SERA US Equity☆

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-K, 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 Form 10-K, 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.

Investors and others should note that we routinely use the Investors section of our website to announce material information to investors and the marketplace. While not all of the information that we post on the Investors section of our website is of a material nature, some information could be deemed to be material. Accordingly, we encourage investors, the media, and others interested in us to review the information that we share on the Investors section of our website, investors.seraprognostics.com.

Overview

We are a women’s health company utilizing our proprietary proteomics and bioinformatics platform to discover, develop, and commercialize clinically meaningful and economically impactful biomarker tests, with an initial focus on improving pregnancy outcomes. We believe that our method of combining the disciplines of proteomics and bioinformatics with rigorous clinical testing and economic analysis enables us to provide physicians and patients with actionable data and information designed to result in better maternal and neonatal health at lower cost. Our vision is to deliver pivotal and actionable information to pregnant women, their physicians, and health care payers to significantly improve maternal and neonatal health and to dramatically reduce health care costs. We have built an advanced, proprietary, and scalable proteomics and bioinformatics platform to characterize the biology of pregnancy and to discover and validate key protein biomarkers found in blood that are highly accurate predictors of dynamic changes that occur during pregnancy. By incorporating our proprietary technology platform into our rigorous data-driven development process, we have created a differentiated approach for effectively addressing major conditions of pregnancy. We envision that our comprehensive approach will enable us to fully characterize one of the most important periods in the lives of women and children, and will help to improve their well-being. Our goal is to develop and commercialize tests that inform important decisions during all pregnancies. We also believe that the work we perform in pregnancy can ultimately be leveraged more broadly to address other areas in medicine and health care.

Our first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a premature delivery, also known as preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman, carrying a single fetus, during weeks 18 through 20 of gestation that provides an accurate prediction of the expectant mother’s risk of delivering spontaneously before 37 weeks’ gestation. Our commercialization strategy includes conducting clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients. Elevance Health, Inc. (formerly known as Anthem, Inc.), or Elevance Health, whose health plans cover more than 10% of U.S. pregnancies annually, agreed to make our PreTRM test available to eligible pregnant members as part of a multi-year contract. Elevance Health is one of the nation’s largest health insurers with greater than 47 million members nationwide. Through this collaboration, a significant number of physicians and patients in the U.S. gain access to early and accurate predictions of preterm birth to enable more informed decision-making during pregnancy. Sera believes that its commercial collaboration with Elevance Health further validates the clinical and economic value of its PreTRM test. We are actively discovering and developing several additional biomarker tests to predict other major conditions of pregnancy, such as preeclampsia, and gestational diabetes, among others, that have the potential to offer significant health benefits to women and their babies.

There are approximately 140 million births globally each year. Of these, it is estimated that as many as 25% are affected by various complications, including: preterm birth, preeclampsia, fetal growth restriction, stillbirth, hypertension of pregnancy, gestational diabetes, and others. In the United States, there are approximately 3.7 million births annually, and 10.5% of those pregnancies result in preterm births with profound short- and long-term health consequences to the mother and baby. These health consequences are estimated to lead to associated costs of approximately $25 billion annually in the United States. Traditional methods to detect prematurity risk in time for proactive management have been limited and fail to identify the vast majority of women who will deliver prematurely.

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Our blood-based biomarkers were demonstrated to be predictive of very early preterm birth of any cause, length of neonatal hospital stay, and neonatal morbidity and mortality in the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP) study, a large prospective U.S. study. Additional new data published in May 2022 showed improved PreTRM Test predictive performance for women whose due dates are more reliably determined by ultrasound. We believe our actionable blood-based biomarker test for prematurity risk can enable patients, physicians, and payers to more proactively manage and mitigate the complications and associated costs of prematurity. Given that pregnancy is the launch point for the future health of babies and a key determinant in the future health of mothers and babies, we believe this area is ripe for innovation and better tools to improve patient outcomes.

Our operations are located in Salt Lake City, Utah, including a CLIA-certified laboratory. Since our inception, we have devoted the majority of our efforts and resources to performing research and development, acquiring product rights, raising capital, establishing facilities, conducting clinical trials, and establishing commercial operations to market the PreTRM test. During this fiscal year, we have incurred annual net losses. We have largely funded our operations with proceeds from the sale and issuance of convertible preferred stock, debt financings, bank loans, and the sale and issuance of Class A common stock in our IPO, which was completed in July 2021. See Note 10—Capital Structure for additional details about the IPO.

We have incurred significant operating losses since inception. Our net losses were $44.2 million and $35.0 million for the years ended December 31, 2022 and 2021, respectively. We expect to incur significant additional operating losses and negative cash flows for the foreseeable future, principally as a result of our commercialization activities for the PreTRM test, and to support additional clinical studies, publications, and anticipated research and development activities.

We have signed an agreement with Elevance Health, pursuant to which Elevance Health agreed to purchase our PreTRM test, and we continue to negotiate contracts with private and governmental payers and health systems that could eventually result in revenues. If we are unable to secure payer contracts that result in significant revenues or access additional funds, we may be required to delay, scale back or abandon some, or all, of our development programs and other operations. Until such time as we can generate significant revenue from the sales of our products, if ever, we may need to continue to finance our cash needs through equity offerings, debt financings or other capital sources, potentially including collaborations or other similar arrangements. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends and may require the issuance of warrants. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may have to significantly delay, reduce, or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition, and results of operations.

Impact of COVID-19

The COVID-19 pandemic continues to evolve. While it appears its most severe effects have subsided, COVID-19 could re-emerge or new public health threats could appear. The future impact of the COVID-19 pandemic or a similar health disruption is highly uncertain and subject to change. We cannot predict the full extent of potential delays or impacts on our business, our clinical trials, health care systems or the global economy as a whole. To date, the primary impacts to our business have been the early cessation of enrollment in our Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls study, or the AVERT PRETERM TRIAL study, in March 2020, the delayed commencement of enrollment in our PRIME study until November 2020 and slower than expected enrollment thereafter, and limited access to ordering clinicians during our early commercialization of our PreTRM test. We have enrolled sufficient numbers of PRIME study patients to enable the interim analysis to occur in 2023, and expect to report the results of that analysis if and when we are able to do so. If COVID-19 re-emerges as a serious public health threat, or if another serious pathogen appears, then we may experience additional disruptions that could severely impact our business, preclinical studies, and clinical trials, including potential delays.

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Factors Affecting Our Performance

We believe there are several important factors that have impacted, and that we expect will continue to impact, our operating performance and results of operations, including:

•our ability to further increase the use and adoption of the PreTRM test;

•our ability to develop and successfully commercialize new products and services in the future;

•the continued development of the market for proteomics and bioinformatics;

•our ability to secure payer and health system contracts that result in significant revenues or to access additional funds;

•raising substantial additional capital to continue operations and execute on our business plan, until such time as we can generate significant revenue from the sales of our products, if ever;

•obtaining and maintaining intellectual property protection for our technology and products; and

•other factors described in the “Risk Factors” section and elsewhere in this report.

Key Components of Our Results of Operations

Revenues

We expect to derive substantially all of our revenue in the near term from sales of the PreTRM test. We generally expect revenue to increase as sales volume continues to increase and as we continue to engage with payers and health systems to close payment contracts. These additional contracts may enable an upfront negotiated payment rate which could eventually result in additional revenues when health care providers order the PreTRM test.

Operating Expenses

Cost of Revenue

Cost of revenue reflects the aggregate costs incurred in delivering the proteomic testing results to clinicians and includes expenses for third-party specimen collection and shipping costs, as well as our lab personnel, materials and supplies, equipment and infrastructure expenses associated with clinical testing, and allocated overhead including rent and equipment depreciation. We expect costs of revenue will generally move in line with the sales of the PreTRM test.

Research and Development Expenses

Research and development expenses consist of costs incurred for our research activities and development of our product candidates. These expenses include:

•clinical studies;

•laboratory processes;

•research and bioinformatic activities;

•biobanking and publication efforts;

•personnel-related expenses, including salaries, payroll taxes, employee benefits, and stock-based compensation charges for employees engaged in these research and development activities;

•direct clinical study expenses incurred under agreements with clinical study sites or contract research organizations;

•consultants engaged in our research and development efforts;

•laboratory materials and supplies;

•facilities costs; and

•depreciation, amortization, and other direct and allocated expenses, including rent, insurance, and other operating costs, incurred as a result of our research and development activities.

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We expense all research and development costs, both internal and external, in the period in which they are incurred. We expect that our research and development expenses will increase in 2023 compared to 2022. Research and development costs may increase in the medium to long-term as we support current and additional clinical studies, publications, and other product development activities.

Selling and Marketing Expenses

Selling and marketing expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for sales, marketing, and payer access personnel. Other significant costs include travel, consulting, public relations, and legal costs related to commercial efforts. We expect selling and marketing expenses to decrease in 2023 compared to 2022 as we took steps in 2022 to streamline our sales team and focus our commercial strategy in response to market dynamics. We expect selling and marketing expenses to increase in the medium-term as we hire personnel to implement our refocused sales strategy, and then in the long-term as we expand our dedicated sales team to more completely cover U.S. sales channels over time as we enter into contracts with payers and health systems.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for personnel in executive, finance, information technology, human resources, and other administrative functions. Other significant costs include facilities, corporate and intellectual property legal fees, accounting, insurance, consulting, and other professional fees.

We expect general and administrative expenses will remain relatively consistent in 2023 compared to 2022, which will maintain the appropriate level of support for our current level of operations. We expect general and administrative expenses to increase in the medium to long-term as needed to support future operations and anticipated revenue growth.

Interest Expense

Interest expense in 2022 represents interest incurred on our finance leases. Interest expense in 2021 represents interest incurred on our finance leases, loans payable and convertible promissory note, amortization of a discount feature on a convertible promissory note, and periodic fair value adjustments on certain liabilities. As of December 31, 2022, we had no outstanding debt.

Other Income, Net

Other income, net consists of interest earned on our cash, cash equivalents, and marketable securities, and other gains and losses. In 2021, other income, net also included periodic fair value adjustments on certain liabilities.

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Results of Operations

The results of operations presented below should be reviewed in conjunction with the financial statements and related notes included elsewhere in this report.

Comparison of the Years Ended December 31, 2022 and 2021

The following table summarizes our results of operations for the years ended December 31, 2022 and 2021:

Year Ended December 31,

(in thousands)

Operating expenses:

Research and Development Expenses

The following table summarizes our research and development expenses for the years ended December 31, 2022 and 2021:

Year Ended December 31,

(in thousands)

Research and development expenses:

The $3.2 million increase was due to a $2.0 million increase in clinical study costs, and a $1.3 million increase in research and bioinformatics expenses, partially offset by a $0.1 million decrease in laboratory operations costs. The $2.0 million increase in clinical study costs was primarily due to a $0.9 million increase resulting from the increased enrollment and site setup activity in the PRIME study, a $0.8 million increase in personnel costs driven by increased average headcount, and a $0.4 million increase in stock-based compensation expense. The $1.3 million increase in research and bioinformatics expenses was primarily due to an increase of $0.8 million in personnel costs driven by increased average headcount, a $0.3 million increase in specimen acquisition costs related to product development, and a $0.3 million increase in stock-based compensation expense. The $0.1 million decrease in laboratory operations costs was primarily due to a $0.4 million decrease in lab supplies, and a $0.1 million decrease in consulting costs, partially offset by a $0.4 million increase in personnel costs driven by increased average headcount.

Selling and Marketing Expenses

The $4.4 million increase was due primarily to increases of $2.2 million in personnel-related costs driven by increased average headcount, $1.0 million of marketing programs and materials development, $0.7 million of travel costs driven by

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increased average headcount and relaxed COVID-19 restrictions, $0.7 million of IT systems to support sales efforts, and $0.5 million of severance costs related to efforts to streamline our sales team, partially offset by a $0.8 million decrease in consulting and outside services.

General and Administrative Expenses

The $2.7 million increase was due primarily to increases of $1.3 million of personnel expenses driven by increased average headcount, $1.4 million of stock-based compensation expense, $0.8 million of director and officer insurance costs which increased as a result of our becoming a public company, and $0.3 million of consulting fees, partially offset by a $0.6 million decrease in recruiting fees, and a $0.3 million decrease related to capitalized employee costs for an internal software project.

Interest Expense

Interest expense for the year ended December 31, 2021 included $0.4 million related to fair value adjustments on certain liabilities that were extinguished in that period and $0.3 million related to debt that was fully repaid during that period. Interest expense for the year ended December 31, 2022 is related to our finance leases.

Other Income, net

The $0.4 million increase in other income was primarily due to a $1.1 million increase related to investment income on our marketable securities and a $0.3 million increase in interest income related to our marketable securities, partially offset by a one-time $1.1 million gain on extinguishment of the Paycheck Protection Program (“PPP”) loan that occurred in the prior year.

Liquidity and Capital Resources

Sources of Liquidity

Since inception, we have not generated a significant amount of commercial revenue from product sales or any other sources and have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. We have financed our operations primarily through proceeds from the sale and issuance of convertible preferred stock and convertible notes, bank loans, and the sale and issuance of Class A common stock in our IPO, which was completed in July 2021. See Note 10—Capital Structure for additional details about the IPO. As of December 31, 2022, we had cash, cash equivalents, and available-for-sale securities of approximately $104.0 million, and an accumulated deficit of $210.7 million.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

Year Ended December 31,

(in thousands)

Net cash (used in) provided by:

Net (decrease) increase in cash and cash equivalents $ (29,054) $ 45,399

Operating Activities

The net cash used in operating activities during the year ended December 31, 2022 was primarily due to a net loss of $44.2 million, partially offset by non-cash charges of $6.0 million and an increase in operating assets and liabilities of $3.6 million. The net cash used in operating activities during the year ended December 31, 2021 was primarily due to a net loss of $35.0 million, partially offset by non-cash charges of $3.4 million.

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Investing Activities

Net cash provided by investing activities for the year ended December 31, 2022 was primarily due to $54.4 million in proceeds from maturities and sales of marketable securities, partially offset by $48.1 million in purchases of marketable securities and $0.8 million in purchases of property and equipment. Net cash used in investing activities for the year ended December 31, 2021 was primarily due to $82.1 million in purchases of marketable securities and $1.3 million in purchases of property and equipment, partially offset by proceeds from maturities and sales of marketable securities of $0.8 million.

Financing Activities

Net cash provided by financing activities for the year ended December 31, 2022 was due to $0.3 million in proceeds from options exercised, partially offset by $0.3 million of finance lease principal payments. Net cash provided by financing activities for the year ended December 31, 2021 was primarily due to net proceeds of $100.1 million from the sale of Series E convertible preferred stock, including $1.1 million allocated to common stock warrants issued in connection with the sale of Series E convertible preferred stock, net proceeds of $66.6 million from our IPO, and $0.6 million in proceeds from options exercised, partially offset by $3.1 million and $4.5 million of loan and note repayments, respectively.

Future Funding Requirements

We expect to incur significant additional operating losses and negative cash flows for the foreseeable future. We expect our losses in the future to arise principally as a result of our commercialization activities for the PreTRM test, and to support additional clinical studies and anticipated research and development activities. There can be no assurance that we will eventually achieve significant revenues or profitability, or if achieved, can sustain either on a continuing basis. If we are unable to achieve significant revenues or raise additional funding, when needed, we may not be able to continue the development or commercialization of our diagnostic products and could be required to delay, scale back, or abandon some or all of our development programs and other operations. No assurance can be given that we will be successful in raising the required capital at reasonable cost and at the required times, or at all. Any additional equity financing may not be available on favorable terms, most likely will be dilutive to our current stockholders, and debt financing, if available, may involve restrictive covenants and dilutive financing instruments. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned. We currently have no credit facility or committed sources of capital. Our future funding requirements will depend on many factors, including the following:

•the timing, receipt, and amount of sales from the PreTRM test;

•the cost and timing of establishing sales, marketing, and other commercialization capabilities in the United States and abroad;

•our ability to develop and commercialize other products;

•the terms and timing of any collaborative, licensing, and other arrangements that we may establish;

•the cost, timing, and outcomes of regulatory approvals;

•the scope, rate of progress, results, and cost of our clinical studies, and other related activities;

•the cost of preparing, filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights;

•the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions;

•partnerships and other strategic options for our product and other product candidates; and

•other factors described in the “Risk Factors” section and elsewhere in this report.

We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.

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Contractual Obligations and Commitments

Our material cash requirements include the following contractual and other obligations.

Leases

We have lease arrangements for certain equipment and facilities. As of December 31, 2022, we had future minimum lease payments of $3.1 million, with $1.1 million payable within 12 months.

Consulting Agreement

We have a consulting agreement with Blue Ox Healthcare Partners, LLC, or Blue Ox, to advise us on development of strategies with the goal to obtain widespread insurance coverage for the PreTRM test. As of December 31, 2022, we had future minimum payments under this agreement of $0.7 million, with $0.6 million payable within 12 months.

Critical Accounting Policies, Significant Judgments and Use of Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Stock-based Compensation

We maintain a stock-based compensation plan as a long-term incentive for employees and non-employee consultants. The plan allows for the issuance of incentive stock options and non-qualified stock options, as well as other stock rights.

We recognize stock-based compensation expense for stock options on a straight-line basis over the requisite service period and estimate forfeitures based on historical evidence. Our stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. Input assumptions used in calculating the fair value of stock-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgment. These input assumptions include the expected term of the awards, the expected common stock price volatility over the term of the awards, risk-free interest rates, and the expected dividend yield. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. We will continue to use judgment in evaluating the expected volatility, expected terms, and interest rates utilized for out stock-based compensation expense calculations on a prospective basis.

Emerging Growth Company and Smaller Reporting Company Status

We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (1) are no longer an EGC or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies, reduce disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and are exempt from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. As an EGC, we are also not required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act. As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates and we are not required to provide auditor attestation regarding requirements of Section 404(b) of Sarbanes-Oxley.

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We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (2) the last day of the fiscal year in which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) December 31, 2026.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that the market value of our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter.

Recent Accounting Pronouncements

A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2—Significant Accounting Policies, appearing in Part II, Item 8 of this Annual Report on Form 10-K.

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

Interest Rate Risk

Our exposure to changes in interest rates relates primarily to interest earned and market value on our cash and cash equivalents and marketable securities.

Our cash and cash equivalents and marketable securities consist of cash held in banks, money market funds, commercial paper, U.S. government securities, U.S. federal agency securities and investment grade corporate securities. Our investment policy and strategy are focused on preservation of capital and supporting our liquidity requirements. Changes in U.S. interest rates affect the interest earned on our cash and cash equivalents and marketable securities, and the market value of those securities. A hypothetical 100 basis point increase in interest rates would have resulted in a decrease of $0.5 million in the market value of our available-for-sale debt securities as of December 31, 2022. Any realized gains or losses resulting from such interest rate changes would only occur if we sold the investments prior to maturity.

Foreign Currency

We do not regularly incur expenses with vendors outside the United States or that are denominated in currencies other than the U.S. dollar. We may incur such expenses in the future at which point exchange rate fluctuations might adversely affect our expenses, results of operations, financial position and cash flows. To date, exchange rate fluctuations have not had a material effect on our results of operations.

Effects of Inflation

We do not believe inflation has had a material effect on our results of operations during the periods presented. However, the current inflationary environment could affect us by increasing our costs of labor, laboratory supplies, and clinical trials and could adversely affect our business, results of operations, financial position and cash flows. In addition, increased inflation has had, and may continue to have, an effect on interest rates and may adversely affect our borrowing rate and our ability to obtain any potential additional funding.

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Item 8. Financial Statements and Supplementary Data

INDEX TO FINANCIAL STATEMENTS

Page

Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) 88

Balance Sheets 89

Statements of Operations and Comprehensive Loss 90

Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 91

Statements of Cash Flows 92

Notes to Financial Statements 93

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Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Sera Prognostics, Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheets of Sera Prognostics, Inc. (the Company) as of December 31, 2022 and 2021, the related statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2012.

Salt Lake City, Utah

March 22, 2023

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SERA PROGNOSTICS, INC.

Balance Sheets

(in thousands, except share and per share data)

December 31,

Assets

Current assets:

Accounts receivable 113 27

Prepaid expenses and other current assets 1,308 1,993

Liabilities and Stockholders' Equity

Current liabilities:

Accrued and other current liabilities 4,444 3,885

Deferred rent, current portion — 139

Finance lease obligation, current portion 464 74

Finance lease obligation, net of current portion 626 54

Operating lease obligation, net of current portion 1,222 —

Commitments and contingencies (Note 13)

Stockholders' equity:

Accumulated other comprehensive loss (981) (183)

Total liabilities and stockholders' equity $ 116,329 $ 147,029

The accompanying notes are an integral part of the financial statements

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SERA PROGNOSTICS, INC.

Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Year Ended December 31,

Operating expenses:

Interest expense (61) (746)

Net loss per share, basic and diluted $ (1.43) $ (2.33)

Other comprehensive loss:

Unrealized loss on available-for-sale debt securities $ (798) $ (183)

Total other comprehensive loss (798) (183)

The accompanying notes are an integral part of the financial statements

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SERA PROGNOSTICS, INC.

Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share and per share data)

Shares Amount Shares Amount Shares Amount

Stock warrant exercises — — — — 22,372 — — — — —

Stock-based compensation expense — — — — — — 3,130 — — 3,130

Other comprehensive loss — — — — — — — (183) — (183)

Stock-based compensation expense — — — — — — 5,055 — — 5,055

Other comprehensive loss — — — — — — — (798) — (798)

The accompanying notes are an integral part of the financial statements

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SERA PROGNOSTICS, INC.

Statements of Cash Flows

(in thousands)

Year EndedDecember 31,

Cash flows from operating activities

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization 756 659

Non-cash lease expense 462 —

Non-cash interest expense 12 588

Gain on extinguishment of PPP loan — (1,050)

Changes in operating assets and liabilities:

Accounts receivable (86) (25)

Prepaid expenses and other assets 718 (1,880)

Accrued and other current liabilities (514) 1,388

Deferred rent — (130)

Net cash used in operating activities (34,610) (31,636)

Cash flows from investing activities

Purchases of marketable securities (48,073) (82,055)

Proceeds from maturities and sales of marketable securities 54,399 800

Purchases of property and equipment (791) (1,304)

Proceeds from disposal of property and equipment 16 —

Net cash provided by (used in) investing activities 5,551 (82,559)

Cash flows from financing activities

Proceeds from exercise of stock options 308 592

Payment of convertible note payable — (4,494)

Payment of loan payable — (3,100)

Finance lease principal payments (303) (70)

Net cash provided by financing activities 5 159,594

Net (decrease) increase in cash and cash equivalents (29,054) 45,399

Cash and cash equivalents at beginning of period 58,932 13,533

Cash and cash equivalents at end of period $ 29,878 $ 58,932

Supplemental disclosure of cash flow information

Cash paid for interest $ 48 $ 1,188

Supplemental disclosure of non-cash investing and financing information

Purchases of property and equipment in accounts payable and accruals $ — $ 154

The accompanying notes are an integral part of the financial statements

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SERA PROGNOSTICS, INC.

Notes to Financial Statements

1. Description of Business and Financial Condition

Sera Prognostics, Inc. (the “Company”) is a women’s health company utilizing its proprietary proteomics and bioinformatics platform to discover, develop, and commercialize biomarker tests with an initial focus on improving pregnancy outcomes. The Company was incorporated in the State of Delaware on January 17, 2008 and its operations are located in Salt Lake City, Utah, including a Clinical Laboratory Improvement Amendments (“CLIA”)-certified laboratory.

Since its inception, the Company’s activities have consisted of performing research and development, conducting clinical studies, acquiring product rights, raising capital, establishing facilities, and organizing commercial operations to market the PreTRM test.

Liquidity and Capital Resources

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

The Company has incurred net losses and negative cash flows from operations since inception and had an accumulated deficit of $210.7 million as of December 31, 2022. The Company’s management expects the Company to incur significant additional operating losses and negative cash flows for the foreseeable future, principally as a result of the Company’s commercialization activities for the PreTRM test, and to support additional clinical and preclinical trials and anticipated research and development activities. There can be no assurance that the Company will eventually achieve significant revenues or profitability to sustain operations, or if achieved, can sustain either on a continuing basis. If the Company is unable to achieve significant revenues or raise additional funds, when needed, it may not be able to continue the development or commercialization of its diagnostic products and could be required to delay, scale back, or abandon some or all of its development programs and other operations. No assurance can be given that the Company will be successful in raising the required capital on reasonable terms and at the required times, or at all. Any additional equity financing, if available to the Company, may not be available on favorable terms and may be dilutive to current stockholders, and any debt financing, if available, may involve restrictive covenants and dilutive financing instruments. The Company’s future operations are highly dependent on a combination of factors, including (i) the successful commercial launch and market acceptance of the PreTRM test; (ii) the success of clinical trials and other research and development programs; (iii) the development of competitive products by other biotechnology and laboratory companies; (iv) the Company’s ability to manage growth of the organization; (v) the Company’s ability to protect its intellectual property, technology, and products; and, ultimately (vi) the timely and successful completion of any additional financing.

The principal sources of the Company’s working capital to date have been the proceeds from the sale and issuance of convertible preferred stock and convertible notes, bank loans, and the sale and issuance of Class A common stock in an initial public offering (“IPO”), which was completed in July 2021. See Note 10—Capital Structure for additional details about the IPO. As of December 31, 2022, the Company had aggregate cash, cash equivalents, and available-for-sale securities of approximately $104.0 million. See Note 3—Cash, Cash Equivalents and Marketable Securities.

The Company believes that its existing financial resources are sufficient to continue operating activities at least 12 months from the issuance date of these financial statements.

2. Significant Accounting Policies

Basis of Presentation

The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (“ASC”), and Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”).

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Use of Estimates

The preparation of the financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. Actual results could differ materially from those estimates.

The Company’s financial statements as of and for the year ended December 31, 2022 reflect the Company’s estimates of the impact of the macroeconomic environment, including the impact of inflation, higher interest rates, and the COVID-19 pandemic. The extent to which these conditions will directly or indirectly impact the Company’s business, results of operations, and financial condition is uncertain. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments, and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the date of this filing.

Cash and cash equivalents

The Company considers all highly liquid financial instruments with maturities of 90 days or less at the date of purchase to be cash equivalents. The carrying amounts reported in the balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value. As of December 31, 2022 and 2021, cash and cash equivalents consisted of cash, money market funds, and commercial paper. Cash and cash equivalents are stated at fair value.

Marketable Securities

The Company has classified its marketable securities, all of which are debt securities, as available-for-sale securities. These securities are carried at estimated fair value with any unrealized gains and losses, net of the related tax effect, included in accumulated other comprehensive loss in stockholders’ equity until realized. Gains and losses on marketable security transactions are reported on the specific-identification method.

A decline in the fair value of any available-for-sale security below cost that is deemed other than temporary results in a charge to other income, net. The Company reviews several factors to determine whether a loss is other than temporary. These factors include but are not limited to: (i) the extent to which the fair value is less than cost and the cause for the fair value decline, (ii) the financial condition and near term prospects of the Company, (iii) the length of time a security is in an unrealized loss position and (iv) the Company’s ability to hold the security for a period of time sufficient to allow for any anticipated recovery in fair value.

Concentration of credit risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company maintains bank deposits in accounts at federally insured financial institutions and these deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institution holding its cash to the extent recorded in the balance sheet. The Company has not experienced any losses on its deposits of cash. The Company’s cash equivalents consist of money market funds and investment grade commercial paper. Marketable securities consist of investments in U.S. government securities, U.S. federal agency securities, investment grade commercial paper, and investment grade corporate securities. The Company’s investment portfolio in corporate debt securities is highly liquid and diversified among individual issuers. The Company did not experience any credit losses related to its investment portfolio for the years ended December 31, 2022 and 2021.

Property and Equipment

Property and equipment are recorded at cost less accumulated depreciation and amortization. The Company capitalizes third-party and relevant internal personnel costs incurred in the application development stage to design and implement the software used for its Laboratory Information Management System (“LIMS”).

Depreciation and amortization are computed using the straight-line method over the shorter of estimated useful lives of the assets or the respective lease term. The estimated useful life of each asset category is as follows:

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Computer equipment 3 years

Software 3 years

Machinery and equipment 5 years

Furniture and fixtures 5 years

Leasehold improvements Shorter of useful life or remaining lease term

Amortization expense of assets acquired through finance leases is included in depreciation and amortization expense in the accompanying statements of operations and comprehensive loss. Costs of repairs and maintenance that do not extend the useful life or improve the related assets are expensed as incurred. Costs of major replacements or improvements are capitalized. When assets are sold, or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and any gain or loss is included in operating expense.

Leases

The Company adopted ASU 2016-02, Leases, (“Topic 842”) and its subsequent updates effective January 1, 2022. The Company adopted Topic 842 using a modified retrospective method. As such, comparative periods ending prior to January 1, 2022 are presented in accordance with ASC 840, Leases, and periods ending after January 1, 2022 are presented in accordance with Topic 842. There was no impact to the Company’s accumulated deficit as a result of adopting Topic 842. The Company used the package of practical expedients permitted under Topic 842. As a result, the Company did not reassess its lease population, classifications of existing leases, or initial direct costs of existing leases as of the adoption date. The Company elected to treat leases with lease terms of 12 months or less as short-term leases. No right-of-use assets or lease liabilities are recognized for short-term leases. The Company also elected not to separate lease components from non-lease components for all classes of leased assets except for building leases.

The adoption of Topic 842 resulted in a right-of-use asset of $0.5 million related to the Company’s operating lease being recognized in other assets on the balance sheets as of January 1, 2022. A corresponding lease liability of $0.6 million related to the Company’s operating lease was recognized in accrued and other liabilities on the balance sheets as of January 1, 2022. In addition, at January 1, 2022, approximately $0.1 million of lease-related liabilities were removed from deferred rent, current portion as a reduction to the initial operating lease right-of-use asset.

As a result of adopting Topic 842, leases classified as capital leases under ASC 840 are now called finance leases. Accordingly, the balance sheet items formerly captioned “Capital lease obligation, current portion” and “Capital lease obligation, net of current portion” will now be captioned “Finance lease obligation, current portion” and “Finance lease obligation, net of current portion”, respectively, beginning in the current period. Amounts in these balance sheet items were capital leases under ASC 840 in periods ending prior to January 1, 2022, while amounts in these balance sheet items are finance leases under ASC 842 in periods ending subsequent to January 1, 2022. The Company’s finance lease right-of-use asset and liability balances were not materially affected by the adoption of Topic 842.

Deferred Revenue

The Company recognizes deferred revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). Deferred revenue is recognized when a customer pays consideration, or the Company has a right to an amount of consideration that is unconditional before the Company transfers the good or service to the customer. The Company’s deferred revenue balance as of December 31, 2022 and 2021 relates to certain contractual minimum payments received by the Company as part of its commercial collaboration agreements. Deferred revenue is recognized as revenue when the Company delivers PreTRM test results to customers pursuant to its commercial collaboration agreements.

Revenue Recognition

Revenue is generated from the sale of PreTRM tests. The Company recognizes revenue based on accounting standards applied to determine the measurement of revenue and timing of when it is recognized. The Company applies the following five-step approach as set forth under ASC 606: (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 Company satisfies a performance obligation. The Company applies the five-step model when it is probable that the Company will collect the consideration it is entitled to in exchange for fulfilling its performance obligation. The Company recognizes revenue upon delivery of test results, which it considers to be the only performance obligation, and allocates all of the transaction price to this performance obligation.

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In determining the transaction price, which is an estimate of the amount of variable consideration expected to be received, the Company uses the expected value method under ASC 606. The Company considers all reasonably available information to identify various possible consideration amounts and considers the probability of the variable consideration for each scenario. The Company’s estimate of transaction price does not include any estimated amount of variable consideration that is constrained.

Significant judgments are required in determining the estimates for each transaction. These estimates include many assumptions, any of which, if incorrect, could result in significant differences between the estimated price and the amount ultimately collected for any given transaction. The Company applies this method consistently to portfolios of similar contracts when estimating the effect of any uncertainty on the amount of variable consideration to which it will be entitled. In the aggregate, across the numerous transactions within each portfolio, these differences can lead to material variances between estimated and actual revenue in any given period.

The estimate of revenue is necessarily founded on assumptions of payer behavior such as changes in payer mix, payer collections, current customer contractual requirements, and experience with ultimate collection from third-party payers and patients. Each of these aspects of payer behavior (and various others) can change significantly from quarter to quarter, and the Company currently has limited experience with historical payment patterns. Each of these contributes to the potential variability between estimated transaction price and actual consideration received as discussed above, which is expected to be more pronounced early in the process of commercializing a diagnostic test.

In the face of the estimation challenges noted above, the Company makes its best efforts to continually refine its estimates of expected consideration as the Company gains additional experience with collections and historical payment patterns. Accordingly, the Company may update its estimate of the amount of revenue to be recognized for previously delivered tests.

Cost of Revenue

Cost of revenue reflects the aggregate costs incurred in delivering the proteomic testing results to clinicians and includes expenses for third-party specimen collection and shipping costs, as well as the Company’s lab personnel, materials and supplies, equipment and infrastructure expenses associated with clinical testing, and allocated overhead including rent and equipment depreciation. Costs associated with performing the Company’s tests are recorded as the tests are processed regardless of whether and when revenue is recognized with respect to such tests.

Research and Development Expenses

The Company expenses all research and development costs as they are incurred. Research and development expenses consist primarily of personnel costs, stock-based compensation charges, clinical trial costs, and third-party contracted services associated with research and development. The Company recognizes expense associated with third-party contracted services based on the completion of activities as specified in the applicable contracts. Costs incurred under contracts with clinical sites are generally accrued as patient encounters occur, consistent with the terms outlined in the associated contract. Upon termination of contracts with third parties, the Company’s obligations are limited to costs incurred or committed to date. As a result, accrued research and development expenses represent the estimated contractual liability to third parties at the reported period.

Stock-based Compensation

The Company recognizes stock-based compensation for all stock-based awards in accordance with ASC 718, Compensation-Stock Compensation, which requires an entity to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award.

The Company estimates the fair value of share-based awards issued under its employee compensation plans using the Black-Scholes option pricing model. Input assumptions used in calculating the fair value of stock-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgment. These input assumptions include the expected term of the awards, the expected common stock price volatility over the term of the awards, risk-free interest rates, and the expected dividend yield.

The fair value of the Company’s Class A common stock is determined by using the closing price per share of the Company’s Class A common stock as reported on Nasdaq. The Company uses the simplified calculation of expected life

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since the Company does not have sufficient historical exercise data to estimate the expected term. Volatility is based on an average of the historical volatility of the Company’s common stock and the volatilities of the common stock of select comparable publicly-traded entities with characteristics similar to those of the Company. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option. Forfeitures are estimated at the time of grant based on the Company’s historical experience and are adjusted as necessary. The fair value of equity awards is recognized as compensation cost on a straight-line basis by the Company over the employee’s requisite service period (vesting period). All stock-based compensation costs are classified in the statements of operations and comprehensive loss based upon the underlying employee’s role within the Company.

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 statement and tax bases 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 deferred tax assets to the extent that it believes these assets are more likely than not to be realized. In making such a determination, the Company 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 the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.

The Company records uncertain tax positions in accordance with ASC 740 on the basis of a two-step process whereby (1) it 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 (2) for those tax positions that meet the more-likely-than-not recognition threshold, it recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.

The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the accompanying statements of operations and comprehensive loss. Any accrued interest and penalties related to uncertain tax positions will be reflected as a liability in the balance sheets.

Retirement Savings Plan

The Company sponsors a 401(k) plan that covers all of the Company’s eligible employees. The plan allows employees to make contributions up to a specified percentage of their compensation, subject to statutory limitations. Beginning in the year ended December 31, 2022, the Company transitioned to a safe harbor 401(k) plan. The Company makes safe harbor matching contributions equal to 100% of the first 3% of a plan participant’s eligible compensation, plus 50% of the next 2% of a plan participant’s eligible compensation. The Company may also make an additional discretionary match or profit sharing contribution to the plan. The Company recorded expense related to its 401(k) plan of $0.6 million for the year ended December 31, 2022. The Company did not provide a match for the year ended December 31, 2021.

Segments

The Company operates as one operating segment, which is developing and commercializing its medical diagnostic products. The Company’s chief operating decision maker, its chief executive officer, reviews financial information on an aggregate basis for making decisions regarding resource allocation and assessing performance.

Comprehensive Loss

Comprehensive loss consists of net loss and other gains and losses affecting stockholders’ equity that, under U.S. GAAP, are excluded from net loss. For the years ended December 31, 2022 and 2021, comprehensive loss includes unrealized losses on the Company’s available-for-sale debt securities.

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Net Loss per Share

Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options and warrants to purchase common stock are considered to be potentially dilutive securities. For periods in which the Company reports a net loss, all potentially dilutive shares are anti-dilutive and are therefore excluded from the calculation of diluted net loss per share.

The Company has two classes of common stock and calculates net loss per share using the two-class method. The rights, including the liquidation and dividend rights, of the holders of the Company’s Class A and Class B common stock are identical, except with respect to voting and conversion. The undistributed earnings for each period are allocated based on the contractual participation rights of the Class A and Class B common shares as if the earnings for the period had been distributed. As the liquidation and dividend rights are identical, the undistributed earnings are allocated on a proportionate basis and the resulting amount per share for Class A and Class B common stock was the same for the years ended December 31, 2022 and 2021.

Emerging Growth Company Status

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (a) no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

Recently Issued Accounting Pronouncements Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The objective of the standard is to provide information about expected credit losses on financial instruments at each reporting date and to change how other-than-temporary impairments on investment securities are recorded. The guidance is effective for the Company beginning on January 1, 2023. The Company is currently evaluating the impact the standard may have on its financial statements and related disclosures but does not currently expect the standard will have a material impact.

Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force) and the SEC did not, or are not believed by the Company’s management to, have a material impact on the Company’s financial position, results of operations or cash flows.

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3.Cash, Cash Equivalents and Marketable Securities

The Company has classified its marketable securities as available-for-sale. The Company’s cash, cash equivalents and marketable securities by major security type as of December 31, 2022 and 2021 were as follows (in thousands):

Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value

Cash and cash equivalents:

Current marketable securities:

Corporate debt securities 507 — (5) 502

Long-term marketable securities:

Corporate debt securities 1,156 — — 1,156

Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value

Cash and cash equivalents:

Cash $ 70 $ — $ — $ 70

Current marketable securities:

Long-term marketable securities:

Corporate debt securities 520 — (3) 517

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The following table summarizes the Company’s available-for-sale debt securities and cash equivalents with unrealized losses as of December 31, 2022, aggregated by major security type and the length of time that individual securities have been in a continuous loss position (in thousands):

Less than 12 months 12 months or greater Total

The Company determined that no available-for-sale securities were other-than-temporarily impaired as of December 31, 2022 and 2021. The Company attributes the declines in the fair value of its available-for-sale securities to normal market and interest rate fluctuations. The declines in fair value are not attributed to declines in credit quality. The Company does not intend to sell investments while they are in an unrealized loss position and does not believe that it is more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be maturity.

The Company’s marketable securities classified by contractual maturities as of December 31, 2022 were as follows (in thousands):

Amortized Cost Fair Value

Due after one year through five years 21,736 21,329

4. Property and Equipment

The following table presents the components of property and equipment, net, as of December 31, 2022 and 2021 (in thousands):

December 31,

Less accumulated depreciation and amortization (6,256) (5,967)

Property and equipment, net $ 3,059 $ 1,773

Depreciation and amortization expense was $0.8 million and $0.7 million for the years ended December 31, 2022 and 2021, respectively.

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5. Accrued and Other Current Liabilities

The following table presents the components of accrued and other current liabilities as of December 31, 2022 and 2021 (in thousands):

December 31,

Accrued 401(k) matching contributions 568 —

Operating lease liability, current portion 519 —

Other current liabilities 637 927

Total accrued and other current liabilities $ 4,444 $ 3,885

6. Other Income, net

The following table presents the components of other income, net, for the years ended December 31, 2022 and 2021 (in thousands):

Year EndedDecember 31,

Investment income (loss), net 1,071 (28)

Fair value remeasurements — (15)

Gain on extinguishment of PPP loan — 1,050

Other gains (losses), net — (20)

7. Loans and Convertible Promissory Notes

Bank Loan

In 2014, through a loan and security agreement with a bank, the Company obtained a term loan for $10.0 million. In March 2021, the Company repaid the outstanding principal of $2.0 million, accrued interest of $6 thousand, and the Final Payment Fee (as defined in that loan and security agreement) of $0.1 million related to this loan.

Convertible Promissory Note

In February 2019, the Company authorized the issuance of a $6.4 million subordinated convertible promissory note (the “Note”) to a stockholder of the Company, bearing 12% interest and a maturity date of February 26, 2021, to provide liquidity and additional working capital. On February 15, 2021, the maturity date was extended to March 28, 2021. The Note was convertible at the option of the holder into shares of Series D Convertible Preferred Stock at a conversion price equal to 80% of the issuance price of the Series D Convertible Preferred Stock of $9.03 per share. In July 2019, $1.9 million of the $6.4 million Note’s principal and $0.1 million of accrued interest were converted into 277,507 shares of the Company’s Series D Preferred Stock.

The conversion feature of the Note met the requirements for separate accounting and was recognized as a liability at the measurement date fair value of $2.4 million, subject to remeasurement to fair value, with any changes in estimated fair value recognized as a component of other income, net. A corresponding discount, which reduced the carrying value of the Note, was also recorded. The unamortized discount was written off in proportion to the partial conversion, with the remaining discount accreted to interest expense until maturity. The Company recognized additional interest expense of $0.1 million from accretion of the discount during the year ended December 31, 2021.

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On March 24, 2021, the Company repaid the outstanding principal of $4.5 million and accrued interest of $1.1 million related to the Note.

Paycheck Protection Loan

In April 2020, the Company obtained a $1.1 million loan through a bank under the Paycheck Protection Program (“PPP”) under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), as amended. The loan’s purpose was to maintain payroll and make rent and utilities payments as specified under the terms of the PPP. Under the PPP, borrowers may apply for loan forgiveness if the funds are used for payroll costs, mortgage interest, rent, and utilities payments over a specified term following receipt of the loan funds. During the term of the agreement, the Company utilized the loan funds for forgivable purposes and applied for forgiveness. In June 2021, the outstanding $1.1 million PPP loan was forgiven and removed from the Company’s balance sheet. As a result of the forgiveness of the PPP loan, a $1.1 million gain on extinguishment was recorded in other income, net for the year ended December 31, 2021.

8. Fair Value Measurements

As of December 31, 2022 and 2021, the carrying amounts of the Company’s receivables, prepaid and other current assets, accounts payable, and accrued and other current liabilities approximate their fair values, principally due to the short-term nature of the assets and liabilities. The recorded values of the finance leases approximate fair value as the interest rates approximate market interest rates.

Money market funds are highly liquid investments and are actively traded. The pricing information on money market funds is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.

U.S. government agency bonds, U.S. government bonds, commercial paper, and corporate debt securities are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date.

The Company follows a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The three levels of the fair value hierarchy are as follows:

Level 1 inputs are observable, quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access at the measurement date.

Level 2 inputs are observable inputs other than quoted prices included in Level 1 that are observable either directly or indirectly or 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 assets or liabilities.

Level 3 inputs are unobservable inputs in which there is little or no market data, which require the Company to develop its own assumptions.

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The following table shows the Company’s assets measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands) as of December 31, 2022:

Level 1 Level 2 Level 3

Assets:

Cash equivalents:

Money market funds $ 2,618 $ — $ —

Commercial paper — 26,347 —

Marketable securities:

Commercial paper — 15,155 —

Corporate debt securities — 1,658 —

U.S. federal agency securities — 38,211 —

U.S. government securities — 19,131 —

The following table shows the Company’s assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands) as of December 31, 2021:

Level 1 Level 2 Level 3

Assets:

Cash equivalents:

Money market funds $ 4,021 $ — $ —

Commercial paper — 54,841 —

Marketable securities:

Commercial paper — 39,672 —

Corporate debt securities — 7,028 —

U.S. federal agency securities — 25,675 —

U.S. government securities — 8,656 —

9. Related Party Transactions

In June 2019, the Company entered into a master services agreement with Carelon Research (formerly known as Healthcore, Inc.), a wholly-owned subsidiary of Elevance Health, Inc. (formerly known as Anthem, Inc., “Elevance Health”). This agreement covers a range of research projects, including Carelon Research’s role as a contract research organization for the Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (“PRIME”) study. The Company paid fees related to this agreement of $2.2 million and $1.8 million for the years ended December 31, 2022 and 2021, respectively. In November 2020, the Company entered into a Laboratory Services Agreement with Elevance Health related to the PRIME study. This agreement provides a contracted rate for certain tests performed pursuant to the study. The Company recognized revenues related to this agreement of $100 thousand and $56 thousand for the years ended December 31, 2022 and 2021, respectively.

In February 2021, the Company entered into a commercial collaboration agreement with Elevance Health and its affiliates (the “Commercial Collaboration Agreement”). The Commercial Collaboration Agreement provides defined payment within a defined period for use of the PreTRM test within Elevance Health’s network of covered members. Pursuant to the Commercial Collaboration Agreement, Elevance Health will purchase a certain minimum number of tests for each of the first three years of the term of the agreement. Additionally, Elevance Health agreed to pay a certain minimum amount per year for the first three years of the term of the Commercial Collaboration Agreement. The Company received $3.1 million during the year ended December 31, 2022, which amount related to the minimum payments for the year ended December 31, 2021. As of December 31, 2022, the Company recorded $6.0 million in other receivables related to the minimum payments for the year ended December 31, 2022, which was received in January 2023. Such minimum payments are initially recorded as deferred revenue. Deferred revenue is recognized as revenue when the Company delivers

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PreTRM test results to Elevance Health patients pursuant to the Commercial Collaboration Agreement. The Company also agreed to develop a sales, marketing, and customer service program, and to provide training and marketing to duly licensed physicians specializing in obstetrics and gynecology or family medicine, or licensed nurse midwives, at the reasonable request of Elevance Health.

Elevance Health has been participating in the Company’s PRIME study and at the conclusion of the PRIME study, under the Commercial Collaboration Agreement, the parties agreed to use commercially reasonable efforts to enter into Elevance Health’s standard lab provider agreement. Unless earlier terminated due to breach, the Commercial Collaboration Agreement will remain in effect until the later of (a) the third anniversary of the effective date or (b) the date on which Elevance Health has purchased a fixed number of PreTRM tests as agreed by the parties.

The Commercial Collaboration Agreement with Elevance Health is considered to be within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”), as the parties are active participants and exposed to the risks and rewards of the collaborative activity. The Company determined the PreTRM tests to be a performance obligation for which Elevance Health is a customer and a unit of account within the scope of ASC 606. The associated transaction price is based on the contractual minimum number of tests and the agreed upon defined payment amount per test. The transaction price was allocated to this single performance obligation, which will be recognized upon delivery of test results expected to occur over the term of the agreement. All other items promised to Elevance Health are immaterial in the context of the Commercial Collaboration Agreement. There were no material revenues related to the Commercial Collaboration Agreement for the years ended December 31, 2022 and 2021.

10. Capital Structure

On July 19, 2021, the Company completed its IPO and issued 4,687,500 shares of its Class A common stock at a price of $16.00 per share for net proceeds of approximately $66.6 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. In connection with the IPO, all shares of convertible preferred stock converted into 22,434,130 shares of Class A common stock and 1,405,259 shares of Class B common stock.

Common Stock

The Company has two authorized classes of common stock, Class A and Class B. The rights of the holders of Class A and Class B common stock are identical, except with respect to voting and conversion. Each share of Class A common stock is entitled to one vote and shares of Class B common stock are non-voting. Each share of Class B common stock may be converted at any time to one share of Class A common stock at the option of its holder, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation.

The Company is authorized to issue up to 150,000,000 shares of Class A common stock, par value $0.0001 per share and 1,500,000 shares of Class B common stock, par value $0.0001 per share. There were 29,612,687 and 29,368,867 shares of Class A common stock issued and outstanding at December 31, 2022 and 2021, respectively. There were 1,405,259 shares of Class B common stock issued and outstanding at December 31, 2022 and 2021.

The following shares of Class A common stock were reserved for future issuance:

December 31,

Preferred Stock

The Company is authorized to issue up to 5,000,000 shares of preferred stock, par value $0.0001 per share. There were no preferred shares outstanding at December 31, 2022 and 2021.

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11. Stock-Based Compensation

Equity Incentive Plans

In November 2011, the Company established the 2011 Employee, Director and Consultant Equity Incentive Plan (the “2011 Plan”) and reserved shares of the Company’s common stock for sale and issuance under the 2011 Plan. Options granted under the 2011 Plan generally vest over a four-year period and generally expire ten years from the date of grant. Options are exercisable only to the extent vested. The 2011 Plan terminated in November 2021, and accordingly, no additional shares are available for grant under the 2011 Plan. The 2011 Plan continues to govern outstanding awards granted under the 2011 Plan.

The 2021 Equity Incentive Plan (the “2021 Plan”) was established in July 2021. The 2021 Plan provides for the grant of incentive and non-statutory stock options as well as other stock rights to employees, directors and consultants of the Company. Options generally vest over a four-year period and generally expire ten years from the date of grant. Options are exercisable only to the extent vested. The 2021 Plan includes provisions for annual automatic increases to the number of shares of Class A common stock reserved for issuance under the 2021 Plan. In addition, any shares that otherwise would be returned to the 2011 Plan as a result of the expiration or cancellation of stock options may be added to the 2021 Plan. As of December 31, 2022, there were 1,926,356 shares of the Company’s Class A common stock that were available for future grants under the 2021 Plan.

The 2021 Employee Stock Purchase Plan (the “2021 ESPP”) was established in July 2021. The 2021 ESPP includes provisions for annual automatic increases to the number of shares of Class A common stock reserved for issuance under the 2021 ESPP. As of December 31, 2022, no shares had been granted under the 2021 ESPP and there were 598,777 shares of the Company’s Class A common stock that were available for future grants under the 2021 ESPP.

Stock Options

Unless otherwise noted, references to “options” in the subsequent disclosures, refers to the combined incentive and non-statutory stock options issued as employee and non-employee stock-based compensation, and authorized under the 2011 Plan and the 2021 Plan. The following table summarizes information about these options granted and outstanding:

The weighted-average grant date fair value of options granted during the years ended December 31, 2022 and 2021 was $1.92 and $5.64 per share, respectively. The total aggregate intrinsic value of options exercised during the years ended December 31, 2022 and 2021 was $0.5 million and $3.3 million, respectively. The total fair value of options vested for the years ended December 31, 2022 and 2021 was $5.8 million and $2.2 million, respectively.

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The fair values calculated using the Black-Scholes option pricing model were estimated on each grant date using the following assumptions:

Year Ended December 31,

Risk-free interest rate 1.7% - 4.3% 0.8% - 1.6%

Expected dividend yield — % — %

The following table presents the impact of stock-based compensation expense in the statements of operations for the periods indicated (in thousands):

Year EndedDecember 31,

Research and development expense $ 1,671 $ 1,046

Sales and marketing expense 590 657

General and administrative expense 2,794 1,427

Total employee stock-based compensation $ 5,055 $ 3,130

At December 31, 2022, there was $9.9 million of unrecognized stock-based compensation cost related to unvested stock options which is expected to be recognized over a weighted average period of 2.4 years.

12. Warrants

Warrants to purchase Class A common stock

All outstanding common stock warrants were exercisable immediately when granted. All outstanding common stock warrants are exercisable for shares of Class A common stock. The Company’s common stock warrants outstanding were as follows:

Number of Warrants Outstanding as of:

During the year ended December 31, 2022, 12,506 common stock warrants expired unexercised.

13. Commitments and Contingencies

Leases

The Company is the lessee in all of its lease arrangements. The Company did not enter into any leases with related parties during the presented periods. The Company makes assumptions and judgments when assessing contracts for lease components, determining lease classifications, and calculating right-of-use asset and lease liability values. These assumptions and judgments may include the useful lives and fair values of the leased assets, the implicit rate underlying the Company’s leases, the Company’s incremental borrowing rate or the Company’s intent to exercise or not exercise options available in lease contracts.

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The following table shows right-of-use assets and lease liabilities, and the associated financial statement line items as of December 31, 2022 (in thousands):

Right-of-use assets:

Operating leases Other assets $ 1,707

Finance leases Property and equipment, net 1,317

Total right-of-use assets $ 3,024

Lease liabilities:

Operating leases Accrued and other current liabilities $ 519

Operating lease obligation, net of current portion 1,222

Finance leases Finance lease obligation, current portion 464

Finance lease obligation, net of current portion 626

Total lease liabilities $ 2,831

Lease costs and other information consisted of the following (in thousands, except terms and rates):

Lease cost

Finance lease cost:

Amortization of right-of-use assets $ 280

Interest on lease liabilities 61

Operating lease cost 504

Total lease cost $ 845

Other information

Finance leases:

Operating cash outflows $ 48

Financing cash outflows $ 303

Right-of-use assets obtained in exchange for lease liabilities $ 1,253

Weighted-average remaining lease term (in years) 2.3

Weighted-average discount rate 6.4%

Operating leases:

Operating cash outflows $ 609

Right-of-use assets obtained in exchange for lease liabilities $ 2,169

Weighted-average remaining lease term (in years) 3.0

Weighted-average discount rate 7.5%

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Future minimum lease payments for the Company’s leases as of December 31, 2022 were as follows (in thousands):

Operating Leases Finance Leases Total

2026 and thereafter — — —

Operating Leases

The Company leases a total of approximately 24,300 square feet of office and laboratory space under a single non-cancelable operating lease (the “Office Lease”). In October 2022, the Office Lease was amended to extend the term of the lease an additional three years to expire on December 31, 2025, and to provide the Company with an early termination right which termination would occur under certain circumstances, as provided in the amended Office Lease, after July 1, 2024 if exercised. The Company is not currently reasonably certain it will exercise the termination right. The rate in the Company’s operating lease is not readily determinable. As such, the Company uses its incremental borrowing rate to calculate the present value of its operating lease liabilities.

Finance Leases

The Company leases certain equipment related to its information technology infrastructure and laboratory operations. All of the Company’s current finance leases include bargain purchase options that the Company is reasonably certain to exercise. The Company has elected not to separate lease and non-lease components for its equipment leases. The rates implicit in the Company’s finance leases are determinable, and the Company uses those rates to calculate the present value of its finance lease liabilities.

Indemnification

The Company has agreed to indemnify its officers and directors for certain events or occurrences, while the officer or director is or was serving at the Company’s request in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company purchases director and officer insurance coverage that provides for corporate reimbursements of covered obligations that limits the Company’s exposure and enables it to recover a portion of potential future amounts paid. The Company is unable to reasonably estimate the maximum amount that could be payable under these arrangements since these obligations are not capped but are conditional to the unique facts and circumstances involved. Accordingly, the Company has no liabilities recorded for these agreements as of December 31, 2022 and 2021. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements.

Employee Agreements

The Company has signed various employment agreements with key executives pursuant to which if their employment is terminated by the Company without cause or by the employees for good reason, or following a change of control of the Company, the employees are entitled to receive certain benefits, including severance payments, accelerated vesting of stock and stock options, and certain insurance benefits.

Legal Matters

The Company is not currently a party to any material litigation or other material legal proceedings. The Company may, from time to time, be involved in various legal proceedings arising from the normal course of business activities, and an unfavorable resolution of any of these matters could materially affect the Company’s future results of operations, cash flows, or financial position.

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14. Income Taxes

The Company has not recorded any income tax expense for the years ended December 31, 2022 and 2021 due to its history of operating losses.

The provision for income taxes includes the following components for the years ended December 31, 2022 and 2021 (in thousands):

Year EndedDecember 31,

Current:

Federal $ — $ —

State — —

Total current benefit (provision) $ — $ —

Deferred:

Change in valuation allowance (11,351) (9,288)

Total deferred benefit (provision) $ — $ —

Total income tax benefit (provision) $ — $ —

The benefit (provision) for income taxes differs from the amount computed at federal statutory rates as follows (in thousands):

Year Ended December 31,

State income taxes, net of federal benefit 1,771 4.01 % 998 2.85 %

State net operating loss carryforward true up (8) (0.02) % (72) (0.21) %

PPP loan forgiveness — — % 221 0.63 %

Income tax benefit (provision) $ — — % $ — — %

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Significant components of the Company’s net deferred income tax assets (liabilities) are as follows (in thousands):

December 31,

Deferred tax assets:

Depreciation and amortization 5 5

Lease liability 438 —

Total deferred tax asset before allowance 54,933 43,153

Total deferred tax asset 429 —

Deferred tax liabilities:

Right-of-use asset (429) —

Net deferred tax assets $ — $ —

Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. A significant piece of objective negative evidence evaluated is the cumulative loss incurred since inception. Such objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth.

On the basis of this evaluation, a full valuation allowance of $54.5 million and $43.2 million has been recorded as of December 31, 2022 and 2021, respectively, as it is more likely than not that the deferred tax assets will not be realized. The valuation allowance increased by $11.4 million and $9.3 million for the years ended December 31, 2022 and 2021, respectively, and there is no tax benefit presented in the accompanying financial statements.

The Company is subject to minimum taxes in several of the state jurisdictions where it files income tax returns. The amounts paid are immaterial and not presented above as a component of the current state tax provision.

As of December 31, 2022, the Company had U.S. federal and state net operating loss carryforwards of approximately $187.9 million and $120.5 million, respectively. Of the federal amount, $117.6 million can be carried forward indefinitely, while the remainder begins to expire after 2028, if not utilized. The state amounts begin to expire at various dates after 2023.

Because of the change of ownership provisions of the Tax Reform Act of 1986, use of a portion of the Company’s NOL and tax credit carryforwards may be limited in future periods. Further, a portion of the carryforwards may expire before being applied to reduce future income tax liabilities. There are currently no federal or state tax audits in progress. All prior tax years remain subject to examination by Federal and State of Utah authorities due to the existence of net operating loss carryforwards.

The Company recognizes the tax benefit of an uncertain tax position only if it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities, based on technical merits. The reversal of the uncertain tax positions would not affect the Company’s effective tax rate to the extent that it continues to maintain a full valuation allowance against its deferred tax assets. As of December 31, 2022 and 2021, the Company did not record any material interest expense or penalties related to uncertain tax positions or the settlement of audits for prior periods. The

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Company does not expect a significant increase or decrease in its uncertain tax positions within the next 12 months. A reconciliation of the beginning and ending amount of uncertain tax positions (in thousands):

Year EndedDecember 31,

Balance at the beginning of the year $ 1,648 $ 1,354

Gross increases—prior period — —

Gross increases—current period 377 294

Balance at the end of the year $ 2,025 $ 1,648

15. Net loss per share

The Company calculates net loss per share of Class A and Class B common stock using the two-class method. For periods in which the Company reports a net loss, all potentially dilutive shares are anti-dilutive and are therefore excluded from the calculation of diluted net loss per share. For the years ended December 31, 2022 and 2021, the Company reported net losses and as such, basic and diluted net loss per share are the same.

As the liquidation and dividend rights are identical for Class A and Class B common shares, the undistributed earnings are allocated on a proportionate basis and the resulting amount per share for Class A and Class B common stock was the same for the years ended December 31, 2022 and 2021.

The following table sets forth the computation of basic and diluted net loss per share of Class A and Class B common stock for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts):

Year Ended December 31,

Class A Class B Class A Class B

Net loss per share — basic and diluted $ (1.43) $ (1.43) $ (2.33) $ (2.33)

The Company excluded the following potentially dilutive securities, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because their impact would have been anti-dilutive:

December 31,

16. Subsequent Events

On February 16, 2023, the Company entered into an amendment (the “Amendment”) to that certain Side Letter, dated as of April 29, 2021, with Baker Bros. Advisors LP and certain affiliates of Baker Bros. Advisors LP (“Baker Bros. Investors”). Pursuant to the Amendment, the Baker Bros. Investors’ right to nominate one director (the “Investors Designee”) to the Company’s board of directors (the “Board”) was amended such that in order to exercise the right (the “Nomination Right”), among other conditions, the Baker Bros. Investors must beneficially own shares or other equity securities of the Company representing at least 9.9% of the then-outstanding total voting power of the Company. This percentage was increased from 4.0% in the original Side Letter.

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The Amendment also provides for an adjustment to the Nomination Right such that, except for those rights common to all Company shareholders, the Baker Bros. Investors will have no further Nomination Right if the Investors Designee is elected to the Board, until such Investors Designee is no longer serving as a director on the Board, at which time the Baker Bros. Investors shall again have the right to nominate a new Investors Designee.

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures

None.

Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2022. Based on the evaluation of our disclosure controls and procedures as of December 31, 2022, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. In addition, our principal executive officer and principal financial officer have concluded that the impact of the COVID-19 pandemic and other macroeconomic factors did not impact our ability to maintain our disclosure controls and procedures.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the period covered by this Annual Report on Form 10-K that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework. Based on our assessment, management believes that, as of December 31, 2022, our internal control over financial reporting is effective based on those criteria.

Item 9B. Other Information

None.

Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections

Not applicable.

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PART III

Item 10. Directors, Executive Officers and Corporate Governance

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance” and “Corporate Code of Conduct and Ethics” in our Proxy Statement to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022 in connection with the solicitation of proxies for our 2023 annual meeting of stockholders.