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 (“U.S. GAAP”), applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company performed an evaluation of its activities through the date of filing this Annual Report and has concluded that there were no subsequent events or transactions that occurred subsequent to the balance sheet date and prior to the filing of this Annual Report, except for the transactions disclosed in Note 13 Subsequent Events. Use of Estimates The preparation of the accompanying financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, income and expenses as well as the related disclosure of contingent assets and liabilities. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Company’s Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results. The full extent to which the COVID-19 pandemic could continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing and distribution will depend on future developments that remain uncertain at this time, particularly as virus variants continue to spread. Reclassifications Certain prior-period amounts have been reclassified to conform to the current presentation. Such reclassifications had no impact on previously reported net loss, total assets, total liabilities, or stockholders’ equity. Concentration of Credit Risk and Significant Suppliers and Distributors 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. As of and during the year ended December 31, 2021 , Customers A, B and C represented 18 % , 17 % and 12 % , respectively, of the Company’s accounts receivable , and Customers C and A accounted for % and 10 %, respectively, of the Company’s revenue . As of and during the year ended December 31, 2020, there was only one customer which represented 100% of the Company’s accounts receivable and revenue. The Company is dependent on one contract manufacturer for commercial manufacturing of the Company’s test kits, key suppliers for certain laboratory materials and inventory items and certain key partners for distribution and fulfillment of customer orders. An interruption in the supply of these materials or disruption of the fulfillment and distribution operations, could temporarily impact the Company’s ability to manufacture its commercial inventory and perform development, testing and clinical trials related to its products. On July 14, 2021, the Company entered into a Distribution Agreement with Switch Health Solutions Inc. (“Switch”), which agreement was subsequently amended on December 21, 2021 (such agreement as amended, the “Distribution Agreement”). Under the Distribution Agreement, the Company appointed Switch as a non-exclusive distributor for the Company’s CHECK IT COVID-19 Test Kits (the “Test Kits”) in Canada. Under the Distribution Agreement, Switch is required to provide the Company with forecasts of the quantity of Test Kits that Switch expects to order for each of the coming 12 calendar months through December 2022 and each six-month period following December 2022 (each, a “Rolling Forecast”). For each calendar month in the Rolling Forecast, Switch is required to purchase at least the quantity of Test Kits set forth in the Rolling Forecast for such month. If the Company fails to fulfill the quantity of Test Kits set forth in any part of the Rolling Forecast for which Switch submits a purchase order(s), then Switch will not be required to purchase the remaining quantity of Test Kits set forth in the Rolling Forecast. If Switch fails to purchase the quantity of Test Kits in any month, or in the aggregate for the 12 month period, in each case as set forth in the Rolling Forecast, then Switch is liable to the Company for a low double-digit percentage of the total price applicable to the quantity of Test Kits set forth in the Rolling Forecast for the two months following such failure by Switch. The Distribution Agreement is for a one-year term and either party has the right to renew the Distribution Agreement for successive periods of one-year each by providing written notice to the other party prior to the expiration of the current term. Either party may terminate the Distribution Agreement (a) for uncured material breach by the other party, (b) if the other party enters into insolvency or bankruptcy or a trustee or receiver or the equivalent is appointed for the other party or proceedings are instituted against the other party relating to dissolution, liquidation, winding up, bankruptcy, insolvency, etc. or (c) for convenience upon 30 days’ notice to the other party. Additionally, either party may terminate immediately upon written notice if a regulatory or governmental agency or court takes action the result of which would prohibit or significantly restrict the sale, distribution, use or manufacture of the Test Kits in accordance with the Distribution Agreement. Fair Value Measurements The carrying value of the Company’s cash, accounts 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 were measured at fair value on a recurring basis and were classified as Level 3 liabilities. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable consist primarily of amounts due to the Company related to product sales. It is the practice of the Company to provide for uncollectible accounts in the year the accounts are determined to be uncollectible. The following table summarizes the activity in the allowance for doubtful accounts: Years Ended December 31, 2021 2020 Beginning balance $ — $ — Amounts charged to costs and expenses 358 — Write-offs (259 ) — Ending balance $ 99 $ — 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 December 31, 2021 and 2020, there were no cash equivalents. As of December 31, 2020, 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 classified as restricted cash equivalents on the Company’s Balance Sheets. The letter of credit matured in November 2021 and as of December 31, 2021, the Company held no restricted cash. 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. As of December 31, 2020, the Company held $1.3 million that met criteria for capitalization. As of December 31, 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. Inventory held as of December 31, 2021 is in the form of raw materials, work in process and finished goods. 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 recorded $6.5 million of inventory obsolescence charges during the year ended December 31, 2021 related to an issue during transit and quality control exceptions related to one of the key raw material components of its product. 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 typically coincides with 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 regularly reviews these estimates to assess the appropriateness of our recorded warranty liabilities and adjust the amounts as necessary. As of December 31, 2021 and 2020, the accrued liability for warranty returns was not significant. 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 Sheets and any resulting gain or loss is reflected in Other income (expense), net 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 on the Balance Sheets. The Company did not have any finance leases as of December 31, 2021 and 2020. 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. Impairment of Long-Lived Assets The Company’s long-lived assets are comprised principally of its property and equipment, including leasehold improvements and ROU assets. The Company reviews long-lived assets whenever events or changes in circumstances indicate that the carrying amount of the asset group may not be fully recoverable. The Company identifies impairments related to long-lived assets when management determines that the remaining carrying value will not be realized through future use. The Company evaluates events or circumstances, including competition in the markets where it operates, that would indicate the carrying value of assets may not be fully recoverable. If an event or circumstance is identified indicating carrying value may not be recoverable, the sum of future undiscounted cash flows is compared to the carrying value. If the carrying value exceeds the future undiscounted cash flows, the carrying value of the asset is reduced to fair value, with the difference recorded as an impairment charge. Assets are evaluated for impairment on an individual basis, which management believes is the lowest level for which there are identifiable cash flows. The Company evaluates assets for impairment by assessing if long-lived assets will be sold or otherwise disposed of significantly before the end of their previously estimated useful life as its primary indicator of potential impairment. The fair value of assets is determined as the present value of the estimated future cash flows, adjusted as necessary for market participant factors. Any required impairment loss would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. During the year ended December 31, 2021, a $1.4 million impairment of long-lived assets charge was recorded, there was no impairment charge recorded during the same period in 2020. See additional discussion in Note 4, Other Financial Information. Redeemable Convertible Preferred Stock The Company’s shares of preferred stock were assessed at issuance for classification and redemption features requiring bifurcation. The Company’s preferred stock was 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 was redeemable if the Company had not been dissolved within 90 days following the occurrence of certain deemed liquidation events, which the Company determined was not solely within its control and thus had classified shares of redeemable convertible preferred stock as temporary equity until such time as the conditions were removed or lapse. The Company initially recorded redeemable convertible preferred stock at fair value, net of issuance costs. 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. There was $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 December 31, 2020. 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. 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 risk and title of the Company’s products and upon customer obtaining control of the product, which occurs at a point in time and is generally upon shipment to the customer, unless terms of contractual arrangements with customers state otherwise in which case the control is transferred upon completion of delivery and customer acceptance of products. Upon transfer of risk and title to the customer, no further performance obligations by the Company to the customer after shipment of the product are present. Revenue is measured based on the amount of consideration that the Company expects to receive as reduced by estimated discounts and allowances. The Company's performance obligations relate to contracts with a duration of less than one year. The Company elected to apply the practical expedient provided in ASC 606, therefore, the Company is not required to disclose the aggregate amount of transaction price allocated to performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period. All of the Company’s revenue has been derived from sales of its test kits through its healthcare, business-to-business, international and direct-to-consumer (e-commerce) channels. Since receiving the initial EUA in the fourth quarter 2020, the Company marketed its test products to physicians and licensed healthcare providers through its healthcare channel 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 within its business-to-business channel, and direct-to-consumer through its partnerships with e-commerce sales and distribution platforms. In 2021, the Company also sold tests internationally through international distributors in Canada, Taiwan, Singapore, and Israel through its international channel. The following table sets forth the Company’s net sales by channel: Years Ended December 31, 2021 2020 Healthcare $ 27,205 $ 269 Business-to-business 41,439 — International 18,262 — Direct-to-consumer (e-commerce) 6,149 — Net sales $ 93,055 $ 269 Collection of the Company’s net revenue generally occurs 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. Collections of revenue from customers in the Company’s e-commerce channel generally occurs instantaneously or within a few days as customers pay using credit cards. Customers in certain countries outside of the United States pay in advance of product delivery. In those instances, payment and delivery typically occur in the same month. Costs to obtain or fulfill a contract are currently expensed when incurred because our performance obligation is satisfied at a point in time. These costs are recorded as Cost of products sold in the Statements of Operations. 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. In those instances, the Company records revenue upon delivery and upon customer acceptance of products to customers when control of products is transferred to customers. 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 net sales by geographic area based on the customers’ locations: Years Ended December 31, 2021 2020 United States $ 74,793 $ 269 Canada 13,066 — All other countries 5,196 — Net sales $ 93,055 $ 269 Shipping and Handling Costs Shipping and handling costs are included in cost of goods sold. Research and Development Grants 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 earns grant income for performing tasks under research and development agreements with governmental agencies. 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 S tatements of O perations. The Company recognized grant income from BARDA of $0.0 million and $1.8 million during the years ended December 31, 2021 and 2020, respectively. In July 2021, BARDA terminated the influenza contract for convenience. The Company recognized grant income from other governmental agencies of $0.6 million and $0.3 million during the years ended December 31, 2021 and 2020, respectively. The Company records a receivable included in Other current assets on the Balance Sheets, which 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. As of December 31, 2021 and 2020, $0.2 million and $0.2 million were unbilled, respectively. 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. 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 value 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. Such estimates in determining the accrued balance in each reporting period are subject to management judgment. As actual costs become known, the Company adjusts its accrued estimates. Advertising and Marketing Costs Costs associated with advertising and marketing activities are expensed as incurred. Total advertising and marketing costs were $1.7 million and immaterial for the years ended December 31, 2021 and 2020, respectively, 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 issued to employees and non-employees and restricted stock units issued to employees. 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. The Company classifies stock-based compensation expense in its S tatements of O perations in the same manner in which the award recipient’s cash compensation costs are classified. The fair value of each stock option 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 of Directors (the “Board”) of the Company 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 expected term was estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise data to estimate the expected term. 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 |