What changed in this filing

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Item 1A. Risk Factors

2023-03-27 compared with 2022-03-31 · 380 added, 600 removed, 1356 unchanged (42% of the section changed)

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others, the following key risks:

operating history of net losses, negative working capital and insufficient cash flows, and

lack of liquidity to pay our current obligations raise doubts about our ability to continue

as a going concern.

COVID-19 global pandemic may continue to materially and adversely impact our business, financial condition and results of operations.

have and may continue to experience intangible asset or other long-lived asset impairment charges.

have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess

our future viability.

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.

results of operations have been adversely affected and, in the future, could be materially adversely impacted by the COVID-19 virus.

war between Russia and Ukraine could materially adversely affect our business, results of operations, and financial condition.

have a history of operating losses, and our clinical services have generated limited revenue.

We may continue to incur net losses

for the foreseeable future and may never achieve or sustain profitability.

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.

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.

rely on third-parties to process and transmit claims to payers for our clinical services, and any delay in processing or transmitting

could have an adverse effect on our revenue and financial condition.

to how we recognize revenue, our quarterly revenue and operating results are likely to fluctuate.

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and results of operations.

depend on sales and reimbursements from our clinical services for more than 50% 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.

private equity firms and their affiliates’ control, on an as-converted basis, an aggregate of 65% of our outstanding

shares of common stock through their holdings of our Series B Preferred Stock, and this concentration of ownership along with their

authority for designation rights for a majority of our directors and their right to approve certain of our actions has a substantial

influence on our decisions.

Our secured lenders have the right to foreclose on substantially

all of our assets if we are unable to timely repay our outstanding obligations.

we are unable to timely repay our outstanding obligations, our secured lenders will have the right to foreclose on our assets.

private equity firms and their affiliates’ control, on an as-converted basis, an aggregate of 64.5% of our outstanding shares

of common stock through their holdings of our Series B Preferred Stock, which has a liquidation preference in the event of a sale

of the Company, and this concentration of ownership along with their authority for designation rights for a majority of our directors

and their right to approve certain of our actions has a substantial influence on our decisions.

for our clinical services tests is complex, and we must dedicate substantial time and resources to the billing process to be paid

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could be compromised.

Our reliance on Medicare reimbursement for our clinical services and our being subject to decisions of the

Center for Medicare and Medicaid Services (“CMS”) regarding reimbursement and pricing of our clinical services which

could have a material adverse effect on our business and financial results, which has temporarily had a material adverse effect on

our business due to a new billing policy issued by CMS in January 2022 whereby CMS stated they would no longer reimburse for the

use of the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier

for the same beneficiary on the same date of service;

while this decision was subsequently reversed in February 2022, the Company

has not yet realized the full cash collection benefit of current and retroactive Thyroid testing and such cash collections may be

temporarily reduced or delayed until we resolved the matter with CMS;

rely on third-parties to process and transmit claims to payers for our clinical services, and any delay in processing or transmitting

could have an adverse effect on our revenue and financial condition.

may experience a decline in demand for our clinical services tests and/or our pharma services products, which may result in a reduction

we are unable to increase sales of our clinical services and the tests and services in our pharma services, we may be unable to achieve

profitability.

may experience a reduction in revenue if physicians or patients decide not to order our clinical services tests.

profitability will be impaired by our obligations to make royalty and milestone payments to our licensors for our clinical services

depend on third parties for the supply of some of the materials used in our clinical and pharma services tests, and we may not be

able to find replacements or transition to alternative suppliers in a timely manner.

markets that our clinical services and pharma services operate in is competitive, and our ability to compete successfully in this

market depends on a variety of reasons, including our ability to keep up with rapid technological, medical, and scientific changes

or our ability to enter into new clinical study collaborations.

If we are unable to compete successfully in the markets our clinical

services and pharma services operate in, we may be unable to increase or sustain our revenue or achieve profitability.

the FDA changes its enforcement policy as to laboratory developed tests (LDTs) or disagrees with our position that our clinical services

tests are LDTs covered by the FDA’s current enforcement discretion policy, we could be subject to a number of enforcement actions,

any of which could have a material adverse effect on our clinical services and/or incur substantial costs and delays associated with

trying to obtain pre-market clearance or approval and comply with applicable post-market requirements.

failure to comply with federal and state laws and regulations, including but not limited to those laws related to billing practices,

fraud, abuse, and payer regulations, could result in our being excluded from participation in Medicare, Medicaid or other governmental

payer programs and/or significant monetary fines, and additionally may decrease our revenues and adversely affect our results of

operations and financial condition for our clinical services.

may not realize all of the anticipated benefits of the acquisition of our pharma services or those benefits may take longer to realize

than expected.

we are unable to successfully utilize, integrate, and/or promote our pharma services in the market, we may be unable to generate

sufficient revenue to sustain our pharma services.

we fail to perform our pharma services in accordance with contractual and regulatory requirements, and ethical considerations, we

could be subject to significant costs, legal liabilities and could experience a decline in revenue.

rely on sole suppliers for some of the materials used in our tests and services, and we may not be able to find replacements or transition

to alternative suppliers in a timely manner.

the FDA changes its enforcement policy as to LDTs or disagrees with our position that our clinical services tests are LDTs covered

by the FDA’s current enforcement discretion policy, we could be subject to a number of enforcement actions, any of which could

have a material adverse effect on our clinical services and/or incur substantial costs and delays associated with trying to obtain

pre-market clearance or approval and comply with applicable post-market requirements.

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

we are unable to compete successfully in the markets our clinical services operate in, we may be unable to increase or sustain our

revenue or achieve profitability.

we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to perform our tests

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healthcare system may have a material adverse effect on our financial condition and operations.

failure to comply with federal and state laws and regulations pertaining to our payment practices could result in substantial penalties.

we do not increase our revenues and successfully manage the size of our operations, our business, financial condition and results

of operations could be materially and adversely affected.

delisting of our common stock from Nasdaq and subsequent trading on OTCQX ® has adversely affected our common stock

and business and financial condition.

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.

believe the delisting of our common stock from Nasdaq and trading on OTCQX ® has adversely affected trading in our

common stock and our ability to seek financing.

we are unable to maintain and implement effective internal controls over financial reporting, investors may lose confidence in the

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Related to our Business

There are substantial

doubts about our ability to continue as a going concern 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

Our ability to become a profitable

operating company is dependent upon our ability to generate revenues and/or obtain financing adequate to support our cost structure.

We do not currently have enough cash on hand to meet our obligations over the next twelve months, and we cannot provide our stockholders

any assurance that we will be able to raise sufficient funding from the generation of revenue, the sale of our common stock, or through

financing to sustain us over the next twelve months.

For the fiscal year ended

December 31, 2021, we had an operating loss of $14.0 million.

As of December 31, 2021, we had cash and cash equivalents of $3.1 million

and current liabilities of $15.7 million.

The Company must fund its operating deficit until a sustainable level of revenue is achieved.

These factors have raised substantial doubts about our ability to continue as a going concern.

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, the doubts raised, relating

to our ability to continue as a going concern, may make investing in our securities an unattractive investment for potential investors.

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

results of operations have been adversely affected and, in the future, could be materially adversely impacted by the coronavirus (COVID-19)

world is currently suffering a COVID-19 pandemic which has resulted in governments around the world implementing stringent measures to

help control the spread of the virus, including stay-at-home orders, temporarily closing businesses, restricting gatherings, restricting

travel, and mandating social distancing and face coverings.

The continuing impact that the COVID-19 pandemic will have on our operations,

including duration, severity and scope, remains highly uncertain and cannot be fully predicted at this time.

Such impact is a function

of the scope of any new virus mutations and outbreaks, the nature of government public health guidelines and the public’s adherence

to those guidelines, the rate of individuals becoming fully vaccinated, the public’s adherence to guidelines to receive booster shots,

the success of business and economic recovery as the pandemic recedes, unemployment levels, the extent to which new shutdowns may be

needed and the impact of any further government economic relief on the U.S.

In particular, the continued spread of the coronavirus

globally is adversely affecting global economies and financial markets which has materially and adversely impacted our operations including,

without limitation, the functioning of our laboratories, the availability of supplies including reagents, the progress and data collection

of our pharma services, demand for our services and travel, customer demand and employee health and availability.

Further, the impact

of the COVID-19 pandemic in part caused us to reevaluate the carrying charge of our intangible assets and led us to restate certain of

our financial statements to record impairment charges and amortization expense.

While we believe we have generally recovered from the

adverse impact that the COVID-19 pandemic had on our business during 2020, we believe that the COVID-19 pandemic could continue to adversely

impact our results of operations, cash flows and financial condition in the future.

ongoing military conflict between Russia and Ukraine has caused geopolitical instability, economic uncertainty, financial markets volatility

and capital markets disruption.

Our business, financial condition and results of operations may be materially adversely affected by any

negative impact on the capital markets resulting from the conflict in Ukraine or any other geopolitical tensions.

late February 2022, Russia invaded Ukraine, significantly amplifying already existing geopolitical tensions among Russia and other countries

in the region and in the west, including the U.S.

Russia’s invasion, the responses of countries and political bodies to Russia’s

actions, the larger overarching tensions, and Ukraine’s military response and the potential for wider conflict have resulted in

financial market volatility and capital markets disruption, potentially increasing in magnitude, and could have severe adverse effects

on regional and global economic markets and international relations.

The extent and duration of the military action, sanctions and resulting

market disruptions are impossible to predict, but could be substantial.

Russia’s actions, various countries, including the U.S., Canada and the United Kingdom, as well as the European Union, issued broad-ranging

economic sanctions against Russia.

Such sanctions included, among other things, a prohibition on doing business with certain Russian

companies, officials and oligarchs;

a commitment by certain countries and the European Union to remove selected Russian banks from the

Society for Worldwide Interbank Financial Telecommunications (SWIFT) electronic banking network that connects banks globally;

Russian oil and gas imports to the U.S.;

and restrictive measures to prevent the Russian Central Bank from undermining the impact of

the sanctions.

The current sanctions (and potential further sanctions in response to continued Russian military activity) and other actions

may have adverse effects on regional and global economic markets and lead to instability and lack of liquidity in capital markets, potentially

making it more difficult for us to obtain additional funds and increasing the volatility of our stock price.

Any of the abovementioned

factors could affect our business, prospects, financial condition, and operating results.

that we have taken to restructure our business to strengthen the Company’s profile, enhance shareholder values, and increase

revenue growth may not be as effective as anticipated.

Fiscal 2020 and 2021, we implemented certain restructuring

and reprioritization plans to strengthen the Company’s profile, enhance shareholder values, and increase revenue growth, by engaging

in actions that included, but were not limited to, corporate reprioritization efforts and implementation of various

cost saving measures.

These plans included the transition of pharma activities from the Rutherford, NJ facility to our Morrisville,

NC facility in order to optimize the operations of laboratory operations within our pharma services.

We invested several million dollars

to facilitate this relocation which was completed in March 2021, including but not limited to the transfer of personnel, expansion of

the Morrisville facility and validation of transferred processes.

While we expect to realize cost-saving benefits from these initiatives,

these actions may not be successful and may not bring the cost saving benefits that we anticipate.

have a history of operating losses, and our clinical and pharma services have generated limited revenue.

We expect to incur net losses

for the foreseeable future and may never achieve or sustain profitability.

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.

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

to support our cost structure.

the fiscal year ended December 31, 2022, we had an operating loss from continuing operations of $3.6 million.

As of December 31,

2022, we had cash and cash equivalents of $4.8 million and current liabilities of $14.3 million.

The Company must fund its operating

deficit until a sustainable level of revenue is achieved.

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

results of operations have been adversely affected and, in the future, could be materially adversely impacted by the COVID-19 virus.

continuing impact that the COVID-19 virus will have on our operations, including duration, severity and scope, remains highly uncertain

and cannot be fully predicted at this time.

Such impact is a function of the scope of any new virus mutations and outbreaks, the nature

of government public health guidelines and the public’s adherence to those guidelines, the rate of individuals becoming fully vaccinated,

the public’s adherence to guidelines to receive booster shots, the success of business and economic recovery as the pandemic recedes,

unemployment levels, the extent to which new shutdowns may be needed and the impact of any further government economic relief on the

The coronavirus may continue to spread globally, adversely affecting global economies and financial markets, has and may

materially and adversely impact our operations including, without limitation, the functioning of our laboratory, the availability of

supplies including reagents, demand for our services and travel, customer demand and employee health and availability.

While we believe

we have generally recovered from the adverse impact that the COVID-19 pandemic had on our business during 2020, we believe that the COVID-19

virus could continue to adversely impact our results of operations, cash flows and financial condition in the future.

At this time, the

Biden Administration does not plan to renew the COVID-19 national and public health emergencies when they expire on May 11, which has

been extended every 90 days since they were established in 2020.

This decision, therefore, appears to represent a de-escalation in the

way the government treats the pandemic, as well as a perception that most people have either been vaccinated or have recovered from a

COVID-19 infection (or both), Despite this anticipated change in policy, COVID-19 is still with us and as the virus continues to reproduce

and mutate, the Administration’s policy may need be adjusted.

In any event, it is likely that we will still need to make adjustments

to our operating plans in reaction to developments that are beyond our control.

war between Russia and Ukraine could materially adversely affect our business, results of operations, and financial condition.

February 2022, Russian military forces invaded Ukraine, and although the length, impact, and outcome of the ongoing war in Ukraine is

highly unpredictable, this war has led, and could continue to lead, to significant market and other disruptions, including instability

in financial markets, supply chain interruptions, political and social instability, and increases in cyberattacks, intellectual property

theft, and espionage.

We are actively monitoring the situation in Ukraine and assessing its impact on our business.

have no way to predict the progress or outcome of the war in Ukraine or its impacts in Ukraine, Russia, or Belarus as the war, and any

resulting government reactions, are rapidly developing and beyond our control.

The extent and duration of the war, sanctions, and resulting

market disruptions could be significant and could potentially have a substantial impact on the global economy and our business for an

unknown period of time.

Any of the above-mentioned factors could materially adversely affect our business, financial condition, and results

of operations.

Any such disruptions may also magnify the impact of other risks described in this “Risk Factors” section and

elsewhere in this Annual Report on Form 10-K.

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.

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.

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.

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.

have a history of operating losses, and our clinical services have generated limited revenue.

We may continue to incur net losses for

the foreseeable future and may never achieve or sustain profitability.

we expect our revenue to grow in the future, there can be no assurance that we will achieve revenue sufficient to offset expenses.

the next several years, we expect to (i) continue to devote resources to increase adoption of, and reimbursement for, our clinical services

tests and assays and to use our bioinformatics data to develop and enhance our clinical services products and services, (ii) leverage

and invest in our pharma services to expand and enhance our pharma services and (iii) develop and acquire additional products and services.

However, our business may never achieve or sustain profitability, and our failure to achieve and sustain profitability in the future

could have a material adverse effect on our business, financial condition and results of operations, as well as cause the market price

of our common stock to decline.

have and may continue to experience intangible asset impairment charges.

are required to evaluate the carrying value of intangibles at least annually, and between annual tests if events or circumstances warrant

We review the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances

indicate that the carrying value of such assets may not be recoverable.

If the sum of the expected future undiscounted cash flows is

less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair

value measured by future discounted cash flows.

This analysis requires estimates of the amount and timing of projected cash flows and,

where applicable, judgments associated with, among other factors, the appropriate discount rate.

Such estimates are critical in determining

whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.

down or reserving for other intangible assets or impairments has had and would have a negative and unexpected impact on our net worth.

January 2021, we filed restated financial statements contained in the Company’s Annual Report 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.

Such restatements reflected

a non-cash impairment charge and amortization expense related to our Barrett’s intangible asset of approximately $18 million.

have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our

future viability.

began commercial sales of our molecular diagnostic tests in late 2014.

On July 15, 2019, we acquired the pharma services business.

conduct our business through our wholly-owned subsidiaries, Interpace Diagnostics, LLC, which was formed in Delaware in 2013, Interpace

Diagnostics Corporation (formerly known as RedPath Integrated Pathology, Inc.), which was formed in Delaware in 2007, and Interpace BioPharma,

Inc., which was formed in Delaware in 2019.

On November 12, 2019 we changed the name of Interpace Diagnostics Group, Inc.

Biosciences, Inc.

and that of our newly-formed subsidiary, Interpace BioPharma, Inc.

to Interpace Pharma Solutions, Inc.

Consequently,

any evaluations about our future success, performance or viability may not be as accurate as they could be if we had a longer operating

the next several years, we expect to continue to devote resources to increase adoption of, and reimbursement for, our clinical services

tests and assays and to use our bioinformatics data to develop and enhance our clinical services products and services, and (ii) develop

and acquire additional products and services.

However, our business may never achieve or sustain profitability, and our failure to achieve

and sustain profitability in the future could have a material adverse effect on our business, financial condition and results of operations,

as well as cause the market price of our common stock to decline.

quarterly and annual revenues and operating results may vary which may cause the price of our common stock to fluctuate.

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of cash collections which could impact or affect net realizable values of sales of our tests and services;

of one or more of our laboratories to perform tests;

of our laboratory to perform tests;

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

or unfavorable decisions about our tests or services or reimbursement rates from government regulators, insurances companies,

customers, or other third party payers;

or unfavorable decisions about our tests or services or reimbursement rates from government regulators, insurances companies, customers,

or other third party payers;

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

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affect the market price of our common stock in a manner unrelated to our long-term operating performance.

depend on sales and reimbursements from our clinical services for more than 50% 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.

than 50% of our revenue is derived from our clinical services.

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.

of our revenue is derived from our clinical services business.

We have molecular diagnostics tests and complimentary service extensions

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rely on third-parties to provide overall processing of claims and to transmit actual claims to payers based on specific payer billing

In 2019, we transitioned to a new third-party processor and there can be no assurance that we will not experience interruptions

or collection delays with our future billings, an occurrence of which may adversely impact our revenue and financial condition.

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

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

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 to handle claim submissions, we may experience delays in our ability to process claims and receive

payment from payers, which could have a material adverse effect on our business, financial condition and results of operations.

to how we recognize revenue, our quarterly revenue and operating results are likely to fluctuate.

adopted Financial Accounting Standards Board (“FASB”) ASU 2014-09, “Revenue from Contracts with Customers (Topic 606)”

adopted Financial Accounting Standards Board (“FASB”) ASC 606 2014-09, “Revenue from Contracts with Customers (Topic

606)” (or “ASC 606”) effective January 1, 2018.

As of this date, all revenue is recognized on the accrual basis, based upon actual

collection histories for tests and services and respective payers or payer groups.

Due to this change in accounting and the estimations

required under ASC 606, our quarterly revenue and operating results are likely to fluctuate.

As we recognize revenue from payers under

ASC 606, we may subsequently determine that certain judgments underlying estimated reimbursement change, or that the estimates we used

at the time we accrued such revenue vary materially from the actual reimbursements subsequently realized, and our financial results could

be negatively impacted in future quarters.

We experienced an adjustment in our estimate for variable consideration under ASC 606 during

the fourth quarter of 2019 which resulted in a $5.2 million reduction in revenue recognized year to date;

however there have been no

such adjustments since then.

As of this date, all revenue is recognized on the accrual basis, based

upon actual collection histories for tests and services and respective payers or payer groups.

Due to this change in accounting and the

estimations required under ASC 606, our quarterly revenue and operating results are likely to fluctuate.

As we recognize revenue from

payers under ASC 606, we may subsequently determine that certain judgments underlying estimated reimbursement change, or that the estimates

we used at the time we accrued such revenue vary materially from the actual reimbursements subsequently realized, and our financial results

could be negatively impacted in future quarters.

a result, comparing our operating results on a period-to-period basis may be difficult due to fluctuations resulting from the estimation

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

Our business is substantially

dependent on third-party reimbursement.

Any change in the overall health care reimbursement system may adversely impact our business.

Our revenues are substantially

dependent on third-party reimbursement.

We are paid directly by private insurers and governmental agencies, often on a fixed fee basis.

If the average fees allowable by private insurers or governmental agencies were reduced, the negative impact on revenues could have a

material effect on our business, financial condition, results of operations and cash flows.

Also, if amounts owed to us by payors are

reduced or not paid on a timely basis, we may be required to increase our concessions and/or decrease our revenues.

Changes to the health

care reimbursement system that favor other technologies or treatment regimens and reduce our reimbursements may adversely affect our

ability to market our services profitably.

Overall, such dependency and potential changes could materially and adversely affect our business,

financial condition, results of operations and cash flows.

business is substantially dependent on third-party reimbursement.

Any change in the overall health care reimbursement system may adversely

impact our business.

revenues are substantially dependent on third-party reimbursement.

We are paid directly by private insurers and governmental agencies,

often on a fixed fee basis.

If the average fees allowable by private insurers or governmental agencies were reduced, the negative impact

on revenues could have a material effect on our business, financial condition, results of operations and cash flows.

Also, if amounts

owed to us by payors are reduced or not paid on a timely basis, we may be required to increase our concessions and/or decrease our revenues.

Changes to the health care reimbursement system that favor other technologies or treatment regimens and reduce our reimbursements may

adversely affect our ability to market our services profitably.

Overall, such dependency and potential changes could materially and adversely

affect our business, financial condition, results of operations and cash flows.

inability to finance our business on acceptable terms in the future may limit our ability to develop and commercialize products and services

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in full at their maturity the Notes extended by our two private equity investors.

The BroadOak loan agreement 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 BroadOak loan agreement 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 BroadOak loan agreement also contains customary events of default.

loan agreement contains affirmative and negative restrictive covenants that are applicable whether or not any amounts are outstanding

under the Comerica loan agreement.

These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments,

encumbrances, etc., could adversely affect our ability to conduct our business.

The Comerica loan agreement also contains financial covenants

requiring specified minimum liquidity and minimum revenue thresholds and also contains customary events of default.

We will need additional funding to repay the Comerica

and BroadOak borrowings as well as to continue operations.

The Comerica loan

agreement contains affirmative and negative restrictive covenants that are applicable whether or not any amounts are outstanding under

the Comerica loan agreement.

These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments, encumbrances,

etc., could adversely affect our ability to conduct our business.

The Comerica loan agreement also contains financial covenants requiring

specified minimum liquidity and minimum revenue thresholds and also contains 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.

2022, the Convertible Note was converted into a subordinated term loan and was added to the outstanding BroadOak loan balance discussed

will need additional funding to repay the Comerica and BroadOak borrowings, which have maturity dates of September 2023 and October 2024,

respectively, as well as to continue operations.

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.

Any public offering of

equity securities must be approved by the holders of our Series B Preferred Stock who are our private equity investors.

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

If we are unable to timely repay the Comerica and BroadOak

borrowings when due, Comerica and BroadOak will have the right to foreclose on our assets (BroadOak being subordinated to Comerica).

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.

seek to raise funds by issuing additional equity securities, dilution to our stockholders could result.

Any public offering of equity

securities must be approved by the holders of our Series B Preferred Stock who are our private equity investors.

In addition, we are

currently ineligible to use a Form S-3 shelf registration statement.

If we are unable to timely repay the Comerica and BroadOak borrowings

when due, Comerica and BroadOak will have the right to foreclose on our assets (BroadOak being subordinated to Comerica).

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.

we are unable to timely repay our outstanding obligations, our secured lenders will have the right to foreclose on our assets.

In October 2021, the Company

entered into a $7.5 million revolving credit facility with Comerica and an $8.0 million term loan with BroadOak, which are secured by

all of our assets.

October 2021, the Company entered into a $7.5 million revolving credit facility with Comerica and an $8.0 million term loan with BroadOak,

which are secured by all of our assets and have maturity dates of September 2023 and October 2024, respectively.

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.

We will need additional funding to repay these outstanding obligations as well as to continue operations.

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on an as converted basis, Ampersand and its affiliates beneficially own 38.4% of the Company’s outstanding common stock of 4,311,414

and 1315 Capital and its affiliates beneficially own 26.3%.

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.

shares and 1315 Capital and its affiliates beneficially own 26.1%.

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.

stockholders, acting together, have control over the outcome of matters submitted to our stockholders for approval, including the election

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holders of our Series B Preferred Stock have preferential rights that may be adverse to holders of our common stock.

holders of our Series B Preferred Stock have preferential rights with respect to distributions upon a liquidation of the Company, including

certain business combinations or sales of assets deemed to be a liquidation.

Accordingly, no distributions upon liquidation may be made

to the holders of common stock until the holders of the Series B Preferred Stock have been paid their liquidation preference.

it is possible that, on a liquidation event and depending on the price thereof, all amounts available for the holders of equity of the

Company would be paid to the holders of Series B Preferred Stock, and that the holders of common stock would not receive any payment.

In addition, the holders of Series B Preferred Stock have the right to approve certain actions of the Company.

holders of our Series B Preferred Stock have preferential rights with respect to distributions upon a liquidation or sale of the Company,

including certain business combinations or sales of assets deemed to be a liquidation.

Accordingly, no distributions upon liquidation

may be made to the holders of common stock until the holders of the Series B Preferred Stock have been paid their liquidation preference.

As a result, it is possible that, on a liquidation event (including a sale of the Company) and depending on the price thereof, all amounts

available for the holders of equity of the Company would be paid to the holders of Series B Preferred Stock, and that the holders of

common stock would not receive any payment.

In addition, the holders of Series B Preferred Stock have the right to approve certain actions

of the Company.

April 2020, 1315 Capital consented to, and agreed to vote (by proxy or otherwise) their Series B Preferred Stock in favor of any “Fundamental

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we must also comply with these requirements.

We may also face

increased risk in our collection efforts, including write-offs of doubtful accounts and long collection cycles, which could have a material

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

Among others, the following factors make the

billing process complex:

We may also face increased

risk in our collection efforts, including write-offs of doubtful accounts and long collection cycles, which could have a material adverse

effect on our clinical services, results of operations and financial condition.

Among others, the following factors make the billing

process complex:

between the list price for our molecular diagnostic tests and the reimbursement rates of payers;

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revenue and cash flow, our ability to achieve profitability, and the consistency and comparability of our results of operations.

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 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.

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 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.

for clinical services tests performed on patients covered by Medicare was approximately 45% of our revenue for the fiscal year ended

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or 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 ® tests when

billed together by the same provider/supplier for the same beneficiary on the same date of service.

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® (0018U) tests has been retroactively reversed

to January 1, 2022.

CMS is currently reimbursing the Company for one of its two thyroid tests, and has agreed to retroactively reimburse

for the second test once they have completed their internal administrative adjustments.

We have been notified by CMS/NCCI that processing of claims for dates

of service after January 1, 2022 will be completed beginning July 1, 2022.

As of the date of this filing, the Company has not yet realized the full cash collection

benefit of current and retroactive Thyroid testing and such cash collections may be temporarily reduced or delayed until we resolved

the matter with CMS.

Solutions has been and is the current regional MAC that handles claims processing for Medicare services with jurisdiction for PancraGEN ® ,

ThyGeNEXT ® , ThyraMIR ® , and RespriDx ® .

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 of service.

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 is currently reimbursing the Company

for one of its two thyroid tests, and has agreed to retroactively reimburse for the second test once they have completed their internal

administrative adjustments.

We have been notified by CMS/NCCI that processing of claims for dates of service after January 1, 2022 will

be completed beginning July 1, 2022.

As of the date of this filing the Company has no remaining outstanding collections regarding

this matter and is fully up to date with CMS.

Effective January 1, 2023, the gapfill price for ThyGeNEXT ® was set at

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

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

PancraGEN ® , ThyraMIR ® and ThyGeNEXT ® tests are reimbursed by Medicare based on applicable

Novitas restricts coverage for PancraGEN ® , our liquidity could be negatively impacted beginning in Fiscal 2023.

PancraGEN ® , ThyraMIR ® v2 and ThyGeNEXT ® tests are reimbursed by Medicare based on applicable

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

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we have contracted rates of reimbursement with certain payers, which establishes allowable rates of reimbursement for our PancraGEN ® ,

ThyGeNEXT ® , ThyraMIR ® and RespriDx ® assays, payers may suspend or discontinue reimbursement

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 or may reduce the reimbursement

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

have contracted rates of reimbursement with select payers for PancraGEN ® , ThyGeNEXT ® and ThyraMIR ®

have contracted rates of reimbursement with select payers for PancraGEN ® , ThyGeNEXT ® and ThyraMIR ® v2

and to a limited extent, RespriDx ® .

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

In addition, our assays are performed at our laboratories rather than by a pathologist in a local laboratory, so pathologists may be

In addition, our assays are performed at our laboratory rather than by a pathologist in a local laboratory, so pathologists may be

reluctant to support our tests.

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Under the Asuragen License Agreement, we are obligated to pay royalties on the future net sales of tests utilizing

the miR Inform ® thyroid platform (i.e., ThyGeNEXT ® ), potentially on certain other thyroid

diagnostics tests and potentially on other tests in development for thyroid cancer.

A similar obligation exists if we elect to launch

any molecular tests utilizing the miR Inform ® pancreas platform.

We are also required by the CPRIT License Agreement

with Asuragen to make certain related royalty payments to CPRIT.

performing the ThyraMIR ® test, we use products supplied by Exiqon A/S (now a part of Qiagen), subject to a license agreement

the miR Inform ® thyroid platform (i.e., ThyGeNEXT ® ), potentially on certain other thyroid diagnostics

tests and potentially on other tests in development for thyroid cancer.

A similar obligation exists if we elect to launch any molecular

tests utilizing the miR Inform ® pancreas platform.

We are also required by the CPRIT License Agreement with Asuragen

to make certain related royalty payments to CPRIT.

performing the ThyraMIR ® v2 test, we use products supplied by Exiqon A/S (now a part of Qiagen), subject to a license agreement

with Exiqon A/S.

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to alternative suppliers in a timely manner.

rely on sole suppliers for certain materials that we use to perform our tests and services, including Asuragen, for our endocrine cancer

diagnostic tests pursuant to our supply agreement with them.

rely on sole suppliers for certain materials that we use to perform our tests and services for our endocrine cancer

diagnostic tests.

We also purchase reagents used in our tests and services from sole-source

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basis, or at all, other tests, assays, services and solutions under development.

new tests, services and solutions will require us to devote considerable resources to research and development, which we may not be

in a position to do.

We may face challenges obtaining sufficient numbers of samples to validate a newly acquired or developed test

new tests, services and solutions will require us to devote considerable resources to research and development, which we may not be in

a position to do.

We may face challenges obtaining sufficient numbers of samples to validate a newly acquired or developed test or service.

In order to develop and commercialize new tests and services, we need to:

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These advances require us to continuously develop our technology and to work to develop new solutions to keep pace with evolving standards

Our clinical services and pharma services could become obsolete unless we continually innovate and expand our product offerings

to include new clinical applications.

If we are unable to develop or acquire new tests, services and solutions or to demonstrate the

applicability of our tests and services for other diseases, our sales could decline and our competitive position could be harmed.

Our services could become obsolete unless we continually innovate and expand our product offerings to include new clinical applications.

If we are unable to develop or acquire new tests, services and solutions or to demonstrate the applicability of our tests and services

for other diseases, our sales could decline and our competitive position could be harmed.

we cannot enter into new clinical study collaborations, our product development and subsequent commercialization could be delayed.

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diagnostic testing.

Most tests that qualify as LDTs are currently subject to enforcement discretion by the FDA, but there is substantial

uncertainty regarding the scope of the FDA’s enforcement discretion policy and the proper interpretation of the definition of LDTs

(as set forth in the 2014 draft guidance described below, which defines LDTs as “those in vitro diagnostic devices (IVD)

that are intended for clinical use and are designed, manufactured and used within a single laboratory”).

In July 2014, the FDA

issued two draft guidance documents:

“Framework for Regulatory Oversight of Laboratory Developed Tests,” which provides an

overview of how the FDA would regulate LDTs through a risk-based approach, and “FDA Notification and Medical Device Reporting for

Laboratory Developed Tests”, which provides guidance on how the FDA intends to collect information on existing LDTs, including

adverse event reports.

Pursuant to the Framework for Regulatory Oversight draft guidance, LDT manufacturers will be subject to medical

device registration, listing, and adverse event reporting requirements.

LDT manufacturers will be required to either submit a pre-market

application and receive the FDA’s approval before an LDT may be marketed or submit a pre-market notification in advance of marketing

unless subject to continued enforcement discretion.

The Framework for Regulatory Oversight draft guidance states that within six months

after the guidance documents are finalized, all laboratories will be required to give notice to the FDA and provide basic information

concerning the nature of the LDTs offered.

January 13, 2017, the FDA released a discussion paper on LDTs outlining a possible, substantially-revised risk-based approach for FDA

and Centers for Medicare & Medicaid Services, or CMS, oversight of LDTs.

According to the 2017 discussion paper, most previously

marketed LDTs would not be expected to comply with most or all FDA oversight requirements (grandfathering), except for adverse event

and malfunction reporting.

In addition, certain new and significantly modified LDTs would not be expected to comply with pre-market review

unless the agency determines certain tests could lead to patient harm.

Since many LDTs currently on the market would be grandfathered

in, pre-market review of new and significantly modified LDTs could be phased-in over a four-year period, as opposed to the nine years

proposed in the Framework for Regulatory Oversight draft guidance.

In addition, tests introduced after the effective date, but before

their phase-in date, could continue to be offered during pre-market review.

discussion paper notes that the FDA will focus on analytical and clinical validity as the basis for marketing authorization.

anticipates laboratories that already conduct proper validation should not be expected to experience new costs for validating their tests

to support marketing authorization and laboratories that conduct appropriate evaluations would not have to collect additional data to

demonstrate analytical validity for FDA clearance or approval.

The evidence of the analytical and clinical validity of all LDTs would

be made publicly available.

LDTs would be encouraged to submit prospective change protocols in their pre-market submission that outline

specific types of anticipated changes, the procedures that will be followed to implement them and the criteria that will be met prior

to implementation.

March 2017, members of Congress posted a discussion draft of “The Diagnostics Accuracy and Innovation Act” (DAIA).

The discussion

draft included language that, if enacted, would have established a new regulatory framework for the oversight of in vitro clinical tests

(“IVCTs”) which include LDTs.

In 2020, members of Congress introduced “The Verifying Accurate, Leading-edge IVCT Development

(VALID) Act”;

this bill was re-introduced in substantially similar form in June 2021.

If enacted, VALID would create a risk-based

approach to regulate IVCTs while grandfathering many existing IVCTs.

The new regulatory framework will include quality control and post-market

reporting requirements.

Each test will be classified as high-risk or low-risk.

Pre-market review will be required for high-risk tests.

To market a high-risk IVCT, reasonable assurance of analytical and clinical validity for the intended use must be established.

VALID, a precertification process would be established which will allow a laboratory to establish that the facilities, methods, and controls

used in the development of certain IVCTs meet quality system requirements.

If pre-certified, low-risk IVCTs it develops will not be subject

to pre-market review.

The new regulatory framework will include quality control and post-market reporting requirements.

have the authority to withdraw from the market IVCTs if it is reasonably possible that such tests will cause serious adverse health consequences

(among other criteria).

We cannot predict whether this bill will become law or the ultimate impact of its passage, or other legislative

or regulatory changes, would have on our business.

If the FDA implements a new framework for enforcement of its regulations against LDTs,

our existing products that are classified as LDTs, if any, and/or any of our future LDTs we seek to develop and market for clinical use,

we may be required to obtain pre-certification or approval before continuing to market such tests in the U.S.

We may not be able to obtain

such pre-certifications or approvals on a timely basis or at all.

Our business could be negatively impacted as a result of commercial

delay that may be caused by any new requirements.

we are required to submit applications for our currently-marketed clinical services tests, we may be required to conduct additional studies,

Most tests offered as LDTs are currently subject to enforcement discretion by the FDA.

LDTs are defined by FDA as

IVDs that are intended for clinical use and are designed, manufactured, and used within a single CLIA-certified, high-complexity clinical

the history of attempts by FDA and Congress to regulate LDTs over the past decade, there is substantial uncertainty concerning whether

FDA’s enforcement discretion policy will continue.

we are required to submit applications to FDA for our currently-marketed clinical tests, we may be required to conduct additional studies,

which may be time-consuming and costly and could result in our currently-marketed tests being withdrawn from the market.

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Failure to comply with applicable regulatory requirements can

result in enforcement action by the FDA, such as fines, product suspensions, warning letters, recalls, injunctions and other civil and

criminal sanctions.

Any other regulatory or legislative proposals that would increase general FDA oversight of clinical laboratories

and LDTs could negatively impact our business if additional requirements are imposed.

We are monitoring developments and anticipate that

our clinical services products will be able to comply with requirements that are ultimately imposed by the FDA.

In the meantime, we maintain

our CLIA accreditation, which permits the use of LDTs for diagnostics purposes.

result in enforcement action by the FDA, such as warning letters, civil monetary penalties, injunctions, criminal prosecution, recall

or seizure, operating restrictions, partial suspension or total shutdown of operations, and denial of or challenges to applications for

clearance or approval, as well as significant adverse publicity.

Any other regulatory or legislative proposals that would increase general

FDA oversight of clinical laboratories or LDTs could negatively impact our business if additional requirements are imposed.

We are monitoring

developments and anticipate that our clinical services products will be able to comply with requirements that are ultimately imposed

In the meantime, we maintain our CLIA accreditation and state licenses, which permit the use of LDTs for diagnostics purposes.

notwithstanding any change in existing enforcement policies, if the FDA determines that any of our clinical services tests are IVDs,

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and financial condition.

Related to our Pharma Services

may not realize all of the anticipated benefits of the acquisition of our pharma services business or those benefits may take longer

to realize than expected.

We may also encounter significant unexpected difficulties in integrating the pharma services business.

ability to realize the anticipated benefits of the acquisition of the pharma services business depends, to a large extent, on our ability

to integrate it successfully.

The combination and integration of two independent operations is a complex, costly and time-consuming process.

As a result, we have been required and are continuing to devote significant management attention and resources to integrating the business

practices and operations of our pharma services with our clinical services practices and operations.

The integration process, which includes

moving laboratory locations, may disrupt the operations and, if implemented ineffectively or if impacted by unforeseen negative economic

or market conditions or other factors, we may not realize the full anticipated benefits of the acquisition.

Our failure to meet the challenges

involved in integrating the two operations to realize the anticipated benefits of such acquisition could cause an interruption of, or

a loss of momentum in, our activities and could adversely affect our results of operations.

addition, the overall integration of the operations may result in material unanticipated problems, expenses, liabilities, competitive

responses, loss of customer relationships, and diversion of management’s attention.

The difficulties of combining the operations

include but are not limited to:

of management’s attention from the management of daily operations to integration matters;

in achieving anticipated cost savings, synergies, business opportunities and growth prospects from combining our pharma services

with our clinical services operations;

entering new markets or new laboratory or data management services where we have no or limited direct prior experience;

in the integration of operations and systems;

in the assimilation of employees and in the retention of key employees;

in retaining employees who may be vital to the integration of departments, information technology systems, including accounting systems,

technologies, books and records, and procedures, and maintaining uniform standards, such as internal accounting controls, procedures,

and policies;

in the assimilation of different corporate cultures and business practices;

in managing the expanded operations of a significantly larger and more complex company;

deterioration in the sales and revenues of the tests and services of our pharma services;

and expenses associated with any undisclosed or potential liabilities;

managing relationships with our new strategic partners, suppliers and customer base;

in maintaining existing, and establishing new business relationships;

as a result of the COVID-19 pandemic.

of these factors are outside of our control and any one of them could result in increased costs, decreases in the amount of expected

revenues and diversion of management’s time and energy, which could materially impact the business, financial condition and our

results of operations.

In addition, even if the operations of our clinical services operations and our pharma services are integrated

successfully, we may not realize the full benefits of the acquisition, including the synergies, cost savings or sales or growth opportunities

that we expect.

These benefits may not be achieved within the anticipated time frame, or at all.

additional unanticipated costs which may be incurred in the continuing integration of operations or unanticipated increases in expenses

unrelated to the acquisition of our pharma services may offset the expected benefits from the acquisition of our pharma services.

addition, our acquisition of the pharma services business has resulted in the incurrence of additional amortization expenses related

to intangible assets, which could have a material adverse effect on the Company’s financial condition, operating results, and cash

Further, the acquisition of the pharma services business resulted in the Company recording significant goodwill and other assets,

and we may be required to incur impairment charges, which could adversely affect our consolidated financial position and results of operations.

Since the acquisition, we have also undergone several cost-cutting initiatives with our pharma services business, including reductions

in headcount.

Further, during Fiscal 2021, the Company experienced a fairly significant decrease in volume within pharma services.

decrease in revenue within pharma services was approximately 32% from the comparable prior year period.

Such revenue headwinds may continue

in future periods.

As such, all of these factors could decrease or delay the expected accretive effect of the pharma services business

acquisition and negatively impact our business, financial condition and results of operations.

As a result, we cannot be certain that

the integration process and resulting combined operations will result in the realization of the full benefits anticipated from the acquisition.

we are unable to increase sales of the tests and services in our pharma services or to successfully develop and commercialize other proprietary

tests in our pharma services, we may be unable to achieve profitability.

pharma services provide pharmaceutical and biotech companies, universities and contract research organizations performing clinical trials

with lab testing services for patient stratification and treatment selection through an extensive suite of molecular- and biomarker-based

testing services, DNA- and RNA- extraction and customized assay development and trial design consultation.

It is unclear whether we will

be able to maintain and grow the number of customers who will avail themselves of our tests and services, or how regular a flow of business

we will be able to obtain from existing customers.

If we are unable to increase sales of our tests and services or to successfully develop,

validate and commercialize other diagnostic tests and services, our pharma services may not produce sufficient revenues to become profitable.

pharmaceutical and biotech companies, universities and contract research organizations performing clinical trials decide not to use our

diagnostic tests and services, we may be unable to generate sufficient revenue to sustain our pharma services.

generate demand for our pharma services, we need to educate pharmaceutical and biotech companies, universities and contract research

organizations performing clinical trials on the utility of our tests and services to improve the outcomes of clinical trials for new

oncology drugs and more rapidly advance targeted therapies through the clinical development process through published papers, presentations

at scientific conferences and one-on-one education sessions by members of our sales force.

We may need to hire additional commercial,

scientific, technical and other personnel to support this process.

If we cannot convince pharmaceutical and biotech companies, universities

and contract research organizations performing clinical trials to order our diagnostic tests and services or other future tests and services

we develop, we will likely be unable to create demand for our tests and services in sufficient volume for us to achieve sustained profitability

of our pharma services.

a result of our pharma services, our quarterly operating results may be subject to significant fluctuations and may be difficult to forecast.

nature of the services of our pharma services is that they tend to come in relatively large projects but episodically, rather than providing

steady sources of revenues.

The timing, size and duration of our contracts with our customers depend on the size, pace and duration of

such customer’s clinical trial, over which we have no control and sometimes limited visibility.

In addition, our expense levels

are based, in part, on expectation of future revenue levels.

A shortfall in expected revenue could, therefore, result in a disproportionate

decrease in our net income.

As a result, our quarterly operating results may be subject to significant fluctuations and may be difficult

we fail to perform our pharma services in accordance with contractual and regulatory requirements, and ethical considerations, we could

be subject to significant costs or liability.

our pharma services offerings, we contract with pharmaceutical and biotech companies, universities and contract research organizations

performing clinical trials to perform lab testing services for patient stratification and treatment selection through an extensive suite

of molecular- and biomarker-based testing services, DNA- and RNA- extraction and customized assay development and trial design consultation.

Such services are complex and subject to contractual requirements, regulatory standards and ethical considerations.

If we fail to perform

our services in accordance with these requirements, standards, and considerations regulatory authorities may take action against us or

our customers.

Such actions may include failure of such regulatory authority to grant marketing approval of our customers’ products,

imposition of holds or delays, suspension or withdrawal of clearances or approvals, rejection of data collected, laboratory license revocation,

product recalls, operational restrictions, civil or criminal penalties or prosecutions, damages or fines.

Any such action could have

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

Related to our Operations

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a small company with less than 100 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 chief financial officer, and others in key management

During January and February 2021, we experienced turnover in our chief executive officer and chief financial officer 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, and increase or maintain pharma services tests and service revenue or to successfully develop and commercialize

other pharma services proprietary tests and services.

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.

members of our senior management team, including our chief executive officer, and others in key management positions.

In September 2022

our chief financial officer entered into a Severance and Consulting Agreement and General Release whereby he would continue to act as

the principal financial officer for up to six (6) months from the date of date of termination.

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.

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

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revenue growth and our ability to achieve profitability.

we cannot maintain our current relationships, or enter into new relationships, with biopharmaceutical companies to leverage our bioinformatics

data, we may be unable to recognize revenues from biopharmaceutical companies and our product development could be delayed.

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.

we have been selling commercial products since 2014, genomic diagnostics and pharma services are new areas 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

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

We may not be able to market, sell, or distribute our existing products or services or other products or services we may develop

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be diminished.

In addition, we have limited history selling our clinical services tests on a direct basis and operating our pharma services,

and leveraging our bioinformatics data and our limited history makes forecasting difficult.

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.

our sales force is not successful, or new additions to our sales team fail to gain traction among our customers, we may not be able to

increase market awareness and sales of our molecular diagnostic tests and pharma services.

If we fail to establish our clinical services

tests and pharma services in the marketplace, it could have a negative effect on our ability to sell subsequent products or services

and hinder the desired expansion of our business.

We have growing, however limited, historical experience forecasting the direct sales

of our clinical services products, and no prior history operating our pharma services before our acquisition of pharma services in 2019.

Our ability to produce product quantities that meet customer demand is dependent upon our ability to forecast accurately and plan production

we are unable to compete successfully in the markets our clinical services and pharma services operate in, we may be unable to increase

or sustain our revenue or achieve profitability.

increase market awareness and sales of our molecular diagnostic tests.

If we fail to establish our clinical services tests in the marketplace,

it could have a negative effect on our ability to sell subsequent products or services and hinder the desired expansion of our business.

We have growing, however limited, historical experience forecasting the direct sales of our clinical services products.

Our ability to

produce product quantities that meet customer demand is dependent upon our ability to forecast accurately and plan production accordingly.

we are unable to compete successfully in the markets our clinical services operate in, we may be unable to increase or sustain our revenue

or achieve profitability.

compete with physicians and the medical community who use traditional methods to diagnose gastrointestinal, endocrine and lung cancers

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 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 has thyroid nodule cancer diagnostic tests which are currently on the market that

compete with our ThyGeNEXT ® and ThyraMIR ® tests.

Quest currently offers Veracyte’s tests via a co-marketing

agreement, and CBL 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.

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 tests.

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.

is also possible that we face future competition from laboratory developed tests, or LDTs, developed by commercial laboratories such

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

respect to our pharma services, we also face competition from companies that currently offer or are developing products to profile genes,

gene expression or protein biomarkers in various cancers.

Precision medicine is a new area of science, and we cannot predict what tests

others will develop that may compete with or provide results superior to the results we are able to achieve with the tests we develop.

Our competitors for our pharma services include public companies such as NeoGenomics and many private companies.

we cannot license rights to use third-party technologies on reasonable terms, we may not be able to commercialize new products or services

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of operations.

a catastrophe strikes any of our laboratories or if any of our laboratories becomes inoperable for any other reason, we will be unable

to perform our testing and pharma services and our business will be harmed.

laboratories and equipment we use to perform our tests and services would be costly to replace and could require substantial lead time

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.

laboratory and equipment we use to perform our tests and services would be costly to replace and could require substantial lead time

to replace and qualify for use if they became inoperable.

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Further continued spread of COVID-19 globally and resulting travel and other restrictions that may be imposed

could negatively impact our ability to obtain raw materials needed for manufacture of our clinical services testing, our ability to provide

testing and our pharma services to patients, our financial condition and our results of operation.

or reimposed could negatively impact our ability to obtain raw materials needed for manufacture of our clinical services testing, our

ability to provide testing to patients, our financial condition and our results of operations.

The extent to which COVID-19 and global

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predicted at this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the COVID-19

At this time, the Biden Administration does not plan to renew the COVID-19 national and public health emergencies when they

expire on May 11, which has been extended every 90 days since they were established in 2020.

This decision, therefore, appears to represent

a de-escalation in the way the government treats the pandemic, as well as a perception that most people have either been vaccinated or

have recovered from a COVID-19 infection (or both), Despite this anticipated change in policy, COVID-19 is still with us and as the virus

continues to reproduce and mutate, the Administration’s policy may need be adjusted.

In any event, it is likely that we will still

need to make adjustments to our operating plans in reaction to developments that are beyond our control.

we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.

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and our reputation.

business requires that we and our third-party service providers collect and store sensitive data, including PHI, personally identifiable information such as genetic information or credit card information about patients or other individuals,

and our proprietary business and financial information.

We must comply with the HIPAA and HITECH privacy, security, and breach notification

regulations with respect to PHI in our capacity as a covered entity and business associate, and with consumer protection and consumer

privacy laws that apply to our processing of this sensitive data, which may increase our operational costs.

Furthermore, the privacy,

security, and breach notification regulations implemented under HIPAA and HITECH as well as other federal and state consumer protection

and consumer privacy laws and regulations that may apply to us provide for significant fines and other penalties, including potential

civil and criminal fines and penalties, for non-compliance.

We face a number of risks relative to our protection of, and our service

providers’ protection of, this critical information, other personally identifiable information, and our proprietary business and

financial information, including loss of access, fraudulent modifications, inappropriate disclosure and inappropriate access, as well

as risks associated with our ability to identify and audit such events.

The secure processing, storage, maintenance and transmission

of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such

Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology

and infrastructure may be vulnerable to attacks by hackers or viruses or otherwise breached due to employee error, malfeasance or other

If such event would 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 without our knowledge, lost or stolen.

business requires that we and our third-party service providers collect and store sensitive data, including PHI, personally identifiable

information such as genetic information or credit card information about patients or other individuals, and our proprietary business

and financial information.

We must comply with the HIPAA and HITECH privacy, security, and breach notification regulations with respect

to PHI in our capacity as a covered entity and business associate, and with consumer protection and consumer privacy laws that apply

to our processing of this sensitive data, which may increase our operational costs.

Furthermore, the privacy, security, and breach notification

regulations implemented under HIPAA and HITECH as well as other federal and state consumer protection and consumer privacy laws and regulations

that may apply to us provide for significant fines and other penalties, including potential civil and criminal fines and penalties, for

non-compliance.

We face a number of risks relative to our protection of, and our service providers’ protection of, this critical

information, other personally identifiable information, and our proprietary business and financial information, including loss of access,

fraudulent modifications, inappropriate disclosure and inappropriate access, as well as risks associated with our ability to identify

and audit such events.

The secure processing, storage, maintenance and transmission of this critical information is vital to our operations

and business strategy, and we devote significant resources to protecting such information.

Although we take measures to protect sensitive

information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers

or viruses or otherwise breached due to employee error, malfeasance or other activities.

If such event would 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 without our knowledge, lost or stolen.

In 2017, we discovered malware installed on certain servers.

After an internal investigation, we do not believe that any PHI or other

sensitive data on the affected servers was accessed or compromised.

After an internal investigation, we do not believe that any PHI or other sensitive data on the affected servers was accessed or compromised.

We removed the malware, and enhanced our cybersecurity procedures.

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to survey and inspection every two years.

Moreover, CLIA inspectors may make random inspections of our clinical reference laboratories.

Moreover, CLIA inspectors may make random inspections of our clinical reference laboratory.

We are also required to maintain State licenses to conduct testing in our Pittsburgh, Pennsylvania laboratory.

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If we were unable to obtain or maintain our

CLIA certificate for our laboratories, whether as a result of revocation, suspension or limitation, we would no longer be able to perform

our current clinical services and pharma services, which could have a material adverse effect on our business, financial condition and

results of operations.

If we were to lose our licenses issued by States where we are required to hold licenses, if such licenses expired

or were not renewed, or if we failed to obtain and maintain a State license that we are required to hold, we may be subject to significant

fines, penalties and liability, and may be forced to cease testing (if Pennsylvania) or cease testing specimens from those States (if

California, New York, Maryland, or Rhode Island), which could have a material adverse effect on our business, financial condition and

results of operations.

New molecular diagnostic tests and pharma services we may develop may be subject to new requirements by governmental

bodies, including state governments, and we may not be able to offer our new molecular diagnostic tests or pharma services in such jurisdictions

until such requirements are met.

CLIA certificate for our laboratory, whether as a result of revocation, suspension or limitation, we would no longer be able to perform

our current clinical services, which could have a material adverse effect on our business, financial condition and results of operations.

If we were to lose our licenses issued by States where we are required to hold licenses, if such licenses expired or were not renewed,

or if we failed to obtain and maintain a State license that we are required to hold, we may be subject to significant fines, penalties

and liability, and may be forced to cease testing (if Pennsylvania) or cease testing specimens from those States (if California, New

York, Maryland, or Rhode Island), which could have a material adverse effect on our business, financial condition and results of operations.

New molecular diagnostic tests we may develop may be subject to new requirements by governmental bodies, including state governments,

and we may not be able to offer our new molecular diagnostic tests in such jurisdictions until such requirements are met.

reforming the U.S.

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tests or reduced medical procedure volumes, all of which may adversely affect our business, financial condition and results of operations.

with numerous statutes and regulations pertaining to our clinical and pharma services is an expensive and time-consuming process, and

any failure to comply could result in substantial penalties.

with numerous statutes and regulations pertaining to our services is an expensive and time-consuming process, and any failure to comply

could result in substantial penalties.

are subject to regulation by both the federal government and the governments of the states in which we conduct our operations.

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health services, unless the financial relationship falls within an applicable exception to the prohibition;

which established 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;

which established 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;

FTC Act and various state consumer privacy laws, which require regulated entities to take reasonable steps to safeguard the personal

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

relationships between our laboratory and the healthcare providers, sales force members, or other parties.

A failure to comply with

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federal and state net operating losses, or NOLs, of approximately $127.2 million and $59.5 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.

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,

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.

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

customers may not accept new molecular diagnostic tests or pharma services from our acquired businesses;

customers may not accept new molecular diagnostic tests;

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

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We removed the malware, and enhanced our cybersecurity procedures.

Additionally, our clinical services and pharma 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.

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

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which could harm our business and future prospects.

January 5, 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.

tier under the OTCQX Rules for U.S.

Companies section 3.2.b.2.

has been provided 180 calendar days from the date of such notice, or until July 3, 2023, to maintain a market capitalization of $5

million for ten consecutive trading days.

If the Company cannot meet this requirement, its common stock will be removed from the

In such event, the Company may be eligible for the OTCQB market.

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

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Report on Form 10-Q for the quarter ended June 30, 2020.

also recently 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.

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.

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

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As of December 31, 2022,

31, 2021, we have reserved 961,450 shares of our common stock for issuance under our 2019 Equity Incentive Plan and 25,715 shares

of our common stock for issuance under our Employee Stock Purchase Plan and 602,077 additional shares available for future grants of

awards under our 2019 Equity Incentive Plan as well as warrants for 1,404,648 shares of our common stock outstanding at prices ranging

from $9.40 to $46.90 per warrant share.

As of December 31, 2021, the aggregate number of shares of common stock that may be issued through

conversion of all of the outstanding Series B Preferred Stock is 7,833,334.

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.

we have reserved 776,849 shares of our common stock for issuance under our 2019 Equity Incentive Plan and 1,000,007 shares of our common

stock for issuance under our Employee Stock Purchase Plan and 1,672,746 additional shares available for future grants of awards under

our 2019 Equity Incentive Plan.

As of December 31, 2022, the aggregate number of shares of common stock that may be issued through conversion

of all of the outstanding Series B Preferred Stock is 7,833,334.

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.

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 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

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

What changed 10-K

Item 1A. Risk Factors