What changed in this filing

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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-27 · 148 added, 175 removed, 692 unchanged (32% of the section changed)

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● There is substantial doubt about our ability to continue as a going concern.

● We may require significant additional financing to sustain our operations and without it we will not be able to continue operations.

● We may need to raise substantial additional capital to commercialize our diagnostic technology, and our failure to obtain funding when needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts or force us to restrict or cease operations.

● We have incurred losses since our inception and may incur losses in the foreseeable future.

We cannot be certain that we will achieve or sustain profitability

● Our ability to expand our business may depend on access to additional capital.

● We are subject to concentrations of revenue risk and concentrations of credit risk in accounts receivable.

● We have been, and may continue to be, subject to costly litigation.

● We may become subject to costly litigation, which could adversely affect our business, financial condition and results of operations.

● Failure to Comply with Insider Trading Regulations and Policies Could Result in Significant Legal and Reputational Consequences.

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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 United States.

● Changes to the UK medical device regulatory framework could require additional compliance measures and affect our ability to market our products in Great Britain.

● Unfavorable U.S.

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If we are unable to establish marketing and sales capabilities and retain the proper talent to execute on our sales and marketing strategy, we may not be able to generate product revenue.

● We need to ensure strong product performance and reliability to maintain and grow our business.

● We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security.

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● We may become subject to the Anti-Kickback Statute, Stark Law, False Claims Act, Civil Monetary Penalties Law and may be subject to analogous provisions of applicable state laws and could face substantial penalties if we fail to comply with such laws.

● The use of artificial intelligence in diagnostic or laboratory applications may subject us to additional regulatory and liability risks.

● We cannot be certain that measures taken to protect our intellectual property will be effective.

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● If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.

● The sale or issuance of our common stock to Alliance Global Partners may cause significant dilution and the sale of the shares of common stock acquired by Alliance Global Partners, or the perception that such sales may occur, could cause the price of our common stock to fall.

● The issuance of our common stock to creditors or litigants may cause significant dilution to our stockholders and cause the price of our common stock to fall.

● Improper timing of equity awards could result in regulatory scrutiny and reputational harm.

● Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

● We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

Risks Related to Our Business and Strategy

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Our consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America applicable for a going concern, which assume that we will realize our assets and discharge our liabilities in the ordinary course of business.

We have incurred substantial operating losses and have used cash in our operating activities for the past few years.

For the year ended December 31, 2024, the Company had a net loss of $4.3 million and net cash provided by operating activities of $0.4 million.

As of December 31, 2024, the

Company had an accumulated deficit of $102.4 million and a working capital deficit of $0.8 million.

We have incurred substantial operating losses and have typically used cash in our operating activities for the past few years.

For the year ended December 31, 2025, the Company had an operating loss of $1.2 million and net cash provided by operating activities of $0.7 million.

As of December 31, 2025, the Company had an accumulated deficit of $102.8 million and working capital of $2.3 million.

Our consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.

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We may never successfully commercialize our diagnostic technology or any future tests, and our business may fail.

We may require significant additional financing to sustain our operations and without it we will not be able to continue operations.

At December 31, 2024, we had a working capital deficit of $0.8 million.

For the year ended December 31, 2024, we had an operating cash flow of $0.4 million and a net loss of $4.3 million.

We do not currently have sufficient financial resources to fund our operations or those of our subsidiaries.

Therefore, we may need additional funds to continue these operations.

Our primary sources of funds to meet our liquidity and capital requirements include cash on hand, funds generated from operations and funding pursuant to a sales agreement with A.G.P./Alliance Global Partners (“AGP”).

To facilitate ongoing operations and product development, on April 14, 2023, we entered into a sales agreement with AGP, pursuant to which we may offer and sell our common stock, par value $0.01 per share (the “Common Stock”) (the “Shares”), having aggregate sales proceeds of up to $5.8 million, to or through AGP, as sales agent (the “AGP 2023 Sales Agreement”), from time to time, in an “at the market offering” (as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended) of the Shares (the “2023 ATM Offering”).

We are limited in the number of shares we can sell in the 2023 ATM Offering due to the offering limitations currently applicable to us under General Instruction I.B.6.

of Form S-3 and our public float as of the applicable date of such sales, as well as the number of authorized and unissued shares available for issuance, in accordance with the terms of the AGP 2023 Sales Agreement.

The extent we rely on AGP as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources.

If obtaining sufficient funding from AGP were to prove unavailable or prohibitively dilutive, we will need to secure another source of funding in order to satisfy our working capital needs.

Even if we sell all $5.8 million under the AGP 2023 Sales Agreement, we may still need additional capital to fully implement our business, operating and development plans.

Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could be a material adverse effect on our business, operating results, financial condition and prospects.

From April 14, 2023 through the date the consolidated financial statements were issued, we received approximately $0.1 million in gross proceeds through the AGP 2023 Sales Agreement from the sale of 11,847 shares of common stock.

We have approximately $3.7 million available for future sales pursuant to the AGP 2023 Sales Agreement.

On April 8, 2024, we filed a prospectus supplement to our prospectus dated April 25, 2023 registering the offer and sales of up to $1,061,478

of shares of our common stock.

We have approximately $1.0 million of remaining availability pursuant to this prospectus supplement.

We may have to raise significant additional capital or obtain additional credit to fund our operations in the future.

Our ability to expand our business may depend on access to additional capital.

As of December 31, 2025, we had cash of $2.6 million and working capital of $2.3 million.

Although we have recently generated positive operating cash flow, our future liquidity will depend on our ability to sustain or improve operating performance and manage working capital.

We may have to raise significant additional capital or obtain additional credit in the future to fund our operations, fund growth initiatives, respond to changes in reimbursement or regulatory requirements, pursue strategic opportunities, or address unforeseen events.

The failure to raise significant capital, or obtain credit when needed, on acceptable terms, could have a material adverse effect on our business, prospects, financial condition and results of operations, and we may not be able to continue our business as currently contemplated or may be required to seek protection under United States federal bankruptcy law.

We may need to raise substantial additional capital to commercialize our diagnostic technology, and our failure to obtain funding when needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts or force us to restrict or cease operations.

As of December 31, 2024, we had cash of $1.4 million and we had a working capital deficit of $0.8 million.

Due to our recurring losses from operations and that we may continue to incur losses in the future, we may be required to raise additional capital to complete the development and commercialization of our current product candidates and to pay off our obligations.

To date, to fund our operations and develop and commercialize our products, we have relied primarily on equity and debt financings.

In future periods, when we seek additional capital, we may seek to sell additional equity and/or debt securities or to obtain a credit facility, which we may not be able to do on favorable terms, or at all.

Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment.

If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unattractive terms.

We have incurred losses since our inception and may incur losses in the foreseeable future.

We cannot be certain that we will achieve or sustain profitability.

We have incurred losses since our inception and may incur losses in the future.

At December 31, 2024, we had a working capital deficit of $0.8 million.

For the year ended December 31, 2024, we had operating cash flow of $0.4 million and a net loss of $4.3 million.

For the year ended December 31, 2024, we have experienced negative cash flow from development of our diagnostic technology, as well as from the costs associated with establishing a laboratory and building a sales force to market our products and services.

We may incur substantial net losses through at least the first half of 2025 as we further develop and commercialize our diagnostic technology.

We also expect that our selling, general and administrative expenses will continue to increase due to the additional costs associated with market development activities and expanding our staff to sell and support our products.

Our ability to achieve or, if achieved, sustain profitability is based on numerous factors, many of which are beyond our control, including the market acceptance of our products, competitive product development and our market penetration and margins.

We may never be able to generate sufficient revenue to achieve or, if achieved, sustain profitability.

Our future capital requirements will depend on numerous factors, including revenue growth, reimbursement trends, regulatory developments, investment in commercialization activities, working capital needs, and potential strategic initiatives.

While we have historically relied on equity and debt financings to fund operations, we may seek additional financing in the future.

There can be no assurance that such financing will be available on favorable terms, or at all.

If we are unable to maintain positive operating performance or obtain additional capital when needed, we may be required to delay or scale back certain growth initiatives, product development efforts or strategic plans.

We have incurred losses since inception and, although recent results reflect improvement, we may incur losses in future periods.

Our ability to achieve and sustain profitability depends on a number of factors, many of which are beyond our control, including market acceptance of our products, competitive dynamics, reimbursement levels, regulatory requirements and operating efficiency.

There can be no assurance that we will achieve or sustain profitability in future periods.

We are subject to concentrations of revenue risk and concentrations of credit risk in accounts receivable .

We have had several customers who, from time to time, have individually represented 10% or more of our total revenue, or whose accounts receivable balances individually represented 10% or more of our total accounts receivable.

For both the years ended December 31, 2024 and 2023, one customer individually represented 10% or more of our total revenue.

For the years ended December 31, 2025 and 2024, one customer individually represented 26% and 17% of our total revenue, respectively.

We expect to maintain ongoing relationships with our customers, however, the loss of, or significant decrease in demand from, any of our top customers could have a material adverse effect on our business, results of operations and financial condition.

At December 31, 2024, one customer accounted for approximately 29% of our total accounts receivable and at December 31, 2023, one customer accounted for approximately 13% of our total accounts receivable.

At December 31, 2025, we had three customers who each individually represented more than 10% of our total accounts receivable.

Collectively they accounted for approximately 56% of our total accounts receivable.

At December 31, 2024, one customer accounted for approximately 29% of our total accounts receivable.

The business risks associated with this concentration, including increased credit risks for these and other customers and the possibility of related credit loss write-offs, could negatively affect our margins and profits.

Additionally, the loss of any of our top customers, whether through competition or consolidation, or a disruption in sales to such a customer, could result in a decrease of the Company’s future sales, earnings and cash flows.

Generally, we do not require collateral or other securities

to support our accounts receivable and while we are directly affected by the financial condition of our customers, management does not believe significant credit risks exist at December 31, 2024.

We have been, and may continue to be, subject to costly litigation.

We have been, and may continue to be, subject to legal proceedings.

Generally, we do not require collateral or other securities to support our accounts receivable and while we are directly affected by the financial condition of our customers, management does not believe significant credit risks exist at December 31, 2025.

We may become subject to costly litigation, which could adversely affect our business, financial condition and results of operations.

Due to the nature of our business and our history of insufficient capital resources to pay our obligations on a timely basis, we may be subject to a variety of regulatory investigations, claims, lawsuits and other proceedings in the ordinary course of our business.

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prohibits trading in the Company’s securities while in possession of material nonpublic information;

restricts trading by directors, executive officers, and designated employees during blackout periods that typically commence 15 days before the end of each fiscal quarter and continue until two full trading days after earnings are publicly disclosed;

restricts trading by directors, executive officers, and designated employees during blackout periods that typically

commence 15 days before the end of each fiscal quarter and continue until two full trading days after earnings are publicly disclosed;

requires pre-clearance of trades for directors, officers, and certain employees to prevent inadvertent violations;

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Certain molecular diagnostics companies have established technologies that may be competitive to our diagnostic product candidates and any future tests that we develop.

Some of these tests may use different approaches or means to obtain diagnostic results, which could be more effective or less expensive than our tests for similar indications.

Some of these tests may use different approaches or means to obtain diagnostic results, which could be more effective or

less expensive than our tests for similar indications.

Moreover, these and other future competitors have or may have considerably greater resources than we do in terms of technology, sales, marketing, commercialization and capital resources.

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It is critical to our success that we anticipate changes in technology and customer requirements and successfully introduce new, enhanced and competitive technologies to meet our customers’ and prospective customers’ needs on a timely and cost-effective basis.

time, however, we must carefully manage the introduction of new products.

At the same time, however, we must carefully manage the introduction of new products.

If customers believe that such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available.

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● boycotts, curtailment of trade and other business restrictions;

● regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the Foreign Corrupt Practices Act of 1977, or FCPA, its books and records provisions, or its anti-bribery provisions or laws similar to the FCPA in other jurisdictions in which we may in the future operate, such as the United Kingdom’s (“UK”) Bribery Act of 2010 and anti-bribery requirements of member states in the European Union (“EU”).

● regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the Foreign Corrupt Practices Act of 1977, or FCPA, its books and records provisions, or its anti-bribery provisions or laws similar to the FCPA in other jurisdictions in which we may in the future operate, such as the United Kingdom’s Bribery Act of 2010 and anti-bribery requirements of member states in the EU.

Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations.

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There may be a risk of delay in placing such products on the market and, once on the market, a risk of review and challenges to certain certified statuses.

On May 12, 2022, we received CE-IVD marking for our HemeScreen® reagents in the EU in accordance with the requirements of the EU IVDD (Directive 98/79/EC).

The new EU IVDR (Regulation 2017/746), came into effect on May 26, 2022 and replaced the IVDD.

The transitional provisions under the IVDR allow for devices with valid CE marking under the IVDD that were placed on the EU market prior to May 26, 2022 to continue to be placed on the market in the EU until deadlines ranging from December 2027 to December 2029, depending on risk classification, provided the manufacturer complies with post-market surveillance, vigilance, and registration requirements under the IVDR.

Our device will need to be re-certified under the IVDR in order to remain on the EU market beyond the deadlines for transition, which will include evaluation by an EU notified body to confirm whether our device meets the general safety and performance requirements under the IVDR.

There is no guarantee that our device will be determined to be compliant with such requirements.

It should also be appreciated that there currently is a severe shortage of capacity of the EU notified bodies to assess all devices that will require notified body certification under the IVDR.

There can be no assurance that our ability to market HemeScreen® reagents in the EU in the future will not be interrupted and this could, in turn, have a negative impact on our business and operating results.

The regulatory framework for medical devices in the UK is likely to evolve now that the UK is no longer part of the EU.

On May 12, 2022, we received CE-IVD marking for our HemeScreen® reagents in the EU in accordance with the requirements of the EU In Vitro Diagnostic Directive ("IVDD") (Directive 98/79/EC).

The EU In Vitro Diagnostic Regulation ("IVDR") (Regulation (EU) 2017/746) came into effect on May 26, 2022 and replaced the IVDD.

Because our CE marking was obtained under the IVDD by self-declaration without notified body involvement, and because our HemeScreen® products require notified body involvement in the conformity assessment procedure under the IVDR, we qualify for the transitional provisions under Article 110(3) of the IVDR, as introduced for self-declared devices by Regulation (EU) 2022/112 and further amended by Regulation (EU) 2024/1860.

These provisions allow devices for which a declaration of conformity was drawn up prior to May 26, 2022 under the IVDD and which require notified body involvement in the conformity assessment procedure under the IVDR to continue to be placed on the EU and Northern Ireland markets until December 31, 2028, assuming a Class C risk classification under the IVDR, provided that certain conditions are met on a continuing basis.

These conditions include:

continued compliance with the IVDD;

no significant changes to the design or intended purpose of the device;

maintenance of a quality management system in accordance with Article 10(8) of the IVDR, which was required to be in place by May 26, 2025;

and compliance with IVDR requirements for post-market surveillance, vigilance, and registration of economic operators and devices.

To maintain eligibility for this transitional period beyond May 26, 2026, we must submit a formal application for conformity assessment to an IVDR-designated notified body by that date, and must conclude a written agreement with a notified body by September 26, 2026.

Failure to meet either of these deadlines would result in the transitional protection lapsing on the relevant date, regardless of whether the transition period would otherwise have continued until December 31, 2028.

These are firm regulatory deadlines and we are actively working to meet them.

Our HemeScreen® products will in any event require full recertification under the IVDR to remain on the EU and Northern Ireland markets beyond the applicable transition deadline.

This will require evaluation by an EU-designated notified body to confirm whether our products meet the general safety and performance requirements of the IVDR.

There is no guarantee that a notified body will determine our products comply with such requirements.

The number of notified bodies currently designated under the IVDR remains limited, and there is currently a significant shortage of notified body capacity to assess the volume of devices requiring certification under the IVDR.

We cannot assure that our ability to market HemeScreen® reagents in the EU and Northern Ireland will not be interrupted in the future.

Any such interruption could negatively impact our business and operating results.

Changes to the UK regulations may require additional review of our devices and there is a risk our devices may not be compliant with any revised UK regulations.

Now that the UK has left the EU, the new UK Conformity Assessed (“UKCA”) mark will replace the EU CE mark in Great Britain (“GB”).

The EU legal framework remains applicable in Northern Ireland (indeed any products placed on the market in Northern Ireland must be compliant with EU law).

EU CE marks will continue to be recognized in GB for in-vitro diagnostic devices that are compliant with the EU IVDD or EU IVDR until June 30, 2030 (except for general in-vitro diagnostic devices where the conformity assessment under the EU IVDD and EU IVDR does not involve a notified body).

In addition, all devices must now be registered with the MHRA in order to be placed on the GB market.

These new requirements under the UK medical devices legislation and any other changes that are brought into force could result in delays in our ability to obtain a UKCA mark and to continue to market our product in the UK.

The UK’s departure from the EU has also impacted customs regulations as well as timing and ease of shipments into the EU from UK.

Our products are subject to evolving regulatory requirements in Great Britain, Northern Ireland and the EU.

In Great Britain, medical devices are subject to MHRA registration requirements, and manufacturers established outside the United Kingdom must appoint a UK Responsible Person to satisfy certain regulatory obligations.

In addition, the UK government is continuing to implement changes to its medical devices regime, including revised post market surveillance requirements and potential future changes to pre market authorization requirements and reliance mechanisms.

In Northern Ireland, EU medical device rules continue to apply under the Windsor Framework.

In addition, our ability to continue placing certain products on the EU and Northern Ireland markets during the IVDR transition period depends on satisfaction of specific legal and procedural conditions.

For devices qualifying under the IVDR transitional provisions, including, as applicable, devices for which a declaration of conformity was drawn up prior to May 26, 2022 under the IVDD and that require Notified Body involvement under the IVDR, continued market access is contingent on ongoing compliance with applicable post market surveillance, vigilance, and registration requirements, timely submission of a formal application to an IVDR designated notified body by May 26, 2026, and execution of a written agreement with such notified body by September 26, 2026.

If these conditions are not met, the applicable transitional protection would cease.

Compliance with these evolving requirements may require significant additional operational, quality, clinical, technical, and regulatory resources.

Any delay in obtaining, maintaining, or renewing required registrations, certifications, notified body arrangements, or other regulatory authorizations, any adverse change in applicable reliance mechanisms or transitional provisions, or any failure to comply with applicable post market obligations could delay or prevent our ability to market our products in Great Britain, Northern Ireland or the EU, disrupt commercialization, increase costs, and materially adversely affect our business, financial condition, and results of operations

Unfavorable U.S.

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trade tariffs, could also strain our collaborators and suppliers, possibly resulting in supply disruption, or cause delays in their payments to us.

The continuing worldwide macroeconomic and geopolitical uncertainty, as well as existing tariffs and trade wars, may adversely affect our business and prospects, both domestically and internationally.

Continued concerns about the systemic impact of potential recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and uncertainty for economic growth in the world.

Our business and results of operations may be adversely impacted by changes in macroeconomic conditions, including inflation, bank failures, rising interest rates, and availability of capital markets.

Economic uncertainty, an increase in unemployment rates, as well as an increase in health insurance premiums, co-payments and deductibles may result in cost-conscious consumers making fewer trips to their physicians and specialists, which in turn would adversely affect demand for our products and procedures.

governments and other third-party payors around the world facing tightening budgets could move to further reduce the reimbursement rates or the scope of coverage offered, which could adversely affect sales of our products.

Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations.

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Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.

We operate globally and sell our products in countries throughout the world.

We operate mainly in the United States but may sell our products in other countries throughout the world.

Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in U.S.

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federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations.

For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the U.S., particularly from China, Canada, and Mexico.

On February 1, 2025, the U.S.

imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.

Historically, tariffs have led to increased trade and political

tensions, between not only the U.S.

and China, but also between the U.S.

and other countries in the international community.

For example, during the prior Trump

administration, increased tariffs were implemented on goods imported into the U.S., particularly from China, Canada, and Mexico.

The current U.S.

administration has threatened to continue to broadly impose tariffs, which could lead to corresponding punitive actions by the countries with which the U.S.

Historically, tariffs have led to increased trade and political tensions.

In response to tariffs, other countries have implemented retaliatory tariffs on U.S.

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trade policies, could have a material adverse effect on our financial condition or results of operations.

Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.

In 2017, the U.S.

Congress and the Trump administration made substantial changes to U.S.

policies, which included comprehensive corporate and individual tax reform referred to as the Taxes Cuts and Jobs Act.

Under current law, a number of such changes to U.S.

tax law are set to expire after December 31, 2025.

In addition, the Trump administration called for significant changes to U.S.

trade, healthcare, immigration and government regulatory policy.

Changes to U.S.

policy occurred under the Biden administration and have continued at a rapid pace under the Trump Administration in 2025, making further changes likely.

Any such changes to U.S.

policy implemented by the U.S.

Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S.

and global economy, international trade relations, unemployment, immigration, healthcare, taxation (including in respect of extending the changes from the Taxes Cuts and Jobs Act, which are set to expire and any other potentially forthcoming tax reform), the U.S.

regulatory environment, inflation and other areas.

Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business.

Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.

We will continue to monitor global capital markets and assessing the potential impact of these factors on our business.

Additionally, severe or prolonged economic downturn or additional global financial crises could result in a variety of risks to our business, including weakened demand for any product candidates we develop or our ability to raise additional capital when needed on acceptable terms, if at all.

For example, on October 1, 2025, the U.S.

federal government entered a shutdown suspending services deemed non-essential as a result of the failure by Congress to enact regular appropriations for the 2026 fiscal year.

If the shutdown continues for a prolonged period of time, it could result in increased uncertainty and volatility in the global economy and financial markets which could have a material adverse effect on our business.

Weak economic conditions or significant uncertainty regarding the stability of financial markets related to stock market volatility, inflation, recession, changes in tariffs or other trade restrictions, trade agreements, trade wars or governmental fiscal, monetary and tax policies, among others, could adversely impact our business, financial condition and operating results.

We depend upon a limited number of key personnel, and if we are not able to retain them or recruit additional qualified personnel, the execution of our strategy, management of our business and commercialization of our product candidates could be delayed or negatively impacted.

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We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates.

We need to ensure strong product performance and reliability to maintain and grow our business.

We need to maintain and continuously improve the performance and reliability of our diagnostic tests to achieve our profitability objectives.

Poor product performance and reliability could lead to customer dissatisfaction, adversely affect our reputation and revenues, and increase our service and distribution costs and working capital requirements.

Our diagnostic tests may contain errors or defects, and while we have made efforts to test them extensively, we cannot assure that our current diagnostic tests, or those developed in the future, will not have performance problems.

Performance issues with our diagnostic tests will increase our costs in the near-term and accordingly adversely affect our business, financial condition and results of operations.

We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security.

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In addition, certain state laws govern privacy and security of personal information, including health information specifically.

These various privacy and security laws may impact our business activities,

including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

These various privacy and security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

State laws are changing rapidly and there are discussions in the U.S.

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If we enable or use solutions that draw controversy due to perceived or actual negative societal impact, we may experience brand or reputational harm, competitive harm or legal liability.

applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts.

The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain such systems to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts.

Our vendors may in turn incorporate artificial intelligence tools into their offerings, and the providers of these artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.

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Compliance with changes in privacy and information security laws and with rapidly evolving industry standards may result in our incurring significant expense due to increased investment in technology and the development of new operational processes.

Like other companies in our industry, we, and our third party vendors, have experienced threats and cybersecurity incidents relating to our information technology systems and infrastructure.

We maintain our information technology systems with safeguards designed to protect against cyberattacks including passive intrusion protection, firewalls and virus detection software.

However, these safeguards do not ensure that a significant cyberattack could not occur.

Although we have taken steps to protect the security of our information systems and the data maintained in those systems, it is possible that our safety and security measures will not prevent the systems’ improper functioning or damage or the improper access or disclosure of personally identifiable information such as in the event of cyberattacks.

Although we have taken steps to protect the security of our information

systems and the data maintained in those systems, it is possible that our safety and security measures will not prevent the systems’ improper functioning or damage or the improper access or disclosure of personally identifiable information such as in the event of cyberattacks.

Security incidents, including physical or electronic break-ins, computer viruses, attacks by hackers and similar cybersecurity incidents, and data breaches, can create system disruptions or shutdowns or the unauthorized disclosure of, access to, or misuse of confidential information.

to affected individuals, and we may be subject to sanctions and civil or criminal penalties if we are found to be in violation of the privacy or security rules under HIPAA or other similar federal or state laws protecting confidential personal information.

In addition, a cyber security incident, data breach of or other adverse event affecting our information systems could damage our reputation, subject us to liability claims or regulatory penalties for compromised personal information and could have a material adverse effect on our business, financial condition and results of operations.

If personal information or protected health information is improperly accessed, tampered with, misused or disclosed as a result of a cybersecurity incident or data breach, we may incur significant costs to notify impacted stakeholders (including affected individuals, investors and regulators) and mitigate potential harm to affected individuals, and we may be subject to sanctions and civil or criminal penalties if we are found to be in violation of the privacy or security rules under HIPAA or other similar federal or state laws protecting confidential personal information.

In addition, a cybersecurity incident, data breach of or other adverse event affecting our information systems could damage our reputation, subject us to liability claims or regulatory penalties for compromised personal information and could have a material adverse effect on our business, financial condition and results of operations.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our privacy and data security obligations.

Further, although we maintain cyber liability insurance, this insurance may not provide adequate coverage against potential liabilities related to any experienced cybersecurity incident or data breach.

Cybersecurity incidents could result in operational disruption, regulatory investigations, required notifications and remediation, litigation, fines, reputational harm, or financial costs that could materially adversely affect our business, financial condition, results of operations, or prospects.

We recently reported that we experienced a cybersecurity incident involving unauthorized access to an employee’s cloud-based storage account that may have resulted in access to certain personally identifiable information and protected health information of individuals, which we publicly disclosed in January 2026.

In response, we initiated an investigation, engaged third-party cybersecurity specialists, secured the impacted account, notified law enforcement authorities, and are conducting a review of the potentially affected data.

The event remains under investigation, and we continue to assess the scope and potential impacts of the incident, including any regulatory, legal, or financial implications.

While we have taken mitigation steps, there can be no assurance that similar incidents will not occur in the future or that additional impacts from this or related incidents will not be identified.

Changes in tax law could adversely affect our business and financial condition.

The rules dealing with U.S.

federal, state and local and non-U.S.

taxation are constantly under review by persons involved in the legislative process, the Internal Revenue Service, the U.S.

Treasury Department and other taxing authorities.

Changes to tax laws or tax rulings, or changes in interpretations of existing laws (which changes may have retroactive application), could adversely affect us or holders of our common stock.

These changes could subject us to additional income-based taxes and non-income taxes (such as payroll, sales, use, value-added, digital tax, net worth, property, and goods and services taxes), which in turn could materially affect our financial position and results of operations.

Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our customers’ and our compliance, operating and other costs, as well as the costs of our products.

In recent years, many such changes have been made, and changes are likely to continue to occur in the future.

Furthermore, as we expand the scale of our business activities, any changes in the U.S.

taxation of such activities may increase our effective tax rate and harm our business, financial condition, and results of operations.

tax laws are subject to change through legislative, administrative and judicial actions.

Changes to tax laws or regulations, or changes in interpretations of existing laws (which changes may have retroactive effect), could increase our tax liability, reduce available tax benefits, or otherwise adversely affect our financial condition and results of operations.

For example, the One Big Beautiful Bill Act (“OBBBA”), signed into law on July 4, 2025, made significant changes to U.S.

federal tax law, including modifications to the treatment of research and development expenditures under Section 174 of the Internal Revenue Code.

Under prior law, research and development expenses were required to be capitalized and amortized.

The OBBBA permits certain taxpayers, beginning in taxable years after December 31, 2024, to elect to immediately deduct qualifying U.S.-based research and development expenditures, while also providing mechanisms to accelerate deductions of previously capitalized amounts.

The application and interpretation of these provisions may affect our cash flow and effective tax rate.

In addition, changes in tax policy, including the potential expiration or modification of provisions enacted under prior tax reform legislation, the imposition of new income or non-income taxes (such as payroll, sales, use, value-added, digital or other taxes), or changes in international tax rules, could increase our compliance costs or overall tax burden.

As we expand our business activities, including internationally, our exposure to tax law changes may increase.

Any such changes could materially adversely affect our financial condition and results of operations.

Our ability to use net operating loss carryforwards to offset future taxable income for U.S.

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Potential product liability or personal injury claims may exceed the amount of our insurance coverage or may be excluded from coverage under the terms of our policy or limited by other claims under our umbrella insurance policy.

Additionally, our existing insurance may not be renewed by us at a cost and level of coverage comparable to that presently in effect, if at all.

Additionally, our existing

insurance may not be renewed by us at a cost and level of coverage comparable to that presently in effect, if at all.

In the event that we are held liable for a claim against which we are not insured or for damages exceeding the limits of our insurance coverage, such claim could have a material adverse effect on our cash flow and thus potentially a materially adverse effect on our business, financial condition and results of operations.

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These changes in federal, state, local, and third-party payer regulations or policies may decrease our revenues and adversely affect our results of operations and our financial condition.

Occasionally, legislative pauses

and changes impact our products that are reimbursed under the Medicare Physician Fee Schedule (“MPFS”), or the Clinical Laboratory Fee Schedule (“CLFS”).

Occasionally, legislative pauses and changes impact our products that are reimbursed under the Medicare Physician Fee Schedule (“MPFS”), or the Clinical Laboratory Fee Schedule (“CLFS”).

Further, CMS and state Medicaid agencies may adopt regulations and policies that change, limit or exclude coverage for our products and services.

We expect that efforts to contain costs will continue and that coverage and reimbursement for our products and services may be impacted.

These efforts, including changes in law or regulations that may occur in the future, may each individually or collectively have a material adverse impact on our business, results of operations, financial condition, and prospects .

These efforts, including changes in law or regulations that may occur in the future, may each

individually or collectively have a material adverse impact on our business, results of operations, financial condition, and prospects .

Changes in payer mix could have a material adverse impact on our net sales and profitability.

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Obtaining the requisite marketing authorizations can be expensive and may involve considerable delay.

Moreover, if the FDA believed we

inappropriately labeled our products as RUO products, it could allege that we had misbranded or adulterated our RUO products.

Moreover, if the FDA believed we inappropriately labeled our products as RUO products, it could allege that we had misbranded or adulterated our RUO products.

If the FDA asserts that our RUO products are subject to marketing authorization, or that our RUO products are adulterated or misbranded, our business, financial condition or results of operations could be adversely affected.

Additionally, our CLIA laboratory offers testing utilizing our laboratory-developed tests (LDTs).

Historically, the FDA has exercised enforcement discretion with respect to most LDTs and has not required laboratories that offer LDTs to comply with the FDA’s requirements for medical devices, such as the FDA’s requirements pertaining to marketing authorization, establishment registration, device listing, the Quality System Regulation, and other post-market controls.

Historically, the FDA has exercised enforcement discretion with respect to most LDTs and has not required laboratories that offer LDTs

to comply with the FDA’s requirements for medical devices, such as the FDA’s requirements pertaining to marketing authorization, establishment registration, device listing, the Quality System Regulation, and other post-market controls.

However, at various points in recent years, the FDA has stated it intends to end its policy of enforcement discretion and to actively regulate LDTs.

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.

● In Phase 1 (effective May 6, 2025), clinical laboratories would be required to comply with medical device reporting, correction/removal reporting, and certain quality systems complaint handling requirements.

● In Phase 2 (effective May 6, 2026), clinical laboratories would be required to comply with all other device requirements (e.g., establishment registration and device listing, labeling, investigational use requirements), except for remaining quality systems requirements and premarket review requirements.

● In Phase 3 (effective May 6, 2027), clinical laboratories would be required to comply with all remaining applicable quality systems requirements.

● In Phase 4 (effective November 6, 2027), clinical laboratories would be required to comply with premarket submission requirements for high-risk tests (i.e., tests subject to FDA’s premarket approval (PMA) requirement).

● 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 classification or the 510(k) requirement).

The final rule potentially extends enforcement discretion for certain tests, such as 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.

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.

On May 29, 2024, the American Clinical Laboratory Association filed a lawsuit challenging the FDA’s authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

Subsequently, on August 19, 2024, the Association for Molecular Pathology filed a lawsuit similarly challenging FDA’s final rule on LDTs.

The outcome of these lawsuits are uncertain at this time.

On April 29, 2024, the U.S.

Food and Drug Administration (“FDA”) published a final rule that, if implemented, would have amended FDA’s regulatory definition of in vitro diagnostics to include laboratory developed tests (“LDTs”) and phased out the agency’s longstanding enforcement discretion for most LDTs over a planned multi-stage implementation period.

The rule would have subjected many LDTs to premarket review and device regulatory requirements.

Subsequently, in March 2025, a federal district court in American Clinical Laboratory Association v.

FDA and Association for Molecular Pathology v.

FDA vacated the April 29, 2024 final rule on the basis that FDA lacked statutory authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

In September 2025, FDA published a rule restoring the regulatory text governing LDTs to the pre-2024 status quo.

As a result, the April 2024 final rule is no longer in effect, and there are currently no FDA-imposed device-style premarket requirements or staged compliance deadlines applicable solely because a laboratory develops and uses an LDT.

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 test may become subject to extensive FDA requirements and our business, financial condition or results of operations may be adversely affected.

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A federal law commonly referred to as the “Anti-Kickback Statute” prohibits the knowing and willful offer, payment, solicitation or receipt of remuneration, directly or indirectly, in return for the referral of patients or arranging for the referral of patients, or in return for the recommendation, arrangement, purchase, lease or order of items or services that are covered, in whole or in part, by a federal healthcare program such as Medicare or Medicaid.

The term “remuneration” has been broadly interpreted to include anything of value such as gifts, discounts, rebates, waiver of payments or providing

anything at less than its fair market value.

The term “remuneration” has been broadly interpreted to include anything of value such as gifts, discounts, rebates, waiver of payments or providing anything at less than its fair market value.

The PPACA amended the intent requirement of the Anti-Kickback Statute such that a person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate the statute.

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rather, the Stark Law is a strict liability statute and any violation is subject to repayment of all amounts arising out of tainted referrals.

If physician self-referral laws are interpreted differently or if other legislative restrictions are issued, we could incur significant sanctions and loss of revenues, or we could have to change our arrangements and operations in a way that could have a material adverse effect on our business, prospects, damage to our reputation, results of operations and financial condition.

If physician self-referral laws are interpreted differently or if other legislative restrictions are issued, we could

incur significant sanctions and loss of revenues, or we could have to change our arrangements and operations in a way that could have a material adverse effect on our business, prospects, damage to our reputation, results of operations and financial condition.

False Claims Act

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The PPACA also provides that claims submitted in connection with patient referrals that result from violations of the Anti-Kickback Statute constitute false claims for the purpose of the FCA, and some courts have held that a violation of the Stark law can result in FCA liability, as well.

In addition, a number of states have adopted their own false claims and whistleblower provisions whereby a private

party may file a civil lawsuit in state court.

In addition, a number of states have adopted their own false claims and whistleblower provisions whereby a private party may file a civil lawsuit in state court.

We are required to provide information to our employees and certain contractors about state and federal false claims laws and whistleblower provisions and protections.

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This law could affect how we have to structure our operations and activities.

The use of artificial intelligence in diagnostic or laboratory applications may subject us to additional regulatory and liability risks .

The integration of artificial intelligence or machine learning technologies into diagnostic or laboratory workflows may subject us to additional regulatory oversight, including potential review by the U.S.

Food and Drug Administration or other regulatory authorities.

Regulatory standards applicable to AI-enabled medical technologies continue to evolve and may require additional validation, documentation, or monitoring.

AI-based tools may be subject to increased scrutiny regarding accuracy, bias, and clinical reliability.

If AI-enabled outputs are determined to be inaccurate or unreliable, we could face liability claims, regulatory enforcement, reputational harm, or limitations on our ability to market such tools.

Intellectual Property Risks Related to Our Business

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We rely upon patents, trade secrets, copyrights and trademarks, as well as non-disclosure agreements and other contractual confidentiality provisions to protect our confidential and proprietary information for which we are not seeking patent protection for various reasons.

Such measures, however, may not provide adequate protection for our trade secrets or other proprietary information.

Such measures, however, may not provide adequate protection for our trade secrets

or other proprietary information.

If such measures do not protect our rights, third parties could use our technology and our ability to compete in the market would be reduced.

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Our commercial success depends in part on our avoiding infringement, misappropriation and other violations of the patents and proprietary rights of third parties.

There is a substantial amount of litigation involving patents and other intellectual property rights in the diagnostic industries, as well as administrative proceedings for challenging patents, including interference and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions.

Recently, under U.S.

patent reform, new procedures including inter partes review and post grant review have been implemented.

As stated above, this reform will bring uncertainty to the possibility of challenge to our patents in the future.

There is a substantial amount of litigation involving patents and other intellectual property rights in the diagnostic industries.

In addition, administrative proceedings for challenging patents,

including interference, reexamination proceedings , inter partes review, and post grant review before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions bring uncertainty to the possibility of challenge to our patents in the future.

Numerous U.S.

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If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.

Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.

Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our technologies or product candidates, including processes for manufacture or methods of use, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.

In either case, such a license may not be available on commercially reasonable terms or at all.

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The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

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Obtaining and enforcing patents in the diagnostic industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.

In addition, the U.S.

has recently enacted and is currently implementing wide-ranging patent reform legislation.

Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.

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In addition, a European Unified Patent Court (UPC) came into force in June 2023.

The UPC is a common patent court that hears patent infringement and revocation proceedings effective for member states of the European Union.

The UPC is a common patent court that hears patent infringement and revocation proceedings effective for member states of the EU .

This could enable third parties to seek revocation of a European patent in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European patent is validated.

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In addition, the stock market in general has experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

In the past, when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock.

If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit.

Such a lawsuit could also divert the time and attention of our management.

Companies that experience significant volatility in the market price of their securities are sometimes subject to securities class action litigation, and we could in the future be subject to such claims.

Such a claim could also divert the time and attention of our management.

The price of our stock may be vulnerable to manipulation.

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Because our unrestricted public float has been small relative to other issuers, previous short selling efforts have impacted, and may in the future continue to impact, the value of our stock in an extreme and volatile manner to our detriment and the detriment of our stockholders.

Efforts by certain market participants to manipulate the price of our

common stock for their personal financial gain may cause our stockholders to lose a portion of their investment, may make it more difficult for us to raise equity capital when needed without significantly diluting existing stockholders, and may reduce demand from new investors to purchase shares of our stock.

Efforts by certain market participants to manipulate the price of our common stock for their personal financial gain may cause our stockholders to lose a portion of their investment, may make it more difficult for us to raise equity capital when needed without significantly diluting existing stockholders, and may reduce demand from new investors to purchase shares of our stock.

If we cannot continue to satisfy Nasdaq listing maintenance requirements and other rules, our securities may be delisted, which could negatively impact the price of our securities.

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Our current controls and any new controls that we develop may become inadequate, and weaknesses in our internal control over financial reporting may be discovered in the future.

Any failure to develop or maintain effective controls could adversely affect the results of periodic management evaluations and annual independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting, which we may be required to include in our periodic reports that we file with the SEC under Section 404 of the Sarbanes-Oxley Act, and could harm our operating results, cause us to fail to meet our reporting obligations, or result in a restatement of our

prior period financial statements.

If we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived as inadequate, or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating results, and the price of our common stock could decline.

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The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting.

We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers.

We are continuing to develop and refine our disclosure controls and other procedures that

are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers.

Our current controls and any new controls that we develop may become inadequate, and weaknesses in our internal control over financial reporting may be discovered in the future.

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The price of our common stock could decline if one or more equity research analysts downgrade our common stock or if they issue other unfavorable commentary or cease publishing reports about us or our business.

The sale or issuance of our common stock to, or through, AGP may cause significant dilution and the sale of the shares of common stock acquired by AGP, or the perception that such sales may occur, could cause the price of our common stock to fall.

On April 14, 2023, we entered into a sales agreement with AGP, pursuant to which we may offer and sell our Common Stock, having aggregate sales proceeds of up to $5.8 million, to or through AGP, from time to time, in the 2023 ATM Offering.

We are limited in the number of shares we can sell in the 2023 ATM Offering due to the offering limitations currently applicable to us under General Instruction I.B.6.

Sales to, or through, AGP by us could result in substantial dilution to the interests of other holders of our common stock.

Additionally, the sale of a substantial number of shares of our common stock, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

From April 14, 2023 through the date of issuance of this Report on From 10-K, we received $0.1 million in gross proceeds through the AGP 2023 Sales Agreement from the sale of 11,847 shares of Common Stock.

The Company has an additional $3.7 million available for future sales pursuant to the AGP 2023 Sales Agreement.

On April 8, 2024, we filed a prospectus supplement to our prospectus dated April 25, 2023 registering the offer and sales of up to $1,061,478 of shares of our common stock.

We have approximately $1.0 million of remaining availability pursuant to this prospectus supplement.

We have issued a substantial number of warrants and equity awards from our equity plans which are exercisable into shares of our common stock which could result in substantial dilution to the ownership interests of our existing stockholders.

As of December 31, 2024, approximately 444,444 shares of our common stock were reserved for issuance upon exercise or conversion of outstanding warrants.

Additionally, 303,932 shares of our common stock were reserved for issuance upon exercise of outstanding stock options.

The exercise or conversion of these securities will result in a significant increase in the number of outstanding shares and substantially dilute the ownership interests of our existing stockholders.

The shares underlying the equity awards from our equity plans are registered on a Form S-8 registration statement.

As a result, upon vesting these shares can be freely exercised and sold in the public market upon issuance, subject to volume limitations applicable to affiliates.

The exercise of options and the subsequent sale of the underlying common stock could cause a decline in our stock price.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our diagnostic technologies or current or future development programs.

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Debt financing, if available, would increase our fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends .

If we raise funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or current or future product candidates or to grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, scale back or discontinue the development and commercialization of one or more of our product candidates, delay our pursuit of potential in-licenses or acquisitions or grant rights to develop and market current or future product candidates that we would otherwise prefer to develop and market ourselves .

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Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in- licenses or acquisitions.

In addition, there is a risk that one or more of our current service providers, manufacturers and

other partners may not survive these difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget.

In addition, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive these difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget.

Our amended and restated bylaws, as amended, designate specific courts in as the exclusive forum for certain litigation that may be initiated by the Company’s stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.

Pursuant to our amended and restated bylaws, as amended (the “bylaws”), unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for state law claims for (1) any derivative action or proceeding brought on our behalf;

(2) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any current or former director, officer or other employee or agent of ours to us or our stockholders or debtholders, (3) any action asserting a claim against us or any director or officer or other employee of ours arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or the bylaws (in each case, as they may be amended from time to time), (4) any action asserting a claim against us or any current or former director or officer or other employee or agent of ours governed by the internal affairs doctrine or (5) any action asserting an “internal corporate claim” as that term is defined in Section 115 of the General Corporation Law of the State of Delaware (the “Delaware Forum Provision”);

(2) any action or proceeding asserting a claim

of breach of a fiduciary duty owed by any current or former director, officer or other employee or agent of ours to us or our stockholders or debtholders, (3) any action asserting a claim against us or any director or officer or other employee of ours arising pursuant to any provision of the Delaware General Corporation Law or our certificate of incorporation or the bylaws (in each case, as they may be amended from time to time), (4) any action asserting a claim against us or any current or former director or officer or other employee or agent of ours governed by the internal affairs doctrine or (5) any action asserting an “internal corporate claim” as that term is defined in Section 115 of the General Corporation Law of the State of Delaware (the “Delaware Forum Provision”);

provided, however, that the Delaware Forum Provision will not apply to any causes of action arising under the Securities Act or the Exchange Act.

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

What changed 10-K

Item 1A. Risk Factors