Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001439725 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-39659 | |
Entity Registrant Name | BIODESIX, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-3986492 | |
Entity Address, Address Line One | 2970 Wilderness Place, | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Boulder | |
Entity Address, State or Province | CO | |
Entity Address, Postal Zip Code | 80301 | |
City Area Code | 303 | |
Local Phone Number | 417-0500 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | BDSX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 39,790,784 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 16,427 | $ 32,712 |
Accounts receivable, net of allowance for doubtful accounts of $100 and $158 | 3,774 | 3,656 |
Other current assets | 7,032 | 7,245 |
Total current assets | 27,233 | 43,613 |
Non‑current assets | ||
Property and equipment, net | 4,028 | 4,179 |
Intangible assets, net | 11,131 | 11,617 |
Operating lease right-of-use assets | 2,219 | |
Goodwill | 15,031 | 15,031 |
Other long-term assets | 2,009 | 1,657 |
Total non‑current assets | 34,418 | 32,484 |
Total assets | 61,651 | 76,097 |
Current liabilities | ||
Accounts payable | 2,120 | 1,662 |
Accrued liabilities | 6,173 | 7,665 |
Deferred revenue | 2,499 | 1,850 |
Current portion of operating lease liabilities | 1,110 | |
Current portion of contingent consideration | 17,821 | 17,764 |
Current portion of notes payable | 51 | 19 |
Other current liabilities | 37 | |
Total current liabilities | 29,811 | 28,960 |
Non‑current liabilities | ||
Long‑term notes payable, net of current portion | 10,055 | 9,993 |
Long-term operating lease liabilities | 1,177 | |
Contingent consideration | 12,212 | 16,028 |
Other long-term liabilities | 615 | 1,389 |
Total non‑current liabilities | 24,059 | 27,410 |
Total liabilities | 53,870 | 56,370 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized; 0 (2022 and 2021) shares issued and outstanding | ||
Common stock, $0.001 par value, 200,000,000 shares authorized; 31,889,317 (2022) and 30,789,649 (2021) shares issued and outstanding | 32 | 31 |
Additional paid‑in capital | 325,308 | 321,669 |
Accumulated deficit | (317,559) | (301,973) |
Total stockholders' equity | 7,781 | 19,727 |
Total liabilities and stockholders' equity | $ 61,651 | $ 76,097 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable | $ 100 | $ 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 | 31,889,317 | 30,789,649 |
Common stock, outstanding | 31,889,317 | 30,789,649 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Revenues | $ 6,548 | $ 28,866 |
Operating expenses: | ||
Direct costs and expenses | 3,235 | 18,218 |
Research and development | 3,206 | 3,321 |
Sales, marketing, general and administrative | 14,487 | 11,927 |
Change in fair value of contingent consideration | 983 | |
Impairment loss on intangible assets | 81 | |
Total operating expenses | 21,009 | 34,449 |
Loss from operations | (14,461) | (5,583) |
Other (expense) income: | ||
Interest expense | (1,137) | (651) |
Loss on debt extinguishment | (728) | |
Other income, net | 12 | 1 |
Total other expense | (1,125) | (1,378) |
Net loss | $ (15,586) | $ (6,961) |
Net loss per share, basic and diluted | $ (0.50) | $ (0.26) |
Weighted-average shares outstanding, basic and diluted | 31,070 | 26,604 |
Condensed Statements of Stockho
Condensed 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 | |||
Exercise of stock options | 475 | 475 | ||
Exercise of stock options, shares | 223,000 | |||
Stock‑based compensation | 1,752 | 1,752 | ||
Net loss | (6,961) | (6,961) | ||
Balances at Mar. 31, 2021 | 36,432 | $ 27 | 302,180 | (265,775) |
Common Stock Balance, Shares at Mar. 31, 2021 | 26,785,000 | |||
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 under employee stock purchase plan | 202 | 202 | ||
Issuance of common stock under employee stock purchase plan, Shares | 99,000 | |||
Issuance of common stock for deferred offering costs | 600 | 600 | ||
Issuance of common stock for deferred offering costs, Shares | 184,000 | |||
Issuance of common stock, net of discounts and commissions | 1,417 | $ 1 | 1,416 | |
Issuance of common stock, net of discounts and commissions, Shares | 709,000 | |||
Exercise of stock options | $ 75 | 75 | ||
Exercise of stock options, shares | 107,000 | 107,000 | ||
Stock‑based compensation | $ 1,346 | 1,346 | ||
Net loss | (15,586) | (15,586) | ||
Balances at Mar. 31, 2022 | $ 7,781 | $ 32 | $ 325,308 | $ (317,559) |
Common Stock Balance, Shares at Mar. 31, 2022 | 31,889,000 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (15,586) | $ (6,961) |
Adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities | ||
Depreciation and amortization | 908 | 746 |
Amortization of lease right-of-use assets | 280 | |
Loss on debt extinguishment | 728 | |
Stock‑based compensation expense | 1,346 | 1,752 |
Change in contingent consideration | 983 | |
Provision for doubtful accounts | (39) | 193 |
Accrued interest, amortization of debt issuance costs and other | 1,006 | 65 |
Inventory excess and obsolescence | 379 | |
Impairment loss on intangible assets | 81 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (78) | (3,256) |
Other current assets | (166) | 1,068 |
Other long-term assets | 466 | 224 |
Accounts payable and other accrued liabilities | (1,304) | (5,744) |
Deferred revenue | (124) | (1,124) |
Current and long-term operating lease liabilities | (268) | |
Net cash and cash equivalents and restricted cash used in operating activities | (13,099) | (11,326) |
Cash flows from investing activities | ||
Purchases of property and equipment | (262) | (466) |
Patent costs and intangible asset acquisition, net | (90) | (50) |
Net cash and cash equivalents and restricted cash used in investing activities | (352) | (516) |
Cash flows from financing activities | ||
Proceeds from the issuance of common stock | 1,599 | |
Proceeds from issuance of common stock under employee stock purchase plan | 202 | |
Proceeds from exercise of stock options | 75 | 475 |
Payment of contingent consideration | (4,625) | |
Proceeds from term loan and notes payable | 103 | 30,000 |
Repayment of term loan and notes payable | (11) | (25,416) |
Equity financing costs | (141) | |
Deferred offering costs | (30) | |
Payment of debt issuance costs | (108) | |
Other | (6) | |
Net cash and cash equivalents and restricted cash (used in) provided by financing activities | (2,834) | 4,951 |
Net decrease in cash and cash equivalents and restricted cash | (16,285) | (6,891) |
Cash, cash equivalents, and restricted cash ‑ beginning of period | 32,798 | 62,306 |
Cash, cash equivalents, and restricted cash ‑ end of period | 16,513 | 55,415 |
Supplemental cash flow information: | ||
Common stock issued for deferred offering costs | 600 | |
Deferred offering costs amortized against Additional paid-in capital | 18 | |
Deferred offering costs included in Accrued liabilities | 85 | |
Equity financing costs included in Accrued liabilities | 24 | |
Operating lease right-of-use assets obtained in exchange for lease liabilities | 2,497 | |
Finance lease right-of-use assets obtained in exchange for lease liabilities | 123 | |
Cash paid for interest | $ 223 | $ 577 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 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, with laboratories in Colorado and Kansas. The Company conducts all of its operations within a single legal entity. Biodesix is a data-driven diagnostic solutions company leveraging state of the art technologies with its proprietary artificial intelligence platform to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in lung disease. In addition to diagnostic tests, the Company provides biopharmaceutical companies with services that include diagnostic research, clinical trial testing, and the discovery, development, and commercialization of companion diagnostics. The Company performs its blood-based diagnostic tests in its laboratory facilities, which are located in Boulder, Colorado and De Soto, Kansas. In May 2020, the Federal Drug Administration (FDA) granted Emergency Use Authorization (EUA) of the Bio-Rad SARS-CoV-2 Droplet Digital polymerase chain reaction (ddPCR) test to detect Coronavirus Disease 2019 (COVID-19) infection. In April 2020, the FDA authorized the Platelia SARS-CoV-2 Total Ab test to detect COVID-19 antibodies. Medical products that are granted an EUA are only permitted to commercialize their products under the terms and conditions provided in the authorization. The FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, if the conditions for the issuance of the EUA are no longer met, or if other circumstances make revocation appropriate to protect the public health or safety. Blood-Based Lung Tests The Company offers five blood-based lung cancer tests across the lung cancer continuum of care: Diagnosis • Nodify XL2® and Nodify CDT® tests, marketed as our Nodify Lung ® Nodule Risk Assessment testing strategy, assess the risk of lung cancer to help identify the most appropriate treatment pathway. We believe we are the only company to offer two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules. Treatment & Monitoring • GeneStrat ddPCR® and VeriStrat® tests, marketed as part of our new IQLung testing strategy, are used following diagnosis of lung cancer to measure the presence of mutations in the tumor and the state of the patient’s immune system to establish the patient’s prognosis and help guide treatment decisions. The GeneStrat ddPCR tumor profiling test and the VeriStrat immune profiling test have a 36-hour average turnaround time, providing physicians with timely results to facilitate treatment decisions. • GeneStrat NGS (NGS) test, also marketed as part of our new IQLung testing strategy, our 72-hour blood-based NGS test, was launched in November 2021 to a select group of physicians, with national launch in January 2022. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced-stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner. 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 infection by the SARS-CoV-2 virus. • Platelia SARS-CoV-2 Total Ab test, which is an antibody test, FDA EUA authorized, 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 to assist in their back-to-work or back-to-school strategies, a crucial element of restarting economic activity. In developing the Company's products, the Company has built or gained access to unique biorepositories, proprietary technology, and bioinformatics methods that it believes are important to the development of new targeted therapies, determining clinical trial eligibility and guiding treatment selection. The Company’s testing services are made available through its clinical laboratories. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X for interim financial information and reflect all adjustments necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. All such adjustments are of a normal recurring nature. Results for interim periods are not indicative of the results for the entire fiscal year. The accompanying Condensed Financial Statements should be read in conjunction with the audited Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Certain information and footnote disclosures, including significant accounting policies, normally included in fiscal year financial statements prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) have been condensed or omitted. The Condensed Balance Sheet as of December 31, 2021 was derived from the audited financial statements. During March 2020, a global pandemic was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus (COVID-19). The COVID-19 pandemic negatively affected, and we expect will continue to negatively affect, our lung diagnostic testing-related revenue and our clinical studies. As of March 31, 2022, we maintained cash and cash equivalents of $ 16.4 million and we have $ 10 million in principal balance outstanding on our 2021 Term Loan. We have incurred significant losses since inception and, as a result, we have funded our operations to date primarily through the sale of common stock, the sale of convertible preferred stock, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which include lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources, including the debt and equity funding and amendments to the 2021 Term Loan and Integrated Diagnostics, Inc. (Indi) Agreement subsequent to March 31, 2022, and needs and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-Q in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our 2021 Term Loan (see Note 6 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our 2021 Term Loan during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balance. We have taken steps to improve our liquidity through raising equity capital during 2022, amendments to our 2021 Term Loan and have also undertaken several proactive measures to mitigate the financial and operational impacts of the COVID-19 pandemic through the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. Subsequent to March 31, 2022, we entered into a $ 25.0 million debt facility with funding for up to $ 25.0 million in two tranches. On May 9, 2022, we closed on the first tranche for gross proceeds of $ 15.0 million (approximately $ 13.0 million, net, after deducting estimated debt issuance costs and original issue discounts (OID)). We also amended the Indi Agreement to delay near term cash requirements and extend the period of milestone payments. To maintain an adequate amount of available liquidity and execute our current operating plan, we will need to continue to raise additional funds from external sources, such as through the issuance of equity or debt securities; however, we have not secured such funding at the time of this filing and any such financing activities are subject to market conditions. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. Our current operating plan, which is in part determined based on our most recent historical actual results and trends, along with the items noted above, raises substantial doubt about the Company’s ability to continue as a going concern. Our unaudited 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit cards. The Company had $ 0.1 million as of March 31, 2022 and December 31, 2021, respectively reported within 'Other current assets' in the balance sheets. Concentration of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial institution with which it holds cash. Periodically throughout the year, the Company has maintained balances in various operating accounts in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. Several of the components for certain of the Company's sample collection kits, test reagents, and test systems are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of March 31, 2022 and December 31, 2021, see Note 9 – Revenue and Accounts Receivable Credit Concentration . Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to ‘Direct costs and expenses’. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and was $ 2.6 million a nd $ 2.9 million as of March 31, 2022 and December 31, 2021 , respectively. Fair Value of Financial Instruments U.S. GAAP for fair value establishes a hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach, and cost approach). We utilize a combination of market and income approaches to value our financial instruments. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. Fair value measurements are categorized within the fair value hierarchy based upon the lowest level of the most significant inputs used to determine fair value. The three levels of the hierarchy and the related inputs are as follows: Level Inputs 1 Unadjusted quoted prices in active markets for identical assets and liabilities. 2 Unadjusted quoted prices in active markets for similar assets and liabilities; Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or Inputs other than quoted prices that are observable for the asset or liability. 3 Unobservable inputs for the asset or liability. The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
Recently Issued Accounting Standards | Note 3 - Recently Issued Accounting Standards Recently adopted accounting standards In February 2016, the FASB issued Account Standard Update (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. T he Company elected this transition method and adopted ASC 842 on January 1, 2022 and as a result, recorded operating lease right-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 beginning retained earnings, and did not materially affect the Company's statement of operations, statement of stockholders' equity or statement of cash flows for the three month period ended March 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. Management determines if an arrangement is a lease at inception or upon modification of a contract. Leases are classified as either financing or operating, with classification affecting the pattern of expense recognition in the statements of operations. When determining whether a lease is a finance lease or an operating lease, ASC 842 does not specifically define criteria to determine the “major part of remaining economic life of the underlying asset” and “substantially all of the fair value of the underlying asset.” 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 7 — 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 with early adoption permitted. The Company is currently evaluating this guidance and assessing the overall impact on its financial statements. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 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 values of outstanding borrowings, which are classified as Level 2, approximate their carrying values as of March 31, 2022 and December 31, 2021, based on interest rates currently available for similar borrowings and were (in thousands): As of March 31, 2022 December 31, 2021 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 10,106 $ 10,106 $ 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 acquisition of Indi which is accounted for as a liability and remeasured through our statements of operations. The table below presents the reported fair values of contingent consideration, which is classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): Description March 31, 2022 December 31, 2021 Current portion of contingent consideration $ 17,821 $ 17,764 Contingent consideration 12,212 16,028 Total contingent consideration $ 30,033 $ 33,792 The following table presents the changes in contingent consideration for the three months ended March 31, 2022 and 2021 (in thousands): For the three months Level 3 Rollforward 2022 2021 Beginning balances - January 1 $ 33,792 $ 29,932 Changes in fair value — 983 Interest expense 866 — Payments of contingent consideration ( 4,625 ) — Ending balances - March 31 $ 30,033 $ 30,915 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 met the Company was required to issue 2,520,108 shares of common stock. For the six months following the achievement of the gross margin target, Indi had the option to require the Company to redeem these common shares for $ 37.0 million in cash over eight equal quarterly installments. If Indi elected to not exercise its option, the Company had 12 months to repurchase the common stock in two equal and consecutive quarterly cash installments totaling $ 37.0 million. The Company met the gross margin target of $ 2.0 million for three consecutive months during the three months ended June 30, 2021. The Company entered into an amendment to the original agreement in August 2021 in which all parties agreed to forgo the issuance of common stock and agreed that the Company will in lieu thereof make six quarterly installments of approximately $ 4.6 million each beginning in January 2022 and a final payment of approximately $ 9.3 million in July 2023 for a total of $ 37.0 million. The aggregate amount of payments owed by the Company under this amendment is the same as if Indi had exercised the put right or the Company had exercised the call right provided for in the original agreement. Our ability to make these payments are subject to consent from our lender under the 2021 Term Loan and related amendments (see Note 6 - Debt ). We obtained consent from our lender and subsequently made the first and second milestone payments of $ 4.6 and $ 2.0 million in January 2022 and April 2022, respectively. See Note 14 – Subsequent Events for further amendments to the milestone payments subsequent to March 31, 2022. The significant unobservable inputs used in the measurement of fair value include the probability of successful achievement of the specified product gross margin targets, the period in which the targets were expected to be achieved, and discount rates which ranged from 11 % to 13.5 %. As a result of the achievement of the gross margin target, the only significant unobservable input used in the measurement of fair value includes the discount rate since all other inputs became fixed and determinable. Significant increases or decreases in the discount rate would result in a significantly higher or lower fair value measurement. Contingent consideration expected to be paid in the next twelve months is recorded in the balance sheets as ‘Current portion of contingent consideration’ while the remaining amount to be paid is recorded as ‘Contingent consideration’ within non-current liabilities. The net change to contingent consideration through the date the gross margin target was met is recorded as operating expenses in the statements of operations. Subsequent changes to the contingent consideration following the achievement of the gross margin target are recorded as ‘Interest expense’ in the statements of operations resulting from the passage of time and fixed payment schedule. Non-Financial Assets and Liabilities Our non-financial assets, which primarily consist of property and equipment, goodwill, and other intangible assets, are not required to be carried at fair value on a recurring basis and are reported at carrying value. There were no changes to the valuation methods during the periods presented. |
Supplementary Balance Sheet Inf
Supplementary Balance Sheet Information | 3 Months Ended |
Mar. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Supplementary Balance Sheet Information | Note 5 – Supplementary Balance Sheet Information Property and equipment consist of the following (in thousands): March 31, 2022 December 31, 2021 Lab equipment $ 6,802 $ 6,784 Leasehold improvements 2,355 2,339 Computer equipment 803 700 Furniture and fixtures 391 391 Software 600 600 Vehicles 97 97 Construction in process 142 17 11,190 10,928 Less: accumulated depreciation ( 7,162 ) ( 6,749 ) Total property and equipment, net $ 4,028 $ 4,179 Depreciation expense for the three months ended March 31, 2022 and 2021 w as $ 0.4 million and $ 0.3 million, respectively. Intangible assets, excluding goodwill, consist of the following (in thousands): March 31, 2022 December 31, 2021 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,747 $ ( 588 ) $ 1,159 $ 1,755 $ ( 566 ) $ 1,189 Purchased technology 16,900 ( 7,042 ) 9,858 16,900 ( 6,572 ) 10,328 Intangible assets not subject to Trademarks 114 — 114 100 — 100 Total $ 18,761 $ ( 7,630 ) $ 11,131 $ 18,755 $ ( 7,138 ) $ 11,617 Amortization expense related to definite-lived intangible assets wa s $ 0.5 million for both the three months ended March 31, 2022 and 2021. Future estimated amortization expense of intangible assets is (in thousands): As of March 31, 2022 Remainder of 2022 $ 1,491 2023 1,977 2024 1,967 2025 1,962 2026 1,948 2027 and thereafter 1,672 Total $ 11,017 Accrued liabilities consist of the following (in thousands): March 31, 2022 December 31, 2021 Compensation related accruals $ 2,594 $ 4,029 Accrued clinical trial expense 893 870 Other expenses 2,686 2,766 Total accrued liabilities $ 6,173 $ 7,665 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 – Debt Our long-term debt primarily consists of notes payable associated with our 2021 Term Loan which is described in further detail below. Long-term notes payable were as follows (in thousands): March 31, 2022 December 31, 2021 2021 Term Loan $ 10,000 $ 10,000 Other 165 75 Unamortized debt discount and issuance costs ( 59 ) ( 63 ) 10,106 10,012 Less: current maturities 51 19 Long-term notes payable $ 10,055 $ 9,993 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 or Lender) and the Company, as borrower, whereby subject to the terms and conditions of the 2021 Term Loan, SVB advanced to the Company an original principal amount of $ 30 million. The 2021 Term Loan provides for an “interest-only” period from the Effective Date through February 28, 2023, with interest due and payable monthly on the first calendar day of each month. However, the Company achieved a revenue milestone of at least $ 65 million on a trailing twelve-month basis during the three months ended March 31, 2021 which automatically extended the interest-only period through February 28, 2024. Beginning on the first calendar day of the month following the end of the interest-only period, the 2021 Term Loan shall be payable in (i) consecutive equal installments of principal through March 1, 2026, plus (ii) monthly payments of accrued interest. The principal amount outstanding under the 2021 Term Loan shall accrue interest at a floating per annum rate equal to the greater of (i) 2.00% above the prime rate, or (ii) 5.25%, which interest, in each case, shall be payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate shall be effective on the effective date of any change to the prime rate. The Company’s final payment, due at maturity on March 1, 2026 , shall include all outstanding principal and accrued and unpaid interest, lender fees and expenses, of which the majority will include a final payment of $ 2.7 million, and all other sums, if any, that shall have become due and payable hereunder with respect to the 2021 Term Loan. The $ 2.7 million final payment is being amortized as interest expense over the term of the loan. The Company has the option to prepay, prior to maturity, the total outstanding principal amount plus accrued and unpaid interest, subject to a prepayment penalty of 3 % of the principal amount if paid prior to the first anniversary of the Effective Date, 2 % of the principal amount if paid on or after the first anniversary but prior to the second anniversary of the Effective Date, 1 % of the principal amount if paid on or after the second anniversary but prior to October 19, 2025, and 0 % thereafter. The Company granted the Lender a security interest in substantially all of the Company’s assets. The 2021 Term Loan requires the Company to comply with a minimum liquidity ratio covenant (as defined) by the 2021 Term Loan of not less than 0.95 to 1.00, and had a trailing six month rolling minimum revenue requirement of not less than 70 % of the Company’s projected revenue performed at the end of each reporting period. On September 30, 2021, we entered into the Consent and First Amendment to Loan and Security Agreement (the 2021 Term Loan Amendment) to, among other things, amend our 2021 Term Loan to eliminate the revenue covenant for the period ended September 30, 2021 and modify the revenue covenant threshold for the three month period ended December 31, 2021. In addition, we agreed to establish a restricted cash collateral account for $ 15 million for the benefit of our lender if the balance of our cash and cash equivalents declined below $ 40 million. On December 31, 2021, we entered into the Consent and Second Amendment to Loan and Security Agreement (the 2021 Term Loan Second Amendment) to, among other things, amend our 2021 Term Loan and First Amendment to: (i) obtain consent for the $ 4.6 million January 2022 milestone payment under the Indi APA, (ii) repay $ 20 million in outstanding principal on December 31, 2021, (iii) waive the $ 600,000 prepayment fee on the $ 20 million Term Loan repayment, (iv) waive the minimum revenue covenant as of December 31, 2021, and (v) modify the minimum revenue requirement to not less than 75 % for the three months ended March 31, 2022 and not less than 75 % on a trailing six month rolling basis for each quarter thereafter of the Company’s projected revenue performed at the end of each reporting period. The Lender agreed to apply the full amount of funds previously established within the restricted cash collateral account to partially repay the $ 20 million in outstanding principal, thereby eliminating the restricted cash collateral account. See Note 14 – Subsequent Events for further amendments to the 2021 Term Loan subsequent to March 31, 2022. The 2021 Term Loan contains certain covenants limiting the ability of the Company to, among other things, incur future debt, transfer assets except for the ordinary course of business, make acquisitions, pay dividends or make other certain restricted payments, or sell assets, subject to certain exceptions, without the prior written consent of the Lender. Failure to comply with the covenants and loan requirements may result in an event of default. As of March 31, 2022, the Company was in compliance with all restrictive and financial covenants associated with its borrowings. In the event of a default, including, among other things, our failure to make any payment when due or our failure to comply with any covenant under the 2021 Term Loan, the Lender may elect to declare all amounts outstanding to be immediately due and payable, and may proceed against the collateral granted to them to secure such indebtedness, including a royalty-free license or other right to use all of our intellectual property without charge. Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of March 31, 2022 Remainder of 2022 $ 36 2023 49 2024 4,050 2025 4,824 2026 1,206 2027 and thereafter — Total $ 10,165 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | Note 7 - 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 as sets 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 . The Company also holds various copier and storage facility leases under non-cancelable lease agreements that expire in the next one to four years . Operating lease expense was $ 0.3 million for both the three months ended March 31, 2022 and 2021 . As of March 31, 2022, the weighted-average remaining lease term and discount rate associated with our operating leases were 1.8 years and 11 %, respectively. Centennial Valley Properties I, LLC Lease Agreement On March 11, 2022, the Company entered into a Lease Agreement (the Lease) with Centennial Valley Properties I, LLC, a Colorado limited liability company (the Landlord) for office and laboratory space located at 919 West Dillion Road; Louisville, Colorado (the Leased Premises). The purpose of the Lease is to replace the Company’s current leased premises at 2970 Wilderness Place, Suite 100 in Boulder, Colorado and the Company intends to move its corporate headquarters to the Leased Premises by mid-2023. 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. As of March 31, 2022, the Lease has not yet commenced under the terms of the agreement nor has the Company begun to account for the Lease Agreement until such time as it is determined that we have met the lease inception date under applicable accounting standards. We expect to recognize the commencement of the Lease for accounting purposes beginning in the second quarter 2022. 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 up to $ 25.00 per rentable square foot (the Extra Allowance Amount). The Company will repay the Extra Allowance Amount actually funded by the Landlord in equal monthly payments with an interest rate of 6 % per year over the Initial Term excluding any part of the Abated Rent Period or Partial Abated Rent Period, which shall start to accrue on the date that the Landlord first disburses the Extra Allowance Amount. The Lease includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature, including maintaining a $ 5.0 million letter of credit (subject to contingent reduction over the term of the lease) to secure the performance of the Company’s obligations under the Lease. The $ 5.0 million letter of credit has to be cash collateralized by the Company through a restricted cash account for the benefit of the Landlord, which we expect to recognize contemporaneously with the commencement of the Lease for accounting purposes beginning in the second quarter 2022. Future minimum lease payments associated with our operating leases were as follows (in thousands): As of March 31, 2022 Remainder of 2022 $ 926 2023 1,534 2024 81 2025 3 2026 2 2027 and thereafter — Total future minimum lease payments 2,546 Less amount representing interest ( 259 ) Total lease liabilities $ 2,287 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 were as follows (in thousands): As of December 31, 2021 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Equity | Note 8 – Equity 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). During the three months ended March 31, 2022, the Company raised approxima tely $ 1.6 m illion ( $ 1.5 m illion, after deducting underwriting discounts and commissions and offering expenses payable) in gross proceeds from the sale of 708,752 common shares at a weighted average price per share of $ 2.26 under these programs . As of March 31, 2022 , the Company had remaining available capacity for share issuances of approximately $ 32.8 million under the at-the-market facility and up to $ 49.2 million under the LPC facility, each subject to the restrictions and limitations of the underlying facilities, as applicable. See Note 14 – Subsequent Events for information regarding further equity financing subsequent to March 31, 2022. Common Stock Purchase Agreement On March 7, 2022 (the 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 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 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 are included on the balance sheet in 'Other long-term assets'. In addition to the Initial Commitment Shares, the Company recorded $ 115,000 of due diligence expenses and legal fees as deferred offering costs. 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 three months ended March 31, 2022 , $ 18,000 of deferred offering costs were charged against 'Additional paid-in capital' with $ 697,000 remaining as of March 31, 2022. 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. 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 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 common stock warrants remain outstanding as of March 31, 2022 . |
Revenue and Accounts Receivable
Revenue and Accounts Receivable Credit Concentration | 3 Months Ended |
Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue and Accounts Receivable Credit Concentration | Note 9 – Revenue and Accounts Receivable Credit Concentration We derive our revenue from two primary sources: (i) providing diagnostic testing in the clinical setting (Diagnostic tests); and (ii) providing biopharmaceutical companies with services that include diagnostic research, clinical research, clinical trial testing, development and testing services generally provided outside the clinical setting and governed by individual contracts with third parties as well as development and commercialization of companion diagnostics (Services). Diagnostic test revenues consist of blood-based lung tests and COVID-19 tests, which are recognized in the amount expected to be received in exchange for diagnostic tests when the diagnostic tests are delivered. The Company conducts diagnostic tests and delivers the completed test results to the prescribing physician or patient, as applicable. The fees for diagnostic tests are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. The Company determines the transaction price related to its diagnostic test contracts by considering the nature of the payer and historical price concessions granted to groups of customers. For diagnostic test revenue, the Company estimates the transaction price, which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on its historical collection experience, using a portfolio approach. The Company recognizes revenues for diagnostic tests upon delivery of the tests to the physicians requesting the tests or patient, as applicable. Services revenue consists of on-market tests, pipeline tests, custom diagnostic testing, and other scientific services for a purpose as defined by any individual customer, which is often with biopharmaceutical companies. The performance obligations and related revenue for these sales is defined by a written agreement between the Company and the customer. These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer. Revenue for these services is recognized upon delivery of the completed test results, or upon completion of the contractual milestone(s). Revenues consisted of the following (in thousands): Three Months Ended March 31, 2022 2021 Diagnostic tests $ 5,633 $ 27,195 Services 915 1,671 Total revenue $ 6,548 $ 28,866 Deferred Revenue Deferred revenue consists of cash payments from customers received in advance of delivery. As test results are delivered, the Company recogn izes 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 , $ 0.3 million was recognized in revenues during the three months ended March 31, 2022 , $ 0.1 million was added to ‘Deferred revenue’ for up-front cash payments received for which the revenue recognition criteria have not been met and $ 0.8 million was reclassified from non-current deferred revenue. The ‘Deferred revenue’ of $ 2.5 million recorded in the balance sheet as o f March 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 March 31, 2022 and December 31, 2021 , the Company had zero and $ 0.8 million in non-current deferred revenue, respectively, recorded within ‘Other long-term liabilities’ in the balance sheets which represent amounts to be recognized in excess of twelve months from the respective balance sheet date. The Company’s customers in excess of 10% of total revenue, and their related revenue as a percentage of total revenue were as follows: Three Months Ended March 31, 2022 2021 The Big Ten Conference — 58 % In addition to the above table, we collect reimbursement on behalf of customers covered by Medicare, which accounted for 41 % and 7 % of the Company’s total revenue for the three months ended March 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 does not perform evaluations of customers' financial condition and does not require collateral. The Company’s third-party payors and other customers in excess of 10% of accounts receivable, and their related accounts receivable as a percentage of total accounts receivable were as follows: As of March 31, 2022 December 31, 2021 Medicare 40 % 30 % Janssen Research and Development, LLC 16 % 14 % LabCorp DD (formerly Covance) 6 % 11 % |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Note 10 – Share-Based Compensation The Company’s share-based compensation awards are issued under the 2020 Equity Incentive Plan (2020 Plan), the predecessor 2016 Equity Incentive Plan (2016 Plan) and 2006 Equity Incentive Plan (2006 Plan). Any awards that expire or are forfeited under the 2016 Plan or 2006 Plan become available for issuance under the 2020 Plan. As of March 31, 2022, 599,585 shares of c ommon stock remained available for future issuance under the 2020 Plan. Share-Based Compensation Expense Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Three Months Ended March 31, 2022 2021 Direct costs and expenses $ 15 $ — Research and development 88 268 Sales, marketing, general and administrative 1,243 1,484 Total $ 1,346 $ 1,752 The remaining unrecognized stock‑based compensation expense for opt ions and restricted stock units was approximately $ 9.7 million as of March 31, 2022 , and is expected to be amortized to expense over the next 3.5 years. Stock Option Activity Stock option activity during the three months ended March 31, 2022, excluding the Bonus Option Program described below, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding ‑ January 1, 2022 2,878 $ 8.08 7.7 $ 6,288 Granted 235 3.69 — — Forfeited/canceled ( 70 ) 9.25 — — Exercised ( 107 ) 0.70 — — Outstanding ‑ March 31, 2022 2,936 $ 7.97 7.7 $ 1,197 Exercisable - March 31, 2022 1,610 $ 5.97 7.0 $ 799 Restricted Stock Unit Activity Restricted stock unit activity during the three months ended March 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 890 3.69 Forfeited/canceled — — Vested — — Outstanding ‑ March 31, 2022 1,041 $ 3.92 Bonus-to-Options Program As part of the Bonus-to-Options Program (Bonus Option Program), the Company recorded the following activity during the three months ended March 31, 2022 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding ‑ January 1, 2022 373 $ 17.00 7.5 $ 76 Granted 244 2.29 — — Forfeited/canceled ( 14 ) 20.89 — — Exercised — — — — Outstanding ‑ March 31, 2022 603 $ 10.96 8.5 $ — Exercisable - March 31, 2022 603 $ 10.96 8.5 — During the three months ended March 31, 2022 and 2021, the Company accrued $ 0.3 million and $ 0.5 million related to the estimate of the Bonus Option Program, respectively. Options granted, if any, pertaining to the performance of the Bonus Option Program are typically approved and granted in first quarter of the year following completion of the fiscal year. Employee Stock Purchase Plan A tota l of 338,106 shares of our co mmon stock have been reserved for issuance under the Employee Stock Purchase Plan (ESPP). The ESPP provides for successive six-month offering perio ds beginning on September 1st and March 1st of each year. As of March 31, 2022 , 142,680 shares have been issued under the ESPP leaving 195,426 shares remaining for f uture issuance. |
Net Loss per Common Share
Net Loss per Common Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Note 11 – Net Loss per Common Share Basic earnings per share (EPS) excludes dilution and is computed by dividing net loss attributable to the common stockholders by the weighted-average shares outstanding during the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised, resulting in the issuance of shares of common stock that would then share in the earnings or losses of the Company. B asic and diluted loss per share for the three months ended March 31, 2022 and 2021 were (in thousands, except per share amounts): Three Months Ended March 31, 2022 2021 Numerator Net loss attributable to common stockholders $ ( 15,586 ) $ ( 6,961 ) Denominator Weighted-average shares outstanding used 31,070 26,604 Net loss per share, basic and diluted $ ( 0.50 ) $ ( 0.26 ) The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Three Months Ended March 31, 2022 2021 Options to purchase common stock 3,539 2,908 Shares committed under ESPP 12 — Warrants 103 103 Restricted stock units 1,041 79 Total 4,695 3,090 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 12 - Income Taxes Since inception, the Company has incurred net taxable losses, and accordingly, no provision for income taxes has been recorded. There was no cash paid for income taxes during the three months ended March 31, 2022 and 2021 . |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 13 – 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 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 had $ 0.1 million in re maining obligations related to the AVEO agreement as of March 31, 2022 . Following the Effective Date, the Company is entitled to a 10 % royalty of net sales of ficlatuzumab and 25 % of license income generated from the licensing of ficlatuzumab from AVEO. There were no expenses related to this agreement for the three months ended March 31, 2022 and 2021. License Agreements In August 2019, we entered into a non-exclusive license agreement with Bio-Rad Laboratories, Inc. (Bio-Rad) (the Bio-Rad License). Under the terms of the Bio-Rad License, the Company received a non-exclusive license, without the right to grant sublicenses, to utilize certain of Bio-Rad’s intellectual property, machinery, materials, reagents, supplies and know-how necessary for the performance of Droplet Digital PCR (ddPCR) in cancer detection testing for third parties in the United States. The Company also agreed to purchase all of the necessary supplies and reagents for such testing exclusively from Bio-Rad, pursuant to a separately executed supply agreement (the Supply Agreement) with Bio-Rad. As further consideration for the non-exclusive license, the Company agreed to pay a royalty of 2.5 % on the net revenue received for the performance of such ddPCR testing collected from third parties. On May 24, 2021, the Company entered into the 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 were no expenses related to this agreement for the three months ended March 31, 2022 and 2021 were not significant. On May 13, 2021 (Effective Date), we reached agreement with CellCarta Biosciences Inc. (formerly “Caprion Biosciences, Inc.”) (the CellCarta License) on a new royalty bearing license agreement for the Nodify XL2 test. The parties agreed to terminate all prior agreements and replace with this new arrangement, which has a 1 % fee on net sales made from the first commercial sale of the Nodify XL2 test to the Effective Date as an upfront make-good payment covering past royalties due and a royalty rate of 0.675 % on future Nodify XL2 test net sales worldwide for 15 years from the first commercial sale, ending in 2034 . Royalty expense under the CellCarta License for the three months ended March 31, 2022 was insignificant. 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 were $ 0.2 million for both the three months ended March 31, 2022 and 2021. Litigation, Claims and Assessments From time to time, we may become involved in legal proceedings or investigations which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. In September 2021, we reached a settlement agreement with the plaintiffs, which received preliminary approval from the Circuit Court of the City of St. Louis, State of Missouri (the Court) on November 10, 2021 regarding a dispute involving the Telephone Consumer Protection Act (TCPA). On January 31, 2022, the Court approved the final settlement payment to third parties of approximately $ 210,000 which was accrued as a legal contingency during the year ended December 31, 2021 and subsequently paid in February 2022. 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. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14 – Subsequent Events The Company continues to address our liquidity needs through improvements to our capital structure. Subsequent to March 31, 2022, the Company entered into: (i) a private placement that raised approximately $ 11.7 million in net equity proceeds, (ii) an amendment and partial repayment of our 2021 Term L oan, (iii) modifications to extend payment terms under the Indi APA, (iv) common stock sales ra ising additional funds through our at-the-market facility, and (v) the closing of a $ 25.0 million debt facility with funding for up to $ 25.0 million occurring in two tranches. O n May 9, 2022, we closed on the first tranche for gross proceeds of $ 15.0 million (approximately $ 13.0 million, net, after deducting estimated debt issuance costs and OID) . Each of the strategic initiatives described above is detailed further below. Subscription Agreements On April 7, 2022, the Company entered into subscription agreements (the Subscription Agreements) with a consortium of investors (the 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 an aggregate of 6,508,376 shares of the Company’s common stock (the Shares) in an offering (the Private Placement). 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 we 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. Pursuant to the Subscription Agreements, the 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 Subscription Agreements include customary representations, warranties and covenants by the parties to the agreement. 2021 Term Loan Amendment and Partial Repayment On April 7, 2022, the Company entered into the Consent and Third Amendment to Loan and Security Agreement (the 2021 Term Loan Third Amendment) by and between SVB and the Company, as borrower, whereby subject to the terms and conditions of the 2021 Term Loan Third Amendment, certain waivers and consents were provided. Under the terms of the 2021 Term Loan Third Amendment, the Company agreed to the repayment of $ 3.0 million in outstanding principal in April 2022 with an additional $ 2.0 million to be paid no earlier than May 15, 2022, which could be extended to September 30, 2022, subject to debt or equity fund raising of at least $ 15 million, inclusive of the $ 11.7 million in funding through the Subscription Agreements noted above, in exchange for the following: • Consent for a $ 2.0 million April 2022 mutually agreed upon milestone payment under the Indi APA, as amended; • Waiver of minimum revenue requirement for the three months ended March 31, 2022 and adjustment of remaining revenue milestones for 2022; and • Waiver and elimination of the prepayment fee on the $ 3.0 million 2021 Term Loan partial repayment in April 2022 and subsequent $ 2.0 million principal repayment. As of the date of this filing, the Company raised sufficient debt and equity funding to extend the remaining $ 2.0 million principal repayment from the 2021 Term Loan Third Amendment to September 30, 2022. Integrated Diagnostics, Inc. Asset Purchase Agreement Amendment On April 7, 2022, the Company entered into Amendment No. 3 to Asset Purchase Agreement and Plan of Reorganization (the Third Amendment), dated June 30, 2018 by and among Integrated Diagnostics, Inc. and IND Funding LLC (collectively, Indi) as amended by Amendment No. 1 to Asset Purchase Agreement and Plan of Reorganization dated as of July 29, 2021 (the First Amendment) and Amendment No. 2 to Asset Purchase Agreement and Plan of Reorganization dated as of August 9, 2021 (the Second Amendment, as amended collectively, the APA Agreement) in order to reduce and extend the payment terms associated with the Company's contingent consideration balance payable to Indi. The modification of key terms under the Third Amendment to the APA Agreement include, among other things, the following: • Make five quarterly installment payments of $ 2.0 million beginning in April 2022, three quarterly installment payments of $ 3.0 million beginning in July 2023, followed by a payment of $ 5.0 million and $ 8.375 million in April 2024 and July 2024, respectively (each an Installment Payment); • Exit fee payment of $ 6.075 million in October 2024; • Interest shall accrue on the excess of the original payment schedule and the aggregate amount of the Installment Payments paid as of any date, at an aggregate per annum rate equal to 10 %, with such interest to be payable quarterly on the following Installment Payment date; • We may choose to pre-pay milestone payments at any time with no pre-payment penalty. At-the-Market Offering In April 2022, the Company raised approxima tely $ 2.7 m illion in gross proceeds from the sale of 1,349,139 common shares at a weighted average price per share of $ 2.04 in an at-the-market offering. The Company received net proceeds of $ 2.7 m illion, after deducting underwriting discounts and commissions and offering expenses payable of approximately $ 80,000 . 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 (the Lender), pursuant to which, among other things, the Lender: (i) purchased a secured convertible promissory note (Promissory Note One) in the aggregate principal amount totaling $ 16,025,000 in exchange for $ 15,000,000 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 $ 10,250,000 in exchange for $ 10,000,000 . Each of the Promissory Notes shall, at the Company's option, be convertible into shares of common stock, $ 0.001 par value per share, of the Company (the Common Stock), upon the terms and subject to the limitations and conditi ons set forth in the Promissory Notes. The Company's net proceeds from the issuance of Promissory Note One were approximately $ 13.0 million, after deducting estimated debt issuance costs and OID, and intends to use the proceeds from such issuance for general corporate purposes. The Company’s election associated with Promissory Note Two is subject to the Company satisfying, among other things, the following conditions : (i) within 9 months following the First Closing Date, the Company will repay in full all outstanding obligations under the SVB 2021 Term Loan, (ii) Com pany shall have received no less than $ 5.6 million in proceeds from the sale (not attributable to Lender or its affiliates) of new equity securities during the period beginning on the First Closing Date and ending on January 31, 2023 (the Second Closing Date), (iii) on or before the Second Closing Date, Company shall have met or exceeded Revenue Milestone 1 (as defined in the Promissory Notes), (iv) the aggregate market value of the Company’s common stock and any other equity securities held by persons that are not affiliates of the Company on the Second Closing Date sh all be greater than or equal to $ 75.0 million or (b) received no less than $ 20.0 million in additional proceeds from the sale (not attributable to Lender or its affiliates) of new equity securities in the Company not counting those proceeds set forth in item (ii) above (for total proceeds o f no less than $ 25.6 million during the period begi nning on the First Closing Date and ending on the Second Closing Date; (v) as of the Second Closing Date, Company is in good standing with Nasdaq Stock Market (the NASDAQ) and has not received any notice of non-compliance; (vi) Company shall be current in its payments to Indi, and (vii) there being no Trigger Event (as defined in the Promissory Notes) under Promissory Note One. If Promissory Note Two is issued, the terms of Promissory Note One and Note Two will be substantively identical. Under the SPA, the parties provided customary representations and warranties to each other. Also, until amounts due under the Promissory Notes are paid in full, the Company agreed, among other things, to: (i) timely make all filings under the Securities Exchange Act of 1934, (ii) ensure the Common Stock continues to be listed on the NASDAQ or New York Stock Exchange, (iii) not enter into any agreement or otherwise agree to any covenant, condition, or obligation that locks up, restricts in any way or otherwise prohibits Company: (a) from entering into a variable rate transaction with Lender or any affiliate of Lender, or (b) from issuing Common Stock, preferred stock, warrants, convertible notes, other debt securities, or any other Company securities to Lender or any affiliate of Lender, (iv) will not make any Restricted Issuances (as defined in the Promissory Notes) without Lender ’s prior written consent, which consent may be granted or withheld in Lender’s sole and absolute discretion (v) within 9 months following the First Closing Date, the Company will repay in full all outstanding obligations under the SVB 2021 Term Loan, (vi) beginning on April 1, 2023, Company shall maintain a minimum liquidity balance of at least $ 3.0 million (which liquidity balance shall only include cash, cash equivalents and accounts receivable), and (vii) offer the Lender the right to purchase up to 30 % of future equity and debt securities offerings, subject to certain exceptions and limitations. The Company also agreed under the SPA to reserve with the Company’s transfer agent 37.0 million shares of Common Stock for potential issuance under the Promissory Notes for shares that may be delivered in connection with the redemption right, which reservation may be increased and decreased in certain circumstances. The Promissory Notes have an interest rate of 6 % per annum. The maturity date of each Promissory Note is 24 months from the issuance date of such Note (the Maturity Date). Promissory Note One was issued with an OID of $ 1,025,000 while Promissory Note Two, if issued, will be subject to an OID of $ 250,000 subject to certain contingencies which could increase the OID by an additional $ 512,500 . The Promissory Notes are eligible for early prepayment, at the Company’s election, subject to a premium of 10 % of the outstanding balance. Beginning on the date that is nine months after the issuance date of the applicable Promissory Note, the Lender has the right to redeem up to $ 1,425,000 and $ 950,000 of the outstanding balance of Promissory Note One and Promissory Note Two per month, respectively. Payments may be made by the Company, at the Company’s option, either in (a) in cash, or (b) in the form of shares of Common Stock with the number of redemption shares being equal to the portion of the applicable redemption amount divided by the Redemption Conversion Price or (c) a combination of cash and shares of Common Stock. The Redemption Conversion Price shall equal 85% multiplied by the lowest daily VWAP during the ten trading days immediately preceding the date the Lender delivers notice electing to redeem a portion of the Promissory Note. The Company’s right to satisfy the redemption amount in shares of Common Stock is subject to certain limitations, including (i) there not being any Equity Conditions Failure (as defined in the Note), (ii) the Lender and its affiliates together not owning more than 9.99% of the outstanding shares of Common Stock, and (iii) the aggregate shares of Common Stock issued upon redemption of the Promissory Notes not exceeding 19.99% of the outstanding Common Stock unless the Company has obtained stockholder approval under NASDAQ rules for such issuance. The Promissory Notes contain certain Trigger Events that generally, if uncured within five trading days, may result in an event of default in accordance with the terms of the Promissory Notes (such event, an Event of Default). Upon an Event of Default, the interest rate may also be increased to the lesser of 15 % per annum or the maximum rate permitted under applicable law. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X for interim financial information and reflect all adjustments necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. All such adjustments are of a normal recurring nature. Results for interim periods are not indicative of the results for the entire fiscal year. The accompanying Condensed Financial Statements should be read in conjunction with the audited Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Certain information and footnote disclosures, including significant accounting policies, normally included in fiscal year financial statements prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) have been condensed or omitted. The Condensed Balance Sheet as of December 31, 2021 was derived from the audited financial statements. During March 2020, a global pandemic was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus (COVID-19). The COVID-19 pandemic negatively affected, and we expect will continue to negatively affect, our lung diagnostic testing-related revenue and our clinical studies. As of March 31, 2022, we maintained cash and cash equivalents of $ 16.4 million and we have $ 10 million in principal balance outstanding on our 2021 Term Loan. We have incurred significant losses since inception and, as a result, we have funded our operations to date primarily through the sale of common stock, the sale of convertible preferred stock, the issuance of notes payable, and from our two primary revenue sources: (i) diagnostic testing, which include lung diagnostic testing and COVID-19 testing, and (ii) providing biopharmaceutical companies with development and testing services. In accordance with Accounting Standards Update 2014-15 (ASC Topic 205-40), Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company is required to evaluate whether there is substantial doubt about its ability to continue as a going concern each reporting period, including interim periods. In evaluating the Company’s ability to continue as a going concern, management projected its cash flow sources, including the debt and equity funding and amendments to the 2021 Term Loan and Integrated Diagnostics, Inc. (Indi) Agreement subsequent to March 31, 2022, and needs and evaluated the conditions and events that could raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements were issued. Management considered the Company’s current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of this Form 10-Q in considering whether it has the ability to meet its obligations. Our ability to meet our obligations as they come due may be impacted by our ability to remain compliant with financial covenants in our 2021 Term Loan (see Note 6 – Debt ) or to obtain waivers or amendments that impact the related covenants. Due to the continued uncertainty caused by the COVID-19 pandemic, significant risks remain with respect to our ability to meet these thresholds and any material adverse effect on our revenues, income and expenses could impact our ability to maintain compliance with these covenants. Based on our current operating plan, unless we raise additional capital (debt or equity) or obtain a waiver from complying with such financial covenants, we expect that we will be unable to maintain our financial covenants under our 2021 Term Loan during the next twelve months, which could result in an Event of Default, as defined, causing an acceleration and repayment of the outstanding balance. We have taken steps to improve our liquidity through raising equity capital during 2022, amendments to our 2021 Term Loan and have also undertaken several proactive measures to mitigate the financial and operational impacts of the COVID-19 pandemic through the reduction of planned capital expenditures and certain operating expenses but we do not expect that these actions alone will be sufficient to maintain our financial covenants. Subsequent to March 31, 2022, we entered into a $ 25.0 million debt facility with funding for up to $ 25.0 million in two tranches. On May 9, 2022, we closed on the first tranche for gross proceeds of $ 15.0 million (approximately $ 13.0 million, net, after deducting estimated debt issuance costs and original issue discounts (OID)). We also amended the Indi Agreement to delay near term cash requirements and extend the period of milestone payments. To maintain an adequate amount of available liquidity and execute our current operating plan, we will need to continue to raise additional funds from external sources, such as through the issuance of equity or debt securities; however, we have not secured such funding at the time of this filing and any such financing activities are subject to market conditions. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. There can be no assurance that additional capital will be available to us or, if available, will be available in sufficient amounts or on terms acceptable to us or on a timely basis. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring capital expenditures, and reducing other operating costs. The Company’s revenues, results of operations and cash flows have been materially adversely impacted by the items noted above. Our current operating plan, which is in part determined based on our most recent historical actual results and trends, along with the items noted above, raises substantial doubt about the Company’s ability to continue as a going concern. Our unaudited 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. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the balance sheet date and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. |
Restricted Cash | Restricted Cash Restricted cash consists of deposits related to the Company’s corporate credit cards. The Company had $ 0.1 million as of March 31, 2022 and December 31, 2021, respectively reported within 'Other current assets' in the balance sheets. |
Concentration of Credit Risk and Other Uncertainties | Concentration of Credit Risk and Other Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. The Company continually monitors its positions with, and the credit quality of, the financial institution with which it holds cash. Periodically throughout the year, the Company has maintained balances in various operating accounts in excess of federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. Several of the components for certain of the Company's sample collection kits, test reagents, and test systems are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, it could suffer delays in being able to deliver its diagnostic solutions, a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results. For a discussion of credit risk concentration of accounts receivable as of March 31, 2022 and December 31, 2021, see Note 9 – Revenue and Accounts Receivable Credit Concentration . |
Inventory | Inventory Inventory consists primarily of material supplies, which are consumed in the performance of testing services and charged to ‘Direct costs and expenses’. Inventory is stated at cost and reported within ‘Other current assets’ in the balance sheet and was $ 2.6 million a nd $ 2.9 million as of March 31, 2022 and December 31, 2021 , respectively. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments U.S. GAAP for fair value establishes a hierarchy that prioritizes fair value measurements based on the types of inputs used for the various valuation techniques (market approach, income approach, and cost approach). We utilize a combination of market and income approaches to value our financial instruments. Our financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. Fair value measurements are categorized within the fair value hierarchy based upon the lowest level of the most significant inputs used to determine fair value. The three levels of the hierarchy and the related inputs are as follows: Level Inputs 1 Unadjusted quoted prices in active markets for identical assets and liabilities. 2 Unadjusted quoted prices in active markets for similar assets and liabilities; Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or Inputs other than quoted prices that are observable for the asset or liability. 3 Unobservable inputs for the asset or liability. The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. See Note 4 — Fair Value for further discussion related to estimated fair value measurements. |
Recently Adopted Accounting Standards | Recently adopted accounting standards In February 2016, the FASB issued Account Standard Update (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. T he Company elected this transition method and adopted ASC 842 on January 1, 2022 and as a result, recorded operating lease right-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 beginning retained earnings, and did not materially affect the Company's statement of operations, statement of stockholders' equity or statement of cash flows for the three month period ended March 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. Management determines if an arrangement is a lease at inception or upon modification of a contract. Leases are classified as either financing or operating, with classification affecting the pattern of expense recognition in the statements of operations. When determining whether a lease is a finance lease or an operating lease, ASC 842 does not specifically define criteria to determine the “major part of remaining economic life of the underlying asset” and “substantially all of the fair value of the underlying asset.” 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 7 — 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 with early adoption permitted. The Company is currently evaluating this guidance and assessing the overall impact on its financial statements. |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Outstanding Borrowings | The fair values of outstanding borrowings, which are classified as Level 2, approximate their carrying values as of March 31, 2022 and December 31, 2021, based on interest rates currently available for similar borrowings and were (in thousands): As of March 31, 2022 December 31, 2021 Carrying Value Fair Value Carrying Value Fair Value Borrowings $ 10,106 $ 10,106 $ 10,012 $ 10,012 |
Schedule of Reported Fair values of Contingent Consideration | The table below presents the reported fair values of contingent consideration, which is classified as Level 3 in the fair value hierarchy, as of the dates indicated (in thousands): Description March 31, 2022 December 31, 2021 Current portion of contingent consideration $ 17,821 $ 17,764 Contingent consideration 12,212 16,028 Total contingent consideration $ 30,033 $ 33,792 |
Schedule of Changes in Contingent Consideration and Financial Liabilities | The following table presents the changes in contingent consideration for the three months ended March 31, 2022 and 2021 (in thousands): For the three months Level 3 Rollforward 2022 2021 Beginning balances - January 1 $ 33,792 $ 29,932 Changes in fair value — 983 Interest expense 866 — Payments of contingent consideration ( 4,625 ) — Ending balances - March 31 $ 30,033 $ 30,915 |
Supplementary Balance Sheet I_2
Supplementary Balance Sheet Information (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): March 31, 2022 December 31, 2021 Lab equipment $ 6,802 $ 6,784 Leasehold improvements 2,355 2,339 Computer equipment 803 700 Furniture and fixtures 391 391 Software 600 600 Vehicles 97 97 Construction in process 142 17 11,190 10,928 Less: accumulated depreciation ( 7,162 ) ( 6,749 ) Total property and equipment, net $ 4,028 $ 4,179 |
Schedule of Intangible Assets, Excluding Goodwill | Intangible assets, excluding goodwill, consist of the following (in thousands): March 31, 2022 December 31, 2021 Cost Accumulated Net Carrying Value Cost Accumulated Net Carrying Value Intangible assets subject to amortization Patents $ 1,747 $ ( 588 ) $ 1,159 $ 1,755 $ ( 566 ) $ 1,189 Purchased technology 16,900 ( 7,042 ) 9,858 16,900 ( 6,572 ) 10,328 Intangible assets not subject to Trademarks 114 — 114 100 — 100 Total $ 18,761 $ ( 7,630 ) $ 11,131 $ 18,755 $ ( 7,138 ) $ 11,617 |
Schedule of Future Estimated Amortization Expense of Intangible Assets | Future estimated amortization expense of intangible assets is (in thousands): As of March 31, 2022 Remainder of 2022 $ 1,491 2023 1,977 2024 1,967 2025 1,962 2026 1,948 2027 and thereafter 1,672 Total $ 11,017 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): March 31, 2022 December 31, 2021 Compensation related accruals $ 2,594 $ 4,029 Accrued clinical trial expense 893 870 Other expenses 2,686 2,766 Total accrued liabilities $ 6,173 $ 7,665 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Notes Payable | Long-term notes payable were as follows (in thousands): March 31, 2022 December 31, 2021 2021 Term Loan $ 10,000 $ 10,000 Other 165 75 Unamortized debt discount and issuance costs ( 59 ) ( 63 ) 10,106 10,012 Less: current maturities 51 19 Long-term notes payable $ 10,055 $ 9,993 |
Scheduled Principal Repayments (Maturities) of Long-term Obligations | Scheduled principal repayments (maturities) of long-term obligations were as follows (in thousands): As of March 31, 2022 Remainder of 2022 $ 36 2023 49 2024 4,050 2025 4,824 2026 1,206 2027 and thereafter — Total $ 10,165 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 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 March 31, 2022 Remainder of 2022 $ 926 2023 1,534 2024 81 2025 3 2026 2 2027 and thereafter — Total future minimum lease payments 2,546 Less amount representing interest ( 259 ) Total lease liabilities $ 2,287 |
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 were as follows (in thousands): As of December 31, 2021 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) | 3 Months Ended |
Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenue | Revenues consisted of the following (in thousands): Three Months Ended March 31, 2022 2021 Diagnostic tests $ 5,633 $ 27,195 Services 915 1,671 Total revenue $ 6,548 $ 28,866 |
Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers | The Company’s customers in excess of 10% of total revenue, and their related revenue as a percentage of total revenue were as follows: Three Months Ended March 31, 2022 2021 The Big Ten Conference — 58 % 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 March 31, 2022 December 31, 2021 Medicare 40 % 30 % Janssen Research and Development, LLC 16 % 14 % LabCorp DD (formerly Covance) 6 % 11 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Pre-tax Share-based Compensation Expense | Share-Based Compensation Expense Pre-tax share-based compensation expense reported in the Company’s statements of operations was (in thousands): Three Months Ended March 31, 2022 2021 Direct costs and expenses $ 15 $ — Research and development 88 268 Sales, marketing, general and administrative 1,243 1,484 Total $ 1,346 $ 1,752 |
Summary of Stock Option Activity | Stock option activity during the three months ended March 31, 2022, excluding the Bonus Option Program described below, was (in thousands, except weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding ‑ January 1, 2022 2,878 $ 8.08 7.7 $ 6,288 Granted 235 3.69 — — Forfeited/canceled ( 70 ) 9.25 — — Exercised ( 107 ) 0.70 — — Outstanding ‑ March 31, 2022 2,936 $ 7.97 7.7 $ 1,197 Exercisable - March 31, 2022 1,610 $ 5.97 7.0 $ 799 |
Summary of Restricted Stock Units Activity | Restricted stock unit activity during the three months ended March 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 890 3.69 Forfeited/canceled — — Vested — — Outstanding ‑ March 31, 2022 1,041 $ 3.92 |
Bonus-To-Options Program | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Option Activity | As part of the Bonus-to-Options Program (Bonus Option Program), the Company recorded the following activity during the three months ended March 31, 2022 (in thousands, excepted weighted average exercise price and weighted average contractual life): Number of Options Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding ‑ January 1, 2022 373 $ 17.00 7.5 $ 76 Granted 244 2.29 — — Forfeited/canceled ( 14 ) 20.89 — — Exercised — — — — Outstanding ‑ March 31, 2022 603 $ 10.96 8.5 $ — Exercisable - March 31, 2022 603 $ 10.96 8.5 — |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Loss per Share Attributable to Stockholders | asic and diluted loss per share for the three months ended March 31, 2022 and 2021 were (in thousands, except per share amounts): Three Months Ended March 31, 2022 2021 Numerator Net loss attributable to common stockholders $ ( 15,586 ) $ ( 6,961 ) Denominator Weighted-average shares outstanding used 31,070 26,604 Net loss per share, basic and diluted $ ( 0.50 ) $ ( 0.26 ) |
Schedule of Common Stock Equivalents Excluded from Diluted Net Loss Attributable to Common Stockholders | The following outstanding common stock equivalents were excluded from diluted net loss attributable to common stockholders for the periods presented because inclusion would be anti-dilutive (in thousands): Three Months Ended March 31, 2022 2021 Options to purchase common stock 3,539 2,908 Shares committed under ESPP 12 — Warrants 103 103 Restricted stock units 1,041 79 Total 4,695 3,090 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
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 were as follows (in thousands): As of December 31, 2021 2022 $ 775 2023 149 2024 9 2025 3 2026 1 2027 and thereafter — Total $ 937 |
Organization and Description _2
Organization and Description of Business - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2022Test | |
Organization And Description Of Business [Abstract] | |
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) - USD ($) | May 09, 2022 | Apr. 01, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Summary Of Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 16,427,000 | $ 32,712,000 | ||
Other Current Assets | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Restricted cash | 100,000 | 100,000 | ||
Inventory | 2,600,000 | $ 2,900,000 | ||
2021 Term Loan | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Principal balance outstanding | $ 10,000,000 | |||
Maximum | Subsequent Event | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Debt facility | $ 25,000 | |||
First Tranche | Subsequent Event | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Gross proceeds from debt issuance costs | $ 15,000,000 | |||
Proceeds from net of debt issuance costs and original issue discounts | $ 13,000,000 | |||
Two Tranche | Subsequent Event | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Debt facility | 25,000,000 | |||
Two Tranche | Maximum | Subsequent Event | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Debt facility | $ 25,000,000 |
Recently issued Accounting St_2
Recently issued Accounting Standards - Additional Information (Details) - USD ($) $ in Thousands | Jan. 01, 2022 | Mar. 31, 2022 | Mar. 31, 2021 |
Accounting Changes and Error Corrections [Abstract] | |||
Right of use assets | $ 1,300 | $ 2,219 | |
Operating Lease, Liability | 1,300 | $ 2,287 | |
Offsetting deferred rent | $ 100 | ||
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Operating Lease, Liability | ||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Right of use assets | ||
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. |
Fair Value - Summary of Fair Va
Fair Value - Summary of Fair Value of Outstanding Borrowings (Details) - Fair Value, Recurring - Level 2 - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Carrying Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 10,106 | $ 10,012 |
Fair Value | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Borrowings | $ 10,106 | $ 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 | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 30,033 | $ 33,792 |
Current Portion of Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | 17,821 | 17,764 |
Contingent Consideration | ||
Fair Value Liabilities Measured On Recurring Basis [Line Items] | ||
Total contingent consideration | $ 12,212 | $ 16,028 |
Fair Value - Schedule of Change
Fair Value - Schedule of Changes in Contingent Consideration (Details) - Fair Value, Recurring - Level 3 - Contingent Consideration - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balances | $ 33,792 | $ 29,932 |
Changes in fair value | 983 | |
Interest expense | 866 | |
Payments of contingent consideration | (4,625) | |
Ending balances | $ 30,033 | $ 30,915 |
Fair Value - Additional Informa
Fair Value - Additional Information (Details) $ in Thousands | Apr. 07, 2022 | Dec. 31, 2021USD ($) | Jul. 31, 2024USD ($) | Apr. 30, 2024USD ($) | Jul. 31, 2023USD ($)Installment | Apr. 30, 2022USD ($)Installment | Jan. 31, 2022USD ($) | Mar. 31, 2022USD ($)Installment | Jun. 30, 2021USD ($) | Dec. 31, 2018USD ($)Installmentshares |
Second Amendment | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Repayments of Debt | $ 20,000 | $ 20,000 | ||||||||
Milestone payment | $ 4,600 | $ 4,600 | ||||||||
Subsequent Event | Second Amendment | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Milestone payment | $ 2,000 | |||||||||
Integrated Diagnostics, Inc | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Business acquisition description | requires additional consideration to be paid by the Company to such shareholders upon attainment of a three-consecutive month | |||||||||
Business acquisition contingent consideration gross margin target | $ 2,000 | $ 2,000 | ||||||||
Business acquisition contingent consideration gross margin target period | 7 years | |||||||||
Integrated Diagnostics, Inc | Subsequent Event | 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 | 10.00% | |||||||||
Integrated Diagnostics, Inc | Scenario Forecast | Third Amendment to APA Agreement | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Contingent consideration number of installments | Installment | 3 | |||||||||
Milestone payment | $ 8,375 | $ 5,000 | $ 3,000 | |||||||
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 | |||||||||
Integrated Diagnostics, Inc | Common Stock | Repurchase | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Contingent consideration number of installments | Installment | 2 | |||||||||
Contingent consideration cash payment | $ 37,000 | |||||||||
Minimum | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 11.00% | |||||||||
Maximum | ||||||||||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||||||||
Percentage of probabilities of contingent consideration successful achievement of specified product gross margin targets discount rates range | 13.50% |
Supplementary Balance Sheet I_3
Supplementary Balance Sheet Information - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 11,190 | $ 10,928 |
Less: accumulated depreciation | (7,162) | (6,749) |
Total property and equipment, net | 4,028 | 4,179 |
Lab Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,802 | 6,784 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 2,355 | 2,339 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 803 | 700 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 391 | 391 |
Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 600 | 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 | $ 142 | $ 17 |
Supplementary Balance Sheet I_4
Supplementary Balance Sheet Information - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property Plant And Equipment [Line Items] | ||
Depreciation expense | $ 0.4 | $ 0.3 |
Amortization expense of definite-lived intangible assets | $ 0.5 | $ 0.5 |
Supplementary Balance Sheet I_5
Supplementary Balance Sheet Information - Intangible Assets, Excluding Goodwill (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finite Lived Intangible Assets [Line Items] | ||
Intangible assets subject to amortization, Net Carrying Value | $ 11,017 | |
Intangible assets, Cost | 18,761 | $ 18,755 |
Intangible assets, Accumulated Amortization | (7,630) | (7,138) |
Intangible assets, Net Carrying Value | 11,131 | 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 | 1,747 | 1,755 |
Intangible assets subject to amortization, Accumulated Amortization | (588) | (566) |
Intangible assets subject to amortization, Net Carrying Value | 1,159 | 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 | (7,042) | (6,572) |
Intangible assets subject to amortization, Net Carrying Value | $ 9,858 | $ 10,328 |
Supplementary Balance Sheet I_6
Supplementary Balance Sheet Information - Schedule of Amortization Related to Remaining Net Intangible Assets Schedule to Amortize (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Balance Sheet Related Disclosures [Abstract] | |
Remainder of 2022 | $ 1,491 |
2023 | 1,977 |
2024 | 1,967 |
2025 | 1,962 |
2026 | 1,948 |
2027 and thereafter | 1,672 |
Intangible assets subject to amortization, Net Carrying Value | $ 11,017 |
Supplementary Balance Sheet I_7
Supplementary Balance Sheet Information - Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Compensation related accruals | $ 2,594 | $ 4,029 |
Accrued clinical trial expense | 893 | 870 |
Other expenses | 2,686 | 2,766 |
Total accrued liabilities | $ 6,173 | $ 7,665 |
Debt - Summary of Long-term Not
Debt - Summary of Long-term Notes Payable (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 19, 2021 |
Debt Instrument [Line Items] | |||
Unamortized debt discount and issuance costs | $ (59) | $ (63) | |
Notes payable, total | 10,106 | 10,012 | |
Less: current maturities | 51 | 19 | |
Long-term notes payable | 10,055 | 9,993 | |
2021 Term Loan | |||
Debt Instrument [Line Items] | |||
Notes/Loan payable | 10,000 | 10,000 | $ 30,000 |
Other | |||
Debt Instrument [Line Items] | |||
Notes/Loan payable | $ 165 | $ 75 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Mar. 19, 2021 | Jan. 31, 2022 | Mar. 31, 2022 |
Debt Instrument [Line Items] | ||||
Cash and cash equivalents | $ 32,712 | $ 16,427 | ||
2021 Term Loan | ||||
Debt Instrument [Line Items] | ||||
Notes/Loan payable | 10,000 | $ 30,000 | 10,000 | |
Debt instrument frequency of periodic payment | monthly | |||
Revenue milestone | $ 65,000 | |||
Debt instrument description | The 2021 Term Loan provides for an “interest-only” period from the Effective Date through February 28, 2023, with interest due and payable monthly on the first calendar day of each month. However, the Company achieved a revenue milestone of at least $65 million on a trailing twelve-month basis during the three months ended March 31, 2021 which automatically extended the interest-only period through February 28, 2024. Beginning on the first calendar day of the month following the end of the interest-only period, the 2021 Term Loan shall be payable in (i) consecutive equal installments of principal through March 1, 2026, plus (ii) monthly payments of accrued interest. The principal amount outstanding under the 2021 Term Loan shall accrue interest at a floating per annum rate equal to the greater of (i) 2.00% above the prime rate, or (ii) 5.25%, which interest, in each case, shall be payable monthly. Changes to the interest rate applicable to the 2021 Term Loan based on changes to the prime rate shall be effective on the effective date of any change to the prime rate. | |||
Debt instrument maturity date | Mar. 1, 2026 | |||
Repayments of debt | $ 2,700 | |||
Debt instrument, covenant description | The 2021 Term Loan requires the Company to comply with a minimum liquidity ratio covenant (as defined) by the 2021 Term Loan of not less than 0.95 to 1.00, and had a trailing six month rolling minimum revenue requirement of not less than 70% of the Company’s projected revenue performed at the end of each reporting period. | |||
2021 Term Loan | Prior to First Anniversary | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, prepayment penalty | 3.00% | |||
2021 Term Loan | Prior to Second Anniversary | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, prepayment penalty | 2.00% | |||
2021 Term Loan | After Second Anniversary, Prior to October 19, 2025 | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, prepayment penalty | 1.00% | |||
2021 Term Loan | Thereafter | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, prepayment penalty | 0.00% | |||
2021 Term Loan | Maximum | ||||
Debt Instrument [Line Items] | ||||
Minimum liquidity ratio covenant | 0.95 | |||
Percentage of minimum revenue requirement | 70.00% | 75.00% | ||
2021 Term Loan Amendment | ||||
Debt Instrument [Line Items] | ||||
Restricted cash collateral account | $ 15,000 | |||
2021 Term Loan Amendment | Maximum | ||||
Debt Instrument [Line Items] | ||||
Cash and cash equivalents | 40,000 | |||
Second Amendment | ||||
Debt Instrument [Line Items] | ||||
Repayments of debt | 20,000 | 20,000 | ||
Milestone payment | 4,600 | $ 4,600 | ||
Prepayment fee waived amount | $ 600,000 | |||
Partial repayments of debt | $ 20,000 |
Debt - Scheduled Principal Repa
Debt - Scheduled Principal Repayments (Maturities) of Long-term Obligations (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Maturities of Long-term Debt [Abstract] | |
Remainder of 2022 | $ 36 |
2023 | 49 |
2024 | 4,050 |
2025 | 4,824 |
2026 | 1,206 |
2027 and thereafter | 0 |
Long-term debt | $ 10,165 |
Leases - Additional Information
Leases - Additional Information (Details) | Mar. 11, 2022USD ($)ft²RenewalOption$ / ft² | Jan. 31, 2022 | Mar. 31, 2022USD ($)ft² | Mar. 31, 2021USD ($) | Jan. 01, 2022USD ($) |
Lessee, Lease, Description [Line Items] | |||||
Operating lease right-of-use assets | $ 2,219,000 | $ 1,300,000 | |||
Operating lease liability | 2,287,000 | $ 1,300,000 | |||
Operating lease expense | $ 300,000 | $ 300,000 | |||
Operating leases, Weighted-average remaining lease term (in years) | 1 year 9 months 18 days | ||||
Operating leases, Weighted-average discount rate | 11.00% | ||||
Centennial Valley Properties I, LLC Lease Agreement | |||||
Lessee, Lease, Description [Line Items] | |||||
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. As of March 31, 2022, the Lease has not yet commenced under the terms of the agreement nor has the Company begun to account for the Lease Agreement until such time as it is determined that we have met the lease inception date under applicable accounting standards. We expect to recognize the commencement of the Lease for accounting purposes beginning in the second quarter 2022. | ||||
Lease term | 12 years | ||||
Lease commencement date | Apr. 1, 2023 | ||||
Lease agreement number of options to extend | RenewalOption | 2 | ||||
Lease option to extend | true | ||||
Leased property building capacity | ft² | 79,980 | ||||
Base rent per month from commencement date | $ 227,000 | ||||
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 | ||||
Extra allowance amount per rentable square feet | $ / ft² | 25 | ||||
Interest rate on extra allowance amount | 6.00% | ||||
Centennial Valley Properties I, LLC Lease Agreement | Letter of Credit | |||||
Lessee, Lease, Description [Line Items] | |||||
Long-term Line of Credit | $ 5,000,000 | ||||
Centennial Valley Properties I, LLC Lease Agreement | Letter of Credit | Cash Collateralized | |||||
Lessee, Lease, Description [Line Items] | |||||
Long-term Line of Credit | $ 5,000,000 | ||||
Minimum | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease, expiration term | 1 year | ||||
Minimum | Centennial Valley Properties I, LLC Lease Agreement | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease renewal term | 7 years | ||||
Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease, expiration term | 4 years | ||||
Maximum | Centennial Valley Properties I, LLC Lease Agreement | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease renewal term | 10 years | ||||
COLORADO | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of office space leased | ft² | 29,722 | ||||
Lease expiration date | 2024-01 | 2023-01 | |||
Operating lease right-of-use assets | $ 1,200,000 | ||||
Operating lease liability | $ 1,200,000 | ||||
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 | Mar. 31, 2022 | Jan. 01, 2022 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
Operating leases, Remainder of 2022 | $ 926 | |
Operating leases, 2023 | 1,534 | |
Operating leases, 2024 | 81 | |
Operating leases, 2025 | 3 | |
Operating leases, 2026 | 2 | |
Operating leases, 2027 and thereafter | 0 | |
Operating leases, Total future minimum lease payments | 2,546 | |
Operating leases, Less amount representing interest | (259) | |
Operating lease liability | $ 2,287 | $ 1,300 |
Leases - Summary of Future Mi_2
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, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 775 |
2023 | 149 |
2024 | 9 |
2025 | 3 |
2026 | 1 |
2027 and thereafter | 0 |
Total | $ 937 |
Equity - Additional Information
Equity - Additional Information (Details) | Mar. 07, 2022USD ($)shares | Mar. 31, 2022USD ($)Facility$ / sharesshares |
Class of Stock [Line Items] | ||
Proceeds from the sale of common shares | $ 1,599,000 | |
Warrants, expires period | Feb. 23, 2028 | |
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 | |
Common Stock Purchase Agreement | Lincoln Park | ||
Class of Stock [Line Items] | ||
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 as deferred offering costs | $ 115,000 | |
Adjustments to additional paid-in capital deferred offering costs | $ 18,000 | |
Deferred offering costs | $ 697,000 | |
Common Stock Purchase Agreement | Lincoln Park | Other Long-term Assets | ||
Class of Stock [Line Items] | ||
Common stock issuable, committed to purchase | 600,000 | |
Common Stock Purchase Agreement | 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 | |
Equity Financing Programs | ||
Class of Stock [Line Items] | ||
Number of facility | Facility | 2 | |
Proceeds from the sale of common shares | $ 1,600,000 | |
Shares of common stock issued and sold | shares | 708,752 | |
Weighted average price per share | $ / shares | $ 2.26 | |
Equity Financing Programs | At-The-Market Facility | ||
Class of Stock [Line Items] | ||
Remaining available capacity for share issuance | $ 32,800,000 | |
Equity Financing Programs | LPC Facility | Maximum | ||
Class of Stock [Line Items] | ||
Remaining available capacity for share issuance | 49,200,000 | |
At-The-Market Offering | ||
Class of Stock [Line Items] | ||
Net proceeds from sale of common shares after deducting underwriting discounts and commissions and offering expenses | $ 1,500,000 | |
IPO | ||
Class of Stock [Line Items] | ||
Warrant issued to purchase shares | shares | 103,326 | |
Warrant, exercise price | $ / shares | $ 4.46 |
Revenue and Accounts Receivab_3
Revenue and Accounts Receivable Credit Concentration - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | 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 | $ 300,000 | ||
Deferred revenue | 2,499,000 | $ 1,850,000 | |
Non-current deferred revenue | $ 800,000 | ||
Revenue | Minimum | Customer Concentration Risk | Medicare | |||
Disaggregation Of Revenue [Line Items] | |||
Concentration risk, percentage | 41.00% | 7.00% | |
Up Front Cash Payments | |||
Disaggregation Of Revenue [Line Items] | |||
Deferred revenue | $ 100,000 | ||
Other Long-term Liabilities | |||
Disaggregation Of Revenue [Line Items] | |||
Non-current deferred revenue | $ 0 | $ 800,000 |
Revenue and Accounts Receivab_4
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 6,548 | $ 28,866 |
Diagnostic Tests | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | 5,633 | 27,195 |
Services | ||
Disaggregation Of Revenue [Line Items] | ||
Revenues | $ 915 | $ 1,671 |
Revenue and Accounts Receivab_5
Revenue and Accounts Receivable Credit Concentration - Summary of Revenue and Accounts Receivable by Third-party Payors and Other Customers (Details) - Customer Concentration Risk - Minimum | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Revenue | The Big Ten Conference | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 58.00% | ||
Revenue | Medicare | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 41.00% | 7.00% | |
Accounts Receivable | Medicare | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 40.00% | 30.00% | |
Accounts Receivable | Janssen Research and Development, LLC | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 16.00% | 14.00% | |
Accounts Receivable | LabCorp DD (formerly Covance) | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 6.00% | 11.00% |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Aug. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock remained available for future issuance | 599,585 | ||
Stock compensation expense | $ 1,346 | $ 1,752 | |
Number of shares reserved for issuance | 195,426 | 338,106 | |
Shares issued | 142,680 | ||
Description of offering period under plan | ESPP provides for successive six-month offering periods beginning on September 1st and March 1st of each year. | ||
Restricted Stock Units (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted average grant date fair value | $ 3.92 | ||
Options and Restricted Stock Units (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Remaining unrecognized stock based compensation expense for options and restricted stock units | $ 9,700 | ||
Amortized to expense period | 3 years 6 months | ||
Bonus-To-Options Program | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock compensation expense | $ 300 | $ 500 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Pre-tax Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | $ 1,346 | $ 1,752 |
Direct Costs and Expenses | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | 15 | |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | 88 | 268 |
Sales, Marketing, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total pre-tax share-based compensation expense | $ 1,243 | $ 1,484 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 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 | 235 | |
Stock Options, Forfeited/canceled | (70) | |
Stock Options, Exercised | (107) | |
Stock Options, Outstanding - March 31, 2022 | 2,936 | 2,878 |
Stock Options Exercisable - March 31, 2022 | 1,610 | |
Weighted Average Exercise Price, Outstanding - January 1, 2022 | $ 8.08 | |
Weighted Average Exercise Price, Granted | 3.69 | |
Weighted Average Exercise Price, Forfeited/canceled | 9.25 | |
Weighted Average Exercise Price, Exercised | 0.70 | |
Weighted Average Exercise Price, Outstanding - March 31, 2022 | 7.97 | $ 8.08 |
Weighted Average Exercise Price, Exercisable - March 31, 2022 | $ 5.97 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 7 years 8 months 12 days | 7 years 8 months 12 days |
Weighted Average Contractual Life (Years), Exercisable - March 31, 2022 | 7 years | |
Aggregate Intrinsic Value, Outstanding - January 1, 2022 | $ 6,288 | |
Aggregate Intrinsic Value, Outstanding - March 31, 2022 | 1,197 | $ 6,288 |
Aggregate Intrinsic Value, Exercisable - March 31, 2022 | $ 799 | |
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 | (14) | |
Stock Options, Outstanding - March 31, 2022 | 603 | 373 |
Stock Options Exercisable - March 31, 2022 | 603 | |
Weighted Average Exercise Price, Outstanding - January 1, 2022 | $ 17 | |
Weighted Average Exercise Price, Granted | 2.29 | |
Weighted Average Exercise Price, Forfeited/canceled | 20.89 | |
Weighted Average Exercise Price, Outstanding - March 31, 2022 | 10.96 | $ 17 |
Weighted Average Exercise Price, Exercisable - March 31, 2022 | $ 10.96 | |
Weighted Average Contractual Life (Years), Outstanding - January 1, 2021 | 8 years 6 months | 7 years 6 months |
Weighted Average Contractual Life (Years), Exercisable - March 31, 2022 | 8 years 6 months | |
Aggregate Intrinsic Value, Outstanding - January 1, 2022 | $ 76 | |
Aggregate Intrinsic Value, Outstanding - March 31, 2022 | $ 76 |
Share-Based Compensation - Su_3
Share-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units shares in Thousands | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
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 | 890 |
Number of Shares, Outstanding - March 31, 2022 | shares | 1,041 |
Weighted Average Grant Date Fair Value Per Share, January 1, 2022 | $ / shares | $ 5.30 |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | 3.69 |
Weighted Average Grant Date Fair Value Per Share, March 31, 2022 | $ / shares | $ 3.92 |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Computation of Basic and Diluted Loss per Share Attributable to Stockholders (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator | ||
Net loss attributable to common stockholders | $ (15,586) | $ (6,961) |
Denominator | ||
Weighted-average shares outstanding, basic and diluted | 31,070 | 26,604 |
Net loss per share, basic and diluted | $ (0.50) | $ (0.26) |
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 | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 4,695 | 3,090 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 3,539 | 2,908 |
Shares Committed Under ESPP | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 12 | |
Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 103 | 103 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total | 1,041 | 79 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | |
Cash paid for income taxes | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | May 13, 2021 | May 01, 2021 | Dec. 02, 2020 | Sep. 30, 2020 | Aug. 31, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Oct. 31, 2016 |
Loss Contingencies [Line Items] | ||||||||
Research and development | $ 3,206,000 | $ 3,321,000 | ||||||
Revenue Share Agreement | Oncimmune Limited | ||||||||
Loss Contingencies [Line Items] | ||||||||
Royalty expense | $ 200,000 | 200,000 | ||||||
Percentage of revenue share payment related to acquired diagnostic test recognized revenue for non-screening tests | 8.00% | |||||||
Minimum annual volume percentage thereafter | 5.00% | |||||||
Period of escalations of sales | through the first four years of sales | |||||||
Litigation Claims and Assessments | ||||||||
Loss Contingencies [Line Items] | ||||||||
Final settlement payment of legal contingency | $ 210,000 | |||||||
Bio-Rad License | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of royalty payments on net revenue | 2.50% | |||||||
Percentage of royalty payments not required on net revenue | 2.50% | |||||||
License expiry date | 2024-08 | |||||||
Royalty expense | 0 | 0 | ||||||
CellCarta License | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of royalty payments on net revenue | 0.675% | |||||||
Percentage of fee payments on net sales | 1.00% | |||||||
Term of royalty payments from first commercial sale | 15 years | |||||||
Year of ending royalty payments from first commercial sale | 2034 | |||||||
AVEO Oncology | ||||||||
Loss Contingencies [Line Items] | ||||||||
Remaining estimated obligation | 100,000 | |||||||
Research and development | $ 0 | $ 0 | ||||||
AVEO Oncology | Ficlatuzumab | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of development and regulatory costs exercised using opt-out right | 50.00% | |||||||
Percentage of royalty payments on net sales | 10.00% | |||||||
Percentage of license income generated from licensing | 25.00% | |||||||
AVEO Oncology | NSCLC POC Trial | ||||||||
Loss Contingencies [Line Items] | ||||||||
Responsible percentage of development and regulatory costs | 50.00% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | Apr. 01, 2023USD ($) | May 11, 2022USD ($)$ / shares | May 09, 2022USD ($) | Apr. 08, 2022USD ($)$ / shares | Apr. 07, 2022shares | Apr. 01, 2022USD ($) | Oct. 31, 2024USD ($) | Jul. 31, 2024USD ($) | Apr. 30, 2024USD ($) | Jul. 31, 2023USD ($)Installment | Feb. 28, 2023USD ($) | Apr. 30, 2022USD ($)Installment$ / sharesshares | Mar. 31, 2022USD ($)$ / shares | Jan. 31, 2023USD ($) | Dec. 31, 2021USD ($)$ / shares |
Subsequent Event [Line Items] | |||||||||||||||
Subscription agreements description | On April 7, 2022, the Company entered into subscription agreements (the Subscription Agreements) with a consortium of investors (the 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 an aggregate of 6,508,376 shares of the Company’s common stock (the Shares) in an offering (the Private Placement). 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 we 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. | ||||||||||||||
Net proceeds | $ 1,599,000 | ||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||
Aggregate market value of common stock and other equity securities | $ 32,000 | $ 31,000 | |||||||||||||
At-The-Market Offering | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Net proceeds from sale of common shares after deducting underwriting discounts and commissions and offering expenses | $ 1,500,000 | ||||||||||||||
Scenario Forecast | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Minimum liquidity balance required | $ 3,000,000 | ||||||||||||||
Scenario Forecast | Promissory Note One | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Promissory Note, up on redemption | $ 1,425,000 | ||||||||||||||
Scenario Forecast | Promissory Note Two | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Promissory Note, up on redemption | $ 950,000 | ||||||||||||||
Scenario Forecast | Securities Purchase Agreement | Minimum | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Aggregate market value of common stock and any other equity securities held by persons | $ 75,000,000 | ||||||||||||||
Proceeds from issuance or sale of equity net | 25,600,000 | ||||||||||||||
Gross proceeds from sale of common shares | $ 5,600,000 | ||||||||||||||
Integrated Diagnostics, Inc | Scenario Forecast | Third Amendment to APA Agreement | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Milestone payment | $ 8,375,000 | $ 5,000,000 | $ 3,000,000 | ||||||||||||
Number of quarterly installment | Installment | 3 | ||||||||||||||
Exit fee payment | $ 6,075,000 | ||||||||||||||
Subsequent Event | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Aggregate purchase price | $ 11,700,000 | ||||||||||||||
Description of securities purchase agreement | (i) purchased a secured convertible promissory note (Promissory Note One) in the aggregate principal amount totaling $16,025,000 in exchange for $15,000,000 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 $10,250,000 in exchange for $10,000,000. | ||||||||||||||
Promissory notes interest rate | 6.00% | ||||||||||||||
Promissory note, maturity term | 24 months | ||||||||||||||
Promissory note issued with an OID | $ 512,500 | ||||||||||||||
Promissory notes early prepayment premium percentage | 10.00% | ||||||||||||||
Promissory note, redemption description | The Redemption Conversion Price shall equal 85% multiplied by the lowest daily VWAP during the ten trading days immediately preceding the date the Lender delivers notice electing to redeem a portion of the Promissory Note. The Company’s right to satisfy the redemption amount in shares of Common Stock is subject to certain limitations, including (i) there not being any Equity Conditions Failure (as defined in the Note), (ii) the Lender and its affiliates together not owning more than 9.99% of the outstanding shares of Common Stock, and (iii) the aggregate shares of Common Stock issued upon redemption of the Promissory Notes not exceeding 19.99% of the outstanding Common Stock unless the Company has obtained stockholder approval under NASDAQ rules for such issuance. | ||||||||||||||
Maximum purchase percentage of investors on future equity and debt securities offerings | $ 30,000 | ||||||||||||||
Aggregate market value of common stock and other equity securities | 37,000,000 | ||||||||||||||
Subsequent Event | First Tranche | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Gross proceeds from debt issuance costs | $ 15,000,000 | ||||||||||||||
Proceeds from net of debt issuance costs and original issue discounts | $ 13,000,000 | ||||||||||||||
Subsequent Event | Two Tranche | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt facility | 25,000,000 | ||||||||||||||
Subsequent Event | Promissory Note One | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Promissory note issued with an OID | 1,025,000 | ||||||||||||||
Subsequent Event | Promissory Note Two | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Promissory note issued with an OID | $ 250,000 | ||||||||||||||
Subsequent Event | 2021 Term Loan Partial Repayment in April 2022 | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Repayments of debt | $ 3,000,000 | ||||||||||||||
Subsequent Event | Principal Repayment | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Repayments of debt | 2,000,000 | ||||||||||||||
Subsequent Event | Maximum | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt facility | 25,000 | ||||||||||||||
Promissory notes interest rate | 15.00% | ||||||||||||||
Subsequent Event | Maximum | Two Tranche | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt facility | $ 25,000,000 | ||||||||||||||
Subsequent Event | Third Amendment to 2021 Term Loan | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt Instrument Remaining Principal Payment | 2,000,000 | ||||||||||||||
Repayments of debt | 3,000,000 | ||||||||||||||
Subsequent Event | Third Amendment to 2021 Term Loan | Minimum | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt or equity fund raising | 15,000,000 | ||||||||||||||
Subsequent Event | To be Paid no Earlier than May 15, 2022 | Third Amendment to 2021 Term Loan | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Repayments of debt | 2,000,000 | ||||||||||||||
Subsequent Event | Subscription Agreements | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Price per share | $ / shares | $ 1.79 | ||||||||||||||
Aggregate purchase price | $ 11,700,000 | ||||||||||||||
Subsequent Event | Subscription Agreements | Third Amendment to 2021 Term Loan | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt or equity fund raising | 11,700,000 | ||||||||||||||
Subsequent Event | Integrated Diagnostics Asset Purchase Agreement | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Subsequent Event | Securities Purchase Agreement | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | ||||||||||||||
Subsequent Event | Securities Purchase Agreement | Promissory Note One | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt instrument, aggregate principal amount | $ 16,025,000 | ||||||||||||||
Debt instrument face amount net of certain expenses | 15,000,000 | ||||||||||||||
Net proceeds from issuance of debt instrument. | $ 13,000,000 | ||||||||||||||
Description on debt instrument conditions | (i) within 9 months following the First Closing Date, the Company will repay in full all outstanding obligations under the SVB 2021 Term Loan, (ii) Company shall have received no less than $5.6 million in proceeds from the sale (not attributable to Lender or its affiliates) of new equity securities during the period beginning on the First Closing Date and ending on January 31, 2023 (the Second Closing Date), (iii) on or before the Second Closing Date, Company shall have met or exceeded Revenue Milestone 1 (as defined in the Promissory Notes), (iv) the aggregate market value of the Company’s common stock and any other equity securities held by persons that are not affiliates of the Company on the Second Closing Date shall be greater than or equal to $75.0 million or (b) received no less than $20.0 million in additional proceeds from the sale (not attributable to Lender or its affiliates) of new equity securities in the Company not counting those proceeds set forth in item (ii) above (for total proceeds of no less than $25.6 million during the period beginning on the First Closing Date and ending on the Second Closing Date; (v) as of the Second Closing Date, Company is in good standing with Nasdaq Stock Market (the NASDAQ) and has not received any notice of non-compliance; (vi) Company shall be current in its payments to Indi, and (vii) there being no Trigger Event (as defined in the Promissory Notes) under Promissory Note One. If Promissory Note Two is issued, the terms of Promissory Note One and Note Two will be substantively identical. | ||||||||||||||
Subsequent Event | Securities Purchase Agreement | Promissory Note Two | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Debt instrument, aggregate principal amount | $ 10,250,000 | ||||||||||||||
Debt instrument face amount net of certain expenses | 10,000,000 | ||||||||||||||
Additional proceeds from issuance or sale of equity | $ 20,000,000 | ||||||||||||||
Subsequent Event | Private Placement | Subscription Agreements | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Shares of common stock issued and sold | shares | 6,508,376 | ||||||||||||||
Subsequent Event | Private Placement | Board of Directors | Subscription Agreements | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Shares of common stock issued and sold | shares | 3,631,284 | ||||||||||||||
Subsequent Event | Private Placement | Existing Shareholders | Subscription Agreements | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Shares of common stock issued and sold | shares | 2,877,092 | ||||||||||||||
Subsequent Event | At-The-Market Offering | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Shares of common stock issued and sold | shares | 1,349,139 | ||||||||||||||
Net proceeds | $ 2,700,000 | ||||||||||||||
Underwriting discounts and commissions and offering expenses payable | 80,000 | ||||||||||||||
Gross proceeds from sale of common shares | $ 2,700,000 | ||||||||||||||
Weighted average price per share | $ / shares | $ 2.04 | ||||||||||||||
Subsequent Event | Integrated Diagnostics, Inc | Third Amendment to APA Agreement | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Milestone payment | $ 2,000,000 | ||||||||||||||
Number of quarterly installment | Installment | 5 | ||||||||||||||
Percentage of interest on installment payments | 10.00% |