Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 10, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | Lucira Health, Inc. | |
Entity Interactive Data Current | Yes | |
Entity Central Index Key | 0001652724 | |
Entity Tax Identification Number | 27-2491037 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity File Number | 001-39976 | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Small Business | true | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 1412 62nd Street | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 350-8071 | |
Trading Symbol | LHDX | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 38,698,789 |
CONDENSED BALANCE SHEETS (Unaud
CONDENSED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | ||
Current assets: | ||||
Cash | $ 161,662 | $ 58,212 | [1] | |
Accounts receivable, net | 3,392 | 293 | [1] | |
Inventory | 36,182 | 4,865 | [1] | |
Grant income receivable | 92 | 183 | [1] | |
Prepaid expenses | 6,164 | 3,496 | [1] | |
Other current assets | 6,099 | 844 | [1] | |
Restricted cash equivalents | 2,338 | 2,338 | [1] | |
Total current assets | 215,929 | 70,231 | [1] | |
Property and equipment, net | 28,153 | 19,408 | [1] | |
Operating lease right-of-use assets | 576 | 748 | [1] | |
Other assets | 31 | 2,316 | [1] | |
Total assets | 244,689 | 92,703 | [1] | |
Current liabilities: | ||||
Accounts payable | 6,673 | 3,981 | [1] | |
Accrued liabilities | 18,672 | 4,445 | [1] | |
Operating lease liabilities, current | 374 | 431 | [1] | |
Customer deposits | 2,916 | |||
Total current liabilities | 28,635 | 8,857 | [1] | |
Convertible notes payable | [1] | 24,694 | ||
Operating lease liabilities, net of current portion | 254 | 380 | [1] | |
Total liabilities | 28,889 | 33,931 | [1] | |
Commitments and contingencies (Note 5) | [1] | |||
Redeemable convertible preferred stock $0.001 par value; 0 and 103,355,827 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 0 and 23,978,747 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference of $0 as of June 30, 2021 | [1] | 121,080 | ||
Stockholders’ equity (deficit): | ||||
Preferred stock $0.001 par value; 10,000,000 and 0 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020 | [1] | |||
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 38,684,546 and 2,712,694 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 39 | 3 | [1] | |
Additional paid-in capital | 308,991 | 1,403 | [1] | |
Accumulated deficit | (93,230) | (63,714) | [1] | |
Total stockholders’ equity (deficit) | 215,800 | (62,308) | [1] | |
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | $ 244,689 | $ 92,703 | [1] | |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
CONDENSED BALANCE SHEETS (Una_2
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Statement Of Financial Position [Abstract] | |||
Redeemable convertible preferred stock par value | $ 0.001 | $ 0.001 | [1] |
Redeemable convertible preferred stock shares authorized | 0 | 103,355,827 | [1] |
Redeemable convertible preferred stock shares issued | 0 | 23,978,747 | [1] |
Redeemable convertible preferred stock shares outstanding | 0 | 23,978,747 | [1] |
Redeemable convertible preferred stock, aggregate liquidation preference | $ 0 | $ 123,126 | |
Preferred stock par value | $ 0.001 | $ 0.001 | [1] |
Preferred stock shares authorized | 10,000,000 | 0 | [1] |
Preferred stock shares issued | 0 | 0 | [1] |
Preferred stock shares outstanding | 0 | 0 | [1] |
Common stock par value | $ 0.001 | $ 0.001 | [1] |
Common stock shares authorized | 200,000,000 | 150,000,000 | [1] |
Common stock shares issued | 38,684,546 | 2,712,694 | [1] |
Common stock shares outstanding | 38,684,546 | 2,712,694 | [1] |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Net sales | $ 12,439 | $ 16,955 | ||
Cost of products sold | 12,505 | 17,873 | ||
Gross loss | (66) | (918) | ||
Operating expenses: | ||||
Research and development | 10,117 | $ 4,574 | 16,399 | $ 7,315 |
Selling, general and administrative | 6,100 | 931 | 12,200 | 1,559 |
Total operating expenses | 16,217 | 5,505 | 28,599 | 8,874 |
Loss from operations | (16,283) | (5,505) | (29,517) | (8,874) |
Other income (expense), net: | ||||
Grant income | 79 | 335 | 281 | 1,977 |
Interest income (expense) | 4 | (10) | 1 | (10) |
Remeasurement of derivative liabilities and convertible notes | (1,444) | (281) | (1,444) | |
Total other income (expense), net | 83 | (1,119) | 1 | 523 |
Net loss | $ (16,200) | $ (6,624) | $ (29,516) | $ (8,351) |
Net loss per share of common stock, basic and diluted | $ (0.42) | $ (2.90) | $ (0.96) | $ (3.68) |
Weighted-average number of shares used in net loss per share of common stock, basic and diluted | 38,483,766 | 2,282,024 | 30,688,349 | 2,270,130 |
CONDENSED STATEMENTS OF REDEEMA
CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($) $ in Thousands | Total | Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | |
Beginning balance at Dec. 31, 2019 | $ (25,665) | $ 2 | $ 699 | $ (26,366) | ||
Beginning balance, shares at Dec. 31, 2019 | 6,712,085 | |||||
Beginning balance at Dec. 31, 2019 | $ 30,960 | |||||
Beginning balance, Shares at Dec. 31, 2019 | 2,257,740 | |||||
Issuance of common stock upon exercise of stock options | 153 | 153 | ||||
Issuance of common stock upon exercise of stock options, shares | 187,164 | |||||
Issuance of Series B redeemable convertible preferred stock, net of issuance costs | $ 17,466 | |||||
Issuance of Series B redeemable convertible preferred stock, net of issuance costs, shares | 3,754,084 | |||||
Stock-based compensation | 117 | 117 | ||||
Net loss | (8,351) | (8,351) | ||||
Ending balance at Jun. 30, 2020 | (33,746) | $ 2 | 969 | (34,717) | ||
Ending balance, Shares at Jun. 30, 2020 | 10,466,169 | |||||
Ending balance at Jun. 30, 2020 | $ 48,426 | |||||
Ending balance, Shares at Jun. 30, 2020 | 2,444,904 | |||||
Beginning balance at Mar. 31, 2020 | (27,334) | $ 2 | 757 | (28,093) | ||
Beginning balance, shares at Mar. 31, 2020 | 10,466,169 | |||||
Beginning balance at Mar. 31, 2020 | $ 48,426 | |||||
Beginning balance, Shares at Mar. 31, 2020 | 2,257,740 | |||||
Issuance of common stock upon exercise of stock options | 153 | 153 | ||||
Issuance of common stock upon exercise of stock options, shares | 187,164 | |||||
Stock-based compensation | 59 | 59 | ||||
Net loss | (6,624) | (6,624) | ||||
Ending balance at Jun. 30, 2020 | (33,746) | $ 2 | 969 | (34,717) | ||
Ending balance, Shares at Jun. 30, 2020 | 10,466,169 | |||||
Ending balance at Jun. 30, 2020 | $ 48,426 | |||||
Ending balance, Shares at Jun. 30, 2020 | 2,444,904 | |||||
Beginning balance at Dec. 31, 2020 | $ (62,308) | [1] | $ 3 | 1,403 | (63,714) | |
Beginning balance, shares at Dec. 31, 2020 | 23,978,747 | [1] | 23,978,747 | |||
Beginning balance at Dec. 31, 2020 | $ 121,080 | [1] | $ 121,080 | |||
Beginning balance, Shares at Dec. 31, 2020 | 2,712,694 | |||||
Issuance of common stock upon exercise of stock options, shares | 37,760 | |||||
Ending balance at Mar. 31, 2021 | $ 230,912 | $ 39 | 307,903 | (77,030) | ||
Ending balance, Shares at Mar. 31, 2021 | 38,550,148 | |||||
Beginning balance at Dec. 31, 2020 | $ (62,308) | [1] | $ 3 | 1,403 | (63,714) | |
Beginning balance, shares at Dec. 31, 2020 | 23,978,747 | [1] | 23,978,747 | |||
Beginning balance at Dec. 31, 2020 | $ 121,080 | [1] | $ 121,080 | |||
Beginning balance, Shares at Dec. 31, 2020 | 2,712,694 | |||||
Conversion of redeemable convertible preferred shares into common stock | 121,080 | $ 24 | 121,056 | |||
Conversion of redeemable convertible preferred shares into common stock, shares | (23,978,747) | |||||
Conversion of redeemable convertible preferred shares into common stock | $ (121,080) | |||||
Conversion of redeemable convertible preferred shares into common stock, shares | 23,978,747 | |||||
Conversion of convertible notes into common stock | 24,982 | $ 2 | 24,980 | |||
Conversion of convertible notes into common stock, shares | 1,470,947 | |||||
Issuance of common stock upon IPO, net of issuance costs | 159,899 | $ 10 | 159,889 | |||
Issuance of common stock upon IPO, net of issuance costs, shares | 10,350,000 | |||||
Issuance of common stock upon exercise of stock options | 190 | 190 | ||||
Issuance of common stock upon exercise of stock options, shares | 172,158 | |||||
Stock-based compensation | 1,473 | 1,473 | ||||
Net loss | (29,516) | (29,516) | ||||
Ending balance at Jun. 30, 2021 | $ 215,800 | $ 39 | 308,991 | (93,230) | ||
Ending balance, Shares at Jun. 30, 2021 | 0 | |||||
Ending balance, Shares at Jun. 30, 2021 | 38,684,546 | |||||
Beginning balance at Mar. 31, 2021 | $ 230,912 | $ 39 | 307,903 | (77,030) | ||
Beginning balance, Shares at Mar. 31, 2021 | 38,550,148 | |||||
Issuance of common stock upon exercise of stock options | $ 143 | 143 | ||||
Issuance of common stock upon exercise of stock options, shares | 134,398 | 134,398 | ||||
Stock-based compensation | $ 945 | 945 | ||||
Net loss | (16,200) | (16,200) | ||||
Ending balance at Jun. 30, 2021 | $ 215,800 | $ 39 | $ 308,991 | $ (93,230) | ||
Ending balance, Shares at Jun. 30, 2021 | 0 | |||||
Ending balance, Shares at Jun. 30, 2021 | 38,684,546 | |||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | ||
Cash flows from operating activities: | ||||||
Net loss | $ (29,516) | $ (8,351) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Stock-based compensation expense | 1,473 | 117 | ||||
Allowance for doubtful accounts | 259 | |||||
Depreciation and amortization | $ 700 | $ 100 | 882 | 118 | ||
Remeasurement of derivative liabilities and convertible notes | 1,444 | 281 | 1,444 | |||
Noncash interest expense | 3 | 6 | ||||
Noncash lease expense | 172 | 150 | ||||
Changes in assets and liabilities: | ||||||
Inventory | (31,317) | |||||
Accounts receivable | (3,358) | |||||
Grant income receivable | 91 | 1,639 | ||||
Prepaid expenses and other current assets | (8,767) | (800) | ||||
Other assets | 3,129 | |||||
Accounts payable | 2,678 | 527 | ||||
Customer deposits | 2,916 | |||||
Accrued liabilities | 13,635 | 47 | ||||
Operating lease liabilities | (183) | (135) | ||||
Net cash used in operating activities | (47,622) | (5,238) | ||||
Cash flows from investing activities: | ||||||
Acquisition of property and equipment | (8,977) | (2,285) | ||||
Net cash used in investing activities | (8,977) | (2,285) | ||||
Cash flows from financing activities: | ||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | 159,899 | |||||
Proceeds from issuance of convertible notes payable net of issuance costs | 5,612 | |||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | 17,466 | |||||
Proceeds from exercise of stock options | 150 | 153 | ||||
Net cash provided by financing activities | 160,049 | 23,231 | ||||
Net increase in cash and restricted cash equivalents | 103,450 | 15,708 | ||||
Cash and restricted cash equivalents, beginning of period | 60,550 | 4,100 | $ 4,100 | |||
Cash and restricted cash equivalents, end of period | 164,000 | 19,808 | 164,000 | 19,808 | 60,550 | |
Reconciliation to amounts on the balance sheets: | ||||||
Cash | 161,662 | 19,808 | 161,662 | 19,808 | 58,212 | [1] |
Restricted cash equivalents | 2,338 | 2,338 | 2,338 | [1] | ||
Cash and restricted cash equivalents, end of period | $ 164,000 | $ 19,808 | 164,000 | $ 19,808 | $ 60,550 | |
Supplemental disclosures of noncash financing and investing activities: | ||||||
Purchase of property and equipment included in accounts payable and accrued liabilities | 650 | |||||
Vesting of early exercise options | 40 | |||||
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | 24,982 | |||||
Conversion of convertible redeemable preferred shares into common stock on IPO | $ 121,080 | |||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Organization
Organization | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | Note 1. Organization Description of Business Lucira Health, Inc. (the “Company”) was incorporated under the laws of the state of Delaware on February 20, 2013 under the name DiAssess Inc. The Company changed its name to Lucira Health, Inc. in January 2020. The Company is located in Emeryville, California. The Company is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. The Company has developed a testing platform that produces high-complexity-laboratory-accurate molecular testing in a single-use and user-friendly test kit that is powered by two AA batteries and fit in the palm of a hand. The Company’s initial focus is within respiratory diseases, and initially for COVID-19 and influenza Types A and B indications. On November 17, 2020, the Company received an Emergency Use Authorization (“EUA”) from the Food and Drug Administration (“FDA”) for (1) prescription at-home use with self-collected nasal swab specimens in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider and (2) use at the point-of-care (“POC”), with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. People who are suspected of COVID-19 are those who are either symptomatic or are thought to have been exposed to COVID-19. On April 9, 2021, the Company received its first FDA EUA authorization for over-the-counter (“OTC”) non-prescription use among symptomatic and asymptomatic individuals aged 14 and older (with self-collection) and children aged two to 13 (with parent collection). Reverse Stock Split On January 28, 2021, the Company’s board of directors (the “Board”) approved a 1-for-4.3103 Initial Public Offering On February 9, 2021, the Company closed its IPO of 10,350,000 shares of its common stock, including 1,350,000 shares of common stock issued pursuant to the full exercise of the underwriters’ option to purchase additional shares in the IPO, at a price to the public of $17.00 per share. The net proceeds to the Company from the IPO were $159.9 million, after deducting underwriting discounts and commissions of $12.3 million and offering expenses of $3.7 million. In connection with the IPO, all shares of redeemable convertible preferred stock and outstanding convertible notes converted into 25,449,694 shares of common stock. Liquidity and Going Concern The Company has incurred recurring losses and negative cash flows from operating activities since inception. The Company anticipates that it will continue to incur net losses into the foreseeable future. As of June 30, 2021, the Company had cash of $161.7 million and had an accumulated deficit of $93.2 million. The Company believes that cash as of June 30, 2021 will be sufficient to fund its planned operations for a period of at least 12 months from the date of the issuance of the accompanying financial statements. Management expects to incur additional losses in the future and in order to continue to fund its operations the Company may need to raise additional capital to fully implement its business plan. The Company may raise additional capital through the issuance of equity securities, debt financings or other sources in order to further implement its business plan. However, if such financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of new test kits. Other Risk and Uncertainties While the Company generated $17.0 million of revenues from the sale of its test kits during the six months ended June 30, 2021, there still remains uncertainty of future revenue from sales of its test kits. The Company is devoting most of its efforts to the sales and marketing and research and development of its test kits. The Company is subject to a number of product risks, including the receipt of regulatory approvals for additional indications of the COVID-19 test kit and timing thereof, size of the market opportunity, demand from the public and members of the medical community for the COVID-19 test kit and rate of adoption of the COVID-19 test kit. The commercial success of the COVID-19 test kit was initially dependent upon physicians, and healthcare providers accepting and adopting our test kit. Since receiving the EUA authorization for OTC use, our commercial business has evolved to include partnerships with testing providers, distributors and businesses. The Company is also subject to risks related to compliance with government regulations, protection of proprietary technology, dependence on third-parties, product liability, and dependence on key individuals. In connection with the COVID-19 pandemic, governments have implemented significant measures, including closures, quarantines, travel restrictions and other social distancing directives, intended to control the spread of the virus. Companies have also taken precautions, such as requiring employees to work remotely, imposing travel restrictions and temporarily closing businesses. The Company believes some of the precautionary measures and challenges resulting from the COVID-19 pandemic may continue as COVID-19 becomes endemic, but there is uncertainty and volatility in these and other trends despite the continued progress of vaccination efforts. To the extent that restrictions remain in place, additional prevention and mitigation measures are implemented in the future, or there is uncertainty about the effectiveness of these or any other measures to contain or treat COVID-19, there is likely to be an adverse impact on global economic conditions and consumer confidence and spending, which could materially and adversely affect the Company’s research and development, as well as operational activities. At this time, the Company is working to manage and mitigate potential disruptions to its research and future manufacturing and supply chain considerations. The Company has not experienced hindrance to its operations or material negative financial impacts as compared to prior periods. At this time, the extent to which the COVID-19 pandemic impacts the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and pursuant to the instructions of the SEC on Form 10-Q and Article 10 of Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the management’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. The accompanying balance sheet as of June 30, 2021, the statements of operations for the three and six months ended June 30, 2021 and June 30, 2020, the statements of redeemable convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and June 30, 2020, and the statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2021 and the results of its operations and cash flows for the six months ended June 30, 2021 and June 30, 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and June 30, 2020 are unaudited. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. These financial statements and accompanying notes should be read in conjunction with the financial statements and notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 31, 2021. Use of Estimates Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to recognition of grant income, the fair value of the Company’s common stock and redeemable convertible preferred stock, the fair value of derivative liabilities and convertible notes payable, stock-based compensation, incremental borrowing rate, estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. Concentration of Credit Risk and Significant Suppliers Financial instruments that potentially subject the Company to credit risk consist principally of cash held by financial institutions, grant income receivables and account receivables. Substantially all of the Company’s cash is held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company’s grant income receivable balance at each respective balance sheet dates results from grant agreements with the U.S. government. As of June 30, 2021, accounts receivable balance was $3.4 million. Two customers accounted for 12% and 10% of accounts receivable balance. As of December 31, 2020, accounts receivable balance was $0.3 million and was comprised by the Company’s only customer. The Company evaluates the collectability of its accounts receivable based on historical collection trends and provides for an allowance for doubtful accounts. Allowance for doubtful accounts was $0.4 million and $0 million as of June 30, 2021 and December 31, 2020, respectively. Two customers accounted for 14% and 10% of the Company’s revenue during the three and six months ended June 30, 2021. The Company is dependent on key suppliers, who are single source, for certain laboratory materials and inventory items. An interruption in the supply of these materials could temporarily impact the Company’s ability to manufacture its commercial inventory and perform development, testing and clinical trials related to its products. Fair Value Measurements The carrying value of the Company’s cash, accounts receivable, grant income receivable, prepaid expenses, other current assets and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s derivative liabilities and convertible notes are measured at fair value on a recurring basis and are classified as Level 3 liabilities until conversion of the notes. The Company records subsequent adjustments to reflect the increase or decrease in estimated fair value at each reporting date on the statement of operations. Cash, and Restricted Cash Equivalents The Company considers highly liquid investments purchased with a remaining maturity date upon acquisition of three months or less to be cash equivalents and are stated at cost, which approximates fair value. As of June 30, 2021 and June 30, 2020, there were no cash equivalents. As of June 30, 2021, the Company held a restricted cash balance of $2.3 million which was used to secure a letter of credit in relation to the Company’s contract manufacturer to secure certain purchases made on the Company’s behalf. The cash was deposited in a money market account with maturities of three months or less and thus considered a restricted cash equivalent. Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company determines are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive clinical test results for the underlying product, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the submission of the regulatory application. The Company closely monitors the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. Prior to obtaining the EUA authorization for its COVID-19 test kit on November 17, 2020, the Company charged $2.3 million of preapproval inventory to research and development expense. After receipt of the EUA in November 2020, the Company accounted for all production item purchases as inventory in accordance with its inventories policy below. Preapproval inventories previously recorded as research and development expense that are subsequently sold will have a zero cost of product. Subsequent to receipt of the EUA in November 2020, the Company utilized a portion of the preapproval inventory resulting in a remaining unused amount of $1.3 million as of December 31, 2020. During the three months ended June 30, 2021, the Company utilized less than $0.1 million of the preapproval inventory write-offs for cost of sales. During the six months ended June 30, 2021, the Company utilized all of the preapproval inventory write-offs for cost of sales of $1.0 million and for selling, general and administrative and research and development activities of $0.3 million. Inventories The Company values its inventory at the lower of cost or net realizable value and determines the cost of inventory using standard costs which closely resembles the first-in, first-out method. Lower of cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. In order to assess the ultimate realization of inventories, the Company is required to make judgments as to future demand requirements compared to current or committed inventory levels. The Company periodically reviews its inventories for shelf life, excess or obsolescence and writes-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Amounts written-down due to unmarketable inventory are recorded in cost of revenue and a new lower-cost basis for the inventory is established. The Company did not record any write down adjustment during the six months ended June 30, 2021. Warranty The Company offers a standard product warranty that our products will perform as intended upon the date of original delivery for a reasonable period of time, which is the shorter of date usage or product shelf life. The Company has the obligation, at its option, to either refund, repair or replace a defective product. At the time revenue is recognized, an estimate of future warranty costs is recorded as a component of cost of products sold. The estimate of future warranty costs is based on historical as well as current product failure rates, service delivery costs incurred in correcting product failures, and warranty policies. The Company will regularly review these estimates to assess the appropriateness of our recorded warranty liabilities and adjust the amounts as necessary. As of June 30, 2021 and December 31, 2020, the accrued liability for warranty returns was not significant. Grant Income Receivable Grant income receivable consists of billed and unbilled amounts earned from various government grants for costs incurred prior to the period end under reimbursement contracts. The amounts are billed to the respective government agencies. As collection is deemed probable, no allowance for doubtful accounts has been established. If amounts become uncollectible, they are recorded as operating expense in the Company’s statements of operations. Of the amounts presented on the balance sheets as grant income receivable, $0.1 million and $0.2 million were unbilled as of June 30, 2021 and December 31, Property and Equipment, Net Property and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and seven years. Leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining term of the related lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in other income or expense in the statements of operations in the period realized. Leases The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as operating or finance. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the balance sheets. The Company did not have any finance leases as of June 30, 2021 and December 31, ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and exclude lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases. Long-Lived Assets The Company’s long-lived assets are comprised principally of its property and equipment, including leasehold improvements and ROU assets. If the Company identifies a change in the circumstances related to its long-lived assets that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. No impairment of long-lived assets was recorded during the six months ended June 30, 2021 and June 30, 2020. Accrued Research and Development Costs The Company records accrued expenses for estimated costs of its research and development activities conducted by third-party service providers, which include clinical trial activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services or supplies provided but not yet invoiced and include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. The Company records accrued expenses for these costs based on factors such as estimates of the work completed or supplies received and in accordance with agreements established with these vendors. Any payments made in advance of services or supplies provided are recorded as prepaid assets, which are expensed as the services or supplies are received. The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. The Company makes significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, the Company adjusts its accrued estimates. Redeemable Convertible Preferred Stock The Company’s shares of preferred stock are assessed at issuance for classification and redemption features requiring bifurcation. The Company’s preferred stock is not mandatorily redeemable. The Company presents as temporary equity any stock which (i) the Company undertakes to redeem at a fixed or determinable price on the fixed or determinable date or dates; (ii) is redeemable at the option of the holders, or (iii) has conditions for redemption which are not solely within the control of the Company. The Company’s preferred stock is redeemable if the Company has not been dissolved within 90 days following the occurrence of certain deemed liquidation events, which the Company determined is not solely within its control and thus has classified shares of redeemable convertible preferred stock as temporary equity until such time as the conditions are removed or lapse. The Company initially records redeemable convertible preferred stock at fair value, net of issuance costs. Because the occurrence of a deemed liquidation event is not currently probable, the carrying values of the shares of redeemable convertible preferred stock are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the shares of redeemable convertible preferred stock would be made only when a deemed liquidation event becomes probable. In connection with the IPO on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. Deferred Offering Costs The Company capitalized certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are recorded as a reduction of the proceeds received from the equity financing. If a planned equity financing is abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the condensed statements of operations. There was $0.0 and $2.2 million of deferred offering costs related to the Company’s IPO recorded as other assets on the Company’s balance sheet as of June 30, 2021 and December 31, 2020, respectively. The Company recorded additional offering costs between December 31, 2020 and February 9, 2021 and recorded $3.7 million as an offset to the IPO proceeds as additional paid in capital on the closing date. Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”), “Revenue from Contracts with Customers” when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Under ASC 606, assuming all other revenue recognition criteria have been met, the Company will recognize revenue for arrangements upon the transfer of control of the Company’s products to its customers, which is currently upon the shipment of the product to the customer under the Company’s standard terms and conditions. There are no further performance obligations by the Company to the customer after shipment of the product. Control of the Company’s products is transferred at a point in time. Revenue is measured based on the amount of consideration that the Company expects to receive as reduced by estimated discounts and allowances. All of the Company’s revenue has been derived from sales of its test kits. During the first quarter 2021 the Company marketed its test products to physicians and licensed healthcare providers in the United States. On April 9, 2021, the Company received its first FDA EUA authorization for OTC non-prescription use and expanded its marketing to include domestic testing providers, distributors, businesses and international distributors. Collection of the Company’s net receivables generally occur within 30 days of billing. Contracts do not contain significant financing components based on the typical period of time between delivery of products and collection of consideration. Costs to obtain or fulfill a contract are currently expensed when incurred because our performance obligation is satisfied at a point in time. The Company invoices its customers upon shipment of product, and records its sales upon shipment in accordance with its standard terms and conditions, unless underlying customer contracts specify otherwise. When necessary, the Company invoices and collects sales tax from its customers for sales of products. The Company has elected to exclude sales tax from the measurement of the transaction price. The following table sets forth the Company’s revenue by geographic area based on the customers’ locations: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 10,277 $ — $ 14,793 $ — International 2,162 — 2,162 — Total revenue $ 12,439 $ — $ 16,955 $ — Grant Income The Company earns grant income for performing tasks under research and development agreements with governmental agencies. In July 2018, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), a division within the U.S. Department of Health and Human Services (“HHS”), for an award of up to $10 million to demonstrate the feasibility of a novel in-home, disposable, point-of-care rapid diagnostic assay for the detection of Influenza A and B for work performed through July 2020. In September 2019, the Company amended its agreement with BARDA to increase the award to $21.5 million and extend the reporting period through July 2022. The Company recognized grant income from BARDA of $0.0 for the three and six months ended June 30, 2021, compared to $0.4 million and $2.0 million for the three and six months ended June 30, 2020, respectively. The Company recognized grant income from other governmental agencies of $0.1 million and $0.3 million during the three and six months ended June 30, 2021, respectively, compared to less than $0.1 million and $0.1 million during the three and six months ended June 30,2020, respectively. Grant income derived from reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with government contracts and grants are recorded at the gross amount within grant income. The costs associated with these reimbursements are reflected as a component of research and development expense in the Company’s statements of operations. Research and Development Costs associated with research and development activities are expensed as incurred and include, but are not limited to, personnel-related expenses including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were $0.9 million and $1.3 million for the three and six months ended June 30, 2021, respectively compared to $0 million in 2020, and are included in selling, general and administrative expenses in the accompanying statements of operations. Stock-Based Compensation The Company’s stock-based awards consist of stock options, restricted stock awards, and employee stock purchase plan issued to grantees. The Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur. In January 2021, the Company’s Board adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The stockholders approved the 2021 Plan in January 2021, and it became effective upon the execution of the underwriting agreement for the IPO on February 4, 2021. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. No further grants will be made under the 2014 Equity Incentive Plan. In February 2021, the Board adopted the 2021 Employee Stock Purchase Plan (the "ESPP"). The Company recognizes stock-based compensation expense related to shares issued pursuant to its ESPP on a straight-line basis over the offering period, which is generally six months. The ESPP allows employees to purchase shares of the Company's common stock at a 15 percent discount. The ESPP also includes a six-month look-back provision for the purchase price if the stock price on the purchase date is less than the stock price on the offering. The Company classifies stock-based compensation expense in its statements of operations in the same manner in which the award recipient’s cash compensation costs are classified. The fair value of each restricted stock award is determined based on the number of shares granted and the value of the Company’s common stock on the date of grant. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of complex assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option. Prior to the Company’s initial public offering, the Company was a private company and lacked company-specific historical and implied fair value information. Therefore, the Board considered numerous objective and subjective factors to determine the fair value of the Company’s common stock options at each meeting in which awards were approved. The factors considered include, but are not limited to (i) the results of contemporaneous independent third-party valuations of the Company’s common stock and the prices, rights, preferences and privileges of the Company’s redeemable convertible preferred stock relative to those of its common stock; (ii) the lack of marketability of the Company’s common stock; (iii) actual operating and financial results;(iv) current business conditions and projections; (v) the likelihood of achieving a liquidity event, such as an IPO or sale of the Company, given prevailing market conditions, and (vi) precedent transactions involving the Company’s shares. The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would adjust the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents of potentially diluted securities outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of redeemable convertible preferred stock, and options outstanding under the Company’s stock option plan. For the six months ended June 30, 2021 and June 30, 2020, there was no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive securities would be anti-dilutive. The following table summarizes the Company’s net loss per share: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator Net loss attributable to common stockholders basic and diluted $ (16,200 ) $ (6,624 ) $ (29,516 ) $ (8,351 ) Denominator |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 3. Fair Value Measurements The Company’s restricted cash equivalent is measured at fair value on recurring basis as of June 30, 2021 and is classified as Level 1 input. The restricted cash equivalent is a money market account that the Company opened in August 2020. The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. Fair Value Measurements as of June 30, 2021 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — Total 2,338 — — Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — 2,338 — — Liabilities Convertible notes payable $ 24,694 Total — — 24,694 The Company did not have any financial instruments measured at fair value on a recurring basis as of June 30, 2021. The change in the fair value of the derivative liabilities and convertible notes accounted for at fair value is summarized below. June 30, 2021 June 30, 2020 Fair value at beginning of the period $ 24,694 $ — Initial fair value of instruments issued — 5,627 Change in fair value of instruments and accrued interest, net 288 1,444 Extinguishment of instruments held at fair value (24,982 ) — Fair value at end of the period $ - $ 7,071 In order to determine the fair value of the convertible notes issued in December 2020, the Company utilized the probability-weighted expected return method (“PWERM”). The PWERM relies on a forward-looking analysis to determine the fair value. Under this method, discrete future outcomes, including an IPO and non-IPO scenarios, are weighted based on the estimated the probability of each scenario. The PWERM is used when discrete future outcomes can be predicted with reasonable certainty based on a probability distribution. The fair value estimate relied upon in the PWERM scenario was based on likelihood of achieving four liquidity events, i) an initial public offering ii) merger or acquisition of the Company given prevailing market conditions iii) change of control iv) maturity of the convertible notes. Estimates and assumptions impacting the fair value measurement include future value under the various conversion scenarios, discount rate, discount period, discount factor and probability of occurrence of each scenario, as best estimated by management. The estimated future value of the notes for each scenario is then discounted to present value using a discount rate. The future value was determined based on the estimated term to the event from valuation date as determined by management. The exit value in an IPO scenario is based on banker indications as well as an analysis of guideline companies that went public within the past few years that are broadly comparable to the Company. The exit value of an M&A scenario is determined by management with an estimated premium applied to the IPO value estimate. The discount rate, discount period, and probability of the occurrence of liquidity scenarios are estimates made by the management. The convertible notes were measured at fair value one last time upon extinguishment on February 9, 2021 in connection with the Company’s IPO. |
Other Financial Information
Other Financial Information | 6 Months Ended |
Jun. 30, 2021 | |
Other Financial Information [Abstract] | |
Other Financial Information | Note 4. Other Financial Information Inventory Inventory consist of the following: June 30, 2021 December 31, 2020 Raw materials $ 35,085 $ 4,865 Finished goods 1,097 — Total $ 36,182 $ 4,865 Property and Equipment, Net June 30, December 31, 2021 2020 Construction in progress $ 12,674 $ 15,308 Machinery and equipment 15,936 4,679 Website development costs 995 — Furniture and fixtures 88 88 Leasehold improvements 507 501 Total, at cost 30,200 20,576 Accumulated depreciation and amortization (2,047 ) (1,168 ) Property and equipment, net $ 28,153 $ 19,408 Depreciation and amortization expense was $0.7 million and $0.9 million for the three and six months ended June 30, 2021, respectively, compared to $0.1 million and $0.1 million for the three and six months ended June 30, 2020, respectively. Construction in progress is related to the setup of manufacturing infrastructure and the purchase of long lead time manufacturing equipment as the Company grows its manufacturing capacity and invests in semi-automation. Construction in progress amounts recorded are not subject to depreciation as such assets are not yet available for their intended use. Accrued Liabilities Accrued liabilities consist of the following: June 30, 2021 December 31, 2020 Professional fees $ 1,367 $ 1,577 Accrued manufacturing and inventory purchases 14,107 1,165 Taxes 359 204 Payroll liabilities 1,866 604 Eiken liabilities 387 — Early exercise liability 224 263 Accrued deferred offering costs — 487 Other 362 145 Total $ 18,672 $ 4,445 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 5. Commitments and Contingencies Commitments License Agreement with Eiken Chemical Co., Ltd. In July 2020, the Company entered into a patent license agreement (“Eiken Agreement”), with Eiken Chemical Co., Ltd. (“Eiken”). Pursuant to the terms of the Eiken Agreement, Eiken granted the Company a royalty bearing non-transferable, non-assignable, sublicensable (to the Company’s affiliates), non-exclusive license under certain patents, which the Company refers to collectively as the Eiken Licensed Patents, relating, in part, to loop-mediated isothermal amplification, to develop, make, use, sell, offer for sale and dispose of any reagent, product, kit, device, equipment and/or system for nucleic acid-based in-vitro diagnostic tests for detection of SARS-CoV-2, which causes COVID-19, which the Company collectively refers to as the Initial Licensed Products, in the United States. The Company also has limited have-made rights with respect to the Eiken Licensed Patents. Under the terms of the Eiken Agreement, the Company also has an option to expand the license to the Eiken Licensed Patents for the Initial Licensed Products outside of the United States for a payment of additional fees. In addition, the Company also has an option to expand the license to the Eiken Licensed Patents for new targets beyond the purpose of testing COVID-19 in the United States, which the Company collectively refer to as the Additional Licensed Products, and together with the Initial Licensed Products, the Licensed Products, for a payment of a one-time fee for each Additional Licensed Product and an additional fee for the expansion of the licensed territory outside of the United States for each Additional Licensed Product. As partial consideration of the rights granted to the Company under the Eiken Agreement, the Company made an upfront payment to Eiken of $24. The Company is also required to make an additional payment by July 2021 for $24 (based on the December 31, 2020 conversion ratio of 103.56 yen to one U.S. dollar). The Company recorded the upfront payment and second payment as research and development expense on the statement of operations for the year ended December 31, 2020. In April 2021, the Company paid the first installment of the world-wide license in the amount of $9. In addition, the Company is obligated to pay a royalty in the low single-digit percentage on total net sales of all Licensed Products, that will be recorded as a cost of goods sold. Royalty expense for the three months and six months ended June 30, 2021 were $0.4 million and $0.5 million, respectively, compared to $0 for the three and six months ended June 30, 2020. The Eiken Agreement will terminate on the expiration date of the last to expire valid claim of the Eiken Licensed Patents in all countries, the latest of which is June 2031. The Company may also terminate the Eiken Agreement at any time upon a certain number of days’ prior written notice to Eiken after Eiken has received the payment due July 2021 mentioned above and all royalties accrued up to the termination date. Eiken may terminate the Eiken Agreement upon (1) not receiving any royalties on Licensed Products for a certain period of time after the Company commences sale of such Licensed Product, (2) a breach by the Company or its affiliates that is not cured within a certain number of days after receiving written notice of the breach, (3) our bankruptcy or insolvency or certain other bankruptcy or insolvency events, (4) the assignment or attempt to assign the Eiken Agreement by the Company in violation of the Eiken Agreement or (5) a challenge by the Company or its affiliates of the validity of any of the Eiken Licensed Patents. Technology Services Agreement with Jabil On September 10, 2020, the Company entered into a technical services agreement (“Jabil TSA”), with Jabil, Inc. (“Jabil”), pursuant to which Jabil will use commercially reasonable efforts to perform certain technical services related to the development of components, assemblies and systems in relation to each project under the agreement as set forth in one or more statement of work, which may include the Company’s COVID-19 test kit and any of its future product candidates. The Company is obligated to pay Jabil all amounts as set forth in each statement of work, which will specify the timeline and schedule for the performance of each service, the compensation to be paid by the Company to Jabil and other relevant terms and conditions. After the initial term of three years, the Jabil TSA will automatically be renewed for successive periods of one year unless a party provides the other party with notice of its intention not to renew the agreement at least 180 days prior to the expiration of the then current term. Either party may terminate the Jabil TSA at any time upon the mutual written consent of both parties. In addition, the agreement may be terminated by either party (a) at will upon at least 180 days’ written notice to the other party, (b) for cause based on a material breach by the other party, subject to a 60-day cure period and (c) for certain bankruptcy or insolvency events enumerated under the agreement. Manufacturing Services Agreement with Jabil On September 10, 2020, the Company entered into a manufacturing services agreement (“Jabil MSA”) with Jabil, pursuant to which Jabil will manufacture, test, pack and ship certain electronic assemblies and systems in accordance with the Company’s specifications. Jabil may not subcontract any of its manufacturing services under the Jabil MSA without the Company’s prior written consent. The Company is obligated to provide, on a monthly basis, a rolling 12-month forecast to Jabil as well as 12-months of historical aggregate end customer demand at the finished product level, when available, which will be used to constitute written purchase orders from the Company, and the Company is obligated to purchase the quantity of products that is required by the first four months of each forecast. Jabil is entitled to reject any purchase orders that are not placed in accordance with the forecast. As of June 30, 2021, the Company has an outstanding non-cancellable purchase commitment of $16.0 million related to the Jabil MSA. The Company is obligated to pay Jabil upon the completion of test kit purchase orders based on a volume pricing matrix, pursuant to which Jabil will review the actual purchases during the then-ending quarter and compare against the forecasted orders in the upcoming quarter. If Jabil determines that the actual purchases correspond to a different pricing band in the volume pricing matrix, Jabil will either issue (a) a credit for any excess price paid by us if the actual price is lower than the invoiced price or (b) an invoice for any shortfall if the actual price is higher than the invoiced price. Jabil may adjust the volume pricing matrix to reflect changes in costs on the first anniversary of its notice to the Company that production qualification can commence, or after the addition of new equipment or labor. The parties will review the prices on a quarterly basis and may revise them based on applicable costs and expenses. The agreement is for an initial term of three years and automatically renewed for successive periods of one year, subject to either party’s notice of intent not to renew, delivered at least 180 days prior to the expiration of the then-current term. The Jabil MSA may be terminated at any time upon the mutual written consent of the parties. In addition, the agreement may be terminated by either party (a) at will upon at least 180 days ’ written notice to the other party, (b) for cause based on a material breach by the other party, subject to a 30-day cure period and (c) for certain bankruptcy or insolvency events enumerated under the agreement. Other Commitments As of June 30, 2021, the Company has additional outstanding non-cancellable purchase commitments for $33.0 million for raw material purchases and fixed assets related to expanding the Company’s manufacturing capacity. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not been subject to any claims or required to defend any action related to its indemnification obligations. The Company’s amended and restated certificate of incorporation contains provisions limiting the liability of directors, and its amended and restated bylaws provide that the Company will indemnify each of its directors to the fullest extent permitted under Delaware law. The Company’s amended and restated certificate of incorporation and amended and restated bylaws also provide the Board with discretion to indemnify its officers and employees when determined appropriate by the Board. In addition, the Company has entered and expects to continue to enter into agreements to indemnify its directors and executive officers. Legal Proceedings From time to time, the Company may become involved in legal proceedings arising out of the ordinary course of its business. Management is currently not aware of any matters that will have a material adverse effect on the financial position, results of operations or cash flows of the Company. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | Note 6. Leases The Company has operating leases for corporate offices, operations and research and development facilities. These leases have remaining lease terms of 1 to 3 years. The lease of operations and research and development facilities includes costs for utilities and common area maintenance which are not included in the calculation of lease payments. Leases with an initial term of 12 months or less are not recorded on the balance sheets, and the Company recognizes lease expense for these leases on a straight-line basis over the lease terms. Operating leases with terms greater than 12 months are included in operating lease ROU assets and operating lease liabilities in the Company’s balance sheets as of June 30, 2021 and December 31, 2020. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Maturities of lease liabilities as of June 30, 2021, are as follows: Operating Leases Year ending December 31: 2021 (July 2021 onwards) $ 229 2022 259 2023 193 2024 33 2025 — Total 714 Less: imputed interest (86 ) Present value of lease liabilities 628 Less: current portion (374 ) Lease liabilities, net of current portion $ 254 The Company made payments of $0.2 million and $0.2 million during the six months ended June 30, 2021 and June 30, 2020, respectively, which are included as cash flow from operating activities on the statements of cash flows. Additional information related to the Company’s leases was as follows for the three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease cost $ 109 $ 109 $ 218 $ 218 Short-term lease cost $ 312 $ 95 $ 627 $ 190 As of June 30, 2021 and December 31, 2020, the weighted-average remaining lease term for operating leases was 2.0 years and 2.4 years, respectively. As of June 30, 2021 and December 31, 2020, the weighted-average discount rate for operating leases was 13.1%. |
Convertible Notes Payable
Convertible Notes Payable | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes Payable | Note 7. Convertible Notes Payable 2020A Notes The Company entered into convertible promissory notes (the “2020A Notes”) in June and July 2020, with several lenders, including current investors. The lenders provided in aggregate $11.1 million in cash consideration to the Company. The 2020A Notes accrued simple interest at 4% per annum that was due and payable upon the request of the holders of a majority of the then outstanding principal amount of the 2020A Notes on or after June 12, 2021. Pursuant to the 2020A Notes, the outstanding principal balance and unpaid accrued interest was automatically convertible into equity shares in the next equity financing round of at least $10 million (“2020A Qualified Financing”) at a price per share equal to the lower of (i) 80% of the price paid per share for equity securities by the investors in the 2020A Qualified Financing or (ii) the quotient resulting from dividing $95 million by the number of shares of outstanding common shares on a diluted basis immediately prior to the closing of the 2020A Qualified Financing. If the next financing was not a 2020A Qualified Financing (“2020A Non-Qualified Financing”), the holders of a majority of the outstanding principal of the 2020A Notes also had the option to convert the outstanding principal balance and unpaid accrued interest into equity shares issued in the 2020A Non-Qualified Financing on the same terms set forth for a 2020A Qualified Financing. In addition, if the Company consummated a change of control, it would be required to convert the outstanding principal balance of the 2020A Notes and any unpaid accrued interest into shares of a newly created series of preferred stock having the identical rights, privileges, preferences and restrictions as the Series B. Additionally, in the event that the 2020A Notes had not converted into equity securities by June 12, 2021, the outstanding principal and unpaid accrued interest of each of the 2020A Notes would have automatically converted into shares of Series B at a conversion price equal to the original issuance price. In August 2020, the Company issued Series C for proceeds of approximately $58.7 million (see Note 8), which met the definition of a 2020A Qualified Financing. Additionally, the 2020A Notes and accrued and unpaid interest of $11.2 million were extinguished and converted into 2,593,110 shares of Series C at $4.3124 per share, which is 80% of the Series C issuance price of $5.3905. The Series C had a fair value of $5.3905 per share on the date of conversion. The Company extinguished the 2020A Notes at fair value along with the accrued interest of $44. 2020B Notes The Company issued and sold convertible promissory notes (the “2020B Notes” and together with the “2020A Notes”, the “2020 Notes”) in December 2020, with several lenders, including current investors. The lenders provided an aggregate amount of $20.0 million in cash consideration to the Company. The 2020B Notes accrue simple interest at 0.15% per annum and this interest is due and payable upon the request of the holders of a majority of the then outstanding principal amount of the 2020B Notes on or after December 11, 2022. The outstanding principal and unpaid accrued interest of each Note is convertible upon occurrence of one of the following events: Maturity or Change in Control. In the event of an equity financing including an IPO with proceeds of not less than $10.0 million (“2020B Qualified Financing”), 2020B notes automatically convert into equity securities sold in the 2020B Qualified Financing at 80% of the price paid for securities sold in the 2020B Qualified Financing. In the event of an equity financing or IPO of less than $10.0 million, the majority holders of the 2020B Notes have the option to treat the offering as a 2020B Qualified Financing at 80% of the price paid for securities sold in the round (“2020B Non-Qualified Financing”). In the case of maturity, all unpaid interest and principal shall be due and payable on the maturity date. If the notes remain outstanding on the maturity date, then the outstanding principal balance and any unpaid accrued interest is automatically converted in Series C Preferred stock based on the Series C original issue price of $ 5.3905 . In addition, if the Company consummates a change of control as defined in Note 8, the holders of the 2020B Notes will receive shares of the Company’s common stock at 70 % of the price paid for shares of common stock. The 2020 Notes are considered freestanding instruments that qualify as liabilities under ASC Topic 480, Distinguishing Liabilities from Equity as the Company is committed to issue an instrument that ultimately may require a transfer of assets. The 2020 Notes were accounted for at fair value and re-measured at each reporting date. Accordingly, the Company classified the 2020 Notes as a liability at their fair value and adjusts the instruments to fair value at each balance sheet date until the 2020 Notes are converted. The Company recorded a change in the fair value of the 2020A Notes of $2.8 million recognized as remeasurement of derivative liabilities and convertible notes in other income (expense), net in the statements of operations prior to their extinguishment in August 2020. The Company recorded a change in the fair value of the 2020B Notes of $4.7 million recognized as remeasurement of derivative liabilities and convertible notes in other income (expense), net in the statements of operations during the year ended December 31, 2020. The Company recorded a change in the fair value of the 2020B Notes of $0.3 million recognized as remeasurement of derivative liabilities and convertible notes in other income (expense), net in the statement of operations during the first quarter of 2021. Conversion of Convertible Notes Payable On February 9, 2021 upon the closing of the IPO, the 2020B Notes and accrued interest automatically converted into shares of common stock at a conversion price equal to 80% of the IPO price per share, which resulted in the issuance of 1,470,947 shares of common stock. |
Capital Stock
Capital Stock | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Capital Stock | Note 8. Capital Stock Redeemable Convertible Preferred Stock Under the Company’s amended and restatement certificate of incorporation, the Company is authorized to issue 14,382,437 shares of preferred stock designated as Series A, of which 3,274,913 were issued in October 2015. On March 6, 2019, the Company amended and restated its certificate of incorporation to, among other things, increase its authorized shares of redeemable convertible preferred stock from 14,382,437 to 27,858,121 shares, of which 13,742,223 shares are designated as Series B and set forth the rights, preferences and privileges of the Series B. On July 24, 2019 the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock from 27,858,121 to 28,931,242, including increasing the shares designated as Series B to 14,815,344. On November 4, 2019, the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock from 28,931,242 to 29,208,635, including increasing the shares designated as Series B to 15,092,737. In March 2019, the Company entered into an agreement with new and existing preferred stockholders, to issue 1,608,300 shares of Series B for $7.5 million in gross proceeds. In addition, as discussed in Note 7, the Company converted all outstanding 2018 Notes and related accrued interest in the amount of $4.1 million into 1,097,048 shares of Series B. From June to August 2019, the Company entered into agreements with new and existing preferred stockholders, to issue an additional 731,824 shares of Series B for $3.4 million in gross proceeds. The Company incurred approximately $83 of issuance costs related to Series B during the year ended December 31, 2019, which has been netted against the gross proceeds. On January 9, 2020, the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock to 45,389,864 including increasing the shares designated as Series B to 31,273,966. On August 6, 2020, the Company amended and restated its certificate of incorporation to increase its authorized shares of redeemable convertible preferred stock to 103,355,827, of which 30,996,574 shares are designated as Series B and 58,243,355 of shares are designated as Series C and set forth the rights, preferences and privileges of Series C. In August 2020, the Company entered into an agreement with new and existing preferred stockholders, to issue 13,512,578 shares of Series C for $69.8 million in proceeds from the sale of Series C and the conversion of convertible notes and related accrued interest in the amount into 2,593,110 shares of Series C. On February 9, 2021 in connection with the closing of the IPO, all shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. On February 9, 2021, the Company amended and restated its certificate of incorporation to authorize two classes of stock, respectively, common stock and preferred stock. The total number of shares which the Company is authorized to issue is 210,000,000 shares. 200,000,000 shares of which shall be Common Stock, having a par value per share of $ 0.001 . 10,000,000 shares of which shall be Preferred Stock, having a par value per share of $ 0.001 . The Company has not issued any preferred stock since the closing of the IPO. As of December 31, 2020, the Company’s redeemable convertible preferred stock consisted of the following: Shares Shares Issued and Net Carrying Liquidation Authorized Outstanding Value Value Series A 14,115,898 3,274,913 $ 15,020 $ 16,763 Series B 30,996,574 7,191,256 33,406 33,523 Series C 58,243,355 13,512,578 72,654 72,840 Total 103,355,827 23,978,747 $ 121,080 $ 123,126 Dividends The Company may not declare, pay or set aside any dividends on shares of the Company unless the holders of the outstanding Series C first receive a dividend on each outstanding share of Series C in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series C. After payment or setting aside dividends to Series C, Series B are entitled to receive, prior and in preference to holders of common stock, a dividend on each outstanding share of Series B in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series B. After payment or setting aside dividends to Series B, Series A are entitled to receive, prior and in preference to holders of common stock, a dividend on each outstanding share of Series A in an amount equal to the dividend payable per share if all participating shares had been converted into common stock multiplied by the number of shares of common stock issuable upon the conversion of Series A. As of June 30, 2021, the Board had not declared any dividends. Liquidation Preference and Redemption In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or a deemed liquidation event, the holders of shares of Series C then outstanding are entitled to be paid before any payment is made to the holders of the Series B, Series A or common stock, the Series C liquidation preference, which is equal to the greater of (i) one times the Series C original issue price, plus any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series C been converted into common stock. Upon satisfaction of Series C liquidation preference, the Series B liquidation preference, which is equal to the greater of (i) the per share liquidation preference plus all declared but unpaid dividends or (ii) the amount per share as would be payable had all shares of Series B been converted into common stock, is paid prior to any other preferences. Upon the satisfaction of the Series B liquidation preference, the Series A liquidation preference, which is equal to the greater of (i) the per share liquidation preference plus all declared but unpaid dividends or (ii) the amount per share as would be payable had all shares of Series A been converted into common stock, is paid prior to any additional preferences. Following the satisfaction of the liquidation preferences, all holders of shares of common stock participate in any remaining distribution on a pro rata basis based on the number of shares of common stock then held. As of December 31, 2020, the liquidation preference per share for Series A, Series B, and Series C was $5.1185, $4.6616 and $5.3905 respectively. Each of the following events is considered a “Deemed Liquidation Event” unless the holders of at least a majority of the outstanding shares of redeemable convertible preferred stock on an as-converted basis elect otherwise by written notice sent to the Company at least five (5) days prior to the effective date of any such event: (a) a merger or consolidation in which (i) the Company is a constituent party or (ii) a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation, except any such merger or consolidation involving the Company or a subsidiary in which the shares of capital stock of the Company outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediately following such merger or consolidation, at least a majority, by voting power, of the capital stock of (1) the surviving or resulting corporation; or (2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation of such surviving or resulting corporation; (b) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by the Company or any subsidiary of the Company of all or substantially all the assets of the Company and its subsidiaries taken as a whole, or the sale or disposition (whether by merger, consolidation or otherwise) of one or more subsidiaries of the Company if substantially all of the assets of the Company and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusive license or other disposition is to a wholly owned subsidiary of the Company; or (c) a share purchase, share exchange or tender offer in which at least a majority, by voting power, of the shares of capital stock of the Company are transferred to another person. Conversion Each share of redeemable convertible preferred stock is automatically convertible into common stock at its then-effective conversion price (discussed below) (i) upon the vote or written consent of the holders of at least a majority of the then outstanding shares of redeemable convertible preferred stock on an as-converted basis, or (ii) upon the completion of a firm underwritten public offering of the Company’s common stock with gross proceeds of at least $50.0 million. In addition, each share of the Company’s redeemable convertible preferred stock are convertible, at the option of the holder, into shares of common stock by dividing the initial conversion prices by the conversion price in effect at the time of conversion. The following table summarizes the number of shares of common stock into which each share of redeemable convertible preferred stock can be converted as of December 31, 2020: Initial Conversion Conversion Conversion Price as of Ratio to Price December 31, 2020 Common Stock Series A $ 5.1185 $ 5.1185 1 Series B $ 4.6616 $ 4.6616 1 Series C $ 5.3905 $ 5.3905 1 The conversion price of Series A, Series B, and Series C is subject to adjustment for recapitalization (i.e. stock dividends, stock splits, reorganization, reclassification, combination of shares), or upon the issuance of shares at a price less than the then current conversion price. Voting The holder of each share of redeemable convertible preferred stock is entitled to one vote for each share of common stock into which it would convert. The holders of Series A, exclusively and as a separate class, are entitled to elect one director. In addition, the holders of record of the shares of Series B, exclusively and as a separate class, are entitled to elect two directors. The holders of Series C, exclusively and as a separate class on an as-converted basis, are entitled to elect one director. Redemption The convertible preferred stock is not redeemable at the option of the holders. Common Stock As of December 31, 2018, the Company was authorized to issue 28,716,724 shares of $0.001 par value common stock. In March 2019, the Company’s certificate of incorporation was amended and restated to increase the number of authorized shares of common stock from 28,716,724 to 50,000,000. In July 2019, the number of authorized shares of common stock was increased to 51,000,000. In November 2019, the number of authorized shares of common stock was increased to 52,000,000. In January 2020, the number of authorized shares of common stock was increased to 75,000,000. Similarly, in August 2020, the certificate of incorporation was amended to increase the number of shares authorized for issuance to 150,000,000 shares of common stock. On February 9, 2021, the Company closed its IPO of 10,350,000 shares of its common stock, including 1,350,000 shares of common stock issued pursuant to the full exercise of the underwriters’ option to purchase additional shares in the IPO, at a price to the public of $17.00 per share. The net proceeds to the Company from the IPO were $159.9 million, after deducting underwriting discounts and commissions of $ 12.3 million and offering expenses of $ 3.7 million. In addition, the Company’s outstanding 2020B convertible notes converted into 1,470,947 shares of common stock. Common stockholders are entitled to dividends as and when declared by the Board, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. The holder of each share of common stock is entitled to one vote. The Company had common shares reserved for future issuance upon the exercise or conversion of the following: June 30, 2021 December 31, 2020 Redeemable convertible preferred stock — 23,978,747 Common stock option grants issued and outstanding under 2014 Plan 4,409,153 4,587,700 Common shares issuable on conversion of convertible notes payable — 1,470,947 Common stock reserved for issuance under 2021 Plan (which superseded the 2014 Plan) 3,505,556 206,012 Common stock option grants issued and outstanding under 2021 Plan 596,509 — Restricted common stock units issued and outstanding 1,097,935 — Common stock reserved for issuance under ESPP 750,000 — Total common shares reserved for future issuance 10,359,153 30,243,406 |
Equity Incentive Plan
Equity Incentive Plan | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity Incentive Plan | Note 9. Equity Incentive Plan In 2014, the Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”) to permit the grant of share-based awards, such as stock grants and incentives and non-qualified stock options to employees, directors, consultants and advisors. The Board has the authority to determine to whom awards will be granted, the number of shares, the term and the exercise price. Awards granted under the 2014 Plan have a term of 10 years and generally vest over a four-year In January 2021, the Board adopted the 2021 Plan. The stockholders approved the 2021 Plan in January 2021, and it became effective upon the execution of the underwriting agreement for the IPO on February 4, 2021. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. A total of 5,200,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Plan. In addition, the number of shares of common stock available for issuance under the 2021 Plan will be automatically increased on the first day of each calendar year during the ten-year term of the 2021 Plan, beginning with January 1, 2022 and ending with January 1, 2031, by an amount equal to 5% of the outstanding number of shares of common stock on December 31st of the preceding calendar year or such lesser amount as determined by the Board. No further grants will be made under the 2014 Equity Incentive Plan. Restricted Stock Units Restricted stock units (“RSUs”) are generally subject to a 4 year vesting period, with 25% of the shares vesting approximately one year from the vesting commencement date and quarterly thereafter over the remaining vesting term. The Company had the following activity for RSUs for the three and six months ended June 30, 2021: Underlying Shares Weighted- Average Grant Date Fair Value Aggregate Fair Value Balance as of December 31, 2020 — — — Granted 264,345 $ 12.79 $ 3,380,272 Vested — — — Canceled or forfeited — — — Balance as of March 31, 2021 264,345 $ 12.79 $ 3,380,272 Granted 833,590 $ 4.85 $ 4,042,912 Vested — — — Canceled or forfeited — — — Balance as of June 30, 2021 1,097,935 $ 6.76 $ 7,423,184 Stock Options A summary of stock option activity for the three and six months ended June 30, 2021 is as follows: Weighted- Average Weighted- Remaining Average Contractual Aggregate Number of Options Exercise Price Term (years) Intrinsic Value Balance as of December 31, 2020 4,587,700 $ 1.51 9.2 $ 3,152 Granted 634,093 17.00 — — Exercised (37,760 ) 0.82 — 596 Cancelled (32,480 ) 17.00 — Balance as of March 31, 2021 5,151,553 $ 3.32 9.1 $ 48,122 Granted — — — — Exercised (134,398 ) 0.95 — 753 Cancelled (11,493 ) 8.19 — — Balance as of June 30, 2021 5,005,662 $ 3.42 8.8 $ 22,512 Options vested and expected to vest as of June 30, 2021 5,005,662 $ 3.42 8.8 $ 22,512 Options vested and exercisable as of June 30, 2021 1,198,274 $ 1.52 8.2 $ 6,421 The aggregate intrinsic value of options exercised was $0.8 million and $1.3 million for the three and six months ended June 30, 2021. The aggregate intrinsic value of options exercised was $0 for the three and six months ended June 30, 2020. The fair value of each option grant was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for three and six months ended: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Estimated fair value of common stock $ - $ 0.73 $ 17.00 $ 0.73 Expected term (in years) — 6.05 5.94 6.05 Risk-free interest rate 0.0 % 0.4 % 0.6 % 0.4 % Dividend yield — — — — Volatility 0.0 % 43.3 % 46.9 % 43.3 % Common stock fair value —Prior to the IPO the fair value of the Company’s common stock is determined by the Board with assistance from management. The Board determines the fair value of common stock by considering independent valuation reports and a number of objective and subjective factors, including valuations of comparable companies, sales of redeemable convertible preferred stock, operating and financial performance, the lack of liquidity of the Company’s common stock and the general and industry-specific economic outlook. Dividend yield of zero —The Company has not declared or paid dividends. Risk-free interest rates —The Company applies the risk-free interest rate based on the US Treasury yield for the expected term of the option. Expected term —The Company calculated the expected term as the average of the contractual term of the option and the vesting period for its employee stock options. Expected volatility —Since the Company does not have sufficient stock price history to estimate the expected volatility of its shares, the expected volatility is calculated based on the average volatility for a peer group in the industry in which the Company does business. The weighted-average grant date fair value of the options granted as calculated using the Black-Scholes option-pricing model was $7.52 and $0.30 per share for the six months ended June 30, 2021 and June 30, 2020, respectively. The Company did not grant options during the three month period ended June 30, 2021 Total compensation cost for share-based payment arrangements recognized were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cost of products sold $ 208 $ - $ 260 $ - Research and development 291 31 421 67 Selling, general and administrative 446 28 792 50 $ 945 $ 59 $ 1,473 $ 117 Total compensation costs as of June 30, 2021 related to non-vested awards to be recognized in future periods was $6.1 million and is expected to be recognized over the weighted-average period of 1.4 years. Employee Stock Purchase Plan The ESPP provides eligible employees with an opportunity to purchase common stock from the Company at a discount through accumulated payroll deductions. The ESPP will be implemented through a series of offerings of purchase rights to eligible employees. Under the ESPP, the Company's Board of Directors may specify offerings but generally provides for a duration of 6 months. The first purchase period began in February 2021 and will close in August 2021. The purchase price will be specified pursuant to the offering, but cannot, under the terms of the ESPP, be less than 85% of the lower of the fair market value per share of the Company's common stock on either the offering date or on the purchase date . The ESPP also includes a six month look-back provision for the purchase price of the stock price on the purchase date is less than the stock price on the offering date. In February 2021, the Company’s employees enrolled in the offering period to purchase a variable number of shares of its common stock under the ESPP at the purchase date. The shares were measured at grant date using with a weighted-average fair value of $5.34 per share. During the three and six months ended June 30, 2021, the Company recorded $0.1 million of stock-based compensation related to its ESPP. There was less than $0.1 million of unrecognized stock-based compensation expense for the three and six month ended June 30, 2021, related to the ESPP that is expected to be recognized over an average vesting period of 0.14 years. The fair value of shares to be issued under the Company’s ESPP was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for three months ended: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Estimated fair value of common stock $ - $ - $ 17.00 $ - Expected term (in years) — — 0.5 — Risk-free interest rate 0.0 % 0.0 % 0.1 % 0.0 % Dividend yield — — — — Volatility 0.0 % 0.0 % 56.4 % 0.0 % |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 10. Income Taxes The Company did not record a provision or benefit for income taxes during the three and six months ended June 30, 2021 and 2020. The Company continues to maintain a full valuation allowance against its net deferred tax assets. |
Retirement Plan
Retirement Plan | 6 Months Ended |
Jun. 30, 2021 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan | Note 11. Retirement Plan In December 2017, the Company adopted the Lucira Health, Inc. 401(k) Plan which allows eligible employees after one month of service to contribute pre-tax and Roth contributions to the plan, as allowed by law. The Company currently does not match employee contributions. |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 12. Related Parties The Company issued Convertible Notes to related parties for a total of $11.5 million during the year ended December 31, 2020, and carried the same terms as those disclosed in Note 7. The Convertible Notes interest expense was not significant during the year ended December 31, 2020. The Company held $8.7 million in 2020B Notes to related parties as of December 31, 2020. The Company incurred less than $0.1 million in consulting expenses with individuals related to an executive officer of the Company during the six months ended June 30, 2021 and June 30, 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information and pursuant to the instructions of the SEC on Form 10-Q and Article 10 of Regulation S-X of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the management’s opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the results of operations and cash flows for the periods presented have been included. The accompanying balance sheet as of June 30, 2021, the statements of operations for the three and six months ended June 30, 2021 and June 30, 2020, the statements of redeemable convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and June 30, 2020, and the statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2021 and the results of its operations and cash flows for the six months ended June 30, 2021 and June 30, 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and June 30, 2020 are unaudited. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. These financial statements and accompanying notes should be read in conjunction with the financial statements and notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 31, 2021. |
Use of Estimates | Use of Estimates Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to recognition of grant income, the fair value of the Company’s common stock and redeemable convertible preferred stock, the fair value of derivative liabilities and convertible notes payable, stock-based compensation, incremental borrowing rate, estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. |
Concentration of Credit Risk and Significant Suppliers | Concentration of Credit Risk and Significant Suppliers Financial instruments that potentially subject the Company to credit risk consist principally of cash held by financial institutions, grant income receivables and account receivables. Substantially all of the Company’s cash is held at one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company’s grant income receivable balance at each respective balance sheet dates results from grant agreements with the U.S. government. As of June 30, 2021, accounts receivable balance was $3.4 million. Two customers accounted for 12% and 10% of accounts receivable balance. As of December 31, 2020, accounts receivable balance was $0.3 million and was comprised by the Company’s only customer. The Company evaluates the collectability of its accounts receivable based on historical collection trends and provides for an allowance for doubtful accounts. Allowance for doubtful accounts was $0.4 million and $0 million as of June 30, 2021 and December 31, 2020, respectively. Two customers accounted for 14% and 10% of the Company’s revenue during the three and six months ended June 30, 2021. The Company is dependent on key suppliers, who are single source, for certain laboratory materials and inventory items. An interruption in the supply of these materials could temporarily impact the Company’s ability to manufacture its commercial inventory and perform development, testing and clinical trials related to its products. |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company’s cash, accounts receivable, grant income receivable, prepaid expenses, other current assets and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s derivative liabilities and convertible notes are measured at fair value on a recurring basis and are classified as Level 3 liabilities until conversion of the notes. The Company records subsequent adjustments to reflect the increase or decrease in estimated fair value at each reporting date on the statement of operations. |
Cash, and Restricted Cash Equivalents | Cash, and Restricted Cash Equivalents The Company considers highly liquid investments purchased with a remaining maturity date upon acquisition of three months or less to be cash equivalents and are stated at cost, which approximates fair value. As of June 30, 2021 and June 30, 2020, there were no cash equivalents. As of June 30, 2021, the Company held a restricted cash balance of $2.3 million which was used to secure a letter of credit in relation to the Company’s contract manufacturer to secure certain purchases made on the Company’s behalf. The cash was deposited in a money market account with maturities of three months or less and thus considered a restricted cash equivalent. |
Inventories Produced in Preparation for Product Launches | Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company determines are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive clinical test results for the underlying product, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the submission of the regulatory application. The Company closely monitors the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. Prior to obtaining the EUA authorization for its COVID-19 test kit on November 17, 2020, the Company charged $2.3 million of preapproval inventory to research and development expense. After receipt of the EUA in November 2020, the Company accounted for all production item purchases as inventory in accordance with its inventories policy below. Preapproval inventories previously recorded as research and development expense that are subsequently sold will have a zero cost of product. Subsequent to receipt of the EUA in November 2020, the Company utilized a portion of the preapproval inventory resulting in a remaining unused amount of $1.3 million as of December 31, 2020. During the three months ended June 30, 2021, the Company utilized less than $0.1 million of the preapproval inventory write-offs for cost of sales. During the six months ended June 30, 2021, the Company utilized all of the preapproval inventory write-offs for cost of sales of $1.0 million and for selling, general and administrative and research and development activities of $0.3 million. |
Inventories | Inventories The Company values its inventory at the lower of cost or net realizable value and determines the cost of inventory using standard costs which closely resembles the first-in, first-out method. Lower of cost or net realizable value is evaluated by considering obsolescence, excessive levels of inventory, deterioration and other factors. In order to assess the ultimate realization of inventories, the Company is required to make judgments as to future demand requirements compared to current or committed inventory levels. The Company periodically reviews its inventories for shelf life, excess or obsolescence and writes-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. Amounts written-down due to unmarketable inventory are recorded in cost of revenue and a new lower-cost basis for the inventory is established. The Company did not record any write down adjustment during the six months ended June 30, 2021. |
Warranty | Warranty The Company offers a standard product warranty that our products will perform as intended upon the date of original delivery for a reasonable period of time, which is the shorter of date usage or product shelf life. The Company has the obligation, at its option, to either refund, repair or replace a defective product. At the time revenue is recognized, an estimate of future warranty costs is recorded as a component of cost of products sold. The estimate of future warranty costs is based on historical as well as current product failure rates, service delivery costs incurred in correcting product failures, and warranty policies. The Company will regularly review these estimates to assess the appropriateness of our recorded warranty liabilities and adjust the amounts as necessary. As of June 30, 2021 and December 31, 2020, the accrued liability for warranty returns was not significant. |
Grant Income Receivable | Grant Income Receivable Grant income receivable consists of billed and unbilled amounts earned from various government grants for costs incurred prior to the period end under reimbursement contracts. The amounts are billed to the respective government agencies. As collection is deemed probable, no allowance for doubtful accounts has been established. If amounts become uncollectible, they are recorded as operating expense in the Company’s statements of operations. Of the amounts presented on the balance sheets as grant income receivable, $0.1 million and $0.2 million were unbilled as of June 30, 2021 and December 31, |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and seven years. Leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining term of the related lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in other income or expense in the statements of operations in the period realized. |
Leases | Leases The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as operating or finance. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the balance sheets. The Company did not have any finance leases as of June 30, 2021 and December 31, ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and exclude lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases. |
Long-Lived Assets | Long-Lived Assets The Company’s long-lived assets are comprised principally of its property and equipment, including leasehold improvements and ROU assets. If the Company identifies a change in the circumstances related to its long-lived assets that indicates the carrying value of any such asset may not be recoverable, the Company will perform an impairment analysis. A long-lived asset is deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. No impairment of long-lived assets was recorded during the six months ended June 30, 2021 and June 30, 2020. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records accrued expenses for estimated costs of its research and development activities conducted by third-party service providers, which include clinical trial activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services or supplies provided but not yet invoiced and include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. The Company records accrued expenses for these costs based on factors such as estimates of the work completed or supplies received and in accordance with agreements established with these vendors. Any payments made in advance of services or supplies provided are recorded as prepaid assets, which are expensed as the services or supplies are received. The Company estimates the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. The Company makes significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, the Company adjusts its accrued estimates. |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock The Company’s shares of preferred stock are assessed at issuance for classification and redemption features requiring bifurcation. The Company’s preferred stock is not mandatorily redeemable. The Company presents as temporary equity any stock which (i) the Company undertakes to redeem at a fixed or determinable price on the fixed or determinable date or dates; (ii) is redeemable at the option of the holders, or (iii) has conditions for redemption which are not solely within the control of the Company. The Company’s preferred stock is redeemable if the Company has not been dissolved within 90 days following the occurrence of certain deemed liquidation events, which the Company determined is not solely within its control and thus has classified shares of redeemable convertible preferred stock as temporary equity until such time as the conditions are removed or lapse. The Company initially records redeemable convertible preferred stock at fair value, net of issuance costs. Because the occurrence of a deemed liquidation event is not currently probable, the carrying values of the shares of redeemable convertible preferred stock are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the shares of redeemable convertible preferred stock would be made only when a deemed liquidation event becomes probable. In connection with the IPO on February 9, 2021, all outstanding shares of redeemable convertible preferred stock converted into 23,978,747 shares of common stock. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalized certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings, including the IPO, as deferred offering costs until such financings are consummated. After consummation of the financing, these costs are recorded as a reduction of the proceeds received from the equity financing. If a planned equity financing is abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the condensed statements of operations. There was $0.0 and $2.2 million of deferred offering costs related to the Company’s IPO recorded as other assets on the Company’s balance sheet as of June 30, 2021 and December 31, 2020, respectively. The Company recorded additional offering costs between December 31, 2020 and February 9, 2021 and recorded $3.7 million as an offset to the IPO proceeds as additional paid in capital on the closing date. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”), “Revenue from Contracts with Customers” when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Under ASC 606, assuming all other revenue recognition criteria have been met, the Company will recognize revenue for arrangements upon the transfer of control of the Company’s products to its customers, which is currently upon the shipment of the product to the customer under the Company’s standard terms and conditions. There are no further performance obligations by the Company to the customer after shipment of the product. Control of the Company’s products is transferred at a point in time. Revenue is measured based on the amount of consideration that the Company expects to receive as reduced by estimated discounts and allowances. All of the Company’s revenue has been derived from sales of its test kits. During the first quarter 2021 the Company marketed its test products to physicians and licensed healthcare providers in the United States. On April 9, 2021, the Company received its first FDA EUA authorization for OTC non-prescription use and expanded its marketing to include domestic testing providers, distributors, businesses and international distributors. Collection of the Company’s net receivables generally occur within 30 days of billing. Contracts do not contain significant financing components based on the typical period of time between delivery of products and collection of consideration. Costs to obtain or fulfill a contract are currently expensed when incurred because our performance obligation is satisfied at a point in time. The Company invoices its customers upon shipment of product, and records its sales upon shipment in accordance with its standard terms and conditions, unless underlying customer contracts specify otherwise. When necessary, the Company invoices and collects sales tax from its customers for sales of products. The Company has elected to exclude sales tax from the measurement of the transaction price. The following table sets forth the Company’s revenue by geographic area based on the customers’ locations: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 10,277 $ — $ 14,793 $ — International 2,162 — 2,162 — Total revenue $ 12,439 $ — $ 16,955 $ — |
Grant Income | Grant Income The Company earns grant income for performing tasks under research and development agreements with governmental agencies. In July 2018, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), a division within the U.S. Department of Health and Human Services (“HHS”), for an award of up to $10 million to demonstrate the feasibility of a novel in-home, disposable, point-of-care rapid diagnostic assay for the detection of Influenza A and B for work performed through July 2020. In September 2019, the Company amended its agreement with BARDA to increase the award to $21.5 million and extend the reporting period through July 2022. The Company recognized grant income from BARDA of $0.0 for the three and six months ended June 30, 2021, compared to $0.4 million and $2.0 million for the three and six months ended June 30, 2020, respectively. The Company recognized grant income from other governmental agencies of $0.1 million and $0.3 million during the three and six months ended June 30, 2021, respectively, compared to less than $0.1 million and $0.1 million during the three and six months ended June 30,2020, respectively. Grant income derived from reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with government contracts and grants are recorded at the gross amount within grant income. The costs associated with these reimbursements are reflected as a component of research and development expense in the Company’s statements of operations. |
Research and Development | Research and Development Costs associated with research and development activities are expensed as incurred and include, but are not limited to, personnel-related expenses including stock-based compensation expense, materials, laboratory supplies, consulting costs, costs associated with setting up and conducting clinical studies and allocated overhead including rent and utilities. |
Advertising and Marketing Costs | Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were $0.9 million and $1.3 million for the three and six months ended June 30, 2021, respectively compared to $0 million in 2020, and are included in selling, general and administrative expenses in the accompanying statements of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based awards consist of stock options, restricted stock awards, and employee stock purchase plan issued to grantees. The Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur. In January 2021, the Company’s Board adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The stockholders approved the 2021 Plan in January 2021, and it became effective upon the execution of the underwriting agreement for the IPO on February 4, 2021. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock or cash-based awards to individuals who are then employees, officers, directors or consultants of the Company. No further grants will be made under the 2014 Equity Incentive Plan. In February 2021, the Board adopted the 2021 Employee Stock Purchase Plan (the "ESPP"). The Company recognizes stock-based compensation expense related to shares issued pursuant to its ESPP on a straight-line basis over the offering period, which is generally six months. The ESPP allows employees to purchase shares of the Company's common stock at a 15 percent discount. The ESPP also includes a six-month look-back provision for the purchase price if the stock price on the purchase date is less than the stock price on the offering. The Company classifies stock-based compensation expense in its statements of operations in the same manner in which the award recipient’s cash compensation costs are classified. The fair value of each restricted stock award is determined based on the number of shares granted and the value of the Company’s common stock on the date of grant. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of complex assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option. Prior to the Company’s initial public offering, the Company was a private company and lacked company-specific historical and implied fair value information. Therefore, the Board considered numerous objective and subjective factors to determine the fair value of the Company’s common stock options at each meeting in which awards were approved. The factors considered include, but are not limited to (i) the results of contemporaneous independent third-party valuations of the Company’s common stock and the prices, rights, preferences and privileges of the Company’s redeemable convertible preferred stock relative to those of its common stock; (ii) the lack of marketability of the Company’s common stock; (iii) actual operating and financial results;(iv) current business conditions and projections; (v) the likelihood of achieving a liquidity event, such as an IPO or sale of the Company, given prevailing market conditions, and (vi) precedent transactions involving the Company’s shares. The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company has not paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to be zero. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would adjust the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents of potentially diluted securities outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of redeemable convertible preferred stock, and options outstanding under the Company’s stock option plan. For the six months ended June 30, 2021 and June 30, 2020, there was no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive securities would be anti-dilutive. The following table summarizes the Company’s net loss per share: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator Net loss attributable to common stockholders basic and diluted $ (16,200 ) $ (6,624 ) $ (29,516 ) $ (8,351 ) Denominator Weighted-average number of common shares outstanding, basic and diluted 38,483,766 2,282,024 30,688,349 2,270,130 Net loss per share attributable to common stockholders, basic and diluted $ (0.42 ) $ (2.90 ) $ (0.96 ) $ (3.68 ) Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): As of June 30, 2021 2020 Redeemable convertible preferred stock - 10,466,169 Options to purchase common stock 5,107,453 2,475,455 Unvested restricted stock 1,097,935 — |
Segment Reporting | Segment Reporting The Company has determined that the Chief Executive Officer is its Chief Operating Decision Maker. The Company’s Chief Executive Officer reviews financial information presented on an aggregate basis for the purposes of assessing the performance and making decisions on how to allocate resources. Accordingly, the Company has determined that it operates in a single |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements, or Accounting Standard Updates (“ASU”) are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. The Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with those standards. This means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company has the option to adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company has elected to use the extended transition period for complying with new or revised accounting standards unless the Company otherwise early adopts select standards. Recently Adopted Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13 , Measurement of Credit Losses on Financial Instruments (Topic 326): Measurement of Credit Losses on Financial Instruments In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Revenue by Geographic Area Based on Customers' Locations | The following table sets forth the Company’s revenue by geographic area based on the customers’ locations: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 10,277 $ — $ 14,793 $ — International 2,162 — 2,162 — Total revenue $ 12,439 $ — $ 16,955 $ — |
Summary of Net Loss per Share | The following table summarizes the Company’s net loss per share: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator Net loss attributable to common stockholders basic and diluted $ (16,200 ) $ (6,624 ) $ (29,516 ) $ (8,351 ) Denominator Weighted-average number of common shares outstanding, basic and diluted 38,483,766 2,282,024 30,688,349 2,270,130 Net loss per share attributable to common stockholders, basic and diluted $ (0.42 ) $ (2.90 ) $ (0.96 ) $ (3.68 ) |
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares): As of June 30, 2021 2020 Redeemable convertible preferred stock - 10,466,169 Options to purchase common stock 5,107,453 2,475,455 Unvested restricted stock 1,097,935 — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | . The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. Fair Value Measurements as of June 30, 2021 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — Total 2,338 — — Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Assets Restricted cash equivalents $ 2,338 $ — $ — 2,338 — — Liabilities Convertible notes payable $ 24,694 Total — — 24,694 |
Schedule of Change in Fair Value of Derivative Liabilities and Convertible Notes | The change in the fair value of the derivative liabilities and convertible notes accounted for at fair value is summarized below. June 30, 2021 June 30, 2020 Fair value at beginning of the period $ 24,694 $ — Initial fair value of instruments issued — 5,627 Change in fair value of instruments and accrued interest, net 288 1,444 Extinguishment of instruments held at fair value (24,982 ) — Fair value at end of the period $ - $ 7,071 |
Other Financial Information (Ta
Other Financial Information (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Other Financial Information [Abstract] | |
Schedule of Inventory | Inventory consist of the following: June 30, 2021 December 31, 2020 Raw materials $ 35,085 $ 4,865 Finished goods 1,097 — Total $ 36,182 $ 4,865 |
Schedule of Property and Equipment, Net | June 30, December 31, 2021 2020 Construction in progress $ 12,674 $ 15,308 Machinery and equipment 15,936 4,679 Website development costs 995 — Furniture and fixtures 88 88 Leasehold improvements 507 501 Total, at cost 30,200 20,576 Accumulated depreciation and amortization (2,047 ) (1,168 ) Property and equipment, net $ 28,153 $ 19,408 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following: June 30, 2021 December 31, 2020 Professional fees $ 1,367 $ 1,577 Accrued manufacturing and inventory purchases 14,107 1,165 Taxes 359 204 Payroll liabilities 1,866 604 Eiken liabilities 387 — Early exercise liability 224 263 Accrued deferred offering costs — 487 Other 362 145 Total $ 18,672 $ 4,445 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities as of June 30, 2021, are as follows: Operating Leases Year ending December 31: 2021 (July 2021 onwards) $ 229 2022 259 2023 193 2024 33 2025 — Total 714 Less: imputed interest (86 ) Present value of lease liabilities 628 Less: current portion (374 ) Lease liabilities, net of current portion $ 254 |
Summary of Additional Information Related to Leases | Additional information related to the Company’s leases was as follows for the three and six months ended June 30: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease cost $ 109 $ 109 $ 218 $ 218 Short-term lease cost $ 312 $ 95 $ 627 $ 190 |
Capital Stock (Tables)
Capital Stock (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Summary of Redeemable Convertible Preferred Stock | As of December 31, 2020, the Company’s redeemable convertible preferred stock consisted of the following: Shares Shares Issued and Net Carrying Liquidation Authorized Outstanding Value Value Series A 14,115,898 3,274,913 $ 15,020 $ 16,763 Series B 30,996,574 7,191,256 33,406 33,523 Series C 58,243,355 13,512,578 72,654 72,840 Total 103,355,827 23,978,747 $ 121,080 $ 123,126 |
Summary of Number of Shares of Common Stock into Which Redeemable Convertible Preferred Stock Shares Converted | The following table summarizes the number of shares of common stock into which each share of redeemable convertible preferred stock can be converted as of December 31, 2020: Initial Conversion Conversion Conversion Price as of Ratio to Price December 31, 2020 Common Stock Series A $ 5.1185 $ 5.1185 1 Series B $ 4.6616 $ 4.6616 1 Series C $ 5.3905 $ 5.3905 1 |
Summary of Common Shares Reserved for Future Issuance | The Company had common shares reserved for future issuance upon the exercise or conversion of the following: June 30, 2021 December 31, 2020 Redeemable convertible preferred stock — 23,978,747 Common stock option grants issued and outstanding under 2014 Plan 4,409,153 4,587,700 Common shares issuable on conversion of convertible notes payable — 1,470,947 Common stock reserved for issuance under 2021 Plan (which superseded the 2014 Plan) 3,505,556 206,012 Common stock option grants issued and outstanding under 2021 Plan 596,509 — Restricted common stock units issued and outstanding 1,097,935 — Common stock reserved for issuance under ESPP 750,000 — Total common shares reserved for future issuance 10,359,153 30,243,406 |
Equity Incentive Plan - (Tables
Equity Incentive Plan - (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Restricted Stock Units Activity | The Company had the following activity for RSUs for the three and six months ended June 30, 2021: Underlying Shares Weighted- Average Grant Date Fair Value Aggregate Fair Value Balance as of December 31, 2020 — — — Granted 264,345 $ 12.79 $ 3,380,272 Vested — — — Canceled or forfeited — — — Balance as of March 31, 2021 264,345 $ 12.79 $ 3,380,272 Granted 833,590 $ 4.85 $ 4,042,912 Vested — — — Canceled or forfeited — — — Balance as of June 30, 2021 1,097,935 $ 6.76 $ 7,423,184 |
Summary of Stock Option Activity | A summary of stock option activity for the three and six months ended June 30, 2021 is as follows: Weighted- Average Weighted- Remaining Average Contractual Aggregate Number of Options Exercise Price Term (years) Intrinsic Value Balance as of December 31, 2020 4,587,700 $ 1.51 9.2 $ 3,152 Granted 634,093 17.00 — — Exercised (37,760 ) 0.82 — 596 Cancelled (32,480 ) 17.00 — Balance as of March 31, 2021 5,151,553 $ 3.32 9.1 $ 48,122 Granted — — — — Exercised (134,398 ) 0.95 — 753 Cancelled (11,493 ) 8.19 — — Balance as of June 30, 2021 5,005,662 $ 3.42 8.8 $ 22,512 Options vested and expected to vest as of June 30, 2021 5,005,662 $ 3.42 8.8 $ 22,512 Options vested and exercisable as of June 30, 2021 1,198,274 $ 1.52 8.2 $ 6,421 |
Summary of Assumptions Used to Estimate Fair Value of Stock Options | The fair value of each option grant was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for three and six months ended: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Estimated fair value of common stock $ - $ 0.73 $ 17.00 $ 0.73 Expected term (in years) — 6.05 5.94 6.05 Risk-free interest rate 0.0 % 0.4 % 0.6 % 0.4 % Dividend yield — — — — Volatility 0.0 % 43.3 % 46.9 % 43.3 % |
Summary of Compensation Cost for Share-Based Payment Arrangements Recognized | Total compensation cost for share-based payment arrangements recognized were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cost of products sold $ 208 $ - $ 260 $ - Research and development 291 31 421 67 Selling, general and administrative 446 28 792 50 $ 945 $ 59 $ 1,473 $ 117 |
Summary of Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plans | The fair value of shares to be issued under the Company’s ESPP was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions on a weighted-average basis for three months ended: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Estimated fair value of common stock $ - $ - $ 17.00 $ - Expected term (in years) — — 0.5 — Risk-free interest rate 0.0 % 0.0 % 0.1 % 0.0 % Dividend yield — — — — Volatility 0.0 % 0.0 % 56.4 % 0.0 % |
Organization - Additional Infor
Organization - Additional Information (Details) $ / shares in Units, $ in Thousands | Feb. 09, 2021USD ($)$ / sharesshares | Jan. 28, 2021 | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | [1] | Jun. 30, 2020USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Entity incorporation, date of incorporation | Feb. 20, 2013 | |||||
Reverse stock split, description | On January 28, 2021, the Company’s board of directors (the “Board”) approved a 1-for-4.3103 reverse stock split (the “Reverse Stock Split”) of the Company’s common stock and each series of its redeemable convertible preferred stock to be consummated prior to the effectiveness of the Company’s initial public offering (“IPO”) on February 4, 2021. | |||||
Stock split conversion ratio | 0.2320 | |||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 159,899 | |||||
Conversion of stock | shares | 23,978,747 | |||||
Cash | 161,662 | $ 58,212 | $ 19,808 | |||
Accumulated deficit | (93,230) | $ (63,714) | ||||
Revenue from sale of test kits | $ 17,000 | |||||
IPO | Common Stock | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares issued in transaction | shares | 10,350,000 | |||||
Shares issued price per share | $ / shares | $ 17 | |||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 159,900 | |||||
Underwriting discounts and commissions | 12,300 | |||||
Offering expenses | $ 3,700 | |||||
Conversion of stock | shares | 25,449,694 | |||||
Underwriters' Option to Purchase Additional Shares | Common Stock | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares issued in transaction | shares | 1,350,000 | |||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | Nov. 17, 2020USD ($) | Feb. 28, 2021 | Feb. 09, 2021USD ($)shares | Sep. 30, 2019USD ($) | Jul. 31, 2018USD ($) | Jun. 30, 2021USD ($)Customer | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)CustomerSegment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Significant Accounting Policies [Line Items] | |||||||||||
Accounts receivable | $ 3,392,000 | $ 3,392,000 | $ 293,000 | [1] | |||||||
Allowance for doubtful accounts | 0 | 0 | |||||||||
Cash equivalents | 0 | $ 0 | 0 | $ 0 | |||||||
Restricted cash balance | 2,300,000 | 2,300,000 | |||||||||
Research and development | 10,117,000 | 4,574,000 | 16,399,000 | 7,315,000 | |||||||
Cost of products sold | 12,505,000 | 17,873,000 | |||||||||
Inventory write-down adjustment | 0 | ||||||||||
Grant income receivable, unbilled | 100,000 | $ 100,000 | 200,000 | ||||||||
Operating lease existence of option to extend [true false] | true | ||||||||||
Operating lease option to extend | options to extend | ||||||||||
Impairment of long-lived assets | $ 0 | 0 | |||||||||
Redeemable convertible preferred stock redemption period after occurrence of certain liquidation events | 90 days | ||||||||||
Net revenues collection period | 30 days | ||||||||||
Grant income | 79,000 | 335,000 | $ 281,000 | 1,977,000 | |||||||
Grant income from other governmental agencies | $ 100,000 | $ 300,000 | 100,000 | ||||||||
Expected dividend yield | 0.00% | ||||||||||
Number of operating segments | Segment | 1 | ||||||||||
Number of reportable segments | Segment | 1 | ||||||||||
ASU 2019-12 | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | |||||||||
Change in accounting principle, accounting standards update, early adoption | true | true | |||||||||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | Jan. 1, 2021 | |||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||||||||
Biomedical Advanced Research And Development Authority | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Maximum amount of award to demonstrate feasibility | $ 10,000,000 | ||||||||||
Demonstrate feasibility period | 2020-07 | ||||||||||
Amount of increase in award to demonstrate feasibility | $ 21,500,000 | ||||||||||
Demonstrate feasibility period extended | 2022-07 | ||||||||||
Grant income | $ 0 | 400,000 | $ 0 | 2,000,000 | |||||||
IPO | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Additional offering costs | $ 3,700,000 | ||||||||||
IPO | Other Assets | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Deferred offering costs | 0 | $ 0 | 2,200,000 | ||||||||
2021 Employee Stock Purchase Plan | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Stock based compensation expense related to shares issued pursuant to plan offering period | 6 months | ||||||||||
Common stock discount on shares percentage | 15.00% | ||||||||||
Common Stock | Redeemable Convertible Preferred Stock | IPO | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Convertible preferred stock converted into common stock | shares | 23,978,747 | ||||||||||
Preapproval Inventory for COVID-19 Test Kit | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Research and development | $ 2,300,000 | ||||||||||
Cost of products sold | $ 0 | ||||||||||
Unused inventory | 1,300,000 | ||||||||||
Minimum | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Property and equipment estimated useful lives | 3 years | ||||||||||
Maximum | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Property and equipment estimated useful lives | 7 years | ||||||||||
Grant income from other governmental agencies | 100,000 | ||||||||||
Cost of Sales | Preapproval Inventory for COVID-19 Test Kit | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Inventory write-offs | $ 1,000,000 | ||||||||||
Cost of Sales | Maximum | Preapproval Inventory for COVID-19 Test Kit | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Inventory write-offs | 100,000 | ||||||||||
Selling General and Administrative and Research and Development Activities | Preapproval Inventory for COVID-19 Test Kit | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Inventory write-offs | 300,000 | ||||||||||
Selling, General and Administrative Expenses | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Advertising and marketing costs | 900,000 | $ 0 | 1,300,000 | $ 0 | |||||||
Credit Concentration Risk | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Allowance for doubtful accounts | $ 400,000 | $ 400,000 | $ 0 | ||||||||
Accounts Receivable | Credit Concentration Risk | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Number of customers | Customer | 2 | ||||||||||
Accounts Receivable | Credit Concentration Risk | Customer One | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Concentration risk percentage | 12.00% | ||||||||||
Accounts Receivable | Credit Concentration Risk | Customer Two | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Concentration risk percentage | 10.00% | ||||||||||
Revenue | Customer Concentration Risk | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Number of customers | Customer | 2 | ||||||||||
Revenue | Customer Concentration Risk | Customer One | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Concentration risk percentage | 14.00% | ||||||||||
Revenue | Customer Concentration Risk | Customer Two | |||||||||||
Significant Accounting Policies [Line Items] | |||||||||||
Concentration risk percentage | 10.00% | ||||||||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Revenue by Geographic Area Based on Customers' Locations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 12,439 | $ 16,955 |
United States | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 10,277 | 14,793 |
International | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 2,162 | $ 2,162 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Numerator | ||||
Net loss | $ (16,200) | $ (6,624) | $ (29,516) | $ (8,351) |
Denominator | ||||
Weighted-average number of shares used in net loss per share of common stock, basic and diluted | 38,483,766 | 2,282,024 | 30,688,349 | 2,270,130 |
Net loss per share of common stock, basic and diluted | $ (0.42) | $ (2.90) | $ (0.96) | $ (3.68) |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Redeemable Convertible Preferred Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 10,466,169 | |
Options To Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 5,107,453 | 2,475,455 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 1,097,935 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Level 1 | ||
Assets | ||
Restricted cash equivalents | $ 2,338 | $ 2,338 |
Total assets, fair value | $ 2,338 | 2,338 |
Level 3 | ||
Liabilities | ||
Convertible notes payable | 24,694 | |
Total liabilities, fair value | $ 24,694 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Change in Fair Value of Derivative Liabilities and Convertible Notes (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | ||
Fair value at beginning of the period | $ 24,694 | |
Initial fair value of instruments issued | $ 5,627 | |
Change in fair value of instruments and accrued interest, net | 288 | 1,444 |
Extinguishment of instruments held at fair value | $ (24,982) | |
Fair value at end of the period | $ 7,071 |
Other Financial Information - S
Other Financial Information - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Other Financial Information [Abstract] | |||
Raw materials | $ 35,085 | $ 4,865 | |
Finished goods | 1,097 | ||
Total | $ 36,182 | $ 4,865 | [1] |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Other Financial Information -_2
Other Financial Information - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | |||
Total, at cost | $ 30,200 | $ 20,576 | |
Accumulated depreciation and amortization | (2,047) | (1,168) | |
Property and equipment, net | 28,153 | 19,408 | [1] |
Construction in Progress | |||
Property Plant And Equipment [Line Items] | |||
Total, at cost | 12,674 | 15,308 | |
Machinery and Equipment | |||
Property Plant And Equipment [Line Items] | |||
Total, at cost | 15,936 | 4,679 | |
Website Development Costs | |||
Property Plant And Equipment [Line Items] | |||
Total, at cost | 995 | ||
Furniture and Fixtures | |||
Property Plant And Equipment [Line Items] | |||
Total, at cost | 88 | 88 | |
Leasehold Improvements | |||
Property Plant And Equipment [Line Items] | |||
Total, at cost | $ 507 | $ 501 | |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Other Financial Information - A
Other Financial Information - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Other Financial Information [Abstract] | ||||
Depreciation and amortization expense | $ 700 | $ 100 | $ 882 | $ 118 |
Other Financial Information -_3
Other Financial Information - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Other Financial Information [Abstract] | |||
Professional fees | $ 1,367 | $ 1,577 | |
Accrued manufacturing and inventory purchases | 14,107 | 1,165 | |
Taxes | 359 | 204 | |
Payroll liabilities | 1,866 | 604 | |
Eiken liabilities | 387 | ||
Early exercise liability | 224 | 263 | |
Accrued deferred offering costs | 487 | ||
Other | 362 | 145 | |
Total | $ 18,672 | $ 4,445 | [1] |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Apr. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments And Contingencies Disclosure [Line Items] | |||||
Additional outstanding, other non-cancellable purchase commitment | $ 33,000 | $ 33,000 | |||
Eiken Agreement | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Upfront payments | 24 | ||||
Additional upfront payments | $ 24 | ||||
Payment for license fee | $ 9 | ||||
Technology Services Agreement with Jabil | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Services agreement initial term | three years | ||||
Service agreement expiration period | 180 days | ||||
Service agreement material breach other party period | 60 days | ||||
Manufacturing Services Agreement with Jabil | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Services agreement initial term | three years | ||||
Service agreement expiration period | 180 days | ||||
Service agreement material breach other party period | 30 days | ||||
Outstanding non-cancellable purchase commitment | $ 16,000 | ||||
Cost of Goods Sold | Eiken Agreement | |||||
Commitments And Contingencies Disclosure [Line Items] | |||||
Royalty expense | $ 400 | $ 0 | $ 500 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | |||
Operating lease payments | $ 0.2 | $ 0.2 | |
Weighted-average remaining lease term for operating leases | 2 years | 2 years 4 months 24 days | |
Weighted-average discount rate for operating leases | 13.10% | 13.10% | |
Minimum | |||
Lessee Lease Description [Line Items] | |||
Operating lease remaining lease term | 1 year | ||
Maximum | |||
Lessee Lease Description [Line Items] | |||
Operating lease remaining lease term | 3 years |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | [1] |
Leases [Abstract] | |||
2021 (July 2021 onwards) | $ 229 | ||
2022 | 259 | ||
2023 | 193 | ||
2024 | 33 | ||
Total | 714 | ||
Less: imputed interest | (86) | ||
Present value of lease liabilities | 628 | ||
Less: current portion | (374) | $ (431) | |
Lease liabilities, net of current portion | $ 254 | $ 380 | |
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Leases - Summary of Additional
Leases - Summary of Additional Information Related to Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Operating lease cost | $ 109 | $ 109 | $ 218 | $ 218 |
Short-term lease cost | $ 312 | $ 95 | $ 627 | $ 190 |
Convertible Notes Payable - Add
Convertible Notes Payable - Additional Information (Details) - USD ($) | Feb. 09, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Jul. 31, 2020 | Jul. 31, 2020 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||||||||||
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | $ 24,982,000 | |||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | 159,899,000 | |||||||||
Remeasurement of derivative liabilities and convertible notes | $ 1,444,000 | $ 281,000 | $ 1,444,000 | |||||||
Common Stock | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Issuance of common stock upon IPO, net of issuance costs, shares | 10,350,000 | |||||||||
Common Stock | IPO | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 159,900,000 | |||||||||
Series C | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Conversion of stock | 2,593,110 | |||||||||
Conversion price | $ 5.3905 | $ 5.3905 | ||||||||
2020A Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Aggregate cash consideration | $ 11,100,000 | |||||||||
Accrued interest rate per annum | 4.00% | 4.00% | ||||||||
Debt instrument, maturity date | Jun. 12, 2021 | |||||||||
Debt conversion, description | Pursuant to the 2020A Notes, the outstanding principal balance and unpaid accrued interest was automatically convertible into equity shares in the next equity financing round of at least $10 million (“2020A Qualified Financing”) at a price per share equal to the lower of (i) 80% of the price paid per share for equity securities by the investors in the 2020A Qualified Financing or (ii) the quotient resulting from dividing $95 million by the number of shares of outstanding common shares on a diluted basis immediately prior to the closing of the 2020A Qualified Financing. | |||||||||
Accrued interest | $ 44,000 | |||||||||
2020A Notes | Other Income (Expense), Net | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Remeasurement of derivative liabilities and convertible notes | $ 2,800,000 | |||||||||
2020A Notes | Series C | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of share issuance price | 80.00% | |||||||||
Share issuance price | $ 5.3905 | |||||||||
Conversion price | $ 5.3905 | |||||||||
2020A Notes | 2020A Qualified Financing | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of price paid per share for equity securities by the investors | 80.00% | |||||||||
Amount of common shares outstanding on diluted basis immediately prior to closing of qualified financing | $ 95,000,000 | $ 95,000,000 | ||||||||
Accrued and unpaid interest | $ 11,200,000 | |||||||||
2020A Notes | 2020A Qualified Financing | Series C | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Proceeds from issuance of temporary equity | $ 58,700,000 | |||||||||
Conversion of stock | 2,593,110 | |||||||||
Conversion price | $ 4.3124 | |||||||||
2020A Notes | 2020A Qualified Financing | Minimum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Conversion of redeemable convertible notes payable principal and interest for common stock on IPO | $ 10,000,000 | |||||||||
2020B Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Aggregate cash consideration | $ 20,000,000 | |||||||||
Accrued interest rate per annum | 0.15% | 0.15% | ||||||||
Debt instrument, maturity date | Dec. 11, 2022 | |||||||||
Debt conversion, description | The outstanding principal and unpaid accrued interest of each Note is convertible upon occurrence of one of the following events: Maturity or Change in Control. In the event of an equity financing including an IPO with proceeds of not less than $10.0 million (“2020B Qualified Financing”), 2020B notes automatically convert into equity securities sold in the 2020B Qualified Financing at 80% of the price paid for securities sold in the 2020B Qualified Financing. In the event of an equity financing or IPO of less than $10.0 million, the majority holders of the 2020B Notes have the option to treat the offering as a 2020B Qualified Financing at 80% of the price paid for securities sold in the round (“2020B Non-Qualified Financing”). | |||||||||
2020B Notes | IPO | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of price paid for securities sold from conversion | 80.00% | |||||||||
2020B Notes | Other Income (Expense), Net | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Remeasurement of derivative liabilities and convertible notes | $ 300,000 | $ 4,700,000 | ||||||||
2020B Notes | Common Stock | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of price paid for securities sold from conversion | 70.00% | |||||||||
Issuance of common stock upon IPO, net of issuance costs, shares | 1,470,947 | |||||||||
2020B Notes | Series C | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Original issue price | $ 5.3905 | |||||||||
2020B Notes | 2020B Qualified Financing | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of price paid for securities sold from conversion | 80.00% | |||||||||
2020B Notes | 2020B Qualified Financing | Maximum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 10,000,000 | |||||||||
2020B Notes | Two Thousand Twenty B Non Qualified Financing | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Proceeds from issuance of common stock on IPO, net of issuance costs | $ 10,000,000 | |||||||||
Percentage of price paid for securities sold from conversion | 80.00% |
Capital Stock - Redeemable Conv
Capital Stock - Redeemable Convertible Preferred Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 09, 2021 | Aug. 31, 2020 | Mar. 31, 2019 | Aug. 31, 2019 | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2021 | Dec. 31, 2020 | Aug. 06, 2020 | Jan. 31, 2020 | Jan. 09, 2020 | Nov. 30, 2019 | Nov. 04, 2019 | Jul. 31, 2019 | Jul. 24, 2019 | Mar. 06, 2019 | Dec. 31, 2018 | Oct. 31, 2015 | |
Class Of Stock [Line Items] | |||||||||||||||||||
Temporary equity shares authorized | 0 | 103,355,827 | [1] | ||||||||||||||||
Temporary equity shares issued | 0 | 23,978,747 | [1] | ||||||||||||||||
Gross proceeds from issuance of redeemable convertible preferred stock | $ 17,466 | ||||||||||||||||||
Outstand 2018 notes converted, amount | $ 4,100 | ||||||||||||||||||
Conversion of stock | 23,978,747 | ||||||||||||||||||
Total number of shares authorized | 210,000,000 | ||||||||||||||||||
Common stock, shares authorized | 200,000,000 | 150,000,000 | 50,000,000 | 200,000,000 | 150,000,000 | [1] | 75,000,000 | 52,000,000 | 51,000,000 | 28,716,724 | |||||||||
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | [1] | $ 0.001 | ||||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 0 | [1] | |||||||||||||||
Preferred stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | [1] | |||||||||||||||
Preferred stock, shares issued | 0 | 0 | [1] | ||||||||||||||||
Preferred Stock | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Preferred stock, shares issued | 0 | ||||||||||||||||||
Series A | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Temporary equity shares authorized | 14,115,898 | 14,382,437 | |||||||||||||||||
Temporary equity shares issued | 3,274,913 | ||||||||||||||||||
Redeemable Convertible Preferred Stock | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Temporary equity shares authorized | 103,355,827 | 45,389,864 | 29,208,635 | 28,931,242 | 27,858,121 | ||||||||||||||
Series B | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Temporary equity shares authorized | 30,996,574 | 30,996,574 | 31,273,966 | 15,092,737 | 14,815,344 | 13,742,223 | |||||||||||||
Temporary equity shares issued | 1,608,300 | 731,824 | |||||||||||||||||
Gross proceeds from issuance of redeemable convertible preferred stock | $ 7,500 | $ 3,400 | |||||||||||||||||
Conversion of stock | 1,097,048 | ||||||||||||||||||
Issuance costs | $ 83 | ||||||||||||||||||
Series C | |||||||||||||||||||
Class Of Stock [Line Items] | |||||||||||||||||||
Temporary equity shares authorized | 58,243,355 | 58,243,355 | |||||||||||||||||
Temporary equity shares issued | 13,512,578 | ||||||||||||||||||
Gross proceeds from issuance of redeemable convertible preferred stock | $ 69,800 | ||||||||||||||||||
Conversion of stock | 2,593,110 | ||||||||||||||||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Capital Stock - Summary of Rede
Capital Stock - Summary of Redeemable Convertible Preferred Stock (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Aug. 06, 2020 | Jan. 09, 2020 | Nov. 04, 2019 | Jul. 24, 2019 | Mar. 06, 2019 | Oct. 31, 2015 | ||
Temporary Equity [Line Items] | ||||||||||
Shares Authorized | 0 | 103,355,827 | [1] | |||||||
Shares Issued and Outstanding | 23,978,747 | |||||||||
Net Carrying Value | [1] | $ 121,080 | ||||||||
Liquidation Value | $ 0 | $ 123,126 | ||||||||
Series A | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Shares Authorized | 14,115,898 | 14,382,437 | ||||||||
Shares Issued and Outstanding | 3,274,913 | |||||||||
Net Carrying Value | $ 15,020 | |||||||||
Liquidation Value | $ 16,763 | |||||||||
Series B | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Shares Authorized | 30,996,574 | 30,996,574 | 31,273,966 | 15,092,737 | 14,815,344 | 13,742,223 | ||||
Shares Issued and Outstanding | 7,191,256 | |||||||||
Net Carrying Value | $ 33,406 | |||||||||
Liquidation Value | $ 33,523 | |||||||||
Series C | ||||||||||
Temporary Equity [Line Items] | ||||||||||
Shares Authorized | 58,243,355 | 58,243,355 | ||||||||
Shares Issued and Outstanding | 13,512,578 | |||||||||
Net Carrying Value | $ 72,654 | |||||||||
Liquidation Value | $ 72,840 | |||||||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Capital Stock - Dividends - Add
Capital Stock - Dividends - Additional Information (Details) | Jun. 30, 2021USD ($) |
Equity [Abstract] | |
Dividends declared | $ 0 |
Capital Stock - Liquidation Pre
Capital Stock - Liquidation Preference and Redemption - Additional Information (Details) | Dec. 31, 2020$ / shares |
Series A | |
Class Of Stock [Line Items] | |
Liquidation preference per share | $ 5.1185 |
Series B | |
Class Of Stock [Line Items] | |
Liquidation preference per share | 4.6616 |
Series C | |
Class Of Stock [Line Items] | |
Liquidation preference per share | $ 5.3905 |
Capital Stock - Conversion - Ad
Capital Stock - Conversion - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Minimum | |
Class Of Stock [Line Items] | |
Gross proceeds from underwritten public offering of common stock. | $ 50,000,000 |
Capital Stock - Summary of Numb
Capital Stock - Summary of Number of Shares of Common Stock into Which Redeemable Convertible Preferred Stock Shares Converted (Details) | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Series A | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 5.1185 |
Conversion Price | $ 5.1185 |
Conversion Ratio to Common Stock | 1 |
Series B | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 4.6616 |
Conversion Price | $ 4.6616 |
Conversion Ratio to Common Stock | 1 |
Series C | |
Class Of Stock [Line Items] | |
Initial Conversion Price | $ 5.3905 |
Conversion Price | $ 5.3905 |
Conversion Ratio to Common Stock | 1 |
Capital Stock - Common Stock -
Capital Stock - Common Stock - Additional Information (Details) - USD ($) | Feb. 09, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | [1] | Aug. 31, 2020 | Jan. 31, 2020 | Nov. 30, 2019 | Jul. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Class Of Stock [Line Items] | ||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 150,000,000 | 150,000,000 | 75,000,000 | 52,000,000 | 51,000,000 | 50,000,000 | 28,716,724 | |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Net proceeds from initial public offering | $ 159,899,000 | |||||||||
Dividends declared | $ 0 | |||||||||
Common stock, voting rights | The holder of each share of common stock is entitled to one vote. | |||||||||
Common Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Convertible notes converted into shares of common stock | 1,470,947 | |||||||||
IPO | Common Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 10,350,000 | |||||||||
Shares issued price per share | $ 17 | |||||||||
Net proceeds from initial public offering | $ 159,900,000 | |||||||||
Underwriting discounts and commissions | 12,300,000 | |||||||||
Offering expenses | $ 3,700,000 | |||||||||
Convertible notes converted into shares of common stock | 1,470,947 | |||||||||
Underwriters' Option to Purchase Additional Shares | Common Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Number of shares issued in transaction | 1,350,000 | |||||||||
[1] | The balance sheet as of December 31, 2020 is derived from the audited financial statements as of that date |
Capital Stock - Summary of Comm
Capital Stock - Summary of Common Shares Reserved for Future Issuance (Details) - shares | Jun. 30, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 10,359,153 | 30,243,406 |
Redeemable Convertible Preferred Stock | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 23,978,747 | |
Common Stock Option Grants Issued and Outstanding under 2014 Plan | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 4,409,153 | 4,587,700 |
Common Shares Issuable on Conversion of Convertible Notes Payable | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 1,470,947 | |
Common Stock Reserved for Issuance under 2021 Plan | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 3,505,556 | 206,012 |
Common Stock Option Grants Issued and Outstanding under 2021 Plan | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 596,509 | |
Restricted Common Stock Units Issued and Outstanding | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 1,097,935 | |
Common Stock Reserved for Issuance under ESPP | ||
Class Of Stock [Line Items] | ||
Total common shares reserved for future issuance | 750,000 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock reserved for issuance | 10,359,153 | 10,359,153 | 30,243,406 | ||||
Aggregate intrinsic value of options exercised | $ 753 | $ 596 | $ 0 | $ 1,300 | $ 0 | ||
Weighted average grant date fair value | $ 7.52 | $ 0.30 | |||||
Options, grants in period | 0 | 634,093 | |||||
Compensation cost to be recognized related to non-vested awards | $ 6,100 | $ 6,100 | |||||
Compensation cost to be recognized related to non-vested awards over weighted average period | 1 year 4 months 24 days | ||||||
Stock-based compensation | $ 945 | $ 59 | $ 1,473 | $ 117 | |||
Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Weighted average grant date fair value | $ 5.34 | $ 5.34 | |||||
Compensation cost to be recognized related to non-vested awards over weighted average period | 1 month 20 days | ||||||
Stock-based compensation | $ 100 | ||||||
Employee Stock Purchase Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Compensation cost to be recognized related to non-vested awards | $ 100 | $ 100 | |||||
Vesting in One-year Cliff | Restricted Stock Units (RSUs) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Award vesting period | 4 years | ||||||
Award vesting rights, percentage | 25.00% | ||||||
2014 Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Award, expiration period | 10 years | ||||||
Award vesting period | 4 years | ||||||
Common stock reserved for issuance | 5,512,742 | ||||||
Number of shares available for grant | 206,012 | ||||||
2014 Plan | Vesting in One-year Cliff | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Award vesting rights, percentage | 25.00% | ||||||
2021 Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock reserved for issuance | 5,200,000 | ||||||
Number of shares available for grant | 0 | ||||||
Share-based compensation arrangement increase in shares available for issuance period | 10 years | ||||||
Percentage of increase in common stock available for issuance amount equal to outstanding number of shares of common stock | 5.00% |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Underlying Shares, Beginning Balance | 264,345 | |
Underlying Shares, Granted | 833,590 | 264,345 |
Underlying Shares, Ending Balance | 1,097,935 | 264,345 |
Weighted-Average Grant Date Fair Value, Beginning Balance | $ 12.79 | |
Weighted-Average Grant Date Fair Value, Granted | 4.85 | $ 12.79 |
Weighted-Average Grant Date Fair Value, Ending Balance | $ 6.76 | $ 12.79 |
Aggregate Fair Value, Balance | $ 3,380,272 | |
Aggregate Fair Value, Granted | 4,042,912 | $ 3,380,272 |
Aggregate Fair Value, Balance | $ 7,423,184 | $ 3,380,272 |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||
Number of Options, Beginning Balance | 5,151,553 | 4,587,700 | 4,587,700 | |||
Number of Options, Granted | 0 | 634,093 | ||||
Number of Options, Exercised | (134,398) | (37,760) | ||||
Number of Options, Cancelled | (11,493) | (32,480) | ||||
Number of Options, Ending Balance | 5,005,662 | 5,151,553 | 5,005,662 | 4,587,700 | ||
Number of Options vested and expected to vest as of June 30, 2021 | 5,005,662 | 5,005,662 | ||||
Number of Options vested and exercisable as of June 30, 2021 | 1,198,274 | 1,198,274 | ||||
Weighted-Average Exercise Price, Beginning Balance | $ 3.32 | $ 1.51 | $ 1.51 | |||
Weighted-Average Exercise Price, Granted | 17 | |||||
Weighted-Average Exercise Price, Exercised | 0.95 | 0.82 | ||||
Weighted-Average Exercise Price, Cancelled | 8.19 | 17 | ||||
Weighted-Average Exercise Price, Ending Balance | 3.42 | $ 3.32 | 3.42 | $ 1.51 | ||
Weighted-Average Exercise Price, Options vested and expected to vest as of June 30, 2021 | 3.42 | 3.42 | ||||
Weighted-Average Exercise Price, Options vested and exercisable as of June 30, 2021 | $ 1.52 | $ 1.52 | ||||
Weighted-Average Remaining Contractual Term, Balance | 9 years 1 month 6 days | 8 years 9 months 18 days | 9 years 2 months 12 days | |||
Weighted-Average Remaining Contractual Term, Options vested and expected to vest as of June 30, 2021 | 8 years 9 months 18 days | |||||
Weighted-Average Remaining Contractual Term, Options vested and exercisable as of June 30, 2021 | 8 years 2 months 12 days | |||||
Aggregate Intrinsic Value, Beginning Balance | $ 48,122 | $ 3,152 | $ 3,152 | |||
Aggregate Intrinsic Value, Exercised | 753 | 596 | $ 0 | 1,300 | $ 0 | |
Aggregate Intrinsic Value, Ending Balance | 22,512 | $ 48,122 | 22,512 | $ 3,152 | ||
Aggregate Intrinsic Value, Options vested and expected to vest as of June 30, 2021 | 22,512 | 22,512 | ||||
Aggregate Intrinsic Value, Options vested and exercisable as of June 30, 2021 | $ 6,421 | $ 6,421 |
Equity Incentive Plan - Summa_3
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Stock Options (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected dividend yield | 0.00% | |||
Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Estimated fair value of common stock | $ 17 | $ 0.73 | $ 17 | $ 0.73 |
Expected term (in years) | 6 years 18 days | 5 years 11 months 8 days | 6 years 18 days | |
Risk-free interest rate | 0.00% | 0.40% | 0.60% | 0.40% |
Volatility | 0.00% | 43.30% | 46.90% | 43.30% |
Equity Incentive Plan - Summa_4
Equity Incentive Plan - Summary of Compensation Cost for Share-Based Payment Arrangements Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total compensation cost | $ 945 | $ 59 | $ 1,473 | $ 117 |
Cost of Sales | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total compensation cost | 208 | 260 | ||
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total compensation cost | 291 | 31 | 421 | 67 |
Selling, General and Administrative Expenses | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total compensation cost | $ 446 | $ 28 | $ 792 | $ 50 |
Equity Incentive Plan - Summa_5
Equity Incentive Plan - Summary of Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plans (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected dividend yield | 0.00% | |||
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Estimated fair value of common stock | $ 17 | $ 17 | ||
Expected term (in years) | 6 months | |||
Risk-free interest rate | 0.00% | 0.00% | 0.10% | 0.00% |
Volatility | 0.00% | 0.00% | 56.40% | 0.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||
Provision or benefit for income taxes | $ 0 | $ 0 |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Maximum | |||
Related Party Transaction [Line Items] | |||
Related party transaction consulting expenses | $ 100,000 | $ 100,000 | |
Convertible notes | |||
Related Party Transaction [Line Items] | |||
Notes issued related parties | $ 11,500,000 | ||
Convertible notes 2020B | |||
Related Party Transaction [Line Items] | |||
Notes to related parties | $ 8,700,000 |