What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-04-17 compared with 2022-03-31 · 613 added, 527 removed, 623 unchanged (65% of the section changed)

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31, 2022 and 2021 was $27,549,876 and $46,371,364, respectively, and our accumulated deficit as of December 31, 2022 was $95,040,362.

can be no assurance that the products under development by us will be approved for sale in the U.S.

There can be no assurance that the products under development by us will be approved for sale in the U.S.

or elsewhere.

Furthermore, there can

be no assurance that if such products are approved, they will be successfully commercialized, and the extent of our future losses and

the timing of our profitability are highly uncertain.

If we are unable to achieve profitability, we may be unable to continue our operations.

there can be no assurance that if such products are approved, they will be successfully commercialized, and the extent of our future

losses and the timing of our profitability are highly uncertain.

If we are unable to achieve profitability, we may be unable to continue

our operations.

If we fail to obtain the capital necessary

to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire investment.

We will need to continue to

seek capital from time to time to continue development of our lead drug candidate beyond our initial combined Phase I/IIa clinical trial

and to acquire and develop other product candidates.

Once approved for commercialization, we cannot provide any assurances that any revenues

it may generate in the future will be sufficient to fund our ongoing operations.

We will need to continue

to seek capital from time to time to continue development of our lead drug candidate beyond our initial combined Phase I/IIa clinical

trial and to acquire and develop other product candidates.

Once approved for commercialization, we cannot provide any assurances that

any revenues it may generate in the future will be sufficient to fund our ongoing operations.

Our business or operations

may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required

to maintain operations, fund expansion, develop new or enhance products, acquire complementary products, business or technologies or otherwise

respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred treatment

In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently envisioned,

and this would require additional capital.

However, we may not be able to secure funding when we need it or on favorable terms.

not be able to raise sufficient funds to commercialize the product candidates we intend to develop.

to maintain operations, fund expansion, develop new or enhance products, acquire complementary products, business or technologies or

otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred

treatment modalities.

In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently

envisioned, and this would require additional capital.

However, we may not be able to secure funding when we need it or on favorable

We may not be able to raise sufficient funds to commercialize the product candidates we intend to develop.

If we cannot raise adequate

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Any of these actions may harm our business, financial condition and results of operations.

The amount of capital we may

need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope

of our preclinical studies and clinical trials;

The amount of capital we

may need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing

and scope of our preclinical studies and clinical trials;

the time and cost necessary to obtain regulatory approvals;

the time and cost necessary

to further develop manufacturing processes and arrange for contract manufacturing;

the time and cost

necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative,

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and 2021, the Company had a net loss of $27,649,876 and $46,371,364, respectively.

There can be no assurances that we will be able to achieve

a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public

offerings and/or bank financing necessary to support our working capital requirements.

To the extent that funds generated from any private

placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital.

No assurance can

be given that additional financing will be available, or if available, will be on acceptable terms.

These conditions raise substantial

doubt about our ability to continue as a going concern.

If adequate working capital is not available, we may be forced to discontinue

operations, which would cause investors to lose their entire investment.

There can be no assurances that we will be able to

achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements,

public offerings and/or bank financing necessary to support our working capital requirements.

To the extent that funds generated from

any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital.

assurance can be given that additional financing will be available, or if available, will be on acceptable terms.

These conditions raise

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

If adequate working capital is not available, we may be forced to

discontinue operations, which would cause investors to lose their entire investment.

We may need to raise additional funding,

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limit or terminate our product development efforts or other operations.

We do not expect that our current

cash position will be sufficient to fund our current operations for the next 12 months.

Our operating plan may change as a result of many

factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt

financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances

and licensing arrangements or a combination of these approaches.

In any event, we will require additional capital to obtain regulatory

approval for, and to commercialize, our product candidates.

Raising funds in the current economic environment may present additional challenges.

Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions

are favorable or if we have specific strategic considerations.

We do not expect that our

current cash position will be sufficient to fund our current operations for the next 12 months.

Our operating plan may change as a result

of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity

or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic

alliances and licensing arrangements or a combination of these approaches.

In any event, we will require additional capital to obtain

regulatory approval for, and to commercialize, our product candidates.

Raising funds in the current economic environment may present

additional challenges.

Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional

capital if market conditions are favorable or if we have specific strategic considerations.

Any additional fundraising

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we may be required to do so on terms that are dilutive to you.

The capital markets have been

unpredictable in the past for unprofitable companies such as ours.

In addition, it is generally difficult for development stage companies

to raise capital under current market conditions.

The amount of capital that a company such as ours is able to raise often depends on

variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive to us, or at all.

are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds are

not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued

viability will be materially adversely affected.

The capital markets have

been unpredictable in the past for unprofitable companies such as ours.

In addition, it is generally difficult for development stage

companies to raise capital under current market conditions.

The amount of capital that a company such as ours is able to raise often

depends on variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive to us, or at

If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.

funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our

continued viability will be materially adversely affected.

market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have

serious adverse consequences on our business, financial condition, and stock price.

global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity

and credit availability, declines in consumer confidence, declines in economic growth, inflationary pressure, and interest rate changes,

increases in unemployment rates and uncertainty about economic stability.

The financial markets and the global economy may also be adversely

affected by the current or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism, or

other geopolitical events.

Sanctions imposed by the United States and other countries in response to such conflicts, including the one

in Ukraine, may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected

countries or others could exacerbate market and economic instability.

More recently, the closures of Silicon Valley Bank (“SVB”)

and Signature Bank and their placement into receivership with the Federal Deposit Insurance Corporation (FDIC) created bank-specific

and broader financial institution liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve, and the

FDIC jointly released a statement that depositors at SVB and Signature Bank would have access to their funds, even those in excess of

the standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions

or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term

working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future credit and financial

market instability and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely

affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market

If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may

cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly and more dilutive.

to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy,

financial performance and stock price and could require us to delay or abandon clinical development plans.

In addition, there is a risk

that one or more of our current service providers, financial institutions, manufacturers and other partners may be adversely affected

by the foregoing risks, which could directly affect our ability to attain our operating goals on schedule and on budget.

does not hold any deposits or securities or maintain any accounts at SVB or Signature Bank.

Risks Related to Product Development, Regulatory

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The regulatory approval process is expensive,

time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates, if

We will not be permitted to

market our product candidates in the United States until we receive approval from the FDA, or in any foreign countries until we receive

time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future product candidates,

We will not be permitted

to market our product candidates in the United States until we receive approval from the FDA, or in any foreign countries until we receive

the requisite approval from corresponding agencies in such countries.

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including, among others, because:

may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA

or foreign regulator;

may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the

FDA or foreign regulator;

results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or foreign regulator

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FDA or foreign regulator may disagree with our interpretation of data from our preclinical studies and clinical trials;

FDA or foreign regulator may not accept data generated at our clinical trial sites or may disagree with us over whether to accept efficacy

results from clinical trial sites outside the United States or outside the EU, as applicable, where the standard of care is potentially

different from that in the United States or in the EU, as applicable;

FDA or foreign regulator may not accept data generated at our clinical trial sites or may disagree with us over whether to accept

efficacy results from clinical trial sites outside the United States or outside the EU, as applicable, where the standard of care

is potentially different from that in the United States or in the EU, as applicable;

and when our BLAs or foreign equivalents are submitted to the applicable regulatory authorities, such agencies may have difficulties

scheduling the necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or require,

as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use

restrictions;

scheduling the necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or

require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution

and use restrictions;

FDA or foreign regulator may require development of a Risk Evaluation and Mitigation Strategy (REMS), which would use risk minimization

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FDA or the other applicable foreign regulatory agencies may change their approval policies or adopt new regulations.

We may encounter substantial delays in completing

our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction

of applicable regulatory authorities.

We may encounter substantial delays in

completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy

to the satisfaction of applicable regulatory authorities.

It is difficult to predict

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among different CROs and trial sites;

● delays in obtaining required Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical

● delays in recruiting a sufficient number of suitable patients to participate in our clinical

● imposition of a clinical hold by regulatory agencies, after an inspection of our clinical

study operations or study sites;

in obtaining required Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical

in recruiting a sufficient number of suitable patients to participate in our clinical studies;

of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

by our CROs, other third parties or us to adhere to the clinical study, regulatory or legal requirements;

● failure to perform in accordance with the FDA’s

good clinical practices (“GCP”) or applicable regulatory guidelines in other countries;

delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

delays in having patients’ complete participation in a study or return for post-treatment follow-up;

clinical study sites or patients dropping out of a study;

delay or failure to address any patient safety concerns that arise during the course of a trial;

unanticipated costs or increases in costs of clinical trials of our product candidates;

occurrence of serious adverse events associated with the product candidates that are viewed to outweigh their potential benefits;

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in

other countries;

delays in the

testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

delays in having patients’

complete participation in a study or return for post-treatment follow-up;

clinical study sites or

patients dropping out of a study;

delay or failure to address

any patient safety concerns that arise during the course of a trial;

unanticipated costs or

increases in costs of clinical trials of our product candidates;

occurrence of serious adverse

events associated with the product candidates that are viewed to outweigh their potential benefits;

changes in regulatory requirements

and guidance that require amending or submitting new clinical protocols.

We could also encounter delays

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Any inability to successfully

complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from product

sales, regulatory and commercialization milestones and royalties.

In addition, if we make manufacturing or formulation changes to our

product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from

product sales, regulatory and commercialization milestones and royalties.

In addition, if we make manufacturing or formulation changes

to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

Clinical study delays could

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are safety concerns or adverse events associated with our other product candidates, we may:

be delayed in obtaining marketing approval for our product candidates, if approved at all;

obtain approval for indications or patient populations that are not as broad as intended or desired;

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

be required to change the way the product is administered;

be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;

experience damage to our reputation.

Additionally, our product candidates

could potentially cause other adverse events that have not yet been predicted.

The inclusion of ill patients in our clinical studies may

result in deaths or other adverse medical events due to other therapies or medications that such patients may be using.

As described above,

any of these events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability

to commercialize our products.

If our future pre-clinical development and

future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product

in obtaining marketing approval for our product candidates, if approved at all;

obtain approval

for indications or patient populations that are not as broad as intended or desired;

obtain approval with labeling

that includes significant use or distribution restrictions or safety warnings;

to change the way the product is administered;

be required to perform

additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities

withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation

experience damage to our

Additionally, our product

candidates could potentially cause other adverse events that have not yet been predicted.

The inclusion of ill patients in our clinical

studies may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using.

described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates and impair

our ability to commercialize our products.

If our future pre-clinical development

and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize, our product

candidates on a timely basis or at all.

The successful completion of

pre-clinical development and multiple clinical trials is critical to the success of our future products.

The successful completion

of pre-clinical development and multiple clinical trials is critical to the success of our future products.

If the pre-clinical development

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clinical trials.

Even if we receive regulatory approval for

any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from their

sales, if any, may be limited.

Even if we receive regulatory approval

for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from

their sales, if any, may be limited.

If approved for marketing,

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of factors, including:

demonstration of clinical safety and efficacy;

relative convenience, dosing burden and ease of administration;

the prevalence and severity of any adverse effects;

the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;

efficacy of our product candidates compared to competing products;

the introduction of any new products that may in the future become available targeting indications for which our product candidates may be approved;

new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility;

pricing and cost-effectiveness;

the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;

the effectiveness of our own or any future collaborators’ sales and marketing strategies;

limitations or warnings contained in approved labeling from regulatory authorities;

our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics;

the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

demonstration

of clinical safety and efficacy;

relative convenience, dosing

burden and ease of administration;

the prevalence and severity

of any adverse effects;

the willingness of physicians

to prescribe our product candidates, and the target patient population to try new therapies;

our product candidates compared to competing products;

the introduction of any

new products that may in the future become available targeting indications for which our product candidates may be approved;

new procedures or therapies

that may reduce the incidences of any of the indications in which our product candidates may show utility;

cost-effectiveness;

the inclusion or omission

of our product candidates in applicable therapeutic and vaccine guidelines;

the effectiveness of our

own or any future collaborators’ sales and marketing strategies;

or warnings contained in approved labeling from regulatory authorities;

our ability to obtain and

maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid,

private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating

the pricing and usage of therapeutics;

the willingness of patients

to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

If any of our product candidates

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A government-mandated or voluntary recall by us or one of our distributors

could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects

or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and have an adverse effect

on our financial condition and results of operations.

The regulatory agencies require that certain classifications of recalls be reported

to them within ten (10) working days after the recall is initiated.

Companies are required to maintain certain records of recalls, even

if they are not reportable to the regulatory agency.

We may initiate voluntary recalls involving our products in the future that we determine

do not require notification of the regulatory agencies.

If the regulatory agency disagrees with our determinations, they could require

us to report those actions as recalls.

A future recall announcement could harm our reputation with customers and negatively affect our

could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling

defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and have an

adverse effect on our financial condition and results of operations.

The regulatory agencies require that certain classifications of

recalls be reported to them within ten (10) working days after the recall is initiated.

Companies are required to maintain certain records

of recalls, even if they are not reportable to the regulatory agency.

We may initiate voluntary recalls involving our products in the

future that we determine do not require notification of the regulatory agencies.

If the regulatory agency disagrees with our determinations,

they could require us to report those actions as recalls.

A future recall announcement could harm our reputation with customers and negatively

affect our sales.

In addition, the regulatory agency could take enforcement action for failing to report the recalls when they were conducted.

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This can be a costly and resource draining activity.

What appear to be promising technologies when we license them may

not lead to viable technologies or products, or to commercial success.

What appear to be promising technologies when we license them

may not lead to viable technologies or products, or to commercial success.

Complying with numerous regulations pertaining

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the program must be covered by the regulated facilities, including certification and survey costs.

To renew this certificate, we are subject

to survey and inspection every two years.

Moreover, CLIA inspectors may make periodic inspections of our clinical laboratory outside of

the renewal process.

The failure to comply with CLIA requirements can result in enforcement actions, including the revocation, suspension,

or limitation of our CLIA certificate of compliance, as well as a directed plan of correction, state on-site monitoring, civil money penalties,

civil injunctive suit and/or criminal penalties.

We must maintain CLIA compliance and certification to be eligible to bill for assays

provided to Medicare beneficiaries.

If we were to be found out of compliance with CLIA program requirements and subjected to sanctions,

our business and reputation could be harmed.

Even if it were possible for us to bring our laboratory back into compliance, we could incur

significant expenses and potentially lose revenue in doing so.

To renew this certificate, we are

subject to survey and inspection every two years.

Moreover, CLIA inspectors may make periodic inspections of our clinical laboratory

outside of the renewal process.

The failure to comply with CLIA requirements can result in enforcement actions, including the revocation,

suspension, or limitation of our CLIA certificate of compliance, as well as a directed plan of correction, state on-site monitoring,

civil money penalties, civil injunctive suit and/or criminal penalties.

We must maintain CLIA compliance and certification to be eligible

to bill for assays provided to Medicare beneficiaries.

If we were to be found out of compliance with CLIA program requirements and subjected

to sanctions, our business and reputation could be harmed.

Even if it were possible for us to bring our laboratory back into compliance,

we could incur significant expenses and potentially lose revenue in doing so.

Additionally, certain states

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to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business.

If we were to lose,

or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens from those

If we were to

lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens

from those states.

Risks Related to the Company and our Business

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Without these licenses, we may not be able to continue to develop our product candidates.

The LLU License Agreement may

be terminated by LLU in the event of a breach by us of any non-payment provision (including the provision that requires us to meet certain

deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after delivery of written notice by

The LLU License Agreement

may be terminated by LLU in the event of a breach by us of any non-payment provision (including the provision that requires us to meet

certain deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after delivery of written

notice by LLU.

Additional Milestone Deadlines include:

(i) the requirement to have regulatory approval of an IND application to initiate first-in-human

clinical trials on or before March 31, 2022, (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii)

the completion of Phase III clinical trials by March 31, 2026 and (iv) biologic licensing approval (BLA) by the FDA by March 31, 2027.

If the LLU License Agreement were to be terminated by LLU, we would lose our most significant asset and may no longer be able to develop

our product candidates, which would have a material adverse effect on our operations.

The February 2020 License Agreement

with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments;

(ii) are not diligently developing and

commercializing Licensed Product (as defined in the February 2020 License Agreement);

(i) the requirement to have regulatory approval of an IND application to initiate

first-in-human clinical trials on or before March 31, 2022 (which has been extended to March 31, 2023 due to payment of a $100,000 extension

fee in March 2022), (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii) the completion of Phase

III clinical trials by March 31, 2026 and (iv) biologic licensing approval (BLA) by the FDA by March 31, 2027.

If the LLU License Agreement

were to be terminated by LLU, we would lose our most significant asset and may no longer be able to develop our product candidates, which

would have a material adverse effect on our operations.

The February 2020 License

Agreement with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments;

(ii) are not diligently developing

and commercializing Licensed Product (as defined in the February 2020 License Agreement);

(iii) miss a milestone described in the agreement;

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If the February

2020 License Agreement were to be terminated by Stanford, we would lose a significant asset and may no longer be able to develop our product

candidates, which would have a material adverse effect on our operations.

2020 License Agreement were to be terminated by Stanford, we would lose a significant asset and may no longer be able to develop our

product candidates, which would have a material adverse effect on our operations.

Our results of operations will be affected

by the level of royalty and milestone payments that we are required to pay to third parties.

The LLU License Agreement and

February 2020 License Agreement with Stanford each require us to remit royalty payments and meet certain performance milestones related

The LLU License Agreement

and February 2020 License Agreement with Stanford each require us to remit royalty payments and meet certain performance milestones related

to in-licensed intellectual property.

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Furthermore, we may enter into additional license agreements in the future, which may also include royalty payments.

We face substantial competition, which may

result in others discovering, developing or commercializing products before or more successfully than we do.

We face substantial competition, which

may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization

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may have a competitive advantage over us due to their greater size, cash flows and institutional experience.

Compared to us, many of our

competitors may have significantly greater financial, technical and human resources.

As a result of these factors, our competitors may

have an advantage in marketing their approved products and may obtain regulatory approval of their product candidates before we are able

to, which may limit our ability to develop or commercialize our product candidates.

Our competitors may also develop drugs that are safer,

more effective, more widely used and less expensive than ours, and may also be more successful than us in manufacturing and marketing

their products.

Mergers and acquisitions in

the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

These companies compete with us in recruiting and retaining qualified scientific, management and

commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies

complementary to, or necessary for, our programs.

Compared to us, many of

our competitors may have significantly greater financial, technical and human resources.

As a result of these factors, our competitors

may have an advantage in marketing their approved products and may obtain regulatory approval of their product candidates before we are

able to, which may limit our ability to develop or commercialize our product candidates.

Our competitors may also develop drugs that

are safer, more effective, more widely used and less expensive than ours, and may also be more successful than us in manufacturing and

marketing their products.

Mergers and acquisitions

in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies.

These companies compete with us in recruiting and retaining qualified scientific,

management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring

technologies complementary to, or necessary for, our programs.

Our technologies and products under development,

and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result.

Successful development of technologies

and our product candidates will require significant additional investment, including costs associated with additional development, completing

trials and obtaining regulatory approval, as well as the ability to manufacture or have others manufacture our products in sufficient

quantities at acceptable costs while also preserving product quality.

Difficulties often encountered in scaling up production include

problems involving production yields, quality control and assurance, shortage of qualified personnel, production costs and process controls.

Successful development of

technologies and our product candidates will require significant additional investment, including costs associated with additional development,

completing trials and obtaining regulatory approval, as well as the ability to manufacture or have others manufacture our products in

sufficient quantities at acceptable costs while also preserving product quality.

Difficulties often encountered in scaling up production

include problems involving production yields, quality control and assurance, shortage of qualified personnel, production costs and process

In addition, we are subject to inherent risks associated with new technologies and products.

These risks include the possibility that

any of our technologies or future products may:

found unsafe;

ineffective or less effective than anticipated;

to receive necessary regulatory approvals;

difficult to competitively price relative to alternative solutions;

harmful to consumers or the environment;

difficult to manufacture on an economically viable scale;

subject to supply chain constraints for raw materials;

to be developed and accepted by the market prior to the successful marketing of alternative products by competitors;

difficult to market because of infringement on the proprietary rights of third parties;

too expensive for commercial use.

These risks include the possibility

that any of our technologies or future products may:

be found unsafe;

be ineffective

or less effective than anticipated;

fail to receive

necessary regulatory approvals;

to competitively price relative to alternative solutions;

to consumers or the environment;

to manufacture on an economically viable scale;

to supply chain constraints for raw materials;

developed and accepted by the market prior to the successful marketing of alternative products by competitors;

to market because of infringement on the proprietary rights of third parties;

be too expensive

for commercial use.

Furthermore, we may be faced

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reduced margins and the inability to achieve market acceptance for our products.

Our competitors may have longer

operating histories, significantly greater resources, greater brand recognition and large customer bases than we do.

As a result, they

may be able to devote greater resources to the manufacture, promotion or sale of their products, receive greater resources and support

Our competitors may have

longer operating histories, significantly greater resources, greater brand recognition and large customer bases than we do.

they may be able to devote greater resources to the manufacture, promotion or sale of their products, receive greater resources and support

from market partners and independent distributors, initiate or withstand substantial price competition or more readily take advantage

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or otherwise negatively affected.

We rely on third parties for

the distribution of our current and future products, including our AditxtScore™ platform.

Our reliance on third parties to distribute

products may present significant risks to us, including the risk that should any of these third parties fail to adequately distribute

our products and services to end consumers and other market participants, our business may be materially harmed.

Additionally, if we need

to enter into agreements for the distribution of our future products with other third parties, there can be no assurance we will be able

to do so on favorable terms, if at all.

We rely on third parties

for the distribution of our current and future products, including our AditxtScore™ platform.

Our reliance on third parties to

distribute products may present significant risks to us, including the risk that should any of these third parties fail to adequately

distribute our products and services to end consumers and other market participants, our business may be materially harmed.

Additionally,

if we need to enter into agreements for the distribution of our future products with other third parties, there can be no assurance we

will be able to do so on favorable terms, if at all.

We may rely on third parties for the production

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for the manufacture of our future products.

Our reliance on third parties to manufacture our future products may present significant risks

to us, including the following:

control over delivery schedules, yields and product reliability;

Our reliance on third parties to manufacture our future products may present significant

risks to us, including the following:

reduced control

over delivery schedules, yields and product reliability;

price increases;

manufacturing

deviations from internal and regulatory specifications;

failure of a key manufacturer to perform as we require for technical, market or other reasons;

● difficulties

of a key manufacturer to perform as we require for technical, market or other reasons;

in establishing additional manufacturer relationships if we are presented with the need to transfer our manufacturing process technologies

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of our intellectual property;

risks in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct

in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct

customers and end users.

If we need to enter into agreements

for the manufacturing of our future products, there can be no assurance we will be able to do so on favorable terms, if at all.

If we need to enter into

agreements for the manufacturing of our future products, there can be no assurance we will be able to do so on favorable terms, if at

If we are unable to establish successful

relations with third-party market partners or distributors, or these market partners or distributors do not focus adequate resources on

selling our products or are otherwise unsuccessful in selling them, sales of our products may not develop.

We anticipate relying on independent

market partners and distributors to distribute and assist us with the marketing and sale of our products.

Our future revenue generation

and growth will depend in large part on our success in establishing and maintaining this sales and distribution channel.

If our market

partners and distributors are unable to sell our products, or receive negative feedback from end users, they may not continue to purchase

or market our products.

In addition, there can be no assurance that our market partners and distributors will focus adequate resources

on selling our products to end users or will be successful in selling them.

Many of our potential market partners and distributors are

in the business of distributing and sometimes manufacturing other, possibly competing, products.

relations with third-party market partners or distributors, or these market partners or distributors do not focus adequate resources

on selling our products or are otherwise unsuccessful in selling them, sales of our products may not develop.

We anticipate relying on

independent market partners and distributors to distribute and assist us with the marketing and sale of our products.

Our future revenue

generation and growth will depend in large part on our success in establishing and maintaining this sales and distribution channel.

our market partners and distributors are unable to sell our products, or receive negative feedback from end users, they may not continue

to purchase or market our products.

In addition, there can be no assurance that our market partners and distributors will focus adequate

resources on selling our products to end users or will be successful in selling them.

Many of our potential market partners and distributors

are in the business of distributing and sometimes manufacturing other, possibly competing, products.

As a result, these market partners

and distributors may perceive our products as a threat to various product lines currently being distributed or manufactured by them.

addition, these market partners and distributors may earn higher margins by selling competing products or combinations of competing products.

If we are unable to establish successful relationships with independent market partners and distributors, we will need to further develop

our own sales and distribution capabilities, which would be expensive and time-consuming and might not be successful.

In addition, these market partners and distributors may earn higher margins by selling competing products or combinations of competing

If we are unable to establish successful relationships with independent market partners and distributors, we will need to further

develop our own sales and distribution capabilities, which would be expensive and time-consuming and might not be successful.

If we are not able to attract and retain

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payments would have a negative effect on our operating results.

Competition for experienced, high-quality employees, consultants and contractors

is intense and we cannot assure that we will be able to recruit and retain such personnel.

We may not be able to hire or retain the necessary

personnel to implement our business strategy.

Our failure to hire and retain such personnel could impair our ability to develop new products

and manage our business effectively.

Competition for experienced, high-quality employees, consultants and

contractors is intense and we cannot assure that we will be able to recruit and retain such personnel.

We may not be able to hire or

retain the necessary personnel to implement our business strategy.

Our failure to hire and retain such personnel could impair our ability

to develop new products and manage our business effectively.

The loss of our management team or other

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Our success will be particularly

dependent upon Mr.

Amro Albanna and Dr.

dependent upon our Chief Executive Officer, Mr.

Amro Albanna and our Chief Innovation Officer, Dr.

Shahrokh Shabahang.

The loss of any one of these individuals or any other future key personnel

could have a material adverse effect on the Company and our ability to further execute our intended business.

The use of our products may be limited by

regulations, and we may be exposed to product liability and remediation claims.

The loss of any

one of these individuals or any other future key personnel could have a material adverse effect on the Company and our ability to further

execute our intended business.

The use of our products may be limited

by regulations, and we may be exposed to product liability and remediation claims.

The use of our planned products

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guarantee that we will be able to avoid product liability exposure.

At the stage customary to do

so, we expect to maintain product liability insurance at levels we believe are sufficient and consistent with industry standards for like

companies and products.

At the stage customary to

do so, we expect to maintain product liability insurance at levels we believe are sufficient and consistent with industry standards for

like companies and products.

However, we cannot guarantee that our product liability insurance will be sufficient to help us avoid product

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of controls must be considered relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of controls

can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Failure of our control systems

to prevent error or fraud could materially adversely affect our business.

Because of the inherent limitations in all control systems, no evaluation of

controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Failure of our control

systems to prevent error or fraud could materially adversely affect our business.

COVID-19 may impact our operations.

On January 30, 2020 the World

Health Organization declared the COVID-19 coronavirus outbreak a “Public Health Emergency of International Concern” and on

March 10, 2020, declared it to be a pandemic.

Actions taken around the world to help mitigate the spread of the coronavirus include restrictions

on travel, and quarantines in certain areas, and forced closures for certain types of public places and businesses.

The COVID-19 coronavirus

and actions taken to mitigate it have had and are expected to continue to have an adverse impact on the economies and financial markets

of many countries, including the geographical area in which the Company operates.

While it is unknown how long these conditions will last

and what the complete financial effect will be to the Company, capital raise efforts and additional development of our technologies may

be negatively affected.

On January 30, 2020, the

World Health Organization declared the COVID-19 coronavirus outbreak a “Public Health Emergency of International Concern”

and on March 10, 2020, declared it to be a pandemic.

Actions taken around the world to help mitigate the spread of the coronavirus include

restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and businesses.

COVID-19 coronavirus and actions taken to mitigate it have had and are expected to continue to have an adverse impact on the economies

and financial markets of many countries, including the geographical area in which the Company operates.

While it is unknown how long

these conditions will last and what the complete financial effect will be to the Company, capital raise efforts and additional development

of our technologies may be negatively affected.

Risks Relating to Our Intellectual Property

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licensing agreements and other intellectual property could materially impact our ability to compete effectively.

In order for our business to

be viable and to compete effectively, we need to develop and maintain, and we will heavily rely on, a proprietary position with respect

In order for our business

to be viable and to compete effectively, we need to develop and maintain, and we will heavily rely on, a proprietary position with respect

to our technologies and intellectual property.

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The risks and uncertainties that we face with respect to our rights principally include the following:

patent applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued

may be subject to interference proceedings;

may be subject to reexamination proceedings;

may be subject to post grant review proceedings;

may be subject to inter partes review proceedings;

may be subject to derivation proceedings;

may be subject to opposition proceedings in the U.S.

pending patent

applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued patents;

we may be subject

to interference proceedings;

we may be subject

to reexamination proceedings;

we may be subject

to post grant review proceedings;

we may be subject

to inter partes review proceedings;

we may be subject

to derivation proceedings;

we may be subject

to opposition proceedings in the U.S.

or in foreign countries;

patents that are issued to us may not provide meaningful protection;

may not be able to develop additional proprietary technologies that are patentable;

companies may challenge patents licensed or issued to us;

companies may have independently developed and patented (or may in the future independently develop and patent) similar or alternative

technologies, or duplicate our technologies;

companies may design around technologies we have licensed or developed;

● enforcement

that are issued to us may not provide meaningful protection;

be able to develop additional proprietary technologies that are patentable;

other companies

may challenge patents licensed or issued to us;

other companies

may have independently developed and patented (or may in the future independently develop and patent) similar or alternative technologies,

or duplicate our technologies;

other companies

may design around technologies we have licensed or developed;

of patents is complex, uncertain and very expensive and we may not be able to secure, enforce and defend our patents;

the event that we were to ever seek to enforce our patents in ligation, there is some risk that they could be deemed invalid, not infringed,

that we were to ever seek to enforce our patents in ligation, there is some risk that they could be deemed invalid, not infringed,

or unenforceable.

We cannot be certain that any

patents will be issued as a result of any pending or future applications, or that any patents, once issued, will provide us with adequate

protection from competing products.

We cannot be certain that

any patents will be issued as a result of any pending or future applications, or that any patents, once issued, will provide us with

adequate protection from competing products.

For example, issued patents may be circumvented or challenged, declared invalid or unenforceable,

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we cannot be certain that we or our licensors were the first to invent or to file patent applications covering them.

It is also possible that others

may have or may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses requiring

the payment of significant fees or royalties in order to enable us to conduct our business.

There is no guarantee that such licenses will

be available based on commercially reasonable terms.

As to those patents that we have licensed, our rights depend on maintaining our obligations

to the licensor under the applicable license agreement, and we may be unable to do so.

It is also possible that

others may have or may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses

requiring the payment of significant fees or royalties in order to enable us to conduct our business.

There is no guarantee that such

licenses will be available based on commercially reasonable terms.

As to those patents that we have licensed, our rights depend on maintaining

our obligations to the licensor under the applicable license agreement, and we may be unable to do so.

If we are unable to obtain and maintain

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The patent position of life

science companies generally is highly uncertain, involves complex legal and factual questions and has in past years been the subject of

much litigation.

In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States

and we may fail to seek or obtain patent protection in all major markets.

science companies generally is highly uncertain, involves complex legal and factual questions and has in past years been the subject

of much litigation.

In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United

States and we may fail to seek or obtain patent protection in all major markets.

For example, unlike the U.S., European patent law restricts

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or the patent rights of others.

An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or

invalidate, our patent rights (whether licensed or otherwise held), allow third parties to commercialize our technology or products and

compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing

An adverse determination in any such submission, proceeding or litigation could reduce the scope of,

or invalidate, our patent rights (whether licensed or otherwise held), allow third parties to commercialize our technology or products

and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing

third-party patent rights.

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able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent is

not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or owned patents may be challenged in the courts

or patent offices in the United States and abroad.

Such challenges may result in loss of exclusivity or freedom to operate or in patent

claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using

or commercializing similar or identical products, or limit the duration of the patent protection of our products.

Given the amount of

time required for the development, testing and regulatory review of new life science product candidates, patents protecting such candidates

might expire before or shortly after such candidates are commercialized.

As a result, our intellectual property rights portfolio may not

provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

The issuance of a patent

is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or owned patents may be challenged in the

courts or patent offices in the United States and abroad.

Such challenges may result in loss of exclusivity or freedom to operate or

in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others

from using or commercializing similar or identical products, or limit the duration of the patent protection of our products.

amount of time required for the development, testing and regulatory review of new life science product candidates, patents protecting

such candidates might expire before or shortly after such candidates are commercialized.

As a result, our intellectual property rights

portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may become involved in lawsuits to protect

or enforce our intellectual property rights, which could be expensive, time-consuming and ultimately unsuccessful.

Competitors may infringe our

intellectual property.

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive

and time-consuming.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging

that we infringe their intellectual property or that our intellectual property is invalid or unenforceable.

In addition, in a patent infringement

proceeding, a court may decide that a licensed or owned patent of ours is invalid or unenforceable, in whole or in part, construe the

patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do

not cover that technology.

Moreover, lawsuits to protect or enforce our intellectual property rights could be expensive, time-consuming

and ultimately unsuccessful.

Competitors may infringe

our intellectual property.

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be

expensive and time-consuming.

Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against

us alleging that we infringe their intellectual property or that our intellectual property is invalid or unenforceable.

in a patent infringement proceeding, a court may decide that a licensed or owned patent of ours is invalid or unenforceable, in whole

or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds

that our patents do not cover that technology.

Moreover, lawsuits to protect or enforce our intellectual property rights could be expensive,

time-consuming and ultimately unsuccessful.

Third parties may initiate legal proceedings

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In addition, we could

be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a

be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed

A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business

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of third parties could have a similar negative impact on our business.

Obtaining and maintaining our

patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental

patent agencies, and our own patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees and

annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment

and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be cured by payment of

a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment

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

Noncompliance

events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond

to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business.

Obtaining and maintaining

our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed

by governmental patent agencies, and our own patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees

and annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee

payment and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be cured by

payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result

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

Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure

to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal

In such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business.

We may be subject to claims by third parties

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Litigation may be necessary to defend against these claims, and any such litigation could have an unfavorable outcome.

In addition, while it is our

policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements

In addition, while it is

our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements

assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops

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we regard as our intellectual property.

If we fail in prosecuting or

defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and adverse results,

If we fail in prosecuting

or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and adverse results,

and be a distraction to management.

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manufacturers.

Some of the intellectual property

rights we own or have licensed have been generated through the use of United States government funding and may therefore be subject to

certain federal regulations.

As a result, the United States government may have certain rights to intellectual property embodied in our

current or future products and product candidates pursuant to the Bayh-Dole Act of 1980.

These United States government rights in certain

inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use

inventions for any governmental purpose.

In addition, the United States government has the right to require us to grant exclusive, partially

exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that:

(i) adequate steps have not

been taken to commercialize the invention;

Some of the intellectual

property rights we own or have licensed have been generated through the use of United States government funding and may therefore be

subject to certain federal regulations.

As a result, the United States government may have certain rights to intellectual property embodied

in our current or future products and product candidates pursuant to the Bayh-Dole Act of 1980.

These United States government rights

in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license

to use inventions for any governmental purpose.

In addition, the United States government has the right to require us to grant exclusive,

partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that:

(i) adequate steps

have not been taken to commercialize the invention;

(ii) government action is necessary to meet public health or safety needs;

or (iii) government

action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”).

The United States government also has the right to take title to these inventions if we fail to disclose the invention to the government

and fail to file an application to register the intellectual property within specified time limits.

In addition, the United States government

may acquire title to these inventions in any country in which a patent application is not filed within specified time limits.

property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require

us to expend substantial resources.

In addition, the United States government requires that any products embodying the subject invention

or produced through the use of the subject invention be manufactured substantially in the United States.

The manufacturing preference

requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to

grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that

under the circumstances domestic manufacture is not commercially feasible.

This preference for United States manufacturers may limit our

ability to contract with non-U.S.

(iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in

The United States government also has the right to take title to these inventions if we fail to disclose the invention

to the government and fail to file an application to register the intellectual property within specified time limits.

In addition, the

United States government may acquire title to these inventions in any country in which a patent application is not filed within specified

Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance

with which may require us to expend substantial resources.

In addition, the United States government requires that any products embodying

the subject invention or produced through the use of the subject invention be manufactured substantially in the United States.

The manufacturing

preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have

been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States

or that under the circumstances domestic manufacture is not commercially feasible.

This preference for United States manufacturers may

limit our ability to contract with non-U.S.

product manufacturers for products covered by such intellectual property.

Any exercise by the government

of any of the foregoing rights could harm our competitive position, business, financial condition, results of operations and prospects.

Intellectual property litigation could cause

us to spend substantial resources and distract our personnel from their normal responsibilities.

Any exercise by

the government of any of the foregoing rights could harm our competitive position, business, financial condition, results of operations

and prospects.

Intellectual property litigation could

cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor,

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in products brought to market.

Not all technologies and candidate

products that initially show potential as the basis for future products ultimately meet the rigors of our development process and as a

result may be abandoned and/or never otherwise result in products brought to market.

In some cases, prior to abandonment we may be

required to incur significant costs developing and maintaining intellectual property and/or maintaining license agreements and our business

could be harmed by such costs.

We rely on information technology, and if

we are unable to protect against service interruptions, data corruption, cyber-based attacks or network security breaches, our operations

Not all technologies and

candidate products that initially show potential as the basis for future products ultimately meet the rigors of our development process

and as a result may be abandoned and/or never otherwise result in products brought to market.

In some cases, prior to abandonment

we may be required to incur significant costs developing and maintaining intellectual property and/or maintaining license agreements

and our business could be harmed by such costs.

We rely on information technology, and

if we are unable to protect against service interruptions, data corruption, cyber-based attacks or network security breaches, our operations

could be disrupted, and our business could be negatively affected.

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delisted from the Nasdaq Stock Market.

On January 18, 2022, we received

a notification from Nasdaq related to our failure to maintain a minimum bid price of $1 per share.

Based upon the closing bid price for

the last 30 consecutive business days, we no longer meet this requirement.

However, the Nasdaq Listing Rules also provide us a compliance

period of 180 calendar days in which to regain compliance.

Accordingly, if at any time from the date of this notice until July 18, 2022,

the closing bid price our common stock is at least $1 for a minimum of ten consecutive business days, Nasdaq will provide us with written

confirmation of compliance and the matter will be closed.

If we do not regain compliance with the minimum bid price requirement by July

18, 2022, we may be afforded a second 180 calendar day period to regain compliance.

To qualify, we would be required to meet all other

initial listing standards, except for the minimum bid price requirement.

In addition, we would be required to notify Nasdaq of our intent

to cure the deficiency during the second compliance period.

If we do not regain compliance with the minimum bid price requirement by the

end of the compliance period (or the second compliance period, if applicable), our common stock will become subject to delisting.

are delisted from Nasdaq, our common stock may be eligible for trading on an over-the-counter market.

If we are not able to obtain a listing

on another stock exchange or quotation service for our common stock, it may be extremely difficult or impossible for stockholders to sell

their shares.

We intend to monitor the closing bid price of our common stock and may be required to seek approval from our stockholders

to affect a reverse stock split of the issued and outstanding shares of our common stock.

However, there can be no assurance that the

reverse stock split would be approved by our stockholders.

Further, there can be no assurance that the market price per new share of our

common stock after the reverse stock split will remain unchanged or increase in proportion to the reduction in the number of old shares

of our common stock outstanding before the reverse stock split.

Even if the reverse stock split is approved by our stockholders, there

can be no assurance that we will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance

with other Nasdaq listing rules.

On January 18, 2022, the

Company received a notification from the Listing Qualifications Staff The Nasdaq Stock Market LLC (“Nasdaq”) related to our

failure to maintain a minimum bid price of $1 per share.

Based upon the closing bid price for the last 30 consecutive business days leading

up to January 18, 2022, the Company no longer met this requirement.

The Nasdaq Listing Rules provided a compliance period of 180 calendar

days in which to regain compliance.

Accordingly, if at any time from the date of this notice until July 18, 2022, the closing bid price

our common stock is at least $1 for a minimum of ten consecutive business days, Nasdaq will provide us with written confirmation of compliance

and the matter will be closed.

On July 19, 2022, the Company

received a letter from the Nasdaq of notifying the Company that it has not regained compliance with the minimum bid price rule in Nasdaq

Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) by July 18, 2022 and is not eligible for a second 180 day extension

as the Company does not comply with the stockholders’ equity initial listing requirement for The Nasdaq Capital market.

The letter also

stated that, unless the Company requests an appeal, the Company’s securities would be delisted from The Nasdaq Capital Market and would

be suspended at the opening of business on July 28, 2022.

The Company submitted an

appeal to Nasdaq, which stayed the delisting and suspension of the Company’s securities pending the decision of the Nasdaq Hearings Panel.

At the hearing in September 2022, the Company presented its views and its plans to regain compliance with the Minimum Bid Price Rule

to the Panel.

On September 28, 2022, the

Company received the determination from Nasdaq that the Company had regained compliance with the requirements to remain listed in the

Nasdaq Capital Market subject to a Panel Monitor of the Company’s compliance with such requirements as set forth in Listing Rule

5815(d)(4)(A) until March 28, 2023.

If, within that monitoring

period, the Listing Qualifications staff (“Staff”) finds the Company out of compliance with one or more listing standards

during that period notwithstanding Rule 5810(c)(2), the Company will not be permitted to provide the Staff with a plan of compliance with

respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect

to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3).

Instead, Staff

will issue a Staff Delist Determination and the Company will have an opportunity to request a new hearing with the initial Hearings Panel

or a newly convened Hearings Panel if the initial Hearings Panel is unavailable.

The Company will have the opportunity to respond/present

to the Hearings Panel as provided by Listing Rule 5815(d)(4)(A).

If the hearing is unsuccessful, the Company’s securities may be

at that time delisted from Nasdaq.

During the monitoring period,

the Company failed to maintain compliance with the minimum bid price of $1.00 per share for 9 consecutive trading days between March 16,

2023 and March 28, 2023.

Since the end of the monitoring period, the Company has failed to maintain compliance with the minimum bid price

of $1.00 per share for 12 consecutive trading days between March 29, 2023 and April 14, 2023.

If we are delisted from Nasdaq,

our common stock may be eligible for trading on an over-the-counter market.

If we are not able to obtain a listing on another stock exchange

or quotation service for our common stock, it may be extremely difficult or impossible for stockholders to sell their shares.

to monitor the closing bid price of our common stock and may be required to seek approval from our stockholders to affect a reverse stock

split of the issued and outstanding shares of our common stock.

However, there can be no assurance that the reverse stock split would

be approved by our stockholders.

Further, there can be no assurance that the market price per new share of our common stock after the

reverse stock split will remain unchanged or increase in proportion to the reduction in the number of old shares of our common stock

outstanding before the reverse stock split.

Even if the reverse stock split is approved by our stockholders, there can be no assurance

that we will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq

listing rules.

If we are delisted from Nasdaq,

but obtain a substitute listing for our common stock, it will likely be on a market with less liquidity, and therefore experience potentially

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Future sales or issuances of substantial

amounts of our common stock, including, potentially, as a result of the acquisition transaction with Cellvera Global f/k/a AiPharma Global,

could result in significant dilution.

amounts of our common stock, including, potentially, as a result of the future acquisitions or strategic transactions, including the transaction

with Cellvera Global, could result in significant dilution.

On December 28, 2021, we entered

into a Share Exchange Agreement with Cellvera Global f/k/a AiPharma Global, pursuant to which we (i)

will acquire 9.5% of the issued and outstanding equity interests in Cellvera Global in exchange for the issuance of 4,816,193 shares of

our common stock of Aditxt and a cash payment of $250,000, at an initial closing upon the satisfaction or waiver of certain conditions

and (ii) acquire the remaining 90.5% of the issued and outstanding equity interests in Cellvera Global in exchange for the

issuance of 39,927,974 shares of our common stock and a cash payment of $250,000 at a secondary closing upon the satisfaction or waiver

of certain conditions to closing.

Additionally, we may elect to raise additional capital due to market conditions or strategic

considerations.

If additional shares are issued in connection with the proposed acquisition transaction or additional capital is raised

through the sale of equity or convertible debt securities, the issuance of those securities could result in further dilution to our stockholders.

into a Share Exchange Agreement with Cellvera Global f/k/a AiPharma Global, pursuant to which we (i) will acquire 9.5% of the issued

and outstanding equity interests in Cellvera Global in exchange for the issuance of 96,324 shares of our common stock of Aditxt and a

cash payment of $250,000, at an initial closing upon the satisfaction or waiver of certain conditions to closing;

and (ii) acquire the

remaining 90.5% of the issued and outstanding equity interests in Cellvera Global in exchange for the issuance of 798,560 shares of our

common stock and a cash payment of $250,000 at a secondary closing upon the satisfaction or waiver of certain conditions to closing.

Additionally,

we may elect to raise additional capital due to market conditions or strategic considerations.

If additional shares are issued in connection

with the proposed acquisition transaction or additional capital is raised through the sale of equity or convertible debt securities, the

issuance of those securities could result in further dilution to our stockholders.

While we have entered into a Share Exchange

Agreement with Cellvera Global , we cannot assure you that the transactions contemplated by

the Share Exchange Agreement will be consummated or, that if such transactions are consummated, they will be accretive to stockholder

initial closing under the Share Exchange Agreement was expected to occur on or before January 31, 2022.

We can provide no assurance that

the conditions to the initial closing will be satisfied.

Further, even if we are able to complete the initial closing following

the satisfaction of such conditions, there is no guarantee that the conditions to the secondary closing, including but not limited to,

the approval of the transaction by our stockholders, will be completed in the time frame or in the manner currently anticipated, or that

we will recognize the anticipated benefits of the transaction.

Agreement with Cellvera Global, we cannot assure you that the transactions contemplated by the Share Exchange Agreement will be

consummated or, that if such transactions are consummated, they will be accretive to stockholder value.

The initial closing under

the Share Exchange Agreement was expected to occur on or before January 31, 2022.

We can provide no assurance that the conditions to

the initial closing will be satisfied.

Further, even if we are able to complete the initial closing following the satisfaction of

such conditions, there is no guarantee that the conditions to the secondary closing, including but not limited to, the approval of the

transaction by our stockholders, will be completed in the time frame or in the manner currently anticipated, or that we will recognize

the anticipated benefits of the transaction.

In connection with the contemplated acquisition

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the Forbearance Agreement, the Company and the Borrower also agreed to certain amendments to the Credit Agreement, including, but not

(i) the delivery by Cellvera Global of certain financial statements and forecasts,

and (ii) certain regularly scheduled payments to be made by Cellvera Global to the Company

during the forbearance period.

If Cellvera Global defaults upon its obligations under the Forbearance Agreement or if we are otherwise

unable to complete the contemplated acquisition of Cellvera Global under the Share Exchange Agreement, we cannot provide any assurance

that we will be able to time collect the amounts due under the Secured Credit Agreement, if at all.

The note receivable to Cellvera Global

was deemed impaired and written down to zero at December 31, 2021.

(i) the delivery by Cellvera Global of certain financial statements and forecasts, and (ii) certain regularly scheduled

payments to be made by Cellvera Global to the Company during the forbearance period.

If Cellvera Global defaults upon its

obligations under the Forbearance Agreement or if we are otherwise unable to complete the contemplated acquisition of Cellvera Global

under the Share Exchange Agreement, we cannot provide any assurance that we will be able to time collect the amounts due under the Secured

Credit Agreement, if at all.

The note receivable to Cellvera Global was deemed impaired and written down to zero as of December 31, 2021.

We may engage in future acquisitions or

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into a Share Exchange Agreement with Cellvera Global in December 2021.

We also entered into a non-binding letter of intent to acquire

a point-of care diagnostic technology development company in December 2021.

We may need to acquire additional financing to fund our obligations

under the Share Exchange Agreement, the letter of intent or to fund other potential acquisitions or strategic transactions (particularly,

if the acquired entity is not cash flow positive or does not have significant cash on hand).

Obtaining financing through the issuance

or sale of additional equity and/or debt securities, if possible, may not be at favorable terms and may result in additional dilution

to our current stockholders.

Additionally, any such transaction may require us to incur non-recurring or other charges, may increase our

near and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely

affect our operations and financial results.

For example, an acquisition or strategic transaction may entail numerous operational and

financial risks, including the risks outlined above and additionally:

We have also entered into other non-binding letters of intent.

We may need to acquire additional financing to fund our obligations under the Share Exchange Agreement, the letter of intent or to fund

other potential acquisitions or strategic transactions (particularly, if the acquired entity is not cash flow positive or does not have

significant cash on hand).

Obtaining financing through the issuance or sale of additional equity and/or debt securities, if possible,

may not be at favorable terms and may result in additional dilution to our current stockholders.

Additionally, any such transaction may

require us to incur non-recurring or other charges, may increase our near and long-term expenditures and may pose significant integration

challenges or disrupt our management or business, which could adversely affect our operations and financial results.

For example, an acquisition

or strategic transaction may entail numerous operational and financial risks, including the risks outlined above and additionally:

to unknown liabilities;

● disruption of our business and diversion of our management’s

time and attention in order to develop acquired products or technologies;

● higher than expected acquisition and integration costs;

● write-downs of assets or goodwill or impairment charges;

● increased amortization expenses;

● difficulty and cost in combining the operations and personnel

of any acquired businesses with our operations and personnel;

● impairment of relationships with key suppliers or customers

of any acquired businesses due to changes in management and ownership;

● inability to retain key employees of any acquired businesses.

of our business and diversion of our management’s time and attention in order to develop acquired products or technologies;

than expected acquisition and integration costs;

● write-downs

of assets or goodwill or impairment charges;

amortization expenses;

and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;

to retain key employees of any acquired businesses.

Accordingly, although there

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dissolution or winding-up of our Company, whether voluntary or involuntary, our assets would be used to pay all of our debts and liabilities,

and only thereafter would any remaining assets be distributed to our stockholders, subject to rights of the holders of the Preferred Stock,

if any, on a pro rata basis.

There can be no assurance that we will have assets available from which to pay any amounts

to our stockholders upon such a liquidation, dissolution or winding-up.

and only thereafter would any remaining assets be distributed to our stockholders, subject to rights of the holders of the Preferred

Stock, if any, on a pro rata basis.

There can be no assurance that we will have assets available from which to pay any

amounts to our stockholders upon such a liquidation, dissolution or winding-up.

In such an event, you would lose all of your investment.

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Amended and Restated Certificate of Incorporation, the Company shall indemnify, hold harmless and provide advancement of expenses, to

the fullest extent permitted by applicable law, directors, officers, employees, and agents that are made a party or threatened to be made

a party to legal proceedings by reason of the fact that such parties were working at the request of the Company.

We direct you to

the Company’s Amended and Restated Certificate of Incorporation for more information.

the fullest extent permitted by applicable law, directors, officers, employees, and agents that are made a party or threatened to be

made a party to legal proceedings by reason of the fact that such parties were working at the request of the Company.

you to the Company’s Amended and Restated Certificate of Incorporation for more information.

Anti-takeover provisions under Delaware

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we incur significant legal, accounting and other expenses.

Our management and other personnel devote a substantial amount of time to comply

with our reporting obligations.

Moreover, these reporting obligations increase our legal and financial compliance costs and make some

activities more time-consuming and costly.

Our management and other personnel devote a substantial amount of time to

comply with our reporting obligations.

Moreover, these reporting obligations increase our legal and financial compliance costs and make

some activities more time-consuming and costly.

Failure to develop our internal controls

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rights, and provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.

Our Amended and Restated Certificate

of Incorporation provides for the authorization to issue up to 3,000,000 shares of “blank check” preferred stock with

designations, rights and preferences as may be determined from time to time by our board of directors.

Our board of directors is empowered,

without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting or other rights

which could dilute the interest of, or impair the voting power of, our common stockholders.

The issuance of a series of preferred stock

could be used as a method of discouraging, delaying or preventing a change in control.

For example, it would be possible for our board

of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change

control of our company.

In addition, advanced notice is required prior to stockholder proposals, which might further delay a change of

Our Amended and Restated

Certificate of Incorporation provides for the authorization to issue up to 3,000,000 shares of “blank check” preferred

stock with designations, rights and preferences as may be determined from time to time by our board of directors.

Our board of directors

is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting

or other rights which could dilute the interest of, or impair the voting power of, our common stockholders.

The issuance of a series

of preferred stock could be used as a method of discouraging, delaying or preventing a change in control.

For example, it would be possible

for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt

to change control of our company.

In addition, advanced notice is required prior to stockholder proposals, which might further delay

a change of control.

Our Amended and Restated Certificate of

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for disputes with the Company or its directors, officers or employees.

Our Amended and Restated Certificate

of Incorporation provides that unless the Company consents in writing to the selection of an alternative forum, the State of Delaware

is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting

a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s

stockholders, (iii) any action asserting a claim against the Company, its directors, officers or employees arising pursuant to any provision

of the Delaware General Corporation Law (the “DGCL”) or our Amended and Restated Certificate of Incorporation or

the Company’s Amended and Restated Bylaws, or (iv) any action asserting a claim against the Company, its directors, officers, employees

or agents governed by the internal affairs doctrine, except for, as to each of (i) through (iv) above, any claim as to which the Court

of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable

party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), which is vested

in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery does not have subject

matter jurisdiction.

This exclusive forum provision would not apply to suits brought to enforce any liability or duty created by the Securities

Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

To the extent that any such claims

may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to

enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

Our Amended and Restated

Certificate of Incorporation provides that unless the Company consents in writing to the selection of an alternative forum, the State

of Delaware is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of the Company, (ii)

any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company

or the Company’s stockholders, (iii) any action asserting a claim against the Company, its directors, officers or employees arising

pursuant to any provision of the Delaware General Corporation Law (the “DGCL”) or our Amended and Restated Certificate

of Incorporation or the Company’s Amended and Restated Bylaws, or (iv) any action asserting a claim against the Company, its directors,

officers, employees or agents governed by the internal affairs doctrine, except for, as to each of (i) through (iv) above, any claim

as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery

(and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination),

which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery

does not have subject matter jurisdiction.

This exclusive forum provision would not apply to suits brought to enforce any liability or

duty created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction

over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

Section 22 of the Securities

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States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities

Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation are deemed to have

notice of and consented to this provision.

Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation are deemed to

have notice of and consented to this provision.

The Supreme Court of Delaware has held that this type of exclusive federal forum provision

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We are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common

stock less attractive to investors.

We are an “emerging growth

company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to take advantage

of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth

companies” including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley

Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from

the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments

not previously approved.

In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we intend

to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new

or revised accounting standards.

In other words, an “emerging growth company” can delay the adoption of certain accounting

standards until those standards would otherwise apply to private companies.

As a result, our financial statements may not be comparable

to those of companies that comply with public company effective dates for complying with new or revised accounting standards.

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our

common stock less attractive to investors.

We are an “emerging

growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to take

advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging

growth companies” including not being required to comply with the auditor attestation requirements of Section 404(b) of the

Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden

parachute payments not previously approved.

In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company”

we intend to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying

with new or revised accounting standards.

In other words, an “emerging growth company” can delay the adoption of certain

accounting standards until those standards would otherwise apply to private companies.

As a result, our financial statements may not

be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.

We cannot predict if investors

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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