Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 11, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
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 $0.001 per share | |
Trading Symbol | BDSX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 27,020,576 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 47,913 | $ 62,126 |
Accounts receivable, net of allowance for doubtful accounts of $168 and $180 | 2,784 | 15,304 |
Other current assets | 5,748 | 8,710 |
Total current assets | 56,445 | 86,140 |
Non‑current assets | ||
Property and equipment, net | 4,432 | 3,178 |
Intangible assets, net | 11,992 | 13,260 |
Other long-term assets | 2,097 | 3,461 |
Goodwill | 15,031 | 15,031 |
Total non‑current assets | 33,552 | 34,930 |
Total assets | 89,997 | 121,070 |
Current liabilities | ||
Accounts payable | 1,600 | 8,964 |
Accrued liabilities | 6,279 | 7,789 |
Deferred revenue | 1,760 | 3,532 |
Current portion of contingent consideration | 13,128 | |
Current portion of notes payable | 20 | 11,840 |
Total current liabilities | 22,787 | 32,125 |
Non‑current liabilities | ||
Long‑term notes payable, net of current portion | 29,975 | 15,926 |
Contingent consideration | 19,722 | 29,932 |
Other long-term liabilities | 1,480 | 1,921 |
Total non‑current liabilities | 51,177 | 47,779 |
Total liabilities | 73,964 | 79,904 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 (2021 and 2020) shares issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 shares authorized; 27,020,070 (2021) and 26,561,504 (2020) shares issued and outstanding | 27 | 27 |
Additional paid‑in capital | 304,697 | 299,953 |
Accumulated deficit | (288,691) | (258,814) |
Total stockholders' equity | 16,033 | 41,166 |
Total liabilities and stockholders' equity | $ 89,997 | $ 121,070 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable | $ 168 | $ 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 | 27,020,070 | 26,561,504 |
Common stock, outstanding | 27,020,070 | 26,561,504 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | $ 6,531 | $ 9,193 | $ 47,282 | $ 18,528 |
Operating expenses: | ||||
Direct costs and expenses | 2,722 | 3,891 | 28,025 | 7,346 |
Research and development | 3,293 | 2,706 | 9,937 | 7,713 |
Sales, marketing, general and administrative | 13,607 | 7,879 | 36,959 | 22,793 |
Change in fair value of contingent consideration | 957 | 1,622 | 957 | |
Total operating expenses | 19,622 | 15,433 | 76,543 | 38,809 |
Loss from operations | (13,091) | (6,240) | (29,261) | (20,281) |
Other income (expense): | ||||
Interest expense | (1,546) | (2,658) | (3,012) | (6,899) |
Change in fair value of warrant liability | (24) | 31 | ||
Gain on debt extinguishment, net | 3,123 | 2,395 | ||
Other income, net | 77 | 1 | 332 | |
Total other expense | 1,577 | (2,605) | (616) | (6,536) |
Net loss | $ (11,514) | $ (8,845) | $ (29,877) | $ (26,817) |
Net loss per share, basic and diluted | $ (0.41) | $ (31.93) | $ (1.09) | $ (99.69) |
Weighted-average shares outstanding, basic and diluted | 28,051 | 277 | 27,467 | 269 |
Condensed Statements of Convert
Condensed 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 | ||||
Temporary Equity Balance at Dec. 31, 2019 | $ 193,959 | ||||
Common Stock Balance, Shares at Dec. 31, 2019 | 255 | ||||
Exercise of stock options | 11 | 11 | |||
Exercise of stock options, shares | 20 | ||||
Net loss | (9,706) | (9,706) | |||
Balances at Mar. 31, 2020 | (234,834) | $ 1 | 2,335 | (237,170) | |
Temporary Equity Balance, Shares at Mar. 31, 2020 | 118,766 | ||||
Temporary Equity Balance at Mar. 31, 2020 | $ 193,959 | ||||
Common Stock Balance, Shares at Mar. 31, 2020 | 275 | ||||
Balances at Dec. 31, 2019 | (225,139) | $ 1 | 2,324 | (227,464) | |
Temporary Equity Balance, Shares at Dec. 31, 2019 | 118,766 | ||||
Temporary Equity Balance at Dec. 31, 2019 | $ 193,959 | ||||
Common Stock Balance, Shares at Dec. 31, 2019 | 255 | ||||
Net loss | (26,817) | ||||
Balances at Sep. 30, 2020 | (251,776) | $ 1 | 2,504 | (254,281) | |
Temporary Equity Balance, Shares at Sep. 30, 2020 | 118,766 | ||||
Temporary Equity Balance at Sep. 30, 2020 | $ 193,959 | ||||
Common Stock Balance, Shares at Sep. 30, 2020 | 290 | ||||
Balances at Mar. 31, 2020 | (234,834) | $ 1 | 2,335 | (237,170) | |
Temporary Equity Balance, Shares at Mar. 31, 2020 | 118,766 | ||||
Temporary Equity Balance at Mar. 31, 2020 | $ 193,959 | ||||
Common Stock Balance, Shares at Mar. 31, 2020 | 275 | ||||
Stock‑based compensation | 55 | 55 | |||
Net loss | (8,266) | (8,266) | |||
Balances at Jun. 30, 2020 | (243,045) | $ 1 | 2,390 | (245,436) | |
Temporary Equity Balance, Shares at Jun. 30, 2020 | 118,766 | ||||
Temporary Equity Balance at Jun. 30, 2020 | $ 193,959 | ||||
Common Stock Balance, Shares at Jun. 30, 2020 | 275 | ||||
Exercise of stock options | 14 | 14 | |||
Exercise of stock options, shares | 15 | ||||
Stock‑based compensation | 100 | 100 | |||
Net loss | (8,845) | (8,845) | |||
Balances at Sep. 30, 2020 | (251,776) | $ 1 | 2,504 | (254,281) | |
Temporary Equity Balance, Shares at Sep. 30, 2020 | 118,766 | ||||
Temporary Equity Balance at Sep. 30, 2020 | $ 193,959 | ||||
Common Stock Balance, Shares at Sep. 30, 2020 | 290 | ||||
Balances at Dec. 31, 2020 | 41,166 | $ 27 | 299,953 | (258,814) | |
Common Stock Balance, Shares at Dec. 31, 2020 | 26,562 | ||||
Exercise of stock options | 475 | 475 | |||
Exercise of stock options, shares | 223 | ||||
Stock‑based compensation | 1,752 | 1,752 | |||
Net loss | (6,961) | (6,961) | |||
Balances at Mar. 31, 2021 | 36,432 | $ 27 | 302,180 | (265,775) | |
Common Stock Balance, Shares at Mar. 31, 2021 | 26,785 | ||||
Balances at Dec. 31, 2020 | $ 41,166 | $ 27 | 299,953 | (258,814) | |
Common Stock Balance, Shares at Dec. 31, 2020 | 26,562 | ||||
Exercise of stock options, shares | 396,000 | ||||
Net loss | $ (29,877) | ||||
Balances at Sep. 30, 2021 | 16,033 | $ 27 | 304,697 | (288,691) | |
Common Stock Balance, Shares at Sep. 30, 2021 | 27,020 | ||||
Balances at Mar. 31, 2021 | 36,432 | $ 27 | 302,180 | (265,775) | |
Common Stock Balance, Shares at Mar. 31, 2021 | 26,785 | ||||
Exercise of stock options | 204 | 204 | |||
Exercise of stock options, shares | 164 | ||||
Stock‑based compensation | 539 | 539 | |||
Net loss | (11,402) | (11,402) | |||
Balances at Jun. 30, 2021 | 25,773 | $ 27 | 302,923 | (277,177) | |
Common Stock Balance, Shares at Jun. 30, 2021 | 26,949 | ||||
Issuance of common stock under employee stock purchase plan | 328 | 328 | |||
Issuance of common stock under employee stock purchase plan, Shares | 43 | ||||
Exercise of stock options | 60 | 60 | |||
Exercise of stock options, shares | 28 | ||||
Stock‑based compensation | 1,386 | 1,386 | |||
Net loss | (11,514) | (11,514) | |||
Balances at Sep. 30, 2021 | $ 16,033 | $ 27 | $ 304,697 | $ (288,691) | |
Common Stock Balance, Shares at Sep. 30, 2021 | 27,020 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (29,877) | $ (26,817) |
Adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities | ||
Depreciation and amortization | 2,323 | 2,174 |
Amortization of convertible notes debt discount | 4,389 | |
Gain on debt extinguishment, net | (2,395) | |
Stock‑based compensation expense | 3,677 | 155 |
Change in contingent consideration | 1,622 | 957 |
Provision for doubtful accounts | 193 | 113 |
Accrued interest, amortization of debt issuance costs and other | 1,607 | 1,165 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 12,327 | (217) |
Other current assets | 2,866 | (4,283) |
Other long-term assets and liabilities | 665 | (5) |
Accounts payable and other accrued liabilities | (9,262) | 5,369 |
Deferred revenue | (1,772) | 4,390 |
Net cash and cash equivalents and restricted cash used in operating activities | (18,026) | (12,610) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,711) | (1,483) |
Patent costs and intangible asset acquisition, net | (195) | (151) |
Payment to acquire Oncimmune assets | (750) | |
Net cash and cash equivalents and restricted cash used in investing activities | (1,906) | (2,384) |
Cash flows from financing activities | ||
Proceeds from issuance of convertible debt payable | 12,955 | |
Proceeds from issuance of common stock under employee stock purchase plan | 328 | |
Proceeds from exercise of stock options | 739 | 25 |
Proceeds from term loan and notes payable | 30,078 | 3,085 |
Repayment of term loan and notes payable | (25,424) | |
Payment of debt issuance costs | (96) | |
Other | (10) | |
Net cash and cash equivalents and restricted cash provided by financing activities | 5,625 | 16,055 |
Net (decrease) increase in cash and cash equivalents and restricted cash | (14,307) | 1,061 |
Cash, cash equivalents, and restricted cash ‑ beginning of period | 62,306 | 5,469 |
Cash, cash equivalents, and restricted cash ‑ end of period | $ 47,999 | $ 6,530 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 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 four blood-based lung cancer tests across the lung cancer continuum of care: • Nodify XL2® and Nodify CDT™ tests, marketed as 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. • GeneStrat® and VeriStrat® tests, marketed as our Biodesix Lung Reflex ® 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 targeted 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. COVID-19 Tests We operate and have commercialized the Biodesix WorkSafe • Bio-Rad SARS-CoV-2 ddPCR test, which is authorized by the FDA to be performed by Clinical Laboratory Institute 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X for interim financial information and reflect all adjustments necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. All such adjustments are of a normal recurring nature. Results for interim periods are not indicative of the results for the entire fiscal year. The accompanying Condensed Financial Statements should be read in conjunction with the audited Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Certain information and footnote disclosures, including significant accounting policies, normally included in fiscal year financial statements prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) have been condensed or omitted. The Condensed Balance Sheet as of December 31, 2020 was derived from the audited financial statements. 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 September 30, 2021, we maintained cash and cash equivalents of $47.9 million and we are fully drawn under our $30 million 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 initial public offering (IPO) in October 2020, the issuance of from 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 (November 15, 2021). Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations due on or before November 15, 2022 in considering whether it has the ability to meet its obligations for at least one year from the date of issuance of this Form 10-Q. 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 6 – Debt Due to 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 minimum liquidity covenant 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 our recent amendment 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 minimum liquidity covenant. 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. 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. Concentration 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 institution 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. Restricted cash consists of deposits related to the Company’s corporate credit cards and prior to March 31, 2021, also included a letter of credit related to an operating lease agreement. As of September 30, 2021 and December 31, 2020, the Company had $0.1 million and $0.2 million in restricted cash, respectively, which was included in ‘Other current assets’ in the accompanying balance sheets. Several of the components for certain of the Company's sample collection kits, test reagents, and test systems 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 September 30, 2021 and 2020, see Note 9 – Revenue and Accounts Receivable Credit Concentration 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 was $2.6 million and $3.2 million as of September 30, 2021 December 31, 2020 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. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 9 Months Ended |
Sep. 30, 2021 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Recently Issued Accounting Standards | Note 3 - Recently Issued Accounting Standards Standards Being Evaluated In February 2016, the FASB issued ASU No. 2016-02 , Leases 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 in our balance sheet and do not expect any material impact to our statement of operations or statement of cash flows . W e 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 |
Fair Value
Fair Value | 9 Months Ended |
Sep. 30, 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 September 30, 2021 and December 31, 2020, based on interest rates currently available for similar borrowings and were (in thousands): As of September 30, 2021 December 31, 2020 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 29,995 $ 29,995 $ 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 Integrated Diagnostics, Inc. (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): Description September 30, 2021 December 31, 2020 Current portion of contingent consideration $ 13,128 $ — Contingent consideration 19,722 29,932 Total contingent consideration $ 32,850 $ 29,932 The following table presents the changes in contingent consideration for the nine months ended September 30, 2021 (in thousands): Level 3 Rollforward For the Nine Months Ended September 30, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 1,296 Ending balances - September 30, 2021 $ 32,850 The following table presents the changes in these financial liabilities for the nine months ended September 30, 2020 (in thousands): For the Nine Months Ended September 30, 2020 Level 3 Rollforward Contingent Consideration Put Option Liability Warrant Liability Contingent Value Rights Beginning balances - January 1, 2020 $ 29,114 $ 3,261 $ 372 $ 60 Additions — 3,389 — — Changes in fair value 957 — 31 (60 ) Ending balances - September 30, 2020 $ 30,071 $ 6,650 $ 403 $ — 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. The contingent consideration arrangement requires additional consideration to be paid by the Company to such shareholders upon attainment of a three-consecutive month gross margin target of $2.0 million within the seven-year 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 each 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 2021 Term Loan Amendment for which we are currently in discussions with our lender. 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 13.5 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 three and nine months ended September 30, 2021 was zero and a loss of $1.6 million, respectively. The amount recorded as ‘Interest expense’ during the three and nine months ended September 30, 2021 was $1.0 million and $1.3 million, respectively. The net change to contingent consideration recorded as operating expenses during both the three and nine months ended September 30, 2020 was an expense of $1.0 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 the nine months ended September 30, 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 (see Note 6 – Debt 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 13 – Commitments and Contingencies 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. |
Supplementary Balance Sheet Inf
Supplementary Balance Sheet Information | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplementary Balance Sheet Information | Note 5 – Supplementary Balance Sheet Information Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Lab equipment $ 7,475 $ 5,730 Leasehold improvements 2,037 1,845 Computer equipment 871 871 Furniture and fixtures 424 424 Software 655 651 Vehicles 97 — Construction in process 268 381 11,827 9,902 Less: accumulated depreciation (7,395 ) (6,724 ) Total property and equipment, net $ 4,432 $ 3,178 Depreciation expense for the three and nine months ended September 30, 2021 was $0.3 million and $0.8 million, respectively, compared to $0.2 million and $0.6 million for the three and nine months ended September 30, 2020, respectively. Noncash purchases of property and equipment included in ‘Accounts payable’ as of September 30, 2021 totaled $0.4 million. Intangible assets, excluding goodwill, consist of the following (in thousands): September 30, 2021 December 31, 2020 Cost Accumulated Amortization Net Carrying Value Cost Accumulated Amortization Net Carrying Value Intangible assets subject to amortization Patents $ 1,667 $ (550 ) $ 1,117 $ 1,474 $ (494 ) $ 980 Purchased technology 16,900 (6,102 ) 10,798 16,900 (4,694 ) 12,206 Intangible assets not subject to amortization Trademarks 77 — 77 74 — 74 Total $ 18,644 $ (6,652 ) $ 11,992 $ 18,448 $ (5,188 ) $ 13,260 Amortization expense related to definite-lived intangible assets was $0.5 million and $1.5 million for the three and nine months ended September 30, 2021 and $0.5 million and $1.6 million for the three and nine months ended September 30, 2020, respectively. Future estimated amortization expense of intangible assets is (in thousands) : As of September 30, 2021 Remainder of 2021 $ 490 2022 1,959 2023 1,955 2024 1,948 2025 1,944 2026 and thereafter 3,619 Total $ 11,915 Accrued liabilities consist of the following (in thousands): September 30, 2021 December 31, 2020 Compensation related accruals $ 2,624 $ 3,975 Accrued clinical trial expense 909 715 Other expenses 2,746 3,099 Total accrued liabilities $ 6,279 $ 7,789 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 – 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): September 30, 2021 December 31, 2020 2021 Term Loan $ 30,000 $ — 2018 Notes — 24,972 Paycheck Protection Program — 3,107 Other 80 — Unamortized debt discount and issuance costs (85 ) (313 ) 29,995 27,766 Less: current maturities 20 11,840 Long-term notes payable $ 29,975 $ 15,926 2021 Term 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, a California corporation (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 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 period. On September 30, 2021, we entered into the Consent and First Amendment to Loan and Security Agreement (the 2021 Term Loan 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. 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 September 30, 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 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 o n August 17, 2021, the Company received legal release and formal notification that the PPP Loan was forgiven in full. As of and for the three months ended September 30, 2021, Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of September 30, 2021 Remainder of 2021 $ 5 2022 19 2023 15 2024 13,217 2025 14,418 2026 and thereafter 2,406 Total $ 30,080 Cash paid for interest was $1.3 million and $1.4 million for the nine months ended September 30, 2021 and 2020, respectively. |
Convertible Preferred Stock
Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2021 | |
Class Of Stock Disclosures [Abstract] | |
Convertible Preferred Stock | Note 7 - Convertible Preferred Stock Prior to its IPO in October 2020, the Company had issued convertible preferred stock from time to time to fund its operations and to make acquisitions. The Company’s convertible preferred stock was reported as temporary equity in the Company’s balance sheet because the preferred shareholders held a majority of the Company’s Board of Directors seats and as a result could have caused certain events to occur outside of the Company’s control, with the result the Company could have been obligated to redeem the convertible preferred stock. Immediately prior to the Company’s IPO and as of September 30, 2020, the Company had issued 118,766,273 convertible preferred shares. On October 27, 2020, upon closing of the Company’s IPO, each outstanding share of Series A-1 Preferred Stock, Series A-2 Preferred Stock, Series A-3 Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock, Series G Preferred Stock and Series H Preferred Stock automatically converted into 0.1684664 share of common stock; and each share of Series B-1 Preferred Stock automatically converted into 0.196 shares of common stock. In the aggregate, all series of preferred stock were converted into 20,090,745 shares of common stock. Subsequent to the Company’s IPO, there are no longer any series of convertible preferred stock outstanding. |
Warrants to Purchase Convertibl
Warrants to Purchase Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants to Purchase Convertible Preferred Stock | Note 8 – Warrants to Purchase 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. As of September 30, 2020 and through the closing of the Company’s IPO in October 2020, 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 outstanding as of September 30, 2020 (in thousands, except weighted average exercise price): Series E Series G (1) Warrants Weighted Average Exercise price Warrants Weighted Average Exercise price Outstanding ‑ January 1, 2020 925 $ 5.00 613 $ 0.75 Granted — — — — Forfeited/canceled (925 ) (5.00 ) — — Exercised — — — — Outstanding ‑ September 30, 2020 — — 613 $ 0.75 The warrants to purchase Series E convertible preferred stock were not exercised and expired during the three months ended June 2020. (1) |
Revenue and Accounts Receivable
Revenue and Accounts Receivable Credit Concentration | 9 Months Ended |
Sep. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue & Accounts Receivable Credit Concentration | Note 9 – 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 and historical price concessions granted to groups of customers. For diagnostic test revenue, the Company estimates the transaction price, which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on 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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Diagnostic tests $ 5,039 $ 8,552 $ 43,072 $ 15,798 Services 1,492 641 4,210 2,730 Total revenue $ 6,531 $ 9,193 $ 47,282 $ 18,528 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, $2.7 million was recognized in revenues. During the nine months ended September 30, 2021, $1.0 million was added to ‘Deferred revenue’ for up-front cash payments received for which the revenue recognition criteria have not been met. The ‘Deferred revenue’ of $1.8 million recorded in the balance sheet as of September 30, 2021 is expected to be recognized in revenues over the next twelve months as test results are delivered and services are performed. As of September 30, 2021 and December 31, 2020, the Company had $1.0 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: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 The Big Ten Conference — — 46 % — Merck 10 % — 1 % — Centura Healthcare — 26 % 6 % 19 % Percent of total revenue 10 % 26 % 53 % 19 % In addition to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for 36% and 14% of the Company’s total revenue for the three and nine months ended September 30, 2021, respectively, and 63% and 61% of total revenue for the three and nine months ended September 30, 2020. 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 September 30, 2021 December 31, 2020 Medicare 28 % 6 % Merck 21 % — The Big Ten Conference — 35 % Centura Healthcare — 24 % Percent of total accounts receivable 49 % 65 % |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | Note 10 – Share-Based Compensation The Company’s share-based compensation awards are issued under the 2020 Equity Incentive Plan (2020 Plan) and the predecessor 2016 Equity Incentive Plan (2016 Plan) and 2006 Equity Incentive Plan (2006 Plan). Any awards that expire or are forfeited under the 2016 Plan or 2006 Plan become available for issuance under the 2020 Plan. As of September 30, 2021, 691,918 shares of common stock remained available for future issuance under the 2020 Plan. Share-Based Compensation Expense Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Direct costs and expenses $ 18 $ — $ 37 $ — Research and development 141 10 465 20 Sales, marketing, general and administrative 1,227 90 3,175 135 Total $ 1,386 $ 100 $ 3,677 $ 155 Stock Option Activity Stock option activity during the nine months ended September 30, 2021, excluding the Bonus Option Program described below, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Aggregate Intrinsic Value Outstanding ‑ January 1, 2021 2,321 $ 1.82 7.4 $ 42,580 Granted 1,104 18.80 9.5 — Forfeited/canceled (163 ) 6.33 — — Exercised (396 ) 1.48 — — Outstanding ‑ September 30, 2021 2,866 $ 8.16 7.9 $ 11,312 Exercisable - September 30, 2021 1,349 $ 4.83 6.8 $ 6,606 Restricted Stock Units and Restricted Stock Activity As of September 30, 2021, there were 119,192 restricted stock units (RSUs) outstanding, with a weighted average grant date fair value of $5.13 per share. The remaining unrecognized stock‑based compensation expense for options and RSUs was approximately $8.6 million as of September 30, 2021, and is expected to be amortized to expense over the next 3.9 years. Bonus-to-Options Program As part of the Bonus-to-Options Program (Bonus Option Program), the Company recorded the following activity during the nine months ended September 30, 2021 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Aggregate Intrinsic Value Outstanding ‑ January 1, 2021 173 $ 11.11 4.9 $ 1,723 Granted 266 20.67 9.4 — Forfeited/canceled (46 ) 19.73 — — Exercised (20 ) 7.69 — — Outstanding ‑ September 30, 2021 373 $ 17.00 7.7 $ 343 Exercisable - September 30, 2021 373 $ 17.00 7.7 $ 343 During the three and nine months ended September 30, 2021, the Company accrued an insignificant amount and $0.7 million related to the estimate of the Bonus Option Program, respectively. During the three and nine months ended September 30, 2020, the Company did not accrue any amounts related to the estimate of the Bonus Option Program. Options granted, if any, pertaining to the performance of the Bonus Option Program are typically approved and granted in first quarter of the year following completion of the fiscal year. Employee Stock Purchase Plan A total of 338,106 shares of our common stock have been reserved for issuance under the Employee Stock Purchase Plan (ESPP). The initial offering period under the ESPP was from January 1, 2021 and concluded 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. |
Earnings per Share
Earnings per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Earnings per Share | Note 11 – Earnings Per 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. The number of common shares issuable upon assumed conversion of convertible debt was based on the Company’s estimated common stock price as of September 30, 2020 as determined by the Company’s Board of Directors with assistance from a valuation firm. In connection with the acquisition of Indi in 2018, the Company recorded contingent consideration (See Note 4 – Fair Value) seven-year As a result of the achievement of the gross margin target, the Company included the Basic and diluted loss per share for the three and nine months ended September 30, 2021 and 2020 were (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator Net loss attributable to common stockholders $ (11,514 ) $ (8,845 ) $ (29,877 ) $ (26,817 ) Denominator Weighted-average shares outstanding used in computing net loss per share, basic and diluted 28,051 277 27,467 269 Net loss per share, basic and diluted $ (0.41 ) $ (31.93 ) (1.09 ) (99.69 ) 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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Options to purchase common stock 2,866 2,843 2,866 2,843 Shares committed under ESPP 5 — 5 — Convertible preferred stock — 119,257 — 119,257 Warrants 103 613 103 613 Restricted stock units 119 79 119 79 Convertible debt — 20,746 — 20,746 Total 3,093 143,538 3,093 143,538 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 12 - Income Taxes Since inception, the Company has incurred net taxable losses, and accordingly, no provision for income taxes has been recorded. There was no cash paid for income taxes during the three and nine months ended September 30, 2021 and 2020. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 13 – Commitments and Contingencies Leases The Company leases facilities under non‑cancelable operating leases. Rent expense was $0.3 million and $0.9 million for the three and nine months ended September 30, 2021, respectively, and $0.4 million and $1.5 million for the three and nine months ended September 30, 2020, respectively. Future minimum lease payments for operating lease obligations are as follows (in thousands): As of September 30, 2021 Remainder of 2021 $ 187 2022 767 2023 140 Total $ 1,094 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. 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. The Company had $ million in remaining obligations related to the AVEO agreement as of September 30 , 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 three and nine months ended September 30, 2021. Expenses related to this agreement for the three and nine months ended September 30, 2020 were $0.3 million and $1.0 million, respectively. License Agreements 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 royalty of 2.5% on . 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 three and nine months ended September 30, 2021 was insignificant and $0.1 million, respectively. Revenue Share Agreement As part of the acquisition of the assets of Oncimmune USA, the Company entered into several agreements to govern the relationship between the parties. The Company agreed to a revenue share payment related to an acquired diagnostic test of 8% of recognized revenue for non-screening tests up to an annual minimum volume and 5% thereafter, with an escalating minimum through the first four years of sales. Revenue share expenses of $0.2 million and $0.5 were incurred for the three and nine months ended September 30, 2021, respectively, and $0.1 million and $0.2 million for the three and nine months ended September 30, 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 plaintiffs, which received preliminary approval from the Circuit Court of the City of St. Louis, State of Missouri on November 10 th |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X for interim financial information and reflect all adjustments necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. All such adjustments are of a normal recurring nature. Results for interim periods are not indicative of the results for the entire fiscal year. The accompanying Condensed Financial Statements should be read in conjunction with the audited Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Certain information and footnote disclosures, including significant accounting policies, normally included in fiscal year financial statements prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) have been condensed or omitted. The Condensed Balance Sheet as of December 31, 2020 was derived from the audited financial statements. 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 September 30, 2021, we maintained cash and cash equivalents of $47.9 million and we are fully drawn under our $30 million 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 initial public offering (IPO) in October 2020, the issuance of from 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 (November 15, 2021). Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations due on or before November 15, 2022 in considering whether it has the ability to meet its obligations for at least one year from the date of issuance of this Form 10-Q. 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 6 – Debt Due to 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 minimum liquidity covenant 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 our recent amendment 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 minimum liquidity covenant. 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. 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. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. |
Concentration of Credit Risk and Other Uncertainties | Concentration 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 institution 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. Restricted cash consists of deposits related to the Company’s corporate credit cards and prior to March 31, 2021, also included a letter of credit related to an operating lease agreement. As of September 30, 2021 and December 31, 2020, the Company had $0.1 million and $0.2 million in restricted cash, respectively, which was included in ‘Other current assets’ in the accompanying balance sheets. Several of the components for certain of the Company's sample collection kits, test reagents, and test systems 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 September 30, 2021 and 2020, see Note 9 – Revenue and Accounts Receivable Credit Concentration |
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 was $2.6 million and $3.2 million as of September 30, 2021 December 31, 2020 |
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. |
Fair Value (Tables)
Fair Value (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2021 and December 31, 2020, based on interest rates currently available for similar borrowings and were (in thousands): As of September 30, 2021 December 31, 2020 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 29,995 $ 29,995 $ 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): Description September 30, 2021 December 31, 2020 Current portion of contingent consideration $ 13,128 $ — Contingent consideration 19,722 29,932 Total contingent consideration $ 32,850 $ 29,932 |
Schedule of Changes in Contingent Consideration and Financial Liabilities | The following table presents the changes in contingent consideration for the nine months ended September 30, 2021 (in thousands): Level 3 Rollforward For the Nine Months Ended September 30, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 1,296 Ending balances - September 30, 2021 $ 32,850 The following table presents the changes in these financial liabilities for the nine months ended September 30, 2020 (in thousands): For the Nine Months Ended September 30, 2020 Level 3 Rollforward Contingent Consideration Put Option Liability Warrant Liability Contingent Value Rights Beginning balances - January 1, 2020 $ 29,114 $ 3,261 $ 372 $ 60 Additions — 3,389 — — Changes in fair value 957 — 31 (60 ) Ending balances - September 30, 2020 $ 30,071 $ 6,650 $ 403 $ — |
Supplementary Balance Sheet I_2
Supplementary Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Lab equipment $ 7,475 $ 5,730 Leasehold improvements 2,037 1,845 Computer equipment 871 871 Furniture and fixtures 424 424 Software 655 651 Vehicles 97 — Construction in process 268 381 11,827 9,902 Less: accumulated depreciation (7,395 ) (6,724 ) Total property and equipment, net $ 4,432 $ 3,178 |
Schedule of Intangible Assets, Excluding Goodwill | Intangible assets, excluding goodwill, consist of the following (in thousands): September 30, 2021 December 31, 2020 Cost Accumulated Amortization Net Carrying Value Cost Accumulated Amortization Net Carrying Value Intangible assets subject to amortization Patents $ 1,667 $ (550 ) $ 1,117 $ 1,474 $ (494 ) $ 980 Purchased technology 16,900 (6,102 ) 10,798 16,900 (4,694 ) 12,206 Intangible assets not subject to amortization Trademarks 77 — 77 74 — 74 Total $ 18,644 $ (6,652 ) $ 11,992 $ 18,448 $ (5,188 ) $ 13,260 |
Schedule of Future Estimated Amortization Expense of Intangible Assets | As of September 30, 2021 Remainder of 2021 $ 490 2022 1,959 2023 1,955 2024 1,948 2025 1,944 2026 and thereafter 3,619 Total $ 11,915 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, 2021 December 31, 2020 Compensation related accruals $ 2,624 $ 3,975 Accrued clinical trial expense 909 715 Other expenses 2,746 3,099 Total accrued liabilities $ 6,279 $ 7,789 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Notes Payable | Long-term notes payable were as follows (in thousands): September 30, 2021 December 31, 2020 2021 Term Loan $ 30,000 $ — 2018 Notes — 24,972 Paycheck Protection Program — 3,107 Other 80 — Unamortized debt discount and issuance costs (85 ) (313 ) 29,995 27,766 Less: current maturities 20 11,840 Long-term notes payable $ 29,975 $ 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 September 30, 2021 Remainder of 2021 $ 5 2022 19 2023 15 2024 13,217 2025 14,418 2026 and thereafter 2,406 Total $ 30,080 |
Warrants to Purchase Converti_2
Warrants to Purchase Convertible Preferred Stock (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Summary of Activity for Convertible Preferred Stock Warrants Outstanding | The following table presents the activity for convertible preferred stock warrants outstanding as of September 30, 2020 (in thousands, except weighted average exercise price): Series E Series G (1) Warrants Weighted Average Exercise price Warrants Weighted Average Exercise price Outstanding ‑ January 1, 2020 925 $ 5.00 613 $ 0.75 Granted — — — — Forfeited/canceled (925 ) (5.00 ) — — Exercised — — — — Outstanding ‑ September 30, 2020 — — 613 $ 0.75 (1) |
Revenue and Accounts Receivab_2
Revenue and Accounts Receivable Credit Concentration (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Summary of Revenue | Revenues consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Diagnostic tests $ 5,039 $ 8,552 $ 43,072 $ 15,798 Services 1,492 641 4,210 2,730 Total revenue $ 6,531 $ 9,193 $ 47,282 $ 18,528 |
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: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 The Big Ten Conference — — 46 % — Merck 10 % — 1 % — Centura Healthcare — 26 % 6 % 19 % Percent of total revenue 10 % 26 % 53 % 19 % As of September 30, 2021 December 31, 2020 Medicare 28 % 6 % Merck 21 % — The Big Ten Conference — 35 % Centura Healthcare — 24 % Percent of total accounts receivable 49 % 65 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Pre-tax Share-based Compensation Expense | Share-Based Compensation Expense Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Direct costs and expenses $ 18 $ — $ 37 $ — Research and development 141 10 465 20 Sales, marketing, general and administrative 1,227 90 3,175 135 Total $ 1,386 $ 100 $ 3,677 $ 155 |
Summary of Stock Option Activity | Stock option activity during the nine months ended September 30, 2021, excluding the Bonus Option Program described below, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Aggregate Intrinsic Value Outstanding ‑ January 1, 2021 2,321 $ 1.82 7.4 $ 42,580 Granted 1,104 18.80 9.5 — Forfeited/canceled (163 ) 6.33 — — Exercised (396 ) 1.48 — — Outstanding ‑ September 30, 2021 2,866 $ 8.16 7.9 $ 11,312 Exercisable - September 30, 2021 1,349 $ 4.83 6.8 $ 6,606 |
Bonus-To-Options Program | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Option Activity | As part of the Bonus-to-Options Program (Bonus Option Program), the Company recorded the following activity during the nine months ended September 30, 2021 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Exercise Price Weighted Average Contractual Life (Years) Aggregate Intrinsic Value Outstanding ‑ January 1, 2021 173 $ 11.11 4.9 $ 1,723 Granted 266 20.67 9.4 — Forfeited/canceled (46 ) 19.73 — — Exercised (20 ) 7.69 — — Outstanding ‑ September 30, 2021 373 $ 17.00 7.7 $ 343 Exercisable - September 30, 2021 373 $ 17.00 7.7 $ 343 |
Earnings per Share (Tables)
Earnings per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Loss per Share Attributable to Stockholders | Basic and diluted loss per share for the three and nine months ended September 30, 2021 and 2020 were (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator Net loss attributable to common stockholders $ (11,514 ) $ (8,845 ) $ (29,877 ) $ (26,817 ) Denominator Weighted-average shares outstanding used in computing net loss per share, basic and diluted 28,051 277 27,467 269 Net loss per share, basic and diluted $ (0.41 ) $ (31.93 ) (1.09 ) (99.69 ) |
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): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Options to purchase common stock 2,866 2,843 2,866 2,843 Shares committed under ESPP 5 — 5 — Convertible preferred stock — 119,257 — 119,257 Warrants 103 613 103 613 Restricted stock units 119 79 119 79 Convertible debt — 20,746 — 20,746 Total 3,093 143,538 3,093 143,538 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments for Operating Lease Obligations | Future minimum lease payments for operating lease obligations are as follows (in thousands): As of September 30, 2021 Remainder of 2021 $ 187 2022 767 2023 140 Total $ 1,094 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2021Test | |
Organization And Description Of Business [Abstract] | |
Number of blood based lung cancer test | 4 |
Number of commercial blood-based test | 2 |
Number of SARS-CoV-2 test | 3 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Mar. 19, 2021 | Dec. 31, 2020 |
Summary Of Significant Accounting Policies [Line Items] | |||
Cash and cash equivalents | $ 47,913 | $ 62,126 | |
Other Current Assets | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | 100 | 200 | |
Inventory | 2,600 | $ 3,200 | |
2021 Term Loan | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Notes/Loan payable | $ 30,000 | $ 30,000 |
Recently issued Accounting St_2
Recently issued Accounting Standards - Additional Information (Details) | Sep. 30, 2021USD ($) |
Accounting Changes And Error Corrections [Abstract] | |
Right of use assets | $ 1,500,000 |
Lease liabilities | $ 1,500,000 |
Fair Value - Summary of Fair Va
Fair Value - Summary of Fair Value of Outstanding Borrowings (Details) - Fair Value, Recurring - Level 2 - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Carrying Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 29,995 | $ 27,766 |
Fair Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 29,995 | $ 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 | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 32,850 | $ 29,932 |
Current Portion of Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | 13,128 | |
Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 19,722 | $ 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 | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 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 | 957 |
Interest expense | 1,296 | |
Ending balances | $ 32,850 | $ 30,071 |
Fair Value - Schedule of Chan_2
Fair Value - Schedule of Changes in Financial Liabilities (Details) - Fair Value, Recurring - Level 3 - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 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 | 957 |
Ending balances | $ 32,850 | 30,071 |
Put Option Liability | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 3,261 | |
Additions | 3,389 | |
Ending balances | 6,650 | |
Warrant Liability | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 372 | |
Changes in fair value | 31 | |
Ending balances | 403 | |
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) $ / shares in Units, $ in Thousands | Mar. 19, 2021USD ($) | Sep. 30, 2020 | Jan. 31, 2016USD ($)shares | Sep. 30, 2021USD ($)Installment$ / sharesshares | Jun. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)Installment$ / sharesshares | Sep. 30, 2020USD ($) | Dec. 31, 2018USD ($)Installmentshares | Feb. 28, 2018USD ($)shares |
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Net change to contingent consideration | $ 1,622 | $ 957 | ||||||||
Put option liability | $ 3,400 | $ 3,400 | ||||||||
Warrants, expires period | Feb. 23, 2028 | Feb. 23, 2028 | ||||||||
Estimated air value of warrants issued | $ 300 | $ 300 | ||||||||
Change in fair value of warrant liability | $ (24) | 31 | ||||||||
Initial Public Offering | ||||||||||
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 | ||||||||
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 | |||||||||
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 | |||||||||
Estimated air value of warrants issued | $ 300 | |||||||||
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 | ||||||||
Operating Expense | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Net change to contingent consideration | $ 0 | $ 1,000 | $ 1,000 | |||||||
Operating Expense | Loss | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Net change to contingent consideration | $ 1,600 | |||||||||
Interest Expense | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Net change to contingent consideration | $ 1,000 | $ 1,300 | ||||||||
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 such shareholders upon attainment of a three-consecutive month | |||||||||
Business acquisition contingent consideration gross margin target | $ 2,000 | $ 2,000 | ||||||||
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 | $ 37,000 | ||||||||
Repayments of Debt | 9,300 | |||||||||
Business combination contingent consideration final payment | $ 37,000 | |||||||||
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 | |||||||||
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% |
Supplementary Balance Sheet I_3
Supplementary Balance Sheet Information - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 11,827 | $ 9,902 |
Less: accumulated depreciation | (7,395) | (6,724) |
Total property and equipment, net | 4,432 | 3,178 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 7,475 | 5,730 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 2,037 | 1,845 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 871 | 871 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 424 | 424 |
Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 655 | 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 | $ 268 | $ 381 |
Supplementary Balance Sheet I_4
Supplementary Balance Sheet Information - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Property Plant And Equipment [Line Items] | ||||
Depreciation expense | $ 0.3 | $ 0.2 | $ 0.8 | $ 0.6 |
Amortization expense of definite-lived intangible assets | $ 0.5 | $ 0.5 | 1.5 | $ 1.6 |
Accounts Payable | ||||
Property Plant And Equipment [Line Items] | ||||
Noncash purchases of property and equipment | $ 0.4 |
Supplementary Balance Sheet I_5
Supplementary Balance Sheet Information - Intangible Assets, Excluding Goodwill (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Net Carrying Value | $ 11,915 | |
Intangible assets, Cost | 18,644 | $ 18,448 |
Intangible assets, Accumulated Amortization | (6,652) | (5,188) |
Intangible assets, Net Carrying Value | 11,992 | 13,260 |
Trademarks | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets not subject to amortization, Cost | 77 | 74 |
Intangible assets not subject to amortization, Net Carrying Value | 77 | 74 |
Patents | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Cost | 1,667 | 1,474 |
Intangible assets subject to amortization, Accumulated Amortization | (550) | (494) |
Intangible assets subject to amortization, Net Carrying Value | 1,117 | 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 | (6,102) | (4,694) |
Intangible assets subject to amortization, Net Carrying Value | $ 10,798 | $ 12,206 |
Supplementary Balance Sheet I_6
Supplementary Balance Sheet Information - Schedule of Amortization Related to Remaining Net Intangible Assets Schedule to Amortize (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Balance Sheet Related Disclosures [Abstract] | |
Remainder of 2021 | $ 490 |
2022 | 1,959 |
2023 | 1,955 |
2024 | 1,948 |
2025 | 1,944 |
2026 and thereafter | 3,619 |
Intangible assets subject to amortization, Net Carrying Value | $ 11,915 |
Supplementary Balance Sheet I_7
Supplementary Balance Sheet Information - Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Compensation related accruals | $ 2,624 | $ 3,975 |
Accrued clinical trial expense | 909 | 715 |
Other expenses | 2,746 | 3,099 |
Total accrued liabilities | $ 6,279 | $ 7,789 |
Debt - Summary of Long-term Not
Debt - Summary of Long-term Notes Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Mar. 19, 2021 | Dec. 31, 2020 | Apr. 30, 2020 | Feb. 28, 2018 |
Debt Instrument [Line Items] | |||||
Unamortized debt discount and issuance costs | $ (85) | $ (313) | |||
Notes payable, total | 29,995 | 27,766 | |||
Less: current maturities | 20 | 11,840 | |||
Long-term notes payable | 29,975 | 15,926 | |||
2021 Term Loan | |||||
Debt Instrument [Line Items] | |||||
Notes/Loan payable | 30,000 | $ 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 | $ 80 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | Mar. 19, 2021 | Apr. 30, 2020 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Feb. 28, 2018 |
Debt Instrument [Line Items] | ||||||||
Cash and cash equivalents | $ 47,913,000 | $ 47,913,000 | $ 62,126,000 | |||||
Estimated air value of warrants issued | 300,000 | 300,000 | ||||||
Gain (loss) on debt extinguishment | 3,123,000 | 2,395,000 | ||||||
Cash paid for interest | 1,300,000 | $ 1,400,000 | ||||||
2021 Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Notes/Loan payable | $ 30,000,000 | 30,000,000 | $ 30,000,000 | |||||
Debt instrument frequency of periodic payment | monthly | |||||||
Revenue milestone | $ 65,000,000 | |||||||
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 | |||||||
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. | |||||||
Loan principle amount | $ 30,000,000 | 30,000,000 | $ 30,000,000 | |||||
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 | 0.95 | |||||||
Percentage of minimum revenue requirement | 70.00% | |||||||
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 | $ 40,000,000 | $ 40,000,000 | ||||||
2018 Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Notes/Loan payable | 24,972,000 | $ 23,000,000 | ||||||
Repayments of Debt | $ 25,900,000 | |||||||
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) | |||||||
Loan principle amount | 24,972,000 | $ 23,000,000 | ||||||
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] | ||||||||
Notes/Loan payable | $ 3,100,000 | 3,107,000 | ||||||
Gain (loss) on debt extinguishment | $ 3,100,000 | |||||||
Loan principle amount | $ 3,100,000 | $ 3,107,000 | ||||||
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% | |||||||
Current portion of notes payable | $ 3,100,000 | $ 3,100,000 | ||||||
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 | Sep. 30, 2021USD ($) |
Maturities Of Long Term Debt [Abstract] | |
Remainder of 2021 | $ 5 |
2022 | 19 |
2023 | 15 |
2024 | 13,217 |
2025 | 14,418 |
2026 and thereafter | 2,406 |
Long-term debt | $ 30,080 |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) | Oct. 27, 2020shares | Sep. 30, 2020shares |
Class Of Stock [Line Items] | ||
Convertible preferred stock, issued | 118,766,273 | |
Number of preferred stock converted into common stock | 20,090,745 | |
Convertible preferred stock, outstanding | 0 | |
Series A-1 Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series A2 Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series A3 Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series B Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series C Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series D Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series E Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series F Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series G Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series H Convertible Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.1684664 | |
Series B1 Convertible Preferred Stock | ||
Class Of Stock [Line Items] | ||
Reverse stock split ratio | 0.196 |
Warrants to Purchase Converti_3
Warrants to Purchase Convertible Preferred Stock - Summary of Activity for Convertible Preferred Stock Warrants Outstanding (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 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 | $ / shares | $ (5) |
Series G Convertible Preferred Stock Warrants | |
Class Of Warrant Or Right [Line Items] | |
Outstanding - January 1, 2020, warrants | shares | 613 |
Outstanding - March 31, 2020, warrants | shares | 613 |
Weighted average exercise price, Outstanding - January 1, 2020, warrants | $ / shares | $ 0.75 |
Weighted average exercise price, Outstanding - March 31, 2020, warrants | $ / shares | $ 0.75 |
Warrants to Purchase Converti_4
Warrants to Purchase Convertible Preferred Stock - Summary of Activity for Convertible Preferred Stock Warrants Outstanding (Parenthetical) (Details) - Series G Convertible Preferred Stock Warrants | Oct. 27, 2020shares |
Class Of Warrant Or Right [Line Items] | |
Warrants to purchase shares of common stock | 103,326 |
Warrants expiration date | Feb. 23, 2028 |
Revenue and Accounts Receivab_3
Revenue and Accounts Receivable Credit Concentration - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | 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 | $ 2,700 | ||||
Deferred revenue | $ 1,760 | $ 1,760 | 3,532 | ||
Revenue | Minimum | Customer Concentration Risk | |||||
Disaggregation Of Revenue [Line Items] | |||||
Concentration risk, percentage | 10.00% | 26.00% | 53.00% | 19.00% | |
Revenue | Minimum | Customer Concentration Risk | Medicare | |||||
Disaggregation Of Revenue [Line Items] | |||||
Concentration risk, percentage | 36.00% | 63.00% | 14.00% | 61.00% | |
Up Front Cash Payments | |||||
Disaggregation Of Revenue [Line Items] | |||||
Deferred revenue | $ 1,000 | $ 1,000 | |||
Other Long-term Liabilities | |||||
Disaggregation Of Revenue [Line Items] | |||||
Non-current deferred revenue | $ 1,000 | $ 1,000 | $ 1,400 |
Revenue and Accounts Receivab_4
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Revenues | $ 6,531 | $ 9,193 | $ 47,282 | $ 18,528 |
Diagnostic Tests | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenues | 5,039 | 8,552 | 43,072 | 15,798 |
Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenues | $ 1,492 | $ 641 | $ 4,210 | $ 2,730 |
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 | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Revenue | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 10.00% | 26.00% | 53.00% | 19.00% | |
Revenue | The Big Ten Conference | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 46.00% | ||||
Revenue | Merck | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 10.00% | 1.00% | |||
Revenue | Centura Healthcare | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 26.00% | 6.00% | 19.00% | ||
Revenue | Medicare | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 36.00% | 63.00% | 14.00% | 61.00% | |
Accounts Receivable | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 49.00% | 65.00% | |||
Accounts Receivable | The Big Ten Conference | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 35.00% | ||||
Accounts Receivable | Merck | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 21.00% | ||||
Accounts Receivable | Centura Healthcare | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 24.00% | ||||
Accounts Receivable | Medicare | |||||
Concentration Risk [Line Items] | |||||
Concentration risk, percentage | 28.00% | 6.00% |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Aug. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock compensation expense | $ 1,386,000 | $ 100,000 | $ 3,677,000 | $ 155,000 | |
Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of shares reserved for issuance | 295,251 | 295,251 | 338,106 | ||
Shares issued | 42,855 | ||||
Description of offering period under plan | On a go-forward basis, the ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. | ||||
Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Restricted stock units outstanding | 119,192 | 119,192 | |||
Weighted average grant date fair value | $ 5.13 | $ 5.13 | |||
Options and Restricted Stock Units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Remaining unrecognized stock based compensation expense for options and RSUs | $ 8,600,000 | $ 8,600,000 | |||
Amortized to expense period | 3 years 10 months 24 days | ||||
Bonus-To-Options Program | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock compensation expense | $ 0 | $ 700,000 | $ 0 | ||
2020 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock remained available for future issuance | 691,918 | 691,918 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Pre-tax Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total pre-tax share-based compensation expense | $ 1,386 | $ 100 | $ 3,677 | $ 155 |
Direct Costs and Expenses | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total pre-tax share-based compensation expense | 18 | 37 | ||
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total pre-tax share-based compensation expense | 141 | 10 | 465 | 20 |
Sales, Marketing, General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total pre-tax share-based compensation expense | $ 1,227 | $ 90 | $ 3,175 | $ 135 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2021 | shares | 2,321 | |
Stock Options, Granted | shares | 1,104 | |
Stock Options, Forfeited/canceled | shares | (163) | |
Stock Options, Exercised | shares | (396) | |
Stock Options, Outstanding - September 30, 2021 | shares | 2,866 | 2,321 |
Stock Options Exercisable - September 30, 2021 | shares | 1,349 | |
Weighted Average Exercise Price, Outstanding - January 1, 2021 | $ / shares | $ 1.82 | |
Weighted Average Exercise Price, Granted | $ / shares | 18.80 | |
Weighted Average Exercise Price, Forfeited/canceled | $ / shares | 6.33 | |
Weighted Average Exercise Price, Exercised | $ / shares | 1.48 | |
Weighted Average Exercise Price, Outstanding - September 30, 2021 | $ / shares | 8.16 | $ 1.82 |
Weighted Average Exercise Price, Exercisable - September 30, 2021 | $ / shares | $ 4.83 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 7 years 10 months 24 days | 7 years 4 months 24 days |
Weighted Average Contractual Life (Years), Granted | 9 years 6 months | |
Weighted Average Contractual Life (Years), Exercisable - September 30, 2021 | 6 years 9 months 18 days | |
Aggregate Intrinsic Value, Outstanding - January 1, 2021 | $ | $ 42,580 | |
Aggregate Intrinsic Value, Outstanding - September 30, 2021 | $ | 11,312 | $ 42,580 |
Aggregate Intrinsic Value, Exercisable - September 30, 2021 | $ | $ 6,606 | |
Bonus-To-Options Program | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2021 | shares | 173 | |
Stock Options, Granted | shares | 266 | |
Stock Options, Forfeited/canceled | shares | (46) | |
Stock Options, Exercised | shares | (20) | |
Stock Options, Outstanding - September 30, 2021 | shares | 373 | 173 |
Stock Options Exercisable - September 30, 2021 | shares | 373 | |
Weighted Average Exercise Price, Outstanding - January 1, 2021 | $ / shares | $ 11.11 | |
Weighted Average Exercise Price, Granted | $ / shares | 20.67 | |
Weighted Average Exercise Price, Forfeited/canceled | $ / shares | 19.73 | |
Weighted Average Exercise Price, Exercised | $ / shares | 7.69 | |
Weighted Average Exercise Price, Outstanding - September 30, 2021 | $ / shares | 17 | $ 11.11 |
Weighted Average Exercise Price, Exercisable - September 30, 2021 | $ / shares | $ 17 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 7 years 8 months 12 days | 4 years 10 months 24 days |
Weighted Average Contractual Life (Years), Granted | 9 years 4 months 24 days | |
Weighted Average Contractual Life (Years), Exercisable - September 30, 2021 | 7 years 8 months 12 days | |
Aggregate Intrinsic Value, Outstanding - January 1, 2021 | $ | $ 1,723 | |
Aggregate Intrinsic Value, Outstanding - September 30, 2021 | $ | 343 | $ 1,723 |
Aggregate Intrinsic Value, Exercisable - September 30, 2021 | $ | $ 343 |
Earnings Per Share - Additional
Earnings Per Share - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2018 | |
Earnings Per Share Basic [Line Items] | ||||||
Weighted-average shares outstanding, basic and diluted | 28,051,000 | 277,000 | 27,467,000 | 269,000 | ||
Integrated Diagnostics, Inc | ||||||
Earnings Per Share Basic [Line Items] | ||||||
Business acquisition description | requires additional consideration to be paid by the Company to such shareholders upon attainment of a three-consecutive month | |||||
Business acquisition contingent consideration gross margin target | $ 2 | $ 2 | ||||
Business acquisition contingent consideration gross margin target period | 7 years | |||||
Integrated Diagnostics, Inc | Common Stock | ||||||
Earnings Per Share Basic [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 $37.0 million. | |||||
Contingent consideration shares | 2,520,108 | |||||
Weighted-average shares outstanding, basic and diluted | 2,520,108 |
Earnings per Share - Schedule o
Earnings per Share - Schedule of Computation of Basic and Diluted Loss per Share Attributable to Stockholders (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator | ||||||||
Net loss attributable to common stockholders | $ (11,514) | $ (11,402) | $ (6,961) | $ (8,845) | $ (8,266) | $ (9,706) | $ (29,877) | $ (26,817) |
Denominator | ||||||||
Weighted-average shares outstanding, basic and diluted | 28,051 | 277 | 27,467 | 269 | ||||
Net loss per share, basic and diluted | $ (0.41) | $ (31.93) | $ (1.09) | $ (99.69) |
Earnings per Share - Schedule_2
Earnings per Share - Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 3,093 | 143,538 | 3,093 | 143,538 |
Convertible Preferred Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 119,257 | 119,257 | ||
Options to Purchase Common Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 2,866 | 2,843 | 2,866 | 2,843 |
Shares Committed Under ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 5 | 5 | ||
Warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 103 | 613 | 103 | 613 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 119 | 79 | 119 | 79 |
Convertible Debt | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Total | 20,746 | 20,746 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 0 | |||
Cash paid for income taxes | $ 0 | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | May 13, 2021 | May 01, 2021 | Dec. 02, 2020 | Sep. 30, 2020 | Aug. 31, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Oct. 31, 2016 |
Loss Contingencies [Line Items] | ||||||||||
Rent expense | $ 300,000 | $ 400,000 | $ 900,000 | $ 1,500,000 | ||||||
Research and development | 3,293,000 | 2,706,000 | $ 9,937,000 | 7,713,000 | ||||||
Revenue Share Agreement | Oncimmune Limited | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Percentage of revenue share 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 | |||||||||
Revenue share expenses | 200,000 | 100,000 | $ 500,000 | 200,000 | ||||||
Litigation Claims and Assessments | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Estimated payment to third parties | 230,000 | |||||||||
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 | |||||||||
CellCarta License | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Percentage of royalty payments on net revenue | 0.675% | |||||||||
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 | |||||||||
Royalty expense | 100,000 | |||||||||
AVEO Oncology | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Remaining estimated obligation | 200,000 | |||||||||
Research and development | $ 0 | $ 300,000 | $ 0 | $ 1,000,000 | ||||||
AVEO Oncology | Ficlatuzumab | ||||||||||
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% | |||||||||
AVEO Oncology | NSCLC POC Trial | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Responsible percentage of development and regulatory costs | 50.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Future Minimum Lease Payments for Operating Lease Obligations (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Leases [Abstract] | |
Remainder of 2021 | $ 187 |
2022 | 767 |
2023 | 140 |
Total | $ 1,094 |