The following discussion and analysis of our financial condition and results of operations should be read together with our audited financial statements and related notes included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. You should carefully read the "Risk Factors" section of this Annual Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled "Special Note Regarding Forward-Looking Statements."

Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is designed to provide material information relevant to an assessment of our financial condition and results of operations, including an evaluation of the amounts and certainty of cash flows from operations and from outside sources. This section is designed to focus on material events and uncertainties known to management that are reasonably likely to cause reported financial information not to be necessarily indicative of future operating results or of future financial condition. This includes descriptions and amounts of matters that have had a material impact on reported operations, as well as matters that are reasonably likely based on management's assessment to have a material impact on future operations.

Overview

Our primary focus is to transform diagnostic testing through innovative molecular diagnostic products that enable customers to deploy accurate, reliable, low cost and rapid molecular testing at the point-of-care for infectious diseases and other conditions.

We are developing the Talis One system which leverages expertise across chemistry, biology, engineering and software to create a fully integrated, cloud-enabled and portable molecular diagnostic solution that customers can rapidly deploy when and where needed. The Talis One system incorporates core proprietary technologies into a compact, easy-to-use instrument, that employs single use test cartridges and software, including a central cloud database, which are designed to work together to provide levels of testing accuracy equivalent to a central laboratory. We intend to commercialize the Talis One system as an integrated solution comprising single use consumables, an instrument and software. Our commercial strategy will focus on building and expanding an installed base of Talis One systems to generate revenue from the purchase of such products. Our first commercial test will be the Talis One COVID-19 Test System, which is a rapid point-of-care molecular diagnostic to detect SARS-CoV-2 directly from a patient sample in less than 30 minutes. We are developing assays for the detection of other respiratory infections that could be included as a panel test with the Talis One COVID-19 Test System as well as tests for infections related to women's health and STIs. In December 2021, we entered into an agreement to act as an authorized distributor for third party COVID-19 antigen tests (Antigen Tests). In January 2022, in order to generate revenue to support our operations and sales forces, we began purchasing and distributing these Antigen Tests as an authorized distributor. We plan to continue to utilize this strategy to both generate revenue for as long as we can provision the tests and sell them for a profit and to help develop our customer base for Talis One.

Our products will require marketing authorization from the FDA prior to commercialization. On November 5, 2021, we received an EUA from the FDA for the emergency use of the Talis One system for our COVID-19 test, which we refer to as the Talis One COVID-19 Test System. Due to the COVID-19 global pandemic, we obtained marketing authorization for our Talis One COVID-19 Test System under an EUA rather than initially pursuing 510(k) clearance or other forms of marketing authorization under the FDA's standard medical device authorities.

We have invested in automated cartridge manufacturing lines, the first of which began to come on-line in the first quarter of 2021. We are currently validating the performance of those automated cartridge manufacturing lines. These manufacturing lines are located at our contract manufacturers' sites and are operating by our contract manufacturing partners. We have also received components to build 5,000 Talis One instruments from our instrument contract manufacturer.

We outsource essentially all of our manufacturing. Design work, prototyping and pilot manufacturing are performed in-house before outsourcing to third party contract manufacturers. Our outsourced production strategy is intended to



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drive rapid scalability. Certain of our suppliers of components and materials are single source suppliers. To support our anticipated commercial launch, we have invested in automated cartridge manufacturing production lines for our Talis One cartridges. Those assets deemed to have an alternative future use have been capitalized as property and equipment while those assets determine to not have an alternative future use have been expensed.

Since our inception in 2013, we have devoted substantially all our efforts to research and development activities, manufacturing capabilities, raising capital, building our intellectual property portfolio and providing selling, general and administrative support for these operations. We have principally financed our operations through the issuance and sale of shares of our convertible preferred stock to outside investors in private equity financings as well as the issuance of convertible promissory notes and receipts from government grants. Prior to our initial public offering, we received $351.5 million from investors in our preferred stock financings and the sale of convertible promissory notes that converted in such financings. Additionally, on February 17, 2021, the Company raised $232.5 million (after deducting underwriting discounts, commissions and offering expenses) through an initial public offering to finance operations going forward.

We have incurred recurring losses since our inception, including net losses of $192.0 million and $91.1 million for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, we had an accumulated deficit of $364.9 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

continue the research and development of our platform and assays for additional diseases;

initiate clinical trials for, or additional preclinical development of, our Talis One system;

further develop and refine the manufacturing processes for our Talis One system and potentially the design of our Talis One system;

change or add manufacturers or suppliers of materials used for our Talis One system;

seek marketing authorizations;

seek to identify and validate diagnostic assays for other disease states;

obtain, maintain, protect and enforce our intellectual property portfolio;

hire and deploy a sales force;

seek to attract and retain new and existing skilled personnel;

create additional infrastructure to support our operations as a public company and incur increased legal, accounting, investor relations and other expenses; and

experience delays or encounter issues with any of the above.

In addition, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. As a result, we will need substantial additional funding to support our operating activities. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, debt and grant revenue. Adequate funding may not be available to us on acceptable terms, or at all.

If we are unable to obtain funding, we will be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Although we continue to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

As of December 31, 2021, we had unrestricted cash and cash equivalents of $232.5 million. We expect that our cash and cash equivalents of $232.5 million as of December 31, 2021 will be sufficient to fund our operations through at least the next 12 months. Our objective is to preserve our current cash reserves to fund operations through the end of 2024. This target could change as we gain more clarity on the timing and trajectory of the Talis One system launch. We may need substantial additional funding to support our continuing operations and pursue our long-term business plan. We may seek additional funding through the issuance of our common stock, other equity or debt financings, or



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collaborations or partnerships with other companies. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our research efforts for our assays and development and manufacturing activities. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital as and when needed would compromise our ability to execute on our business plan and may cause us to significantly delay or scale back our operations.

On March 15, 2022, we implemented a reduction in force, of approximately 25%, designed to reduce our operating expenses, preserve cash and align our remaining resources to focus on, among other things, developing internal manufacturing expertise to support the commercial launch of the Talis One system. We anticipate that we will incur approximately $1.0 million of expenses related to the reduction in force, substantially all of which will consist of one-time charges related to the staff reduction, including cash expenditures and other costs. Substantially all of the committed actions under the reduction in force will take place by the end of March 2022. Going forward, we estimate annualized savings of $10.0 million in compensation expenses and $26.0 million in other expenses related to these reductions.

COVID-19 pandemic

Since it was reported to have surfaced in December 2019, a novel strain of coronavirus (COVID-19) has spread across the world and was declared a pandemic by the World Health Organization. Efforts to contain the spread of COVID-19 intensified in 2020 and 2021 and governments around the world, including in the United States, Europe and Asia, implemented travel restrictions, social distancing requirements, stay-at-home orders and delayed the commencement of non-COVID-19-related clinical trials, among other restrictions. As a result, the current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and has been affecting our employees, patients, communities and business operations, as well as contributing to significant volatility and negative pressure on the U.S. economy and in financial markets.

We expect that COVID-19 precautions will directly or indirectly impact the timeline for some of our planned clinical trials for our non-COVID-19 related products in development, and we are continuing to assess the potential impact of the COVID-19 pandemic on our current and future business and operations, including our expenses and clinical trials, as well as on our industry and the healthcare system.

As a result of the outbreak, many companies have experienced disruptions in their operations and in markets served. We are considered an essential business and therefore the impact to our operations has been limited. To date, we have initiated some and may take additional temporary precautionary measures intended to help ensure our employees' well-being and minimize business disruption. For the safety of our employees and their families, we have temporarily reduced the presence of our employees in our labs. Certain of our third-party service providers have also experienced shutdowns or other business disruptions. We are continuing to assess the impact of the COVID-19 pandemic on our current and future business and operations, including our expenses and planned clinical trial and other development timelines, as well as on our industry and the healthcare system.

As a result of the COVID-19 pandemic, or similar pandemics and outbreaks, we have and may in the future experience severe disruptions, including:

interruption of or delays in receiving products and supplies from the third parties we rely on to, among other things, manufacture components of our instruments, due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems, which may impair our ability to sell our products and consumables;

limitations on our business operations by the local, state, or federal government that could impact our ability to sell or deliver our instruments and consumables;

delays in customers' purchasing decisions and negotiations with customers and potential customers;

business disruptions caused by workplace, laboratory and office closures and an increased reliance on employees working from home, travel limitations, cyber security and data accessibility limits, or communication or mass transit disruptions; and



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limitations on employee resources that would otherwise be focused on the conduct of our activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.

Three vaccines for COVID-19 have been authorized for emergency use by the FDA as of March 2022. While we do not foresee the authorizations having an immediate and near-term impact on the demand for COVID-19 tests, the vaccines could reduce the future demand for such tests depending on the effectiveness of the vaccines.

Components of our results of operations

Revenue

To date, we have not generated any revenue from sales of our Talis One system. We expect to generate revenue in the future from product sales of our Talis One instruments and single use cartridges. Our business model is focused on driving the adoption of the Talis One system. Customers would gain access to our instrument via a direct sales model or a reagent rental model. Under direct platform sales, our customers would directly purchase our Talis One instrument and make subsequent independent purchases of our cartridges. This would include, during our early customer engagements, a fully paid workflow license to practice the desired workflow(s) in a specific field of use. In addition, we would also offer platform support to the extent customers require further system and workflow optimization following platform implementation. When we place a system under a reagent rental agreement, we plan to install equipment in the customer's facility without a fee and the customer agrees to purchase our cartridges at a stated price over the term of the reagent rental agreement. Some of these agreements could include minimum purchase commitments. Under a reagent rental model, we plan to retain title to the equipment and such title is transferred to the customer at the conclusion of the initial arrangement. The cost of the instrument under the agreement is expected to be recovered in the fees charged for consumables, to the extent sold, over the term of the agreement.

We cannot predict when, or to what extent we will generate revenue from the commercialization and sale of our system. While we have obtained EUA for our Talis One COVID-19 Test System, we have not generated any revenue from the sales of such system. We rely, and expect to continue to rely, on third parties for the manufacture of the Talis One system and our tests, as well as for commercial supply. Our contract manufacturers may not have the ability to produce quality product at scale to meet commercial demand which could delay commercialization efforts. Further, we may not succeed in maintaining regulatory approval for the Talis One COVID-19 Test System or obtaining regulatory approval for other products. Growth and predictability of recurring revenue is impacted by the timing of commercialization and expansion of our products. It is our goal and expectation that recurring revenue will grow over time, both in absolute dollars and as a percentage of our revenue.

Grant revenue

Through December 31, 2021, all of our revenue has been derived from government grants, which includes an April 2018 subaward grant from Boston University as part of the CARB-X program, a May 2018 grant from the NIH to support our advancement of a Diagnostics via Rapid Enrichment, Identification, and Phenotypic Antibiotic Susceptibility Testing of Pathogens from Blood project (NIH grant), a July 2020 subaward grant from the University of Massachusetts Medical School for Phase 1 of the NIH's Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx) initiative and the NIH Contract, a contract from the NIH directly for Phase 2 of the RADx initiative.

In October 2021, we and the NIH agreed to amend the NIH Contract to extend the time to perform the remaining milestones to January 30, 2022 and reduce the potential milestone payments from $4.0 million to $2.0 million. The NIH Contract expired on January 30, 2022.

Under the NIH grant, there is the possibility of an additional $1.8 million in payments through April 2023.

In October 2021, we chose not to pursue additional option periods under the CARB-X grant. Therefore, there is no additional funding available under this grant.

These grants are not in the scope of the contracts with customers accounting guidance as the government entities and/or government-sponsored entities are not customers under the agreements.



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Operating expenses

Research and development expenses

Research and development expenses consist primarily of internal and external costs incurred for our research activities, the development of our platform, investment in manufacturing capabilities as well as costs incurred pursuant to our government grants and include:

salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

the cost of laboratory supplies and developing and manufacturing of our platform;

contract services, other outside costs and costs to develop our technology capabilities;

facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs;

cost of outside consultants, including their fees and related travel expenses, engaged in research and development functions;

expenses related to regulatory affairs; and

fees related to our scientific advisory board.

Until future commercialization is considered probable and the future economic benefit is expected to be realized, we do not capitalize pre-launch inventory costs prior to completion of marketing authorization unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable, and future economic benefit can be asserted. We record such costs to research and development costs, or if used in marketing evaluations, record such cost to selling, general and administrative expense. A number of factors are taken into consideration, based on management's judgment, including the current status in the regulatory approval process, potential impediments to the approval process, anticipated research and development initiatives and risk of technical feasibility, viability of commercialization and marketplace trends.

Prior to receiving an EUA and until future commercialization is considered probable, costs of property and equipment related to scaling up our manufacturing capacity for commercial launch are recorded to research and development expense when the asset does not have an alternative future use.

Research and development activities are central to our business model. We focus our research and development efforts on the Talis One COVID-19 Test System and the development of respiratory panels and tests for infections related to women's and sexual health. We expect to continue to incur significant research and development expenses in the future as we continue the research and development of our platform and assays for other infectious diseases and disease states, initiate clinical trials for future tests, further develop and refine the manufacturing processes for our platform, and continue commercialization efforts. There are numerous factors associated with the successful commercialization of any assay we may develop in the future for other diseases or disease states, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.

Selling, general and administrative expenses

Selling, general and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, sales, product management, corporate and business development and administrative functions. Selling, general and administrative expenses also include professional fees for legal, patent, accounting, information technology, auditing, tax and consulting services, travel expenses and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

Other income (expense)

Other income (expense), net consists primarily of interest income on cash deposits held at financial institutions, gains and losses on holdings invested in money market funds, and unrealized and realized foreign exchange gains and losses.



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Results of operations

Comparison for the twelve months ended December 31, 2021 and 2020

The following table summarizes our results of operations (in thousands):



                                        Twelve Months Ended
                                            December 31,
(in thousands)                           2021          2020          Change
Grant revenue                         $    8,193     $  10,938     $   (2,745 )
Operating expenses:
Research and development                 157,591        89,019         68,572

Selling, general and administrative 42,418 13,103 29,315 Total operating expenses

                 200,009       102,122         97,887
Loss from operations                    (191,816 )     (91,184 )     (100,632 )
Other (expense) income, net                 (220 )          54           (274 )

Net loss and comprehensive loss $ (192,036 ) $ (91,130 ) $ (100,906 )

Grant revenue

Our revenue for the twelve months ended December 31, 2021 and 2020 relates to the CARB-X and NIH grants and the RADx initiative. During the twelve months ended December 31, 2021, $7.7 million and $0.5 million of revenue was recognized related the RADx initiative and NIH grant, respectively. During the twelve months ended December 31, 2020, $9.3 million, $1.1 million and $0.6 million of revenue was recognized related the RADx initiative and NIH and CARB-X grants, respectively.

Research and development expenses

Substantially all of our research and development expenses incurred for the twelve months ended December 31, 2021 and 2020 were related to the manufacturing scale-up and development of our first potential commercial product utilizing the Talis One COVID-19 Test System.

Research and development expenses were $157.6 million for the twelve months ended December 31, 2021, compared to $89.0 million for the twelve months ended December 31, 2020. The increase of $68.6 million was primarily driven by investments in manufacturing scale up associated with developing aspects of the production line, consisting of $22.9 million for the automation of consumable manufacturing, $16.3 million of Talis One cartridge materials for the COVID-19 assay, and $15.4 million in instrument component costs. Additionally, we incurred incremental manufacturing scale up expenses of $5.4 million related to personnel and payroll related expenses, $4.8 million of depreciation, facilities and IT costs, $2.3 million in freight costs and $1.5 million in outside services and consulting expenses.

Research and development expenses of $157.6 million for the twelve months ended December 31, 2021 included $69.6 million related to manufacturing scale-up, $21.7 million in pre-launch instrument inventory, and $11.8 million in pre-launch cartridge inventory. Research and development expenses of $89.0 million for the twelve months ended December 31, 2020 included $40.9 million related to manufacturing scale-up. The instrument and cartridge inventory amounts are recorded as research and development expenses until future commercialization is considered probable.

The build-out of our automated consumable manufacturing lines, which began in the middle of 2020, has substantially concluded as of December 31, 2021. Costs associated with the remainder of the scale-up project will be substantially reduced as we shift from building our manufacturing infrastructure to validation and optimization.

Selling, general and administrative expenses

Selling, general and administrative expenses were $42.4 million for the twelve months ended December 31, 2021, compared to $13.1 million for the twelve months ended December 31, 2020. The increase of $29.3 million was primarily due to an incremental $20.1 million in personnel and payroll related expenses including salaries and wages, sales commission and stock compensation expenses to support our commercial launch, an increase of $4.5 million in facilities, insurance and IT costs and an increase of $3.8 million in outside services and consulting related to being a public company.



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Liquidity and capital resources

Sources of liquidity

Through December 31, 2021, we funded our operations primarily through public equity offerings, private placements of equity securities and through government grants.

On February 17, 2021, we completed our initial public offering (IPO), pursuant to which we issued and sold 13,800,000 shares of our common stock and an additional 2,070,000 shares pursuant to the exercise in full by the underwriters of their option to purchase additional shares of our common stock, at a public offering price of $16.00 per share. The net proceeds from the IPO were $232.5 million after deducting underwriting discounts and commissions and other offering expenses.

In July 2021, the Company made a payment of $29.6 million to one of the Company's contract manufacturing organizations in connection with the purchase of certain instrument components. The Company's $33.0 million letter of credit (LOC), that was entered into in 2020 and required to be held as collateral by the contract manufacturing organization, was concurrently terminated.

As of December 31, 2021, we had unrestricted cash and cash equivalents of $232.5 million. We believe our cash and cash equivalents balance as of December 31, 2021 is sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments. Our objective is to preserve our current cash reserves to fund operations through the end of 2024. This target could change as we gain more clarity on the timing and trajectory of the Talis One system launch.

On March 15, 2022, we implemented a reduction in force, of approximately 25%, designed to reduce our operating expenses, preserve cash and align our remaining resources to focus on, among other things, developing internal manufacturing expertise to support the commercial launch of the Talis One system. We anticipate that we will incur approximately $1.0 million of expenses during the three months ended March 31, 2022 related to the reduction in force. Going forward, we estimate annualized savings of $10.0 million in compensation expenses and $26.0 million in other expenses related to these reductions.

Future funding requirements

We do not have any commercial-scale manufacturing facilities and expect to rely on third parties to manufacture the Talis One system and related cartridges. We have entered into, and expect to enter into additional, agreements with contract manufacturers to support our manufacturing scale up. We have engaged a third-party logistics provider to manage the movement of materials between suppliers and contract manufacturers and for finished goods warehousing.

Until we can generate a sufficient amount of revenue from the commercialization of Talis One system and third party products that we sell, including the Antigen Tests, if ever, we expect to finance our future cash needs through public or private equity offerings or debt financings.

To date, our primary uses of cash have been to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. We have made a prepayment to the landlord of one of our leased properties in advance of commencement. We currently have no other ongoing material financing commitments, such as other lines of credit or guarantees. We expect to incur significant research and development and commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of any future collaborators. We expect to incur additional costs associated with operating as a public company. Accordingly, we may choose to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $364.9 million through December 31, 2021. We expect to incur substantial additional losses in the future as we conduct and expand our research and development, manufacturing and commercialization activities. Based on our planned operations, we expect that our unrestricted cash and cash equivalents of $232.5 million as of December 31, 2021, will be sufficient to fund our operations for at least 12 months after these financial statements are issued. However, we may need to raise additional capital through equity or debt financing, or



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potential additional collaboration proceeds prior to achieving commercialization of our products. Our ability to continue as a going concern is dependent upon our ability to successfully secure sources of financing and ultimately achieve profitable operations.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of the Talis One system, we are unable to estimate the exact amount of our operating capital requirements. Our future capital requirements will depend on many factors, including:

our ability to maintain an EUA for our Talis One COVID-19 Test System;

our ability to receive, and the timing of receipt of future regulatory approval for other products;

our ability to manufacture the Talis One COVID-19 Test System at scale to meet market demand;

the effectiveness and availability of the three vaccines that were authorized as of March 2022;

the amount of capital, and related timing of payments, required to build sufficient inventory of our Talis One system and test cartridges in advance of and during commercial launch;

the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for the Talis One system;

limitations of, or interruptions in, the quality or quantity of materials from our third party suppliers;

our ability to implement an effective manufacturing, marketing and commercialization operation;

the scope, progress, results and costs of our ongoing and planned operations;

the costs associated with expanding our operations;

the number and development requirements of assays for other diseases or disease states that we may pursue;

intervention, interruptions or recalls by government or regulatory agencies;

enhancements and disruptive advances in the diagnostic testing industry;

our estimates and forecasts of the market size addressable by our Talis One system;

security breaches, data losses or other disruptions affecting our information systems;

the regulatory and political landscape upon the launch of our commercialization of the Talis One system;

the revenue, if any, received from commercial sales of our products if approved, including additional working capital requirements if we pursue a reagent rental model for our Talis One instrument, or from commercial sales of third party products, including the Antigen Tests;

the costs to defend any shareholder suits or other third party litigation;

our ability to establish strategic collaborations; and

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims.



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Cash flows



The following table summarizes our cash flows for each of the periods presented
(in thousands):

                                                           Year Ended December 31,
                                                           2021               2020
                                                               (in thousands)
Net cash used in operating activities                  $    (171,384 )    $    (87,024 )
Net cash used in investing activities                         (2,866 )          (8,201 )
Net cash provided by financing activities                    234,429           246,754
Net increase in cash, cash equivalents and
restricted cash                                        $      60,179      $    151,529


Operating activities

During the year ended December 31, 2021, net cash used in operating activities was $171.4 million, resulting from our net loss of $192.0 million partially offset by non-cash items of $11.8 million including stock-based compensation of $9.2 million as we increased headcount to support our commercialization. Our net loss was further offset by a decrease of $12.0 million in prepaid research and development driven by the substantial completion of our manufacturing scale up project as of December 31, 2021 and an increase of $2.2 million in accrued expenses and other liabilities. These cash inflows were offset by an increase in other long term assets of $5.5 million.

During the year ended December 31, 2020, net cash used in operating activities was $87.0 million, resulting from our net loss of $91.1 partially offset by non-cash items of $5.1 million. Non-cash items primarily include stock-based compensation of $3.7 million and depreciation expense of $0.8 million. The increase in prepaid research and development of $11.7 million was offset by increases in accounts payable of $3.2 million and accrued expenses and other current liabilities of $7.3 million.

Investing activities

During the years ended December 31, 2021 and 2020 we used $2.9 and $8.2 million of cash for investing activities related to purchases of property and equipment.

Financing activities

During the year ended December 31, 2021, net cash provided by financing activities was $234.4 million, primarily consisting of $232.5 million of proceeds from the issuance of common stock in our initial public offering, $1.4 million in proceeds from stock option exercises, and $0.4 million in proceeds from common stock issued pursuant to the Company's employee stock purchase plan.

During the year ended December 31, 2020, net cash provided by financing activities was $246.8 million primarily consisting of $248.2 million of proceeds from the issuance of preferred stock offset by $1.5 million of deferred initial public offering costs.



Contractual obligations

Leases

See Note 6. Commitments and contingencies, to our audited financial statements included in Item 8 of this Annual Report for a summary of our operating lease commitments as of December 31, 2021.

In January 2021, we entered into a lease agreement with an initial term of 10.5 years for office space in Redwood City, California, with expected occupancy to commence in the third quarter of 2022.

Manufacturing production lines

In 2020, the Company began developing production lines to automate the production of its Talis One cartridges for the COVID-19 assay with the intention to scale up its manufacturing capabilities to meet demand. These commitments represent firm commitments relating to the scale-up of manufacturing capacity for Talis One cartridges, primarily attributed to investments in production lines. We expect to incur commitments, in the normal



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course of business, related to the scale up of production lines of $6.6 million which is expected to be incurred in the twelve month period subsequent to December 31, 2021.

Purchase commitments

Purchase obligations include agreements to purchase goods or services that are enforceable and legally binding to us and that specify all significant terms. Purchase obligations exclude agreements that are cancelable without penalty. Recognition of purchase obligations occurs when products or services are delivered. We have purchase commitments of $15.8 million. Our purchase commitments are incurred in the normal course of business and made up of $12.8 million related to Talis One cartridges, $2.0 million for Talis One instruments, and $1.0 million relating to the purchase of the Antigen Tests for distribution, all of which will be incurred in the twelve month period subsequent to December 31, 2021.

Apart from the contracts with payment commitments that we have reflected above, we have entered into other contracts in the normal course of business with certain contract manufacturing organizations and other third parties for manufacturing services. Payments due upon cancellation consist only of payments for services provided and expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation.

Critical accounting policies and significant judgments and estimates

This MD&A is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in greater detail in Note 2 to our financial statements appearing within Item 8 of this Annual Report, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

Research and development expenses

Capitalizing pre-launch inventory costs will not occur prior to obtaining an EUA or other FDA marketing authorization unless the regulatory review process has progressed to a point that objective and persuasive evidence of regulatory approval is sufficiently probable, commercialization is considered probable and future economic benefit can be asserted. We have incurred significant costs related to the scale-up of manufacturing activities for commercialization. We record such costs as research and development expenses, or if used in marketing evaluations costs are recorded as selling, general and administrative expenses. A number of factors are taken into consideration, based on our management's judgment, including the current status in the regulatory approval process, potential impediments to the approval process, anticipated research and development initiatives and risk of technical feasibility, viability of commercialization and marketplace trends.

All materials, equipment, and external consulting costs associated with developing aspects of the production line that do not have an alternative future use are expensed as research and development costs until regulatory approval or clearance is obtained, and commercialization is probable. Materials, equipment, and external consulting costs associated with developing aspects of the production line that are deemed to have an alternative future use are capitalized as property and equipment, assessed for impairment and depreciated over their related useful lives. These research and development costs, including expenditures for property and equipment with no alternative future use, are classified as operating cash outflows within our statements of cash flows.

For certain research and development services where we have not yet been invoiced or otherwise notified of actual cost from the third-party contracted service providers, we are required to estimate the extent of the services that have been performed on our behalf and the associated costs incurred at each reporting period. The majority of our service providers invoice us monthly in arrears for services performed. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary.



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Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Stock-based compensation

We measure stock-based compensation expense for stock options and restricted stock units (RSUs) granted to our employees and directors on the date of grant and recognize the corresponding compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. We also recognize stock-based compensation expense associated with our employee stock purchase plan (ESPP) based on the grant date fair value required under authoritative guidance. Forfeitures are recorded as they occur.

From time to time, we may grant stock options to employees, including executive officers, that vest upon the satisfaction of both service-based and performance-based vesting conditions. We recognize stock-based compensation over the requisite service period using the accelerated attribution method for awards with a performance condition if the performance condition is deemed probable of being met.

We estimate the fair value of stock options granted to our employees and directors on the grant date, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the use of subjective assumptions which determine the fair value of stock option awards. These assumptions include:

Expected term. The expected term of options represents the period of time that options are expected to be outstanding. Our historical stock option exercise experience does not provide a reasonable basis upon which to estimate an expected term due to lack of sufficient data. We estimate the expected term by using the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options.

Expected volatility. Prior to our IPO, there has been no public market for our common stock, and as a result we do not have any trading history of our common stock, expected volatility is estimated based on the average volatility for comparable publicly traded diagnostic companies over a period equal to the expected term of the stock option grants. The comparable companies are chosen based on their similar size, stage in the life cycle or area of specialty.

Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the stock option grants.

Expected dividend yield. We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we use an expected dividend yield of zero.

Following the closing of our IPO, we determine the fair market value of our common stock based on its closing price as reported on the date of grant on the primary stock exchange on which our common stock is traded.

Prior to our IPO, there has been no public market for our common stock. As such, the estimated fair value of the common stock underlying our stock options was determined by our board of directors, with input from management, considering our most recently available third-party valuations of common stock and our board of directors' assessment of additional objective and subjective factors that it believed were relevant, and factors that may have changed from the date of the most recent valuation through the date of the grant, which intended all options granted to be exercisable at a price per share not less than the per share fair value of our common stock underlying those options on the date of grant. We believe that our board of directors has the relevant experience and expertise to determine the fair value of our common stock. Prior to our IPO, given the absence of a public trading market for our common stock, the valuations of our common stock were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date.



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The assumptions we used in the pre-IPO valuation model were based on future expectations combined with management judgment. In the absence of a public trading market, our board of directors with input from management exercised significant judgment and considered numerous objective and subjective factors to determine the fair value of our common stock as of the date of each option grant, including the following factors:

contemporaneous independent valuations performed at periodic intervals by an independent third-party valuation firm;

the prices at which we sold shares of preferred stock and the superior rights and preferences of the preferred stock relative to our common stock at the time of each grant;

the progress of our research and development programs, including the status and results of preclinical studies for our platform;

our stage of development and commercialization and our business strategy;

external market conditions affecting the diagnostics industry and trends within the diagnostics industry;

the lack of an active public market for our common stock; and

the likelihood of achieving a liquidity event, such as an initial public offering or sale of our company in light of prevailing market conditions.

In March 2020, we offered to reprice the unexercised stock options of each employee or non-employee director with an exercise price equal to $6.38 or higher per share to the estimated fair market value of our Class A Common Stock on March 13, 2020 of $1.51 per share. The repriced options were subject to the same terms as the original granted options, except for the new exercise price. As a result of the offering, we modified the exercise price of stock options for the purchase of 407,415 shares of common stock with a weighted average exercise price of $15.55 per share, by cancelling these options and reissuing stock options with an exercise price of $1.51 per share to purchase 407,415 shares of common stock. The calculation of the incremental compensation expense is based on the excess of the fair value of the award measured immediately before and after the modification. As a result of the modification, we recognized incremental compensation expense of $0.3 million for the year ended December 31, 2020.

Leases

Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the remaining lease term. The present value of future lease payments are discounted using the interest rate implicit in lease contracts if that rate is readily determinable; otherwise we utilize our incremental borrowing rate (IBR), which reflects the fixed rate at which we could borrow on a collateralized basis over a similar term, the amount of the lease payments in a similar economic environment. After lease commencement and the establishment of a right-to-use asset and operating lease liability, lease expense is recorded on a straight-line basis over the lease term.

Recoverability of long-lived assets

We review the carrying amount of our long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset or an asset group may not be fully recoverable. If indicators of impairment exist, an impairment loss would be recognized when the estimated undiscounted future cash flows expected to result from the use of the asset or asset group and its eventual disposition are less than its carrying amount. The impairment charge is determined based upon the excess of the carrying value of the asset over its estimated fair value, with estimated fair value determined based upon an estimate of discounted future cash flows or other appropriate measures of estimated fair value. For purposes of recognition of impairment for long-lived assets, we group assets and liabilities at the lowest level for which cash flows are separately identifiable.

Recently issued accounting pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our audited financial statements included within Item 8 of this Annual Report.



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Emerging growth company status

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an emerging growth company may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Therefore, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected to avail ourselves of this extended transition period and, as a result, we may adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies instead of the dates required for other public companies. However, we may early adopt these standards, for example we elected to early adopt ASC 842, Leases.

In addition, as an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:

reduced disclosure about the compensation paid to our executive officers;

not being required to submit to our stockholders' advisory votes on executive compensation or golden parachute arrangements;

an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act; and

an exemption from new or revised financial accounting standards until they would apply to private companies and from compliance with any new requirements adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation.

We may take advantage of these exemptions for up to the last day of the fiscal year ending after the fifth anniversary of our initial public offering or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (1) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (2) the last day of our fiscal year following the fifth anniversary of the date of our initial public offering; (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. We may choose to take advantage of some but not all of these exemptions.

We are also a "smaller reporting company" meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

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