Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 02, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001439725 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-39659 | ||
Entity Registrant Name | Biodesix, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-3986492 | ||
Entity Address, Address Line One | 2970 Wilderness Place | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, City or Town | Boulder | ||
Entity Address, State or Province | CO | ||
Entity Address, Postal Zip Code | 80301 | ||
City Area Code | 303 | ||
Local Phone Number | 417-0500 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
ICFR Auditor Attestation Flag | false | ||
Trading Symbol | BDSX | ||
Security Exchange Name | NASDAQ | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Voluntary Filers | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 77,974,861 | ||
Entity Public Float | $ 34.1 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Denver, CO | ||
Auditor Firm ID | 185 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the Company’s definitive Proxy Statement for its 2023 Annual Meeting of Shareholders are to be incorporated by reference into Part III, as specifically set forth in Part III.) |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 43,088 | $ 32,712 |
Accounts receivable, net of allowance for doubtful accounts of $118 and $158 | 5,065 | 3,656 |
Other current assets | 5,181 | 7,245 |
Total current assets | 53,334 | 43,613 |
Non‑current assets | ||
Property and equipment, net | 5,848 | 4,179 |
Intangible assets, net | 9,797 | 11,617 |
Operating lease right-of-use assets | 2,973 | |
Goodwill | 15,031 | 15,031 |
Other long-term assets | 5,923 | 1,657 |
Total non‑current assets | 39,572 | 32,484 |
Total assets | 92,906 | 76,097 |
Current liabilities | ||
Accounts payable | 1,685 | 1,662 |
Accrued liabilities | 8,218 | 7,665 |
Deferred revenue | 962 | 1,850 |
Current portion of operating lease liabilities | 1,543 | |
Current portion of contingent consideration | 10,341 | 17,764 |
Current portion of notes payable | 49 | 19 |
Other current liabilities | 41 | |
Total current liabilities | 22,839 | 28,960 |
Non‑current liabilities | ||
Long-term notes payable, net of current portion | 25,004 | 9,993 |
Long-term operating lease liabilities | 5,254 | |
Contingent consideration | 18,645 | 16,028 |
Other long-term liabilities | 558 | 1,389 |
Total non‑current liabilities | 49,461 | 27,410 |
Total liabilities | 72,300 | 56,370 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value, 5,000,000 authorized; 0 (2022 and 2021) issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 authorized; 77,614,358 (2022) and 30,789,649 (2021) shares issued and outstanding | 78 | 31 |
Additional paid‑in capital | 387,948 | 321,669 |
Accumulated deficit | (367,420) | (301,973) |
Total stockholders' equity | 20,606 | 19,727 |
Total liabilities and stockholders' equity | $ 92,906 | $ 76,097 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable | $ 118 | $ 158 |
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 | 77,614,358 | 30,789,649 |
Common stock, outstanding | 77,614,358 | 30,789,649 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Revenues | $ 38,212 | $ 54,506 |
Operating expenses: | ||
Direct costs and expenses | 14,154 | 30,518 |
Research and development | 13,102 | 12,789 |
Sales, marketing, general and administrative | 61,462 | 50,517 |
Change in fair value of contingent consideration | 1,622 | |
Impairment loss on intangible assets | 81 | |
Total operating expenses | 88,799 | 95,446 |
Loss from operations | (50,587) | (40,940) |
Other (expense) income: | ||
Interest expense | (8,072) | (4,508) |
(Loss) gain on extinguishment of liabilities, net | (6,981) | 2,298 |
Change in fair value of warrant liability | 84 | |
Other income (loss), net | 109 | 9 |
Total other expense | (14,860) | (2,219) |
Net loss | $ (65,447) | $ (43,159) |
Net loss per share, basic | $ (1.55) | $ (1.58) |
Net loss per share, diluted | $ (1.55) | $ (1.58) |
Weighted-average shares outstanding, basic | 42,103,000 | 27,365,000 |
Weighted-average shares outstanding, diluted | 42,103,000 | 27,365,000 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balances at Dec. 31, 2020 | $ 41,166 | $ 27 | $ 299,953 | $ (258,814) |
Common Stock Balance, Shares at Dec. 31, 2020 | 26,562,000 | |||
Issuance of common stock, net shares | 3,757,000 | |||
Issuance of common stock, net | 15,679 | $ 4 | 15,675 | |
Issuance of common stock under employee stock purchase plan, Shares | 43,000 | |||
Issuance of common stock under employee stock purchase plan | 328 | 328 | ||
Exercise of stock options, shares | 428,000 | |||
Exercise of stock options | 769 | 769 | ||
Share-based compensation | 4,944 | 4,944 | ||
Net loss | (43,159) | (43,159) | ||
Balances at Dec. 31, 2021 | 19,727 | $ 31 | 321,669 | (301,973) |
Common Stock Balance, Shares at Dec. 31, 2021 | 30,790,000 | |||
Issuance of common stock, net shares | 45,705,000 | |||
Issuance of common stock, net | 56,235 | $ 46 | 56,189 | |
Issuance of common stock under employee stock purchase plan, Shares | 194,000 | |||
Issuance of common stock under employee stock purchase plan | 355 | 355 | ||
Issuance of common stock for deferred offering costs, Shares | 184,000 | |||
Issuance of common stock for deferred offering costs | $ 600 | 600 | ||
Exercise of stock options, shares | 384,000 | 384,000 | ||
Exercise of stock options | $ 269 | $ 1 | 268 | |
Release of restricted stock units, shares | 357,000 | |||
Issuance of Initial Warrants | 2,906 | 2,906 | ||
Share-based compensation | 5,961 | 5,961 | ||
Net loss | (65,447) | (65,447) | ||
Balances at Dec. 31, 2022 | $ 20,606 | $ 78 | $ 387,948 | $ (367,420) |
Common Stock Balance, Shares at Dec. 31, 2022 | 77,614,000 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (65,447) | $ (43,159) |
Adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities | ||
Depreciation and amortization | 3,597 | 3,178 |
Amortization of lease right-of-use assets | 2,247 | |
Loss (gain) on extinguishment of liabilities, net | 6,981 | (2,298) |
Share based compensation expense | 5,961 | 4,944 |
Change in fair value of warrant liability | (84) | |
Change in contingent consideration | 1,622 | |
Provision for doubtful accounts | 93 | 193 |
Accrued interest, amortization of debt issuance costs and other | 5,037 | 2,706 |
Inventory excess and obsolescence | 906 | 0 |
Impairment loss on intangible assets | 81 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,501) | 11,454 |
Other current assets | 1,113 | 1,369 |
Other long-term assets | (3,504) | 875 |
Accounts payable and other accrued liabilities | (773) | (7,425) |
Deferred revenue | (1,213) | (1,682) |
Tenant improvement allowances received | 2,471 | |
Current and long-term operating lease liabilities | (937) | |
Net cash and cash equivalents and restricted cash used in operating activities | (44,972) | (28,223) |
Cash flows from investing activities | ||
Purchase of property and equipment | (3,298) | (2,241) |
Patent costs and intangible asset acquisition, net | (236) | (306) |
Net cash and cash equivalents and restricted cash used in investing activities | (3,534) | (2,547) |
Cash flows from financing activities | ||
Proceeds from the issuance of common stock | 59,538 | 16,343 |
Proceeds from issuance of common stock under employee stock purchase plan | 355 | 328 |
Proceeds from exercise of stock options | 269 | 769 |
Payment of contingent consideration | (10,822) | |
Proceeds from term loan and notes payable | 45,102 | 30,078 |
Repayment of term loan and notes payable | (28,604) | (45,428) |
Payment of debt issuance costs | (3,725) | (164) |
Deferred offering costs | (129) | |
Equity financing costs | (3,069) | (664) |
Other | (33) | |
Net cash and cash equivalents and restricted cash provided by financing activities | 58,882 | 1,262 |
Net increase (decrease) in cash and cash equivalents and restricted cash | 10,376 | (29,508) |
Cash, cash equivalents, and restricted cash ‑ beginning of period | 32,798 | 62,306 |
Cash, cash equivalents, and restricted cash ‑ end of period | 43,174 | 32,798 |
Supplemental cash flow information | ||
Common stock issued for deferred offering costs | 600 | |
Deferred offering costs amortized against Additional paid-in capital | 75 | |
Issuance of Perceptive Warrants | 3,051 | |
Debt issuance costs included in Accounts payable and other accrued liabilities | 631 | 15 |
Equity financing costs included in Accounts payable and other accrued liabilities | 160 | |
Operating lease right-of-use assets obtained in exchange for lease liabilities at adoption of ASC 842 | 1,269 | |
Operating lease right-of-use assets obtained in exchange for lease liabilities | 3,936 | |
Finance lease right-of-use assets obtained in exchange for lease liabilities | 123 | |
Cash paid for interest | $ 1,009 | $ 1,676 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
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 and performs its blood-based diagnostic tests in its laboratory facilities, which are located in Boulder, Colorado and De Soto, Kansas. The Company conducts all of its operations within a single legal entity. Biodesix is a leading 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. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. We derive our revenue from two sources: (i) providing diagnostic testing services associated with (a) blood-based lung tests and (b) Coronavirus Disease 2019 (COVID-19) tests (Diagnostic Tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, 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). Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung strategy for lung cancer patients integrates the GeneStrat® ddPCR test, the GeneStrat NGS test and the VeriStrat® test to support treatment decisions across all stages of lung cancer. The Company also offers three SARS-CoV-2 tests. The Bio-Rad SARS-CoV-2 ddPCR test, the cPASS neutralization antibody test kit, and the Platelia SARS-CoV-2 Total Ab test have been granted Emergency Use Authorization (EUA) by the Federal Drug Administration (FDA) under Section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA). 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. The EUA declaration under Section 564 of the FDCA is distinct from and independent of the declaration by the Secretary of HHS of a public health emergency under Section 319 of the Public Health Service Act (the PHS Act). On January 30, 2023, the White House issued a Statement of Administration Policy announcing the President’s intention to allow the Public Health Emergency declaration under Section 319 to expire on May 11, 2023. Because the EUA declaration from the FDA is distinct from the declaration under Section 319 of the PHS Act, the FDA EUA may remain in effect beyond the duration of the Section 319 declaration. We cannot predict how long the EUAs for the SARS-CoV-2 tests will remain in place. 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 leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Blood-Based Lung Tests The Company offers five blood-based lung cancer tests across the lung cancer continuum of care: Diagnosis • Nodify XL2 and Nodify CDT tests, marketed as our Nodify Lung Nodule Risk Assessment testing strategy, assess a suspicious lung nodule's risk of lung cancer to help identify the most appropriate treatment pathway. We believe we are the only company to offer two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules. Treatment & Monitoring • GeneStrat ddPCR and VeriStrat tests, marketed as part of our IQLung testing strategy, are used following diagnosis of lung cancer to measure the presence of mutations in the tumor and the state of the patient’s immune system to establish the patient’s prognosis and help guide treatment decisions. The GeneStrat ddPCR tumor profiling test and the VeriStrat immune profiling test have a turnaround time of two business days, providing physicians with timely results to facilitate treatment decisions. • GeneStrat NGS (NGS) test, also marketed as part of our IQLung testing strategy, is our blood-based NGS test with results in three business days. The NGS test was launched in November 2021 to a select group of physicians, with national launch in January 2022. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced-stage lung cancer patients identify targeted therapy mutations in genes, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner. COVID-19 Tests We operate and have commercialized the Biodesix WorkSafe testing program, under which the Company offers three SARS-CoV-2 tests: • Bio-Rad SARS-CoV-2 ddPCR test, which is FDA EUA authorized 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 current infection by the SARS-CoV-2 virus. • Platelia SARS-CoV-2 Total Ab test, which is an antibody test, FDA EUA 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 a previous SARS-CoV-2 infection. This test was commercially introduced in partnership with GenScript Biotech Corporation. These tests under the Biodesix WorkSafe testing program are utilized by healthcare providers, including hospitals and nursing homes, and are also offered to businesses and educational systems. 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 | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation and Estimates The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; the estimation of the fair value of goodwill and other intangible assets; fair value of stock options; income tax uncertainties, including a valuation allowance for deferred tax assets; warrant liabilities; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recognized revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. As of December 31, 2022, we maintained cash and cash equivalents of $ 43.1 million and we have $ 30.0 million in outstanding aggregate principal amount on our Perceptive 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, the sale of convertible preferred stock, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which includes lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources, including the debt and equity funding and amendments to the Integrated Diagnostics, Inc. (Indi) Agreement, and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-K in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our loan agreement (see Note 8 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic and the associated impacts on the recovery of our diagnostic testing and services, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we continue to raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our existing loan agreement during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balances. We have taken steps to improve our liquidity through raising debt and equity capital during 2022, amendments to our 2021 Term Loan and amended the Indi Agreement to delay near term cash requirements and extend the period of milestone payments. We have also undertaken several proactive measures including, among other things, the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. On November 21, 2022, the Company funded and/or closed various financing transactions, including: (i) a term loan facility for up to $ 50.0 million, with funding of $ 30.0 million and the issuance of warrants exercisable into 3,000,000 shares of the Company’s common stock occurring on November 21, 2022, and two additional contingently issuable tranches of $ 10.0 million each subject to certain terms and conditions, including revenue milestones, (ii) a follow-on equity offering of common stock and (iii) a subscription agreement for the issuance of common stock to certain members of the Company’s management team. Collectively, the Company raised gross proceeds of approximately $ 70.7 million ($ 65.7 million after deducting commissions, fees and expenses payable). Approximately $ 23.9 million of the net proceeds were used to retire outstanding debt of the Company with Streeterville Capital, LLC and Silicon Valley Bank. 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 raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. We expect to continue to incur operating losses in the near term while we make investments to support our anticipated growth. 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 for a period beyond one year after these financial statements are issued. Our audited financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments that might be necessary should we be unable to continue as a going concern. Segment Reporting The Company has a single operating segment focused on providing diagnostic testing services to customers. All of the Company’s revenue and long-lived assets were derived or located in the United States for the years ended December 31, 2022 and 2021 . Revenue Recognition The Company generates revenues from (i) diagnostic tests and (ii) assay development and testing services (services revenue). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company determines the transaction price related to its blood-based lung diagnostic test contracts using a portfolio approach by considering the nature of the payer and historical price concessions granted to groups of customers. The transaction price associated with COVID-19 testing arrangements are determined on the basis of the individual contract with each customer. Services revenue consists of various types of tests or other scientific services for a purpose as defined by any individual customer, which are often larger biopharmaceutical companies, as defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or achievement of contractual milestone(s) as defined in the customer agreements. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach as discussed above. In determining the amount to accrue for a delivered test, the Company considers factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and the Company, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. Variable consideration, if any, is estimated based on an analysis of historical experience and adjusted as better estimates become available. These estimates require significant judgment by management. The Company also provides services to patients with whom the Company does not have contracts as defined in Financial Accounting Standards Board (FASB) Accounting Standards Codification 606 (ASC 606). The Company recognizes revenue for these patients when contracts, as defined in ASC 606, are established at the amount of consideration to which it expects to be entitled, or when the Company receives substantially all of the consideration subsequent to satisfaction and delivery of the performance obligations. Deferred revenue consists of payments received for research, development, and testing services fees received prior to the completion of performance of these tests and services. See Note 11 — Revenue and Accounts Receivable Credit Concentration for additional information. Direct Costs and Expenses The components of our cost of diagnostic tests and testing services consist of cost of materials, direct labor, including bonuses, benefit and share-based compensation, depreciation of laboratory equipment, rent costs, amortization of leasehold improvements and information technology costs associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing of license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. Costs associated with performing tests are expensed as the test is processed regardless of whether and when revenue is recognized with respect to that test. Research and Development Expenses Research and development expenses include external and internal costs incurred to develop our technology, collect clinical samples, and conduct clinical studies to develop and support our products. External costs consist primarily of payments to clinical trial sites, sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, process development and clinical development activities, infrastructure expenses, including allocated facility occupancy and information technology costs. Internal expenses include employee-related costs, including salaries, share-based compensation, and related benefits for employees engaged in research and development functions. The Company estimates and accrues its expenses resulting from its obligations under contracts with vendors and consultants in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payments that do not match the periods over which materials or services are provided under such contracts. The Company’s estimates depend on the timeliness and accuracy of the data provided by consultants and vendors regarding the status of each activity. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information received. Research and development costs are expensed as incurred. Sales, Marketing, General and Administrative Expenses Selling expenses consist primarily of costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel, and share-based compensation, as well as marketing and educational activities and allocated overhead expenses. Sales, marketing, general and administrative expenses also include costs for our marketing and sales organizations, and other functions including finance, legal, human resources, and information technology. These expenses consist principally of salaries, bonuses, employee benefits, travel, share-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and allocated overhead expenses. Concentrations of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial 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. 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, the Company could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of December 31, 2022 and 2021, see Note 11 – Revenue and Accounts Receivable Credit Concentration . Cash and Cash Equivalents Cash equivalents consist of short-term, highly-liquid instruments with an original maturity of three months or less from the date of purchase. Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit card. As of December 31, 2022 and 2021, the Company had $ 0.1 million restricted cash, respectively, which was included in ‘ Other current assets ’ in the accompanying balance sheets. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are stated at the amount management expects to collect from customers based on their outstanding invoices. Management reviews accounts receivable quarterly to determine if any receivable will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value based on historical experience, customer creditworthiness, facts, and circumstances specific to outstanding balances, and payment terms. Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to ‘Direct c osts and expenses’. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and was $ 1.4 million and $ 2.9 million as of December 31, 2022 and 2021 , respectively. The Company recorded a reserve for excess inventory of $ 0.1 million and zero , primarily associated with the wind down of the COVID-19 testing operation, as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021 , the Company recorded $ 0.9 million and zero , respectively, to the statement of operations for excess and obsolete inventory. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years . Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations in the period realized. Long-lived assets to be held and used are evaluated for impairment when events or circumstances indicate the carrying value of a long-lived asset or asset group is less than the undiscounted cash flows from the use and eventual disposition over its remaining useful life. The Company assesses recoverability by comparing the sum or projected undiscounted cash flows from the use and eventual disposition of the asset or asset group to its carrying value, and records an impairment loss if the carrying value is greater than the undiscounted future cash flows. There were no impairments for th e years ended December 31, 2022 and 2021 . Intangible Assets Intangible assets primarily consist of intangible assets acquired as part of business combinations, external costs associated with patent applications that are probable of future economic benefits, and trademark costs. Finite-lived intangibles are stated at cost, net of accumulated amortization. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 9 to 10 years , based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. Trademarks are considered indefinite lived and are not amortized. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate a reduction to fair value below their carrying amounts. There was an immaterial impairment during the year ended December 31, 2022 and there were no impairments for th e year ended December 31, 2021 . Goodwill Goodwill represents the excess of purchase price over amounts allocated to acquired assets and liabilities assumed in business combinations. The carrying value of goodwill is evaluated for impairment at least annually or more frequently when events or circumstances occur indicate a potential for impairment. The annual impairment test is performed on the last day of our fourth quarter. Prior to performing a quantitative evaluation, an assessment of qualitative factors may be performed to determine whether it is more likely than not that the fair value of the reporting unit exceeds its carrying value. In the event the Company determines that it is more likely than not the carrying value of our single reporting unit is higher than its estimated fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. Through December 31, 2022, there were no accumulated impairment losses. Other Assets As of December 31, 2022 , the Company has a $ 5.0 million cash refundable deposit to secure the performance of the Company’s obligations associated with the operating lease agreement with Centennial Valley Properties I, LLC (see Note 9 – Leases ). The $ 5.0 million refundable deposit is reported within 'Other long-term assets' in the balance sheet. 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, other long-term assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. Contingent Consideration In connection with the purchase transaction with Indi, the Company recorded contingent consideration for amounts potentially payable to Indi’s shareholder upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value through the date the gross margin target was achieved 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. Warrant Liability As consideration for the Perceptive Term Loan Facility (see Note 8 - Debt ), the Company issued a warrant to purchase common stock to the Lender of up to 5,000,000 shares of the Company's common stock (the Perceptive Warrant), with warrants exercisable into 3,000,000 shares of the Company’s common stock issued on the funding date of the Tranche A Loan (the Initial Warrants) as well as up to 2,000,000 additional warrants that are contingent upon the Company’s borrowing the remaining availability under the Perceptive Term Loan Facility (the Additional Warrants). The Initial Warrants are equity classified (see Note 10 - Equity ) while the Additional Warrants are classified as liabilities and subject to fair value measurement (see Note 4 – Fair Value ). Share‑Based Compensation Stock Options The Company grants service condition and performance condition stock options. Stock options are granted with exercise prices equal to the fair market value of our common stock on the date of grant. The grant date fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model, which requires the use of assumptions, including the expected term of the option, expected volatility of our stock price, expected dividend yield, and the risk-free interest rate, among others. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. These assumptions involve inherent uncertainties including market conditions and employee behavior that are generally outside of the Company’s control. Service condition stock options are expensed based on the grant date fair value of the awards using the straight-line method over the requisite service period. Performance-condition stock options vest based on achievement of multiple weighted performance goals, certification of performance achievement by the Compensation Committee of the Board of Directors, and continued service. For performance-condition stock options, compensation expense is updated for our expected performance level against performance goals at the end of each reporting period, which involves judgment as to achievement of certain performance metrics. Restricted Stock Units (RSUs) The Company grants service-condition RSUs. The grant date fair values of these RSUs are based on the closing market price of our common stock on the grant date. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. The service-condition RSUs vest based on continued service with compensation expense recognized on a straight-line basis over the requisite service period. See Note 12 — Share-Based Compensation for additional information related to share-based compensation. Income Taxe s The Company accounts for income taxes in accordance with ASC 740 - Income Taxes , under which deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year. In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results, or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required. A valuation allowance is recorded when it is more likely than not that a deferred tax asset will not be realized. The recorded valuation allowance is based on significant estimates and judgments and if the facts and circumstances change, the valuation allowance could materially change. In accounting for uncertainty in income taxes, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. See Note 14 — Income Taxes for additional information related to income taxes. Net Loss per Common Share Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding for the period, if dilutive, using the treasury stock method. Potentially dilutive securities consisting of options to purchase common stock, warrants to purchase common stock, RSUs and shares subject to purchase under our employee stock purchase plan were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. |
Recent Issued Accounting Standa
Recent Issued Accounting Standards | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
Recent Issued Accounting Standards | Note 3 – Recent Issued Accounting Standards Recently adopted accounting standards In February 2016, the FASB issued ASU No. 2016-2, Leases (ASC 842). This ASU intends to make accounting for leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and corresponding lease liability, including leases accounted for as operating leases. In addition to other related amendments, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements , which offers an additional transition method whereby entities may apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings rather than application of the new leases standard at the beginning of the earliest period presented in the financial statements. The Company elected this transition method and adopted ASC 842 on January 1, 2022 and as a result, recorded operating lease rig ht-of-use (ROU) assets of $ 1.3 million, including offsetting deferred rent of $ 0.1 million, along with the associated operating lease liabilities of $ 1.3 million. On January 1, 2022, the Company did not have any finance leases. The adoption of ASC 842 did not result in a cumulative effect adjustment to beginn ing retained earnings, and did not materially affect the Company's statement of operations, statement of stockholders' equity or statement of cash flows for the year ended December 31, 2022. In addition, the Company elected the following practical expedients permitted under the transition guidance within the new standard: • Package of practical expedients which allows the Company to carry forward the historical lease classification; • Hindsight practical expedient which allows the Company to use hindsight in determining the lease term, in assessing purchase options, and in assessing impairment of ROU assets; • Short-term lease practical expedient which allows the Company to capitalize only those leases with an initial term of twelve months or more, and; • The practical expedient to account for lease and non-lease components (such as common area maintenance, utilities, insurance and taxes) as a single lease component for all classes of underlying assets. For lease classification determination, Management continues to use (i) 75% or greater to determine whether the lease term is a major part of the remaining economic life of the underlying asset and (ii) 90% or greater to determine whether the present value of the sum of lease payments is substantially all of the fair value of the underlying asset. ROU assets represent the Company's right to use an underlying asset for the lease term. Lease liabilities represent the Company's obligation to make lease payments under the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses either the rate implicit in the lease or its incremental borrowing rate, as applicable, based on the information available at lease commencement date. The Company applies the estimated incremental borrowing rates on a lease-by-lease level based on the economic environment associated with the lease. The operating lease ROU asset also includes any lease prepayments, net of lease incentives. Certain of the Company's leases include options to extend or terminate the lease. As leases approach maturity, the Company considers various factors such as market conditions and the terms of any renewal and termination options that may exist to determine whether we will renew or terminate the lease, as such, we generally do not include renewal or termination options in our lease terms for calculating our lease liability, as the options allow us to maintain operational flexibility and we are not reasonably certain we will exercise these options at the time of the lease commencement. The Company's lease agreements do not contain any material residual value guarantees or restrictive covenants. Lease expense for lease payments of operating leases is recognized on a straight-line basis over the term of the lease. The Company uses the long-lived assets impairment guidance to determine recognition and measurement of an ROU asset impairment, if any. The Company monitors for events or changes in circumstances that require a reassessment. Additional information and disclosures required by this new standard are contained in Note 9 — Leases . Standards Being Evaluated In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments (ASC Topic 326). This ASU requires measurement and recognition of expected credit losses for financial assets. This guidance will become effective for the Company beginning January 1, 2023. The Company evaluated the guidance and determined the overall impact of the adoption will have an immaterial impact on our financial statements. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2022 | |
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 value of borrowings as of December 31, 2022 is primarily associated with the Perceptive Term Loan entered into with Perceptive Credit Holdings IV, LP, in November 2022 and was determined using a discounted cash flow analysis, excluding the fair value of Perceptive Warrant issued in conjunction with the transaction. The difference between the carrying value and fair value of outstanding borrowings as of December 31, 2022 is due to the debt issuance costs and the fair value of Perceptive Warrant netted against the Perceptive Term Loan. The carrying value of outstanding borrowings as of December 31, 2021, approximates fair value based on interest rates available at that time for similar borrowings. The table below presents the carrying and fair values of outstanding borrowings, which are classified as Level 2, as of the dates indicated (in thousands): As of December 31, 2022 2021 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 25,053 $ 26,785 $ 10,012 $ 10,012 The financial liabilities that are measured and recorded at estimated fair value on a recurring basis consist of our contingent consideration associated with our previous acquisition of Indi and the warrant liabilities granted as consideration for the Perceptive Term Loan Facility (see Note 8 - Debt ), which were accounted for as liabilities and remeasured through our statements of operations. The table below presents the reported fair values of contingent consideration and warrant liabilities, which are classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): As of December 31, Description 2022 2021 Current portion of contingent consideration $ 10,341 $ 17,764 Contingent consideration 18,645 16,028 Total contingent consideration $ 28,986 $ 33,792 Warrant liabilities $ 61 $ — The following table presents the changes in contingent consideration and warrant liabilities for the dates indicated (in thousands): For the year ended December 31, 2022 Level 3 Rollforward Contingent Consideration Warrant Liabilities Beginning balances - January 1, 2022 $ 33,792 $ — Additions — 145 Changes in fair value — ( 84 ) Interest expense 3,082 — Loss on extinguishment of liabilities 2,934 — Payments ( 10,822 ) — Ending balances - December 31, 2022 $ 28,986 $ 61 The following table presents the changes in contingent consideration as of the date indicated (in thousands): Level 3 Rollforward For the year ended December 31, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 2,238 Loss on extinguishment of liabilities — Payments of contingent consideration — Ending balances - December 31, 2021 $ 33,792 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 Indi APA). 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 period after the acquisition date. Under the terms of the original agreement, when the gross margin target was achieved the Company was required to issue 2,520,108 shares of common stock. For the six months following the achievement of the gross margin target, Indi had the option to require the Company to redeem these common shares for $ 37.0 million in cash over eight equal quarterly installments. If Indi elected to not exercise its option, the Company had 12 months to repurchase the common stock in two equal and consecutive quarterly cash installments totaling $ 37.0 million. The Company achieved 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 Milestone Payments and each individually a Milestone Payment). 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. On April 7, 2022, the Company entered into Amendment No. 3 to the Indi APA in which the parties agreed to restructure the Milestone Payments whereby the Company will make five quarterly installments of $ 2.0 million each beginning in April 2022, three quarterly installments of $ 3.0 million beginning in July 2023, one installment of $ 5.0 million in April 2024, and one installment of approximately $ 8.4 million in July 2024. In addition, the Company agreed to an exit fee of approximately $ 6.1 million in October 2024. Interest shall accrue on the difference between the payment schedule as agreed in the August 2021 amendment and the April 2022 amended payment schedule, at an aggregate per annum rate equal to 10 %, with such interest to be payable quarterly on the following installment payment date. Our ability to make these payments is subject to ongoing compliance under the Perceptive Term Loan and commencing January 1, 2024, consent from Perceptive (see Note 8 - Debt ). The contingent consideration liability is accounted for at fair value and subject to certain unobservable inputs. The significant unobservable inputs used in the measurement of the fair value include the probability of successful achievement of the specified product gross margin targets, the period in which the targets were expected to be achieved, and discount rates which ranged from 11 % to 16 %. As a result of the achievement of the gross margin target, the only remaining 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 could result in a significantly higher or lower fair value measurement. During the three months ended June 30, 2022, the Company recorded $ 1.1 million in interest expense due to the passage of time and fixed payment schedule, partially offset by a reduction to the contingent consideration balance of $ 1.0 million due to an increase in the discount rate to reflect current market and Company specific conditions, resulting in $ 0.1 million, net recorded as ‘ Interest expense ’ in the statements of operations. The Company evaluated Amendment No. 3 to the Indi APA in accordance with applicable accounting standards under U.S. GAAP which resulted in the extinguishment of the original instrument due to the substantially different terms. As a result, during the three months ended June 30, 2022, we recorded a loss on extinguishment of $ 2.9 million in the statements of operations. During the years ended December 31, 2022 and 2021, the Company recorde d $ 3.1 million and $ 2.2 million, r espectively, in interest expense due to the passage of time and fixed payment schedule. 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 achieved 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. Warrant liabilities On November 21, 2022, as consideration for the Perceptive Term Loan Facility (see Note 8 - Debt ), the Company issued the Perceptive Warrant to purchase up to 5,000,000 shares of the Company's common stock, including Initial Warrants and Additional Warrants. The Initial Warrants are equity classified (see Note 10 - Equity ) while the Additional Warrants are classified as liabilities within 'Other long-term liabilities' and recognized at fair value . The fair value of the Additional Warrants is determined using a Black-Scholes model and subject to certain unobservable inputs. The significant unobservable inputs used in the measurement of the fair value include the fair value of the Company's common stock, risk-free rate, the volatility of common stock which ranged from 78 % to 82 %, and the probability of the expected borrowing. Significant increases or decreases in the unobservable inputs could result in a significantly higher or lower fair value measurement. The Company determined the initial fair value of the Additional Warrants to be $ 0.1 million and during the year ended December 31, 2022 , the Company recorded $ 0.1 million as a change in fair value through the statement of operations due to changes in unobservable inputs. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 5 – Property and Equipment Property and equipment consist of the following (in thousands): As of December 31, 2022 2021 Lab equipment $ 6,035 $ 6,784 Leasehold improvements 2,365 2,339 Computer equipment 749 700 Furniture and fixtures 349 391 Software 324 600 Vehicles 97 97 Construction in process 2,947 17 12,866 10,928 Less accumulated depreciation ( 7,018 ) ( 6,749 ) Total property and equipment, net $ 5,848 $ 4,179 Depreciation expense related to pr operty and equipment was: Year Ended December 31, 2022 2021 Direct costs and expenses $ 591 $ 614 Selling, marketing, general and administrative 1,031 614 Total $ 1,622 $ 1,228 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Note 6 – Goodwill and Intangible Assets Intangible assets, excluding goodwill, consist of the following (in thousands): December 31, 2022 December 31, 2021 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,880 $ ( 647 ) $ 1,233 $ 1,755 $ ( 566 ) $ 1,189 Purchased technology 16,900 ( 8,450 ) 8,450 16,900 ( 6,572 ) 10,328 Intangible assets not subject to Trademarks 114 — 114 100 — 100 Total $ 18,894 $ ( 9,097 ) $ 9,797 $ 18,755 $ ( 7,138 ) $ 11,617 Amortization expense related to definite-lived intangible assets was (in thousands): Year Ended December 31, 2022 2021 Direct costs and expenses $ 2 $ 5 Sales, marketing, general and administrative 1,973 1,945 Total $ 1,975 $ 1,950 Future estimated amortization expense of intangible assets is (in thousands): As of 2023 $ 1,972 2024 1,963 2025 1,957 2026 1,943 2027 992 2028 and thereafter 856 Total $ 9,683 |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Note 7 – Accrued Liabilities Accrued liabilities consist of the following (in thousands): As of December 31, 2022 2021 Compensation related accruals $ 4,671 $ 4,029 Accrued clinical trial expense 1,232 870 Other expenses 2,315 2,766 Total accrued liabilities $ 8,218 $ 7,665 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Note 8 – Debt Our long-term debt primarily consists of notes payable associated with our Perceptive Term Loan which is described in further detail below. Long-term notes payable were as follows (in thousands): As of December 31, 2022 2021 Perceptive Term Loan $ 30,000 $ — 2021 Term Loan — 10,000 Other 127 75 Unamortized debt discount and debt issuance costs ( 5,074 ) ( 63 ) 25,053 10,012 Less: current maturities 49 19 Long-term notes payable $ 25,004 $ 9,993 Perceptive Term Loan Facility On November 16, 2022 (the Closing Date), the Company entered into a Credit Agreement and Guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP as the lender and administrative agent (the Lender). The Credit Agreement provides for a senior secured delayed draw term loan facility with Perceptive Advisors LLC (Perceptive), in an aggregate principal amount of up to $ 50.0 million (the Perceptive Term Loan Facility). The initial funding of the Perceptive Term Loan Facility was subject to a capital raise of at least $ 30.0 million in gross proceeds from an equity offering of the Company's common stock. On November 21, 2022 (the Funding Date), the Company raised approximately $ 40.6 million in gross proceeds from the sale of common stock (the Public Offering and November 2022 Subscription Agreements, together, "the Equity Offerings", see Note 10 - Equity ). The Tranche A Loan, in an aggregate amount of up to $ 30.0 million (the Tranche A Loan), was funded under the Perceptive Term Loan Facility substantially and concurrently with the closing of the Equity Offerings on the Funding Date. In addition to the Tranche A Loan, the Perceptive Term Loan Facility includes an additional Tranche B Loan, in an aggregate amount of up to $ 10.0 million, and an additional Tranche C Loan, in an aggregate amount of up to $ 10.0 million, which will be accessible by the Company so long as the Company satisfies certain customary conditions precedent, including revenue milestones. The Tranche B and C loans have loan commitments dates through December 31, 2023 and September 30, 2024, respectively. The Perceptive Term Loan Facility has a maturity date of November 21, 2027 (the Maturity Date) and provides for an interest-only period during the term of the loan with principal due at the Maturity Date. The Company's net proceeds from the Tranche A Loan were approximately $ 27.9 million, after deducting debt issuance costs and expenses. Interest Rate The Perceptive Term Loan Facility will accrue interest at an annual rate equal to the greater of (a) forward-looking one-month term SOFR as posted by CME Group Inc. and (b) 3.0 % per annum, plus an applicable margin of 9.0 %. As of December 31, 2022 , the stated interest rate was approximately 13.3 %. Amortization and Prepayment On the Maturity Date, the Company is required to pay the Lender the aggregate outstanding principal amount underlying the Loan and any accrued and unpaid interest thereon. Prior to the Maturity Date, there will be no scheduled principal payments under the Perceptive Term Loan Facility. The Perceptive Term Loan Facility may be prepaid at any time, subject to a prepayment premium equal to 2 % to 10 % of the aggregate outstanding principal amount being prepaid, depending on the date of prepayment. Security Instruments and Warrants Pursuant to a Security Agreement, dated as of the Funding Date (the Security Agreement), between the Company and the Lender, substantially all of the Company’s obligations under the Credit Agreement are secured by a first lien perfected security interest on all of the Company’s assets, subject to customary exceptions. As consideration for the Credit Agreement, the Company has issued, on the Funding Date, the Perceptive Warrant of up to 5,000,000 shares of the Company's common stock , including the Initial Warrants which are equity classified at a per share exercise price equal to $ 1.0648 which is equal to the lower of (A) the 10-day volume weighted average price (VWAP) of the Company’s common stock, on the business day immediately prior to the Closing Date of the Tranche A Loan or (B) the public offering price per share of Common Stock of $ 1.15 (see Note 10 - Equity ) . In addition to the Initial Warrants, the Additional Warrants will each become exercisable into 1,000,000 shares of common stock concurrently with the borrowing date of the Tranche B and C Loans, respectively. The per share exercise price for the Additional Warrants will be equal to the lower of (A) the Initial Warrant exercise price or (B) the 10-day VWAP ending on the business day immediately preceding the funding date of the Tranche B Loan or the Tranche C loan, res pectively. Each warrant will be exercisable, in whole or in part, until the 10th anniversary of the applicable date of issuance. If the Tranche B or C loans are not drawn by the respective loan commitment dates, the associated Additional Warrants expire and will not become exercisable. The Company accounts for the Additional Warrants as liabilities as the Additional Warrants do not meet the criteria for equity treatment (see Note 4 - Fair Value ). Representations, Warranties, Covenants, and Events of Default The Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants, financial covenants, and conditions that are customarily required for similar financings. The affirmative covenants, among other things, require the Company to undertake various reporting and notice requirements, maintain insurance and maintain in full force and effect all Regulatory Approvals, Material Agreements, Material Intellectual Property (each as defined in the Credit Agreement) and other rights, interests or assets (whether tangible or intangible) reasonably necessary for the operations of the Company’s business. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain Investments or Restricted Payments (each as defined in the Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that has the impact of restricting the Company’s ability to make loan repayments under the Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $ 2.5 million; and (ii) as of the last day of each fiscal quarter commencing on the fiscal quarter ending March 31, 2023, receive revenue in amounts agreed to between the Company and Perceptive from time to time. The Credit Agreement also contains certain customary Events of Default which include, among others, non-payment of principal, interest, or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross- defaults to material contracts, certain regulatory-related events and events constituting a change of control. As of December 31, 2022, the Company was in compliance with all restrictive and financial covenants associated with its borrowings. The occurrence of an Event of Default could result in, among other things, the declaration that all outstanding principal and interest under the Perceptive Term Loan Facility are immediately due and payable in whole or in part. The Initial Warrants and Additional Warrants were valued at $ 2.9 million and $ 0.1 million, respectively, using the Black-Scholes option-pricing model, estimated settlement probabilities and estimated exercise prices. As a result of the fees paid to Perceptive and the value of the Perceptive Warrant, the Company recognized a discount on the Perceptive Term Loan in the amount of $ 5.2 million. The Company recorded the debt discount as a reduction to the principal amount of the debt and is amortized as interest expense over the life of the debt. Securities Purchase Agreement On May 9, 2022 (the First Closing Date), the Company entered into a securities purchase agreement (the SPA) with Streeterville Capital, LLC (Streeterville), pursuan t to which, among other things, Streeterville: (i) purchased a secured promissory note (Promissory Note One) in the aggregate principal amount totaling $ 16.0 million in exchange for $ 15.0 million less certain expenses and (ii) agreed to purchase another secured promissory note at the Company’s election (Promissory Note Two and, together with Promissory Note One, the Promissory Notes), subject to certain conditions precedent in aggregate principal amount totaling $ 10.3 million in exchange for $ 10.0 million in cash proceeds. Each of the Promissory Notes, at the Company's option, could be settled in cash or shares of common stock of the Company, upon the terms and subject to the limitations and conditions set forth in the Promissory Notes. The Company's net proceeds from the issuance of Promissory Note One were approximately $ 12.8 million, after deducting debt issuance costs and original issue discount (OID). The Promissory Notes had a stated interest rate of 6 % per annum. The maturity date of each Promissory Note was 24 months from the issuance date of such Note. Promissory Note One was issued with an OID of $ 1.0 million while Promissory Note Two, if issued, would have been subject to an OID of $ 0.3 million subject to certain contingencies which could increase the OID by an additional $ 0.5 million. The Promissory Notes were eligible for early payment for cash, at the Company’s election, subject to a prepayment premium of 10 % of the outstanding principal balance. During the year ended December 31, 2022, the Company recorded $ 1.8 million for accrued interest, amortization of the OID and debt issuance costs to interest expense in the accompanying statements of operations. Substantially and concurrently with the completion of the Equity Offerings, the Company fully repaid all outstanding principal, accrued and unpaid interest, and prepayment and other fees due under the existing SPA with Streeterville in the amount of $ 18.2 million. As a result of the extinguishment of Promissory Note One, t he Company recorded a loss on debt extinguishment of $ 3.6 million during the three months ended December 31, 2022, associated with the prepayment premium and with the write-off of unamortized debt issuance costs and OID. 2021 Term Loan On March 19, 2021 (Effective Date), the Company entered into a Loan and Security Agreement (the 2021 Term Loan) by and between Silicon Valley Bank, a California corporation (SVB) 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 provided 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 was 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 accrued 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, was payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate were effective on the effective date of any change to the prime rate. The Company’s final payment to SVB included a payment of $ 2.7 million and was amortized as interest expense over the term of the 2021 Term Loan. During the year ended December 31, 2022 and through the Closing Date of the Perceptive Term Loan Facility, the Company repaid $ 7.0 million in outstanding principal on the 2021 Term Loan. Substantially and concurrently with the completion of the Equity Offerings, the Company fully repaid all outstanding principal, accrued and unpaid interest, and other fees due under the existing 2021 Term Loan with SVB in the amount of $ 5.7 million, which included $ 3.0 million in remaining outstanding principal. As a result of the extinguishment of the 2021 Term Loan, t he Company recorded a loss on debt extinguishment of $ 0.4 million during the three months ended December 31, 2022, associated with the final payment and the write-off of unamortized debt issuance costs. Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of 2023 $ 49 2024 50 2025 21 2026 7 2027 30,000 2028 and thereafter — Total $ 30,127 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Note 9 – Leases Operating Leases The Company acts as a lessee under all its lease agreements. The Company leases its headquarters and laboratory facilities in Boulder, Colorado, under a non-cancelable lease agreement for approximately 29,722 square feet that was set to expire in January 2023 . In January 2022, the Company amended the agreement to extend the lease agreement through January 2024 , resulting in an additional $ 1.2 million in ROU assets and lease liabilities recorded during the three months ended March 31, 2022. The Company also leases laboratory and office space in De Soto, Kansas, under a non-cancelable lease agreement for approximately 9,066 square feet that expires in October 2023, however, we are currently in discussions to extend this lease agreement . The Company also holds various copier and storage facility leases under non-cancelable lease agreements that expire in the next one to four years . Centennial Valley Properties I, LLC Lease Agreement On March 11, 2022, the Company entered into a Lease Agreement (the Lease) with Centennial Valley Properties I, LLC, a Colorado limited liability company (the Landlord) for office and laboratory space in Louisville, Colorado (the Leased Premises). The purpose of the Lease is to replace the Company’s current leased premises in Boulder, Colorado. The Company intends to move its corporate headquarters to the Leased Premises by mid-2023. The initial term of the Lease is twelve years (the Initial Term) from the commencement date, which is the earlier of: (i) the Company conducting revenue generating business (as defined in the Lease), or (ii) April 1, 2023 (the Commencement Date), unless earlier terminated in accordance with the Lease. The Company has two renewal options to extend the term of the Lease for an additional seven or ten year terms for each renewal. During the three months ended June 30, 2022, the lease commenced for accounting purposes resulting in $ 2.0 million in ROU assets and lease liabilities being recorded. Under the Lease, the Company will lease approximately 79,980 square feet at the Leased Premises. The Company will pay base rent over the life of the Lease beginning at approximately $ 227,000 per month and escalating, based on fixed escalation provisions, to approximately $ 326,000 per month, plus certain operating expenses and taxes. The Company's obligation to pay base rent shall be abated, commencing as of the Commencement Date and ending on and including the date that is 12 months after the Commencement Date (the Abated Rent Period). Further, the Company's obligation to pay base rent with respect to a portion of the area of the Lease Premises equal to 19,980 square feet shall be abated (the Partial Abated Rent), commencing as of the day after the end of the Abated Rent Period and ending on and including the date that is 24 months after the Commencement Date (the Partial Abated Rent Period). Pursuant to a work letter entered by the parties in connection with the Lease, the Landlord will contribute an aggregate of $ 18.8 million toward the cost of construction and improvements for the Leased Premises and the Company exercised its option for an additional tenant improvement allowance of $ 2.0 million (the Extra Allowance Amount). The Company will repay the Extra Allowance Amount actually funded by the Landlord in equal monthly payments with an interest rate of 6 % per year over the Initial Term excluding any part of the Abated Rent Period or Partial Abated Rent Period, which shall start to accrue on the date that the Landlord first disburses the Extra Allowance Amount. The Company made an accounting policy election to reduce the right-of-use asset and lease liability at lease commencement because the Lease specifies a maximum level of reimbursement for tenant improvements which are probable of being incurred and within the Company's control. Due to the tenant improvement allowances at the accounting lease commencement date and rent abatement periods described above, the Company expects the lease liability to accrete to approximately $ 25.7 million by March 2024 after receiving $ 20.8 million in lessor reimbursements. As of December 31, 2022, the Company has incurre d $ 2.5 million in capital expenditures for leasehold improvements related to the Leased Premises which are tenant improvements and have been reimbursed from the Landlord during the three months ended December 31, 2022. As of December 31, 2022, the Company had remaining capacity under the tenant improvement allowances of approximately $ 18.3 million. The Lease includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature. During the three months ended September 30, 2022, a $ 5.0 million cash collateralized letter of credit under the operating lease agreement was released and the funds were subsequently transferred to the Landlord as a refundable deposit (subject to contingent reduction over the term of the lease) to secure the performance of the Company’s obligations. The $ 5.0 million refundable deposit is included within ' Other long-term assets ' in the balance sheet as of December 31, 2022. Operating lease expense for all operating leases was $ 2.6 million and $ 1.2 million and for the year ended December 31, 2022 and 2021, respectively. As of December 31, 2022 , the weighted-average remaining lease term and discount rate associated with our operating leases were 9.0 years and 11.40 %, respe ctively. Future minimum lease payments associated with our operating leases were as follows (in thousands): As of 2023 $ 2,289 2024 2,619 2025 3,710 2026 3,978 2027 4,063 2028 and thereafter 32,263 Total future minimum lease payments 48,922 Less amount representing interest ( 23,802 ) Less amount representing tenant improvement allowances (1) ( 18,323 ) Total lease liabilities $ 6,797 (1) The remaining contractually agreed upon tenant improvement allowances of $ 18.3 million are expected to be received during fiscal year 2023. Future minimum lease payments, which do not include amounts for common area maintenance, insurance, or taxes, for operating lease obligations in accordance with ASC 840 - Leases were as follows (in thousands): As of 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 |
Equity
Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Equity | Note 10 – Equity Common Stock The Company’s Restated Certificate of Incorporation authorizes the Company to issue up to 200,000,000 shares of common stock with a par value of $ 0.001 per share. The holder of each share of common stock is entitled to one vote per share. The common shareholders are entitled to dividends whenever funds and assets are legally available and when and if declared by the Board of Directors. The Company is currently subject to restrictions on the payment of dividends (see Note 8 - Debt ) and no dividends have been declared as of December 31, 2022. Preferred Stock The Company’s Restated Certificate of Incorporation authorizes the Company to issue up to 5,000,000 shares of preferred stock with a par value of $ 0.001 per share. As of December 31, 2022 and 2021 , no shares of preferred stock were issued or outstanding. Equity Financing Programs The Company maintains two facilities that enable equity financing on an ongoing basis at the Company’s sole discretion, our at-the-market offering and our common stock purchase agreement with Lincoln Park Capital Fund, LLC (the LPC facility). In November 2021, the Company entered into a sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $ 50.0 million (the Shares), subject to terms and conditions. The Shares will be offered and sold by the Company pursuant to its previously filed and currently effective registration statement on Form S-3. The Shares may only be offered and sold by means of a prospectus, including a prospectus supplement, forming part of the effective registration statement. Sales of the common stock, if any, will be made at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The NASDAQ Global Market, or any other existing trading market for our common stock. On March 7, 2022 (the LPC Effective Date), the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park), pursuant to which Lincoln Park has committed to purchase up to $ 50.0 million of the Company's common stock (the Purchase Agreement). Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 50.0 million of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the LPC Effective Date. The number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is 50,000 shares, but that amount may be increased up to 100,000 shares, depending upon the market price of the Company’s common stock at the time of sale and subject to a maximum limit of $ 1.5 million per regular purchase. The purchase price per share for each such regular purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale as computed under the Purchase Agreement. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases. Under applicable rules of the NASDAQ Capital Market, in no event may the Company issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.20 per share, such that issuances and sales of the common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable NASDAQ rules. Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the Purchase Agreement if doing so would result in Lincoln Park beneficially owning more than 9.99 % of its common stock. Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds, if any, under the Purchase Agreement will depend on the frequency and prices at which the Company sells shares of its common stock to Lincoln Park. The Company intends to use any net proceeds from the sale of its common stock to Lincoln Park to advance its growth strategy and for general corporate purposes. On the LPC Effective Date, the Company issued 184,275 shares of common stock to Lincoln Park as a commitment fee (the Initial Commitment Shares) for which the Company did not receive consideration and, upon the available amount being reduced to an amount equal to or less than $ 20.0 million, the Company will be required to issue 61,425 shares (the Additional Commitment Shares and together with the Initial Commitment Shares, collectively, the Commitment Shares). The Initial Commitment Shares issued were valued at $ 600,000 and, together with due diligence expenses and legal fees of $ 129,000 , reflect deferred offering costs of $ 729,000 , which are included on the balance sheet in 'Other long-term assets'. The deferred offering costs will be charged against 'Additional paid-in capital' upon future proceeds from the sale of common stock under the Purchase Agreement. During the year ended December 31, 2022 , $ 75,000 of deferred offering costs were charged against 'Additional paid-in capital'. As of December 31, 2022 , $ 654,000 of deferred offering costs remain. The Purchase Agreement may be terminated by the Company at any time, at its sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the common stock. Although the Company has agreed to reimburse Lincoln Park for a limited portion of the fees it incurred in connection with the Purchase Agreement, the Company did not pay any additional amounts to reimburse or otherwise compensate Lincoln Park in connection with the transaction, other than the issuance of the Commitment Shares. During the year ended December 31, 2022 , the Company raised approximately $ 7.3 million ($ 6.8 million after deducting underwriting discounts and commissions and offering expenses payable), in gross proceeds from the sale of 3,886,893 common shares at a weighted average price per share of $ 1.87 under these programs. As of December 31, 2022 , the Company had remaining available capacity for share issuances of approximately $ 29.5 million under the at-the-market facility and up to $ 46.9 million under the LPC facility, each subject to the restrictions and limitations of the underlying facilities, as well as volume limitations under applicable SEC rules and regulations that limit their availability as sources of funding. On December 30, 2021, the Company raised approximately $ 16.3 million in gross proceeds from the sale of 3,756,994 common shares at a public offering price of $ 4.35 per share in an at-the-market offering . The Company received net proceeds of $ 15.7 million, after deducting underwriting discounts and commissions and offering expenses payable of approximately $ 0.7 million. Public Offering On November 21, 2022, the Company closed an underwritten public offering (the Public Offering) of 35,075,000 shares of its common stock (the Public Offering Shares), including 4,575,000 shares purchased by the underwriter pursuant to an option to purchase additional shares. The Public Offering Shares were issued and sold pursuant to an underwriting agreement, dated November 16, 2022, by and between the Company and William Blair & Company, L.L.C., as sole underwriter, at a public offering price per share of $ 1.15 . The Company received net proceeds of approximately $ 37.5 million from the Public Offering after deducting underwriting discounts, commissions, and offering expenses payable by the Company. The Public Offering was made pursuant to the Company’s effective Registration Statement on Form S-3 previously filed with the Securities and Exchange Commission on November 29, 2021 and a prospectus supplement, dated November 16, 2022, relating to the Offering. Subscription Agreements On April 7, 2022, the Company entered into subscription agreements (the April 2022 Subscription Agreements) with a consortium of investors (the April 2022 Investors), including three members of our Board of Directors and other existing shareholders of the Company, for the issuance and sale by the Company of 6,508,376 shares of the Company’s common stock in a private placement offering. The three members of our Board of Directors acquired an aggregate of 3,631,284 shares pursuant to the form of a Subscription Agreement that did not include any registration rights. The remaining 2,877,092 shares were acquired by others pursuant to the form of a Subscription Agreement whereby the Company agreed to file, subject to certain exceptions, a shelf registration statement with respect to resales of such shares with the Securities and Exchange Commission no later than 60 days from April 7, 2022, which the Company filed on June 6, 2022. Pursuant to the April 2022 Subscription Agreements, the April 2022 Investors purchased shares at a purchase price (determined in accordance with NASDAQ rules relating to the “Minimum Value” of the Company’s common stock) of $ 1.79 per share, which is equal to the closing price of the Company's common stock on April 7, 2022, for an aggregate purchase price of approximately $ 11.7 million. The April 2022 Subscription Agreements include customary representations, warranties and covenants by the parties to the agreement. On November 21, 2022, the Company entered into subscription agreements (the November 2022 Subscription Agreements) with certain members of management (the November 2022 Investors), including the Company’s Chief Executive Officer and Chief Financial Officer, for the issuance and sale by the Company of an aggregate of 235,056 shares of the Company’s common stock in a private placement offering. The November 2022 Subscription Agreement did not include any registration rights and included lock up restrictions that will be in effect during the period ending 90 days subsequent to November 21, 2022. Pursuant to the November 2022 Subscription Agreements, the November 2022 Investors purchased shares at a purchase price (determined in accordance with NASDAQ rules relating to the “Minimum Value” of the Company’s common stock) of $ 1.15 per share, which is equal to the public offer price in the Public Offering, for an aggregate purchase price of approximately $ 270,000 . The November 2022 Subscription Agreements include customary representations, warranties and covenants by the parties to the agreement. Warrants During 2018, the Company issued warrants to purchase shares of convertible preferred stock in conjunction with the sale of certain convertible preferred shares and issuance of debt. The Company issued to the lender a warrant to purchase 613,333 shares of Series G convertible preferred stock, at an exercise price of $ 0.75 per share, subject to adjustment upon specified dilutive issuances. The warrant was immediately exercisable upon issuance and expires on February 23, 2028 . Through the effective date of the Company’s initial public offering (IPO) in October 2020, the Series G warrants were remeasured to an estimate of fair value using a Black-Scholes pricing model. As a result of the Company’s IPO, the preferred stock warrants were automatically converted to warrants to purchase 103,326 shares of common stock with a weighted average exercise price of $ 4.46 and were also transferred to additional paid-in capital. All Series G common stock warrants remain outstanding as of December 31, 2022. On November 21, 2022, as consideration for the Perceptive Term Loan Facility (see Note 8 - Debt ), the Company issued the Perceptive Warrant to purchase up to 5,000,000 shares of the Company's common stock, including the Initial Warrants. In addition to the Initial Warrants, the Additional Warrants will each become exercisable into 1,000,000 shares of common stock concurrently with the borrowing date of the Tranche B and C Loans, respectively. The Company accounts for the Additional Warrants as liabilities as the Additional Warrants do not meet the criteria for equity treatment (see Note 4 - Fair Value ). The per share exercise price for the Initial Warrants is equal to $ 1.0648 , which is equal to the lower of (A) the 10-day VWAP of the Company’s common stock on the business day immediately prior to the Closing Date of the Tranche A Loan or (B) the public offering price per share of common stock of $ 1.15 . The Initial Warrants are equity classified and were immediately exercisable upon issuance and expire on November 21, 2032 . The Initial Warrants were valued at $ 2.9 million using the Black-Scholes option-pricing model assuming an expected term of 10 years, a volatility of 81.3 %, a dividend yield of 0 % and a risk-free interest rate of 3.67 %. All Initial Warrants remain outstanding as of December 31, 2022 . |
Revenue and Accounts Receivable
Revenue and Accounts Receivable Credit Concentration | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue and Accounts Receivable Credit Concentration | Note 11 – Revenue and Accounts Receivable Credit Concentration We derive our revenue from two primary sources: (i) providing diagnostic testing in the clinical setting (Diagnostic tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, clinical trial testing, development and testing services generally provided outside the clinical setting and governed by individual contracts with third parties as well as development and commercialization of companion diagnostics (Services). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company conducts diagnostic tests and delivers the completed test results to the prescribing physician or patient, as applicable. The fees for diagnostic tests are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. The Company determines the transaction price related to its diagnostic test contracts by considering the nature of the payer 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): Year Ended December 31, 2022 2021 Diagnostic tests $ 34,538 $ 48,937 Services 3,674 5,569 Total revenue $ 38,212 $ 54,506 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 $ 1.9 million in ‘Deferred revenue’ recorded in the balance sheet as of December 31, 2021, $ 1.2 million was recognized in revenues during the year ended December 31, 2022. In addition, $ 0.7 million was added to ‘Deferred revenue’ for up-front cash payments received for which the revenue recognition criteria have not been met and $ 0.4 million was reclassed to non-current deferred revenue. The ‘Deferred revenue’ of $ 1.0 million re corded in the balance sheet as of December 31, 2022 is expected to be recognized in revenues over the next twelve months as test results are delivered and services are performed. As of December 31, 2022 and 2021 , the Company had $ 0.4 million and $ 0.8 million in non-cu rrent 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 both pertain to our COVID-19 diagnostic testing services, and their related revenue as a percentage of total revenue were as follows: Year Ended December 31, 2022 2021 The State of Colorado 10 % — The Big Ten Conference — 40 % In addit ion to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for 37 % and 18 % of the Company’s total revenue for the years ended December 31, 2022 and 2021 , respectively. The Company is subject to credit risk from its accounts receivable related to services provided to its customers. The Company’s third-party payors and other customers in excess of 10% of accounts receivable, and their related accounts receivable as a percentage of total accounts receivable were as follows: As of December 31, 2022 2021 Medicare 23 % 30 % Astrazeneca UK 18 % — Janssen Research and Development, LLC — 14 % LabCorp DD (formerly Covance) — 11 % |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share Based Compensation | Note 12 – Share Based Compensation Predecessor 2016 and 2006 Equity Incentive Plans Under the 2006 Equity Incentive Plan (2006 Plan), the Company was authorized to grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards and RSUs. No additional awards may be granted under the 2006 Plan. In February 2016, the Company adopted the 2016 Equity Incentive Plan (2016 Plan) as a successor to and continuation of the prior 2006 Plan. The 2016 Plan provided for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock awards to directors, employees, and consultant. Awards granted under the 2016 Plan or the 2006 Plan that were unallocated, expired or otherwise terminated, or were forfeited, cancelled, or repurchased by the Company, became available for future issuance under the 2016 Plan. In addition, shares subject to an award were withheld to satisfy a participant’s tax withholding obligations, or were reacquired by the Company as consideration for the exercise or purchase price of a stock award also became available for future issuance under the 2016 Incentive Plan. No additional awards may be granted under the 2016 Plan. 2020 Equity Incentive Plan Effective upon the closing of our IPO, the Company’s Board of Directors approved the 2020 Equity Incentive Plan (2020 Plan), which replaced the 2016 Plan. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSUs, performance awards and other stock awards. Officers, directors, employees, consultants, agents, and independent contractors who provide services to the Company may receive awards. The terms of all awards are governed by an agreement between the Company and the recipients, as administered and approved by the Compensation Committee of the Board of Directors). Any awards that expire or are forfeited under the 2016 Plan or 2006 Plan become available for issuance under the 2020 Plan. The number of shares originally reserved for issuance under the 2020 Plan was 1,893,395 . The 2020 Plan includes an annual increase on the first day of each calendar year, beginning with the calendar year ending December 31, 2022, and continuing until, and including, the calendar year ending December 31, 2030. The annual increase will be equal to the lesser of (i) 4 % of the number of shares of our common stock issued and outstanding as of December 31st of the immediately preceding calendar year and (ii) such lesser amount determined by the Board of Directors. To the extent an equity award granted under the 2020 Plan (other than any substitute award) or granted under any other equity plan maintained by us under which awards are outstanding as of the effective date of the 2020 Plan (the Prior Plans) expires or otherwise terminates without having been exercised or paid in full, or is settled in cash, the shares subject to such award will become available for future grant under the 2020 Plan. In addition, to the extent shares subject to an award are withheld to satisfy a participant’s tax withholding obligation upon the exercise or settlement of such award (other than any substitute award) or to pay the exercise price of a stock option granted under the 2020 Plan or a prior plan, such shares will become available for future grant under the 2020 Plan. The total number of shares available for grant under all plans as of December 31, 2022 was 233,519 . Employee Stock Purchase Plan Effective with our IPO in October 2020, the Company’s Board of Directors and its stockholders approved the Company’s Employee Stock Purchase Plan (the ESPP). The number of shares originally reserved for issuance under the ESPP was 338,106 . The maximum number of shares of our common stock available under the ESPP will automatically increase on the first trading day of each calendar year by an amount equal to the lesser of (i) 1 % of the shares of our common stock issued and outstanding on December 31st of the immediately preceding calendar year, and (ii) an amount determined by our Board of Directors. Subject to any plan limitations, the ESPP allows eligible employees to contribute, normally through payroll deductions, up to 15 % of their earnings for the purchase of the Company’s common stock at a discounted price per share. The price at which common stock is purchased under the ESPP is equal to 85 % of the fair market value of the Company’s common stock on the first or last day of the offering period, whichever is lower. No employee may participate in an offering period if the employee owns 5% or more of the total combined voting power or value of the Company’s stock. The initial offering period was from January 1, 2021 through August 31, 2021. On a go-forward basis, the ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. As of December 31, 2022 , 237,961 shares have been issued under the ESPP leaving 100,145 shares remaining for future issuance. Description of Awards Granted The Company has granted incentive stock options, non-statutory stock options, performance-based stock options, and RSUs. Incentive stock options, which may only be issued to employees, are granted at an exercise price per share equal to the closing market price of the Company’s common stock on the grant date, and vest over time as determined by the Compensation Committee, provided that the term of the options may not exceed ten years from the date of grant. Accelerated vesting may occur in the event of an optionee's death, disability, or other events. Non-statutory stock options, which may be issued to employees, non-employees and directors, are granted at an exercise price per share equal to the closing market price of the Company’s common stock on the grant date, and vest over time as determined by the Compensation Committee, provided that the term of the options may not exceed ten years from the date of grant. Accelerated vesting may occur in the event of an optionee's death, disability, or other events. Performance-based stock options are typically granted on an annual basis and consist of a performance-based and service-based component. The performance targets and vesting conditions for performance-condition options are based on achievement of recognized revenue targets. Performance-based options vest in three equal annual installments beginning one year after the grant date , pending certification of performance achievement by the Compensation Committee and continued service. The fair value of performance-condition awards is based on the closing market price of the Company’s common stock on the grant date. There are no performance-based stock options outstanding as of December 31, 2022. RSUs and the related terms and conditions are awarded at the discretion of the Compensation Committee. RSU holders have a contractual right to receive a share of common stock when vested. RSUs vest over time as determined by the Compensation Committee. RSU agreements may provide for accelerated vesting in the event of a stock unit holder's death, disability, or retirement or other events. Our Compensation Committee may grant other stock awards that are based on or related to shares of our common stock, such as awards of shares of common stock granted as bonus and not subject to any vesting conditions, deferred stock units, stock purchase rights, and shares of our common stock issued in lieu of our obligations to pay cash under any compensatory plan or arrangement. Bonus-To-Options Program The Company also has a Bonus-to-Options Program (the Bonus Option Program) which is separate from previously described plans and was initially adopted by the Board of Directors in 2008, and subsequently amended and restated in 2010, 2011, 2015, and 2022. For fiscal year 2022, the Bonus Option Program is subject to the shares reserved under the 2020 Plan. The Bonus Option Program, which is limited to participation of the Chief Executive Officer, direct reports to the Chief Executive Officer and Vice Presidents of the Company, allows participants who so elect to convert all or a portion of their annual cash bonus into fully vested, non-qualified stock options to purchase shares of common stock (Bonus Options). The exercise price for the options under the Bonus Option Program equals the closing market price of the Company's common stock on the grant date, as disclosed below under “ Fair Value of Common Stock ”. Bonus Options issued must be exercised within a ten-year term. The Company recorded the following activity related to the Bonus Option Program during the year ended December 31, 2022 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Weighted Average Weighted Average Aggregate Outstanding ‑ January 1, 2022 373 $ 17.00 7.5 $ 76 Granted 244 2.29 — — Forfeited/canceled ( 91 ) 14.03 — — Exercised — — — — Outstanding ‑ December 31, 2022 526 $ 10.69 7.6 $ 2 Exercisable ‑ December 31, 2022 526 $ 10.69 7.6 $ 2 The Company record ed $ 1.1 million and $ 0.8 million du ring the years ended December 31, 2022 and 2021, respectively, associated with the estimate of options to be delivered to eligible participants under the Bonus Option Program and which were granted in the first quarter of 2023 and 2022, respectively, by the Compensation Committee of the Board of Directors. In determining the amount of share-based compensation to recognize under the Bonus Option Program, the Company estimates the bonus attainment for the year and determines the expected number of options to be delivered to eligible participants. A Black-Scholes option pricing model is used to determine the estimated fair value of the expected number of options to be delivered to eligible participants. The key elements in determining the estimated fair value include assumptions for volatility, the risk-free interest rate, expected dividends and strike price, utilizing the measurement date closing stock price until the grants are authorized. Share-Based Compensation Expense Share-based compensation expense reported in the Company’s statements of operations was (in thousands): Year Ended December 31, 2022 2021 Direct costs and expenses $ 65 $ 49 Research and development 427 572 Sales, marketing, general and administrative 5,469 4,323 Total $ 5,961 $ 4,944 The unrecognized remaining share-based compensation expense for options and RSUs was approximately $ 7.1 million as of December 31, 2022 and is expected to be amortized to expense over the next 2.8 years. Stock Options Stock option activity during the year ended December 31, 2022, excluding the Bonus Option Program described above, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Weighted Average Weighted Average Aggregate Outstanding - January 1, 2022 2,878 $ 8.08 7.7 $ 6,288 Granted 380 2.92 — — Forfeited/canceled ( 333 ) 8.23 — — Exercised ( 384 ) 0.70 — — Outstanding ‑ December 31, 2022 2,541 $ 8.40 7.4 $ 1,489 Exercisable ‑ December 31, 2022 1,525 $ 7.28 6.8 $ 1,067 Fair Value of Common Stock The fair value of the Company’s common stock is determined based on its closing market price on the date of grant. The estimated grant date fair value of stock options was calculated using the Black-Scholes option-pricing model, based on the following assumptions: • Expected Term : The expected term represents the period that the options granted are expected to be outstanding using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). • Expected Volatility : The Company uses an average historical stock price of selected comparable companies over the expected term of the awards as the Company does not have sufficient trading history for its common stock. • Risk-Free Interest Rate : The Company uses the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. • Expected Dividend Yield : The Company is currently subject to restrictions on the payment of dividends (see Note 8 - Debt ) and no dividends have been declared as of December 31, 2022 and 2021. The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero. The fair value of each option grant was estimated on the grant date with the following weighted average assumptions for the years indicated: Year Ended December 31, 2022 2021 Expected term (in years) 5.65 6.01 Expected volatility 72.6 % 68.5 % Risk‑free rate 1.32 % 0.79 % Expected dividend yield — % — % Restricted Stock Units Restricted stock unit activity during the year ended December 31, 2022 was (in thousands, except weighted average grant date fair value per share): Number of Shares Weighted Average Outstanding ‑ January 1, 2022 151 $ 5.30 Granted 1,473 2.75 Forfeited/canceled ( 56 ) 3.69 Released ( 357 ) 5.01 Outstanding ‑ December 31, 2022 1,211 $ 2.36 |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Note 13 – Net Loss per Common Share Basic net loss per share excludes dilution and is computed by dividing net loss attributable to the common stockholders by the weighted-average shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised, resulting in the issuance of shares of common stock that would then share in the earnings or losses of the Company. In connection with the acquisition of Indi in 2018, the Company recorded contingent consideration (See Note 4 – Fair Value ) for amounts contingently payable to Indi's selling shareholders pursuant to the terms of the Indi APA. The contingent consideration arrangement requires additional consideration to be paid by the Company to Indi upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. When the gross margin target was achieved, the Company was required to issue 2,520,108 shares of common stock. The Company achieved the gross margin target of $ 2.0 million for three consecutive months during the three months ended June 30, 2021. As a result of the achievement of the gross margin target, the Company included the 2,520,108 shares of common stock in the calculation of weighted-average shares outstanding used in computing basic and diluted net loss per share for the three and six months ended June 30, 2021. In August 2021, the Company entered into an amendment of the original agreement in which the Company has agreed to forgo the issuance of its common stock. Therefore, these shares are not included in the statements of stockholders' equity or shares issued and outstanding in the balance sheets and are not included in our earnings per share calculation subsequent to August 2021. Basic and diluted loss per share for the years ended December 31, 2022 and 2021 were (in thousands, except per share amounts): Year Ended December 31, 2022 2021 Numerator Net loss attributable to common stockholders $ ( 65,447 ) $ ( 43,159 ) Denominator Weighted-average shares outstanding used 42,103 27,365 Net loss per share, basic and diluted $ ( 1.55 ) $ ( 1.58 ) The potentially dilutive securities as of December 31, 2022 and 2021 primarily represent the shares subject to future issuance under stock options awards, warrants, RSUs, and shares subject to purchase under our employee stock purchase plan, the terms of which are described in further detail in Note 12 – Share Based Compensation . The potentially dilutive securities would be subject to the treasury stock method when dilutive. The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Year Ended December 31, 2022 2021 Options to purchase common stock 3,067 3,251 Shares committed under ESPP 80 30 Warrants 5,103 103 Restricted stock units 1,211 151 Total 9,461 3,535 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 14 - Income Taxes Since inception, the Company has incurred net taxable losses, and accordingly, no current provision for income taxes has been recorded. The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 Federal statutory income tax rate 21 % 21 % State income taxes, net of federal benefit 5 5 Research and developments credits 1 1 Permanent items ( 4 ) ( 1 ) Change in valuation allowance ( 23 ) ( 26 ) Effective income tax rate — % — % The tax effects of temporary differences that give rise to significant portions of the deferred income tax assets and liabilities are as follows (in thousands): As of December 31, 2022 2021 Deferred Tax Assets: Net operating loss carryforwards $ 70,822 $ 61,874 Research and development tax credits 3,807 3,372 Interest expense limitation 3,036 554 Property and equipment 234 215 Capitalized research costs 2,874 — Share-based compensation 1,619 1,977 Accruals and reserves 1,932 1,618 Total 84,324 69,610 Valuation allowance ( 82,552 ) ( 67,457 ) Total deferred tax assets after valuation allowance 1,772 2,153 Deferred Tax Liabilities: Intangible assets ( 1,772 ) ( 2,153 ) Total deferred tax liabilities ( 1,772 ) ( 2,153 ) Net deferred tax assets and liabilities $ — $ — At December 31, 2022, the Company ha d $ 299.9 million and $ 4.8 million of federal net operating loss and research and experimentation tax carryforwards, respectively, which are set to expire beginning in 2026 . The Internal Revenue Code contains provisions that may limit the net operating loss carryovers available to be used in any year if certain events occur, including significant changes in ownership interest. In assessing the realizability of its deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. As the Company does not have any historical taxable income, projections of future taxable income over the periods in which the deferred tax assets are deductible, and after consideration of the history of operating losses, the Company does not believe it is more likely than not that it will realize the benefits of net deferred tax assets and, accordingly, has established a valuation allowance equal to 100 % of net deferred tax assets. The valuation allowance increased by $ 15.1 million during 2022 and $ 11.4 million during 2021. The Company determined that it had uncertain tax positions related to its U.S. research and development credits. As of December 31, 2022 and 2021, there w as no accrued interest related to uncertain tax positions. The Company does not believe it is reasonably possible that its unrecognized tax benefits will significantly change in the next twelve months. A reconciliation of beginning and ending balances for unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2022 2021 Balance at January 1 $ 843 $ 715 Additions for tax positions related to the current year 109 128 Additions for tax positions related to prior years — — Reductions for tax positions related to prior years — — Reductions related to settlements — — Reductions related to a lapse of statute — — Balance at December 31 $ 952 $ 843 The Company monitors proposed and issued tax law, regulations, and cases to determine the potential impact of uncertain income tax positions. At December 31, 2022, the Company had not identified any potential subsequent events that would have a material impact on unrecognized income tax benefits within the next twelve months. The Company’s federal and state returns for all years will remain open to examination by federal and state tax authorities for three and four years, respectively, from the date of utilization of any net operating loss carryforwards. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15 – Commitments and Contingencies Co‑Development Agreement In April 2014 and amended in October 2016, the Company entered into a worldwide agreement with AVEO to develop and commercialize AVEO's hepatocyte growth factor inhibitory antibody ficlatuzumab with the Company's proprietary companion diagnostic test, BDX004, a version of the Company’s serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). Under the terms of the agreement, AVEO will conduct a proof of concept (POC) clinical study of ficlatuzumab for NSCLC in which BDX004 will be used to select clinical trial subjects (the NSCLC POC Trial). Under the agreement, the Company and AVEO would share equally in the costs of the NSCLC POC Trial, and each would be responsible for 50 % of development and regulatory costs associated with all future clinical trials agreed upon by the Company and AVEO. The Company and AVEO continue to conduct POC clinical trials of ficlatuzumab in combination with BDX004. In September 2020, the Company exercised its opt-out right with AVEO for the payment of 50 % of development and regulatory costs for ficlatuzumab effective December 2, 2020 (the AVEO Effective Date). In September 2021, AVEO announced that the FDA has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma. In November 2021 AVEO also announced plans to initiate a potential registrational Phase 3 clinical trial for ficlatuzumab in the first half of 2023. The Company ha d $ 0.1 million in remaining obligations related to the AVEO agreement as of December 31, 2022 . Following the AVEO 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 royalties received or expenses related to this agreement for the years ended December 31, 2022 and 2021. License Agreement In August 2019, we entered into a non-exclusive license agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) (the Bio-Rad License). Under the terms of the Bio-Rad License, the Company received a non-exclusive license, without the right to grant sublicenses, to utilize certain of Bio-Rad’s intellectual property, machinery, materials, reagents, supplies and know-how necessary for the performance of Droplet Digital PCR (ddPCR) in cancer detection testing for third parties in the United States. The Company also agreed to purchase all of the necessary supplies and reagents for such testing exclusively from Bio-Rad, pursuant to a separately executed supply agreement (the Supply Agreement) with Bio-Rad. As further consideration for the non-exclusive license, the Company agreed to pay a royalty of 2.5 % on the net revenue received for the performance of such ddPCR testing collected from third parties. On May 24, 2021, the Company entered into the First Amendment to the Non-Exclusive License Agreement with Bio-Rad which amended the Bio-Rad License such that, effective May 1, 2021, the Company will no longer pay a royalty of 2.5 % on the net revenue received for the performance of such ddPCR testing collected from third parties. The Bio-Rad License expires in August 2024. Either party may terminate for the other’s uncured material breach or bankruptcy events. Bio-Rad may terminate the Bio-Rad License if the Company does not purchase licensed products under the Supply Agreement for a consecutive twelve-month period or for any material breach by us of the Supply Agreement. There wer e no expenses related to this agreement for the year ended December 31, 2022 and were insignificant for the year ended December 31, 2021. On May 13, 2021 (the CellCarta 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 CellCarta 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 each of the years ended December 31, 2022 and 2021 wa s $ 0.1 million, respective ly. 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 license agreement and royalty 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 . Royalty expenses we re $ 0.9 million and $ 0.7 million f or the years ended December 31, 2022 and 2021, 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. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Estimates | Basis of Presentation and Estimates The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; the estimation of the fair value of goodwill and other intangible assets; fair value of stock options; income tax uncertainties, including a valuation allowance for deferred tax assets; warrant liabilities; and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recognized revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions. As of December 31, 2022, we maintained cash and cash equivalents of $ 43.1 million and we have $ 30.0 million in outstanding aggregate principal amount on our Perceptive 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, the sale of convertible preferred stock, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which includes lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources, including the debt and equity funding and amendments to the Integrated Diagnostics, Inc. (Indi) Agreement, and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-K in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our loan agreement (see Note 8 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic and the associated impacts on the recovery of our diagnostic testing and services, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we continue to raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our existing loan agreement during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balances. We have taken steps to improve our liquidity through raising debt and equity capital during 2022, amendments to our 2021 Term Loan and amended the Indi Agreement to delay near term cash requirements and extend the period of milestone payments. We have also undertaken several proactive measures including, among other things, the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. On November 21, 2022, the Company funded and/or closed various financing transactions, including: (i) a term loan facility for up to $ 50.0 million, with funding of $ 30.0 million and the issuance of warrants exercisable into 3,000,000 shares of the Company’s common stock occurring on November 21, 2022, and two additional contingently issuable tranches of $ 10.0 million each subject to certain terms and conditions, including revenue milestones, (ii) a follow-on equity offering of common stock and (iii) a subscription agreement for the issuance of common stock to certain members of the Company’s management team. Collectively, the Company raised gross proceeds of approximately $ 70.7 million ($ 65.7 million after deducting commissions, fees and expenses payable). Approximately $ 23.9 million of the net proceeds were used to retire outstanding debt of the Company with Streeterville Capital, LLC and Silicon Valley Bank. 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 raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. We expect to continue to incur operating losses in the near term while we make investments to support our anticipated growth. 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 for a period beyond one year after these financial statements are issued. Our audited financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments that might be necessary should we be unable to continue as a going concern. |
Segment Reporting | Segment Reporting The Company has a single operating segment focused on providing diagnostic testing services to customers. All of the Company’s revenue and long-lived assets were derived or located in the United States for the years ended December 31, 2022 and 2021 . |
Revenue Recognition | Revenue Recognition The Company generates revenues from (i) diagnostic tests and (ii) assay development and testing services (services revenue). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company determines the transaction price related to its blood-based lung diagnostic test contracts using a portfolio approach by considering the nature of the payer and historical price concessions granted to groups of customers. The transaction price associated with COVID-19 testing arrangements are determined on the basis of the individual contract with each customer. Services revenue consists of various types of tests or other scientific services for a purpose as defined by any individual customer, which are often larger biopharmaceutical companies, as defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or achievement of contractual milestone(s) as defined in the customer agreements. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach as discussed above. In determining the amount to accrue for a delivered test, the Company considers factors such as payment history, payer coverage, whether there is a reimbursement contract between the payer and the Company, payment as a percentage of agreed upon rate (if applicable), amount paid per test and any current developments or changes that could impact reimbursement. Variable consideration, if any, is estimated based on an analysis of historical experience and adjusted as better estimates become available. These estimates require significant judgment by management. The Company also provides services to patients with whom the Company does not have contracts as defined in Financial Accounting Standards Board (FASB) Accounting Standards Codification 606 (ASC 606). The Company recognizes revenue for these patients when contracts, as defined in ASC 606, are established at the amount of consideration to which it expects to be entitled, or when the Company receives substantially all of the consideration subsequent to satisfaction and delivery of the performance obligations. Deferred revenue consists of payments received for research, development, and testing services fees received prior to the completion of performance of these tests and services. See Note 11 — Revenue and Accounts Receivable Credit Concentration for additional information. |
Direct Costs and Expenses | Direct Costs and Expenses The components of our cost of diagnostic tests and testing services consist of cost of materials, direct labor, including bonuses, benefit and share-based compensation, depreciation of laboratory equipment, rent costs, amortization of leasehold improvements and information technology costs associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing of license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. Costs associated with performing tests are expensed as the test is processed regardless of whether and when revenue is recognized with respect to that test. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include external and internal costs incurred to develop our technology, collect clinical samples, and conduct clinical studies to develop and support our products. External costs consist primarily of payments to clinical trial sites, sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, process development and clinical development activities, infrastructure expenses, including allocated facility occupancy and information technology costs. Internal expenses include employee-related costs, including salaries, share-based compensation, and related benefits for employees engaged in research and development functions. The Company estimates and accrues its expenses resulting from its obligations under contracts with vendors and consultants in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payments that do not match the periods over which materials or services are provided under such contracts. The Company’s estimates depend on the timeliness and accuracy of the data provided by consultants and vendors regarding the status of each activity. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information received. Research and development costs are expensed as incurred. |
Sales, Marketing, General and Administrative Expenses | Sales, Marketing, General and Administrative Expenses Selling expenses consist primarily of costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel, and share-based compensation, as well as marketing and educational activities and allocated overhead expenses. Sales, marketing, general and administrative expenses also include costs for our marketing and sales organizations, and other functions including finance, legal, human resources, and information technology. These expenses consist principally of salaries, bonuses, employee benefits, travel, share-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and allocated overhead expenses. |
Concentrations of Credit Risk and Other Uncertainties | Concentrations of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial 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. 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, the Company could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of December 31, 2022 and 2021, see Note 11 – Revenue and Accounts Receivable Credit Concentration . |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash equivalents consist of short-term, highly-liquid instruments with an original maturity of three months or less from the date of purchase. |
Restricted Cash | Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit card. As of December 31, 2022 and 2021, the Company had $ 0.1 million restricted cash, respectively, which was included in ‘ Other current assets ’ in the accompanying balance sheets. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are stated at the amount management expects to collect from customers based on their outstanding invoices. Management reviews accounts receivable quarterly to determine if any receivable will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value based on historical experience, customer creditworthiness, facts, and circumstances specific to outstanding balances, and payment terms. |
Inventory | Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to ‘Direct c osts and expenses’. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and was $ 1.4 million and $ 2.9 million as of December 31, 2022 and 2021 , respectively. The Company recorded a reserve for excess inventory of $ 0.1 million and zero , primarily associated with the wind down of the COVID-19 testing operation, as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021 , the Company recorded $ 0.9 million and zero , respectively, to the statement of operations for excess and obsolete inventory. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and five years . Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations in the period realized. Long-lived assets to be held and used are evaluated for impairment when events or circumstances indicate the carrying value of a long-lived asset or asset group is less than the undiscounted cash flows from the use and eventual disposition over its remaining useful life. The Company assesses recoverability by comparing the sum or projected undiscounted cash flows from the use and eventual disposition of the asset or asset group to its carrying value, and records an impairment loss if the carrying value is greater than the undiscounted future cash flows. There were no impairments for th e years ended December 31, 2022 and 2021 . |
Intangible Assets | Intangible Assets Intangible assets primarily consist of intangible assets acquired as part of business combinations, external costs associated with patent applications that are probable of future economic benefits, and trademark costs. Finite-lived intangibles are stated at cost, net of accumulated amortization. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 9 to 10 years , based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. Trademarks are considered indefinite lived and are not amortized. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate a reduction to fair value below their carrying amounts. There was an immaterial impairment during the year ended December 31, 2022 and there were no impairments for th e year ended December 31, 2021 . |
Goodwill | Goodwill Goodwill represents the excess of purchase price over amounts allocated to acquired assets and liabilities assumed in business combinations. The carrying value of goodwill is evaluated for impairment at least annually or more frequently when events or circumstances occur indicate a potential for impairment. The annual impairment test is performed on the last day of our fourth quarter. Prior to performing a quantitative evaluation, an assessment of qualitative factors may be performed to determine whether it is more likely than not that the fair value of the reporting unit exceeds its carrying value. In the event the Company determines that it is more likely than not the carrying value of our single reporting unit is higher than its estimated fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. Through December 31, 2022, there were no accumulated impairment losses. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments U.S. GAAP for fair value establishes a hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach, and cost approach). We utilize a combination of market and income approaches to value our financial instruments. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. Fair value measurements are categorized within the fair value hierarchy based upon the lowest level of the most significant inputs used to determine fair value. The three levels of the hierarchy and the related inputs are as follows: Level Inputs 1 Unadjusted quoted prices in active markets for identical assets and liabilities. 2 Unadjusted quoted prices in active markets for similar assets and liabilities; Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or Inputs other than quoted prices that are observable for the asset or liability. 3 Unobservable inputs for the asset or liability. The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, other long-term assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. |
Contingent Consideration | Contingent Consideration In connection with the purchase transaction with Indi, the Company recorded contingent consideration for amounts potentially payable to Indi’s shareholder upon attainment of a three-consecutive month gross margin target of $ 2.0 million within the seven-year period after the acquisition date. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value through the date the gross margin target was achieved 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. |
Warrant Liability | Warrant Liability As consideration for the Perceptive Term Loan Facility (see Note 8 - Debt ), the Company issued a warrant to purchase common stock to the Lender of up to 5,000,000 shares of the Company's common stock (the Perceptive Warrant), with warrants exercisable into 3,000,000 shares of the Company’s common stock issued on the funding date of the Tranche A Loan (the Initial Warrants) as well as up to 2,000,000 additional warrants that are contingent upon the Company’s borrowing the remaining availability under the Perceptive Term Loan Facility (the Additional Warrants). The Initial Warrants are equity classified (see Note 10 - Equity ) while the Additional Warrants are classified as liabilities and subject to fair value measurement (see Note 4 – Fair Value ). |
Share-Based Compensation | Share‑Based Compensation Stock Options The Company grants service condition and performance condition stock options. Stock options are granted with exercise prices equal to the fair market value of our common stock on the date of grant. The grant date fair value of each employee stock option is estimated on the date of grant using the Black-Scholes option-pricing model, which requires the use of assumptions, including the expected term of the option, expected volatility of our stock price, expected dividend yield, and the risk-free interest rate, among others. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. These assumptions involve inherent uncertainties including market conditions and employee behavior that are generally outside of the Company’s control. Service condition stock options are expensed based on the grant date fair value of the awards using the straight-line method over the requisite service period. Performance-condition stock options vest based on achievement of multiple weighted performance goals, certification of performance achievement by the Compensation Committee of the Board of Directors, and continued service. For performance-condition stock options, compensation expense is updated for our expected performance level against performance goals at the end of each reporting period, which involves judgment as to achievement of certain performance metrics. Restricted Stock Units (RSUs) The Company grants service-condition RSUs. The grant date fair values of these RSUs are based on the closing market price of our common stock on the grant date. We estimate forfeitures and adjust these estimates to actual forfeitures as they occur. The service-condition RSUs vest based on continued service with compensation expense recognized on a straight-line basis over the requisite service period. See Note 12 — Share-Based Compensation for additional information related to share-based compensation. Income Taxe s The Company accounts for income taxes in accordance with ASC 740 - Income Taxes , under which deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year. In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results, or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required. A valuation allowance is recorded when it is more likely than not that a deferred tax asset will not be realized. The recorded valuation allowance is based on significant estimates and judgments and if the facts and circumstances change, the valuation allowance could materially change. In accounting for uncertainty in income taxes, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. See Note 14 — Income Taxes for additional information related to income taxes. |
Income Taxes | Income Taxe s The Company accounts for income taxes in accordance with ASC 740 - Income Taxes , under which deferred income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year. In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results, or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required. A valuation allowance is recorded when it is more likely than not that a deferred tax asset will not be realized. The recorded valuation allowance is based on significant estimates and judgments and if the facts and circumstances change, the valuation allowance could materially change. In accounting for uncertainty in income taxes, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. See Note 14 — Income Taxes for additional information related to income taxes. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding for the period, if dilutive, using the treasury stock method. Potentially dilutive securities consisting of options to purchase common stock, warrants to purchase common stock, RSUs and shares subject to purchase under our employee stock purchase plan were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented. |
Other Assets | Other Assets As of December 31, 2022 , the Company has a $ 5.0 million cash refundable deposit to secure the performance of the Company’s obligations associated with the operating lease agreement with Centennial Valley Properties I, LLC (see Note 9 – Leases ). The $ 5.0 million refundable deposit is reported within 'Other long-term assets' in the balance sheet. |
Recently Adopted Accounting Standards | Recently adopted accounting standards In February 2016, the FASB issued ASU No. 2016-2, Leases (ASC 842). This ASU intends to make accounting for leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and corresponding lease liability, including leases accounted for as operating leases. In addition to other related amendments, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements , which offers an additional transition method whereby entities may apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings rather than application of the new leases standard at the beginning of the earliest period presented in the financial statements. The Company elected this transition method and adopted ASC 842 on January 1, 2022 and as a result, recorded operating lease rig ht-of-use (ROU) assets of $ 1.3 million, including offsetting deferred rent of $ 0.1 million, along with the associated operating lease liabilities of $ 1.3 million. On January 1, 2022, the Company did not have any finance leases. The adoption of ASC 842 did not result in a cumulative effect adjustment to beginn ing retained earnings, and did not materially affect the Company's statement of operations, statement of stockholders' equity or statement of cash flows for the year ended December 31, 2022. In addition, the Company elected the following practical expedients permitted under the transition guidance within the new standard: • Package of practical expedients which allows the Company to carry forward the historical lease classification; • Hindsight practical expedient which allows the Company to use hindsight in determining the lease term, in assessing purchase options, and in assessing impairment of ROU assets; • Short-term lease practical expedient which allows the Company to capitalize only those leases with an initial term of twelve months or more, and; • The practical expedient to account for lease and non-lease components (such as common area maintenance, utilities, insurance and taxes) as a single lease component for all classes of underlying assets. For lease classification determination, Management continues to use (i) 75% or greater to determine whether the lease term is a major part of the remaining economic life of the underlying asset and (ii) 90% or greater to determine whether the present value of the sum of lease payments is substantially all of the fair value of the underlying asset. ROU assets represent the Company's right to use an underlying asset for the lease term. Lease liabilities represent the Company's obligation to make lease payments under the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses either the rate implicit in the lease or its incremental borrowing rate, as applicable, based on the information available at lease commencement date. The Company applies the estimated incremental borrowing rates on a lease-by-lease level based on the economic environment associated with the lease. The operating lease ROU asset also includes any lease prepayments, net of lease incentives. Certain of the Company's leases include options to extend or terminate the lease. As leases approach maturity, the Company considers various factors such as market conditions and the terms of any renewal and termination options that may exist to determine whether we will renew or terminate the lease, as such, we generally do not include renewal or termination options in our lease terms for calculating our lease liability, as the options allow us to maintain operational flexibility and we are not reasonably certain we will exercise these options at the time of the lease commencement. The Company's lease agreements do not contain any material residual value guarantees or restrictive covenants. Lease expense for lease payments of operating leases is recognized on a straight-line basis over the term of the lease. The Company uses the long-lived assets impairment guidance to determine recognition and measurement of an ROU asset impairment, if any. The Company monitors for events or changes in circumstances that require a reassessment. Additional information and disclosures required by this new standard are contained in Note 9 — Leases . Standards Being Evaluated In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments (ASC Topic 326). This ASU requires measurement and recognition of expected credit losses for financial assets. This guidance will become effective for the Company beginning January 1, 2023. The Company evaluated the guidance and determined the overall impact of the adoption will have an immaterial impact on our financial statements. |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Outstanding Borrowings | The table below presents the carrying and fair values of outstanding borrowings, which are classified as Level 2, as of the dates indicated (in thousands): As of December 31, 2022 2021 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 25,053 $ 26,785 $ 10,012 $ 10,012 |
Schedule of Reported Fair values of Contingent Consideration | The table below presents the reported fair values of contingent consideration and warrant liabilities, which are classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): As of December 31, Description 2022 2021 Current portion of contingent consideration $ 10,341 $ 17,764 Contingent consideration 18,645 16,028 Total contingent consideration $ 28,986 $ 33,792 Warrant liabilities $ 61 $ — |
Schedule of Changes in Contingent Consideration and WarrantLiabilities | The following table presents the changes in contingent consideration and warrant liabilities for the dates indicated (in thousands): For the year ended December 31, 2022 Level 3 Rollforward Contingent Consideration Warrant Liabilities Beginning balances - January 1, 2022 $ 33,792 $ — Additions — 145 Changes in fair value — ( 84 ) Interest expense 3,082 — Loss on extinguishment of liabilities 2,934 — Payments ( 10,822 ) — Ending balances - December 31, 2022 $ 28,986 $ 61 The following table presents the changes in contingent consideration as of the date indicated (in thousands): Level 3 Rollforward For the year ended December 31, 2021 Beginning balances - January 1, 2021 $ 29,932 Changes in fair value 1,622 Interest expense 2,238 Loss on extinguishment of liabilities — Payments of contingent consideration — Ending balances - December 31, 2021 $ 33,792 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): As of December 31, 2022 2021 Lab equipment $ 6,035 $ 6,784 Leasehold improvements 2,365 2,339 Computer equipment 749 700 Furniture and fixtures 349 391 Software 324 600 Vehicles 97 97 Construction in process 2,947 17 12,866 10,928 Less accumulated depreciation ( 7,018 ) ( 6,749 ) Total property and equipment, net $ 5,848 $ 4,179 |
Schedule of Depreciation Expense Related to Property and Equipment | Depreciation expense related to pr operty and equipment was: Year Ended December 31, 2022 2021 Direct costs and expenses $ 591 $ 614 Selling, marketing, general and administrative 1,031 614 Total $ 1,622 $ 1,228 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets, Excluding Goodwill | Intangible assets, excluding goodwill, consist of the following (in thousands): December 31, 2022 December 31, 2021 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,880 $ ( 647 ) $ 1,233 $ 1,755 $ ( 566 ) $ 1,189 Purchased technology 16,900 ( 8,450 ) 8,450 16,900 ( 6,572 ) 10,328 Intangible assets not subject to Trademarks 114 — 114 100 — 100 Total $ 18,894 $ ( 9,097 ) $ 9,797 $ 18,755 $ ( 7,138 ) $ 11,617 |
Schedule of Amortization Expense Related to Definite-Lived Intangible Assets | Amortization expense related to definite-lived intangible assets was (in thousands): Year Ended December 31, 2022 2021 Direct costs and expenses $ 2 $ 5 Sales, marketing, general and administrative 1,973 1,945 Total $ 1,975 $ 1,950 |
Schedule of Future Estimated Amortization Expense of Intangible Assets | Future estimated amortization expense of intangible assets is (in thousands): As of 2023 $ 1,972 2024 1,963 2025 1,957 2026 1,943 2027 992 2028 and thereafter 856 Total $ 9,683 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): As of December 31, 2022 2021 Compensation related accruals $ 4,671 $ 4,029 Accrued clinical trial expense 1,232 870 Other expenses 2,315 2,766 Total accrued liabilities $ 8,218 $ 7,665 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Notes Payable | Long-term notes payable were as follows (in thousands): As of December 31, 2022 2021 Perceptive Term Loan $ 30,000 $ — 2021 Term Loan — 10,000 Other 127 75 Unamortized debt discount and debt issuance costs ( 5,074 ) ( 63 ) 25,053 10,012 Less: current maturities 49 19 Long-term notes payable $ 25,004 $ 9,993 |
Scheduled Principal Repayments (Maturities) of Long-term Obligations | As of 2023 $ 49 2024 50 2025 21 2026 7 2027 30,000 2028 and thereafter — Total $ 30,127 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments for Operating Leases | Future minimum lease payments associated with our operating leases were as follows (in thousands): As of 2023 $ 2,289 2024 2,619 2025 3,710 2026 3,978 2027 4,063 2028 and thereafter 32,263 Total future minimum lease payments 48,922 Less amount representing interest ( 23,802 ) Less amount representing tenant improvement allowances (1) ( 18,323 ) Total lease liabilities $ 6,797 (1) The remaining contractually agreed upon tenant improvement allowances of $ 18.3 million are expected to be received during fiscal year 2023. |
Summary of Future Minimum Lease Payments for Operating Lease Obligations | Future minimum lease payments, which do not include amounts for common area maintenance, insurance, or taxes, for operating lease obligations in accordance with ASC 840 - Leases were as follows (in thousands): As of 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 |
Revenue and Accounts Receivab_2
Revenue and Accounts Receivable Credit Concentration (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenue | Revenues consisted of the following (in thousands): Year Ended December 31, 2022 2021 Diagnostic tests $ 34,538 $ 48,937 Services 3,674 5,569 Total revenue $ 38,212 $ 54,506 |
Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers | Year Ended December 31, 2022 2021 The State of Colorado 10 % — The Big Ten Conference — 40 % In addit ion to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for 37 % and 18 % of the Company’s total revenue for the years ended December 31, 2022 and 2021 , respectively. The Company is subject to credit risk from its accounts receivable related to services provided to its customers. As of December 31, 2022 2021 Medicare 23 % 30 % Astrazeneca UK 18 % — Janssen Research and Development, LLC — 14 % LabCorp DD (formerly Covance) — 11 % |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Share-based Compensation Expense | Share-based compensation expense reported in the Company’s statements of operations was (in thousands): Year Ended December 31, 2022 2021 Direct costs and expenses $ 65 $ 49 Research and development 427 572 Sales, marketing, general and administrative 5,469 4,323 Total $ 5,961 $ 4,944 |
Summary of Stock Option Activity | Stock option activity during the year ended December 31, 2022, excluding the Bonus Option Program described above, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Weighted Average Weighted Average Aggregate Outstanding - January 1, 2022 2,878 $ 8.08 7.7 $ 6,288 Granted 380 2.92 — — Forfeited/canceled ( 333 ) 8.23 — — Exercised ( 384 ) 0.70 — — Outstanding ‑ December 31, 2022 2,541 $ 8.40 7.4 $ 1,489 Exercisable ‑ December 31, 2022 1,525 $ 7.28 6.8 $ 1,067 |
Summary of Weighted Average Assumptions | The fair value of each option grant was estimated on the grant date with the following weighted average assumptions for the years indicated: Year Ended December 31, 2022 2021 Expected term (in years) 5.65 6.01 Expected volatility 72.6 % 68.5 % Risk‑free rate 1.32 % 0.79 % Expected dividend yield — % — % |
Summary of Restricted Stock Units Activity | Restricted stock unit activity during the year ended December 31, 2022 was (in thousands, except weighted average grant date fair value per share): Number of Shares Weighted Average Outstanding ‑ January 1, 2022 151 $ 5.30 Granted 1,473 2.75 Forfeited/canceled ( 56 ) 3.69 Released ( 357 ) 5.01 Outstanding ‑ December 31, 2022 1,211 $ 2.36 |
Bonus-To-Options Program | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Summary of Stock Option Activity | The Company recorded the following activity related to the Bonus Option Program during the year ended December 31, 2022 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Weighted Average Weighted Average Aggregate Outstanding ‑ January 1, 2022 373 $ 17.00 7.5 $ 76 Granted 244 2.29 — — Forfeited/canceled ( 91 ) 14.03 — — Exercised — — — — Outstanding ‑ December 31, 2022 526 $ 10.69 7.6 $ 2 Exercisable ‑ December 31, 2022 526 $ 10.69 7.6 $ 2 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted loss per share for the years ended December 31, 2022 and 2021 were (in thousands, except per share amounts): Year Ended December 31, 2022 2021 Numerator Net loss attributable to common stockholders $ ( 65,447 ) $ ( 43,159 ) Denominator Weighted-average shares outstanding used 42,103 27,365 Net loss per share, basic and diluted $ ( 1.55 ) $ ( 1.58 ) |
Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders | The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Year Ended December 31, 2022 2021 Options to purchase common stock 3,067 3,251 Shares committed under ESPP 80 30 Warrants 5,103 103 Restricted stock units 1,211 151 Total 9,461 3,535 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | The effective income tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 Federal statutory income tax rate 21 % 21 % State income taxes, net of federal benefit 5 5 Research and developments credits 1 1 Permanent items ( 4 ) ( 1 ) Change in valuation allowance ( 23 ) ( 26 ) Effective income tax rate — % — % |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred income tax assets and liabilities are as follows (in thousands): As of December 31, 2022 2021 Deferred Tax Assets: Net operating loss carryforwards $ 70,822 $ 61,874 Research and development tax credits 3,807 3,372 Interest expense limitation 3,036 554 Property and equipment 234 215 Capitalized research costs 2,874 — Share-based compensation 1,619 1,977 Accruals and reserves 1,932 1,618 Total 84,324 69,610 Valuation allowance ( 82,552 ) ( 67,457 ) Total deferred tax assets after valuation allowance 1,772 2,153 Deferred Tax Liabilities: Intangible assets ( 1,772 ) ( 2,153 ) Total deferred tax liabilities ( 1,772 ) ( 2,153 ) Net deferred tax assets and liabilities $ — $ — |
Reconciliation of Unrecognized Tax Benefits | A reconciliation of beginning and ending balances for unrecognized tax benefits is as follows (in thousands): Year Ended December 31, 2022 2021 Balance at January 1 $ 843 $ 715 Additions for tax positions related to the current year 109 128 Additions for tax positions related to prior years — — Reductions for tax positions related to prior years — — Reductions related to settlements — — Reductions related to a lapse of statute — — Balance at December 31 $ 952 $ 843 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2022 Test | |
Organization And Description Of Business [Line Items] | |
Number of blood based lung cancer test | 5 |
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) | 3 Months Ended | 12 Months Ended | |||
Nov. 21, 2022 USD ($) shares | Jun. 30, 2021 USD ($) | Dec. 31, 2022 USD ($) Segment shares | Dec. 31, 2021 USD ($) | Dec. 31, 2018 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Cash and cash equivalents | $ 43,088,000 | $ 32,712,000 | |||
Number of operating segments | Segment | 1 | ||||
Restricted cash | $ 100,000 | $ 100,000 | |||
Restricted Cash, Current, Statement of Financial Position [Extensible Enumeration] | Other current assets | Other current assets | |||
Impairment of long-lived assets | $ 0 | $ 0 | |||
Impairment of intangible assets | 0 | ||||
Goodwill impairments loss | 0 | ||||
Gross proceeds from financing transactions | $ 70,700,000 | ||||
Proceeds after deducting commissions, fees and expenses payable | 65,700,000 | ||||
Amount used to retire outstanding debt | 23,900,000 | 28,604,000 | 45,428,000 | ||
Reserve for inventory | 100,000 | 0 | |||
Excess and obsolete inventory | $ 906,000 | 0 | |||
Integrated Diagnostics, Inc | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Business acquisition contingent consideration gross margin target | $ 2,000,000 | $ 2,000,000 | |||
Business acquisition contingent consideration gross margin target period | 7 years | ||||
Minimum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property, plant and equipment, useful Lives | 3 years | ||||
Minimum | Product Life and Patent Life | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Finite-lived intangible asset, useful life | 9 years | ||||
Maximum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Property, plant and equipment, useful Lives | 5 years | ||||
Maximum | Product Life and Patent Life | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Finite-lived intangible asset, useful life | 10 years | ||||
Other Current Assets | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Inventory | $ 1,400,000 | $ 2,900,000 | |||
Other Long-term Assets | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Refundable deposit | 5,000,000 | ||||
Perceptive Term Loan | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Cash and cash equivalents | 43,100,000 | ||||
Principal balance outstanding | $ 30,000,000 | ||||
Funding amount | $ 30,000,000 | ||||
Warrants exercisable | shares | 3,000,000 | ||||
Perceptive Term Loan | First Tranche | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Debt instrument, aggregate principal amount | $ 10,000,000 | ||||
Warrants exercisable | shares | 3,000,000 | ||||
Perceptive Term Loan | Two Tranche | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Debt instrument, aggregate principal amount | $ 10,000,000 | ||||
Additional warratns exercisable | shares | 1,000,000 | ||||
Perceptive Term Loan | Maximum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Debt instrument, aggregate principal amount | $ 50,000,000 | ||||
Warrant issued to purchase shares | shares | 5,000,000 | ||||
Additional warratns exercisable | shares | 2,000,000 |
Recent Issued Accounting Stan_2
Recent Issued Accounting Standards - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Jan. 01, 2022 | Dec. 31, 2022 | |
Accounting Changes and Error Corrections [Abstract] | ||
Right of use assets | $ 1,300 | $ 2,973 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Right of use assets | |
Offsetting Deferred Rent | $ 100 | |
Operating lease liability | $ 1,300 | $ 6,797 |
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Operating lease liability | |
Description of lease | For lease classification determination, Management continues to use (i) 75% or greater to determine whether the lease term is a major part of the remaining economic life of the underlying asset and (ii) 90% or greater to determine whether the present value of the sum of lease payments is substantially all of the fair value of the underlying asset. |
Business Combinations - Additio
Business Combinations - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||||
Goodwill | $ 15,031 | $ 15,031 | ||
Integrated Diagnostics, Inc | ||||
Business Acquisition [Line Items] | ||||
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 | ||||
Business Acquisition [Line Items] | ||||
Contingent consideration shares | 2,520,108 |
Fair Value - Summary of Fair Va
Fair Value - Summary of Fair Value of Outstanding Borrowings (Details) - Fair Value, Recurring - Level 2 - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Carrying Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 25,053 | $ 10,012 |
Fair Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 26,785 | $ 10,012 |
Fair Value - Schedule of Report
Fair Value - Schedule of Reported Fair values of Contingent Consideration (Details) - Fair Value, Recurring - Level 3 - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 28,986 | $ 33,792 |
Warrant liabilities | 61 | |
Current Portion of Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | 10,341 | 17,764 |
Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 18,645 | $ 16,028 |
Fair Value - Schedule of Change
Fair Value - Schedule of Changes in Contingent Consideration and Warrant Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Loss on extinguishment of liabilities | $ 6,981 | $ (2,298) |
Fair Value, Recurring | Level 3 | Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | 33,792 | 29,932 |
Changes in fair value | 1,622 | |
Interest expense | 3,082 | 2,238 |
Loss on extinguishment of liabilities | 2,934 | |
Payments | (10,822) | |
Ending balances | 28,986 | $ 33,792 |
Fair Value, Recurring | Level 3 | Warrant Liabilities | ||
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Additions | 145 | |
Changes in fair value | (84) | |
Ending balances | $ 61 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Jul. 31, 2023 USD ($) Installment | Apr. 07, 2022 | Oct. 31, 2024 USD ($) | Jul. 31, 2024 USD ($) Installment | Apr. 30, 2024 USD ($) Installment | Apr. 30, 2022 USD ($) Installment | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2022 USD ($) Installment $ / shares shares | Dec. 31, 2021 USD ($) | Dec. 31, 2018 USD ($) Installment shares | Nov. 21, 2022 shares | |
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Loss on debt extinguishment | $ (6,981) | $ 2,298 | ||||||||||
Net change to contingent consideration | 1,622 | |||||||||||
Change in fair value of warrant liability | $ (84) | |||||||||||
Warrants, expires period | Feb. 23, 2028 | |||||||||||
IPO | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Warrant, exercise price | $ / shares | $ 4.46 | |||||||||||
Warrant issued to purchase shares | shares | 103,326 | |||||||||||
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 | |||||||||||
Warrant, exercise price | $ / shares | $ 0.75 | |||||||||||
Integrated Diagnostics, Inc | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
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] | ||||||||||||
Contingent consideration shares | shares | 2,520,108 | |||||||||||
Contingent Consideration | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Interest expense due to passage of time and fixed payment schedule | $ 1,100 | $ 3,100 | $ 2,200 | |||||||||
Reduction in contingent consideration | 1,000 | |||||||||||
Contingent Consideration | Discount Rate | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Changes in fair value | $ 100 | |||||||||||
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Interest Expense | |||||||||||
Contingent Consideration | Interest Expense | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Loss on debt extinguishment | $ (2,900) | |||||||||||
Contingent Consideration | 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 | |||||||||||
Contingent Consideration | Integrated Diagnostics, Inc | Third Amendment to APA Agreement | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Contingent consideration number of installments | Installment | 5 | |||||||||||
Milestone payment | $ 2,000 | |||||||||||
Percentage of interest on installment payments | 10% | |||||||||||
Contingent Consideration | Integrated Diagnostics, Inc | Third Amendment to APA Agreement | Scenario Forecast | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Contingent consideration number of installments | Installment | 3 | 1 | 1 | |||||||||
Milestone payment | $ 3,000 | $ 8,400 | $ 5,000 | |||||||||
Exit fee payment | $ 6,100 | |||||||||||
Contingent Consideration | 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 | 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 | |||||||||||
Contingent Consideration | 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 | |||||||||||
Contingent Consideration | 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% | |||||||||||
Contingent Consideration | 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 | 16% | |||||||||||
Warrant Liabilities | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Warrant issued to purchase shares | shares | 5,000,000 | |||||||||||
Initial fairvalue of additional warrants | $ 100 | |||||||||||
Change in fair value of warrant liability | $ 100 | |||||||||||
Warrant Liabilities | Minimum | Volatility rate | Tranche B Loan | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Warrants and Rights Outstanding, Measurement Input | 78 | |||||||||||
Warrant Liabilities | Maximum | Volatility rate | Tranche B Loan | ||||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||||
Warrants and Rights Outstanding, Measurement Input | 82 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 12,866 | $ 10,928 |
Less accumulated depreciation | (7,018) | (6,749) |
Total property and equipment, net | 5,848 | 4,179 |
Lab Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 6,035 | 6,784 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,365 | 2,339 |
Computer Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 749 | 700 |
Furniture and Fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 349 | 391 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 324 | 600 |
Vehicles | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 97 | 97 |
Construction in Process | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,947 | $ 17 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Depreciation Expense Related to Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Direct Costs and Expenses | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 591 | |
Selling, Marketing, General and Administrative | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | 1,031 | |
Property and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 1,622 | $ 1,228 |
Property and Equipment | Direct Costs and Expenses | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | 614 | |
Property and Equipment | Selling, Marketing, General and Administrative | ||
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 614 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Intangible Assets, Excluding Goodwill (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Net Carrying Value | $ 9,683 | |
Intangible assets, Cost | 18,894 | $ 18,755 |
Intangible assets, Accumulated Amortization | (9,097) | (7,138) |
Intangible assets, Net Carrying Value | 9,797 | 11,617 |
Trademarks | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets not subject to amortization, Cost | 114 | 100 |
Intangible assets not subject to amortization, Net Carrying Value | 114 | 100 |
Patents | ||
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Cost | 1,880 | 1,755 |
Intangible assets subject to amortization, Accumulated Amortization | (647) | (566) |
Intangible assets subject to amortization, Net Carrying Value | 1,233 | 1,189 |
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 | (8,450) | (6,572) |
Intangible assets subject to amortization, Net Carrying Value | $ 8,450 | $ 10,328 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of Amortization Expense Related to Definite-Lived Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | $ 1,975 | $ 1,950 |
Direct Costs and Expenses | ||
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | 2 | 5 |
Sales, Marketing, General and Administrative | ||
Finite Lived Intangible Assets [Line Items] | ||
Amortization expense related to definite-lived intangible assets | $ 1,973 | $ 1,945 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Schedule of Amortization Related to Remaining Net Intangible Assets Schedule to Amortize (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | |
2023 | $ 1,972 |
2024 | 1,963 |
2025 | 1,957 |
2026 | 1,943 |
2027 | 992 |
2028 and thereafter | 856 |
Intangible assets subject to amortization, Net Carrying Value | $ 9,683 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Compensation related accruals | $ 4,671 | $ 4,029 |
Accrued clinical trial expense | 1,232 | 870 |
Other expenses | 2,315 | 2,766 |
Total accrued liabilities | $ 8,218 | $ 7,665 |
Debt - Summary of Long-term Not
Debt - Summary of Long-term Notes Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 19, 2021 |
Debt Instrument [Line Items] | |||
Unamortized debt discount and debt issuance costs | $ (5,074) | $ (63) | |
Notes payable, total | 25,053 | 10,012 | |
Less: current maturities | 49 | 19 | |
Long-term notes payable | 25,004 | 9,993 | |
Perceptive Term Loan | |||
Debt Instrument [Line Items] | |||
Notes/Loan payable | 30,000 | ||
2021 Term Loan | |||
Debt Instrument [Line Items] | |||
Notes/Loan payable | 3,000 | 10,000 | $ 30,000 |
Other | |||
Debt Instrument [Line Items] | |||
Notes/Loan payable | $ 127 | $ 75 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | 2 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Nov. 21, 2022 | Nov. 16, 2022 | May 09, 2022 | Mar. 19, 2021 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||||||
Proceeds from the issuance of common stock | $ 59,538,000 | $ 16,343,000 | ||||||
Description of securities purchase agreement | (i) purchased a secured promissory note (Promissory Note One) in the aggregate principal amount totaling $16.0 million in exchange for $15.0 million less certain expenses and (ii) agreed to purchase another secured promissory note at the Company’s election (Promissory Note Two and, together with Promissory Note One, the Promissory Notes), subject to certain conditions precedent in aggregate principal amount totaling $10.3 million in exchange for $10.0 million in cash proceeds. | |||||||
Promissory notes interest rate | 6% | |||||||
Promissory note, maturity term | 24 months | |||||||
Promissory notes early prepayment premium percentage | 10% | |||||||
Accrued interest, amortization of OID and debt issuance costs | $ 1,800,000 | |||||||
Loss on debt extinguishment | $ (6,981,000) | 2,298,000 | ||||||
Debt instrument description | The 2021 Term Loan provided 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 was 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 accrued 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, was payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate were effective on the effective date of any change to the prime rate. | |||||||
Securities Purchase Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayments of debt | $ 18,200,000 | |||||||
Promissory Note One | Securities Purchase Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | 16,000,000 | |||||||
Net proceeds from debt, after deducting debt issuance costs and expenses | 12,800,000 | |||||||
Proceeds from Notes Payable | 15,000,000 | |||||||
Original issue discounts on debt instrument issuance | 1,000,000 | |||||||
Loss on debt extinguishment | $ (3,600,000) | |||||||
Promissory Note Two | Securities Purchase Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | 10,300,000 | |||||||
Proceeds from Notes Payable | 10,000,000 | |||||||
Original issue discounts on debt instrument issuance | 300,000 | |||||||
Increase in original issue discounts on debt instrument issuance, subject to contingencies | $ 500,000 | |||||||
Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from the issuance of common stock | $ 40,600,000 | |||||||
Debt instrument maturity date | Nov. 21, 2027 | |||||||
Interest rate | 3% | |||||||
Applicable margin rate | 9% | |||||||
Effective interest rate | 13.30% | 13.30% | 13.30% | |||||
Warrant, exercise price | $ 1.0648 | |||||||
Public offering price per share of common stock | $ 1.15 | |||||||
Minimum cash balance at maturity date | $ 2,500,000 | |||||||
Initial warrants amount | 2,900,000 | |||||||
Additional warrants amount | 100,000 | |||||||
Debt instrument, discount | 5,200,000 | |||||||
Repayments of debt | $ 7,000,000 | |||||||
Tranche A Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Net proceeds from debt, after deducting debt issuance costs and expenses | $ 27,900,000 | |||||||
Tranche B Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional warratns exercisable | 1,000,000 | |||||||
Tranche C Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional warratns exercisable | 1,000,000 | |||||||
Minimum | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Gross proceeds from an equity offering of common stock | $ 30,000,000 | |||||||
Prepayment premium percentage of aggregate outstanding principal amount | 2% | |||||||
Maximum | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | $ 50,000,000 | |||||||
Prepayment premium percentage of aggregate outstanding principal amount | 10% | |||||||
Warrant issued to purchase shares | 5,000,000 | |||||||
Maximum | Tranche A Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | 30,000,000 | |||||||
Maximum | Tranche B Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | 10,000,000 | |||||||
Maximum | Tranche C Loan | Perceptive Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, aggregate principal amount | $ 10,000,000 | |||||||
2021 Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Repayments of debt | $ 2,700,000 | $ 5,700,000 | ||||||
Loss on debt extinguishment | $ (400,000) | |||||||
Loan principle amount | 30,000,000 | $ 3,000,000 | $ 3,000,000 | $ 3,000,000 | $ 10,000,000 | |||
Revenue milestone | $ 65,000,000 |
Debt - Scheduled Principal Repa
Debt - Scheduled Principal Repayments (Maturities) of Long-term Obligations (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Maturities of Long-Term Debt [Abstract] | |
2023 | $ 49 |
2024 | 50 |
2025 | 21 |
2026 | 7 |
2027 | 30,000 |
Total | $ 30,127 |
Leases - Additional Information
Leases - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||
Mar. 11, 2022 USD ($) ft² RenewalOption | Mar. 31, 2024 USD ($) | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Sep. 30, 2023 ft² | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jan. 01, 2022 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease right-of-use assets | $ 2,973,000 | $ 1,300,000 | ||||||
Operating lease liability | 6,797,000 | $ 1,300,000 | ||||||
Restricted cash | $ 100,000 | $ 100,000 | ||||||
Restricted Cash, Current, Statement of Financial Position [Extensible Enumeration] | Other Assets, Current | Other Assets, Current | ||||||
Operating lease expense | $ 2,600,000 | $ 1,200,000 | ||||||
Operating leases, Weighted-average remaining lease term (in years) | 9 years | |||||||
Operating leases, Weighted-average discount rate | 11.40% | |||||||
Lease expiration date | 2023-01 | |||||||
Scenario Forecast | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Accretion of lease liability | $ 25,700,000 | |||||||
Centennial Valley Properties I, LLC Lease Agreement | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease right-of-use assets | $ 2,000,000 | |||||||
Operating lease liability | $ 2,000,000 | |||||||
Lease description | The initial term of the Lease is twelve years (the Initial Term) from the commencement date, which is the earlier of: (i) the Company conducting revenue generating business (as defined in the Lease), or (ii) April 1, 2023 (the Commencement Date), unless earlier terminated in accordance with the Lease. The Company has two renewal options to extend the term of the Lease for an additional seven or ten year terms for each renewal. During the three months ended June 30, 2022, the lease commenced for accounting purposes resulting in $2.0 million in ROU assets and lease liabilities being recorded. | |||||||
Lease term | 12 years | |||||||
Lease commencement date | Apr. 01, 2023 | |||||||
Lease agreement number of options to extend | RenewalOption | 2 | |||||||
Lease option to extend | true | |||||||
Leased property building capacity | ft² | 79,980 | |||||||
Base rent per month from commencement date | $ 227,000 | |||||||
Rent after fixed escalation provisions | $ 326,000 | |||||||
Area of leased premised obligated to pay base rent | ft² | 19,980 | |||||||
Landlord contribution towards cost of construction and tenant improvements | $ 18,800,000 | |||||||
Additional Tenant improvement allowance | $ 2,000,000 | |||||||
Interest rate on extra allowance amount | 6% | |||||||
Capital expenditure for leasehold improvements related to leases premises which are tenant improvements | 2,500,000 | |||||||
Remaining capacity under the tenant improvement allowances | $ 18,300,000 | |||||||
Lessor reimbursements received | $ 20,800,000 | |||||||
Restricted Cash, Current, Statement of Financial Position [Extensible Enumeration] | Other Assets, Noncurrent | |||||||
Centennial Valley Properties I, LLC Lease Agreement | Letter of Credit | Cash Collateralized Letter Of Credit | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Long-term Line of Credit | $ 5,000,000 | |||||||
Maximum | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease, expiration term | 4 years | |||||||
Minimum | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease, expiration term | 1 year | |||||||
Other Long-term Assets | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Refundable deposit | $ 5,000,000 | |||||||
Other Long-term Assets | Centennial Valley Properties I, LLC Lease Agreement | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Refundable deposit | $ 5,000,000 | |||||||
COLORADO | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Operating lease right-of-use assets | $ 1,200,000 | |||||||
Operating lease liability | $ 1,200,000 | |||||||
Area of office space leased | ft² | 29,722 | |||||||
Lease expiration date | 2024-01 | |||||||
KANSAS | ||||||||
Lessee, Lease, Description [Line Items] | ||||||||
Area of office space leased | ft² | 9,066 | |||||||
Lease expiration date | 2023-10 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments for Operating Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | ||
2023 | $ 2,289 | |
2024 | 2,619 | |
2025 | 3,710 | |
2026 | 3,978 | |
2027 | 4,063 | |
2028 and thereafter | 32,263 | |
Total future minimum lease payments | 48,922 | |
Less amount representing interest | (23,802) | |
Less amount representing tenant improvement allowances | (18,323) | |
Total lease liabilities | $ 6,797 | $ 1,300 |
Leases - Summary of Future Mi_2
Leases - Summary of Future Minimum Lease Payments for Operating Leases (Parenthetical) (Details) $ in Millions | Dec. 31, 2022 USD ($) |
Leases [Abstract] | |
Tenant improvement allowances expected to be received | $ 18.3 |
Leases - Summary of Future Mi_3
Leases - Summary of Future Minimum Lease Payments Which Do Not Include Amounts for Common Area Maintenance, Insurance, Or Taxes, for Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2021 USD ($) |
Leases [Abstract] | |
2022 | $ 775 |
2023 | 149 |
2024 | 9 |
2025 | 3 |
2026 | 1 |
Total | $ 937 |
Equity - Additional Information
Equity - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||||||
Nov. 21, 2022 USD ($) $ / shares shares | Nov. 16, 2022 USD ($) $ / shares | Apr. 08, 2022 USD ($) $ / shares | Apr. 07, 2022 shares | Mar. 07, 2022 USD ($) shares | Dec. 30, 2021 USD ($) $ / shares shares | Nov. 30, 2021 USD ($) | Dec. 31, 2022 USD ($) Facility $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Class Of Stock [Line Items] | |||||||||
Common stock, authorized | shares | 200,000,000 | 200,000,000 | |||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||
Common stock, voting rights | The holder of each share of common stock is entitled to one vote per share. | ||||||||
Dividends | $ | $ 0 | $ 0 | |||||||
Stock issuable per day, number of shares | $ | 56,235,000 | 15,679,000 | |||||||
Proceeds from the sale of common shares | $ | $ 59,538,000 | $ 16,343,000 | |||||||
Preferred stock, authorized | shares | 5,000,000 | 5,000,000 | |||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||
Preferred stock, issued | shares | 0 | 0 | |||||||
Preferred stock, outstanding | shares | 0 | 0 | |||||||
Warrants, expires period | Feb. 23, 2028 | ||||||||
Perceptive Term Loan | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants, expires period | Nov. 21, 2032 | ||||||||
Public offering price per share of common stock | $ / shares | $ 1.15 | ||||||||
Initial warrants amount | $ | $ 2,900,000 | ||||||||
Perceptive Term Loan | Expected Term | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants expected term | 10 years | ||||||||
Perceptive Term Loan | Volatility | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants and rights outstanding, measurement input | 0.813 | ||||||||
Perceptive Term Loan | Dividend Yield | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants and rights outstanding, measurement input | 0 | ||||||||
Perceptive Term Loan | Risk-Free Interest Rate | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants and rights outstanding, measurement input | 0.0367 | ||||||||
Perceptive Term Loan | Tranche A Loan | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrant, exercise price | $ / shares | $ 1.0648 | ||||||||
Perceptive Term Loan | Tranche B Loan | |||||||||
Class Of Stock [Line Items] | |||||||||
Additional warratns exercisable | shares | 1,000,000 | ||||||||
Series G Preferred Stock | 2018 Notes | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrant issued to purchase shares | shares | 613,333 | ||||||||
Warrant, exercise price | $ / shares | $ 0.75 | ||||||||
Subscription Agreements | |||||||||
Class Of Stock [Line Items] | |||||||||
Price per share | $ / shares | $ 1.15 | $ 1.79 | |||||||
Aggregate purchase price | $ | $ 270,000 | $ 11,700,000 | |||||||
Maximum | |||||||||
Class Of Stock [Line Items] | |||||||||
Stock issuable per day, number of shares | $ | $ 50,000,000 | ||||||||
Maximum | Perceptive Term Loan | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrant issued to purchase shares | shares | 5,000,000 | ||||||||
Additional warratns exercisable | shares | 2,000,000 | ||||||||
Equity Financing Programs | |||||||||
Class Of Stock [Line Items] | |||||||||
Number of facility | Facility | 2 | ||||||||
Shares of common stock issued and sold | shares | 3,756,994 | 3,886,893 | |||||||
Proceeds from the sale of common shares | $ | $ 16,300,000 | $ 7,300,000 | |||||||
Weighted Average Price Per Share | $ / shares | $ 1.87 | ||||||||
Equity Financing Programs | At-The-Market Facility | |||||||||
Class Of Stock [Line Items] | |||||||||
Line of Credit Facility, Remaining Borrowing Capacity | $ | $ 29,500,000 | ||||||||
Equity Financing Programs | LPC Facility | |||||||||
Class Of Stock [Line Items] | |||||||||
Line of Credit Facility, Remaining Borrowing Capacity | $ | 46,900,000 | ||||||||
Equity Financing Programs | Lincoln Park | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock issuable, committed to purchase | $ | $ 600,000 | ||||||||
Purchase agreement term | 36 months | ||||||||
Stock issuable per day, number of shares | shares | 50,000 | ||||||||
Shares issued or issuable, threshold limit description | Under applicable rules of the NASDAQ Capital Market, in no event may the Company issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.20 per share, such that issuances and sales of the common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable NASDAQ rules. | ||||||||
Maximum percentage of common stock allowed to purchase by counterparty | 9.99% | ||||||||
Shares issued as commitment fee | shares | 184,275 | ||||||||
Commitment shares issuable on conditional basis | shares | 61,425 | ||||||||
Diligence expenses and legal fees | $ | $ 129,000 | ||||||||
Adjustments to additional paid-in capital deferred offering costs | $ | 75,000 | ||||||||
Deferred offering costs | $ | 729,000 | 654,000 | |||||||
Equity Financing Programs | Lincoln Park | Maximum | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock issuable, committed to purchase | $ | $ 50,000,000 | ||||||||
Stock issuable per day, number of shares | shares | 100,000 | ||||||||
Stock issuable per day, value | $ | $ 1,500,000 | ||||||||
Shares issued as commitment fee, value | $ | $ 20,000,000 | ||||||||
At-The-Market Offering | |||||||||
Class Of Stock [Line Items] | |||||||||
Proceeds from the sale of common shares | $ | 15,700,000 | ||||||||
Net proceeds from sale of common shares after deducting underwriting discounts and commissions and offering expenses | $ | $ 6,800,000 | ||||||||
Underwriting discounts and commissions and offering expenses payable | $ | $ 700,000 | ||||||||
Common stock price per share | $ / shares | $ 4.35 | ||||||||
Public Offering | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares of common stock issued and sold | shares | 35,075,000 | ||||||||
Shares purchased by underwriter | shares | 4,575,000 | ||||||||
Proceeds from the sale of common shares | $ | $ 37,500,000 | ||||||||
Common stock price per share | $ / shares | $ 1.15 | ||||||||
Private Placements | Subscription Agreements | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares of common stock issued and sold | shares | 6,508,376 | ||||||||
Private Placements | Subscription Agreements | Board of Directors | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares of common stock issued and sold | shares | 3,631,284 | ||||||||
Private Placements | Subscription Agreements | Existing Shareholders | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares of common stock issued and sold | shares | 2,877,092 | ||||||||
Private Placements | Subscription Agreements | Chief Executive Officer and Chief Financial Officer | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares of common stock issued and sold | shares | 235,056 | ||||||||
IPO | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrant, exercise price | $ / shares | $ 4.46 | ||||||||
Warrant issued to purchase shares | shares | 103,326 |
Revenue and Accounts Receivab_3
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 38,212 | $ 54,506 |
Diagnostic Tests | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | 34,538 | 48,937 |
Services | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 3,674 | $ 5,569 |
Revenue and Accounts Receivab_4
Revenue and Accounts Receivable Credit Concentration - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
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 | $ 1,200 | |
Deferred revenue | $ 962 | $ 1,850 |
Non-current deferred revenue | $ 400 | |
Revenue | Minimum | Customer Concentration Risk | Medicare | ||
Disaggregation Of Revenue [Line Items] | ||
Concentration risk, percentage | 37% | 18% |
Other Long-term Liabilities | ||
Disaggregation Of Revenue [Line Items] | ||
Non-current deferred revenue | $ 400 | $ 800 |
Up Front Cash Payments | ||
Disaggregation Of Revenue [Line Items] | ||
Deferred revenue | $ 700 |
Revenue and Accounts Receivab_5
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers (Details) - Customer Concentration Risk - Minimum | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | The State of Colorado | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 10% | |
Revenue | The Big Ten Conference | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 40% | |
Revenue | Medicare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 37% | 18% |
Accounts Receivable | Medicare | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 23% | 30% |
Accounts Receivable | Astrazeneca UK | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 18% | |
Accounts Receivable | Janssen Research and Development, LLC | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 14% | |
Accounts Receivable | LabCorp DD (formerly Covance) | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 11% |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Oct. 31, 2020 | Feb. 29, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of outstanding stock options granted | 2,541,000 | 2,878,000 | ||
Number of performance-condition options granted | 380,000 | |||
Exercise price | $ 2.92 | |||
Stock compensation expense | $ 5,961,000 | $ 4,944,000 | ||
Dividends | $ 0 | $ 0 | ||
Restricted Stock Units (RSUs) | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted average grant date fair value | $ 2.36 | |||
Bonus-To-Options Program | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of outstanding stock options granted | 526,000 | 373,000 | ||
Number of performance-condition options granted | 244,000 | |||
Exercise price | $ 2.29 | |||
Stock compensation expense | $ 1,100,000 | $ 800,000 | ||
Options and Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized remaining stock based compensation balance | $ 7,100,000 | |||
Amortization period | 2 years 9 months 18 days | |||
Maximum | Bonus-To-Options Program | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Option expiration period | 10 years | |||
2020 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares reserved for issuance | 1,893,395 | |||
2020 Equity Incentive Plan | Performance Condition Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting term | Performance-based options vest in three equal annual installments beginning one year after the grant date | |||
Number of outstanding stock options granted | 0 | |||
2020 Equity Incentive Plan | Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Option expiration period | 10 years | |||
2020 Equity Incentive Plan | Common Stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Percentage of number of shares of common stock issued and outstanding | 4% | |||
2006 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Additional stock awards granted | 0 | |||
2016 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Additional stock awards granted | 0 | |||
2006 Plan, 2016 Plan and 2020 Equity Incentive Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Additional stock awards granted | 233,519 | |||
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares reserved for issuance | 100,145 | 338,106 | ||
Percentage of number of shares of common stock issued and outstanding | 1% | |||
Percentage of earnings used for purchase of common stock | 15% | |||
Percentage of fair market value of common stock for purchase under plan | 85% | |||
Description of voting power or value of stock for employee participation in offering period | No employee may participate in an offering period if the employee owns 5% or more of the total combined voting power or value of the Company’s stock. | |||
Description of offering period under plan | The initial offering period was from January 1, 2021 through August 31, 2021. On a go-forward basis, the ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. As of December 31, 2022, 237,961 shares have been issued under the ESPP leaving 100,145 shares remaining for future issuance. | |||
Number of common stock may be issued under incentive plan | 237,961 |
Share Based Compensation - Summ
Share Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2022 | 2,878 | |
Stock Options, Granted | 380 | |
Stock Options, Forfeited/canceled | (333) | |
Stock Options, Exercised | (384) | |
Stock Options, Outstanding - December 31, 2022 | 2,541 | 2,878 |
Stock Options, Exercisable - December 31, 2022 | 1,525 | |
Weighted Average Exercise Price, Outstanding - January 1, 2022 | $ 8.08 | |
Weighted Average Exercise Price, Granted | 2.92 | |
Weighted Average Exercise Price, Forfeited/canceled | 8.23 | |
Weighted Average Exercise Price, Exercised | 0.70 | |
Weighted Average Exercise Price, Outstanding - December 31, 2022 | 8.40 | $ 8.08 |
Weighted Average Exercise Price, Exercisable - December 31, 2022 | $ 7.28 | |
Weighted Average Contractual Life (Years), Outstanding | 7 years 4 months 24 days | 7 years 8 months 12 days |
Weighted Average Contractual Life (Years), Exercisable - December 31, 2022 | 6 years 9 months 18 days | |
Aggregate Intrinsic Value, Outstanding - January 1, 2022 | $ 6,288 | |
Aggregate Intrinsic Value, Outstanding - December 31, 2022 | 1,489 | $ 6,288 |
Aggregate Intrinsic Value, Outstanding - Exercisable - December 31, 2022 | $ 1,067 | |
Bonus-To-Options Program | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock Options, Outstanding - January 1, 2022 | 373 | |
Stock Options, Granted | 244 | |
Stock Options, Forfeited/canceled | (91) | |
Stock Options, Outstanding - December 31, 2022 | 526 | 373 |
Stock Options, Exercisable - December 31, 2022 | 526 | |
Weighted Average Exercise Price, Outstanding - January 1, 2022 | $ 17 | |
Weighted Average Exercise Price, Granted | 2.29 | |
Weighted Average Exercise Price, Forfeited/canceled | 14.03 | |
Weighted Average Exercise Price, Outstanding - December 31, 2022 | 10.69 | $ 17 |
Weighted Average Exercise Price, Exercisable - December 31, 2022 | $ 10.69 | |
Weighted Average Contractual Life (Years), Outstanding | 7 years 7 months 6 days | 7 years 6 months |
Weighted Average Contractual Life (Years), Exercisable - December 31, 2022 | 7 years 7 months 6 days | |
Aggregate Intrinsic Value, Outstanding - January 1, 2022 | $ 76 | |
Aggregate Intrinsic Value, Outstanding - December 31, 2022 | 2 | $ 76 |
Aggregate Intrinsic Value, Outstanding - Exercisable - December 31, 2022 | $ 2 |
Share Based Compensation - Su_2
Share Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | $ 5,961 | $ 4,944 |
Direct Costs and Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | 65 | 49 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | 427 | 572 |
Sales, Marketing, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | $ 5,469 | $ 4,323 |
Share Based Compensation - Su_3
Share Based Compensation - Summary of Weighted Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (in years) | 5 years 7 months 24 days | 6 years 3 days |
Expected volatility | 72.60% | 68.50% |
Risk‑free rate | 1.32% | 0.79% |
Share Based Compensation - Su_4
Share Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units shares in Thousands | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Outstanding - January 1, 2022 | shares | 151 |
Number of Shares, Granted | shares | 1,473 |
Number of Shares, Forfeited/canceled | shares | (56) |
Number of Shares, Released | shares | (357) |
Number of Shares, Outstanding - December 31, 2022 | shares | 1,211 |
Weighted Average Grant Date Fair Value Per Share, January 1, 2022 | $ / shares | $ 5.30 |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | 2.75 |
Weighted Average Grant Date Fair Value Per Share, Forefeited/canceled | $ / shares | 3.69 |
Weighted Average Grant Date Fair Value Per Share, Released | $ / shares | 5.01 |
Weighted Average Grant Date Fair Value Per Share, December 31, 2022 | $ / shares | $ 2.36 |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2018 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Weighted-average shares outstanding, basic | 2,520,108 | 2,520,108 | 42,103,000 | 27,365,000 | |
Weighted-average shares outstanding, diluted | 2,520,108 | 2,520,108 | 42,103,000 | 27,365,000 | |
Integrated Diagnostics, Inc | |||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Business acquisition contingent consideration gross margin target | $ 2 | $ 2 | |||
Business acquisition contingent consideration gross margin target period | 7 years | ||||
Integrated Diagnostics, Inc | Common Stock | |||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | |||||
Contingent consideration shares | 2,520,108 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Computation of Basic and Diluted Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | |||||
Net loss attributable to common stockholders | $ (65,447) | $ (43,159) | $ (65,447) | ||
Denominator | |||||
Weighted-average shares outstanding used in computing net loss per share, basic | 2,520,108 | 2,520,108 | 42,103,000 | 27,365,000 | |
Weighted-average shares outstanding used in computing net loss per share, diluted | 2,520,108 | 2,520,108 | 42,103,000 | 27,365,000 | |
Net loss per share, basic | $ (1.55) | $ (1.58) | |||
Net loss per share, diluted | $ (1.55) | $ (1.58) |
Net Loss per Common Share - S_2
Net Loss per Common Share - Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 9,461 | 3,535 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 3,067 | 3,251 |
Shares Committed Under ESPP | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 80 | 30 |
Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 5,103 | 103 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 1,211 | 151 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Contingency [Line Items] | ||
Provision for income taxes | $ 0 | |
Federal net operating loss carryforwards | 299,900,000 | |
Research and experimentation tax carryforwards | $ 4,800,000 | |
Description of tax credit carryforward expiration | expire beginning in 2026 | |
Valuation allowance, deferred tax asset, explanation of change | Company does not believe it is more likely than not that it will realize the benefits of net deferred tax assets and, accordingly, has established a valuation allowance equal to 100% of net deferred tax assets. | |
Percentage of valuation allowance equal to net deferred tax assets | 100% | |
Increase in valuation allowance | $ 15,100,000 | $ 11,400,000 |
Accrued interest related to uncertain tax positions | $ 0 | $ 0 |
Income tax examination details | federal and state returns for all years will remain open to examination by federal and state tax authorities for three and four years, respectively, from the date of utilization of any net operating loss carryforwards. | |
Income tax examination, likelihood of unfavorable settlement | For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. | |
Income Tax Examination, Description | federal and state returns for all years will remain open to examination by federal and state tax authorities for three and four years, respectively, from the date of utilization of any net operating loss carryforwards. |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21% | 21% |
State income taxes, net of federal benefit | 5% | 5% |
Research and developments credits | 1% | 1% |
Permanent items | (4.00%) | (1.00%) |
Change in valuation allowance | (23.00%) | (26.00%) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Tax Assets: | ||
Net operating loss carryforwards | $ 70,822 | $ 61,874 |
Research and development tax credits | 3,807 | 3,372 |
Interest expense limitation | 3,036 | 554 |
Property and equipment | 234 | 215 |
Capitalized research costs | 2,874 | |
Share-based compensation | 1,619 | 1,977 |
Accruals and reserves | 1,932 | 1,618 |
Total | 84,324 | 69,610 |
Valuation allowance | (82,552) | (67,457) |
Total deferred tax assets after valuation allowance | 1,772 | 2,153 |
Deferred Tax Liabilities: | ||
Intangible assets | (1,772) | (2,153) |
Total deferred tax liabilities | $ (1,772) | $ (2,153) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at January 1 | $ 843 | $ 715 |
Additions for tax positions related to the current year | 109 | 128 |
Balance at December 31 | $ 952 | $ 843 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
May 13, 2021 | May 01, 2021 | Dec. 02, 2020 | Sep. 30, 2020 | Aug. 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 31, 2016 | |
Loss Contingencies [Line Items] | ||||||||
Research and development | $ 13,102,000 | $ 12,789,000 | ||||||
Revenue Share Agreement | Oncimmune Limited | ||||||||
Loss Contingencies [Line Items] | ||||||||
Royalty expense | $ 900,000 | 700,000 | ||||||
Percentage of license agreement and royalty payment related to acquired diagnostic test recognized revenue for non-screening tests | 8% | |||||||
Minimum annual volume percentage thereafter | 5% | |||||||
Period of escalations of sales | through the first four years of sales | |||||||
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% | |||||||
Royalty expense | $ 0 | |||||||
CellCarta License | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of royalty payments on net revenue | 0.675% | |||||||
Royalty expense | 100,000 | 100,000 | ||||||
Percentage of fee payments on net sales | 1% | |||||||
Term of royalty payments from first commercial sale | 15 years | |||||||
Year of ending royalty payments from first commercial sale | 2034 | |||||||
AVEO Oncology | ||||||||
Loss Contingencies [Line Items] | ||||||||
Remaining estimated obligation | 100,000 | |||||||
Research and development | $ 0 | $ 0 | ||||||
AVEO Oncology | NSCLC POC Trial | ||||||||
Loss Contingencies [Line Items] | ||||||||
Responsible percentage of development and regulatory costs | 50% | |||||||
Ficlatuzumab | AVEO Oncology | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of development and regulatory costs exercised using opt-out right | 50% | |||||||
Percentage of royalty payments on net sales | 10% | |||||||
Percentage of license income generated from licensing | 25% |