accruals and reserves 1,618 1,406 Total 69,610 58,538 Valuation allowance ( 67,457 ) ( 56,083 ) Total deferred tax assets after valuation allowance 2,153 2,455 Deferred Tax Liabilities: Intangible assets ( 2,153 ) ( 2,455 ) Total deferred tax liabilities ( 2,153 ) ( 2,455 ) Net deferred tax assets and liabilities $ — $ — |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of beginning and ending balances for unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2021 2020 Balance at January 1 $ 715 $ — Additions for tax positions related to the current year 128 106 Additions for tax positions related to prior years — 609 Reductions for tax positions related to prior years — — Reductions related to settlements — — Reductions related to a lapse of statute — — Balance at December 31 $ 843 $ 715 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments Which Do Not Include Amounts for Common Area Maintenance, Insurance, or Taxes for Operating Lease Obligations | Future minimum lease payments, which do not include amounts for common area maintenance, insurance, or taxes, for operating lease obligations are as follows (in thousands): As of 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) $ / shares in Units, $ in Thousands | Oct. 27, 2020USD ($)$ / sharesshares | Dec. 31, 2021USD ($)Test$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares |
Organization And Description Of Business [Line Items] | |||
Number of blood based lung cancer test | Test | 5 | ||
Number of commercial blood-based test | Test | 2 | ||
Number of SARS-CoV-2 test | Test | 3 | ||
Common stock, shares authorized | 200,000,000 | 200,000,000 | |
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | |
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | |
Proceeds from initial public offering | $ | $ 72,000 | ||
Net proceeds | $ | $ 16,343 | ||
Initial Public Offering | |||
Organization And Description Of Business [Line Items] | |||
Shares of common stock issued and sold | 4,000,000 | ||
Common stock price per share | $ / shares | $ 18 | ||
Proceeds from initial public offering | $ | $ 63,800 | ||
Convertible preferred stock and convertible notes payable converted into shares of common stock | 21,939,025 | ||
Warrants to purchase shares of common stock | 103,326 | 103,326 | |
At-the-Money Offering | |||
Organization And Description Of Business [Line Items] | |||
Shares of common stock issued and sold | 3,756,994 | ||
Common stock price per share | $ / shares | $ 4.35 | ||
Gross proceeds from sale of common shares | $ | $ 16,300 | ||
Net proceeds | $ | $ 15,700 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Dec. 31, 2018USD ($) | Mar. 19, 2021USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Cash and cash equivalents | $ 32,712,000 | $ 62,126,000 | |||
Number of operating segments | Segment | 1 | ||||
Deferred revenue | $ 1,850,000 | 3,532,000 | |||
Impairment of long-lived assets | 0 | 0 | |||
Impairment of intangible assets | 0 | 0 | |||
Goodwill impairments loss | 0 | ||||
Integrated Diagnostics, Inc | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Business acquisition contingent consideration gross margin target | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | ||
Business acquisition contingent consideration gross margin target period | 7 years | ||||
Minimum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property, plant and equipment, useful Lives | 3 years | ||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 11.00% | ||||
Minimum | Product Life and Patent Life | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Finite-lived intangible asset, useful life | 9 years | ||||
Maximum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property, plant and equipment, useful Lives | 5 years | ||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 13.50% | ||||
Maximum | Product Life and Patent Life | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Finite-lived intangible asset, useful life | 10 years | ||||
Other Current Assets | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Restricted cash | $ 100,000 | 200,000 | |||
Inventory | 2,900,000 | $ 3,200,000 | |||
2021 Term Loan | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Notes/Loan payable | 10,000,000 | $ 30,000,000 | |||
Principal balance outstanding | $ 10,000,000 |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements - Additional Information (Details) $ in Millions | Dec. 31, 2021USD ($) |
Accounting Changes and Error Corrections [Abstract] | |
Right of use assets | $ 1.5 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other Assets Noncurrent |
Lease liabilities | $ 1.5 |
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Lease liabilities |
Business Combinations - Additio
Business Combinations - Additional Information (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)Installment | Dec. 31, 2018USD ($)Installmentshares | Dec. 31, 2020USD ($) | |
Business Acquisition [Line Items] | ||||
Goodwill | $ 15,031 | $ 15,031 | ||
Integrated Diagnostics, Inc | ||||
Business Acquisition [Line Items] | ||||
Business acquisition description | requires additional consideration to be paid by the Company to Indi upon attainment of a three-consecutive month | |||
Business acquisition contingent consideration gross margin target | $ 2,000 | $ 2,000 | $ 2,000 | |
Business acquisition contingent consideration gross margin target period | 7 years | |||
Integrated Diagnostics, Inc | Common Stock | ||||
Business Acquisition [Line Items] | ||||
Business acquisition description | If Indi elected to not exercise its option, the Company had 12 months to repurchase the common stock in two equal and consecutive quarterly cash installments totaling $37.0 million. | |||
Contingent consideration shares | shares | 2,520,108 | |||
Contingent consideration number of installments | Installment | 6 | 8 | ||
Contingent consideration arrangements, common shares, redemption amount | $ 4,600 | $ 37,000 | ||
Integrated Diagnostics, Inc | Common Stock | Repurchase | ||||
Business Acquisition [Line Items] | ||||
Contingent consideration number of installments | Installment | 2 | |||
Contingent consideration cash payment | $ 37,000 |
Fair Value - Summary of Fair Va
Fair Value - Summary of Fair Value of Outstanding Borrowings (Details) - Fair Value, Recurring - Level 2 - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Carrying Value | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Borrowings | $ 10,012 | $ 27,766 |
Fair Value | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Borrowings | $ 10,012 | $ 27,766 |
Fair Value - Schedule of Report
Fair Value - Schedule of Reported Fair values of Contingent Consideration (Details) - Fair Value, Recurring - Level 3 - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 33,792 | $ 29,932 |
Current Portion of Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | 17,764 | |
Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 16,028 | $ 29,932 |
Fair Value - Schedule of Change
Fair Value - Schedule of Changes in Contingent Consideration (Details) - Fair Value, Recurring - Level 3 - Contingent Consideration - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | $ 29,932 | $ 29,114 |
Changes in fair value | 1,622 | 818 |
Interest expense | 2,238 | |
Ending balances | $ 33,792 | $ 29,932 |
Fair Value - Schedule of Chan_2
Fair Value - Schedule of Changes in Financial Liabilities (Details) - Fair Value, Recurring - Level 3 - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | $ 29,932 | $ 29,114 |
Changes in fair value | 1,622 | 818 |
Ending balances | $ 33,792 | 29,932 |
Put Option Liability | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 3,261 | |
Additions | 3,389 | |
Reclassified to additional paid-in capital | (6,650) | |
Warrant Liability | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 372 | |
Changes in fair value | 1,252 | |
Reclassified to additional paid-in capital | (1,624) | |
Contingent Value Rights | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 60 | |
Changes in fair value | $ (60) |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) | Dec. 31, 2021USD ($)Installment$ / sharesshares | Mar. 19, 2021USD ($) | Jan. 31, 2022USD ($) | Sep. 30, 2020 | Jan. 31, 2016USD ($)shares | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)Installment$ / sharesshares | Dec. 31, 2020USD ($) | Dec. 31, 2018USD ($)Installmentshares | Oct. 27, 2020shares | Feb. 28, 2018USD ($)shares |
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Net change to contingent consideration | $ 1,622,000 | $ 818,000 | |||||||||
Put option liability | 3,400,000 | ||||||||||
Warrants, expires period | Feb. 23, 2028 | Feb. 23, 2028 | |||||||||
Estimated air value of warrants issued | $ 300,000 | $ 300,000 | |||||||||
Increase in value of the warrant liability | 1,252,000 | ||||||||||
IPO | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Warrant, exercise price | $ / shares | $ 4.46 | $ 4.46 | |||||||||
Warrant issued to purchase shares | shares | 103,326 | 103,326 | 103,326 | ||||||||
Series F Preferred Stock | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Contingent value rights shares | shares | 3,999 | ||||||||||
Contingent value rights | $ 500,000 | ||||||||||
Contingent value rights percentage | 0.00375% | ||||||||||
Net proceeds percentage of cash payment to the CVR holders | 15.00% | ||||||||||
Series F Preferred Stock | AVEO Oncology | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Percentage of development and regulatory costs exercised using opt-out right | 50.00% | ||||||||||
2018 Notes | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Repayments of Debt | $ 25,900,000 | ||||||||||
Estimated air value of warrants issued | $ 300,000 | ||||||||||
2018 Notes | Series G Preferred Stock | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Warrant issued to purchase shares | shares | 613,333 | 613,333 | 613,333 | ||||||||
Warrant, exercise price | $ / shares | $ 0.75 | $ 0.75 | |||||||||
Second Amendment | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Repayments of Debt | $ 20,000,000 | ||||||||||
Milestone payment | $ 4,600,000 | ||||||||||
Second Amendment | Subsequent Event | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Milestone payment | $ 4,600,000 | ||||||||||
Operating Expense | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Net change to contingent consideration | $ 800,000 | ||||||||||
Operating Expense | Loss | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Net change to contingent consideration | $ 1,600,000 | ||||||||||
Interest Expense | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Net change to contingent consideration | $ 2,200 | ||||||||||
Integrated Diagnostics, Inc | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Business acquisition description | requires additional consideration to be paid by the Company to Indi upon attainment of a three-consecutive month | ||||||||||
Business acquisition contingent consideration gross margin target | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | ||||||||
Business acquisition contingent consideration gross margin target period | 7 years | ||||||||||
Integrated Diagnostics, Inc | Common Stock | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Business acquisition description | If Indi elected to not exercise its option, the Company had 12 months to repurchase the common stock in two equal and consecutive quarterly cash installments totaling $37.0 million. | ||||||||||
Contingent consideration shares | shares | 2,520,108 | ||||||||||
Contingent consideration number of installments | Installment | 6 | 6 | 8 | ||||||||
Contingent consideration arrangements, common shares, redemption amount | $ 4,600,000 | $ 37,000,000 | |||||||||
Repayments of Debt | 9,300,000 | ||||||||||
Business combination contingent consideration final payment | $ 37,000,000 | ||||||||||
Integrated Diagnostics, Inc | Common Stock | Repurchase | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Contingent consideration number of installments | Installment | 2 | ||||||||||
Contingent consideration cash payment | $ 37,000,000 | ||||||||||
Minimum | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 11.00% | ||||||||||
Maximum | |||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 13.50% |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 10,928 | $ 9,902 |
Less accumulated depreciation | (6,749) | (6,724) |
Total property and equipment, net | 4,179 | 3,178 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,784 | 5,730 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 2,339 | 1,845 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 700 | 871 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 391 | 424 |
Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 600 | 651 |
Vehicles | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 97 | |
Construction in Process | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 17 | $ 381 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Depreciation Expense Related to Property and Equipment (Details) - Property and Equipment - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 1,228 | $ 839 |
Direct Costs and Expenses | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | 614 | 361 |
Selling, Marketing, General and Administrative | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 614 | $ 478 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Intangible Assets, Excluding Goodwill (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Net Carrying Value | $ 11,517 | |
Intangible assets, Cost | 18,755 | $ 18,448 |
Intangible assets, Accumulated Amortization | (7,138) | (5,188) |
Intangible assets, Net Carrying Value | 11,617 | 13,260 |
Trademarks | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets not subject to amortization, Cost | 100 | 74 |
Intangible assets not subject to amortization, Net Carrying Value | 100 | 74 |
Patents | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Cost | 1,755 | 1,474 |
Intangible assets subject to amortization, Accumulated Amortization | (566) | (494) |
Intangible assets subject to amortization, Net Carrying Value | 1,189 | 980 |
Purchased Technology | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Cost | 16,900 | 16,900 |
Intangible assets subject to amortization, Accumulated Amortization | (6,572) | (4,694) |
Intangible assets subject to amortization, Net Carrying Value | $ 10,328 | $ 12,206 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of Amortization Expense Related to Definite-Lived Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | $ 1,950 | $ 2,064 |
Direct Costs and Expenses | ||
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | 5 | 13 |
Sales, Marketing, General and Administrative | ||
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | $ 1,945 | $ 2,051 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Schedule of Amortization Related to Remaining Net Intangible Assets Schedule to Amortize (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Finite Lived Intangible Assets Future Amortization Expense [Abstract] | |
2022 | $ 1,975 |
2023 | 1,969 |
2024 | 1,959 |
2025 | 1,954 |
2026 | 1,941 |
2027 and thereafter | 1,719 |
Intangible assets subject to amortization, Net Carrying Value | $ 11,517 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Compensation related accruals | $ 4,029 | $ 3,975 |
Accrued clinical trial expense | 870 | 715 |
Other expenses | 2,766 | 3,099 |
Total accrued liabilities | $ 7,665 | $ 7,789 |
Debt - Summary of Long-term Not
Debt - Summary of Long-term Notes Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Mar. 19, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | Feb. 28, 2018 |
Debt Instrument [Line Items] | |||||
Unamortized debt discount and debt issuance costs | $ (63) | $ (313) | |||
Notes payable, total | 10,012 | 27,766 | |||
Less: current maturities | 19 | 11,840 | |||
Long-term notes payable | 9,993 | 15,926 | |||
2021 Term Loan | |||||
Debt Instrument [Line Items] | |||||
Notes/Loan payable | 10,000 | $ 30,000 | |||
2018 Notes | |||||
Debt Instrument [Line Items] | |||||
Notes/Loan payable | 24,972 | $ 23,000 | |||
PPP Loan | CARES Act | |||||
Debt Instrument [Line Items] | |||||
Notes/Loan payable | $ 3,107 | $ 3,100 | |||
Other | |||||
Debt Instrument [Line Items] | |||||
Notes/Loan payable | $ 75 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | Dec. 31, 2021 | Mar. 19, 2021 | Apr. 30, 2020 | Mar. 31, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 28, 2018 |
Debt Instrument [Line Items] | |||||||||
Estimated air value of warrants issued | $ 300,000 | $ 300,000 | |||||||
Cash and cash equivalents | 32,712,000 | 32,712,000 | $ 62,126,000 | ||||||
Gain (loss) on debt extinguishment | 2,298,000 | ||||||||
Estimated value of put option liability | 3,400,000 | ||||||||
Cash paid for interest | 1,676,000 | $ 1,844,000 | |||||||
Common Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument converted to common stock | 20,091,000 | ||||||||
2021 Term Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan principle amount | 10,000,000 | $ 30,000,000 | $ 10,000,000 | ||||||
Debt instrument frequency of periodic payment | monthly | ||||||||
Revenue milestone | $ 65,000,000 | ||||||||
Debt instrument, covenant description | The 2021 Term Loan requires the Company to comply with a minimum liquidity ratio covenant (as defined) by the 2021 Term Loan of not less than 0.95 to 1.00, and has a trailing six month rolling minimum revenue requirement of not less than 70% of the Company’s projected revenue performed at the end of each reporting period. | ||||||||
Debt instrument, covenant compliance | the Company was in compliance with all restrictive and financial covenants associated with its borrowings. | ||||||||
Debt instrument description | The 2021 Term Loan provides for an “interest-only” period from the Effective Date through February 28, 2023, with interest due and payable monthly on the first calendar day of each month. However, the Company achieved a revenue milestone of at least $65 million on a trailing twelve-month basis during the three months ended March 31, 2021 which automatically extended the interest-only period through February 28, 2024. Beginning on the first calendar day of the month following the end of the interest-only period, the 2021 Term Loan shall be payable in (i) consecutive equal installments of principal through March 1, 2026, plus (ii) monthly payments of accrued interest. The principal amount outstanding under the 2021 Term Loan shall accrue interest at a floating per annum rate equal to the greater of (i) 2.00% above the prime rate, or (ii) 5.25%, which interest, in each case, shall be payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate shall be effective on the effective date of any change to the prime rate. | ||||||||
Debt instrument maturity date | Mar. 1, 2026 | ||||||||
Repayments of Debt | $ 2,700,000 | ||||||||
2021 Term Loan | Prior to First Anniversary | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, prepayment penalty | 3.00% | ||||||||
2021 Term Loan | Prior to Second Anniversary | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, prepayment penalty | 2.00% | ||||||||
2021 Term Loan | After Second Anniversary, Prior to October 19, 2025 | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, prepayment penalty | 1.00% | ||||||||
2021 Term Loan | Thereafter | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, prepayment penalty | 0.00% | ||||||||
2021 Term Loan | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Minimum liquidity ratio covenant | 0.0095 | ||||||||
Percentage of minimum revenue requirement | 70.00% | 75.00% | |||||||
2021 Term Loan | Maximum | Forecast | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of minimum revenue requirement | 75.00% | ||||||||
2021 Term Loan Amendment | |||||||||
Debt Instrument [Line Items] | |||||||||
Restricted cash collateral account | 15,000,000 | $ 15,000,000 | |||||||
2021 Term Loan Amendment | Maximum | |||||||||
Debt Instrument [Line Items] | |||||||||
Cash and cash equivalents | 40,000 | $ 40,000 | |||||||
Second Amendment | |||||||||
Debt Instrument [Line Items] | |||||||||
Milestone payment | 4,600,000 | ||||||||
Gain (loss) on debt extinguishment | (100,000) | ||||||||
Partial repayments of debt | 20,000,000 | ||||||||
Prepayment fee waived amount | 600,000 | ||||||||
Write-off of debt issuance costs | 20,000,000 | ||||||||
Repayments of Debt | $ 20,000,000 | ||||||||
2018 Notes | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan principle amount | $ 24,972,000 | $ 23,000,000 | |||||||
Facility fee amount | 200,000 | ||||||||
Estimated air value of warrants issued | $ 300,000 | ||||||||
Interest rate | 10.00% | ||||||||
Percentage of interest rate, paid in cash | 7.50% | ||||||||
Percentage of interest rate added to principal value of notes payable | 2.50% | ||||||||
Interest added to principal value | 1,700,000 | 1,700,000 | |||||||
Gain (loss) on debt extinguishment | $ (700,000) | ||||||||
Repayments of Debt | $ 25,900,000 | ||||||||
2018 Notes | Series G Preferred Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Warrant issued to purchase shares | 613,333 | 613,333 | 613,333 | ||||||
PPP Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument description | The PPP Loan had a maturity date on the two-year anniversary of the funding date, April 2022, and included a fixed rate of 1.00% per annum. Monthly principal and interest payments, less the amount of any potential forgiveness (as discussed below), were scheduled to commence in September 2021. The Company did not provide any collateral or guarantees in connection with the PPP Loan, nor did the Company pay any facility charge to obtain the PPP Loan. | ||||||||
PPP Loan | Interest-bearing Deposits | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate | 1.00% | ||||||||
PPP Loan | CARES Act | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan principle amount | $ 3,100,000 | $ 3,107,000 | |||||||
Gain (loss) on debt extinguishment | $ 3,100,000 | ||||||||
Current portion of notes payable | $ 3,100,000 | ||||||||
Percentage for non-payroll costs | 40.00% | ||||||||
Upper limit of employee salary to reduce forgiveness | $ 100,000 | ||||||||
Percentage of upper limit of employee salary to reduce forgiveness | 25.00% | ||||||||
PPP Loan | Minimum | CARES Act | |||||||||
Debt Instrument [Line Items] | |||||||||
Payroll costs excludes compensation of an employee | $ 100,000 |
Debt - Scheduled Principal Repa
Debt - Scheduled Principal Repayments (Maturities) of Long-term Obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Maturities Of Long Term Debt [Abstract] | |
2022 | $ 19 |
2023 | 15 |
2024 | 4,017 |
2025 | 4,818 |
2026 | 1,206 |
2026 and thereafter | 0 |
Total | $ 10,075 |
Warrants to Purchase Converti_3
Warrants to Purchase Convertible Preferred Stock - Summary of Activity for Convertible Preferred Stock Warrants (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Series E Convertible Preferred Stock Warrants | |
Class Of Warrant Or Right [Line Items] | |
Outstanding - January 1, 2020, warrants | shares | 925 |
Forfeited/canceled, warrants | shares | (925) |
Weighted average exercise price, Outstanding - January 1, 2020, warrants | $ / shares | $ 5 |
Weighted average exercise price, Forfeited/canceled, warrants | $ / shares | $ (5) |
Series G Convertible Preferred Stock Warrants | |
Class Of Warrant Or Right [Line Items] | |
Outstanding - January 1, 2020, warrants | shares | 613 |
Reclassification of warrant liability to additional paid-in capital, warrants | shares | (613) |
Weighted average exercise price, Outstanding - January 1, 2020, warrants | $ / shares | $ 0.75 |
Weighted average exercise price, Reclassification of warrant liability to additional paid-in capital, warrants | $ / shares | $ (0.75) |
Warrants to Purchase Converti_4
Warrants to Purchase Convertible Preferred Stock - Summary of Activity for Convertible Preferred Stock Warrants (Parenthetical) (Details) - Series G Convertible Preferred Stock Warrants | Oct. 27, 2020$ / sharesshares |
Class Of Warrant Or Right [Line Items] | |
Warrants to purchase shares of common stock | shares | 103,326 |
Warrants expiration date | Feb. 23, 2028 |
Warrant, exercise price | $ / shares | $ 4.46 |
Equity - Additional Information
Equity - Additional Information (Details) - USD ($) | Oct. 27, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | |||
Common stock, authorized | 200,000,000 | 200,000,000 | |
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, voting rights | The holder of each share of common stock is entitled to one vote per share. | ||
Dividends | $ 0 | $ 0 | |
Proceeds from initial public offering | $ 72,000,000 | ||
Proceeds from the sale of common shares | $ 16,343,000 | ||
Preferred stock, authorized | 5,000,000 | 5,000,000 | |
Preferred stock, par value | $ 0.001 | $ 0.001 | |
Preferred stock, issued | 0 | 0 | |
Preferred stock, outstanding | 0 | 0 | |
Initial Public Offering | |||
Class Of Stock [Line Items] | |||
Shares of common stock issued and sold | 4,000,000 | ||
Common stock price per share | $ 18 | ||
Proceeds from initial public offering | $ 63,800,000 | ||
Underwriting discounts and commissions | 5,000,000 | ||
Direct offering expenses | $ 3,200,000 | ||
At-The-Market Offering | |||
Class Of Stock [Line Items] | |||
Shares of common stock issued and sold | 3,756,994 | ||
Common stock price per share | $ 4.35 | ||
Proceeds from the sale of common shares | $ 16,300,000 | ||
Net proceeds from sale of common shares after deducting underwriting discounts and commissions and offering expenses | 15,700,000 | ||
Underwriting discounts and commissions and offering expenses payable | $ 700,000 |
Revenue and Accounts Receivab_3
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 54,506 | $ 45,557 |
Diagnostic Tests | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | 48,937 | 40,919 |
Services | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 5,569 | $ 4,638 |
Revenue and Accounts Receivab_4
Revenue and Accounts Receivable Credit Concentration - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Primary sources of revenue, description | We derive our revenue from two primary sources: (i) providing diagnostic testing in the clinical setting (Diagnostic Tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, clinical trial testing, development and testing services generally provided outside the clinical setting and governed by individual contracts with third parties as well as development and commercialization of companion diagnostics (Services). | |
Revenue recognized | $ 3,000,000 | |
Deferred revenue | $ 1,850,000 | $ 3,532,000 |
Revenue | Minimum | Customer Concentration Risk | Medicare | ||
Disaggregation Of Revenue [Line Items] | ||
Concentration risk, percentage | 18.00% | 17.00% |
Other Long-term Liabilities | ||
Disaggregation Of Revenue [Line Items] | ||
Non-current deferred revenue | $ 800 | $ 1,400,000 |
Up Front Cash Payments | ||
Disaggregation Of Revenue [Line Items] | ||
Deferred revenue | $ 1,400,000 |
Revenue and Accounts Receivab_5
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers (Details) - Customer Concentration Risk - Minimum | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue | The Big Ten Conference | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 40.00% | 30.00% |
Revenue | Centura Healthcare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 5.00% | 17.00% |
Revenue | Medicare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 18.00% | 17.00% |
Accounts Receivable | The Big Ten Conference | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 35.00% | |
Accounts Receivable | Centura Healthcare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 24.00% | |
Accounts Receivable | Medicare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 30.00% | 6.00% |
Accounts Receivable | Janssen Research and Development, LLC | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 14.00% | 5.00% |
Accounts Receivable | LabCorp DD (formerly Covance) | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 11.00% | 2.00% |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Details) | Jan. 01, 2019$ / sharesshares | Dec. 31, 2021USD ($)Installment$ / sharesshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019shares | Oct. 31, 2020shares | Feb. 29, 2016shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of performance-condition options granted | 1,190 | |||||
Exercise price | $ / shares | $ 17.87 | |||||
Stock compensation expense | $ | $ 4,944,000 | $ 3,709,000 | ||||
Dividends | $ | $ 0 | 0 | ||||
Restricted Stock Units (RSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
RSUs outstanding | 150,811 | |||||
Weighted average grant date fair value | $ / shares | $ 5.30 | |||||
Bonus-To-Options Program | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of performance-condition options granted | 266,000 | |||||
Exercise price | $ / shares | $ 20.67 | |||||
Stock compensation expense | $ | $ 800,000 | $ 3,400,000 | ||||
Options and Restricted Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Unrecognized remaining stock based compensation balance | $ | $ 7,800,000 | |||||
Amortization period | 3 years 9 months 18 days | |||||
Service Condition R S Us | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of RSUs granted | 71,707 | |||||
Maximum | Bonus-To-Options Program | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option expiration period | 10 years | |||||
2020 Equity Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares reserved for issuance | 1,893,395 | |||||
2020 Equity Incentive Plan | Performance Condition Options | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option expiration period | 10 years | |||||
Vesting term | Performance-based options vest in three equal annual installments beginning one year after the grant date | |||||
Number of equal annual installments for award vesting | Installment | 3 | |||||
Number of performance-condition options granted | 168,466 | |||||
Exercise price | $ / shares | $ 0.77 | |||||
Options vested | 56,156 | 56,155 | ||||
Options forfeited | 56,155 | |||||
2020 Equity Incentive Plan | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option expiration period | 10 years | |||||
2020 Equity Incentive Plan | Common Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of number of shares of common stock issued and outstanding | 4.00% | |||||
2020 Equity Incentive Plan | Common Stock | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of common stock may be issued under incentive plan | 1,893,395 | |||||
2006 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Additional stock awards granted | 0 | |||||
2016 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Additional stock awards granted | 0 | |||||
2006 Plan, 2016 Plan and 2020 Equity Incentive Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Additional stock awards granted | 630,685 | |||||
Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares reserved for issuance | 295,251 | 338,106 | ||||
Percentage of number of shares of common stock issued and outstanding | 1.00% | |||||
Percentage of earnings used for purchase of common stock | 15.00% | |||||
Percentage of fair market value of common stock for purchase under plan | 85.00% | |||||
Description of voting power or value of stock for employee participation in offering period | No employee may participate in an offering period if the employee owns 5% or more of the total combined voting power or value of the Company’s stock. | |||||
Description of offering period under plan | The initial offering period was from January 1, 2021 through August 31, 2021. On a go-forward basis, the ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. As of December 31, 2021, 42,855 shares have been issued under the ESPP leaving 295,251 shares remaining for future issuance. | |||||
Number of common stock may be issued under incentive plan | 42,855 |
Share Based Compensation - Summ
Share Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2021 | 2,321,000 | |
Stock Options, Granted | 1,190 | |
Stock Options, Forfeited/canceled | (225) | |
Stock Options, Exercised | (408) | |
Stock Options, Outstanding - December 31, 2021 | 2,878,000 | 2,321,000 |
Stock Options, Exercisable - December 31, 2021 | 1,428 | |
Weighted Average Exercise Price, Outstanding - January 1, 2021 | $ 1.82 | |
Weighted Average Exercise Price, Granted | 17.87 | |
Weighted Average Exercise Price, Forfeited/canceled | 7.22 | |
Weighted Average Exercise Price, Exercised | 1.51 | |
Weighted Average Exercise Price, Outstanding - December 31, 2021 | 8.08 | $ 1.82 |
Weighted Average Exercise Price, Exercisable - December 31, 2021 | $ 5.02 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 7 years 8 months 12 days | 7 years 4 months 24 days |
Weighted Average Contractual Life (Years), Exercisable - December 31, 2021 | 6 years 8 months 12 days | |
Aggregate Intrinsic Value, Outstanding - January 1, 2021 | $ 42,580 | |
Aggregate Intrinsic Value, Outstanding - December 31, 2021 | 6,288 | $ 42,580 |
Aggregate Intrinsic Value, Outstanding - Exercisable - December 31, 2021 | $ 3,849 | |
Bonus-To-Options Program | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2021 | 173,000 | |
Stock Options, Granted | 266,000 | |
Stock Options, Forfeited/canceled | (46,000) | |
Stock Options, Exercised | (20,000) | |
Stock Options, Outstanding - December 31, 2021 | 373,000 | 173,000 |
Stock Options, Exercisable - December 31, 2021 | 373,000 | |
Weighted Average Exercise Price, Outstanding - January 1, 2021 | $ 11.11 | |
Weighted Average Exercise Price, Granted | 20.67 | |
Weighted Average Exercise Price, Forfeited/canceled | 20.03 | |
Weighted Average Exercise Price, Exercised | 7.69 | |
Weighted Average Exercise Price, Outstanding - December 31, 2021 | 17 | $ 11.11 |
Weighted Average Exercise Price, Exercisable - December 31, 2021 | $ 17 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 7 years 6 months | 4 years 10 months 24 days |
Weighted Average Contractual Life (Years), Exercisable - December 31, 2021 | 7 years 6 months | |
Aggregate Intrinsic Value, Outstanding - January 1, 2021 | $ 1,723 | |
Aggregate Intrinsic Value, Outstanding - December 31, 2021 | 76 | $ 1,723 |
Aggregate Intrinsic Value, Outstanding - Exercisable - December 31, 2021 | $ 76 |
Share Based Compensation - Su_2
Share Based Compensation - Summary of Pre-tax Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | $ 4,944 | $ 3,709 |
Direct Costs and Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | 49 | |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | 572 | 589 |
Sales, Marketing, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | $ 4,323 | $ 3,120 |
Share Based Compensation - Su_3
Share Based Compensation - Summary of Weighted Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions And Methodology [Abstract] | ||
Expected term (in years) | 6 years 3 days | 5 years 8 months 23 days |
Expected volatility | 68.50% | 77.00% |
Risk‑free rate | 0.79% | 0.34% |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 27,365,000 | 4,838,000 | ||
Integrated Diagnostics, Inc | ||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Business acquisition contingent consideration gross margin target | $ 2 | $ 2 | $ 2 | |
Business acquisition contingent consideration gross margin target period | 7 years | |||
Integrated Diagnostics, Inc | Common Stock | ||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Contingent consideration shares | 2,520,108 | |||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 2,520,108 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Computation of Basic and Diluted Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | ||
Net loss attributable to common stockholders | $ (43,159) | $ (31,350) |
Denominator | ||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 27,365 | 4,838 |
Net loss per share, basic and diluted | $ (1.58) | $ (6.48) |
Net Loss per Common Share - S_2
Net Loss per Common Share - Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 3,535 | 2,677 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 3,251 | 2,495 |
Shares Committed Under ESPP | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 30 | |
Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 103 | 103 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 151 | 79 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | |
Federal net operating loss carryforwards | 267,100,000 | |
Research and experimentation tax carryforwards | $ 4,200,000 | |
Description of tax credit carryforward expiration | expire beginning in 2026 | |
Valuation allowance, deferred tax asset, explanation of change | Company does not believe it is more likely than not that it will realize the benefits of net deferred tax assets and, accordingly, has established a valuation allowance equal to 100% of net deferred tax assets. | |
Percentage of valuation allowance equal to net deferred tax assets | 100.00% | |
Increase in valuation allowance | $ 11,400,000 | $ 7,000,000 |
Accrued interest related to uncertain tax positions | $ 0 | $ 0 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State income taxes, net of federal benefit | 5.00% | 2.00% |
Research and developments credits | 1.00% | (1.00%) |
Permanent items | (1.00%) | (6.00%) |
Change in valuation allowance | (26.00%) | (16.00%) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Tax Assets: | ||
Net operating loss carryforwards | $ 61,874 | $ 53,128 |
Research and development tax credits | 3,372 | 2,860 |
Interest expense limitation | 554 | |
Property and equipment | 215 | 279 |
Stock-based compensation | 1,977 | 865 |
Accruals and reserves | 1,618 | 1,406 |
Total | 69,610 | 58,538 |
Valuation allowance | (67,457) | (56,083) |
Total deferred tax assets after valuation allowance | 2,153 | 2,455 |
Deferred Tax Liabilities: | ||
Intangible assets | (2,153) | (2,455) |
Total deferred tax liabilities | $ (2,153) | $ (2,455) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | ||
Balance at January 1 | $ 715 | |
Additions for tax positions related to the current year | 128 | $ 106 |
Additions for tax positions related to prior years | 609 | |
Balance at December 31 | $ 843 | $ 715 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | Jan. 31, 2022 | May 13, 2021 | May 01, 2021 | Dec. 02, 2020 | Sep. 30, 2020 | Aug. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 31, 2016 |
Loss Contingencies [Line Items] | |||||||||
Rent expense | $ 1,200,000 | $ 1,700,000 | |||||||
Research and development | 12,789,000 | 10,818,000 | |||||||
Revenue Share Agreement | Oncimmune Limited | |||||||||
Loss Contingencies [Line Items] | |||||||||
Royalty expense | $ 700,000 | 300,000 | |||||||
Percentage of license agreement and royalty payment related to acquired diagnostic test recognized revenue for non-screening tests | 8.00% | ||||||||
Minimum annual volume percentage thereafter | 5.00% | ||||||||
Period of escalations of sales | through the first four years of sales | ||||||||
Litigation Claims and Assessments | |||||||||
Loss Contingencies [Line Items] | |||||||||
Accrued legal contingency | $ 210,000 | ||||||||
Litigation Claims and Assessments | Subsequent Event | |||||||||
Loss Contingencies [Line Items] | |||||||||
Final settlement payment to third parties | $ 210,000 | ||||||||
Bio-Rad License | |||||||||
Loss Contingencies [Line Items] | |||||||||
Percentage of royalty payments on net revenue | 2.50% | ||||||||
Percentage of royalty payments not required on net revenue | 2.50% | ||||||||
License expiry date | 2024-08 | ||||||||
Royalty expense | 100,000 | ||||||||
CellCarta License | |||||||||
Loss Contingencies [Line Items] | |||||||||
Percentage of royalty payments on net revenue | 0.675% | ||||||||
Royalty expense | 100,000 | ||||||||
Percentage of fee payments on net sales | 1.00% | ||||||||
Term of royalty payments from first commercial sale | 15 years | ||||||||
Year of ending royalty payments from first commercial sale | 2034 | ||||||||
AVEO Oncology | |||||||||
Loss Contingencies [Line Items] | |||||||||
Remaining estimated obligation | 100,000 | ||||||||
Research and development | $ 0 | $ 900,000 | |||||||
AVEO Oncology | NSCLC POC Trial | |||||||||
Loss Contingencies [Line Items] | |||||||||
Responsible percentage of development and regulatory costs | 50.00% | ||||||||
Ficlatuzumab | AVEO Oncology | |||||||||
Loss Contingencies [Line Items] | |||||||||
Percentage of development and regulatory costs exercised using opt-out right | 50.00% | ||||||||
Percentage of royalty payments on net sales | 10.00% | ||||||||
Percentage of license income generated from licensing | 25.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Future Minimum Lease Payments Which Do Not Include Amounts for Common Area Maintenance, Insurance, or Taxes for Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 775 |
2023 | 149 |
2024 | 9 |
2025 | 3 |
2026 | 1 |
Total | $ 937 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | Mar. 11, 2022USD ($)ft²RenewalOption$ / ft² | Mar. 07, 2022USD ($)shares | Dec. 31, 2021 |
Common Stock Purchase Agreement | Lincoln Park | |||
Subsequent Event [Line Items] | |||
Shares issued or issuable, threshold limit description | Under applicable rules of the Nasdaq Capital Market, in no event may the Company issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.20 per share, such that issuances and sales of the common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable Nasdaq rules. | ||
Centennial Valley Properties I, LLC Lease Agreement | |||
Subsequent Event [Line Items] | |||
Lease description | The initial term of the Lease will extend twelve years (the Initial Term) from the commencement date, which is the earlier of: (i) the Company conducting revenue generating business (as defined in the Lease), or (ii) April 1, 2023 (the Commencement Date), unless earlier terminated in accordance with the Lease. The Company has two renewal options to extend the term of the Lease for an additional seven or ten year terms for each renewal. | ||
Subsequent Event | Common Stock Purchase Agreement | Lincoln Park | |||
Subsequent Event [Line Items] | |||
Purchase agreement term | 36 months | ||
Stock issuable per day, number of shares | shares | 50,000 | ||
Maximum percentage of common stock allowed to purchase by counterparty | 9.99% | ||
Shares issued as commitment fee | shares | 184,275 | ||
Commitment shares issuable on conditional basis | shares | 61,426 | ||
Subsequent Event | Common Stock Purchase Agreement | Lincoln Park | Maximum | |||
Subsequent Event [Line Items] | |||
Common stock issuable, committed to purchase | $ 50,000,000 | ||
Stock issuable per day, number of shares | shares | 100,000 | ||
Stock issuable per day, value | $ 1,500,000 | ||
Shares issued as commitment fee, value | $ 20,000,000 | ||
Subsequent Event | Centennial Valley Properties I, LLC Lease Agreement | |||
Subsequent Event [Line Items] | |||
Lease term | 12 years | ||
Lease commencement date | Apr. 1, 2023 | ||
Lease agreement number of options to extend | RenewalOption | 2 | ||
Lease option to extend | true | ||
Leased property building capacity | ft² | 79,980 | ||
Base rent per month from commencement date | $ 227,000,000 | ||
Rent after fixed escalation provisions | $ 326,000,000 | ||
Area of leased premised obligated to pay base rent | ft² | 19,980 | ||
Landlord contribution towards cost of construction and tenant improvements | $ 18,800,000 | ||
Extra allowance amount per rentable square feet | $ / ft² | 25 | ||
Interest rate on extra allowance amount | 6.00% | ||
Subsequent Event | Centennial Valley Properties I, LLC Lease Agreement | Letter of Credit | |||
Subsequent Event [Line Items] | |||
Long-term Line of Credit | $ 5,000,000 | ||
Subsequent Event | Centennial Valley Properties I, LLC Lease Agreement | Letter of Credit | Cash Collateralized | |||
Subsequent Event [Line Items] | |||
Long-term Line of Credit | $ 5,000,000 | ||
Subsequent Event | Centennial Valley Properties I, LLC Lease Agreement | Minimum | |||
Subsequent Event [Line Items] | |||
Lease renewal term | 7 years | ||
Subsequent Event | Centennial Valley Properties I, LLC Lease Agreement | Maximum | |||
Subsequent Event [Line Items] | |||
Lease renewal term | 10 years |