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These risks include, among others, the following:
−Removed: • We need to scale our infrastructure in advance of demand for our products and services, and our failure to generate sufficient demand for our products and services would have a negative impact on our business and our ability to attain profitability.
+Added: • We need to scale our infrastructure in advance of demand for our products and services, and our failure to sustain sufficient demand for our products and services would have a negative impact on our business and our ability to maintain profitability.
• We face intense competition.
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• If third-party payors, including managed care organizations, private health insurers and government health plans, do not provide adequate reimbursement for our tests, or seek to amend or renegotiate their fee reimbursement schedules, or if we are unable to comply with their requirements for reimbursement, our commercial success could be negatively affected.
+Added: • We use artificial intelligence in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.
• We may need to raise additional capital to fund our existing operations, develop additional products and services, commercialize new products and services or expand our operations.
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• Our operating results could be subject to significant fluctuation, which could increase the volatility of our stock and warrant prices and cause losses to our stockholders.
−Removed: • We may be unable to realize the level of the anticipated benefits that we expect from exiting businesses and restructuring our operations, which may adversely impact our business and results of operations.
−Removed: • Changes in FDA enforcement discretion for LDTs could subject our operations to much more significant regulatory requirements.
+Added: • Changes in FDA oversight for LDTs could subject our operations to much more significant regulatory requirements.
+Added: • A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
• Compliance with the HIPAA security, privacy and breach notification regulations may increase our costs.
1 unchanged sentence
• Our inability to effectively protect our proprietary products, processes, and technologies, including the confidentiality of our trade secrets, could harm our competitive position.
−Removed: Table of Co ntents
• Security breaches, privacy issues, loss of data and other incidents could compromise sensitive, protected, or personal information related to our business, could prevent it from accessing critical information, and could expose it to regulatory liability, which could adversely affect our business.
Risks Related to Our Business, Industry and Operations
−Removed: We need to scale our infrastructure in advance of demand for our tests, and our failure to generate sufficient demand for our tests would have a negative impact on our business and our ability to attain profitability.
+Added: We need to scale our infrastructure in advance of demand for our tests, and our failure to sustain sufficient demand for our tests would have a negative impact on our business and our ability to maintain profitability.
Our success depends in large part on our ability to extend our market position, to provide customers with high-quality test reports quickly and at a lower price than our competitors, and to achieve sufficient test volume to realize economies of scale.
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Even if we successfully scale our infrastructure and operations, there can be no assurance that tests will increase at levels consistent with the growth of our infrastructure.
−Removed: If we fail to generate demand commensurate with this growth or if we fail to scale our infrastructure sufficiently in advance of demand to successfully meet such demand, our business, prospects, financial condition and results of operations could be adversely affected.
−Removed: If we are not able to continue to generate substantial demand for our tests, our commercial success will be negatively affected.
−Removed: Our business model assumes that we will be able to generate significant test volume, particularly with respect to exome sequencing and whole genome sequencing in addition to our panel testing offerings, and we may not succeed in continuing to drive adoption of our tests to achieve sufficient volumes.
+Added: If we fail to sustain demand commensurate with this growth or if we fail to scale our infrastructure sufficiently in advance of demand to successfully meet such demand, our business, prospects, financial condition and results of operations could be adversely affected.
+Added: If we are not able to sustain substantial demand for our tests, our commercial success will be negatively affected.
+Added: Our business model assumes that we will be able to sustain significant test volume, particularly with respect to exome sequencing and whole genome sequencing in addition to our panel testing offerings, and we may not succeed in continuing to drive adoption of our tests to achieve sufficient volumes.
Inasmuch as detailed genetic data from exome and whole genome sequencing has only recently become available at relatively affordable prices, the continued pace and degree of clinical acceptance of the utility of such testing is uncertain.
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In addition, potential customers may not adopt our tests if adequate reimbursement is not available, or if we are not able to maintain low prices relative to our competitors.
−Removed: If we are not able to generate demand for our tests at sufficient volume, or if it takes significantly more time to generate this demand than we anticipate, our business, prospects, financial condition and results of operations could be materially harmed.
+Added: If we are not able to sustain demand for our tests at sufficient volume, or if it takes significantly more time to generate this demand than we anticipate, our business, prospects, financial condition and results of operations could be materially harmed.
If our laboratories become inoperable due to disasters, health epidemics or for any other reasons, we will be unable to perform tests, and our business will be harmed.
We perform all of our exome sequencing and whole genome sequencing tests at our production facilities in Gaithersburg, Maryland.
+Added: This concentration heightens our exposure to risks associated with this region, including natural disasters, severe weather conditions, public health crises, acts of terrorism, political or social instability, regulatory changes, and failures of local infrastructure or utilities.
+Added: In the event of a disruption affecting this location, we may experience interruptions to operations, loss of productivity, data or systems outages, delays in service delivery, and reputational harm.
+Added: While we have business continuity and disaster recovery plans in place, such plans may not be sufficient to fully mitigate the impact of all potential disruptions, particularly those that are prolonged or widespread.
Our laboratories and the equipment we use to perform our tests would be costly to replace and could require substantial lead time to replace and qualify for use.
Our laboratories may be harmed or rendered inoperable by natural or man-made disasters, including flooding, fire and power outages, or by health epidemics, which may render it difficult or impossible for us to perform our tests for some period of time.
−Removed: The inability to perform our tests or the backlog that could develop if our laboratories are inoperable for even a short period of time may result in the loss of customers or harm our reputation.
+Added: The inability to perform our tests or the
+Added: backlog that could develop if our laboratories are inoperable for even a short period of time may result in the loss of customers or harm our reputation.
Although we maintain insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to cover all potential losses and may not continue to be available to us on acceptable terms, if at all.
−Removed: Table of Co ntents
Other companies or institutions may develop and market novel or improved technologies, which may make our technologies less competitive or obsolete.
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• public and private research organizations.
−Removed: We may be unable to compete effectively against our competitors either because their products and services are superior or because they may have more expertise, experience, financial resources, or stronger business relationships.
+Added: We may be unable to compete effectively against our competitors either because their products and services are perceived to be superior or because they may have more expertise, experience, financial resources, or stronger business relationships.
These competitors may have broader product lines and greater name recognition than we do.
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Our businesses face changing technologies, shifting provider and patient needs, and frequent introductions of rival products and services.
−Removed: To compete successfully, we must accurately anticipate technology developments and deliver innovative, relevant and useful products, services, and technologies in a timely manner.
+Added: To compete successfully, we must accurately anticipate technological developments and deliver innovative, relevant and useful products, services, and technologies in a timely manner.
As our businesses evolve, the competitive pressure to innovate will encompass a wider range of products and services.
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We have many competitors in different industries.
−Removed: Our current and potential domestic and international competitors range from large and established companies to emerging start-ups in addition to academic and scientific institutions, and public and private research organizations.
+Added: Our current and potential domestic and international competitors range from large established companies to emerging start-ups in addition to academic and scientific institutions, and public and private research organizations.
Some competitors have longer operating histories than our Company in various sectors.
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If our competitors are more successful than us in developing compelling products and services for or in attracting and retaining customers or partners in the market for genetic testing and screening, health information and data science products and services, our operating results could be harmed.
−Removed: Table of Co ntents
If third-party payors, including managed care organizations, private health insurers and government health plans, do not provide adequate reimbursement for our tests, or seek to amend or renegotiate their fee reimbursement schedules, or if we are unable to comply with their requirements for reimbursement, our commercial success could be negatively affected .
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In the past, we have been required to repay certain amounts to payors as a result of such audits.
−Removed: For more information regarding this matter, see Note 3, “ Revenue Recognition ” to our consolidated financial statements included within this Annual Report.
+Added: See Note 4, “ Revenue Recognition ” to our consolidated financial statements for more information.
In addition to potential repayment obligations, failure to comply with payor reimbursement policies could result in government enforcement actions and, potentially, exclusion from certain payor programs, which could have a material adverse effect on our business.
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We use artificial intelligence in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations.
−Removed: We currently incorporate artificial intelligence (“AI”) solutions into our workflows and these applications may become important in our operations over time.
−Removed: Further, we are in the process of enhancing and broadening our offerings with AI technologies, and we are exploring potential third-party partnerships to help us offer more robust solutions for providers and patients.
+Added: We currently incorporate artificial intelligence (“AI”) solutions into our workflows and these applications may become increasingly important in our operations over time.
+Added: Further, we are in the process of enhancing and broadening our offerings with AI technologies, including through the use of Fabric Genomics’ AI-based platform for Next Generation Sequencing analysis, which provides interpretation and clinical reporting for rare disease, hereditary risk, and cancer testing.
+Added: In addition, we are exploring potential third-party partnerships to help us offer more robust solutions for providers and patients.
Our competitors or other third parties may incorporate AI into their products and offerings more quickly or more successfully than us, which could impair our ability to compete effectively and adversely affect our results of operations.
Additionally, if the content, analyses, or recommendations that AI applications assist in producing are or are alleged to be inaccurate, deficient, or biased, our business, financial condition and results of operations may be adversely affected.
−Removed: The use of AI applications has resulted in, and may in the future result in, cybersecurity incidents that implicate the personal medical and genetic data of patients analyzed within
−Removed: Table of Co ntents
−Removed: such applications.
+Added: The use of AI applications in the future may result in
+Added: cybersecurity incidents that implicate the personal medical and genetic data of patients analyzed within such applications, including the risk that we might not be able to effectively manage the use of AI technologies by our employees, consultants and vendors.
Any such cybersecurity incidents related to our use of AI applications to analyze personal data could adversely affect our reputation and results of operations.
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The rapid evolution of AI, including potential government regulation of AI and its various uses, may require significant resources to develop, test and maintain offerings, services, and features to help us implement AI ethically in order to minimize unintended, harmful impact.
+Added: Several governmental authorities have already proposed or enacted laws and other guidance governing AI, such as the EU Artificial Intelligence Act.
+Added: These and other developing obligations may prevent or make it harder for us to conduct or enhance our business using AI, or lead to regulatory fines, penalties, or other liability.
We may need to raise additional capital to fund our existing operations, develop additional products and services, commercialize new products and services or expand our operations.
−Removed: We have incurred net losses and negative cash flows from operations since our inception, with an accumulated deficit of $1.4 billion as of December 31, 2024.
+Added: We have incurred net losses since our inception, with an accumulated deficit of approximately $1.4 billion as of December 31, 2025.
We may seek to sell common or preferred equity or convertible debt securities, enter into credit facilities or other forms of third-party funding or debt financing, or dispose of assets or businesses.
−Removed: For example, we have an effective shelf registration statement that we filed with the SEC in August of 2022, registering $300 million of shares of our Class A common stock and other securities.
−Removed: As of December 31, 2024, approximately $102 million of securities remained available under this registration statement.
−Removed: Further, we have entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”) pursuant to which we may, but are not obligated to, offer and sell, from time to time, shares of our Class A common stock with an aggregate offering price up to $75.0 million through TD Cowen, as sales agent, subject to the terms and conditions described in the Sales Agreement and SEC rules and regulations (our “ATM offering”).
+Added: For example, in October 2025, we filed an automatic universal shelf registration statement that provides for the sale of our Class A common stock and other securities, and up to an aggregate of $100.0 million of our Class A common stock that may be issued from time to time under a Sales Agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”).
+Added: The Sales Agreement was implemented following the use in full of a prior sales agreement for up to $75.0 million of Class A common stock with TD Cowen.
As of December 31, 2025, approximately $78.2 million of capacity remained available under this ATM offering.
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In particular, our credit agreement includes customary affirmative and negative covenants and events of default, including negative covenants that restrict, among other things, our ability to incur indebtedness and liens, dispose of property and make investments.
−Removed: In addition, the credit agreement requires us to maintain aggregate
−Removed: Table of Co ntents
−Removed: unrestricted cash of not less than $5.0 million and minimum levels of quarterly core revenue through the third quarter of 2028.
+Added: In addition, the credit agreement requires us to maintain aggregate unrestricted cash of not less than $5.0 million and minimum levels of quarterly core revenue through the third quarter of 2028.
The operating and financial restrictions in the credit agreement, as well as any other financing arrangements that we may enter into, may limit our ability to finance our operations, or engage in, expand, or otherwise pursue our business activities and strategies.
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If we fail to comply with federal and state laboratory licensing requirements or standards, we could lose the ability to perform our tests or experience disruptions to our business.
−Removed: We are subject to Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease.
+Added: We are subject to the CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease.
CLIA regulations establish specific standards with respect to personnel qualifications, facility administration, proficiency testing, quality control, quality assurance and inspections.
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Several states require the licensure of out-of-state laboratories that accept specimens from certain states.
−Removed: In addition to having a laboratory license in New York, our clinical reference laboratory is approved on test-specific bases for the tests it runs as laboratory-developed tests (“LDTs”), by the New York State Department of Health (“NYDOH”).
+Added: In addition to having a laboratory license in New York, our clinical reference laboratory is approved on test-specific bases for the tests it runs as LDTs, by the New York State Department of Health (“NYDOH”).
Other states may adopt similar licensure requirements in the future, which may require us to modify, delay or stop our operations in such jurisdictions.
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Complying with licensure requirements in new jurisdictions may be expensive, time-consuming, and subject us to significant and unanticipated delays.
−Removed: Failure to comply with applicable clinical laboratory licensure requirements or standards may result in a range of enforcement actions, including license suspension, limitation, or revocation, directed plan of action, onsite monitoring, civil monetary penalties, criminal sanctions, and cancellation of the laboratory’s approval to receive Medicare and Medicaid payment for our services, as well as significant adverse publicity.
+Added: Failure to comply with applicable clinical laboratory licensure requirements or standards may result in a range of enforcement actions, including license suspension, limitation, or revocation, directed plan of action, onsite monitoring, civil monetary penalties, criminal sanctions, and cancellation of the laboratory’s approval to receive Medicare and Medicaid payment for our
+Added: services, as well as significant adverse publicity.
Any sanction imposed under CLIA, its implementing regulations, or state or foreign laws or regulations governing clinical laboratory licensure, or our failure to renew our CLIA certifications, a state or foreign license, or accreditation, could have a material adverse effect on our business, financial condition and results of operations.
Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so.
−Removed: Table of Co ntents
The CAP maintains a clinical laboratory accreditation program.
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require CAP accreditation as a condition to permitting clinical laboratories to test samples taken from their citizens.
−Removed: We have a CAP accreditations for our laboratory.
+Added: We have a CAP accreditation for our laboratory.
Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests and the results of our operations.
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International expansion of our business could expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the U.S.
−Removed: When cleared, authorized or approved, we and our collaborators may market, sell, and distribute our products and services outside of the U.S., and our business would be subject to risks associated with doing business outside of the U.S., including an increase in
−Removed: Table of Co ntents
−Removed: our expenses and diversion of our management’s attention from the development of future products and services.
+Added: When cleared, authorized or approved, we and our collaborators may market, sell, and distribute our products and services outside of the U.S., and our business would be subject to risks associated with doing business outside of the U.S., including an increase in our expenses and diversion of our management’s attention from the development of future products and services.
+Added: In addition, we plan to use Fabric Genomics as our platform for international expansion.
Accordingly, our business and financial results in the future could be adversely affected due to a variety of factors, including:
−Removed: • multiple, conflicting and changing laws and regulations such as privacy, security and data use regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, anticorruption laws, regulatory requirements, reimbursement or payor regimes and other governmental approvals, permits and licenses;
+Added: • multiple, conflicting and changing laws and regulations such as AI, privacy, security and data use regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, anticorruption laws, regulatory requirements, reimbursement or payor regimes and other governmental approvals, permits and licenses;
• failure by us, our collaborators or our distributors to obtain regulatory clearance, authorization or approval for the use of our products and services in various countries;
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We also have significant supply contracts that are short-term and, as we enter into the renewal cycles for these contracts, we may face material price increases upon renewal.
−Removed: In particular, challenging macroeconomic conditions, including cost inflation, decreases in per capita income and levels of disposable income, increased and/or prolonged unemployment or a decline in consumer confidence, as well as limited or significantly reduced points of access of our tests, could have a material adverse effect on the demand for our tests.
+Added: In particular, challenging macroeconomic conditions, including cost inflation, decreases in per capita income and levels of disposable income, tariffs, increased and/or prolonged unemployment or a decline in consumer confidence, as well as limited or significantly reduced points of access of our tests, could have a material adverse effect on the demand for our tests.
Under difficult economic conditions, consumers may seek to reduce discretionary spending by forgoing our tests.
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We have sourced and will continue to source components of our diagnostic testing workflow, including sequencers and other laboratory equipment, reagents, lab supplies and other laboratory services and materials and related services, from third parties.
−Removed: Table of Co ntents
Our failure to maintain a continued supply of our sequencers and other laboratory equipment, reagents, lab supplies and other laboratory services and materials, along with the right to use certain hardware and software and related services, would adversely impact our business, financial condition, and results of operations.
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We rely on a limited number of product and service providers for data infrastructure and analytics capabilities, and any disruption of, or interference with, our use of data and workflow services could adversely affect our business, financial condition, and results of operations, and we may not be able to find replacements or immediately transition to alternative products or service providers.
−Removed: We currently rely upon third-party services for data storage and workflow management, including cloud storage solution providers, such as Microsoft Azure (“Azure”), Amazon Web Services (“AWS”), and Oracle Cloud Infrastructure (“OCI”).
+Added: We currently rely upon third-party services for data storage and workflow management, including cloud storage solution providers.
We rely on each of these providers to complete several vital workflows in our health information and data science service delivery.
To varying degrees some of those services are proprietary to how each platform performs in connection with our current usage of the services.
−Removed: Nearly all of our data storage and analytics are conducted on, and the data and content we generate on our platforms are processed through, servers hosted by these providers, particularly Azure, AWS and OCI.
+Added: Nearly all of our data storage and analytics are conducted on, and the data and content we generate on our platforms are processed through, servers hosted by these providers.
We also rely on email service providers, bandwidth providers, internet service providers and mobile networks to deliver communications to patients, physicians and partners and to allow patients, physicians and our partners to access various offerings from our platforms.
If our third-party vendors are unable or unwilling to provide the services necessary to support our business, or if our agreements with such vendors are terminated, our operations could be significantly disrupted.
−Removed: Some of our vendor agreements may be unilaterally terminated by the licensor for convenience, including with respect to Azure, AWS or OCI, and if such agreements are terminated, we may not be able to enter into similar relationships in the future on reasonable terms or at all.
+Added: Some of our vendor agreements may be unilaterally terminated by the licensor for convenience, and if such agreements are terminated, we may not be able to enter into similar relationships in the future on reasonable terms or at all.
Any damage to, or failure of, our systems or the systems of our third-party data centers or our other third-party providers could result in interruptions to the availability or functionality of database and platforms.
As a result, we could lose health information data and miss opportunities to acquire and retain patients, physicians and partners including health systems and pharmaceutical and biotech companies, which could result in decreased revenue.
−Removed: If for any reason our arrangements with our data centers or third-party providers are terminated or interrupted, such termination or interruption could adversely affect our business, financial
−Removed: Table of Co ntents
−Removed: condition and results of operations.
+Added: If for any reason our arrangements with our data centers or third-party providers are terminated or interrupted, such termination or interruption could adversely affect our business, financial condition and results of operations.
We exercise little control over these providers, which increases our vulnerability to problems with the services they provide.
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Failure to achieve widespread market acceptance of our platform and related products and services would materially harm our business, financial condition and results of operations.
−Removed: Our projections are subject to significant risks, assumptions, estimates and uncertainties, including assumptions regarding the adoption of our products and services.
+Added: Our projections are subject to significant risks, assumptions, estimates and uncertainties, including assumptions regarding the adoption of our products and services and their estimated global market opportunity.
As a result, our projected revenues, market share, expenses and profitability may differ materially from our expectations in any given fiscal quarter or year.
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This may result in decreased revenue, and we may be unable to adopt measures in a timely manner to compensate for any unexpected shortfall in revenue.
−Removed: This inability could cause our operating results in a given fiscal quarter or year to be higher or lower than expected.
+Added: This inability could cause our operating results in a given fiscal quarter or year to be higher or lower than
Any failure to achieve our projected operating results could harm the trading price of our securities and our financial position.
−Removed: Table of Co ntents
−Removed: We have estimated the global market opportunity for our current and future products and services, and these markets may be smaller than we estimate.
−Removed: Our estimates of the global market opportunity for our current products and services and those under development are based on a number of internal and third-party estimates, including, the market opportunity for rare disease and pediatric developmental disorders, adult disorders and newborn screening.
+Added: In addition, our estimates of the global market opportunity for our current products and services and those under development are based on a number of internal and third-party estimates, including, the market opportunity for rare disease and pediatric developmental disorders, adult disorders and newborn screening.
The estimates also depend on whether we or our collaborators are able to engage, diagnose or treat patients through or using our products and services, the number of potential clinical tests utilized per treatment course per patient, the ongoing engagement by patients, physicians and health systems on our platforms, and the assumed prices at which we can sell our current and future products and services for markets that have not been established.
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These and other factors beyond our control could result in delays or other difficulties in the research and development, approval, production, launch, marketing or distribution of enhanced or new tests and could adversely affect our competitive position and results of operations.
−Removed: Table of Co ntents
We currently use, and in the future expect to increase our use of, information and rights from customers, strategic partners, and collaborators for several aspects of our operations, and if we cannot maintain current and enter new relationships with these parties with adequate access and authorization to such information, our business will suffer.
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The success of our products depends on the market’s confidence that we can provide reliable products and services that enable high quality diagnostic testing and health information services with high sensitivity and specificity and short turnaround times.
−Removed: There is no guarantee that the accuracy and reproducibility we have demonstrated to date will continue as our product deliveries increase and our product and service portfolio expands.
+Added: There is no guarantee that the accuracy and reproducibility we have demonstrated to date will continue to meet customer expectations as our product deliveries increase and our product and service portfolio expands.
Our products and services use a number of complex and sophisticated biochemical and bioinformatics processes, many of which are highly sensitive to external factors.
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Further, we must expend resources to operationalize our existing collaborations with our health system partners, which requires
−Removed: Table of Co ntents
substantial effort in areas such as integrations for testing workflow, electronic medical record, consents, marketing, and billing.
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Disagreements or disputes with our health systems and other partners, including disagreements over customers, proprietary or other rights or our or their compliance with financial or other contractual obligations, might cause delays or impair the development or commercialization of our products, services, and technologies, lead to additional responsibilities for us with respect to new products, services and technologies, or result in litigation or arbitration, any of which would divert management attention and resources and be time-consuming and expensive.
−Removed: If our relationships are not successful, our ability to develop and improve of products, services and technologies, and to successfully execute our commercial strategy regarding such products, services and technologies, could be compromised.
+Added: If our relationships are not successful, our ability to develop and improve our products, services and technologies, and to successfully execute our commercial strategy regarding such products, services and technologies, could be compromised.
Our operating results could be subject to significant fluctuation, which could increase the volatility of our stock and warrant prices and cause losses to our stockholders.
Our operating results may fluctuate significantly, depending on a variety of factors, including the following:
−Removed: • our success in marketing and selling, and changes in demand for, our tests, and the level of reimbursement and collection obtained for such tests;
+Added: • our success in marketing and selling, and changes in demand for our tests;
• seasonal and environmental variations affecting healthcare provider recommendations for our tests and patient compliance with healthcare provider recommendations, including without limitation holidays, weather events, and circumstances such as the outbreak of coronavirus or influenza that may limit patient access to medical practices for diagnostic tests and preventive services;
2 unchanged sentences
• circumstances affecting our ability to provide our tests, including weather events, supply shortages, or regulatory or other circumstances that adversely affect our ability to manufacture our tests or process tests in our clinical laboratories;
−Removed: • circumstances affecting our ability to provide health information and data science services to biopharma partners, including software or hardware failures, insufficient capacity, regulatory changes or other circumstances that adversely affect the ability of us to deliver these services;
+Added: • circumstances affecting our ability to provide health information and data science services to biopharma partners, including software or hardware failures, insufficient capacity, regulatory changes or other circumstances that adversely affect our ability to deliver these services;
• fluctuations in the amount and timing of our selling and marketing costs and our ability to manage costs and expenses and effectively implement our business;
11 unchanged sentences
Due to these factors and the evolving nature of our business, our historical revenue growth rate and historical gross operating margins may not be indicative of our future performance.
−Removed: Table of Co ntents
−Removed: Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited.
−Removed: As of December 31, 2024, our total gross deferred tax assets were approximately $318 million.
−Removed: Future realization of the tax benefits of existing temporary differences and carryforwards ultimately depends on the existence of sufficient taxable income within the carryforward period.
−Removed: As of December 31, 2024 and December 31, 2023, the Company performed an evaluation to determine whether a valuation allowance was needed.
−Removed: Based on the Company’s analysis, which considered all available evidence, both positive and negative, the Company determined that it is more likely than not that a significant portion of its deferred tax assets will not be realized.
−Removed: Accordingly, the Company maintained a full valuation allowance as of December 31, 2024 and December 31, 2023.
−Removed: Furthermore, under Section 382 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards (“NOLs”) and other pre-change tax attributes (such as research tax credits) to offset its future taxable income may be limited.
−Removed: In general, an “ownership change” occurs if there is a cumulative change in its ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period.
−Removed: Our existing NOLs and tax credit carryovers may be subject to limitations arising from previous ownership changes, and if we undergo one or more ownership changes in connection with completed acquisitions, including the Business Combination or the Acquisition, or future transactions in our stock, our ability to utilize NOLs and tax credit carryovers could be further limited by Section 382 of the Internal Revenue Code.
−Removed: As a result, if we earn future taxable income, our ability to use our pre-change net operating loss and tax credit carryforwards to offset U.S.
−Removed: federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us.
−Removed: In addition, the Tax Cuts and Jobs Act limits the deduction for NOLs to 80% of current year taxable income and eliminates NOL carrybacks.
−Removed: Further, there may also be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state liability.
+Added: Our ability to utilize our net operating loss carry forwards and certain other tax attributes may be limited.
+Added: As of December 31, 2025, we had total gross deferred tax assets of approximately $342 million, including net operating loss carryforwards (“NOLs”) and tax credit carryforwards.
+Added: The realization of these deferred tax assets depends on our ability to generate sufficient taxable income within the applicable carryforward periods.
+Added: Based on our evaluation of available positive and negative evidence, we have recorded a full valuation allowance against our deferred tax assets as of December 31, 2025 and December 31, 2024.
+Added: If we are unable to generate sustained taxable income in future periods, we may be unable to realize some or all of these tax benefits.
+Added: In addition, our ability to utilize NOLs and certain other tax attributes may be limited under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), if we experience an “ownership change.” An ownership change generally occurs if the percentage of our stock owned by one or more 5% shareholders increases by more than 50 percentage points over a rolling three-year period.
+Added: We may have experienced ownership changes in the past, and future transactions involving our equity, including acquisitions such as the Business Combination or the Acquisition, financings, or other changes in our stock ownership, could result in additional ownership changes.
+Added: If an ownership change occurs, our ability to utilize pre-change NOLs and other tax attributes could be subject to annual limitations, which could materially reduce or eliminate the benefit of these tax assets.
+Added: Furthermore, under the Tax Cuts and Jobs Act, NOLs generated in taxable years beginning after December 31, 2017 may offset only up to 80% of current-year taxable income and generally may not be carried back to prior years.
+Added: State tax laws may impose similar or additional restrictions, and in certain jurisdictions the use of NOLs may be suspended or otherwise limited.
+Added: As a result of these limitations, we could incur increased federal and state income tax liabilities in future periods, which could materially and adversely affect our results of operations and cash flows.
+Added: Declines in the future expected cash flows for the Company’s businesses or changes to underlying assumptions used to calculate fair value could result in impairment charges which could have a material adverse effect on the Company’s financial results of operations.
+Added: Our total assets reflect goodwill and amortizable intangible assets, including developed technology, tradenames and trademarks and customer relationships.
+Added: The Company is required under U.S.
+Added: GAAP to review its long-lived assets for impairment when events or changes in circumstances indicate the carrying value may not be recoverable, and is also required to conduct impairment tests on goodwill annually or more frequently, if circumstances indicate that the carrying value may not be recoverable or that an other-than-temporary impairment exists.
+Added: Future events or factors may occur that could adversely affect the fair value of the Company’s assets and require impairment charges, including, but not limited to, divestitures of certain businesses or product lines, strategic decisions made in response to changes in economic and competitive conditions, the impact of the economic environment on the Company’s sales and customer base, a material adverse change in the Company’s relationship with significant customers or business partners, or a sustained decline in the Company’s stock price.
+Added: In the event any such impairment indicators become known or are present, the Company may be required to perform impairment tests based on changes in the economic environment and other factors, and these tests could result in impairment charges in the future.
Risks Related to Our Key Relationships
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We typically receive blood and saliva samples for analysis at our laboratory facilities within days of collection from the patient.
−Removed: Disruptions and errors in these delivery service and accessioning errors and breaches, whether due to error by the delivery service, labor disruptions, bad weather, natural disaster, terrorist acts or threats, outbreaks of disease or for other reasons, could adversely affect specimen integrity, our ability to process or store samples in a timely manner and to service our customers, and ultimately our reputation and our business.
+Added: Disruptions or errors in delivery service and accessioning errors and breaches, whether due to error by the delivery service, labor disruptions, bad weather, natural disaster, terrorist acts or threats, outbreaks of disease or for other reasons, could adversely affect specimen integrity, our ability to process or store samples in a timely manner and to service our customers, and ultimately our reputation and our business.
In addition, if we are unable to continue to obtain expedited delivery services on commercially reasonable terms, our operating results may be adversely affected.
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From time to time, we may consider additional opportunities to acquire other products or technologies that may enhance our product platform or technology, expand the breadth of our markets or customer base, or advance our business strategies.
−Removed: In addition, we exited both our reproductive and women's health testing business and our somatic tumor testing business, which involves the divestiture of these businesses, and we may consider disposing other assets or businesses in the future.
+Added: For example, in May of 2025, we completed the acquisition of Fabric Genomics.
+Added: The integration of acquired businesses involves significant risks and uncertainties, including difficulties in integrating operations, technologies, systems, realizing anticipated synergies or strategic benefits and managing increased operational complexity.
+Added: If we are unable to successfully integrate acquired businesses or realize the expected benefits of such transactions, our business, financial condition, and results of operations could be adversely affected.
Potential acquisitions involve numerous risks, including:
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• increased legal and accounting costs relating to the acquisitions or compliance with regulatory matters.
−Removed: We do not know if we will be able to identify any other acquisitions we deem suitable, whether we will be able to successfully complete any acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired products
−Removed: Table of Co ntents
−Removed: or technologies.
+Added: We do not know if we will be able to identify any other acquisitions we deem suitable, whether we will be able to successfully complete any acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired products or technologies.
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition.
+Added: We may also consider disposing of assets or business in the future.
Dispositions may similarly involve risks associated with the potential disruption of our ongoing business and distraction of our management team, and the anticipated benefits and cost savings of these transactions may not be realized fully, or at all, or take longer to realize than anticipated.
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The cost of compliance with these laws and regulations may become significant, and our failure to comply may result in substantial fines or other consequences, and either could negatively affect our operating results.
−Removed: Changes in FDA enforcement discretion for laboratory developed tests LDTs could subject our operations to much more significant regulatory requirements.
+Added: Changes in FDA oversight for laboratory developed tests LDTs could subject our operations to much more significant regulatory requirements.
We currently offer an LDT version of certain tests.
Historically, the FDA has exercised a policy of enforcement discretion with respect to most LDTs, whereby the FDA did not actively enforce its medical device regulatory requirements for such tests.
−Removed: However, at various points in recent years, FDA has indicated that it intends to end enforcement discretion for many tests offered as LDTs, and to require such tests to comply with certain FDA regulatory requirements.
+Added: However, at various points in recent years, the FDA has indicated that it intends to end enforcement discretion for many tests offered as LDTs, and to require such tests to comply with certain FDA regulatory requirements.
Agency officials have previously expressed significant concerns regarding performance disparities between some LDTs and in vitro diagnostics that have been reviewed, cleared, authorized or approved by the FDA.
−Removed: Most recently, on April 29, 2024, the FDA published a final rule on LDTs, in which FDA outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period.
−Removed: In Phase 1 (effective May 6, 2025), clinical laboratories would be required to comply with medical device (adverse event) reporting, correction/removal reporting, and certain quality systems complaint handling requirements.
−Removed: In Phase 2 (effective May 6, 2026), clinical laboratories would be required to comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for remaining quality systems requirements and premarket review.
−Removed: In Phase 3 (effective May 6, 2027), clinical laboratories would be required to comply with all remaining applicable quality systems requirements.
−Removed: In Phase 4 (effective November 6, 2027), clinical laboratories would be
−Removed: Table of Co ntents
−Removed: required to comply with premarket submission requirements for high-risk tests (i.e., tests subject to premarket approval (PMA) requirement).
−Removed: Finally, in Phase 5 (effective May 6, 2028), clinical laboratories would be required to comply with premarket submission requirements for moderate- and low-risk tests (i.e., tests subject to de novo or 510(k) requirement).
−Removed: The final rule potentially extends enforcement discretion for certain tests – e.g., LDTs approved by the New York State Department of Health, and LDTs first marketed prior to May 6, 2024 which are not modified or are modified in certain limited ways – from certain FDA regulatory requirements, provided certain important limitations have been met.
−Removed: We are actively reviewing the final rule to evaluate its applicability to our operations, and the extent to which we may be required to modify our operations to comply with its requirements.
−Removed: Multiple lawsuits have been filed challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.
−Removed: The outcome of these lawsuits is uncertain at this time.
−Removed: If the FDA were to determine that certain tests offered by us as LDTs are no longer eligible for enforcement discretion for any reason, including new rules, policies or guidance, or due to changes in statute, our tests may become subject to extensive FDA requirements or our business may otherwise be adversely affected.
+Added: On April 29, 2024, the FDA published a final rule on LDTs, in which the FDA outlined its plans to end enforcement discretion for many LDTs in five stages over a four-year period.
+Added: In response, multiple lawsuits were filed challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
+Added: On March 31, 2025, the U.S.
+Added: District Court for the Eastern District of Texas struck down the 2024 final rule on the grounds that the FDA exceeded its authority under the FDCA.
+Added: The FDA did not appeal the court’s ruling.
+Added: As a result, clinical laboratories offering LDTs are not required to comply with any of the phases of the final rule.
+Added: Legislative proposals addressing the FDA’s oversight of LDTs have also been introduced in previous Congresses, and we expect that new legislative proposals will be introduced from time-to-time.
+Added: If the FDA ultimately regulates certain LDTs, or we voluntarily choose to submit certain test(s) for FDA review, our tests may become subject to extensive FDA requirements and our business may otherwise be adversely affected.
If the FDA were to actively regulate our LDTs, we could experience reduced revenue or increased costs, which could adversely affect our business, prospects, results of operations and financial condition.
−Removed: If required, the regulatory marketing authorization process required to bring our current or future LDTs into compliance may involve, among other things, successfully completing additional clinical validations and submitting to and obtaining clearance from the FDA for a premarket clearance (510(k)) submission or authorization for a de novo submission or approval of a premarket approval application.
−Removed: Furthermore, pending legislative proposals, if enacted, such as the VALID Act, could create new or different regulatory and compliance burdens on us and could have a negative effect on our ability to keep products on the market or develop new products, which could have a material effect on our business.
−Removed: In the event that the FDA requires marketing authorization of our LDTs in the future, the FDA may not ultimately grant any clearance, authorization or approval requested by us in a timely manner, may limit our indication in a way that is not commercially desirable, or refuse to provide such authorization at all.
+Added: The regulatory marketing authorization process may involve, among other things, successfully completing additional clinical validations and preparing submissions that comply with applicable premarket review requirements.
+Added: Furthermore, legislative proposals, if enacted, such as the VALID Act, could create new or different regulatory and compliance burdens on us and could have a negative effect on our ability to keep products on the market or develop new products, which could have a material effect on our business.
+Added: In the event that the FDA requires or we voluntarily seek marketing authorization of our LDTs in the future, the FDA may not ultimately grant any clearance, authorization or approval requested by us in a timely manner, may limit our indication in a way that is not commercially desirable, or refuse to provide such authorization at all.
In addition, if the FDA inspects our laboratory in relation to the marketing of any FDA-authorized test, any enforcement action the FDA takes might not be limited to the FDA-authorized test carried by us and could encompass our other testing services.
+Added: A breakthrough device designation by the FDA, even though granted, may not lead to a faster development, regulatory review or authorization, nor a designation increase the likelihood that any of our product candidates will receive regulatory authorization in the United States.
+Added: In October 2025, we received Breakthrough Device Designation from the FDA for the “Breakthrough Device Designation Indications” using our ExomeDx TM and GenomeDx TM tests.
+Added: Breakthrough Device Designation provides certain benefits, including more interactive and timely communications with FDA staff, potential use of post-market data collection to facilitate expedited development and review, opportunities for more efficient and flexible clinical study design, and prioritized review of premarket submissions.
+Added: However, there can be no guarantee that these benefits will materialize or significantly impact our development and regulatory authorization process.
+Added: We may not experience a faster development process, review, or authorization compared to conventional FDA procedures.
+Added: Breakthrough Device Designation does not alter the regulatory standards for marketing authorization or guarantee that we will ultimately obtain FDA authorization for the Breakthrough Device Designation Indications using our ExomeDx TM and GenomeDx TM tests.
+Added: Furthermore, the FDA may rescind Breakthrough Device Designation if it believes that the designation is no longer supported by data from our clinical development program.
+Added: As with all FDA marketing authorizations, we will need to continue to comply with applicable regulations and standards, which may change over time.
Our business is subject to various complex laws and regulations applicable to clinical diagnostics.
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Development of the existing commercialization strategy for our tests and planned development of products in our pipeline has been based on existing healthcare policies.
−Removed: Table of Co ntents
−Removed: cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition and results of operations.
+Added: We cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition and results of operations.
If we or our partners fail to comply with these laws and regulations, it could incur significant fines and penalties and our reputation and prospects could suffer.
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In addition, the Company has experienced a number of “security incidents” (as defined under HIPAA) that involved the unauthorized disclosure of PHI.
−Removed: A subset of these incidents was determined to be reportable breaches requiring disclosure to
−Removed: Table of Co ntents
−Removed: OCR, as well as to the affected patients.
+Added: A subset of these incidents was determined to be reportable breaches requiring disclosure to OCR, as well as to the affected patients.
Moreover, we cannot confirm that we have identified all previous incidents that could constitute reportable breaches, or that the mitigation steps undertaken in response to known breaches are adequate to satisfy applicable regulatory requirements and prevent any future unauthorized disclosures.
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As currently drafted, EKRA potentially expands the universe of arrangements that could be subject to government enforcement under federal fraud and abuse laws.
−Removed: In addition, while the Anti-Kickback Statute, includes certain exceptions that are widely relied upon in the healthcare industry, including safe harbors applicable to certain employees and personal service contracts, and not all of those same exceptions apply under EKRA.
+Added: In addition, while the Anti-Kickback Statute includes certain exceptions that are widely relied upon in the healthcare industry, including safe harbors applicable to certain employees and personal service contracts, not all of those same exceptions apply under EKRA.
EKRA expressly does not protect employee compensation that varies by the number of individuals referred to a laboratory, the number of tests performed by a laboratory, or the amount billed to or received from a health benefit program from individuals referred to a laboratory.
−Removed: Because EKRA is a relatively new law, there is no agency guidance and only two courts have addressed the application of EKRA and those courts reached opposite conclusions.
−Removed: One Court ruled that the commission-based compensation provisions of a laboratory employee’s contract did not violate EKRA while the other court expressly disagreed.
+Added: Because EKRA is a relatively new law, there is no agency guidance and only a few courts have addressed the application of EKRA and those courts reached opposite conclusions on the issue of whether laboratory payments to employees for sales and marketing activities implicate or violate EKRA.
Given the conflicting opinions, we cannot be assured that courts in our jurisdiction will reach the same conclusion or that the decision will not be overturned if there is an appeal.
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In addition, inaccurate or otherwise improper claims for reimbursement could constitute a false claim, meaning that we or our partners must carefully and accurately code claims for reimbursement, proactively monitor the accuracy and appropriateness of claims and payments received, diligently investigate any credible information indicating that we or our partners may have received an overpayment, and promptly return any overpayments.
−Removed: Medicare payments are subject to audit, including through the Comprehensive Error Rate Testing (“CERT”),
−Removed: Table of Co ntents
−Removed: program, and payments may be recouped by CMS if it is determined that they were improperly made.
+Added: Medicare payments are subject to audit, including through the Comprehensive Error Rate Testing (“CERT”), program, and payments may be recouped by CMS if it is determined that they were improperly made.
Currently, a small percentage of our revenues are generated by payments from Medicare.
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Changes in state licensure laws that affect our ability to offer and provide research and diagnostic products and services across state or foreign country lines could materially and adversely affect our business.
−Removed: In addition, state and foreign requirements for laboratory certification may be costly or difficult to meet and could affect our ability to receive specimens from certain states or foreign countries.
+Added: In addition, state
+Added: and foreign requirements for laboratory certification may be costly or difficult to meet and could affect our ability to receive specimens from certain states or foreign countries.
Any sanction imposed under CLIA, its implementing regulations or state or foreign laws or regulations governing licensure, or our failure to renew a CLIA certificate, a state or foreign license or accreditation, could have a material adverse effect on our business.
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If we or our collaborators fail to comply with regulatory requirements in international markets or to obtain and maintain required regulatory clearances, authorizations or approvals in international markets, or if those approvals are delayed, our target market will be reduced and our ability to realize the full market potential of our products and services will be unrealized.
−Removed: Table of Co ntents
Complying with numerous statutes and regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
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• the General Data Protection Regulation (“GDPR”) and UK Data Protection Act 2018 (“UK GDPR”), which imposes strict privacy and security requirements on controllers and processors of European and UK personal data, including enhanced protections for “special categories” of personal data, including sensitive information such as health and genetic information of data subjects;
−Removed: • the CCPA , and similar consumer privacy laws in Colorado, Connecticut, Utah, and Virginia, which, among other things, regulate how subject businesses may collect, use, disclose and/or sell the personal information of consumers who reside in each state, affords rights to consumers that they may exercise against businesses that collect their information, and requires implementation of reasonable security measures to safeguard personal information of consumers;
+Added: • the CCPA, and similar consumer privacy laws in other states, which, among other things, regulate how subject businesses may collect, use, disclose and/or sell the personal information of consumers who reside in each state, affords rights to consumers that they may exercise against businesses that collect their information, and requires implementation of reasonable security measures to safeguard personal information of consumers;
• laws governing genetic counseling services, relating to, among other things, the adequacy of health care, the practice of medicine and other health professions (including the provision of remote care and cross-coverage practice), equipment, personnel, operating policies and procedures and the prerequisites for ordering laboratory tests.
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• the 21st Century Cures Act information blocking prohibition, which prohibits covered actors from engaging in certain practices that are likely to interfere with the access, exchange, or use of electronic health information;
−Removed: Table of Co ntents
• the Physician Payments Sunshine Act and similar state laws that require reporting of certain payments and other transfers of value made by applicable manufacturers, directly or indirectly, to or on behalf of covered recipients including physicians (defined to include doctors of medicine, osteopathy, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse midwives and teaching hospitals as well as ownership and investment interests held by physicians and their immediate family members;
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We face uncertainty related to healthcare reform, pricing, coverage and reimbursement, which could reduce our revenue.
−Removed: Healthcare reform laws, including the Patient Protection and Affordable Care Act (“ACA,”) and the Protecting Access to Medicare Act of 2014 (“PAMA,”) are significantly affecting the U.S.
+Added: Healthcare reform laws, including the Patient Protection and Affordable Care Act (“ACA”) and PAMA, are significantly affecting the U.S.
healthcare and medical services industry.
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We cannot predict whether future healthcare reform initiatives will be implemented at the federal or state level or the effect any such future legislation or regulation will have on it.
−Removed: The taxes imposed by new legislation, cost reduction measures and the expansion in the government’s role in the
−Removed: Table of Co ntents
+Added: The taxes imposed by new legislation, cost reduction measures and the expansion in the government’s role in the U.S.
healthcare industry may result in decreased profits to us, which may adversely affect our business, financial condition and results of operations.
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Product and professional liability suits against us could result in expensive and time-consuming litigation, payment of substantial damages and increases in our insurance rates.
−Removed: The sale and use of our solutions, products and services could lead to product or professional liability claims, including class action lawsuits.
+Added: The sale and use of our solutions, products and services could lead to product or professional liability claims, including class action lawsuits, and the growth in the sale and use of our solutions, products and services could lead to greater exposure to product or professional liability claims.
We may also be subject to liability for errors in the test results, including health information it provides to healthcare providers or patients or for a misunderstanding of, or inappropriate reliance upon, the information it provides.
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Any of these developments could harm our business and operating results.
−Removed: Table of Co ntents
We are subject to increasingly complex taxation rules and practices, which may affect how we conduct our business and our results of operations.
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We are and may be subject to the examination of our tax returns by federal, state and foreign tax authorities.
−Removed: If our tax strategies are ineffective or it is not in compliance with domestic and international tax laws, as applicable, our financial position, operating results and cash flows could be adversely affected.
+Added: If our tax strategies are ineffective or not in compliance with domestic and international tax laws, as applicable, our financial position, operating results and cash flows could be adversely affected.
Risks Related to Our Intellectual Property
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However, we expect that potential patent coverage we may obtain will not be sufficient to prevent substantial competition.
−Removed: In this regard, we believe it is probable that others will independently develop similar or alternative technologies or design around those technologies for which we may obtain patent protection.
−Removed: In addition, any patent applications we file may be rejected during examination and may not result in issued patents, or may be invalidated or narrowed in scope after they are issued.
+Added: regard, we believe it is probable that others will independently develop similar or alternative technologies or design around those technologies for which we may obtain patent protection.
+Added: In addition, there is no guarantee that any patent applications we file will result in issued patents;
+Added: and, even if issued patents are obtained, they remain subject to third-party contestation via post-grant patent challenges.
Questions as to inventorship or ownership may also arise.
−Removed: Any finding that our patents or applications are unenforceable could harm our ability to prevent others from practicing the related technology, and a finding that others have inventorship or ownership rights to our patents and applications could require us to obtain certain rights to practice related technologies, which may not be available on favorable terms, if at all.
+Added: Any finding that our patents or applications are unenforceable or invalid would harm our ability to prevent others from practicing the related technology, and a finding that others have inventorship or ownership rights to our patents and applications could require us to obtain certain rights to practice related technologies, which may not be available on favorable terms, if at all.
It would be expensive, if we initiate lawsuits to protect or enforce our patents or trade secrets, or defend against third-party IP claims, and if we lose, we may lose some of our intellectual property rights.
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this becomes increasingly important as we expand our operations and enter into strategic collaborations with partners to develop and commercialize products outside of the U.S.
−Removed: The laws of some foreign countries do not protect proprietary
−Removed: Table of Co ntents
−Removed: rights to the same extent as the laws of the U.S., and we may encounter difficulties in establishing and enforcing its proprietary rights in some jurisdictions.
+Added: The laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the U.S., and we may encounter difficulties in establishing and enforcing its proprietary rights in some jurisdictions.
In addition, the proprietary positions of companies developing and commercializing tools for molecular diagnostics, including our own, generally are uncertain and involve complex legal and factual questions.
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Congress or the U.S.
−Removed: Patent & Trademark Office (“USPTO”) may change the standards of patentability and validity of patents within the screening and diagnostics space, and any such changes could have a negative impact on our business.
+Added: Patent & Trademark Office (“USPTO”) may change the standards of patentability and validity of patents within the screening and diagnostics space, and any such changes could have an impact on our business.
There have been several cases involving “gene patents” and diagnostic claims that have been considered by the U.S.
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The guidance indicates that claims directed to a law of nature, a natural phenomenon, or an abstract idea that do not meet the eligibility requirements should be rejected as non-statutory, patent ineligible subject matter.
−Removed: While these guidelines may be subject to review and modification by the USPTO over time, we cannot assure you that our intellectual property strategy or patent portfolio will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO.
+Added: While these guidelines may be subject to review and modification by the USPTO over time, we cannot assure you that our intellectual property strategy or patent
+Added: portfolio will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO.
Additional substantive changes to patent law, whether new or associated with the America Invents Act which substantially revised the U.S.
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If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
−Removed: Failure to maintain our trademark registrations, or to obtain new trademark registrations in the future, could limit our ability to protect our trademarks and impede our marketing efforts in the countries in which we operate.
+Added: Failure to maintain our trademark registrations, or to obtain new trademark registrations in the future, could limit our ability to protect our trademarks and impede our marketing efforts, including our efforts on GeneDx Infinity TM , in the countries in which we operate.
We may not be able to protect our rights to trademarks and trade names which we may need to build name recognition with potential partners or customers in our markets of interest.
−Removed: As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark
−Removed: Table of Co ntents
−Removed: claims against third parties or initiate trademark opposition proceedings.
+Added: As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings.
This can be expensive and time-consuming, and possibly unsuccessful.
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Third parties, including our competitors, have asserted and may in the future assert that we are infringing their intellectual property rights.
−Removed: We may also become subject to and/or initiate future intellectual property litigation as our product portfolio and the level of competition in our industry grow.
−Removed: Because the USPTO maintains patent applications in secrecy until a patent application publishes or the patent is issued, we have no way of knowing if others may have filed patent applications covering technologies used by it or our partners.
+Added: We may also become subject to and/or initiate future intellectual property litigation as our IP and product portfolio and the level of competition in our industry grow.
+Added: Because the USPTO maintains patent applications in secrecy until a patent application publishes, which is typically 18 months after the filing date, we have no way of knowing if others may have filed patent applications covering technologies used by it or our partners during this non-publication window.
Additionally, there may be third-party patents, and other intellectual property rights relevant to our technologies that may block us from commercializing our technologies.
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Even if third-party claims are without merit, defending a lawsuit may result in substantial expense to us and may divert the attention of management and key personnel.
−Removed: In addition, we cannot provide assurance that we would prevail in any such suits to the extent necessary to conduct our business according to our strategic plan or that the damages or other remedies, if any, awarded against us would not be substantial.
+Added: In addition, we cannot
+Added: provide assurance that we would prevail in any such suits to the extent necessary to conduct our business according to our strategic plan or that the damages or other remedies, if any, awarded against us would not be substantial.
Claims of intellectual property infringement may require that we, or our strategic partners, enter into unsustainably high royalty or license agreements with third parties that may only be available on unacceptable terms, if at all.
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There is little legal precedent governing the interpretation of certain terms of these licenses, and therefore the potential impact of these terms on our business is unknown and may result in unanticipated obligations regarding our products and technologies.
−Removed: If an author or other third party that distributes such open-source software were to allege
−Removed: Table of Co ntents
−Removed: that we had not complied with the conditions of one or more of these licenses, we could be required to incur significant legal expenses defending against such allegations.
+Added: If an author or other third party that distributes such open-source software were to allege that we had not complied with the conditions of one or more of these licenses, we could be required to incur significant legal expenses defending against such allegations.
In addition, if we combine our proprietary software with open-source software in a certain manner, under some open-source licenses, we could be required to release the source code of our proprietary software, which could substantially help our competitors develop products that are similar to or better than our products.
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There can be no assurance that any current contractual arrangements between us and third parties or between our strategic partners and other third parties will be continued on materially similar terms and will not be breached or terminated early.
−Removed: Any failure to obtain or retain the rights to necessary technologies on acceptable commercial terms could require us to re-configure our products and services, which could negatively impact their commercial sale or increase the associated costs, either of which could materially harm our business and adversely affect our future revenues and ability to achieve sustained profitability.
+Added: Any failure to obtain or retain the rights to necessary technologies on acceptable commercial terms could require us to re-configure our products and services, which could negatively impact their commercial sale or increase the associated costs, either of which could materially harm our business and adversely affect our future financial condition and results of operations.
We expect to continue and expand our reliance on collaborative and licensing arrangements.
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In addition to storing and transmitting sensitive data that is subject to multiple legal protections, these applications and data encompass a wide variety of business-critical information including research and development information, commercial information, and business and financial information.
−Removed: We continue to face a number of risks relative to protecting this critical information, including loss of access risk, inappropriate disclosure, inappropriate modification, and the risk
−Removed: Table of Co ntents
−Removed: of our being unable to adequately monitor and modify our controls over our critical information.
+Added: We continue to face a number of risks relative to protecting this critical information, including loss of access risk, inappropriate disclosure, inappropriate modification, and the risk of our being unable to adequately monitor and modify our controls over our critical information.
Any technical problems that may arise in connection with the data that we access and our systems, including those that are hosted by third-party providers, could result in interruptions to our business and operations or exposure to security vulnerabilities.
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The CCPA regulates how certain for-profit businesses that meet one or more CCPA applicability thresholds collect, use, and disclose the personal information of consumers who reside in California.
−Removed: Among other things, the CCPA confers to California consumers the right to receive notice of the categories of personal information that will be collected by a business,
−Removed: Table of Co ntents
−Removed: how the business will use and share the personal information, and the third parties who will receive the personal information;
+Added: Among other things, the CCPA confers to California consumers the right to receive notice of the categories of personal information that will be collected by a business, how the business will use and share the personal information, and the third parties who will receive the personal information;
the CCPA also confers rights to access, delete, or transfer personal information;
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Any failure or perceived failure by us to comply with these laws may also subject us to enforcement action or litigation, any of which could harm our business.
−Removed: We can provide no assurance that it is or will remain in compliance with diverse privacy and data security requirements in all of the jurisdictions in which we do business.
+Added: We can provide no assurance that it is or will remain in compliance with diverse privacy and data
+Added: security requirements in all of the jurisdictions in which we do business.
Failure to comply with privacy and data security requirements could result in a variety of consequences, or damage to our reputation, any of which could have a material adverse effect on our business.
−Removed: Data privacy and security concerns relating to our technology and our practices could damage our reputation, subject it to significant legal and financial exposure, and deter current and potential users or customers from using our products and services.
+Added: Data privacy and security concerns relating to our technology, including our use of AI, and our practices could damage our reputation, subject it to significant legal and financial exposure, and deter current and potential users or customers from using our products and services.
Software bugs or defects, security breaches, and attacks on our systems could result in the improper disclosure and use of user data and interference with our users and customers’ ability to use our products and services, harming our business operations and reputation.
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Attacks and security issues could also compromise trade secrets and other sensitive information, harming our business.
−Removed: Table of Co ntents
−Removed: While we have dedicated significant resources to privacy and security incident response capabilities, including dedicated worldwide incident response teams, our response process may not be adequate, may fail to accurately assess the severity of an incident, may not respond quickly enough, or may fail to sufficiently remediate an incident.
+Added: While we have dedicated significant resources to privacy and security incident response capabilities, including dedicated incident response teams, our response process may not be adequate, may fail to accurately assess the severity of an incident, may not respond quickly enough, or may fail to sufficiently remediate an incident.
As a result, we may suffer significant legal, reputational, or financial exposure, which could harm our business, financial condition, and operating results.
9 unchanged sentences
Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious internal or external human acts and natural disasters.
−Removed: Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems.
+Added: Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins,
+Added: computer viruses and similar disruptive problems.
Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our information technology and telecommunications systems, failures or significant downtime of these systems or those used by our collaborators or subcontractors could prevent it from conducting our comprehensive screening analysis, clinical diagnostics and drug discovery, preparing and providing reports to researchers, clinicians and our collaborators, billing payors, handling physician inquiries, conducting research and development activities and managing the administrative aspects of our business.
7 unchanged sentences
We incur significant costs and demands on management as a result of compliance with laws and regulations applicable to public companies, which could harm our operating results.
−Removed: As a public company, we incur significant legal, accounting and other expenses, including costs associated with public company reporting requirements.
+Added: As a public company, we incur significant legal, accounting and other expenses associated with public company reporting requirements.
In addition, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) as well as rules implemented by the SEC and the Nasdaq Stock Market (“Nasdaq”) impose a number of requirements on public companies, including with respect to corporate governance practices.
1 unchanged sentence
In addition, the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), enacted in 2010, includes significant corporate governance and executive-compensation-related provisions.
−Removed: Our management and other personnel will need to devote a substantial amount of time to these
−Removed: Table of Co ntents
−Removed: compliance and disclosure obligations.
+Added: Our management and other personnel will need to devote a substantial amount of time to these compliance and disclosure obligations.
If these requirements divert the attention of our management and personnel from other aspects of our business concerns, they could have a material adverse effect on our business, financial condition and results of operations.
Moreover, these rules and regulations applicable to public companies substantially could increase our legal, accounting and financial compliance costs, require that we hire additional personnel and make some activities more time consuming and costly.
−Removed: A market for our securities may not continue, which would adversely affect the liquidity and price of our securities.
−Removed: The price of our securities may fluctuate significantly due to general market and economic conditions.
−Removed: An active trading market for our securities may not be sustained.
−Removed: In addition, the price of our securities can vary due to general economic conditions and forecasts, our general business condition and the release of our financial reports.
−Removed: You may be unable to sell your securities when desired or at an acceptable price unless an active trading market can be sustained.
−Removed: If we do not meet the expectations of investors, stockholders or financial analysts, the market price of our securities may decline.
−Removed: If we do not meet the expectations of investors or securities analysts, the market price of our securities may decline.
−Removed: In addition, fluctuations in the price of our securities could contribute to the loss of all or part of your investment.
−Removed: If an active market for our securities does not continue, the trading price of our securities could be volatile and subject to wide fluctuations in response to various factors, some of which are beyond our control.
−Removed: Any of the risk factors noted in this Annual Report could have a material adverse effect on your investment in our securities and our securities may trade at prices significantly below the price you paid for them.
−Removed: In such circumstances, the trading price of our securities may not recover and may experience a further decline.
−Removed: Factors affecting the trading price of our securities may include:
−Removed: • actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us;
−Removed: • changes in the market’s expectations about our operating results;
−Removed: • the public’s reaction to our press releases, our other public announcements and our filings with the SEC;
−Removed: • speculation in the press or investment community;
−Removed: • announcements of technological innovation, new products, acquisitions, strategic alliances, significant agreements by us or competitors;
−Removed: • success of competitors;
−Removed: • our operating results falling below our financial guidance or other projections or failing to meet the expectation of securities analysts or investors in a particular period;
−Removed: • changes in financial estimates and recommendations by securities analysts concerning us or the market in general;
−Removed: • operating and stock price performance of other companies that investors deem comparable to us;
−Removed: • our ability to market new and enhanced products on a timely basis;
−Removed: • changes in laws and regulations affecting our business;
−Removed: • commencement of, or involvement in, litigation involving us;
−Removed: • changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
−Removed: • the volume of shares of our Class A common stock available for public sale;
−Removed: • any major change in our Board or management;
−Removed: • sales of substantial amounts of Class A common stock by our directors, officers or significant stockholders or the perception that such sales could occur;
−Removed: • the expiration of any market stand-off or contractual lock-up agreements;
−Removed: • the realization of any of the risk factors described herein;
−Removed: • additions or departures of key personnel;
−Removed: • failure to comply with the requirements of the Nasdaq;
−Removed: • failure to comply with the Sarbanes-Oxley Act or other laws or regulations;
−Removed: • actual, potential or perceived control, accounting or reporting problems;
−Removed: • changes in accounting principles, policies and guidelines;
−Removed: • general economic and political conditions such as recessions, fluctuating inflation, interest and tariff rates, uncertainty with respect to the U.S.
−Removed: federal budget, rising global tensions, global conflicts such as the war in Ukraine, fuel prices, international currency fluctuations and acts of war or terrorism.
−Removed: Broad market and industry factors may materially harm the market price of our securities irrespective of our operating performance.
−Removed: The stock market in general and Nasdaq have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the particular companies affected.
+Added: Further, as a result of no longer being an emerging growth company, we will incur significant additional expenses that we did not previously incur in complying with the Sarbanes-Oxley Act and rules implemented by the SEC.
+Added: The cost of compliance with Section 404 of the Sarbanes-Oxley Act has required, and will continue to require, us to incur substantial expense and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements.
+Added: We have also previously taken advantage of the reduced disclosure requirements of the Jumpstart Our Business Startups Act applicable to emerging growth companies regarding executive compensation disclosures and exemption from the requirements of holding advisory “say-on-pay” votes on executive compensation.
+Added: We are no longer eligible for such reduced disclosure requirements and exemptions and, as such, we will be required to hold a “say-on-pay” vote and a “say-on-frequency” vote at our 2026 annual meeting of stockholders.
+Added: We expect that the increased disclosure requirements will require additional attention from management and will result in increased costs to us, which could include higher legal fees, accounting fees, and fees associated with investor relations activities, among others.
+Added: The market price of our securities may be volatile or decline due to market conditions, or failure to meet investor, stockholder or analyst expectations, which could result in a loss of your investment.
+Added: The trading price and valuation of life sciences companies, including ours, have been and may continue to be highly volatile, which has often been unrelated or disproportionate to the operating performance of the particular companies affected.
The trading prices and valuations of these stocks, and of our securities, may not be predictable.
−Removed: A loss of investor confidence in the market for the stocks of other
−Removed: Table of Co ntents
−Removed: companies which investors perceive to be similar to us could depress our stock price regardless of our business, prospects, financial conditions or results of operations.
+Added: Future volatility in the market price for our securities may occur in response to factors beyond our control, including actual or anticipated fluctuations in our quarterly financial results, changes in market expectations regarding our operating performance, public reaction to our press releases and SEC filings, competitive developments, changes in financial estimates or recommendations by securities analysts which may result in the loss of investor confidence, and general economic and political conditions.
+Added: These risk factors, and any other risk factors described in this Annual Report, could materially adversely affect our business and the market price of our securities, which may trade at prices significantly below the price paid for them and may not
A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future.
In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price.
+Added: This type of litigation could result in substantial costs and divert management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or settle litigation.
In particular, on September 7, 2022, a shareholder class action lawsuit was filed in the U.S.
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In addition, on November 28, 2023, a stockholder filed a lawsuit in the U.S.
−Removed: District Court for the District of Delaware against, among other parties, certain of the Company’s current and former officers and directors and on June 25, 2024, a substantially similar stockholder derivative suit was filed in federal court in the District of Connecticut.
−Removed: For more information, see Note 10, “ Purchase Commitments and Contingencies ” in the consolidated financial statements included in this Annual Report.
−Removed: This type of litigation could result in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation.
−Removed: For example, on December 2, 2024, we settled a lawsuit that a stockholder commenced in the Delaware Court of Chancery on February 7, 2023 against, among other parties, certain of the Company’s current and former directors, for approximately $21 million.
−Removed: See also Note 10, “ Purchase Commitments and Contingencies ” in the consolidated financial statements included in this Annual Report.
+Added: District Court for the District of Delaware against, among other parties, certain of the Company’s current and former officers and directors and on June 25, 2024 and August 15, 2025, substantially similar stockholder derivative suits were filed in federal court in the District of Connecticut and District of Delaware, respectively.
+Added: During the first quarter of 2026, we reached an agreement in principle to resolve all claims for approximately $4.8 million.
+Added: See also Note 11, “ Purchase Commitments and Contingencies ” to our consolidated financial statements for more information.
If securities or industry analysts cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our Class A common stock adversely, then the price and trading volume of our Class A common stock could decline.
19 unchanged sentences
• a prohibition on stockholders calling a special meeting and the requirement that a meeting of stockholders may only be called by a majority of the board, our chairman of the board or our chief executive officer and may not be called by any other person, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;
−Removed: Table of Co ntents
• the requirement that changes or amendments to certain provisions of our Charter must be approved by holders of at least two-thirds of our Class A common stock;
• advance notice procedures that stockholders must comply with in order to nominate candidates to our Board or to propose matters to be acted upon at a meeting of stockholders, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
−Removed: The JOBS Act permits “emerging growth companies” like us to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies.
−Removed: We currently qualify as an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act (the “JOBS Act”).
−Removed: As such, we take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continue to be an emerging growth company, including:
−Removed: (i) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act;
−Removed: (ii) the exemptions from say-on-pay, say-on-frequency and say-on-golden parachute voting requirements;
−Removed: and (iii) reduced disclosure obligations regarding executive compensation in our periodic reports.
−Removed: As a result, our stockholders may not have access to certain information they deem important.
−Removed: We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year:
−Removed: (a) following September 1, 2025, the fifth anniversary of the initial public offering of CMLS;
−Removed: (b) in which we have total annual gross revenue of at least $1.235 billion;
−Removed: or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Class A common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
−Removed: In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the exemption from complying with new or revised accounting standards provided in Section 7(a)(2)(B) of the Securities Act as long as we are an emerging growth company.
−Removed: An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
−Removed: The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies, but any such election to opt out is irrevocable.
−Removed: We have elected to avail ourselves of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.
−Removed: This may make comparison of our financial statements with another public company that is neither an emerging growth company nor an emerging growth company that has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
−Removed: We cannot predict if investors will find our Class A common stock less attractive because we rely on these exemptions.
−Removed: If some investors find our Class A common stock less attractive as a result, there may be a less active trading market for our Class A common stock and our stock price may be more volatile.
−Removed: We no longer qualify as a “smaller reporting company” and as a result, we will no longer be able to avail ourselves of certain reduced reporting requirements applicable to smaller reporting companies starting with our first quarterly report in 2025.
−Removed: We currently take advantage of certain of the scaled disclosures available to “smaller reporting companies,” as defined in Item 10(f)(1) of Regulation S-K.
−Removed: Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of consolidated financial statements.
−Removed: However, based on the market value of our Class A common stock held by non-affiliates as of June 28, 2024 (the last business day of our most recently completed second fiscal quarter), we will no longer be eligible to rely on the scaled disclosure exemptions available to smaller reporting companies starting with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2025.
−Removed: We expect that the loss of our “smaller reporting company” status and compliance with additional requirements will increase our legal and financial compliance costs.
−Removed: Any failure to comply with additional requirements in a timely manner, or at all, could have an adverse effect on our business and results of operations and could cause a decline in the price of our Class A common stock.
−Removed: Our internal controls over financial reporting may not be effective which could have a significant and adverse effect on our business and reputation.
−Removed: As a public company, we are required to comply with the SEC’s rules implementing Sections 302 and 404 of Sarbanes-Oxley Act, which require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of internal control over financial reporting.
−Removed: To comply with the requirements of being a public company, we are required to provide management’s assessment on internal controls, and we may need to undertake
−Removed: Table of Co ntents
−Removed: various actions, such as implementing additional internal controls and procedures and hiring additional accounting or internal audit staff.
−Removed: Further, as an emerging growth company, our independent registered public accounting firm is not required to formally attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404 until the date we are no longer an emerging growth company.
−Removed: At such time, our independent registered public accounting firm may issue a report that is adverse in the event that it is not satisfied with the level at which the controls of the company are documented, designed or operating.
−Removed: Testing and maintaining these controls can divert our management’s attention from other matters that are important to the operation of our business.
−Removed: If we identify material weaknesses in the internal control over financial reporting of the company or are unable to comply with the requirements of Section 404 or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal controls over financial reporting when we no longer qualify as an emerging growth company, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Class A common stock could be negatively affected, and we could become subject to investigations by the SEC or other regulatory authorities, which could require additional financial and management resources.
+Added: We have identified a material weakness in our internal control over information technology general controls, or “ITGCs”.
+Added: If remediation of the material weakness is not effective, or if we fail to maintain effective internal control over financial reporting, we could have material misstatements in our financial statements, which could have a significant and adverse effect on our business and reputation.
+Added: A material weakness is defined by the Public Company Accounting Oversight Board (the “PCAOB”) as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
+Added: As further detailed in Item 9A.
+Added: Controls and Procedures, we identified a material weakness in internal control related to deficiencies in the design and operating effectiveness of IT general controls related to segregation of duties in the program change management process for a single IT system that supports certain aspects of our revenue processes as of December 31, 2025.
+Added: As a result, certain automated controls and business process controls related to recording revenue that are dependent on the affected IT system or the information from such IT system were also deemed ineffective.
+Added: Although we have not identified any errors or misstatements in our consolidated financial statements as a result of this material weakness, these deficiencies created a reasonable possibility that a material misstatement of our annual or interim financial statements would not have been prevented or detected on a timely basis as of December 31, 2025.
+Added: We are committed to the remediation of the material weakness described above, as well as the continued improvement of our internal control over financial reporting.
+Added: Our remediation efforts related to the material weakness are described in Item 9A.
+Added: Controls and Procedures.
+Added: While we believe that the measures already designed and implemented will be sufficient, the material weakness, in the aggregate, will not be considered fully remediated until all aspects of the control operate for a sufficient period of time and we have concluded, through testing, that these controls are operating effectively.
+Added: Any failure to remediate the material weakness, or the identification of new material weaknesses in our internal control over financial reporting, could result in material misstatements in our financial statements that may continue undetected, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Class A common stock could be negatively affected.
+Added: Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.
+Added: We are also required to disclose changes made in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting on a quarterly basis.
+Added: To comply with the requirements of being a public company, we have undertaken, and may need to further undertake in the future, various actions, such as implementing new internal controls and procedures and hiring additional accounting staff.
+Added: As a public company, significant resources and management oversight are required.
+Added: As a result, management’s attention may be diverted from other business concerns, which could harm our business, financial condition and operating results.
Our Charter and our Bylaws designate the Court of Chancery of the State of Delaware and federal court within the State of Delaware as the exclusive forum for certain types of actions and proceedings that our stockholders may initiate, which could limit a stockholder’s ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
9 unchanged sentences
will be, to the fullest extent permitted by law, the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
−Removed: Any person or entity purchasing or otherwise acquiring or holding any interest in any of our securities shall be deemed to have notice of and consented these provisions in our Charter and our Bylaws.
+Added: Any person or entity purchasing or otherwise acquiring or holding any interest in any of our securities shall be deemed to have notice of and consented to these provisions in our Charter and our Bylaws.
These provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, or other employees, which may discourage lawsuits with respect to such claims.
3 unchanged sentences
These provisions may limit a stockholders’ ability to bring a claim, and may result in increased costs for a stockholder to bring a claim in a judicial forum of their choosing for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees.
−Removed: Table of Co ntents
Risks Related to Our Common Stock and Warrants
The ownership of our outstanding Class A common stock is concentrated, with certain of our stockholders owning significant percentages of our outstanding shares.
−Removed: Icahn School of Medicine at Mount Sinai (“ISMMS”), entities affiliated with Casdin Partners Master Fund, L.P.
+Added: Entities affiliated with Casdin Partners Master Fund, L.P.
(“Casdin Partners”), and Corvex Management, L.P.
1 unchanged sentence
In addition, Mr.
−Removed: Casdin, one of our directors, is affiliated with Casdin Partners and CMLS Holdings, LLC (“CMLS Holdings”), which owned approximately 1% of our outstanding shares of our Class A common stock as of December 31, 2024, and Mr.
+Added: Casdin, one of our directors, is affiliated with Casdin Partners and CMLS Holdings, LLC (“CMLS Holdings”) and Mr.
Keith Meister, one of our directors, is affiliated with Corvex Management and CMLS Holdings.
22 unchanged sentences
Sales of substantial numbers of such shares in the public market could adversely affect the market price of our Class A common stock.
−Removed: Table of Co ntents
Our warrants are accounted for as liabilities and the changes in value of our warrants could have a material effect on our financial results.
−Removed: Included on our consolidated balance sheet as of December 31, 2024, are liabilities related to our public and private warrants which are each remeasured at fair value at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in earnings in the statement of operations.
+Added: Included on our consolidated balance sheet as of December 31, 2025, are liabilities related to our public and private warrants which are each remeasured at fair value at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in earnings in the consolidated statements of operations and comprehensive loss.
As a result of the recurring fair value measurement, our financial statements and results of operations may fluctuate quarterly, based on factors, which are outside of our control.
8 unchanged sentences
There is no guarantee that the public warrants will ever be in the money, and they may expire worthless and the terms of our public warrants may be amended.
−Removed: The exercise price for the public warrants is $379.50 per share of Class A common stock.
+Added: The exercise price for the public warrants is $379.50 per share of Class A common stock and expire pursuant to their terms on July 22, 2026.
There is no guarantee that the public warrants will ever be in the money prior to their expiration, and as such, the public warrants may expire worthless.
−Removed: We cannot guarantee that we will be able to satisfy the continued listing standards of Nasdaq going forward and if we fail to satisfy the continued listing requirements of Nasdaq, including the minimum closing bid price requirement, Nasdaq may take steps to delist our Class A common stock.
−Removed: Our Class A common stock and public warrants are listed on the Nasdaq Global Select Market under the symbols “WGS” and “WGSWW,” respectively.
−Removed: However, we cannot ensure that we will be able to satisfy the continued listing standards of Nasdaq, including the minimum closing bid price requirement, going forward.
−Removed: If we cannot satisfy the continued listing standards going forward, The Nasdaq Stock Market may commence delisting procedures against us, which could result in our Class A common stock or public warrants being removed from listing on Nasdaq.
−Removed: If either of our Class A common stock or public warrants were to be delisted, the liquidity of our Class A common stock or warrants could be adversely affected and the market price of our Class A common stock or warrants could decrease.
−Removed: Delisting could also adversely affect our securityholders’ ability to trade or obtain quotations on our securities because of lower trading volumes and transaction delays.
−Removed: These factors could contribute to lower prices and larger spreads in the bid and ask price for our securities.
−Removed: Investors may also not be able to resell their Class A common stock or warrants at or above the price they paid for such securities or at all.
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.