What changed in this filing

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Item 1A. Risk Factors

2026-02-26 compared with 2025-02-25 · 143 added, 163 removed, 918 unchanged (25% of the section changed)

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We have incurred significant operating losses since our inception.

Our net loss attributable to our stockholders was approximately $547.0 million, $892.9 million, and $2.1 billion for the fiscal years ended December 31, 2024, 2023 and 2022, respectively.

As of December 31, 2025, we had an accumulated deficit of approximately $6.2 billion.

We may incur losses and negative cash flow from operating activities for the foreseeable future as we continue to invest significant additional funds toward further developing our platform and customer offerings, the cell engineering programs we perform on behalf of our customers and otherwise growing our business, including our Biosecurity and Automation business units.

We expect that our operating expenses will either remain consistent or decline in 2025 as compared to 2024, reflecting a stabilization in our operational overhead and restructuring actions commenced in 2024.

However, our operating expenses could increase in connection with employee incentive programs offered or from additional costs or expenses resulting from our restructuring actions.

We have derived a significant portion of our revenues from fees and milestone payments from technical development services provided to customers to advance programs, as well as a significant portion of our revenues from Biosecurity.

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We may need substantial additional capital in the future in order to fund our business.

We have consumed considerable amounts of capital to date, and we expect to incur continued net losses for the foreseeable future as we continue to develop our business, advance our programs, expand and enhance our platform and customer offerings, perform on behalf of our customers, make the capital investments necessary to scale up our Foundry operations and Codebase assets and as we continue our restructuring actions commenced in 2024 .

We have consumed considerable amounts of capital to date, and we expect to incur continued net losses for the foreseeable future as we continue to develop our business, advance our programs, expand and enhance our platform and customer offerings, perform on behalf of our customers, and make the capital investments necessary to scale up our business.

We have used, and may continue to use, additional capital for Biosecurity, strategic investments and acquisitions.

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As a result of these and other factors, we do not know whether additional financing will be available when needed, or, if available, whether such financing would be on terms favorable to our stockholders or us.

If future financings involve the issuance of equity securities, our existing stockholders would suffer dilution.

If additional future financings, including pursuant to our at-the-market program, involve the issuance of equity securities, our existing stockholders would suffer dilution.

See “Management’s Discussion and Analysis – At-The-Market Program” for more information.

If we raise debt financing in the future, we may be subject to restrictive covenants that limit our ability to conduct our business.

Our ability to raise funds may be adversely impacted by current or future economic conditions.

Our ability to raise funds may be adversely impacted by current or future economic

If we fail to raise sufficient funds and continue to incur losses, our ability to fund our operations, take advantage of strategic opportunities, or otherwise respond to competitive pressures could be significantly limited.

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We believe that our culture has been a critical component of our success.

We have invested substantial time and resources in building our team and nurturing a culture of empowerment of, and active engagement by, our employees.

We have invested substantial time and resources in our team and have continued to nurture a culture of empowerment of, and active engagement by, our employees.

In addition, in order to manage through these periods of organizational change, we will need to continue to adapt our operational, financial, and management controls and processes, as well as our reporting systems and procedures.

As we manage our business and mature as a public company, we may find it difficult to maintain our culture and adapt effectively.

Any failure to manage our organizational changes in a manner that preserves the key aspects of our culture and allows us to effectively adapt, could be detrimental to future success in pursuing our objectives, including our ability to recruit and retain personnel, maintain reliable service levels and offerings for our customers, and achieve the necessary level of capacity,

quality and efficiency in performing services and other development activities, or the necessary level of efficiency in our organizational structures.

Any failure to manage our organizational changes in a manner that preserves the key aspects of our culture and allows us to effectively adapt could be detrimental to future success in pursuing our objectives, including our ability to recruit and retain personnel, maintain reliable service levels and offerings for our customers, and achieve the necessary level of capacity, quality and efficiency in performing services and other development activities, or the necessary level of efficiency in our organizational structures.

This, in turn, could adversely affect our business, results of operations, and financial condition.

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Our Biosecurity offering consists of pathogen testing, sequencing, and insights delivery which are subject to inherent risks of commercial viability, such as demand for services and price or market share erosion due to competition.

For example, the White House and World Health Organization each announced the end of the public health emergency effective May 2023 and the revenue stream of our COVID-19 school testing services ended in the third quarter of 2023.

As a result, our Biosecurity business is now focusing on global surveillance programs and analytic services.

Our Biosecurity business is focused on global surveillance programs and analytic services.

However, creating the commercial and technical infrastructure to provide Biosecurity services globally is expensive.

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Any litigation to which we become a party may result in an onerous or unfavorable judgment, or may be resolved with a monetary payment.

If we cannot maintain and expand current customer partnerships and enter into new customer partnerships, our cell engineering business could be adversely affected.

We do not generate substantial revenue from our own products, and instead generate revenue from selling end-to-end cell engineering solutions and tools service offerings.

We receive fees for such solutions and tools, and for our end-to-end cell engineering solutions, we also have historically received downstream value in the form of royalties, milestone payments, and/or equity.

As a result, our success depends on our ability to expand the number, size and scope of our customer programs.

Our ability to win new business depends on many factors, including our reputation in the market, the quality of our service offerings relative to alternatives, the pricing and efficiency of our services relative to alternatives, our technical and operational capabilities, our sales team effectiveness, and the customer’s ability to fund new work.

If we fail to maintain a position of strength in any of these factors, our ability to deliver on customer programs, sign new customer programs, and/or launch new programs with existing customers may suffer and this could adversely affect our prospects.

Additionally, in the process of delivering programs, we generate Foundry know-how and accumulate meaningful biological and data assets, including optimized proteins and organisms, characterized genetic parts, enhanced understanding of metabolic pathways, biological, chemical, and genetic libraries, and other elements of biological data.

Data and know-how generated from our programs provide the basis for expanded capabilities that we believe further supports our customer relationships.

As a result, in addition to reducing our revenue or delaying the delivery of our programs, the loss of one or more of our customer relationships or the failure to add new customers or programs may hinder our accumulation of such information, thus hindering our efforts to advance our technological differentiation and improve our platform.

We engage in conversations with companies regarding potential customer relationships on an ongoing basis.

We may spend considerable time and money engaging in these conversations and feasibility assessments, including understanding the technical approach, customer concerns and limitations, and legal or regulatory landscape of a potential program or offering, which may not result in a commercial agreement.

Even if an agreement is reached, the resulting relationship is not always successful, which may be for many reasons, including our inability to complete a program to our customers’ specifications or within our customers’ time frames, or, in the case of end-to-end cell engineering solutions, unsuccessful development or commercialization of products or processes by our customers.

In such circumstances, our revenues and downstream value potential from such a collaboration has been and might in the future be meaningfully reduced.

If we cannot attract new customers, retain existing customers, and expand our relationships across both our cell engineering solutions and tools businesses, our business, financial condition, and results of operations could be adversely affected.

We generate revenue from our cell engineering solutions and cell engineering tools businesses.

In our cell engineering solutions business, which has been our core business since inception and continues to be the primary driver of our revenues, we receive fees for performing R&D activities and, for some of our legacy arrangements, downstream value in the form of royalties, milestone payments and/or equity.

In our more recently launched cell engineering tools business, we receive fees from performing data generation services and from the sale of our automation hardware, software and ongoing customer support services.

Our ability to achieve our growth objectives depends in significant part on our success in attracting new customers to each of these businesses, retaining and expanding our relationships with existing customers, and driving broader adoption and utilization of both our solutions and tools offerings over time.

Our ability to win new business and expand existing relationships in both businesses depends on many factors, including our reputation in the market, the quality, reliability and performance of our service and product offerings, our pricing and commercial terms, the features and interoperability of our tools, the perceived and demonstrated return on investment for our customers, our technical and operational capabilities, the effectiveness of our sales, marketing and customer success organizations, and broader conditions in our customers’ industries.

If we fail to maintain a position of strength in any of these areas, or if our offerings do not meet evolving customer expectations, we may be unable to acquire new customers, retain existing customers or increase the scope of work or level of spend with existing customers, which could adversely affect our business and prospects.

As a relatively new entrant in the cell engineering tools market, we face additional risks in establishing and expanding our customer base in this business.

We compete with incumbent providers that have established brands, larger installed bases and longer operating histories, and whose hardware and software are often already deeply integrated into customers’ laboratories and IT environments.

These factors can create significant barriers to adoption of our tools, as customers may be reluctant to incur the time, expense and operational disruption associated with evaluating, validating, integrating and maintaining new systems.

In order to justify replacing or augmenting existing systems, customers must perceive our offerings as providing meaningful and durable advantages in functionality, performance, scalability, data quality, ease of use, support and total cost of ownership.

Our sales cycles for tools can be long and resource-intensive, often involving proof-of-concept projects, technical integration work and customer-specific validation.

If we are unable to effectively demonstrate the benefits of our tools, if initial deployments do not meet customer expectations, or if we are unable to provide high-quality implementation, training, maintenance and support, customers may decide not to adopt our tools, may limit their use to smaller-scale projects or may discontinue or fail to renew support, software or service contracts.

Any of these outcomes could limit the growth of our tools business and could also negatively affect our reputation in the market.

In our cell engineering solutions business, we typically generate valuable know-how in the course of performing customer programs, such as onboarding of new high-throughput assays or the development of optimized proteins and chassis strains.

This know-how not only advances our technical and operational capabilities, but also serves as an important product development engine for expanding and refining our tools offerings.

As a result, the loss of one or more significant customer relationships, the failure to renew, extend or expand existing programs, delays in starting new programs, or our inability to

attract new solutions customers or programs would not only reduce our revenues and potential downstream value, but could also slow our accumulation of know-how and data assets, thereby hindering our ability to advance our technological differentiation and improve our tools and services offerings.

We engage in conversations with prospective and existing customers regarding potential solutions and tools relationships on an ongoing basis.

We may devote substantial time and resources to business development discussions, technical evaluations, feasibility assessments, pilot projects, proof-of-concept studies and legal and regulatory diligence that may not result in a commercial agreement or that may result in only limited scope relationships.

Even where a commercial agreement is reached, the resulting relationship may not be successful for various reasons.

For example, in the case of cell engineering solutions, our customers may be unsuccessful in developing or commercializing products or processes based on our work, may change their strategic priorities or budgets, or may experience internal or external challenges that limit the size or duration of their programs with us, which has in the past and may in the future materially reduce both our near-term revenues and our downstream value opportunity from such collaborations.

Similarly, in the case of cell engineering tools, customers may fail to deploy our tools at the scale initially contemplated, may not expand to additional sites, use cases or workflows, or may discontinue use of our offerings if they do not meet expectations.

Any such outcomes could adversely affect our revenues, our ability to scale our platform, and our prospects for long-term growth.

We have exposure to the volatility and liquidity risks inherent in holding equity interests in other operating companies and other non-cash consideration.

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We leverage our own resources and partner with strategic and financial investors in order to help early stage companies and innovators secure funding and benefit from our platform, which exposes us to a number of risks.

Since our founding, we have helped to launch new companies by bringing together strategic and financial investors to secure funding for early stage and small companies.

Since our founding, alongside strategic and financial investors, we have leveraged our own resources to help secure funding for early stage and small companies.

Going forward, we may continue to leverage our own balance sheet and partner with investors to enable companies at all stages to benefit from our platform.

Partnering with and investing in early stage and small companies may expose us to a number of risks, including that early stage and small companies may have:

● shorter operating histories, narrower product lines and smaller market shares than larger businesses, which tend to render small companies more vulnerable to competitors’ actions and market conditions, as well as general economic downturns;

● more limited access to capital and higher funding costs, may be in a weaker financial position and may need more capital than originally anticipated to expand, compete and operate their business;

● the inability to obtain financing from the public capital markets or other traditional sources, such as commercial banks, in part because loans made to these types of companies entail higher risks than loans made to companies that have larger businesses, greater financial resources or are otherwise able to access traditional credit sources on more attractive terms;

● a higher likelihood of holding cash deposits or maintaining lines of credit with banks focused on providing banking services to early stage or venture-backed companies, such as Silicon Valley Bank (“SVB”), which failed in March 2023;

● a higher likelihood of depending on the management talents and efforts of a small group of persons;

therefore, the death, disability, resignation or termination of one or more of these persons could have a material adverse impact on such company and, in turn, on us;

● less predictable operating results, may be engaged in rapidly changing businesses with products subject to a substantial risk of obsolescence, and may require substantial additional capital to support their operations, finance expansion or maintain their competitive position;

● particular vulnerabilities to changes in customer preferences and market conditions, depend on a limited number of customers, and face intense competition, including from companies with greater financial, technical, managerial and marketing resources;

● fewer administrative resources, which can lead to greater uncertainty in their ability to generate accurate and reliable financial data, including their ability to deliver audited financial statements.

Any of these factors or changes thereto could impair an early stage or small company’s financial condition, results of operation, cash flow or result in other adverse events, such as bankruptcy.

This, in turn, could result in losses in our investments and a change in our income (loss) on investments.

Partnering with and investing in early stage and small companies has exposed and may continue to expose us to losses on our invested capital and the loss of revenue from the inability to recover fees for our services from these companies.

Such companies are exposed to a number of risks that could impair an early stage or small company’s financial condition, results of operation, or cash flow or result in other adverse events, such as bankruptcy.

We may be unable to complete future strategic acquisitions or successfully integrate strategic acquisitions which could adversely affect our business and financial condition.

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Our business strategy includes the acquisition of technologies and businesses that complement or augment our existing products and services.

We may continue to seek attractive opportunities to acquire technologies or businesses, enter into joint ventures and make other investments that are complementary to our existing strengths.

We may continue to seek attractive opportunities to acquire technologies or businesses, enter into joint ventures and make other investments that are

complementary to our existing strengths.

There are no assurances, however, that any strategic acquisition opportunities will arise or, if they do, that they will be consummated.

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We have made acquisitions in the past and, as appropriate opportunities become available, we may acquire additional businesses, assets, technologies, or products to enhance our business or engage in other strategic transactions in the future, but our ability to do so successfully cannot be ensured.

We have also made investments in companies that we view as

synergistic with our business.

We have also made investments in companies that we view as synergistic with our business.

Although we conduct due diligence on these acquisitions and investments, such processes may underestimate or fail to reveal significant liabilities and we could incur losses resulting from liabilities of the acquired business that are not covered by indemnification we may obtain from the seller.

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The achievement of many of these milestones may be outside of our control.

All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources, constraints, and priorities, progress of and results from R&D activities, and other factors, any of which may cause the timing of achievement of the milestones to vary considerably.

All of these milestones are based on a variety of assumptions, including

assumptions regarding capital resources, constraints, and priorities, progress of and results from R&D activities, and other factors, any of which may cause the timing of achievement of the milestones to vary considerably.

If we, our collaborators, or our customers fail to achieve milestones in the expected timeframes, the commercialization of our programs may be delayed, our credibility may be undermined, our expectations with respect to potential future downstream value may be inaccurate, our ability to earn royalties may be impacted, our business and results of operations may be harmed, and the trading price of our common stock may decline.

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Widespread inflationary pressures and other adverse macroeconomic pressures, such as tariffs, increased duties and taxes, international trade disputes, political instability, supply or raw material shortages, and labor disruptions, exist across global economies, resulting in disruptions or higher costs for disposable lab equipment, raw materials and synthetic biology materials and services, and significant increases in the future could adversely affect our results of operations.

We have experienced shortages in some of our key equipment and supplies, including those required in our labs, as well as disruptions in services provided by third parties, and may do so in the future as a result of supply chain issues tied to global

pandemics, conflicts, or otherwise.

We may also experience price increases, quality issues and longer lead times due to unexpected material shortages, service disruptions, and other unanticipated events, which may adversely affect our supply of lab equipment, lab supplies, chemicals, reagents, supplies, and lab services.

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We do not currently have the infrastructure or capability internally to manufacture these items at the necessary scale or at all.

Although we have a reserve of supplies and although alternative suppliers exist for some of these critical products, services, and equipment, our existing processes used in our Foundry have been designed based on the functions, limitations, features, and specifications of the products, services, and equipment that we currently utilize.

Although we have a reserve of supplies and although alternative suppliers exist for some of these critical products, services, and equipment, our existing processes used in our Autonomous Lab have been designed based on the functions, limitations, features, and specifications of the products, services, and equipment that we currently utilize.

While we work with a variety of domestic and international suppliers, our suppliers may not be obligated to supply products or services or our arrangements may be terminated with relatively short notice periods.

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● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, widespread inflationary pressure, the impact of local and regional financial crises, on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

● natural disasters, political and economic instability, including wars, terrorism and political unrest, the outbreak of disease, or public health epidemics/pandemics, such as COVID-19, which could have an adverse impact on our employees, contractors, customers, partners, travel and the global economy;

● natural disasters, political and economic instability, including wars, terrorism and political unrest, the outbreak of disease, or public health epidemics/pandemics, which could have an adverse impact on our employees, contractors, customers, partners, travel and the global economy;

● breakdowns in infrastructure, utilities and other services;

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Our investments in and use of AI may result in reputational harm, liabilities, or other adverse consequences to our business operations.

In August 2023, we entered into a strategic partnership with Google Cloud to develop and deploy AI tools for biology and biosecurity.

In August 2023, we entered into a strategic partnership with Google Cloud to develop and deploy AI tools for biology and biosecurity, which included certain minimum annual commitment obligations that we must pay.

Under the strategic partnership, Ginkgo has developed and will continue to develop new, state-of-the-art large language models (“LLMs”) running on Google Cloud's Vertex AI platform across genomics, protein function, and synthetic biology, helping Ginkgo's customers accelerate innovation and discovery in fields as diverse as drug discovery, agriculture, industrial manufacturing, and biosecurity.

Effective October 3, 2025, we entered into an amendment to the partnership to reduce our annual commitment amounts, which required a one-time payment of $14 million to be released from the obligations of the original agreement.

If we are not able to meet our minimum annual commitment obligations again in the future, additional shortfall liabilities may be incurred.

In September 2024, we launched our first model API, a tool aimed at making biological AI models accessible to researchers, developers, and machine learning scientists.

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Emerging regulations may pertain to data privacy, data protection, and the ethical use of AI, as well as clarifying intellectual property considerations.

pose confidentiality or security risks, ethical concerns, or legal liability, as well as brand or reputational harm, and our business and results of operations may suffer.

Challenges inherent to the use of AI generally or specific to Google's AI systems could adversely impact the reliability of our data and subject us to delays and competitive harm, result in new or enhanced governmental or regulatory scrutiny, pose confidentiality or security risks, ethical concerns, or legal liability, as well as brand or reputational harm, and our business and results of operations may suffer.

Our use of AI could result in cybersecurity incidents that implicate the personal data or confidential information of the Company or our customers, which could adversely affect our reputation and results of operations.

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In connection with our plans to reduce operational expenditures, we implemented a restructuring plan, including a reduction in workforce and a planned consolidation and subleasing of certain facilities.

Initial workforce reductions commenced in June 2024 and continued throughout 2024, with further reductions expected in 2025.

All reductions are expected to be substantially completed in 2025, subject to compliance with applicable laws.

Our restructuring actions may result in other disruptions to our business, including customer program delivery issues, loss of historical customer or technical knowledge, our ability to comply with applicable laws and regulations, and our ability to retain key employees.

Initial workforce reductions commenced in June 2024 and continued throughout 2025.

Our reductions in force were substantially completed in 2025, although certain reductions will continue into 2026, subject to compliance with applicable laws.

Our restructuring actions

may result in other disruptions to our business, including customer program delivery issues, loss of historical customer or technical knowledge, our ability to comply with applicable laws and regulations, and our ability to retain key employees.

Our efforts to reduce the size of our patent portfolio may result in inadequate protection of our intellectual property assets.

The Company plans to consolidate certain facilities through various actions, including combining office and laboratory operations into fewer locations, subleasing unused or underutilized facilities, and has taken or plans to take other related measures.

While the Company aims to complete the majority of its facility consolidation actions in 2025, the actual timing may vary, especially for subleasing unused or underutilized facilities, which may extend beyond 2025 or may not occur prior to termination of such leases, depending on market conditions.

The Company has consolidated certain facilities through various actions, including combining office and laboratory operations into fewer locations, subleasing unused or underutilized facilities, and has taken or plans to take other related measures.

While the Company completed the majority of its facility consolidation actions in 2025, we continue to look for opportunities for subleasing unused or underutilized facilities, which will extend beyond 2026 or may not occur prior to termination of such leases, depending on market conditions.

Additionally, restructuring expenses related to potential asset impairments, contract amendments or terminations for any facilities no longer in use or underutilized could be material.

The Company currently estimates the costs for the reduction in force to range from $20.0 million to $23.0 million primarily in the Cell Engineering segment and to consist of cash severance and related costs.

For the years ended December 31, 2025 and 2024, the costs associated with our reductions in force was $11.4 million and $19.3 million, respectively, consisting of cash severance and related costs.

Risks Related to Our Customers

We are dependent on our customers’ willingness and ability to develop, produce and manufacture products using the engineered cells, other biological assets and/or biomanufacturing processes that we develop and on the success of our customers’ development, production, and manufacturing efforts.

We sell end-to-end cell engineering solutions and cell engineering tools service offerings.

For our solutions offerings, we rely on our customers to commercialize products that may be enabled by our engineered cells, other biological assets (e.g., enzyme DNA sequences) and/or biomanufacturing processes.

A portion of the value in such customer collaborations has historically been earned through downstream value sharing in the form of royalty streams, milestone payments, and/or equity interests.

If our customers are not successful in bringing these products to market, or if these products are not successful once on the market, the downstream portion of our value will be adversely impacted.

Because we do not directly control manufacturing, product or downstream process development or commercialization, we have limited ability to impact the quality of our partners’ production processes and ultimate commercial success.

Our ability to secure new business for our R&D services and tools is dependent on our customers’ willingness and ability to invest into R&D and continued outsourcing.

Our business could be significantly impacted by any decline in R&D spending or outsourcing activities.

In addition, our customers have chosen, and may in the future choose, not to develop or commercialize a product we have enabled in which we are entitled to downstream value sharing.

In our current relationships, we would have limited or no recourse to find alternative methods to monetize these products without the original customer.

Because this industry is still nascent and the regulatory environment is evolving, we have limited historical information on the probability of commercial success for bioengineered products or biomanufacturing processes in the market and have limited ability to underwrite the likelihood that our customers will be able to create valuable products or processes in their market using the results of their programs with us.

If we overestimate the probability or scale of commercial success, the price of our common stock may be adversely impacted as a result of lower expectations for future cash flows from customer collaborations.

We are dependent on our customers’ willingness and ability to successfully develop, produce and commercialize products using the cell engineering solutions we deliver and to a lesser extent, on the successful adoption and use of our cell engineering tools.

We sell cell engineering solutions and cell engineering tools.

Our solutions offering involves performing R&D services to engineer cells, biological assets and biomanufacturing processes for our customers which are intended to be scaled-up and deployed for commercialization.

We rely on our customers to advance, manufacture, and commercialize products enabled by our work.

A portion of the value from some of these customer collaborations has historically been earned through downstream value sharing in the form of royalty streams, milestone payments, and/or equity interests.

If they are not successful in development, regulatory approval, manufacturing or commercialization, or if they choose to delay, deprioritize or discontinue such programs, the downstream value we expect to receive will be reduced or may not be realized at all.

Because we do not control our customers’ development, regulatory, manufacturing or commercial activities, we have limited ability to influence these outcomes.

Our ability to secure new solutions business and expand existing programs also depends on our customers’ R&D budgets, strategic priorities and willingness to outsource cell engineering work.

If customers reduce R&D spending, shift focus away from synthetic biology or biomanufacturing, decide to bring work in-house, or experience business, financial or operational difficulties, they may not initiate, renew or expand collaborations with us, which could reduce both our near-term services revenues and longer-term downstream value opportunity (in the collaborations where downstream value applies).

Our cell engineering tools business is generally less directly tied to customers’ product-level commercial outcomes because we earn revenue primarily from sales of hardware, software and related services.

However, if customers do not achieve expected benefits from our tools, or if their internal R&D or manufacturing efforts are unsuccessful, they may reduce or discontinue use of our tools or limit further deployments, which could adversely affect the growth of our tools business.

Because many of the products pursued by our customers are at early stages of development and the markets and regulatory frameworks for bioengineered products and processes continue to evolve, we have limited historical information to accurately estimate the probability, timing and scale of commercial success.

If we overestimate the probability or scale of commercial success, our actual future revenues and cash flows from customer collaborations may be lower than expected, which could adversely affect the market price of our common stock.

Our revenue is concentrated in a limited number of customers, some of which are related parties, and our revenue, results of operations, cash flows and reputation may suffer upon the loss of a significant customer.

We have derived, and may continue to derive, a significant portion of our revenue from a limited number of large customers.

During the year ended December 31, 2024, three customers each represented more than 10% of our total

revenue and cumulatively represented 49% of our total revenue.

Due to the significant time required to acquire new customers, to plan and develop new programs for customers, and to satisfactorily execute on existing programs, the loss of any of these customers, or the loss of any other significant customer or a significant reduction in the amount of demand from a significant customer would adversely affect our revenue, results of operations, cash flows and reputation in the marketplace.

For the year ended December 31, 2025, one customer in the Cell Engineering segment accounted for 15% of the Company’s total revenue, while one customer in the Biosecurity segment accounted for 12% of the Company’s total revenue .

revenue, results of operations, cash flows and reputation in the marketplace.

There is always a risk that existing customers will not elect to do business with us in the future or will experience financial difficulties.

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The price of our common stock may decline as a result of a public announcement of unexpected results or developments in our partnerships, or as a result of our partners not consenting to an announcement or withholding information.

Risks Related to our Historic COVID-19 Testing Services

We may be subject to tort liability if the COVID-19 tests we utilized in our testing programs provided inaccurate results.

The Public Readiness and Emergency Preparedness Act (the “PREP Act”) provides immunity for manufacturers, distributors, program planners, qualified persons, and their officials, agents, and employees from certain claims under state or federal law for a “loss” arising out of the administration or use of a “covered countermeasure” in the United States.

Distributors are certain persons or entities engaged in the distribution of drugs, biologics, or devices.

Program planners include persons who supervise or administer a program with respect to the administration, distribution, provision, or use of a Covered Countermeasure (as defined in the PREP Act).

Covered Countermeasures include security countermeasures and “qualified pandemic or epidemic products,” including products intended to diagnose or treat pandemic or epidemic disease, such as COVID-19 diagnostic tests, as well as treatments intended to address conditions caused by such products.

Covered Countermeasures must also be approved, cleared, or authorized for emergency use, or otherwise authorized for investigational use, by the FDA in order to be considered Covered Countermeasures under the PREP Act.

For these immunities to apply, the Secretary of HHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency.

On March 10, 2020, the Secretary of HHS issued a declaration under the PREP Act and has issued subsequent amendments thereto to provide liability immunity for activities related to certain countermeasures against the COVID-19 pandemic.

In the past, we were the authorized distributor of certain third-party COVID-19 tests and collection kits that received an EUA and supervised testing programs for COVID-19 testing customers.

There can be no assurance that our test distribution

and program planning activities regarding these programs would be covered under the provisions of the PREP Act.

Also, there can be no assurance that the U.S.

Congress will not act in the future to reduce coverage under the PREP Act or to repeal it altogether.

Furthermore, some of the third-party tests that were used as part of our pooled testing program were not covered by an EUA and, at this time, we do not believe that such testing services, administration, or program planning related to our pooled testing program will qualify for PREP Act immunity.

If product liability lawsuits are brought against us in connection with allegations of harm connected to our prior COVID-19 testing services, we may incur substantial liabilities.

The PREP Act is a complex law with limited judicial precedent, and thus even for the third-party COVID-19 tests and collection kits used in our testing services that were subject to EUAs, we may have to expend significant time and legal resources to obtain dismissal of a lawsuit on the basis of PREP Act immunity.

If we cannot successfully defend ourselves against claims that our COVID-19 testing services caused injuries and if we are not entitled to immunity under the PREP Act, or the U.S.

Congress limits or eliminates coverage under the PREP Act, or if the liability protections under the PREP Act are not adequate to cover all claims, we may incur substantial liabilities.

Regardless of merit or eventual outcome, product liability claims may result in decreased demand for our services, injury to our reputation, costs to defend litigation, loss of revenue, and substantial money awards to customers.

Risks Related to the Synthetic Biology Industry

Rapidly changing technology and emerging competition in the synthetic biology industry could make the platform, programs, and products we and our customers are developing obsolete or non-competitive unless we continue to develop our platform and pursue new market opportunities.

Rapidly changing technology and emerging competition in the synthetic biology industry could make the platform, programs, services, tools, and products we and our customers are developing obsolete or non-competitive unless we continue to develop our platform and pursue new market opportunities.

The synthetic biology industry is still emerging and is characterized by rapid and significant technological changes, frequent new product introductions and enhancements, and evolving industry demands and standards.

Our future success will depend on our ability to sign and initiate new programs that address the evolving needs of our customers on a timely and cost-effective basis, to advance existing programs and to pursue new market opportunities that develop as a result of technological and scientific advances.

Additionally, our customers may face significant competition or other risks which may adversely impact our business and results of operations.

There are a number of companies in the broader synthetic biology industry, and our future success will depend on our ability to maintain a competitive position with respect to technological advances.

Technological developments, including emerging AI technologies , may result in our platform becoming obsolete.

Our ability to compete successfully will depend on our ability to develop proprietary technologies that enable our customers to develop products using our platform in a manner that is either less expensive, faster, superior or otherwise differentiated from what a competitor’s technologies and products might enable.

If we are unable to continue to successfully advance our platform or the services it provides at scale, or if our customers are unable to commercialize the products or processes made or improved upon by using our platform, our business and results of operations will be adversely impacted.

We participate in this industry through both our R&D services (cell engineering solutions) and our cell engineering tools (including automation hardware, software and data-generation offerings).

Our future success will depend on our ability to sign and initiate new programs and deploy tools that address the evolving needs of our customers on a timely and cost-effective basis, to advance existing programs, and to pursue new market opportunities that develop as a result of technological and scientific advances.

Additionally, our customers may face significant competition or other risks in their own markets which may impact demand for our services and tools thereby adversely impacting our business and results of operations.

There are a number of companies in the broader synthetic biology industry, and our future success will depend on our ability to maintain a competitive position with respect to technological advances in both cell engineering solutions and tools.

Technological developments, including emerging AI and machine learning technologies, may result in our platform, our service offerings or our hardware and software tools becoming less differentiated, obsolete or non-competitive.

For example, competitors or customers could develop alternative cell engineering platforms, in silico design capabilities, or automation and analytics tools that reduce the need for, or attractiveness of, our R&D services or tools.

Our ability to compete successfully will depend on our ability to develop and maintain proprietary technologies, such as our Autonomous Lab, that enable our customers to develop products using our platform in a manner that is less expensive, faster, superior or

otherwise differentiated from what a competitor’s technologies and products might enable and to integrate our tools into customers’ existing laboratory and data environments.

If we are unable to continue to successfully advance our platform or the services it provides at scale, or to keep our tools offerings current, effective, interoperable and cost-competitive, or if our customers are unable to commercialize the products or processes made or improved upon by using our R&D services and tools, our business and results of operations will be adversely impacted.

Due to the significant lead time involved in launching a new program or developing a new product or process using our platform, our customers are required to make a number of assumptions and estimates regarding the commercial feasibility of a new product, including assumptions and estimates regarding the size of an emerging product category and demand for those end-products and processes which will use our technology, the ability to scale-up manufacturing processes to produce a product on a commercial scale, the ability to penetrate that emerging product category, customer adoption of a downstream product, the existence or non-existence of products being simultaneously developed by competitors, potential market penetration and obsolescence, planned or unplanned.

As a result, it is possible that we may commence a new program with a customer who wishes to develop a product or process that has been displaced by the time of launch, addresses a market that no longer exists or is smaller than previously thought, that end-consumers do not like or otherwise is not competitive at the time of launch, in each case, after the incurrence of significant opportunity costs on our part to develop such product.

The ultimate success of the products developed by our customers using our services may be dependent on the success of other markets in which we or our customers do not operate in or have knowledge or expertise or which, in each case, may not reach the size anticipated by us or our customers or may be replaced by another emerging product category or eliminated entirely.

The ultimate success of the products developed by our customers using our services and tools may be dependent on the success of other markets in which we or our customers do not operate in or have knowledge or expertise or which, in each case, may not reach the size anticipated by us or our customers or may be replaced by another emerging product category or eliminated entirely.

The market, including customers and potential investors, may be skeptical of our ability to deliver on programs because they are based on a relatively novel and complex technology.

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If regulatory approval of the Genetically Modified Materials or resulting products is not secured, our business operations, financial condition and our ability to grow as a business could be adversely affected.

We expect to encounter regulations regarding Genetically Modified Materials in most, if not all, of the countries in which our customers may seek to establish production capabilities or sell their products and the scope and nature of these regulations will likely be different from country to country.

different from country to country.

Governmental authorities could, for safety, social or other purposes, impose limits on, or implement regulation of, the use, production or marketing of Genetically Modified Materials.

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Unless and until our pending applications issue, their protective scope is impossible to determine and, even after issuance, their protective scope may be limited.

Recent changes in patent law may make patents covering life science inventions more difficult to obtain and enforce.

Further legislative changes or changes in the interpretation of existing patent law could increase the uncertainty and cost surrounding the prosecution of our owned patent applications and the maintenance, enforcement or defense of our owned patents.

The Leahy-Smith America Invents Act (“the Leahy-Smith Act”) included changes that affect the way patent applications are prosecuted;

redefine prior art;

enable third-party submission of prior art to the United States Patent and Trademark Office (“USPTO”) during patent prosecution;

and provide cost-effective avenues for competitors and other third parties to challenge the validity of patents at USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings.

Thus, the Leahy-Smith Act and its continued implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Other changes in the law may further detract from the value of life science patents and facilitate challenges to our patents.

Changes in patent law may make patents covering life science inventions more difficult to obtain and enforce.

Further legislative changes or changes in the interpretation of existing patent law could increase the uncertainty and cost

surrounding the prosecution of our owned patent applications and the maintenance, enforcement or defense of our owned patents.

In some cases, we develop inventions with the assistance of machine learning and other computational tools that may be considered to be AI, and we expect to use such tools, and to use generative AI, in future development.

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If we are unsuccessful in litigating any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could have a material adverse effect on our competitive business position and prospects.

Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to use or commercialize our technology or products, which license might not be available on commercially reasonable terms, or at all.

commercially reasonable terms, or at all.

Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our management and employees.

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Any litigation concerning any of these issues would be expensive, time consuming and uncertain.

There can be no assurances that we would prevail in any suit brought by us or against us by third parties, or successfully settle or

otherwise resolve those claims.

There can be no assurances that we would prevail in any suit brought by us or against us by third parties, or successfully settle or otherwise resolve those claims.

Significant litigation would have substantial costs, even if the eventual outcome were favorable to us, and would divert management’s attention from our business objectives.

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There are other international treaties, as well as local legislation in many countries, with similar objectives.

Under the Nagoya Protocol and many other treaties and laws, countries possessing genetic resources (“source countries”) are tasked with setting up procedures and institutional infrastructure for researchers to obtain prior informed consent, both from the source country and from any relevant indigenous or traditional communities, for biological research.

Under the Nagoya Protocol and many other treaties and laws, countries possessing genetic resources (“source countries”) are tasked with

setting up procedures and institutional infrastructure for researchers to obtain prior informed consent, both from the source country and from any relevant indigenous or traditional communities, for biological research.

Many have been slow to adopt workable institutions permitting the rational negotiation of benefit-sharing agreements.

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Customers that must certify their compliance with Nagoya Protocol obligations may be reluctant to do business with us unless we engage in expensive and time-consuming benefit-sharing negotiations with source countries of publicly available genetic sequences.

Moreover, the World Intellectual Property Organization is considering requiring disclosures in patents of the origin of genetic resources, which may further increase uncertainty and the cost of patent

These changes could increase our R&D costs and adversely affect our business, financial condition, and results.

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If we must spend significant time and money designing around or licensing patents held by others, our business and financial prospects may be harmed.

We may be restricted from carrying out certain operations in our Foundry, or we may be limited in our ability to design new products for our customers.

We may be restricted from carrying out certain operations, or we may be limited in our ability to design new products for our customers.

We may become subject to claims by third parties alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights.

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We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest.

At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.

At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our

ability to build brand identity and possibly leading to market confusion.

In addition, there could be potential trade name or trademark infringement, dilution or tarnishment claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.

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If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on our share price.

Further, our agreements with some of our customers, suppliers or other entities require us to defend or indemnify these parties if they become involved in infringement claims that target our products, services or technologies, or in certain other

If we must defend or indemnify third parties, we could incur significant costs and expenses that could adversely affect our business, operating results or financial condition.

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Disputes with any of these third parties over uses or terms could result in the payment of additional royalties or penalties by us, cancellation or non-renewal of the underlying license, termination of supplies or rights to use, or litigation.

In the event that we cannot resolve issues of this kind, we may be required to discontinue or limit our use of the operations, platform, products, services or offerings that include or incorporate the licensed intellectual property.

licensed intellectual property.

Any such discontinuation or limitation could have a material and adverse impact on our business, financial condition and results of operation.

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We could be subject to similar suits by parties claiming ownership of what we believe to be open-source software or claiming noncompliance with open-source licensing terms.

cannot guarantee that we will be successful, that all open-source software is reviewed prior to use in our platform, that our developers have not incorporated open- source software into our products that we are unaware of or that they will not do so in the future.

While we monitor our use of open-source software and try to ensure that none is used in a manner that would require us to disclose our proprietary source code or that would otherwise breach the terms of an open-source agreement, we cannot guarantee that we will be successful, that all open-source software is reviewed prior to use in our platform, that our developers have not incorporated open- source software into our products that we are unaware of or that they will not do so in the future.

Furthermore, there are an increasing number of open-source software license types, almost none of which have been interpreted by U.S.

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Risks Related to Personnel, IT and Physical Infrastructure

Loss of key personnel, including our founders and senior executives, and/or failure to attract, train and retain additional key personnel could delay our cell engineering programs, harm our platform development efforts, limit our biosecurity and public health offerings, and harm our ability to meet our business objectives, particularly given the substantial investment required to recruit, hire and train our employees.

Loss of key personnel, including our founders and senior executives, and/or failure to attract, train and retain additional key personnel , or unintended consequences caused by our workforce reduction, could delay our cell engineering programs, harm our platform development efforts, limit our biosecurity and public health offerings, and harm our ability to meet our business objectives, particularly given the substantial investment required to recruit, hire and train our employees.

Our business involves complex, global operations across a variety of markets and requires a management team and employee workforce that is knowledgeable in the many areas in which we operate.

Our future success depends upon our ability to attract, train, retain and motivate highly qualified management, scientific, engineering, information technology, operations, business development and marketing personnel, among others.

In addition, the market for qualified personnel is competitive because of (a) the limited number of people available who have the necessary technical skills and understanding of our technology and products and (b) the nature of our industry which requires certain of our technical personnel to be on-site in our facilities.

In addition, the market for qualified personnel is

competitive because of (a) the limited number of people available who have the necessary technical skills and understanding of our technology and products and (b) the nature of our industry which requires certain of our technical personnel to be on-site in our facilities.

We compete for qualified technical personnel with other life sciences and information technology companies, as well as academic institutions and research institutions in the markets in which we operate, including:

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and Switzerland.

In addition, as we add international operations, we will increasingly need to recruit qualified personnel outside the United States.

However, doing so may also require us to comply with laws to which we are not currently subject, which could cause us to allocate or divert capital, personnel and other resources from our organization, which could adversely affect our business, financial condition, results of operations, prospects and reputation.

Establishing international operations and recruiting personnel has in the past been impacted by COVID-19 travel and operational restrictions.

Our senior leadership team is critical to our vision, strategic direction, platform development, operations and commercial efforts.

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The departure of one or more of our founders, senior leadership team members or other key employees could be disruptive to our business until we are able to hire qualified successors.

In addition, we implemented a workforce reduction of more than 50% of our employees, which was substantially completed in 2025.

While we believe this workforce reduction was necessary to help realign the Company’s cost structure, this reduction may yield unintended consequences, such as the loss of certain institutional knowledge and technical expertise, as well as attrition beyond our intended reduction in workforce and reduced employee morale, which may cause our employees who were not affected by the reduction in workforce to seek alternate employment.

Additional attrition could impede our ability to meet our operational goals, which could have a material adverse effect on our financial performance.

Our continued platform development, growth and commercial success depends, in part, on recruiting and retaining highly-trained personnel across our various target industries and markets with the necessary background and ability to develop and use our platform and to effectively identify and sell to current and new customers.

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If we are unable to offer competitive compensation this may make it more difficult for us to attract and retain key employees.

To the extent our compensation programs and workplace culture are not viewed as competitive, or changes in our workforce and related restructuring, reduction-in-force, or other initiatives are not viewed favorably, our ability to attract, retain and motivate employees can be weakened, which could harm our results of operations.

Moreover, if the perceived value of our equity awards declines, it may adversely affect our ability to attract and retain key employees.

do not maintain the necessary personnel to accomplish our business objectives, we may experience staffing constraints that adversely affect our ability to support our programs and operations.

If we do not maintain the necessary personnel to accomplish our business objectives, we may experience staffing constraints that adversely affect our ability to support our programs and operations.

In addition, some of our personnel are qualified foreign nationals whose ability to live and work in the U.S.

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In order to properly conduct our business, we need access to sufficient laboratory space and equipment to perform the activities necessary to advance and complete our programs.

Additionally, we need to ensure that our laboratories and corporate offices remain operational at all times, which includes maintaining suitable physical infrastructure, including electrical, plumbing and HVAC, logistics and transportation systems and network infrastructure.

Additionally, we need to ensure that our laboratories and corporate offices remain operational at all times, which includes maintaining suitable physical infrastructure, including electrical, waste management, plumbing and HVAC, logistics and transportation systems and network infrastructure.

We own certain properties in California and lease most of our laboratories and office spaces.

We rely on the landlords for basic maintenance of our leased laboratories and office buildings.

If one of our landlords has not maintained a leased property sufficiently, we may be forced into an early exit from the facility, which could be disruptive to our business.

Furthermore, we may continue to acquire laboratories not built by us in order to sufficiently scale and expand our output capacity.

We rely on the landlords, as applicable, for basic maintenance of our leased laboratories and office buildings.

If one of our landlords has not maintained a leased property sufficiently, we may be forced to stop working on a particular program or even exit early from the facility, which could be disruptive to our business.

Furthermore, we may continue to acquire laboratories not built by us in order to sufficiently scale and expand our output

If we discover that these buildings and their infrastructure assets are not in the condition we expected when they were acquired, we may be required to incur substantial additional costs to repair or upgrade the laboratories.

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● sabotage, vandalism and cyberattacks;

● local epidemics or global pandemics such as the COVID-19 pandemic.

Certain of our facilities are located in an active earthquake and tsunami zone, and certain of our suppliers conduct their operations in the same region or in other locations that are susceptible to natural disasters.

● local epidemics or global pandemics.

Certain of our facilities are located in an active floor, earthquake and/or tsunami zone, and certain of our suppliers conduct their operations in the same region or in other locations that are susceptible to natural disasters.

The occurrence of a natural or other disaster, such as an earthquake, tsunami, hurricane, drought, flood, fire, wildfire or any potential effects of climate change or localized extended outages of critical utilities or transportation systems, or any critical resource shortages affecting us or our suppliers or manufacturers could cause a significant interruption in our business, damage or destroy our facilities, production equipment or inventory or those of our suppliers and cause us to incur significant costs or result in limitations on the availability of our raw materials, any of which could harm our business, financial condition and results of operations.

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As a result, service interruptions or significant equipment damage in our laboratories could result in difficulty maintaining program timelines for these customers and potential claims related to such failures.

Because the services we provide in our laboratories are critical to many of our customers’ businesses, service interruptions or significant equipment damage in our laboratories could also

result in lost revenue or other indirect or consequential damages to our customers.

We cannot guarantee that a court would enforce any contractual limitations on our liability in the event that one of our customers brings a lawsuit against us as a result of a problem at one of our laboratories and we may decide to reach settlements with affected customers irrespective of any such contractual limitations.

Because the services we provide in our laboratories are critical to many of our customers’ businesses, service interruptions or significant equipment damage in our laboratories could also result in lost revenue or other indirect or consequential damages to our customers.

We cannot guarantee that a court would enforce any contractual limitations on our liability in the event that one of our customers brings a lawsuit against us result of a problem at one of our laboratories and we may decide to reach settlements with affected customers irrespective of any such contractual limitations.

In addition, any loss of service, equipment damage or inability to meet our service obligations could reduce the confidence of our customers and could consequently impair our ability to obtain and retain customers, which would adversely affect both our ability to generate revenues and our operating results.

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federal income tax purposes.

As of December 31, 2024, we had federal net operating loss carryforwards of approximately $1.2 billion, of which $139.2 million will begin to expire in 2029 and $1.1 billion can be carried forward indefinitely.

As of December 31, 2024, we had state net operating loss carryforwards of approximately $1.2 billion, of which $991.7 million will begin to expire in 2030 and $162.3 million can be carried forward indefinitely.

As of December 31, 2024, we had federal research and development tax credit carryforwards of approximately $37.7 million, which begin to expire in 2029.

As of December 31, 2024, we also had state research and development and investment tax credit carryforwards of approximately $30.2 million, which begin to expire in 2030.

As of December 31, 2025, the Company had federal net operating loss carryforwards of approximately $1.8 billion, of which $139.2 million will begin to expire in 2029 and $1.6 billion can be carried forward indefinitely.

As of December 31, 2025, the Company had state net operating loss carryforwards of approximately $1.5 billion, of which $1.2 billion will begin to expire in 2030 and $257.5 million can be carried forward indefinitely.

The Company also had $3.9 million of foreign net operating losses as of December 31, 2025, of which $1.5 million will begin to expire in 2034 and $2.4 million can be carried forward indefinitely.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research tax credits, to offset its post-ownership change income or taxes may be limited.

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As a result, even if we earn taxable income, we may be unable to use a material portion of our net operating loss carryforwards and other tax attributes, which could adversely affect our future cash flows.

There is also a risk that regulatory changes, such as suspensions on the use of net operating losses or other unforeseen reasons, may result in our existing net operating loss carryforwards expiring or otherwise becoming unavailable

to offset future taxable income.

For these reasons, we may not be able to utilize a material portion of our net operating loss carryforwards and other tax attributes even if we attain profitability.

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The material weakness identified did not result in any material misstatement of our financial statements.

The material weakness identified for the year ended December 31, 2023 was remediated as of December 31, 2024.

The material weakness identified for the

year ended December 31, 2023 was remediated as of December 31, 2024.

However, we may in the future discover other areas of our internal controls that require remediation.

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Actual or rumored events involving reduced or limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, have in the past and may in the future lead to market-wide liquidity problems.

For example, the closures of SVB, Signature Bank and First Republic Bank in the spring of 2023 created bank-specific and broader financial institution liquidity risk and concerns.

Future adverse developments with respect to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access working capital needs, and create additional market and economic uncertainty.

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Department of Justice, HHS, Office of Inspector General, and other federal and state governmental authorities.

Although our offerings are not currently billed

to any third-party payor, including any commercial payor or government healthcare program, we may, in the future, submit claims for our services to third-party payors, including government healthcare programs.

Although our offerings are not currently billed to any third-party payor, including any commercial payor or government healthcare program, we may, in the future, submit claims for our services to third-party payors, including government healthcare programs.

If we submit claims to third-party payors, such activity will expand the scope of federal and state healthcare laws applicable to us.

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● the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits a physician, in the absence of an applicable exception, from making a referral for certain designated health services covered by the Medicare or Medicaid program, including clinical laboratory services, if the physician or an immediate family member of the physician has a financial relationship with the entity providing the designated health services.

The Stark Law also prohibits the entity furnishing the designated health services from billing, presenting or causing to be presented a claim for the designated health services furnished pursuant to the prohibited referral;

Stark Law also prohibits the entity furnishing the designated health services from billing, presenting or causing to be presented a claim for the designated health services furnished pursuant to the prohibited referral;

● the federal civil false claims laws, including without limitation the federal False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on behalf of the federal government), and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.

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● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) enacted as part of the American Recovery and Reinvestment Act of 2009, and its implementing regulations, and as amended again by the Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act;

Other Modifications to the HIPAA Rules, commonly referred to as the Final HIPAA Omnibus Rule, published in January 2013, which imposes certain obligations, including mandatory contractual terms, on covered entities subject to HIPAA (i.e., health plans, healthcare clearinghouses and certain healthcare providers), as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health

information, to safeguard the privacy, security and transmission of individually identifiable health information from any unauthorized use or disclosure;

Food, Drug, and Cosmetic Act (“FDCA”) which imposes civil and criminal liability for engaging in any of a number of Prohibited acts, including distributing drugs, devices and foods that are adulterated or misbranded.

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We may face claims and proceedings by private parties, and claims, investigations and other proceedings by governmental authorities, relating to allegations that our business practices do not comply with current or future laws or regulations involving applicable fraud and abuse or other healthcare laws and regulations, and it is possible that courts or governmental authorities may conclude that we or any of our partners have not complied with them, or that we may find it necessary or appropriate to settle any such claims or other proceedings.

Any action brought against us for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Any action brought against us for violation of these or other

laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

If our operations are found to be in violation of any federal or state laws described above or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to claims and proceedings by private parties, investigations and other proceedings by governmental authorities, as well as penalties, including significant criminal, civil and administrative penalties, damages and fines, disgorgement, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws or regulations, imprisonment for individuals and exclusion from participation in government programs, such as Medicare and Medicaid, as well as contractual damages and reputational harm.

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If in the future we engage in certain types of standard electronic transactions involving payors, including billing the Medicare or Medicaid programs or commercial health plans, we will be subject to HIPAA as a “covered entity.” We are currently subject to HIPAA as a “business associate” because we performed certain services involving the use or disclosure of PHI on behalf of covered entity customers with respect to our prior COVID-19 testing service offerings.

Implementation of the infrastructure necessary to meet HIPAA standards requires substantial investment.

Implementation of the infrastructure necessary to

meet HIPAA standards requires substantial investment.

Being subject to HIPAA as a covered entity or business associate exposes us to significant fines and penalties, including criminal fines and penalties.

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The data privacy laws under consideration by federal and state legislators also include sector-specific laws.

The My Health My Data Act, which recently became effective in Washington, contains new notice and consent requirements

for the processing of “consumer health data” with the potential for large penalties enforceable through private lawsuits.

The My Health My Data Act, which recently became effective in Washington, contains new notice and consent requirements for the processing of “consumer health data” with the potential for large penalties enforceable through private lawsuits.

The FTC and other authorities are likewise imposing standards for the collection, use, dissemination and security of personal information under consumer protection laws.

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The TCPA places certain restrictions on making certain outbound calls, faxes, and text messages to consumers.

The CAN-SPAM Act imposes penalties for the transmission of commercial emails that do not comply with certain requirements, such as providing an opt-out mechanism for stopping future emails from the sender.

The CAN-SPAM Act imposes penalties for the

transmission of commercial emails that do not comply with certain requirements, such as providing an opt-out mechanism for stopping future emails from the sender.

Further, state and federal auto-renewal laws continue to evolve, which may require us to make changes to our processes in order to comply with such laws.

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government contracts, could impact our performance and compliance costs, including by limiting or delaying our ability to share information with business partners, customers and investors.

government has in the past and may in the future demand contract terms that are less favorable than standard arrangements with private sector customers and may have statutory, contractual, or other legal rights to terminate contracts with us for convenience or for other reasons.

government has in the past and may in the future demand contract terms that are less favorable than standard arrangements with private sector customers, including certain financial requirements obligating the Company to hold surety bonds which restrict our cash, and may have statutory, contractual, or other legal rights to terminate contracts with us for convenience or for other reasons.

Generally, U.S.

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government contracts grant the government the right to use technologies developed by us under the government contract or the right to share data related to our technologies, for or on behalf of the government.

Under our government contracts, we may not be able to limit third parties, including our competitors, from accessing certain of these technology or data rights, including intellectual property, in providing products and services to the government.

government contracts, we may not be able to limit third parties, including our competitors, from accessing certain of these technology or data rights, including intellectual property, in providing products and services to the government.

In addition, failure by us, our employees, representatives, contractors, partners, agents, intermediaries, other customers or other third parties to comply with these regulations and requirements could result in reductions of the value of contracts, contract modifications or termination, claims for damages, refund obligations, the assessment of civil or criminal penalties and fines, loss of rights in our intellectual property and temporary suspension or permanent debarment from government contracting, all of which could negatively impact our results of operations and financial condition.

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Security incidents result from the actions of a wide variety of actors with a wide range of motives and expertise, such as traditional hackers, personnel or the personnel of third parties, sophisticated nation-states and nation-state-supported actors.

While we have developed systems and processes designed to protect the integrity, confidentiality and security of the confidential and personal information under our control, we cannot guarantee that any security measures that we or our third-party service providers implement will be effective in preventing security breaches and incidents, cyberattacks or similar events such as viruses and worms, phishing attacks and other forms of social engineering, denial-of-

service attacks, ransomware attacks, physical or electronic break-ins, third-party or employee theft or misuse, and other negligent actions, errors or malfeasance by employees or other third parties, and similar disruptions from unauthorized tampering with our servers and computer systems or those of third parties that we use in our operations.

we or our third-party service providers implement will be effective in preventing security breaches and incidents, cyberattacks or similar events such as viruses and worms, phishing attacks and other forms of social engineering, denial-of-service attacks, ransomware attacks, physical or electronic break-ins, third-party or employee theft or misuse, and other negligent actions, errors or malfeasance by employees or other third parties, and similar disruptions from unauthorized tampering with our servers and computer systems or those of third parties that we use in our operations.

These incidents could lead to interruptions, delays, loss or corruption of critical data, and unauthorized access to or acquisition of health-related and other personal information.

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Our activities are also subject to the economic sanctions, laws and regulations of the United States and other jurisdictions.

Such controls prohibit certain transactions, potentially including financial transactions and the transfer of products, technologies and services, to sanctioned countries, governments and persons, without a license or other appropriate authorization.

Such controls prohibit certain transactions, potentially including financial transactions and the transfer of products,

technologies and services, to sanctioned countries, governments and persons, without a license or other appropriate authorization.

sanctions policy changes could affect our or our customers’ ability to interact, directly and indirectly, with targeted companies or companies in sanctioned countries.

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Only our employees and directors are entitled to hold shares of Class B common stock (including shares of Class B common stock granted or otherwise issued to our employees and directors in the future), which shares have ten votes per share.

adoption of certain amendments to our organizational documents and the approval of any merger, consolidation, sale of all or substantially all of our assets, or other major corporate transaction requiring stockholder approval.

This limits or precludes other stockholders’ ability to influence the outcome of matters submitted to stockholders for approval, including the election of directors, the approval of certain employee compensation plans, the adoption of certain amendments to our organizational documents and the approval of any merger, consolidation, sale of all or substantially all of our assets, or other major corporate transaction requiring stockholder approval.

Shares of our Class B common stock have ten votes per share, whereas shares of our Class A common stock have one vote per share and shares of our Class C common stock have no voting rights (except as otherwise expressly provided in our amended and restated certificate of incorporation (the “Charter”) or required by applicable law).

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In addition, the conversion of Class B common stock to Class A common stock would dilute holders of Class A common stock in terms of voting power within the Class A common stock.

Because holders of Class C common stock have no voting rights (except as otherwise expressly provided in the Charter or required by applicable law), the holders of Class B common stock may be able to significantly influence the outcome of matters submitted to our stockholders for approval for a longer period of time than would be the case if we issued Class A common stock rather than Class C common stock in such transactions.

Because holders of Class C common stock have no voting rights (except as otherwise expressly provided in the Charter or required

by applicable law), the holders of Class B common stock may be able to significantly influence the outcome of matters submitted to our stockholders for approval for a longer period of time than would be the case if we issued Class A common stock rather than Class C common stock in such transactions.

Our share price may change significantly over time, and you may not be able to resell our common stock at or above the price you paid or at all, and you could lose all or part of your investment as a result.

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Our compensation committee of our board of directors may determine the exact number of shares to be reserved for future issuance under our equity incentive plans at its discretion.

We have filed, and expect to file in the future, one or more registration statements on Form S-8 under the Securities Act of 1933, as amended (the “Securities Act”) to register shares of Class A common stock or securities convertible into or exchangeable for shares of Class A common stock

issued pursuant to our equity incentive plans.

Any such Form S-8 registration statements automatically become effective upon filing.

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See “Risk Factors-Risks Related to Our Common Stock Organizational Structure and Governance-Only our employees and directors are entitled to hold shares of Class B common stock (including shares of Class B common stock granted or otherwise issued to our employees and directors in the future), which shares have ten votes per share.

This limits or precludes other stockholders’ ability to influence the outcome of matters submitted to stockholders for approval, including the election of directors, the approval of certain employee compensation plans, the adoption of amendments to our organizational documents and the approval of any merger, consolidation, sale of all or substantially all of our assets or other major corporate transaction requiring stockholder approval.”

organizational documents and the approval of any merger, consolidation, sale of all or substantially all of our assets or other major corporate transaction requiring stockholder approval.”

Under our Charter, we are authorized to issue 800.0 million shares of Class C common stock, which have no voting rights (except as otherwise expressly provided in the Charter or required by applicable law).

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Our authorized but unissued shares of Class C common stock are available for issuance with the approval of our board of directors without stockholder approval, except as may be required by the Listing Rules of the NYSE.

Because the Class C common stock carries no voting rights (except as otherwise expressly provided in the Charter or required by applicable law), is not convertible into any other capital stock, and is not listed for trading on an exchange or registered for sale with the SEC, shares of Class C common stock may be less liquid and less attractive to any future recipients of these shares than shares of Class A common stock, although we may seek to list the Class C common stock

for trading and register shares of Class C common stock for sale in the future.

In addition, because our Class C common stock has no voting rights (except as otherwise expressly provided in the Charter or required by applicable law), the holders of Class B common stock may be able to significantly influence the outcome of matters submitted to our stockholders for approval for a longer period of time than would be the case if we issued Class A common stock rather than Class C common stock in such transactions.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors