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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-31 · 744 added, 820 removed, 914 unchanged (63% of the section changed)

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These risks include, among others, the following

We face substantial risks

due to our operating history of net losses, negative working capital and insufficient cash flows, and lack of liquidity to pay our current

obligations and if we are unable to continue our business, our shares may have little or no value.

We depend on a few payers for a significant portion of our revenue for our clinical services, and if one or more significant payers, including CMS, stops providing reimbursement, particularly with respect to our PancraGEN test which is being reviewed by CMS, or decreases the amount of reimbursement for our tests, or if we are unable to successfully negotiate additional reimbursement contracts for our clinical services tests, our revenue could decline and our commercial success could be compromised.

We depend on sales and reimbursements from our clinical services for all of our revenue, and we will need to generate sufficient revenue from these and other products and/or solutions that we develop or acquire to grow our business.

We have issued and may issue additional preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

Two private equity firms and their affiliate’s control, on an as-converted basis, an aggregate of 84% of our outstanding shares of common stock through their holdings of our Series C Preferred Stock, and this concentration of ownership may have a substantial influence on our decisions.

We depend on a few payers for a significant portion of our revenue

for our clinical services, and if one or more significant payers, including CMS, stops providing reimbursement as CMS did for our

now discontinued PancraGEN ® test, or decreases the amount of reimbursement for our tests, or if we are unable to successfully

negotiate additional reimbursement contracts for our clinical services tests, our revenue could decline and our commercial success

could be compromised.

We depend on sales and reimbursements from our clinical services for all of our revenue, specifically our molecular diagnostic tests for thyroid cancer, ThyGeNEXT ® and ThyraMIR ® v2, and we will need to generate sufficient revenue from these and other products and/or solutions that we develop or acquire to grow our business.

We may issue preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

Two private equity firms and their affiliates control, an aggregate of 84% of our outstanding shares of common stock through their holdings, and this concentration of ownership may have a substantial influence on our decisions.

If payers do not provide reimbursement, rescind or modify their reimbursement policies or delay payments for clinical services, or if we are unable to successfully negotiate additional reimbursement contracts for our clinical services tests, our commercial success could be compromised.

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If we are unable to identify collaborators willing to work with us to conduct clinical utility studies, or the results of those studies do not demonstrate that a molecular diagnostic test provides clinically meaningful information and value, commercial adoption of such test may be slow, which would negatively impact our business.

Developing new tests and related services and solutions involves a lengthy and complex process, and we may not be able to commercialize on a timely basis, or at all, other tests, assays, services and solutions under development.

Our existing clinical utility studies may be outdated and may not reflect current medical practice, which could adversely affect acceptance of our products and services.

If we are unable to develop or acquire tests, services and solutions to keep pace with rapid technological, medical and scientific change, our operating results and competitive position in the market could be affected.

FDA implementation of the LDT final rule would have a material adverse effect on our clinical services and/or cause us to incur substantial costs and delays associated with trying to obtain pre-market clearance or approval and comply with applicable pre- and post-market requirements.

We may not be able to successfully implement future restructuring activities or other significant organizational changes.

We may not be able to successfully implement any necessary future restructuring activities or other significant organizational changes.

The loss of members of our senior management team or our inability to attract and retain key personnel could adversely affect our business.

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The price and trading volume of our common stock may be highly volatile and could be further affected by events not within our control, and an investment in our common stock could suffer a decline in value.

The delisting of our common stock from Nasdaq and potential delisting from OTCQX ® has adversely affected our common stock and business and financial condition.

The restatement of prior period financial statements may affect investor confidence and raise reputational issues.

If we do not effectively

remediate the material weakness in our internal control existing as of December 31, 2024 ,

or if we otherwise fail to maintain and implement effective internal controls over financial reporting, investors may lose

confidence in the accuracy and completeness of our reported financial information and the market price of our common stock may be

negatively affected.

The delisting of our common stock from Nasdaq, the removal of our common stock from trading on the OTCQX on August 18, 2025 and the subsequent trading of our common stock on the OTCID has adversely affected our common stock and business and financial condition.

If we fail to maintain and implement effective internal controls over financial reporting, investors may lose confidence

in the accuracy and completeness of our reported financial information and the market price of our common stock may be negatively affected.

Any weakness in our disclosure controls and procedures and our internal controls could have a material adverse effect on us.

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Risks Related to our Business

We face substantial

risks due to our operating history of net losses, negative working capital and insufficient cash flows, and lack of liquidity to pay our

current obligations and if we are unable to continue our business, our shares may have little or no value.

Our ability to maintain being

a profitable operating company is dependent upon our ability to continue to generate revenues and/or obtain financing adequate to support

our cost structure.

For the fiscal year ended

December 31, 2024, we had operating income from continuing operations of $8.1 million.

As of December 31, 2024, we had cash and cash equivalents

of $1.5 million and current liabilities of $10.6 million.

We may need to attempt to raise additional equity capital by selling shares

of common stock or other dilutive or non-dilutive means, if necessary.

However, investing in our securities may be an unattractive investment

for potential investors.

These factors, among others, may make it difficult to raise any additional capital.

a few payers for a significant portion of our revenue for our clinical services, and if one or more significant payers, including CMS,

stops providing reimbursement or decreases the amount of reimbursement for our tests, or if we are unable to successfully negotiate additional

reimbursement contracts for our clinical services tests, our revenue could decline and our commercial success could be compromised.

We depend on a few

payers for a significant portion of our revenue for our clinical services, and if one or more significant payers, including CMS,

stops providing reimbursement as CMS did with our now discontinued PancraGEN ® test, or decreases the amount of

reimbursement for our tests, or if we are unable to successfully negotiate additional reimbursement contracts for our clinical

services tests, our revenue could decline and our commercial success could be compromised.

Revenue for clinical services

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more payers were to stop reimbursing for our clinical services tests or change their reimbursement amounts.

In January 2022, the Company

announced that CMS issued a new billing policy whereby CMS will no longer reimburse for the use of the Company’s ThyGeNEXT ®

and ThyraMIR ® v2 tests when billed together by the same provider/supplier for the same beneficiary on the same date

On February 28, 2022, the Company announced that the National Correct Coding Initiative (NCCI) program issued a response on

behalf of CMS stating that the January 2022 billing policy reimbursement change for ThyGeNEXT ® (0245U) and ThyraMIR ® v2

(0018U) tests has been retroactively reversed to January 1, 2022.

CMS was reimbursing the Company for one of its two thyroid tests, and

had agreed to retroactively reimburse for the second test once they had completed their internal administrative adjustments.

We were notified

by CMS/NCCI that processing of claims for dates of service after January 1, 2022 would be completed beginning July 1, 2022.

date of this filing the Company has no remaining outstanding collections regarding this matter and is fully up to date with CMS.

January 1, 2023, the gapfill price for ThyGeNEXT ® was set at $1,266.07.

Along with many laboratories,

we have been negatively impacted by LCD L39365, which was finalized on April 24, 2025 by our local Medicare Administrative Contractor,

This LCD, which governs “Genetic Testing for Oncology,” resulted in the loss of existing coverage for one of our

molecular tests, PancraGEN ® .

On January 9, 2025, the Company

announced the new LCD established non-coverage for its PancraGEN ® test, and that it would stop offering the test and would

not accept specimens for first-line fluid chemistry and PancraGEN ® testing after February 7, 2025.

As a result of the

established non-coverage for PancraGEN ® , the Company announced in January 2025 that its board of directors had approved

a restructuring and cost-savings plan to reduce operating costs and better align its workforce with the loss of PancraGEN ®

(the “Restructuring Plan”).

On January 27, 2025, the

Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay

implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.

On April 24, 2025, the

Company announced that the LCD would take effect immediately.

Because PancraGEN ® was primarily ordered for Medicare patients,

the decision to end reimbursement coverage meant that the Company was no longer able to continue offering this test.

Specimens for first-line

fluid chemistry and PancraGEN ® testing were not accepted by the Company after May 2, 2025.

As a result of the loss of

PancraGEN ® , on April 25, 2025, the Company announced implementation of its previously approved Restructuring Plan whereby

it reduced its workforce and impacted employees received severance benefits.

Novitas has been and is the

current regional MAC that handles claims processing for Medicare services with jurisdiction for PancraGEN ® , ThyGeNEXT ® ,

ThyraMIR ® v2, and RespriDx ® .

On a five-year rotational basis, Medicare requests bids for its regional MAC

Any future changes in the MAC processing or coding for Medicare claims for our molecular diagnostic tests could result in a

change in the coverage or reimbursement rates for such molecular diagnostic tests, or the loss of coverage.

On June 5, 2023

we announced that Novitas issued the final LCD of Genetic Testing for Oncology (L39365) which if implemented, would have established

non-coverage for the Company’s widely used PancraGEN ® test effective July 17, 2023.

On July 6, 2023, Novitas announced

that it would not be implementing the final Genetic Testing for Oncology LCD (L39365) as scheduled on July 17, 2023.

Novitas then issued

a new, virtually identical proposed LCD affecting the same companies and tests and reaching the same conclusions as noted in the previously

rescinded LCD on July 27, 2023.

In response, we participated in a public meeting presentation and submitted detailed written comments

supporting the use of PancraGEN ® .

The timing and content of any final, implemented LCD was uncertain at that time.

a result, we are able to continue offering PancraGEN ® and the related Point2 ® fluid chemistry tests for

amylase, CEA, and glucose throughout 2024.

On January 9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN ®

test, and it would stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing

after February 7, 2025.

On January 27, 2025, the Company announced that CMS had directed Novitas to delay implementation of the Genetic

Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.

The Company stated that this change of effective date

will allow the Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical

evidence for the PancraGEN ® assay, and fully assess the negative impact on patient care if the currently proposed LCD

comes into effect.

In the event Novitas ultimately restricts coverage for the PancraGEN ® test, our liquidity could be

negatively impacted.

current regional MAC that handles claims processing for Medicare services with jurisdiction for ThyGeNEXT ® and ThyraMIR ® v2.

On a five-year rotational basis, Medicare requests bids for its regional MAC services.

Any future changes in the MAC processing or coding

for Medicare claims for our molecular diagnostic tests could result in a change in the coverage or reimbursement rates for such molecular

diagnostic tests, or the loss of coverage.

Our ThyraMIR ® v2

and ThyGeNEXT ® tests are and, until April 24, 2025 our PancraGEN ® test is reimbursed by Medicare based on

applicable CPT codes.

RespriDx ® is currently only covered by the Medicare Advantage program and our BarreGEN ®

assay is not reimbursed at all.

Any future reductions from the current reimbursement rates for our clinical services tests would have

a material adverse effect on business and results of operations.

and ThyGeNEXT ® tests are reimbursed by Medicare based on applicable CPT codes.

Any future reductions from the current reimbursement

rates for our clinical services tests would have a material adverse effect on business and results of operations.

Although we have entered into

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Any such actions could have a negative effect on our revenue for our clinical services tests.

Adverse developments

affecting financial institutions, companies in the financial services industry or the financial services industry generally, including

those we do business with, could adversely affect our operations and liquidity.

Actual events involving limited

liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial

services industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past

and may in the future lead to market-wide liquidity problems.

For example, on March 10, 2023, Silicon Valley Bank was closed by the California

Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, or the FDIC, as receiver.

Our access to our cash and

cash equivalents and our ability to access bank financing in amounts adequate to finance our operations could be significantly impaired

by the financial institutions with which we have arrangements directly facing liquidity constraints or failures.

In addition, investor

concerns regarding the U.S.

or international financial systems could result in less favorable commercial financing terms, including higher

interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources,

thereby making it more difficult for us to acquire or take down financing on acceptable terms or at all.

Any material decline in available

funding or our ability to access our cash and cash equivalents or our ability to access bank financing could adversely impact our ability

to meet our operating expenses and result in breaches of our contractual obligations which could have material adverse impacts on our

operations and liquidity.

Our quarterly and annual

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progress or lack of progress in developing and commercializing tests and services;

favorable or unfavorable decisions about our tests or services or reimbursement rates from government regulators, insurances companies, customers, or other third party payers;

favorable or unfavorable decisions about our tests or services or reimbursement rates from government regulators, insurance companies, customers, or other third-party payers;

the commencement, delay, cancellation or completion of sales and marketing programs;

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All of our revenue is derived

from our clinical services business.

We have molecular diagnostics tests and complimentary service extensions that are in development,

but there can be no assurance that we will be able to successfully commercialize or sufficiently increase revenues from those tests.

we are unable to increase sales of our molecular diagnostic tests, expand reimbursement for these tests, or successfully develop and commercialize

other molecular diagnostic tests, our revenue and our ability to achieve and sustain profitability would be impaired, and this could have

a material adverse effect on our business, financial condition and results of operations, and the market price of our common stock could

from our clinical services business and specifically our ThyraMIR ® v2 and ThyGeNEXT ® tests.

We have molecular

diagnostics tests and complimentary service extensions that are in development, but there can be no assurance that we will be able to

successfully commercialize or sufficiently increase revenues from those tests.

If we are unable to increase sales of our molecular diagnostic

tests, expand reimbursement for these tests, or successfully develop and commercialize other molecular diagnostic tests, our revenue and

our ability to achieve and sustain profitability would be impaired, and this could have a material adverse effect on our business, financial

condition and results of operations, and the market price of our common stock could decline.

We rely on third parties

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If claims for our

clinical services are not submitted to payers on a timely basis, or if we are again required to switch to a different third-party processor

clinical services are not submitted to payers on a timely basis, or if we are required to switch to a different third-party processor

to handle claim submissions, we may experience delays in our ability to process claims and receive payment from payers, which could have

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business in the future through collaborations, equity offerings, debt financings, licensing arrangements or other dilutive or non-dilutive

On January 7, 2021, we entered into promissory notes (“Notes”) with our two private equity investors in the aggregate

amount of $5 million with a maturity date of June 30, 2021 which were secured by all of our assets.

In October 2021, the Company entered

into a $7.5 million revolving credit facility with Comerica Bank (“Comerica”).

In addition, also in October 2021, the Company

entered into an $8.0 million term loan with BroadOak, the proceeds of which were used to repay in full at their maturity the Notes extended

by our two private equity investors (the “Term Loan”).

The Term Loan contains affirmative and negative restrictive covenants,

including restrictions on certain mergers, acquisitions, investments and encumbrances which could adversely affect our ability to conduct

our business.

The Term Loan also contains customary events of default.

The Comerica agreement was repaid in full in 2023 and the agreement

was terminated in February 2024.

The Comerica loan agreement contained affirmative and negative restrictive covenants that were applicable

whether or not any amounts are outstanding under the Comerica loan agreement.

These restrictive covenants, which included restrictions

on certain mergers, acquisitions, investments, encumbrances, etc., could have adversely affected our ability to conduct our business.

The Comerica loan agreement also contained financial covenants requiring specified minimum liquidity and minimum revenue thresholds as

well as customary events of default.

In May 2022, the Company issued a Convertible Note to BroadOak, pursuant to which BroadOak funded

a term loan in the aggregate principal amount of $2 million.

In August 2022, the Convertible Note was converted into a subordinated term

loan and was added to the outstanding BroadOak loan balance discussed above.

The term loan has been subsequently amended several times.

See Note 13, Notes Payable to Notes to Consolidated Financial Statements.

Additional funding may not

be available to us on acceptable terms, or at all.

If we seek to raise funds by issuing additional equity securities, dilution to our

stockholders could result.

Over the last four years, we have entered into $5 million secured promissory notes with our two private equity investors, a $7.5

million revolving credit facility with Comerica Bank, an $8 million term loan (the “Term Loan”) with BroadOak Fund V, L.P.

(“BroadOak”), and a $2 million convertible note with BroadOak, all of which has been repaid.

New funding may not be available

to us on acceptable terms, or at all.

If we seek to raise funds by issuing additional equity securities, dilution to our stockholders

could result.

Since our common stock has been delisted from Nasdaq and is currently quoted on the OTCID, it has been very difficult for

us to raise funds on the public markets.

In addition, we are currently ineligible to use a Form S-3 shelf registration statement.

If we are unable to

timely repay the BroadOak borrowing when due, BroadOak will have the right to foreclose on our assets.

The incurrence of additional indebtedness

or the issuance of certain equity securities could result in increased fixed payment obligations and could also result in restrictive

covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire

or license intellectual property rights, limitations on our ability to enter into mergers or acquisition of assets, and other operating

restrictions that could adversely affect our ability to conduct our business.

If we are unable to

timely repay our outstanding obligations, our secured lender will have the right to foreclose on our assets.

In October 2021, the Company

entered into an $8.0 million term loan with BroadOak, which is secured by all of our assets and has a maturity date of December 31, 2025.

In May 2022, the Company issued a Convertible Note to BroadOak, pursuant to which BroadOak funded a term loan in the aggregate principal

amount of $2 million.

In August 2022, the Convertible Note was converted into a subordinated term loan and was added to the outstanding

BroadOak loan balance discussed above.

The term loan has been subsequently amended several times.

See Note 13, Notes Payable to

Notes to Consolidated Financial Statements.

We may need additional funding to repay these outstanding obligations as well as to continue

Additional funding may not be available to us on acceptable terms, or at all.

If we are unable to timely repay these outstanding

obligations, our secured lender will have the right to foreclose on substantially all of our assets.

incurrence of additional indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations

and could also result in restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity,

limitations on our ability to acquire or license intellectual property rights, limitations on our ability to enter into mergers or acquisition

of assets, and other operating restrictions that could adversely affect our ability to conduct our business.

Risks Related to our Preferred Stock

We have issued and may

issue additional preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

We may issue additional

preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

We are authorized to issue

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of Series C Preferred Stock.

These shares were converted to common stock in January 2026.

Two private equity firms

and their affiliate’s control, on an as-converted basis, an aggregate of 84% of our outstanding shares of common stock through their

holdings of our Series C Preferred Stock, and this concentration of ownership may have a substantial influence on our decisions.

Ampersand holds 28,000 shares

of our Series C Preferred Stock and 1315 Capital holds 19,000 shares of our Series C Preferred Stock.

Accordingly, on an as converted

basis, Ampersand and its affiliates beneficially own 50% of the Company’s outstanding common stock of 4,423,093 shares and 1315

Capital and its affiliates beneficially own 34%.

The conversion and sale by such holders of one or more large blocks of our common stock

could have a negative impact on the market price of our common stock.

and their affiliates control an aggregate of 84% of our outstanding shares of common stock and this concentration of ownership may have

a substantial influence on our decisions.

As of February 28, 2026, Ampersand

and its affiliates beneficially own 50% of the Company’s outstanding common stock of 27,700,904 shares and 1315 Capital and its

affiliates beneficially own 34%.

The sale by such holders of one or more large blocks of our common stock could have a negative impact

on the market price of our common stock.

These stockholders, acting

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any merger, consolidation or sale of all or substantially all of our assets.

The Series C Preferred Stock issuance removed the director

designation rights that Ampersand and 1315 Capital had as holders of Series B Preferred Stock, now exchanged for Series C Preferred Stock.

This concentration of ownership of Ampersand and 1315 Capital might harm the market price of our common stock by delaying, deterring or

preventing a change in control, making some transactions more difficult or impossible to complete without the support of these shareholders,

regardless of the impact of this transaction on our other shareholders.

Such ownership interests could effectively deter a third party

from making an offer to buy us, which might involve a premium over our current stock price or other benefits for our stockholders, or

otherwise prevent changes in the control or management.

For example, this concentration of ownership may have the effect of impeding a

merger, consolidation, takeover or other business combination involving us or discouraging a potential acquirer from making a tender offer

or otherwise attempting to obtain control of us.

This concentration of ownership of Ampersand and 1315 Capital

might harm the market price of our common stock by delaying, deterring or preventing a change in control, making some transactions more

difficult or impossible to complete without the support of these shareholders, regardless of the impact of this transaction on our other

shareholders.

Such ownership interests could effectively deter a third party from making an offer to buy us, which might involve a premium

over our current stock price or other benefits for our stockholders, or otherwise prevent changes in the control or management.

this concentration of ownership may have the effect of impeding a merger, consolidation, takeover or other business combination involving

us or discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

Risks Related to our Clinical Services

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compliance with complex federal and state regulations related to billing Medicare;

changes in billing policy reimbursement by CMS, particularly with respect to PancraGEN;

changes in billing policy reimbursement by CMS;

disputes among payers as to which party is responsible for payment;

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and undertake internal audits to evaluate compliance with applicable laws and regulations as well as internal compliance policies and

Payers also conduct external audits to evaluate payments, which add further complexity to the billing process.

Payers also conduct external audits to evaluate payments, which adds further complexity to the billing process.

These billing

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Although we have contracted

rates of reimbursement with certain payers, which establishes allowable rates of reimbursement for our PancraGEN ® , ThyGeNEXT ® ,

ThyraMIR ® v2 and RespriDx ® assays, payers may suspend or discontinue reimbursement at any time, may require

or increase co-payments from patients, may impose pre-authorization requirements, may establish non-coverage for our tests, or may reduce

the reimbursement rates paid to us.

Any such actions could have a negative effect on our revenue for our clinical services tests.

Part I – Item 1 – “Business – Government Regulations and Industry Guidelines - Third Party Coverage

and Reimbursement for our Clinical Services – Novitas LCD for PancraGEN ® .

rates of reimbursement with certain payers, which establishes allowable rates of reimbursement for our ThyGeNEXT ® and ThyraMIR ® v2

assays, payers may suspend or discontinue reimbursement at any time, may require or increase co-payments from patients, may impose pre-authorization

requirements, may establish non-coverage for our tests, or may reduce the reimbursement rates paid to us.

Any such actions could have

a negative effect on our revenue for our clinical services tests.

See “Business – Government Regulations and Industry Guidelines

- Third Party Coverage and Reimbursement for our Clinical Services.”

We have contracted rates of

reimbursement with select payers for PancraGEN ® , ThyGeNEXT ® and ThyraMIR ® v2 and to a limited

extent, RespriDx ® .

Without a contracted rate for reimbursement, claims may be denied upon submission, and we may need to

appeal the claims.

The appeals process is time consuming and expensive, and may not result in payment.

We expect to continue to focus

resources on increasing adoption of and coverage and reimbursement for our molecular diagnostic tests.

We cannot, however, predict whether,

under what circumstances, or at what payment levels payers will reimburse us for our molecular diagnostic tests, if at all.

to our current commercial products on the market and in our pipeline, the launch of any new molecular diagnostic tests in the future may

require that we expend substantial time and resources in order to obtain and retain reimbursement.

Also, payer consolidation can create

uncertainty as to whether coverage and contracts with existing payers will even remain in effect.

Finally, commercial payers may tie their

allowable rates to Medicare rates, and should Medicare reduce their rates, we may be negatively impacted.

If we fail to establish broad

adoption of and reimbursement for our assays, or if we are unable to maintain existing reimbursement from payers, our ability to generate

revenue for our clinical services tests could be harmed and this could have a material adverse effect on our business, financial condition

and results of operations.

reimbursement with select payers for ThyGeNEXT ® and ThyraMIR ® v2.

Without a contracted rate for reimbursement,

claims may be denied upon submission, and we may need to appeal the claims.

The appeals process is time-consuming and expensive and may

not result in payment.

We expect to continue to focus resources on increasing adoption of, and coverage and reimbursement for, our molecular

diagnostic tests.

We cannot, however, predict whether, under what circumstances, or at what payment levels payers will reimburse us for

our molecular diagnostic tests, if at all.

In addition to our current commercial products on the market and in our pipeline, the launch

of any new molecular diagnostic tests in the future may require that we expend substantial time and resources in order to obtain and retain

reimbursement.

Also, payer consolidation can create uncertainty as to whether coverage and contracts with existing payers will even remain

Finally, commercial payers may tie their allowable rates to Medicare rates, and should Medicare reduce their rates, we may

be negatively impacted.

If we fail to establish broad adoption of and reimbursement for our assays, or if we are unable to maintain existing

reimbursement from payers, our ability to generate revenue for our clinical services tests could be harmed and this could have a material

adverse effect on our business, financial condition and results of operations.

We may experience a

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in the United States have recommended therapies or surgery to determine if a patient’s condition is malignant or benign.

physicians may be reluctant to order a diagnostic test that may suggest surgery is unnecessary.

physicians may be reluctant to order a diagnostic test that is not recommended by practice guidelines.

In addition, our assays are performed

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obtain coverage and adequate reimbursement for them.

For more information, on how reimbursement has been affected for our PancraGEN test,

please see Part I – Item 1 – “Business – Government Regulations and Industry Guidelines - Third Party Coverage

and Reimbursement for our Clinical Services – Novitas LCD for PancraGEN .”

Our existing clinical

utility studies may be outdated and may not reflect current medical practice, which could adversely affect acceptance of our products

and services.

The clinical utility studies

supporting our products were conducted several years ago.

Since that time, standards of care, clinical guidelines, competing technologies

and diagnostic methodologies may have evolved.

As a result, earlier studies may not fully reflect current clinical practice, patient populations,

treatment paradigms or payer expectations.

Physicians, payers or other stakeholders may view older studies as less persuasive or less

relevant than more recent data, particularly if competing products are supported by newer evidence or more contemporary study designs.

If our existing clinical utility studies are perceived as outdated, incomplete or not reflective of current standards of care, adoption

of our products and services could be adversely affected.

In addition, payers may require more recent or supplemental clinical utility

data as a condition of coverage or reimbursement.

We may therefore need to conduct additional or updated clinical utility studies to maintain

or expand market acceptance and reimbursement.

Such studies may be costly and time-consuming, may require collaboration with third parties,

and may not generate results that are favorable or sufficient to support broader adoption or coverage.

If we are unable to successfully

conduct additional studies, or if the results do not demonstrate meaningful clinical benefit under current standards of care, our business,

financial condition and results of operations could be materially adversely affected.

We rely on sole suppliers

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our quality specifications, or if we cannot obtain acceptable substitute materials, an interruption in test processing and services could

Any such interruption may directly impact our revenue and cause us to incur higher costs.

In particular, the continued spread of

the coronavirus globally could materially and adversely impact our operations including without limitation our supply chain, which may

have a material and adverse effect on our business, financial condition and results of operations.

Any such interruption may directly impact our revenue and cause us to incur higher costs, which could materially and adversely

impact our operations including without limitation our supply chain, which may have a material and adverse effect on our business, financial

condition and results of operations.

We may experience problems

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clinical laboratory.

On April 29, 2024, however,

the FDA published a final rule on LDTs, in which the 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 running LDTs will be required to comply with medical

device (adverse event) reporting and correction/removal reporting requirements, as well as requirements for maintenance of complaint files

under the FDA’s quality systems regulation (QSR).

In Phase 2 (effective May 6, 2026), clinical laboratories will be required to

comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for the remaining QSR requirements

and premarket review.

In Phase 3 (effective May 6, 2027), clinical laboratories will be required to comply with all remaining applicable

QSR requirements.

In Phase 4 (effective November 6, 2027), clinical laboratories will be required to comply with premarket review requirements

for high-risk tests (i.e., tests subject to the premarket approval (PMA) requirement).

Finally, in Phase 5 (effective May 6, 2028), clinical

laboratories will be required to comply with premarket review requirements for moderate- and low-risk tests (i.e., tests subject to the

de novo or 510(k) requirement).

Under the final rule, several

types of tests will be eligible for some degree of continued enforcement discretion.

For example, LDTs approved by the New York State

Department of Health will be exempt from premarket review requirements but will remain subject to the requirements of Phases 1 through

Similarly, LDTs first marketed prior to May 6, 2024 that are not subsequently modified, or are modified only in certain limited ways,

will be exempt from the premarket review and most quality systems requirements, but will remain subject to the requirements of Phases

The FDA notes, however, that it retains discretion to pursue enforcement action for violations of the Federal Food, Drug and

Cosmetic Act at any time and intends to do so when appropriate.

The FDA further explains that it may update any of the enforcement discretion

policies set forth in the final rule as circumstances warrant or if the circumstances that inform those policies change, consistent with

the FDA’s good guidance practices.

While subject to oversight

by CMS through its enforcement of CLIA, the FDA has historically asserted authority to regulate IVDs, including LDTs, as medical devices

under the Federal Food, Drug and Cosmetic Act.

Historically, the FDA exercised

enforcement discretion over most LDTs.

On April 29, 2024, the FDA published a final rule that would have phased out enforcement discretion

for many LDTs.

On March 31, 2025, the United States District Court for the Eastern District of Texas vacated the final rule.

date of this filing, the vacatur remains in effect and the FDA has not implemented the rule.

Accordingly, the FDA continues to exercise

enforcement discretion with respect to most LDTs, consistent with historical practice.

The FDA retains statutory

authority over medical devices, and it is possible that the FDA could pursue revised rulemaking or that Congress could enact legislation

establishing a new regulatory framework for in vitro clinical tests.

We cannot predict whether or when such action may occur.

regulatory or legislative developments result in expanded FDA oversight of LDTs, our clinical services could become subject to additional

regulatory requirements, which could increase costs or delay commercialization of new tests.

If we are required to submit

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action against us may have a material adverse effect on our clinical services and results of operations.

The ultimate risk classification

of our assays under the FDA framework remains uncertain.

If any of our assays are classified as high-risk devices subject to premarket

approval, we may be required to conduct additional clinical studies, which could be costly and time-consuming.

Furthermore, if FDA regulation

of LDTs is implemented while CMS and Medicare Administrative Contractors continue to impose independent coverage and coding requirements,

we may face duplicative or conflicting regulatory obligations.

Evolving regulation

of algorithm-based and bioinformatics tools could increase compliance obligations.

Certain of our diagnostic

assays incorporate proprietary algorithms and bioinformatics tools.

Evolving FDA and international regulatory expectations regarding algorithm

transparency, modification controls, and validation could require additional documentation, testing, regulatory submissions, or disclosure.

Any such requirements could increase development costs or limit our flexibility to modify or enhance our assays.

If we are sued for product

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had approved the Restructuring Plan (as defined below) to reduce operating costs and better align its workforce with the loss of PancraGEN ® .

As a result of CMS’ determination to delay implementation of the Genetic Testing for Oncology LCD (L39365) until April 24, 2025,

the Company is re-evaluating certain parts of the Restructuring Plan and will determine what parts will or will not be postponed, or cancelled.

For more information on the Restructuring Plan, please see Part II – Item 7 – “Management’s Discussion and

Analysis of Financial Condition and Results of Operations – Potential Restructuring .

In the event we proceed with

some or all parts of the Restructuring Plan, there are significant costs involved with the execution of restructuring programs or other

significant organizational changes, including expenses related to severance, asset impairments and other potential charges.

also significant risks involved with such changes, including the potential for significant business disruption, diversion of management’s

time and attention from ongoing operations, loss of human capital talent, temporarily reduced productivity and the risk of failing to

achieve some or all of the anticipated benefits of the restructuring or organizational changes.

We may need to implement additional restructuring

plans or other strategic initiatives in the future in response to market or product changes, performance issues, changes in strategy,

acquisitions and/or other internal or external considerations.

If we are unable to successfully manage and implement any future restructuring

plan, we may not achieve or sustain the expected growth or cost savings benefits of these activities, or do so within the expected timeframe,

and in such instance, our financial condition and results of operations could be materially adversely impacted.

Analysis of Financial Condition and Results of Operations – Restructuring .

There are significant costs

involved with the execution of restructuring programs or other significant organizational changes, including expenses related to severance,

asset impairments and other potential charges.

There are also significant risks involved with such changes, including the potential for

significant business disruption, diversion of management’s time and attention from ongoing operations, loss of human capital talent,

temporarily reduced productivity and the risk of failing to achieve some or all of the anticipated benefits of the restructuring or organizational

We may need to implement additional restructuring plans or other strategic initiatives in the future in response to market or

product changes, performance issues, changes in strategy, acquisitions and/or other internal or external considerations.

If we are unable

to successfully manage and implement any future restructuring plan, we may not achieve or sustain the expected growth or cost savings

benefits of these activities, or do so within the expected timeframe, and in such instance, our financial condition and results of operations

could be materially adversely impacted.

The loss of members

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102 employees, the success of our business depends largely on the skills, experience and performance of members of our senior management

team, including our chief executive officer, and others in key management positions The efforts of these persons will be critical to us

as we continue to grow our clinical services and develop and/or acquire additional molecular diagnostic tests.

If we were to lose one

or more of these key employees, we may experience difficulties in competing effectively, developing our technologies and implementing

our business strategy.

In addition, our commercial laboratory operations depend on our ability to attract and retain highly skilled scientists,

including licensed clinical laboratory scientists.

We may not be able to attract or retain qualified scientists and technicians in the

future due to the competition for qualified personnel, and we may have to pay higher salaries to attract and retain qualified personnel.

We may also be at a disadvantage in recruiting and retaining key personnel as our small size, limited resources, and limited liquidity

may be viewed as providing a less stable environment, with fewer opportunities than would be the case at one of our larger competitors.

If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints

that could adversely affect our ability to support our clinical laboratory and commercialization.

team, including our chief executive officer, our chief financial officer, and others in key management positions The efforts of these

persons will be critical to us as we continue to grow our clinical services and develop and/or acquire additional molecular diagnostic

If we were to lose one or more of these key employees, we may experience difficulties in competing effectively, developing our

technologies and implementing our business strategy.

In addition, our commercial laboratory operations depend on our ability to attract

and retain highly skilled scientists, including licensed clinical laboratory scientists.

We may not be able to attract or retain qualified

scientists and technicians in the future due to the competition for qualified personnel, and we may have to pay higher salaries to attract

and retain qualified personnel.

We may also be at a disadvantage in recruiting and retaining key personnel as our small size, limited

resources, and limited liquidity may be viewed as providing a less stable environment, with fewer opportunities than would be the case

at one of our larger competitors.

If we are not able to attract and retain the necessary personnel to accomplish our business objectives,

we may experience constraints that could adversely affect our ability to support our clinical laboratory and commercialization.

If we lose the support

of key opinion leaders or KOL’s, it may limit our revenue growth from our tests or services and our ability to achieve profitability.

of key opinion leaders, it may limit our revenue growth from our tests or services and our ability to achieve profitability.

We have established relationships

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are more effective, or if they elect to use internally developed products, we would encounter significant difficulty validating our testing

platform, driving adoption, or establishing our tests as a standard of care, which would limit our revenue growth and our ability to achieve

platform, driving adoption, or establishing our tests as a standard of care, which would limit our revenue growth and our ability to maintain

profitability.

We have limited experience

in marketing and selling our products, and if we are unable to expand our direct sales and marketing force to adequately address our customer’s

needs, our business may be adversely affected.

Although we have been selling

commercial products since 2014, genomic diagnostics is a relatively new area of science, and we continue to focus and refine our efforts

to sell, market and receive reimbursement for our clinical service products and to leverage our bioinformatics data.

We may not be able

to market, sell, or distribute our existing products or services or other products or services we may develop effectively enough to support

our planned growth.

Our future sales will depend

in large part on our ability to develop, and substantially expand, our sales force and to increase the scope of our marketing efforts.

Our target market of physicians is a large and diverse market.

As a result, we believe it is necessary to develop a sales force that includes

sales representatives with specific technical backgrounds.

We will also need to attract and develop marketing personnel with industry

Competition for such employees is intense.

We may not be able to attract and retain personnel or be able to build an efficient

and effective sales and marketing force, which could negatively impact sales and market acceptance of our products and services and limit

our revenue growth and potential profitability.

Our expected future growth

will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, and integrate

additional employees.

Our future financial performance and our ability to commercialize our products and leverage our data and to compete

effectively will depend in part on our ability to manage this potential future growth effectively, without compromising quality.

If our sales force is

less successful than anticipated, our business expansion plans could suffer and our ability to generate revenues could be diminished.

In addition, we have limited history selling our clinical services tests on a direct basis, and leveraging our bioinformatics data and

our limited history makes forecasting difficult.

If our sales force is not

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We compete with physicians

and the medical community who use traditional methods to diagnose gastrointestinal, endocrine and lung cancers and to conduct clinical

In many cases, practice guidelines in the United States have recommended non-molecular testing like cytology or diagnostic surgery

to determine if a patient’s condition is malignant or benign.

As a result, we believe that we will need to continue to educate physicians

and the medical community on the value and benefits of our clinical services tests in order to impact clinical practices.

we face competition from other companies that offer diagnostic tests.

Specifically, in regard to our thyroid diagnostic tests, Veracyte,

(“Veracyte”) has thyroid nodule cancer diagnostic tests which are currently on the market that compete with our ThyGeNEXT ®

and ThyraMIR ® v2 tests.

and the medical community who use traditional methods to diagnose endocrine and to conduct clinical trials.

In many cases, practice guidelines

in the United States have recommended non-molecular testing like cytology or diagnostic surgery to determine if a patient’s condition

is malignant or benign.

As a result, we believe that we will need to continue to educate physicians and the medical community on the value

and benefits of our clinical services tests in order to impact clinical practices.

In addition, we face competition from other companies

that offer diagnostic tests.

Specifically, in regard to our thyroid diagnostic tests, Veracyte, Inc.

(“Veracyte”) has thyroid

nodule cancer diagnostic tests which are currently on the market that compete with our ThyGeNEXT ® and ThyraMIR ® v2

Quest Diagnostics Inc.

currently offers Veracyte’s tests via a co-marketing agreement,

and CBLPath, Inc.

is offering a diagnostic test performed via the University of Pittsburgh Medical Center (UPMC) that analyzes genetic

alterations using next-generation sequencing mutation panel for pancreatic cysts.

While we do not believe we currently have significant

direct competition for PancraGEN ® in the gastrointestinal market, technology such as a next-generation sequencing mutation

panel could in the future lead to increased competition.

currently offers Veracyte’s tests via a co-marketing agreement, and CBLPath, Inc.

is offering a diagnostic

test performed via the University of Pittsburgh Medical Center (UPMC) that analyzes genetic alterations using next-generation sequencing

mutation panel for pancreatic cysts.

It is also possible that we

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Furthermore, we may be subject to competition as a result of the

new, unforeseen technologies that can be developed by our competitors in the gastrointestinal and endocrine cancer molecular diagnostic

testing space.

To compete successfully, we must be able to demonstrate, among other things, that our test results are accurate and cost

effective, and we must secure a meaningful level of reimbursement for our tests.

Since our clinical services began in 2014, many of our

potential competitors have stronger brand recognition and greater financial capabilities than we do.

Others may develop a test with a

lower price than ours that could be viewed by physicians and payers as functionally equivalent to our molecular diagnostic tests or offer

a test at prices designed to promote market penetration, which could force us to lower the price of our clinical services tests and affect

our ability to achieve and maintain profitability.

If we are unable to compete successfully against current and future competitors, we

may be unable to increase market acceptance of our clinical services tests and overall sales, which could prevent us from increasing our

revenue or achieving profitability and cause the market price of our common stock to decline.

As we add new clinical services tests and

other products and services, we will likely face many of these same competitive risks that we do currently.

new, unforeseen technologies that can be developed by our competitors in the endocrine cancer molecular diagnostic testing space.

successfully, we must be able to demonstrate, among other things, that our test results are accurate and cost effective, and we must secure

a meaningful level of reimbursement for our tests.

Since our clinical services began in 2014, many of our potential competitors have stronger

brand recognition and greater financial capabilities than we do.

Others may develop a test with a lower price than ours that could be

viewed by physicians and payers as functionally equivalent to our molecular diagnostic tests or offer a test at prices designed to promote

market penetration, which could force us to lower the price of our clinical services tests and affect our ability to achieve and maintain

profitability.

If we are unable to compete successfully against current and future competitors, we may be unable to increase market acceptance

of our clinical services tests and overall sales, which could prevent us from increasing our revenue or sustaining profitability and cause

the market price of our common stock to decline.

As we add new clinical services tests and other products and services, we will likely

face many of these same competitive risks that we do currently.

If we cannot license

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or injunctive relief against us that could have a material adverse effect on our business, financial condition and results of operations.

If a catastrophe strikes

our laboratory or if it becomes inoperable for any other reason, we will be unable to perform our testing and our business will be harmed.

If a catastrophe

strikes our laboratory or if it becomes inoperable for any other reason, we will be unable to perform our testing and our business will

The laboratory and equipment

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due to employee error, malfeasance or other activities.

If such event would occur and cause interruptions in our operations, our networks

If such event were to occur and cause interruptions in our operations, our networks

would be compromised and the information we store on those networks could be accessed by unauthorized parties, publicly disclosed, modified

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reform measures that have been and may be adopted in the future, may result in more rigorous coverage criteria, new payment methodologies

and in additional downward pressure on the price that we receive for any approved product or service, and could seriously harm our future

and additional downward pressure on the price that we receive for any approved product or service, and could seriously harm our future

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from

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Supreme Court upheld the surviving portions of the law in 2021.

President Biden has used executive

President Biden had used executive

orders to undo certain changes to the PPACA made by the Trump administration and has indicated it will advocate for legislation to build

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CDLTs that are not ADLTs.

Under these laws, the next data reporting period is January 1, 2025 through March 31, 2025, and will be based

upon the data collected during the January 1, 2019 to June 30, 2019 period.

Any reductions to payment rates resulting from the new methodology

are limited to 10% per test per year in each of the years 2018 through 2020 and to 15% per test per year in each of the years 2025 through

Payments will not be reduced for 2021 through 2024 for CDLTs.

PAMA requires certain laboratories to report private payer rate data to CMS during designated reporting periods.

CMS has implemented payment reductions subject to statutory caps, including reductions of up to 15% per test per year through 2027 for

applicable tests.

Future legislative or regulatory changes could further modify reporting requirements or payment methodologies under

We cannot predict whether

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HIPAA, which establishes comprehensive federal standards with respect to the privacy and security of PHI and requirements for the use of certain standardized electronic transactions, and amendments made in 2013 to HIPAA under the Health Information Technology for Economic and Clinical Health Act, which strengthen and expand HIPAA privacy and security compliance requirements, increase penalties for violators, extend enforcement authority to state attorneys general, and impose requirements for breach notification;

The Department of Justice Final Rule on Preventing Access to Bulk US Sensitive Data by Countries of Concern

prohibits or significantly restrict the transfer of or other access to bulk US sensitive personal data and US government-related data

through certain data transactions to countries of concern, which are countries or entities the US government deems high-risk, as well

as certain covered persons as named by the U.S.

Attorney General.

The Final Rule, which largely entered effect on April 8, 2025, with

additional record-keeping requirements taking effect on October 6, 2025, imposes civil and criminal penalties for violations.

The FTC Act and various state consumer privacy laws, which require regulated entities to take reasonable steps to safeguard the personal information of consumers, make certain disclosures about our data privacy and security practices to the public and certain state or federal regulators, minimize our use of personal information of consumers, and provide consumers with certain rights as to their personal data such as the right to correct or delete their personal information;

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Human Services’ Office of the Inspector General and the Department of Defense.

Many of these bodies have all issued subpoenas and

other requests for information to conduct investigations of, and commenced civil or criminal litigation against, healthcare companies

based on financial arrangements with health care providers, regulatory compliance, product promotional practices and documentation, and

coding and billing practices.

Whistleblowers have filed numerous qui tam lawsuits against healthcare companies under the federal and state

False Claims Acts in recent years, in part because the whistleblower can receive a portion of the government’s recovery under such

Many of these bodies have issued subpoenas and other

requests for information to conduct investigations of, and commenced civil or criminal litigation against, healthcare companies based

on financial arrangements with health care providers, regulatory compliance, product promotional practices and documentation, and coding

and billing practices.

Whistleblowers have filed numerous qui tam lawsuits against healthcare companies under the federal and state False

Claims Acts in recent years, in part because the whistleblower can receive a portion of the government’s recovery under such suits.

The growth of our business

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These arrangements, like any arrangement that includes compensation to a healthcare provider or potential referral source, may trigger

federal or state anti-kickback, Stark Law liability, and False Claims Act liability.

There are no guarantees that the federal or state

governments will find that these arrangements are designed properly or that they do not trigger liability under federal and state laws.

Under existing laws, arrangements generally must be commercially reasonable and often compensation must be fair market value.

require some subjective analysis.

Safe harbors in the anti-kickback laws do not necessarily equate to exceptions in the Stark Law, and

there is no guarantee that the government will agree with our payment practices with respect to the relationships between our laboratory

and the healthcare providers, sales force members, or other parties.

A failure to comply with Federal and State laws and regulations pertaining

to our payment practices could result in substantial penalties and adversely affect our business, financial condition and results of operations.

federal or state anti-kickback, Stark Law, and False Claims Act liability.

There are no guarantees that the federal or state governments

will find that these arrangements are designed properly or that they do not trigger liability under federal and state laws.

Under existing

laws, arrangements generally must be commercially reasonable and often compensation must be fair market value.

These terms require some

subjective analysis.

Safe harbors in the anti-kickback laws do not necessarily equate to exceptions in the Stark Law, and there is no

guarantee that the government will agree with our payment practices with respect to the relationships between our laboratory and the healthcare

providers, sales force members, or other parties.

A failure to comply with federal and state laws and regulations pertaining to our payment

practices could result in substantial penalties and adversely affect our business, financial condition and results of operations.

In addition, federal law prohibits

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can result in fines of up to $200,000, up to 10 years in prison, or both, per violation.

As drafted, EKRA does not clearly protect incentive

compensation to sales employees, a practice that is common in the industry.

A failure to comply with EKRA could result in substantial

penalties and other adverse consequences that adversely affect our business, financial condition and results of operations.

Recent enforcement activity and judicial interpretations

suggest that EKRA may apply more broadly than initially anticipated, including potentially to commission-based compensation arrangements

for laboratory sales personnel.

Regulatory guidance remains limited and enforcement interpretations may evolve.

A failure to comply with

EKRA could result in substantial penalties and other adverse consequences that adversely affect our business, financial condition and

results of operations.

Our business activities

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companies operating in our industry, our success is somewhat dependent on intellectual property, particularly on obtaining and enforcing

Obtaining and enforcing patents of molecular diagnostics tests, like our molecular diagnostic tests in our PancraGEN ®

and miR Inform ® platforms (including ThyGeNEXT ® ), involves both technological and legal complexity,

and is therefore costly, time-consuming and inherently uncertain.

Obtaining and enforcing patents of molecular diagnostics tests, like our molecular diagnostic tests in our miR Inform

platforms (including ThyGeNEXT ® ), involves both technological and legal complexity, and is therefore costly, time-consuming

and inherently uncertain.

From time-to-time the U.S.

Supreme Court, other Federal courts, the

Congress or the United States Patent and Trademark Office, or the USPTO, may change the standards of patentability and any such changes

could have a negative impact on our business.

For instance, on October 30, 2008, the Court of Appeals for the Federal Circuit issued a

decision that methods or processes cannot be patented unless they are tied to a machine or involve a physical transformation.

Supreme Court, other Federal courts, the U.S.

Congress or the United States Patent

and Trademark Office, or the USPTO, may change the standards of patentability and any such changes could have a negative impact on our

For instance, on October 30, 2008, the Court of Appeals for the Federal Circuit issued a decision that methods or processes

cannot be patented unless they are tied to a machine or involve a physical transformation.

Supreme Court later

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patents or in third-party patents.

may be involved in litigation related to intellectual property, which could be time-intensive and costly and may adversely affect our

business, operating results or financial condition.

may receive notices of claims of direct or indirect infringement or misappropriation or misuse of other parties’ proprietary rights

from time to time and some of these claims may lead to litigation.

We cannot assume that we will prevail in such actions, or that other

actions alleging misappropriation or misuse by us of third-party trade secrets, infringement by us of third-party patents and trademarks

or other rights, or the validity of our patents, trademarks or other rights, will not be asserted or prosecuted against us.

not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first

to file patent applications for these inventions.

No assurance can be given that other patent applications will not have priority over

our patent applications.

If third parties bring these proceedings against our patents, we could incur significant costs and experience

management distraction.

Litigation may be necessary for us to enforce our patents and proprietary rights or to determine the scope, coverage

and validity of the proprietary rights of others.

Defending any litigation, and particularly patent litigation, is expensive and time-consuming,

and the outcome of any litigation or other proceeding is inherently uncertain and might not be favorable to us.

It is also possible that

we might not be able to obtain licenses to technology that we require on acceptable terms or at all.

In addition, if we resort to legal

proceedings to enforce our intellectual property rights or to determine the validity, scope and coverage of the intellectual property

or other proprietary rights of others, the proceedings could be burdensome and expensive, even if we were to prevail.

Any litigation

that may be necessary in the future could result in substantial costs and diversion of resources and could have a material adverse effect

on our business, financial condition and operating results.

the event of a successful claim of infringement against us, we may be required to pay damages and ongoing royalties, and obtain one or

more licenses from third parties, or be prohibited from selling our products.

We may not be able to obtain these licenses on acceptable

terms, if at all.

We could incur substantial costs related to royalty payments for licenses obtained from third parties, which could

negatively affect our financial results.

In addition, our agreements with some of our customers, suppliers or other entities with whom

we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims, including the

types of claims described above.

If we are required or agree to defend or indemnify third parties in connection with any infringement

claims, we could incur significant costs and expenses that could have a material adverse effect on our business, financial condition,

and results of operations.

Risks Related to our Business

ability to use our net operating loss carryforwards may be limited and may result in increased future tax liability to us.

incurred net losses from 2015-2022 and may never achieve sustained profitability.

As of the fiscal year ended December 31, 2024, we had

We may be involved in

litigation related to intellectual property, which could be time-intensive and costly and may adversely affect our business, operating

results or financial condition.

We may receive notices of

claims of direct or indirect infringement or misappropriation or misuse of other parties’ proprietary rights from time to time and

some of these claims may lead to litigation.

We cannot assume that we will prevail in such actions, or that other actions alleging misappropriation

or misuse by us of third-party trade secrets, infringement by us of third-party patents and trademarks or other rights, or the validity

of our patents, trademarks or other rights, will not be asserted or prosecuted against us.

We might not have been the first to make the

inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these

No assurance can be given that other patent applications will not have priority over our patent applications.

If third parties

bring these proceedings against our patents, we could incur significant costs and experience management distraction.

Litigation may be

necessary for us to enforce our patents and proprietary rights or to determine the scope, coverage and validity of the proprietary rights

Defending any litigation, and particularly patent litigation, is expensive and time-consuming, and the outcome of any litigation

or other proceeding is inherently uncertain and might not be favorable to us.

It is also possible that we might not be able to obtain

licenses to technology that we require on acceptable terms or at all.

In addition, if we resort to legal proceedings to enforce our intellectual

property rights or to determine the validity, scope and coverage of the intellectual property or other proprietary rights of others, the

proceedings could be burdensome and expensive, even if we were to prevail.

Any litigation that may be necessary in the future could result

in substantial costs and diversion of resources and could have a material adverse effect on our business, financial condition and operating

In the event of a successful

claim of infringement against us, we may be required to pay damages and ongoing royalties, and obtain one or more licenses from third

parties, or be prohibited from selling our products.

We may not be able to obtain these licenses on acceptable terms, if at all.

incur substantial costs related to royalty payments for licenses obtained from third parties, which could negatively affect our financial

In addition, our agreements with some of our customers, suppliers or other entities with whom we do business require us to defend

or indemnify these parties to the extent they become involved in infringement claims, including the types of claims described above.

we are required or agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs

and expenses that could have a material adverse effect on our business, financial condition, and results of operations.

Other Risks Related to our Business

Our ability to use our

net operating loss carryforwards may be limited and may result in increased future tax liability to us.

We incurred net losses

in prior years but have sustained profitability for the last three years and expect to continue to remain profitable going forward.

As a result, we have released a portion of the valuation allowance related to our NOLs.

As of the fiscal year ended December 31,

2025, we had U.S.

federal and state net operating losses, or NOLs, of approximately $102.8 million and $78.0 million, respectively.

Subject to the

final two sentences of this paragraph, the federal and state NOL carryforwards will begin to expire, if not utilized, beginning in 2028

for certain states.

These NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities.

Under current

federal income tax law, federal NOLs incurred in tax years beginning after December 31, 2017 may be carried forward indefinitely, but

the deductibility of such federal NOLs is limited to 80% of Federal taxable income.

the extent that we continue to generate taxable losses, unused losses will carry forward to offset future taxable income, if any.

may be limited in the portion of NOL and tax credit carryforwards that we can use in the future to offset taxable income for U.S.

and state income tax purposes.

Sections 382 and 383 of Internal Revenue Code of 1986, or the Code, limit the use of NOLs and tax credits

after a cumulative change in corporate ownership of more than 50% occurs within a three-year period.

The limitation could prevent us

from using some or all of our NOLs and tax credits, as it places a formula limit of how much of our NOL and tax credit carryforwards

we would be permitted to use in a tax year.

The amount of the annual limitation, if any, will be determined based on the value of our

company immediately prior to an ownership change.

During the periods 2017 through 2019, the company experienced greater than 50% changes

in ownership and as a result, NOLs attributable to the pre-ownership change are subject to a substantial annual limitation under Section

382 of the Code due to the ownership changes.

The Company has adjusted their NOL carryforwards to address the impact of the Section 382

Subject to the final two sentences of this paragraph, the federal and state NOL carryforwards will begin to expire, if not utilized,

beginning in 2028 for certain states.

These NOL carryforwards could expire unused and be unavailable to offset future income tax

Under current federal income tax law, federal NOLs incurred in tax years beginning after December 31, 2017 may be

carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of Federal taxable income.

To the extent that we continue

to generate taxable losses, unused losses will carry forward to offset future taxable income, if any.

We may be limited in the portion

of NOL and tax credit carryforwards that we can use in the future to offset taxable income for U.S.

federal and state income tax purposes.

Sections 382 and 383 of Internal Revenue Code of 1986, or the Code, limit the use of NOLs and tax credits after a cumulative change in

corporate ownership of more than 50% occurs within a three-year period.

The limitation could prevent us from using some or all of our

NOLs and tax credits, as it places a formula limit of how much of our NOL and tax credit carryforwards we would be permitted to use in

The amount of the annual limitation, if any, will be determined based on the value of our company immediately prior to an

ownership change.

During the periods 2017 through 2019, the company experienced greater than 50% changes in ownership and as a result,

NOLs attributable to the pre-ownership change are subject to a substantial annual limitation under Section 382 of the Code due to the

ownership changes.

Federal Net Operating Losses of $66.5 million are subject to annual limitation for ownership changes and the Company

is utilizing $4.0 million during the current year.

The remaining $52.5 million of NOLs incurred post July 15, 2019 are not subject to

any annual limitation and can be carried forward indefinitely.

Subsequent ownership changes may further affect the limitation in future

In the event we have undergone or will undergo an ownership change under Section 382 of the Code, if we earn net taxable income,

our ability to use our pre-change NOL carryforwards to offset U.S.

federal taxable income may become subject to these limitations, which

could potentially result in increased future tax liability to us.

Comprehensive

tax reform could adversely affect our business and financial condition.

income, sales and use or other tax laws or regulations could be enacted at any time, which could adversely affect our business operations

and financial performance.

The Company has adjusted their NOL carryforwards to address the impact of the Section 382 ownership changes.

Net Operating Losses of $55.4 million are subject to annual limitation for ownership changes and the Company is utilizing none

during the current year.

The remaining $53.2 million of NOLs incurred post July 15, 2019 are not subject to any annual limitation and

can be carried forward indefinitely.

Subsequent ownership changes may further affect the limitation in future years.

In the event we have

undergone or will undergo an ownership change under Section 382 of the Code, if we earn net taxable income, our ability to use our pre-change

NOL carryforwards to offset U.S.

federal taxable income may become subject to these limitations, which could potentially result in increased

future tax liability to us.

Comprehensive tax reform

could adversely affect our business and financial condition.

New income, sales and use

or other tax laws or regulations could be enacted at any time, which could adversely affect our business operations and financial performance.

Further, existing tax laws and regulations could be interpreted, modified or applied adversely to us.

events could require us to pay additional taxes on a prospective or retroactive basis, as well as penalties, interest and other costs

for past amounts deemed to be due.

New laws, or laws that are changed, modified or newly interpreted or applied, also could increase

our compliance, operating and other costs, as well as the costs of our products.

Changes in corporate tax rates, the realization of net

operating losses, and other deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of

expenses could have a material impact on the value of our deferred tax assets and could increase our future tax expense.

We urge investors

to consult with their legal and tax advisers regarding the implications of potential changes in tax laws or regulations on an investment

in our common stock.

economic and political instability and geopolitical events could adversely affect our business, financial condition or results of operations.

business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions,

including as a result of an economic downturn and geopolitical events, such as changes in U.S.

federal policy that affect the geopolitical

Changes to 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, the U.S.

regulatory environment, inflation and other areas.

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.

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.

but also between the U.S.

and other countries in the international community.

In response to tariffs, other countries have implemented

retaliatory tariffs on U.S.

Political tensions as a result of trade policies could reduce trade volume, investment, technological

exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic

conditions and the stability of global financial markets.

Any changes in political, trade, regulatory, and economic conditions, including

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

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.

The global credit and financial markets have also generally experienced severe volatility and disruptions in the past

several years.

A severe or prolonged economic downturn, such as the global financial crisis, could result in a variety of risks to our

business, including our ability to raise additional capital when needed on acceptable terms, if at all.

There can be No assurance that

further deterioration in credit and financial markets and confidence in economic conditions will not occur.

weak or declining economy could also result in supply chain disruptions, volatile demand for our products, abrupt changes in our customers’

buying patterns, limitations on our customers’ access to financial resources and ability to satisfy obligations to us, or other

adverse impacts to our ability to place our Growth Direct systems.

Furthermore, although we do not have any customer or direct supplier

relationships in Ukraine, Russia or the Middle East at this time, the ongoing military conflicts in those regions and related sanctions,

as well as export controls or actions that may be initiated by nations including the United States, the European Union, Russia or other

jurisdictions, and other potential uncertainties could adversely affect our business and/or our supply chain, business partners or customers.

In the event geopolitical tensions fail to abate or deteriorate further, additional governmental sanctions may be enacted adversely impacting

the global economy, its banking and monetary systems, markets or customers for our products.

may acquire businesses or assets or make investments in other companies or testing, service or solution technologies that could harm

our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

part of our strategy, we may pursue acquisitions of synergistic businesses or other related assets.

If we make any further acquisitions,

we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent

Any future acquisition by us also could result in significant write-offs or the incurrence of debt and contingent liabilities,

any of which could harm our operating results and financial condition.

Integration of an acquired company or business will also likely

require management resources that otherwise would be available for ongoing development of our existing business.

We may not identify

or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits

of any acquisition.

To finance any acquisitions or investments, we may choose to issue shares of our common stock as consideration, which

would dilute the ownership of our stockholders.

If the price of our common stock is low or volatile, we may not be able to acquire other

companies for stock.

Alternatively, it may be necessary for us to raise additional funds for these activities through public or private

Additional funds may not be available on terms that are favorable to us, or at all.

If these funds are raised through the

sale of equity or convertible debt securities, dilution to our stockholders could result.

Consummating an acquisition poses a number

of risks including:

may not be able to accurately estimate the financial impact of an acquisition on our overall business;

acquisition may require us to incur debt or other obligations, incur large and immediate write-offs, issue capital stock potentially

dilutive to our stockholders or spend significant cash, or may negatively affect our operating results and financial condition;

we spend significant funds or incur additional debt or other obligations, our ability to obtain financing for working capital or

other purposes could decline;

than expected performance of an acquired business may result in the impairment of intangible assets;

may be unable to realize the anticipated benefits and synergies from acquisitions as a result of inherent risks and uncertainties,

including difficulties integrating acquired businesses or retaining key personnel, partners, customers or other key relationships,

and risks that acquired entities may not operate profitably or that acquisitions may not result in improved operating performance;

may fail to successfully manage relationships with customers, distributors and suppliers;

customers may not accept new molecular diagnostic tests;

may fail to effectively coordinate sales and marketing efforts of our acquired businesses;

may fail to combine product offerings and product lines of our acquired businesses timely and efficiently;

acquisition may involve unexpected costs or liabilities, including as a result of pending and future shareholder lawsuits relating

to acquisitions or exercise by stockholders of their statutory appraisal rights, or the effects of purchase accounting may be different

from our expectations;

acquisition may involve significant contingent payments that may adversely affect our future liquidity or capital resources;

for contingent payments requires significant judgment and changes to the assumptions used in determining the fair value of our contingent

payments could lead to significant volatility in earnings;

and subsequent integration of these companies may disrupt our business and distract our management from other responsibilities;

costs of an unsuccessful acquisition may adversely affect our financial performance.

risks of integration of an acquired business include:

information technology, internal control, financial reporting and record-keeping systems;

in accounting policies and procedures;

unanticipated

additional transaction and integration-related costs;

or operations of acquired businesses in remote locations and the inherent risks of operating in unfamiliar legal and regulatory environments;

products, including the risk that any underlying intellectual property associated with such products may not have been adequately

protected or that such products may infringe on the proprietary rights of others.

our information technology or communications systems fail or we experience a significant interruption in their operation, our reputation,

business and results of operations could be materially and adversely affected.

efficient operation of our business is dependent on our information technology and communications systems.

Increasingly, we are also

dependent upon our ability to electronically interface with our customers.

The failure of these systems to operate as anticipated could

disrupt our business and result in decreased revenue and increased overhead costs.

In addition, we do not have complete redundancy for

all of our systems and our disaster recovery planning cannot account for all eventualities.

Our information technology and communications

systems, including the information technology systems and services that are maintained by third party vendors, are vulnerable to damage

or interruption from natural disasters, fire, terrorist attacks, epidemics, pandemics including COVID-19, malicious attacks by computer

viruses or hackers, power loss, failure of computer systems, Internet, telecommunications or data networks.

Additionally, our services

are largely dependent on our partially internally developed and partially purchased Laboratory Information Management Systems or LIMS,

which is our automated basis of managing operations and storing data and customer information.

If these systems or services become unavailable

or suffer a security breach, or are uneconomical or impossible to update and modify, we may expend significant resources to address these

problems, and our reputation, business and results of operations could be materially and adversely affected.

Related To Our Common Stock Price

price and trading volume of our common stock may be highly volatile and could be further affected by events not within our control, and

an investment in our common stock could suffer a decline in value.

2024, our common stock traded at a low of $0.82 and a high of $3.54.

During 2023, our common stock traded at a low of $0.62 and a high

Volatility in our stock price or trading volume may be in response to various factors, some of which may be beyond our control.

In addition to the other factors discussed or incorporated by reference herein, factors that may cause fluctuations in our stock price

or trading volume, include, among others:

volatility in the trading markets;

impact of the delisting of our common stock from Nasdaq;

research and development results;

fluctuations in our quarterly operating results;

changes in our cash and cash equivalent reserves;

liquidity and ability to obtain additional capital, including the market’s reaction to any announced capital-raising transactions;

assessments of any announced strategic transaction, including the likelihood that it would be completed and the timing for completion;

negative market reaction to the terms or volume of any issuance of shares of our common stock, preferred stock or other securities

to new investors, pursuant to strategic or capital-raising transactions or to employees, directors or other service providers;

of substantial amounts of our common stock, or the perception that substantial amounts of our common stock may be sold, by stockholders

in the public market;

announcements

regarding our business or the business of our competitors;

Announcements

regarding CMS/Novitas reimbursement decisions of our PancraGEN product;

announcements

regarding our equity offerings;

actions by us or our competitors, such as acquisitions or restructurings;

and/or regulatory developments;

in revenue mix;

in revenue and revenue growth rates for us and for the industries in which we operate;

in accounting standards, policies, guidance, interpretations or principles;

or changes in opinions, ratings or earnings estimates made, or the failure to make, by brokerage firms or industry analysts relating

to the markets in which we operate or expect to operate;

market and economic conditions.

issuance of additional shares of our common stock in any future offerings could be dilutive to stockholders.

In order to raise additional

capital, such securities may be at prices that are not the same as the price per share in previous offerings.

We cannot assure investors

that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the

price per share paid by investors in previous offerings, and investors purchasing shares or other securities in the future could have

rights superior to existing stockholders.

Moreover, to the extent that we issue options or warrants to purchase, or securities convertible

into or exchangeable for, shares of our common stock in the future (including our Series C Preferred Stock), and those options, warrants

or other securities are exercised, converted or exchanged, stockholders may experience further dilution.

delisting of our common stock from Nasdaq and potential delisting from OTCQX ® has adversely affected our common stock

and business and financial condition.

February 25, 2020, our common stock was delisted from the Nasdaq Capital Market (“Nasdaq”) and commenced trading on the OTCQX ®

Best Market tier of the OTC Markets Group Inc.

(the “OTCQX”), an electronic quotation service operated by OTC Markets

in stock quoted on the OTCQX is often thin, volatile, and characterized by wide fluctuations in trading prices, due to many factors that

may have little to do with the issuer’s operations, results or business prospects.

The availability of buyers and sellers represented

by this volatility could lead to a market price for our Common Stock that is unrelated to operating performance.

Moreover, the OTCQX

is not a stock exchange, and trading of securities quoted on the OTCQX is often more volatile than the trading of securities listed on

a stock exchange like Nasdaq or the New York Stock Exchange.

The OTCQX quotation system may provide less liquidity than Nasdaq.

for securities traded solely on the OTCQX quotation system may be difficult to obtain, and holders of our common stock may be unable

to resell their shares at or near their original acquisition price or at any price.

Further, our delisting from Nasdaq and commencement

of trading on the OTCQX has and may continue to have negative implications, including an adverse effect on the price of our common stock,

increased volatility in our common stock, the loss of federal preemption of state securities laws, greater difficulty in raising capital

through the public or private sale of equity securities, deterring broker-dealers from making a market in or otherwise seeking or generating

interest in our common stock, a loss of current or future coverage by certain sell-side analysts, deterring certain institutions and

persons from investing in our securities at all and a loss of confidence of our customers, collaborators, vendors, suppliers and employees,

which could harm our business and future prospects.

December 28, 2023, we received notice from the OTCQX indicating that the Company’s market capitalization has been below the required

$5 million for 30 consecutive calendar days preceding the date of such notice, and that the Company no longer meets the standards for

continued qualification for the OTCQX U.S.

These events could require us to

pay additional taxes on a prospective or retroactive basis, as well as penalties, interest and other costs for past amounts deemed to

New laws, or laws that are changed, modified or newly interpreted or applied, also could increase our compliance, operating and

other costs, as well as the costs of our products.

Changes in corporate tax rates, the realization of net operating losses, and other

deferred tax assets relating to our operations, the taxation of foreign earnings, and the deductibility of expenses could have a material

impact on the value of our deferred tax assets and could increase our future tax expense.

We urge investors to consult with their legal

and tax advisers regarding the implications of potential changes in tax laws or regulations on an investment in our common stock.

Global economic and

political instability and geopolitical events could adversely affect our business, financial condition or results of operations.

Our business could be adversely

affected by unstable economic and political conditions within the United States and foreign jurisdictions, including as a result of an

economic downturn and geopolitical events, such as changes in U.S.

federal policy that affect the geopolitical landscape.

Changes to 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, the U.S.

environment, inflation and other areas.

For example, during the prior

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

During fiscal year 2025, new tariffs were imposed in the U.S.

for imports from a broad range of countries and materials.

Several countries

also implemented or proposed retaliatory tariffs on imports from the U.S., as well as other barriers to trade.

In February 2026, the U.S.

Supreme Court ruled that the President lacks authority under the International Emergency Economic Powers Act to impose tariffs, invalidating

certain tariffs that had been imposed pursuant to that statute.

As a result, certain tariffs imposed during fiscal year 2025 are no longer

being collected.

However, the ruling does not limit the ability of the U.S.

government to impose tariffs under other statutory authorities.

In response to the ruling, President Trump has announced new tariffs, including a global tariff of 10%imposed pursuant to a separate executive

order and trade authority.

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.

Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange

and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions

and the stability of global financial markets.

Any changes in political, trade, regulatory, and economic conditions, including U.S.

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

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

The global credit and financial markets have also generally experienced severe volatility and disruptions in the past several

A severe or prolonged economic downturn, such as the global financial crisis, could result in a variety of risks to our business,

including our ability to raise additional capital when needed on acceptable terms, if at all.

There can be no assurance that further deterioration

in credit and financial markets and confidence in economic conditions will not occur.

A weak or declining economy

could also result in supply chain disruptions, volatile demand for our products, abrupt changes in our customers’ buying patterns,

limitations on our customers’ access to financial resources and ability to satisfy obligations to us, or other adverse impacts to

our ability to place our Growth Direct systems.

Furthermore, although we do not have any customer or direct supplier relationships in

Ukraine, Russia or the Middle East at this time, the ongoing military conflicts in those regions and related sanctions, as well as export

controls or actions that may be initiated by nations including the United States, the European Union, Russia or other jurisdictions, and

other potential uncertainties could adversely affect our business and/or our supply chain, business partners or customers.

geopolitical tensions fail to abate or deteriorate further, additional governmental sanctions may be enacted adversely impacting the global

economy, its banking and monetary systems, markets or customers for our products.

We may acquire businesses

or assets or make investments in other companies or testing, service or solution technologies that could harm our operating results, dilute

our stockholders’ ownership, increase our debt or cause us to incur significant expense.

As part of our strategy, we

may pursue acquisitions of synergistic businesses or other related assets.

If we make any acquisitions, we may not be able to integrate

these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities.

Any future acquisition

by us also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could harm our operating

results and financial condition.

Integration of an acquired company or business will also likely require management resources that otherwise

would be available for ongoing development of our existing business.

We may not identify or complete these transactions in a timely manner,

on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition.

To finance any acquisitions

or investments, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders.

If the price of our common stock is low or volatile, we may not be able to acquire other companies for stock.

Alternatively, it may be

necessary for us to raise additional funds for these activities through public or private financings.

Additional funds may not be available

on terms that are favorable to us, or at all.

If these funds are raised through the sale of equity or convertible debt securities, dilution

to our stockholders could result.

Consummating an acquisition poses a number of risks including:

we may not be able to accurately estimate the financial impact of an acquisition on our overall business;

an acquisition may require us to incur debt or other obligations, incur large and immediate write-offs, issue capital stock potentially dilutive to our stockholders or spend significant cash, or may negatively affect our operating results and financial condition;

if we spend significant funds or incur additional debt or other obligations, our ability to obtain financing for working capital or other purposes could decline;

worse than expected performance of an acquired business may result in the impairment of intangible assets;

we may be unable to realize the anticipated benefits and synergies from acquisitions as a result of inherent risks and uncertainties, including difficulties integrating acquired businesses or retaining key personnel, partners, customers or other key relationships, and risks that acquired entities may not operate profitably or that acquisitions may not result in improved operating performance;

we may fail to successfully manage relationships with customers, distributors and suppliers;

our customers may not accept new molecular diagnostic tests;

we may fail to effectively coordinate sales and marketing efforts of our acquired businesses;

we may fail to combine product offerings and product lines of our acquired businesses timely and efficiently;

an acquisition may involve unexpected costs or liabilities, including as a result of pending and future shareholder lawsuits relating to acquisitions or exercise by stockholders of their statutory appraisal rights, or the effects of purchase accounting may be different from our expectations;

an acquisition may involve significant contingent payments that may adversely affect our future liquidity or capital resources;

accounting for contingent payments requires significant judgment and changes to the assumptions used in determining the fair value of our contingent payments could lead to significant volatility in earnings;

acquisitions and subsequent integration of these companies may disrupt our business and distract our management from other responsibilities;

the costs of an unsuccessful acquisition may adversely affect our financial performance.

Additional risks of integration

of an acquired business include:

differing information technology, internal control, financial reporting and record-keeping systems;

differences in accounting policies and procedures;

unanticipated additional transaction and integration-related costs;

facilities or operations of acquired businesses in remote locations and the inherent risks of operating in unfamiliar legal and regulatory environments;

new products, including the risk that any underlying intellectual property associated with such products may not have been adequately protected or that such products may infringe on the proprietary rights of others.

If our information technology

or communications systems fail or we experience a significant interruption in their operation, our reputation, business and results of

operations could be materially and adversely affected.

The efficient operation of

our business is dependent on our information technology and communications systems.

Increasingly, we are also dependent upon our ability

to electronically interface with our customers.

The failure of these systems to operate as anticipated could disrupt our business and

result in decreased revenue and increased overhead costs.

In addition, we do not have complete redundancy for all of our systems and our

disaster recovery planning cannot account for all eventualities.

Our information technology and communications systems, including the

information technology systems and services that are maintained by third party vendors, are vulnerable to damage or interruption from

natural disasters, fire, terrorist attacks, epidemics, pandemics including COVID-19, malicious attacks by computer viruses or hackers,

power loss, failure of computer systems, Internet, telecommunications or data networks.

Additionally, our services are largely dependent

on our partially internally developed and partially purchased Laboratory Information Management Systems or LIMS, which is our automated

basis of managing operations and storing data and customer information.

If these systems or services become unavailable or suffer a security

breach, or are uneconomical or impossible to update and modify, we may expend significant resources to address these problems, and our

reputation, business and results of operations could be materially and adversely affected.

Risks Related To Our Common Stock Price

The price and trading

volume of our common stock may be highly volatile and could be further affected by events not within our control, and an investment in

our common stock could suffer a decline in value.

During 2025, our common stock

traded at a low of $0.44 and a high of $2.70.

During 2024, our common stock traded at a low of $0.82 and a high of $3.54.

Volatility in

our stock price or trading volume may be in response to various factors, some of which may be beyond our control.

In addition to the other

factors discussed or incorporated by reference herein, factors that may cause fluctuations in our stock price or trading volume, include,

among others:

general volatility in the trading markets;

the impact of the delisting of our common stock from Nasdaq;

adverse research and development results;

significant fluctuations in our quarterly operating results;

significant changes in our cash and cash equivalent reserves;

our liquidity and ability to obtain additional capital, including the market’s reaction to any announced capital-raising transactions;

market assessments of any announced strategic transaction, including the likelihood that it would be completed and the timing for completion;

potential negative market reaction to the terms or volume of any issuance of shares of our common stock, preferred stock or other securities to new investors, pursuant to strategic or capital-raising transactions or to employees, directors or other service providers;

sales of substantial amounts of our common stock, or the perception that substantial amounts of our common stock may be sold, by stockholders in the public market;

announcements regarding our business or the business of our competitors;

announcements regarding our equity offerings;

strategic actions by us or our competitors, such as acquisitions or restructurings;

industry and/or regulatory developments;

changes in revenue mix;

changes in revenue and revenue growth rates for us and for the industries in which we operate;

changes in accounting standards, policies, guidance, interpretations or principles;

statements or changes in opinions, ratings or earnings estimates made, or the failure to make, by brokerage firms or industry analysts relating to the markets in which we operate or expect to operate;

general market and economic conditions.

The issuance of additional

shares of our common stock in any future offerings could be dilutive to stockholders.

The issuance of additional

shares of our common stock in any future offerings could be dilutive to stockholders.

In order to raise additional capital, such securities

may be at prices that are not the same as the price per share in previous offerings.

We cannot assure investors that we will be able to

sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by

investors in previous offerings, and investors purchasing shares or other securities in the future could have rights superior to existing

stockholders.

Moreover, to the extent that we issue options or warrants to purchase, or securities convertible into or exchangeable for,

shares of our common stock in the future, and those options, warrants or other securities are exercised, converted or exchanged, stockholders

may experience further dilution.

The delisting of our

common stock from Nasdaq has adversely affected our common stock and business and financial condition.

On February 25, 2021, our

common stock was delisted from the Nasdaq Capital Market (“Nasdaq”) and commenced trading on the OTCQX ® Best

Market tier of the OTC Markets Group Inc.

(the “OTCQX”), an electronic quotation service operated by OTC Markets Group Inc.

On May 20, 2025, we received

notice from the OTCQX indicating that the Company’s market capitalization has stayed below the required $5 million for 30 consecutive

calendar days preceding the date of such notice, and that the Company no longer meets the standards for continued qualification for the

tier under the OTCQX Rules for U.S.

Companies section 3.2.b.2.

On March 20, 2024 we received

notice from the OTCQX indicating that the Company’s market capitalization has stayed above the required $5 million for ten consecutive

trading days preceding the date of such notice, and that the Company currently satisfies the standards for continued qualification for

the OTCQX U.S.

tier under the OTCQX Rules for U.S.

from the OTCQX could adversely affect our ability to raise additional financing through public or private sales of equity securities,

would significantly affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our

Common Stock.

Delisting could also have other negative results, including the potential loss of confidence by employees and customers,

the loss of institutional investor interest and fewer business development opportunities.

The Company may seek an uplisting of its common

stock to Nasdaq, but no assurances can be given that a Nasdaq listing will be achieved.

risks associated with penny stock classification could affect the marketability of the Company’s common stock and stockholders

could find it difficult to sell their shares.

the Company’s shares of Common Stock do not maintain a trading price of $5.00 or more per share, the Company’s common stock

will be subject to “penny stock” rules as defined in Exchange Act Rule 3a51-1.

The SEC adopted rules that regulate broker-dealer

practices in connection with transactions in penny stocks.

Transaction costs associated with purchases and sales of penny stocks are

likely to be higher than those for other securities.

The Company’s common stock was removed from being quoted

on the OTCQX on August 18, 2025.

In August 2025, the Company

was approved to have its common stock quoted on the OTCID ® tier of the OTC Markets Group Inc.

(the “OTCQX”),

an electronic quotation service operated by OTC Markets Group Inc.

The trading of the Company’s common stock commenced on OTCID

at the open of business on August 18, 2025 under the trading symbol IDXG.

Trading in stock quoted on

the OTCID is often thin, volatile, and characterized by wide fluctuations in trading prices, due to many factors that may have little

to do with the issuer’s operations, results or business prospects.

The availability of buyers and sellers represented by this volatility

could lead to a market price for our Common Stock that is unrelated to operating performance.

Moreover, the OTCID is not a stock exchange,

and trading of securities quoted on the OTCID is often more volatile than the trading of securities listed on a stock exchange like Nasdaq

or the New York Stock Exchange.

The OTCID quotation system may provide less liquidity than Nasdaq.

Prices for securities traded

solely on the OTCID quotation system may be difficult to obtain, and holders of our common stock may be unable to resell their shares

at or near their original acquisition price or at any price.

Further, our delisting from Nasdaq and commencement of trading on the OTCID

has and may continue to have negative implications, including an adverse effect on the price of our common stock, increased volatility

in our common stock, the loss of federal preemption of state securities laws, greater difficulty in raising capital through the public

or private sale of equity securities, deterring broker-dealers from making a market in or otherwise seeking or generating interest in

our common stock, a loss of current or future coverage by certain sell-side analysts, deterring certain institutions and persons from

investing in our securities at all and a loss of confidence of our customers, collaborators, vendors, suppliers and employees, which could

harm our business and future prospects.

Delisting from Nasdaq has

adversely affected our ability to raise additional financing through public or private sales of equity securities, could significantly

affect the ability of investors to trade our securities and could negatively affect the value and liquidity of our Common Stock.

could also have other negative results, including the potential loss of confidence by employees and customers, the loss of institutional

investor interest and fewer business development opportunities.

The Company may seek an uplisting of its common stock to Nasdaq, but no

assurances can be given that a Nasdaq listing will be achieved.

The risks associated

with penny stock classification could affect the marketability of the Company’s common stock and stockholders could find it difficult

to sell their shares.

If the Company’s shares

of Common Stock do not maintain a trading price of $5.00 or more per share, the Company’s common stock will be subject to “penny

stock” rules as defined in Exchange Act Rule 3a51-1.

The SEC adopted rules that regulate broker-dealer practices in connection with

transactions in penny stocks.

Transaction costs associated with purchases and sales of penny stocks are likely to be higher than those

for other securities.

Penny stocks generally are equity securities with a price of less than $5.00.

penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a

standardized risk disclosure document that provides information about penny stocks and the nature and level of risks in the penny stock

The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation

of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock

held in the customer’s account.

The bid and offer quotations, and the broker-dealer and salesperson compensation information, must

be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before

or with the customer’s confirmation.

addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from such rules;

the broker-dealer

must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s

written agreement to the transaction.

These disclosure requirements may have the effect of reducing the level of trading activity in

the secondary market for the Company’s common stock and stockholders may find it more difficult to sell their shares.

Relating to Being a Public Company

will continue to incur increased costs and demands on management as a result of compliance with laws and regulations applicable to public

companies, which could harm our operating results.

a public company, we are incurring significant legal, accounting and other expenses.

In addition to being required to comply with certain

requirements of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act), we are required to comply with certain requirements of the Dodd

Frank Wall Street Reform and Consumer Protection Act, as well as rules and regulations subsequently implemented by the SEC, including

the establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.

that compliance with these requirements will continue to increase our legal and financial compliance costs and will make some activities

more time consuming and costly.

In addition, we expect that our management and other personnel will continue to need to divert attention

from operational and other business matters to devote substantial time to these public company requirements.

example, in 2020, our Audit Committee conducted an independent investigation in accordance with Section 10A of the Exchange Act into

complaints of certain employment and billing and compliance matters and concluded that the allegations made in the complaints were unsubstantiated

and that there was no evidence of any illegal acts.

The completion of the investigation caused us to be late in filing our Quarterly

Report on Form 10-Q for the quarter ended June 30, 2020.

also spent considerable management time in connection with our restatement of previously issued financial statements contained in our

Annual Reports on Form 10-K for the years ended December 31, 2014 through 2019 as well as the financial statements contained in the Quarterly

Reports on Form 10-Q for each quarterly period within those fiscal years as well as the quarterly periods ended March 31, 2020 and June

This was due to evaluating and recording an impairment charge and amortization expense relating to our BarreGen asset, as disclosed

in Item 9A of our Report on Form 10-K for the fiscal year 2021.

the Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting and disclosure

controls and procedures.

In particular, we must perform system and process evaluation and testing of our internal control over financial

reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section

404 of the Sarbanes-Oxley Act.

In addition, if we lose our status as a “smaller reporting company,” we will be required to

have our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting.

Our compliance with Section 404 of the Sarbanes-Oxley Act, as applicable, requires us to incur substantial accounting expense and expend

significant management efforts.

We currently do not have an internal audit group, and we will need to continue to hire additional accounting

and financial staff with appropriate public company experience and technical accounting knowledge.

If we or our independent registered

public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses,

such as the material weakness described in Item 9A of this report, the market price of our stock could decline and we could be subject

to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

we are unable to maintain and implement effective internal controls over financial reporting, investors may lose confidence in the accuracy

and completeness of our reported financial information and the market price of our common stock may be negatively affected.

a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such

internal control.

See the material weakness described in Item 9A.

Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate

and determine the effectiveness of our internal control over financial reporting and provide a management report on our internal controls

on an annual basis.

If we have material weaknesses in our internal control over financial reporting, we may not detect errors on a timely

basis and our financial statements may be materially misstated.

We will need to maintain and enhance these processes and controls as

we grow, and we will require additional management and staff resources to do so.

Additionally, even if we conclude our internal controls

are effective for a given period, we may in the future identify one or more material weaknesses in our internal controls, in which case

our management will be unable to conclude that our internal control over financial reporting is effective.

Even if our management concludes

that our internal control over financial reporting is effective, our independent registered public accounting firm may conclude that

there are material weaknesses with respect to our internal controls or the level at which our internal controls are documented, designed,

implemented or reviewed.

we are unable to conclude that our internal control over financial reporting is effective, investors could lose confidence in the accuracy

and completeness of our financial disclosures, which could cause the price of our common stock to decline.

Irrespective of compliance

with Section 404, any failure of our internal control over financial reporting could have a material adverse effect on our reported operating

results and harm our reputation.

The penny stock rules require

a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure

document that provides information about penny stocks and the nature and level of risks in the penny stock market.

The broker-dealer also

must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson

in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account.

The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or

in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer’s confirmation.

In addition, the penny stock

rules require that prior to a transaction in a penny stock not otherwise exempt from such rules;

the broker-dealer must make a special

written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement

to the transaction.

These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market

for the Company’s common stock and stockholders may find it more difficult to sell their shares.

Risks Relating to Being a Public Company

We will continue to

incur increased costs and demands on management as a result of compliance with laws and regulations applicable to public companies, which

could harm our operating results.

As a public company, we are

incurring significant legal, accounting and other expenses.

In addition to being required to comply with certain requirements of the Sarbanes-Oxley

Act of 2002 (the Sarbanes-Oxley Act), we are required to comply with certain requirements of the Dodd Frank Wall Street Reform and Consumer

Protection Act, as well as rules and regulations subsequently implemented by the SEC, including the establishment and maintenance of effective

disclosure and financial controls and changes in corporate governance practices.

We expect that compliance with these requirements will

continue to increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

we expect that our management and other personnel will continue to need to divert attention from operational and other business matters

to devote substantial time to these public company requirements.

For example, in 2020, our

Audit Committee conducted an independent investigation in accordance with Section 10A of the Exchange Act into complaints of certain employment

and billing and compliance matters and concluded that the allegations made in the complaints were unsubstantiated and that there was no

evidence of any illegal acts.

The completion of the investigation caused us to be late in filing our Quarterly Report on Form 10-Q for

the quarter ended June 30, 2020.

We also spent considerable

management time in connection with our restatement of previously issued financial statements contained in our Annual Reports on Form 10-K

for the years ended December 31, 2014 through 2019 as well as the financial statements contained in the Quarterly Reports on Form 10-Q

for each quarterly period within those fiscal years as well as the quarterly periods ended March 31, 2020 and June 30, 2020.

due to evaluating and recording an impairment charge and amortization expense relating to our BarreGen asset, as disclosed in Item 9A

of our Report on Form 10-K for the fiscal year 2021.

Further, the Sarbanes-Oxley

Act requires, among other things, that we maintain effective internal control over financial reporting and disclosure controls and procedures.

In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management

to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.

In addition, if we lose our status as a “smaller reporting company,” we will be required to have our independent registered

public accounting firm attest to the effectiveness of our internal control over financial reporting.

Our compliance with Section 404 of

the Sarbanes-Oxley Act, as applicable, requires us to incur substantial accounting expense and expend significant management efforts.

We currently do not have an internal audit group, and we will need to continue to hire additional accounting and financial staff with

appropriate public company experience and technical accounting knowledge.

If we or our independent registered public accounting firm identify

deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, such as the material weakness

described in Item 9A of this report, the market price of our stock could decline and we could be subject to sanctions or investigations

by the SEC or other regulatory authorities, which would require additional financial and management resources.

If we are unable to

maintain and implement effective internal controls over financial reporting, investors may lose confidence in the accuracy and completeness

of our reported financial information and the market price of our common stock may be negatively affected.

As a public company, we are

required to maintain internal control over financial reporting and to report any material weaknesses in such internal control.

material weakness described in Item 9A.

Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate and determine the effectiveness

of our internal control over financial reporting and provide a management report on our internal controls on an annual basis.

material weaknesses in our internal control over financial reporting, we may not detect errors on a timely basis and our financial statements

may be materially misstated.

We will need to maintain and enhance these processes and controls as we grow, and we will require additional

management and staff resources to do so.

Additionally, even if we conclude our internal controls are effective for a given period, we

may in the future identify one or more material weaknesses in our internal controls, in which case our management will be unable to conclude

that our internal control over financial reporting is effective.

Even if our management concludes that our internal control over financial

reporting is effective, our independent registered public accounting firm may conclude that there are material weaknesses with respect

to our internal controls or the level at which our internal controls are documented, designed, implemented or reviewed.

If we are unable to conclude

that our internal control over financial reporting is effective, investors could lose confidence in the accuracy and completeness of our

financial disclosures, which could cause the price of our common stock to decline.

Irrespective of compliance with Section 404, any failure

of our internal control over financial reporting could have a material adverse effect on our reported operating results and harm our reputation.

Internal control deficiencies could also result in a restatement of our financial results.

reached a determination to restate certain of our previously issued consolidated financial statements as a result of the identification

of errors in previously issued consolidated financial statements, which resulted in unanticipated costs and may affect investor confidence

and raise reputational issues.

discussed in the Explanatory Note, in Note 2 of our consolidated financial statements, Restatement of Previously Issued Consolidated

Financial Statements , and in Note 22, Restatement of Unaudited Quarterly Results , in this Annual Report on Form 10-K for the

year ended December 31, 2024, we reached a determination to restate certain of our historical consolidated financial statements and related

disclosures for the periods disclosed in those notes after identifying errors in our accounting treatment of accrued royalty expenses.

The restatement also included corrections for previously identified immaterial errors in the impacted periods.

As a result, we have incurred

unanticipated costs for accounting and legal fees in connection with or related to the restatement, and have become subject to

a number of additional risks and uncertainties, which may affect investor confidence in the accuracy of our financial disclosures and

may raise reputational risks for our business, both of which could harm our business and financial results.

Relating to Our Corporate Structure and Our Common Stock

have a substantial number of authorized shares of common and preferred stock available for future issuance that could cause dilution

of our stockholders’ interest, adversely impact the rights of holders of our common stock and cause our stock price to decline.

have a total of 100,000,000 shares of common stock and 5,000,000 shares of preferred stock authorized for issuance.

As of December 31,

2024, we had 95,460,337 shares of common stock and 4,953,000 shares of preferred stock available for issuance.

As of December 31, 2024,

we have reserved 481,494 shares of our common stock for issuance under our 2019 Equity Incentive Plan, 1,000,007 shares of our common

stock for issuance under our Employee Stock Purchase Plan and 1,796,268 additional shares available for future grants of awards under

our 2019 Equity Incentive Plan.

As of December 31, 2024, the aggregate number of shares of common stock that may be issued through conversion

of all of the outstanding Series C Preferred Stock is 23,267,326.

Provided that we have a sufficient number of unreserved authorized

capital stock available, we may seek financing that could result in the issuance of additional shares of our capital stock and/or rights

to acquire additional shares of our capital stock.

We may also make acquisitions that result in issuances of additional shares of our

capital stock.

Those additional issuances of capital stock could result in substantial dilution of our existing stockholders.

the book value per share of our common stock may be reduced.

This reduction would occur if the exercise price of any issued warrants,

the conversion price of any convertible notes or the conversion ratio of any issued preferred stock is lower than the book value per

share of our common stock at the time of such exercise or conversion.

Additionally, new investors in any subsequent issuances of our

securities could gain rights, preferences and privileges senior to those of holders of common stock.

addition of a substantial number of shares of our common stock into the market or the registration of any of our other securities under

the Securities Act may significantly and negatively affect the prevailing market price for our common stock.

The future sales of shares

of our common stock issuable upon the exercise of outstanding warrants and options may have a depressive effect on the market price of

our common stock, as such warrants and options would be more likely to be exercised at a time when the price of our common stock is greater

than the exercise price.

weakness in our disclosure controls and procedures and our internal controls could have a material adverse effect on us .

discussed in “Item 9A-Controls and Procedures,” our senior management has identified material weaknesses in our disclosure

controls and procedures and our internal controls over financial reporting.

We cannot assure you that additional material weaknesses

will not be identified in the future.

Any such failure could adversely affect our ability to report financial results on a timely and

accurate basis, which could have other material effects on our business, reputation, results of operations, financial condition or liquidity.

If we do not effectively remediate the material weakness or if we otherwise fail to maintain effective internal control over financial

reporting, our ability to report our financial results on a timely and on an accurate basis could be impaired, which may cause investors

to lose confidence in our reported financial information which could adversely affect the market price of our common stock.

have anti-takeover defenses that could delay or prevent an acquisition and could adversely affect the price of our common stock.

certificate of incorporation, as amended, and amended and restated bylaws include provisions, such as providing for three classes of

directors, which may make it more difficult to remove our directors and management and may adversely affect the price of our common stock.

In addition, our certificate of incorporation, as amended, authorizes the issuance of “blank check” preferred stock, which

allows our Board to create one or more classes of preferred stock with rights and preferences greater than those afforded to the holders

of our common stock without separate shareholder approval.

This provision could have the effect of delaying, deterring or preventing

a future takeover or a change in control, unless the takeover or change in control is approved by our Board.

We are also subject to laws

that may have a similar effect.

For example, Section 203 of the General Corporation Law of the State of Delaware prohibits us from engaging

in a business combination with an interested stockholder for a period of three years from the date the person became an interested stockholder

unless certain conditions are met.

As a result of the foregoing, it will be difficult for another company to acquire us and, therefore,

could limit the price that possible investors might be willing to pay in the future for shares of our common stock.

In addition, the

rights of our common stockholders are subject to, and may be adversely affected by, the rights of holders of any class or series of preferred

stock that may be issued in the future and by the rights of holders of warrants issued in the future.

may be subject to securities litigation, which is expensive and could divert our management’s attention.

market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their

securities have been subject to securities class action litigation.

Risks Relating to Our Corporate Structure and

Our Common Stock

We have a substantial

number of authorized shares of common and preferred stock available for future issuance that could cause dilution of our stockholders’

interest, adversely impact the rights of holders of our common stock and cause our stock price to decline.

We have a total of 100,000,000

shares of common stock and 5,000,000 shares of preferred stock authorized for issuance.

As of December 31, 2025, we had 95,430,667 shares

of common stock and 4,953,000 shares of preferred stock available for issuance.

As of December 31, 2025, we have reserved 396,222 shares

of our common stock for issuance under our 2019 Equity Incentive Plan, 1,000,007 shares of our common stock for issuance under our Employee

Stock Purchase Plan and 1,851,870 additional shares available for future grants of awards under our 2019 Equity Incentive Plan.

December 31, 2025, the aggregate number of shares of common stock that may be issued through conversion of all of the outstanding Series

C Preferred Stock was 23,267,326.

On January 20, 2026, all shares of Series C Preferred Stock were converted into common stock.

that we have a sufficient number of unreserved authorized capital stock available, we may seek financing that could result in the issuance

of additional shares of our capital stock and/or rights to acquire additional shares of our capital stock.

We may also make acquisitions

that result in issuances of additional shares of our capital stock.

Those additional issuances of capital stock could result in substantial

dilution of our existing stockholders.

Furthermore, the book value per share of our common stock may be reduced.

This reduction would

occur if the exercise price of any issued warrants, the conversion price of any convertible notes or the conversion ratio of any issued

preferred stock is lower than the book value per share of our common stock at the time of such exercise or conversion.

Additionally, new

investors in any subsequent issuances of our securities could gain rights, preferences and privileges senior to those of holders of common

The addition of a substantial

number of shares of our common stock into the market or the registration of any of our other securities under the Securities Act may significantly

and negatively affect the prevailing market price for our common stock.

The future sales of shares of our common stock issuable upon the

exercise of yet to be issued warrants and options may have a depressive effect on the market price of our common stock, as such warrants

and options would be more likely to be exercised at a time when the price of our common stock is greater than the exercise price.

Any weakness in our disclosure controls

and procedures and our internal controls could have a material adverse effect on us .

As discussed in “Item

9A-Controls and Procedures,” our senior management had identified material weaknesses in our disclosure controls and procedures

and our internal controls over financial reporting in 2024.

We cannot assure you that additional material weaknesses will not be identified

in the future.

Any such failure could adversely affect our ability to report financial results on a timely and accurate basis, which could

have other material effects on our business, reputation, results of operations, financial condition or liquidity.

If we fail to maintain effective internal control over financial reporting, our ability to

report our financial results on a timely and on an accurate basis could be impaired, which may cause investors to lose confidence in our

reported financial information which could adversely affect the market price of our common stock.

We have anti-takeover

defenses that could delay or prevent an acquisition and could adversely affect the price of our common stock.

Our certificate of incorporation,

as amended, and amended and restated bylaws include provisions, such as providing for three classes of directors, which may make it more

difficult to remove our directors and management and may adversely affect the price of our common stock.

In addition, our certificate

of incorporation, as amended, authorizes the issuance of “blank check” preferred stock, which allows our Board to create one

or more classes of preferred stock with rights and preferences greater than those afforded to the holders of our common stock without

separate shareholder approval.

This provision could have the effect of delaying, deterring or preventing a future takeover or a change

in control, unless the takeover or change in control is approved by our Board.

We are also subject to laws that may have a similar effect.

For example, Section 203 of the General Corporation Law of the State of Delaware prohibits us from engaging in a business combination

with an interested stockholder for a period of three years from the date the person became an interested stockholder unless certain conditions

As a result of the foregoing, it will be difficult for another company to acquire us and, therefore, could limit the price that

possible investors might be willing to pay in the future for shares of our common stock.

In addition, the rights of our common stockholders

are subject to, and may be adversely affected by, the rights of holders of any class or series of preferred stock that may be issued in

the future and by the rights of holders of warrants issued in the future.

We may be subject to

securities litigation, which is expensive and could divert our management’s attention.

The market price of our securities

may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject

to securities class action litigation.

We may be the target of this type of litigation in the future.

litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which

could seriously harm our business.

indemnification rights provided to our directors, officers and employees may result in substantial expenditures by us and may discourage

lawsuits against its directors, officers, and employees.

certificate of incorporation, as amended, contains provisions permitting us to enter into indemnification agreements with our directors,

officers, and employees.

The foregoing indemnification obligations could result in us incurring substantial expenditures to cover the

cost of settlement or damage awards against directors and officers, which we may be unable to recoup.

These provisions and resultant

costs may also discourage us from bringing a lawsuit against our directors and officers for breaches of their fiduciary duties and may

similarly discourage the filing of derivative litigation by our stockholders against our directors and officers even though such actions,

if successful, might otherwise benefit us and our stockholders.

Securities litigation against us

could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm

our business.

The indemnification

rights provided to our directors, officers and employees may result in substantial expenditures by us and may discourage lawsuits against

its directors, officers, and employees.

Our certificate of incorporation,

as amended, contains provisions permitting us to enter into indemnification agreements with our directors, officers, and employees.

foregoing indemnification obligations could result in us incurring substantial expenditures to cover the cost of settlement or damage

awards against directors and officers, which we may be unable to recoup.

These provisions and resultant costs may also discourage us from

bringing a lawsuit against our directors and officers for breaches of their fiduciary duties and may similarly discourage the filing of

derivative litigation by our stockholders against our directors and officers even though such actions, if successful, might otherwise

benefit us and our stockholders.

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