What changed in this filing

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Item 1A. Risk Factors

2024-04-16 compared with 2023-04-17 · 837 added, 981 removed, 255 unchanged (88% of the section changed)

Risk Factors.

You should carefully consider the risks described

below, as well as general economic and business risks and the other information in this Annual Report on Form 10-K.

The occurrence

of any of the events or circumstances described below or other adverse events could have a material adverse effect on our business, results

of operations and financial condition and could cause the trading price of our common stock to decline.

Additional risks or uncertainties

not presently known to us or that we currently deem immaterial may also harm our business.

Risks Related to Our Financial Position and

Need for Capital

We have generated no significant revenue

from commercial sales to date and our future profitability is uncertain.

We were incorporated in September

2017 and have a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business

Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently

encountered in connection with development and expansion of a new business enterprise.

Since inception, we have incurred losses and expect

to continue to operate at a net loss for at least the next several years as we commence our research and development efforts, conduct

clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

Our net loss for the years ended December

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.

should carefully consider the risks described below, as well as general economic and business risks and the other information in this

Annual Report on Form 10-K.

The occurrence of any of the events or circumstances described below or other adverse events could have

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

stock to decline.

Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our

Related to Our Financial Position and Need for Capital

have generated no significant revenue from commercial sales to date and our future profitability is uncertain.

were incorporated in September 2017 and have a limited operating history and our business is subject to all of the risks inherent in

the establishment of a new business enterprise.

Our likelihood of success must be considered in light of the problems, expenses, difficulties,

complications and delays frequently encountered in connection with development and expansion of a new business enterprise.

Since inception,

we have incurred losses and expect to continue to operate at a net loss for at least the next several years as we commence our research

and development efforts, conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

for the years ended December 31, 2023 and 2022 was $32,390,447 and $27,549,876, respectively, and our accumulated deficit as of December

31, 2023 was $127,635,389.

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

or elsewhere.

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.

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 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

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.

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.

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.

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 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 terms.

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

If we cannot raise adequate

funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical

studies or future operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements may

require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights

to future product candidates or certain major geographic markets.

This could result in sharing revenues which we might otherwise retain

for ourselves.

we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development

activities, clinical studies or future operations.

We may also be required to obtain funds through arrangements with collaborators, which

arrangements may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing,

including rights to future product candidates or certain major geographic markets.

This could result in sharing revenues which we might

otherwise retain for ourselves.

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;

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;

our ability to enter into and maintain collaborative,

licensing and other commercial relationships;

and our partners’ commitment of time and resources to the development and commercialization

of our products.

Our financial situation creates doubt whether

we will continue as a going concern.

The Company was incorporated

on September 28, 2017 and through the date of this report has generated no significant revenues.

For the years ended December 31, 2022

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.

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,

which may not be available on acceptable terms, or at all.

Failure to obtain this necessary capital when needed may force us to delay,

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.

Any additional fundraising

efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize

our product candidates.

In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable

to us, if at all.

Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance

of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares

the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into

and maintain collaborative, licensing and other commercial relationships;

and our partners’ commitment of time and resources to

the development and commercialization of our products.

financial situation creates doubt whether we will continue as a going concern.

Company was incorporated on September 28, 2017 and through the date of this report has generated no significant revenues.

For the years

ended December 31, 2023 and 2022, the Company had a net loss of $32,390,447 and $27,649,876, 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.

may need to raise additional funding, which may not be available on acceptable terms, or at all.

Failure to obtain this necessary capital

when needed may force us to delay, limit or terminate our product development efforts or other operations.

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.

additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to

develop and commercialize our product candidates.

In addition, we cannot guarantee that future financing will be available in sufficient

amounts or on terms acceptable to us, if at all.

Moreover, the terms of any financing may adversely affect the holdings or the rights

of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may

cause the market price of our shares to decline.

The sale of additional equity or convertible securities may dilute our existing stockholders.

The incurrence of indebtedness

would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations

on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other

operating restrictions that could adversely impact our ability to conduct our business.

We could also be required to seek funds through

arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to

relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have

a material adverse effect on our business, operating results and prospects.

If we are unable to obtain

funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development

programs or the commercialization of any product candidate or be unable to expand our operations or otherwise capitalize on our business

opportunities, as desired, which could materially affect our business, financial condition and results of operations.

Even if we can raise additional funding,

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

The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive

covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual

property rights and other operating restrictions that could adversely impact our ability to conduct our business.

We could also be required

to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and

we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to

us, any of which may have a material adverse effect on our business, operating results and prospects.

we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our

research or development programs or the commercialization of any product candidate or be unable to expand our operations or otherwise

capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of

if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

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.

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.

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.

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

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

Risks Related to Product Development, Regulatory

Approval, Manufacturing and Commercialization

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,

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.

The testing, manufacturing, labeling, approval, selling, marketing

and distribution of health and life science-related products are subject to extensive regulation, which regulations differ from country

Successfully completing our

clinical program and obtaining approval of a Biologics License Application (“BLA”) is a complex, lengthy, expensive and uncertain

process, and the FDA or other applicable foreign regulator may delay, limit or deny approval of our product candidates for many reasons,

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;

Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

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 any.

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.

The testing, manufacturing, labeling,

approval, selling, marketing and distribution of health and life science-related products are subject to extensive regulation, which

regulations differ from country to country.

completing our clinical program and obtaining approval of a Biologics License Application (“BLA”) is a complex, lengthy,

expensive and uncertain process, and the FDA or other applicable foreign regulator may delay, limit or deny approval of our product candidates

for many reasons, 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;

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.

It is difficult to predict

if or when any of our product candidates, will prove safe or effective in humans or will receive regulatory approval.

obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies

to demonstrate the safety and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming and uncertain

as to outcome.

We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all.

of one or more clinical studies can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical

development include:

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.

is difficult to predict if or when any of our product candidates, will prove safe or effective in humans or will receive regulatory

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive

clinical studies to demonstrate the safety and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming

and uncertain as to outcome.

We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if

A failure of one or more clinical studies can occur at any stage of testing.

Events that may prevent successful or timely completion

of clinical development include:

in reaching, or failing to reach, a consensus with regulatory agencies on study design;

in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations

(“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly

among different CROs and trial 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;

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

other countries;

delays in reaching,

or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”)

and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs

and trial sites;

delays in obtaining required

Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical study site;

delays in recruiting a

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

imposition of a clinical

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

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

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and guidance that require amending or submitting new clinical protocols.

We could also encounter delays

if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted,

by an independent Safety Review Board (“SRB”) for such trial or by the FDA, European Medicines Agency (“EMA”),

or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors, including

failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical

trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen

safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative

actions or lack of adequate funding to continue the clinical trial.

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.

Clinical study delays could

also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors

to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such

trials are being conducted, by an independent Safety Review Board (“SRB”) for such trial or by the FDA, European Medicines

Agency (“EMA”), or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due

to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols,

inspection of the clinical trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition

of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in

governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

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.

study delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow

our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates.

addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development

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or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

The outcome of preclinical

studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial

do not necessarily predict final results.

Further, preclinical and clinical data are often susceptible to various interpretations and

analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical

trials have, nonetheless, failed to obtain marketing approval.

If the results of our clinical studies are inconclusive or if there

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

outcome of preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results

of a clinical trial do not necessarily predict final results.

Further, preclinical and clinical data are often susceptible to various

interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical

studies and clinical trials have, nonetheless, failed to obtain marketing approval.

If the results of our clinical studies are inconclusive

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

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

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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.

If the pre-clinical development

and clinical trials are unsuccessful or produce inconsistent results or unanticipated adverse side effects, or if we are unable to collect

reliable data, regulatory approval of our products could be delayed or not given and as a result we may be unable to commercialize our

Generally, we expect to engage third parties such as consultants, universities or other collaboration partners to conduct clinical

trials on our behalf.

Incompatible practices or misapplication of our products by these third parties could impair the success of our

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.

If approved for marketing,

the commercial success of our product candidates will depend upon each product’s acceptance by the medical community, including

physicians, patients and health care payors.

The degree of market acceptance for any of our product candidates will depend on a number

of factors, including:

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

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.

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.

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

the pre-clinical development and clinical trials are unsuccessful or produce inconsistent results or unanticipated adverse side effects,

or if we are unable to collect reliable data, regulatory approval of our products could be delayed or not given and as a result we may

be unable to commercialize our products.

Generally, we expect to engage third parties such as consultants, universities or other collaboration

partners to conduct clinical trials on our behalf.

Incompatible practices or misapplication of our products by these third parties could

impair the success of our clinical trials.

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.

approved for marketing, the commercial success of our product candidates will depend upon each product’s acceptance by the medical

community, including physicians, patients and health care payors.

The degree of market acceptance for any of our product candidates will

depend on a number of factors, including:

demonstration

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

If any of our product candidates

are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate

sufficient revenues and we may not be able to achieve or sustain profitability.

Our efforts to educate the medical community and third-party

payors on the benefits of our product candidates may require significant resources and may never be successful.

In addition, even if we obtain

regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates

successfully.

For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability

to develop competing products or establish market dominance.

Any regulatory approval we ultimately obtain may be limited or subject to

restrictions or post-approval commitments that render our product candidates not commercially viable.

For example, regulatory authorities

may approve any of our product candidates for fewer or more limited indications than we request, may grant approval contingent on the

performance of costly post-marketing clinical trials, or may approve any of our product candidates with a label that does not include

the labeling claims necessary or desirable for the successful commercialization for that indication.

Further, the FDA or comparable foreign

regulatory authorities may place conditions on approvals or require risk management plans or a Risk Evaluation and Mitigation Strategy

(“REMS”) to assure the safe use of the drug.

If the FDA or applicable foreign regulatory agency concludes a REMS is needed,

the sponsor of the BLA must submit a proposed REMS;

the regulatory agencies will not approve the BLA without an approved REMS, if required.

A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution

methods, patient registries and other risk minimization tools.

The regulatory agencies may also require a REMS for an approved product

when new safety information emerges.

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution,

prescription or dispensing of our product candidates.

Moreover, product approvals may be withdrawn for non-compliance with regulatory

standards or if problems occur following the initial marketing of the product.

Any of the foregoing scenarios could materially harm the

commercial success of our product candidates.

Adverse events involving our products may

lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that could

harm our reputation, business and financial results.

Once a product receives regulatory

clearance or approval, the agency has the authority to require the recall of commercialized products in the event of adverse side effects,

material deficiencies or defects in design or manufacture.

The authority to require a recall must be based on a regulatory finding that

there is a reasonable probability that the product would cause serious injury or death.

Manufacturers may, under their own initiative,

recall a product if any material deficiency in a product is found.

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 sales.

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

The in-licensing of technologies and the

successful testing and early development of technologies in the laboratory may not be indicative of future results and may not result

in commercially viable technologies or products.

Further, our future products may have to be modified from their originally conceived

versions in order to reach or be successful in the market.

Positive results from laboratory

testing and early developmental successes, may not be predictive of future successful development, commercialization and sales results

and should not be relied upon as evidence that products developed from our technologies will become commercially viable and successful.

Further, the products we plan to develop in the future may have to be significantly modified from their originally conceived versions

in order for us to control costs, compete with similar products, receive market acceptance, meet specific development and commercialization

any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and

patients, we may not generate sufficient revenues and we may not be able to achieve or sustain profitability.

Our efforts to educate

the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never

be successful.

addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize

our product candidates successfully.

For example, if the approval process takes too long, we may miss market opportunities and give other

companies the ability to develop competing products or establish market dominance.

Any regulatory approval we ultimately obtain may be

limited or subject to restrictions or post-approval commitments that render our product candidates not commercially viable.

regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may grant approval

contingent on the performance of costly post-marketing clinical trials, or may approve any of our product candidates with a label that

does not include the labeling claims necessary or desirable for the successful commercialization for that indication.

Further, the FDA

or comparable foreign regulatory authorities may place conditions on approvals or require risk management plans or a Risk Evaluation

and Mitigation Strategy (“REMS”) to assure the safe use of the drug.

If the FDA or applicable foreign regulatory agency concludes

a REMS is needed, the sponsor of the BLA must submit a proposed REMS;

the regulatory agencies will not approve the BLA without an approved

REMS, if required.

A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted

distribution methods, patient registries and other risk minimization tools.

The regulatory agencies may also require a REMS for an approved

product when new safety information emerges.

Any of these limitations on approval or marketing could restrict the commercial promotion,

distribution, prescription or dispensing of our product candidates.

Moreover, product approvals may be withdrawn for non-compliance with

regulatory standards or if problems occur following the initial marketing of the product.

Any of the foregoing scenarios could materially

harm the commercial success of our product candidates.

events involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or

result in product recalls that could harm our reputation, business and financial results.

a product receives regulatory clearance or approval, the agency has the authority to require the recall of commercialized products in

the event of adverse side effects, material deficiencies or defects in design or manufacture.

The authority to require a recall must

be based on a regulatory finding that there is a reasonable probability that the product would cause serious injury or death.

Manufacturers

may, under their own initiative, recall a product if any material deficiency in a product is found.

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 sales.

In addition, the regulatory agency could take enforcement action for failing to report

the recalls when they were conducted.

in-licensing of technologies and the successful testing and early development of technologies in the laboratory may not be indicative

of future results and may not result in commercially viable technologies or products.

Further, our future products may have to be modified

from their originally conceived versions in order to reach or be successful in the market.

results from laboratory testing and early developmental successes, may not be predictive of future successful development, commercialization

and sales results and should not be relied upon as evidence that products developed from our technologies will become commercially viable

and successful.

Further, the products we plan to develop in the future may have to be significantly modified from their originally conceived

versions in order for us to control costs, compete with similar products, receive market acceptance, meet specific development and commercialization

timeframes, avoid potential infringement of the proprietary rights of others, or otherwise succeed in developing our business and earning

3 unchanged sentences

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

Complying with numerous regulations pertaining

to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.

We are subject to the Clinical

Laboratory Improvement Amendment of 1988, or CLIA, which is a federal law regulating clinical laboratories that perform testing on specimens

derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease.

Our clinical laboratory

is located in Richmond, Virginia and must be certified under CLIA in order for us to perform testing on human specimens.

CLIA is intended

to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel

qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance

and inspections.

with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result

in substantial penalties.

are subject to the Clinical Laboratory Improvement Amendment of 1988, or CLIA, which is a federal law regulating clinical laboratories

that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment

Our clinical laboratory is located in Richmond, Virginia and must be certified under CLIA in order for us to perform testing

on human specimens.

CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating

specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management,

quality control, quality assurance and inspections.

We currently hold a CLIA certificate to perform high-complexity testing.

Laboratories performing high complexity testing

are required to meet more stringent requirements than laboratories performing less complex tests.

CLIA regulations require clinical laboratories

like ours to comply with various operational, personnel, facilities administration, quality, and proficiency testing requirements intended

to ensure that testing services are accurate, reliable and timely.

CLIA certification is a prerequisite for reimbursement eligibility

for services provided to state and federal health care program beneficiaries.

CLIA is user-fee funded.

Therefore, all costs of administering

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.

Additionally, certain states

require laboratory licenses in order to test specimens from patients in those states or received from ordering physicians in those states.

We may also be subject to regulation in foreign jurisdictions if we seek to expand international distribution of our assays outside the

United States.

If we were to lose our CLIA

certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer be able

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 states.

Risks Related to the Company and our Business

Our technology is subject to licenses from

LLU and Stanford, each of which are revocable in certain circumstances, including in the event we do not achieve certain payments and

milestone deadlines.

performing high complexity testing are required to meet more stringent requirements than laboratories performing less complex tests.

CLIA regulations require clinical laboratories like ours to comply with various operational, personnel, facilities administration, quality,

and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.

CLIA certification is

a prerequisite for reimbursement eligibility for services provided to state and federal health care program beneficiaries.

CLIA is user-fee

Therefore, all costs of administering the program must be covered by the regulated facilities, including certification and survey

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 require laboratory licenses in order to test specimens from patients in those states or received from ordering physicians

in those states.

We may also be subject to regulation in foreign jurisdictions if we seek to expand international distribution of our

assays outside the United States.

we were to lose our CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we

would no longer be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our

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.

Related to the Company and our Business

Certain technologies are subject to licenses

from LLU and Stanford, each of which are revocable in certain circumstances, including in the event we do not achieve certain payments

and milestone deadlines.

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 LLU.

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 (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;

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

application to initiate first-in-human clinical trials on or before March 31, 2023 (which has been extended to March 31, 2024 with a payment

of a $100,000 extension fee), (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.

February 2020 License Agreement with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments;

are not diligently developing and commercializing Licensed Product (as defined in the February 2020 License Agreement);

milestone described in the agreement;

(iv) are in breach of any other provision of the agreement;

or (v) if we provide a false report to Stanford.

The Termination discussed

above will take effect only upon 30 days written notice by Stanford unless we remedy the breach within a 30-day cure period.

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.

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

to in-licensed intellectual property.

Any failure on our part to pay royalties owed or meet milestones could lead to us losing rights

under our licenses and could thereby adversely affect our business.

As our product sales increase, we may, from time-to-time, disagree

with our third-party collaborators as to the appropriate royalties owed and the resolution of such disputes may be costly and may consume

management’s time.

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.

The development and commercialization

of drugs is highly competitive.

We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies,

as well as products and processes being developed at universities and other research institutions.

Our competitors have developed, are

developing or will develop product candidates and processes competitive with our product candidates.

Competitive therapeutic treatments

include those that have already been approved and accepted by the medical community and any new treatments that may enter the market.

We believe that a significant number of products are currently available, under development, and may become commercially available in

the future, for the treatment of indications for which we may try to develop product candidates.

More established companies

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

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

or (v) if we provide a false

report to Stanford.

The Termination discussed above will take effect only upon 30 days written notice by Stanford unless we remedy

the breach within a 30-day cure period.

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

The Company is current with its obligations and have submitted a year end report as well as provided additional

milestone plans for research and development as well as commercialization.

results of operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties.

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.

Any failure on our part to pay royalties owed or meet milestones could lead

to us losing rights under our licenses and could thereby adversely affect our business.

As our product sales increase, we may, from time-to-time,

disagree with our third-party collaborators as to the appropriate royalties owed and the resolution of such disputes may be costly and

may consume management’s time.

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

royalty payments.

face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

development and commercialization of drugs is highly competitive.

We compete with a variety of multinational pharmaceutical companies

and specialized biotechnology companies, as well as products and processes being developed at universities and other research institutions.

Our competitors have developed, are developing or will develop product candidates and processes competitive with our product candidates.

Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments

that may enter the market.

We believe that a significant number of products are currently available, under development, and may become

commercially available in the future, for the treatment of indications for which we may try to develop product candidates.

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

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.

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.

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.

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.

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:

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

with lengthy market partner or distributor evaluation and approval processes.

Consequently, we may incur substantial expenses and devote

significant management effort in order to customize products for market partner or distributor acceptance, though there can be no assurance

of such acceptance.

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.

we may be faced with lengthy market partner or distributor evaluation and approval processes.

Consequently, we may incur substantial

expenses and devote significant management effort in order to customize products for market partner or distributor acceptance, though

there can be no assurance of such acceptance.

As a result, we cannot accurately predict the volume or timing of any future sales.

Customers may not adopt our products quickly,

Customers in the sector in

which we operate can be generally cautious in their adoption of new products and technologies.

In addition, given the relative novelty

of our future planned products (including our AditxtScore™ platform), customers of those products may require education regarding

their utility and use, which may delay their adoption.

There can be no assurance that customers will adopt our products quickly, or at

The significant level of competition in

the markets for our products developed in the future may result in pricing pressure, reduced margins or the inability of our future products

to achieve market acceptance.

The markets for our future

products are intensely competitive and rapidly changing.

We may be unable to compete successfully, which may result in price reductions,

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.

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

of acquisition or other opportunities.

We rely on third parties for the distribution

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

If these parties do not distribute our products in

a satisfactory or timely manner, in sufficient quantities or at an acceptable cost, our sales and development efforts could be delayed

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 may rely on third parties for the production

of our future products.

If these parties do not produce our products at a satisfactory quality, in a timely manner, in sufficient

quantities or at an acceptable cost, our sales and development efforts could be delayed or otherwise negatively affected.

We may rely on third parties

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:

may not adopt our products quickly, or at all.

in the sector in which we operate can be generally cautious in their adoption of new products and technologies.

In addition, given the

relative novelty of our future planned products (including our AditxtScore™ platform), customers of those products may require

education regarding their utility and use, which may delay their adoption.

There can be no assurance that customers will adopt our products

quickly, or at all.

significant level of competition in the markets for our products developed in the future may result in pricing pressure, reduced margins

or the inability of our future products to achieve market acceptance.

markets for our future products are intensely competitive and rapidly changing.

We may be unable to compete successfully, which may result

in price reductions, reduced margins and the inability to achieve market acceptance for our products.

competitors may have longer operating histories, significantly greater resources, greater brand recognition and large customer bases

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 from market partners and independent distributors, initiate or withstand substantial price competition

or more readily take advantage of acquisition or other opportunities.

rely on third parties for the distribution of our current and future products, including our AditxtScore™ platform.

parties do not distribute our products in a satisfactory or timely manner, in sufficient quantities or at an acceptable cost, our sales

and development efforts could be delayed or otherwise negatively affected.

rely on third parties for the distribution of our current and future products, including our AditxtScore™ platform.

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

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.

may rely on third parties for the production of our future products.

If these parties do not produce our products at a satisfactory

quality, in a timely manner, in sufficient quantities or at an acceptable cost, our sales and development efforts could be delayed or

otherwise negatively affected.

may rely on third parties 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:

reduced control

9 unchanged sentences

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

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.

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.

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

highly skilled employees and contractors, we may not be able to implement our business model successfully.

We will rely upon employees

and third-party consultant/contractors to effectively establish, manage and grow our business.

Consequently, we believe that our future

viability will depend largely on our ability to attract and retain highly skilled personnel.

In order to do so, we may need to pay

higher compensation, fees, and/or other incentives to our employees or consultants than we currently expect, and such higher compensation

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.

The loss of our management team or other

key personnel would have an adverse impact on our future development and impair our ability to succeed.

In the early stages of development,

our business will be significantly dependent on the Company’s management team and other key personnel.

Our success will be particularly

dependent upon our Chief Executive Officer, Mr.

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.

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

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

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.

these market partners and distributors may perceive our products as a threat to various product lines currently being distributed or

manufactured by them.

In 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.

we are not able to attract and retain highly skilled employees and contractors, we may not be able to implement our business model successfully.

will rely upon employees and third-party consultant/contractors to effectively establish, manage and grow our business.

Consequently,

we believe that our future viability will depend largely on our ability to attract and retain highly skilled personnel.

to do so, we may need to pay higher compensation, fees, and/or other incentives to our employees or consultants than we currently expect,

and such higher compensation 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.

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.

loss of our management team or other key personnel would have an adverse impact on our future development and impair our ability to succeed.

the early stages of development, our business will be significantly dependent on the Company’s management team and other key personnel.

Our success will be particularly 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 use of our planned products

may be regulated by various local, state, federal and foreign regulators.

Even if we are able to comply with all such regulations

and obtain all necessary registrations, we cannot provide assurance that our future products will not cause injury to the environment,

people, or animals and/or otherwise have unintended adverse consequences, under all circumstances.

For example, our products may be improperly

combined with other chemicals or, even when properly combined, our products may be blamed for damage caused by those other chemicals.

The costs of remediation or products liability could materially adversely affect our results, financial condition and operations.

We may be held liable for, or incur costs

to settle, liability and remediation claims if any products we develop, or any products that use or incorporate any of our technologies,

cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use.

These risks exist even with respect

to products that have received, or may in the future receive, regulatory approval, registration or clearance for commercial use.

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.

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

liability-related losses.

In the future, it is possible that meaningful insurance coverage may not be available on commercially reasonable

terms or at all.

In addition, a product liability claim could result in liability to us greater than our assets or insurance coverage.

Moreover, even if we have adequate insurance coverage, product liability claims or recalls could result in negative publicity or force

us to devote significant time and attention to these matters, which could harm our business.

There may be limitations on the effectiveness

of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our Company.

We do not expect that internal

control over financial accounting and disclosure, even if timely and well established, will prevent all error and all fraud.

system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s

objectives will be met.

Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits

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.

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.

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

The failure to obtain or maintain patents,

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

to our technologies and intellectual property.

However, there are significant risks associated with our actual or proposed intellectual

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.

use of our products may be limited by regulations, and we may be exposed to product liability and remediation claims.

use of our planned products may be regulated by various local, state, federal and foreign regulators.

Even if we are able to comply

with all such regulations and obtain all necessary registrations, we cannot provide assurance that our future products will not cause

injury to the environment, people, or animals and/or otherwise have unintended adverse consequences, under all circumstances.

our products may be improperly combined with other chemicals or, even when properly combined, our products may be blamed for damage caused

by those other chemicals.

The costs of remediation or products liability could materially adversely affect our results, financial condition

and operations.

may be held liable for, or incur costs to settle, liability and remediation claims if any products we develop, or any products that use

or incorporate any of our technologies, cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or

These risks exist even with respect to products that have received, or may in the future receive, regulatory approval, registration

or clearance for commercial use.

We cannot guarantee that we will be able to avoid product liability exposure.

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 liability-related losses.

In the future, it is possible that meaningful insurance coverage may not be available

on commercially reasonable terms or at all.

In addition, a product liability claim could result in liability to us greater than our assets

or insurance coverage.

Moreover, even if we have adequate insurance coverage, product liability claims or recalls could result in negative

publicity or force us to devote significant time and attention to these matters, which could harm our business.

may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may

materially harm our Company.

do not expect that internal control over financial accounting and disclosure, even if timely and well established, will prevent all error

and all fraud.

A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that

the control system’s objectives will be met.

Further, the design of a control system must reflect the fact that there are resource

constraints, and the benefits 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.

Relating to Our Intellectual Property Rights

failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete

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.

However, there are significant risks associated with our actual

or proposed intellectual property.

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

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.

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.

or in foreign countries;

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;

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

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

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

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,

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.

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

or narrowed in scope.

In addition, since publication of discoveries in scientific or patent literature often lags behind actual discoveries,

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.

If we are unable to obtain and maintain

patent protection for our products, or if the scope of the patent protection obtained is not sufficiently broad, competitors could develop

and commercialize products similar or identical to ours, and our ability to successfully commercialize our products could be impaired.

The patent prosecution process

is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable

cost, in a timely manner, or in all jurisdictions.

It is also possible that we will fail to identify patentable aspects of our development

output before it is too late to obtain patent protection.

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.

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

the patentability of methods of treatment of the human body.

Our pending and future patent applications may not result in patents being

issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive

technologies and products.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries

may diminish the value of our patents or narrow the scope of our patent protection, even post-grant.

Recent patent reform legislation

has increased the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued

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, or narrowed in scope.

In addition, since publication of discoveries in scientific or patent literature often

lags behind actual discoveries, we cannot be certain that we or our licensors were the first to invent or to file patent applications

covering them.

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.

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.

we are unable to obtain and maintain patent protection for our products, or if the scope of the patent protection obtained is not sufficiently

broad, competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize

our products could be impaired.

patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent

applications at a reasonable cost, in a timely manner, or in all jurisdictions.

It is also possible that we will fail to identify patentable

aspects of our development output before it is too late to obtain patent protection.

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.

For example, unlike the U.S.,

European patent law restricts the patentability of methods of treatment of the human body.

Our pending and future patent applications

may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others

from commercializing competitive technologies and products.

Changes in either the patent laws or interpretation of the patent laws in

the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection, even post-grant.

patent reform legislation has increased the uncertainties and costs surrounding the prosecution of patent applications and the enforcement

or defense of issued patents.

On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law.

The Leahy-Smith Act

includes a number of significant changes to United States patent law.

These include provisions that affect the way patent applications

are prosecuted and may also affect patent litigation.

Patent and Trademark Office, or USPTO, recently developed new regulations

and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the

Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013.

Accordingly, it is not clear

what, if any, impact the Leahy-Smith Act will have on the operation of our business.

The Leahy-Smith Act includes a number of significant changes to United States patent law.

These include provisions that affect the way

patent applications are prosecuted and may also affect patent litigation.

Patent and Trademark Office, or USPTO, recently developed

new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated

with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013.

Accordingly, it is

not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business.

However, the Leahy-Smith Act and its implementation

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issued patents, all of which could have a material adverse effect on our business and financial condition.

Moreover, we may be subject

to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter

we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter

partes review, post-grant review or interference proceedings challenging our patent rights (whether licensed or otherwise held)

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current or future product candidates.

Even if our patent applications

(whether licensed or otherwise held) result in the issuance of patents, they may not issue in a form that will provide us with any meaningful

protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be

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.

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.

if our patent applications (whether licensed or otherwise held) result in the issuance of patents, they may not issue in a form that

will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive

Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies

or products in a non-infringing manner.

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.

may become involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and

ultimately unsuccessful.

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

3 unchanged sentences

time-consuming and ultimately unsuccessful.

Third parties may initiate legal proceedings

alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.

Our commercial success depends

upon our ability to develop, manufacture, market and sell our product candidates without infringing the proprietary rights of third parties.

parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would

be uncertain.

commercial success depends upon our ability to develop, manufacture, market and sell our product candidates without infringing the proprietary

rights of third parties.

There is considerable intellectual property litigation in the life sciences industry.

We cannot guarantee that our product candidates

will not infringe third-party patents or other proprietary rights.

We may become party to, or threatened with, future adversarial proceedings

or litigation regarding intellectual property rights with respect to our products and technology, including inter partes review,

interference, or derivation proceedings before the USPTO and similar bodies in other countries.

Third parties may assert infringement

claims against us based on existing intellectual property rights and intellectual property rights that may be granted in the future.

If we are found to infringe

a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing

and marketing our products.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed

We cannot guarantee that

our product candidates will not infringe third-party patents or other proprietary rights.

We may become party to, or threatened with,

future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including inter

partes review, interference, or derivation proceedings before the USPTO and similar bodies in other countries.

Third parties

may assert infringement claims against us based on existing intellectual property rights and intellectual property rights that may be

granted in the future.

we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third

party to continue developing and marketing our products.

However, we may not be able to obtain any required license on commercially reasonable

terms or at all.

Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same

technologies licensed to us.

We could be forced, including by court order, to cease commercializing the infringing technology or product.

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

operations, which could materially harm our business.

Claims that we have misappropriated the confidential information or trade secrets

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 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

asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own

intellectual property.

Certain employees and contractors

were previously employed at universities or other companies, including potential competitors.

Although we try to ensure that our employees

and contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these

employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s

former employer.

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

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

intellectual property that we regard as our own.

Our and their assignment agreements may not be self-executing or may be breached, and

we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what

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.

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.

Some intellectual property which we own

or have licensed may have been discovered through government funded programs such as, for example, the government funded programs referenced

in intellectual property licensed under the LLU License Agreement, and thus may be subject to federal regulations such as “march-in”

rights, certain reporting requirements, and a preference for United States industry.

Compliance with such regulations may limit our exclusive

rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S.

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 patent.

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

some of our business operations, which could materially harm our business.

Claims that we have misappropriated the confidential information

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

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.

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 patent.

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.

In such an event, our competitors might be able to enter our markets, which could have a material

adverse effect on our business.

may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming

ownership of what we regard as our own intellectual property.

employees and contractors were previously employed at universities or other companies, including potential competitors.

Although we try

to ensure that our employees and contractors do not use the proprietary information or know-how of others in their work for us, we may

be subject to claims that these employees or we have used or disclosed intellectual property, including trade secrets or other proprietary

information, of any such employee’s former employer.

Litigation may be necessary to defend against these claims, and any such litigation

could have an unfavorable outcome.

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 intellectual property that we regard as our own.

Our and their assignment agreements may not be self-executing or

may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine

the ownership of what we regard as our intellectual property.

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.

intellectual property which we own or have licensed may have been discovered through government funded programs such as, for example,

the government funded programs referenced in intellectual property licensed under the LLU License Agreement, and thus may be subject

to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United States industry.

Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements,

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

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;

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

(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.

Even if resolved in our favor,

litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract

our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results

of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be

negative, it could have an adverse effect on the price of our common stock.

Such litigation or proceedings could increase our operating

losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

Some of our competitors may be

able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to

compete in the marketplace.

We may spend considerable resources developing

and maintaining patents, licensing agreements and other intellectual property that may later be abandoned or may otherwise never result

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

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

We rely on information technology

networks and systems to process, transmit and store electronic and financial information;

to coordinate our business;

and to communicate

within our Company and with customers, suppliers, partners and other third-parties.

These information technology systems may be susceptible

to damage, disruptions or shutdowns, hardware or software failures, power outages, computer viruses, cyber-attacks, telecommunication

failures, user errors or catastrophic events.

If our information technology systems suffer severe damage, disruption or shutdown, and

our business continuity plans do not effectively resolve the issues in a timely manner, our operations could be disrupted, and our business

could be negatively affected.

In addition, cyber-attacks could lead to potential unauthorized access and disclosure of confidential information,

and data loss and corruption.

There is no assurance that we will not experience these service interruptions or cyber-attacks in the future.

Risks Related to Our Common Stock

We received a written notice from Nasdaq

that we have failed to comply with certain listing requirements of the Nasdaq Stock Market, which could result in our Common Stock being

delisted from the Nasdaq Stock Market.

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

more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares of common stock on any such substitute

market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market.

of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our common stock, warrants and pre-funded warrants

would likely be significantly adversely affected.

A delisting of our common stock from Nasdaq could also adversely affect our ability

to obtain financing for our operations and/or result in a loss of confidence by investors, employees and/or business partners.

We do not expect to pay dividends in the

foreseeable future.

We do not intend to declare

dividends for the foreseeable future, as we anticipate that we will reinvest any and all future earnings in the development and growth

of our business.

Therefore, investors will not receive any funds unless they sell their securities, and holders may be unable to sell

their securities on favorable terms or at all.

We cannot assure you of a positive return on your investment or that you will not lose

the entire amount of your investment.

Future sales or issuances of substantial

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 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 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

of Cellvera Global, we have provided secured loans to Cellvera Global in the aggregate principal amount of $14.5 million, which amounts

came due on January 31, 2022.

Although, we have agreed to forbear from exercising our rights and remedies against Cellvera Global while

we continue to work towards an initial closing under the Share Exchange Agreement, if we are unable to complete the transactions contemplated

by the Share Exchange Agreement, we cannot provide any assurance that we will be able to timely collect such amounts from Cellvera Global,

In connection with the contemplated

acquisition of Cellvera Global, we entered into a Secured Credit Agreement with Cellvera Global, pursuant to which we have provided secured

loans to Cellvera Global in the aggregate principal amount of $14.5 million, which amounts became due on January 31, 2022.

14, 2022, we entered into a Forbearance Agreement with Cellvera Global, pursuant to which we agreed to forbear from exercising our rights

and remedies against Cellvera Global until the earlier of June 30, 2022 or the date of any default under the Forbearance Agreement.

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 as of December 31, 2021.

We may engage in future acquisitions or

strategic transactions, including the transaction with Cellvera Global, which may require us to seek additional financing or financial

commitments, increase our expenses and/or present significant distractions to our management.

As described herein, we entered

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

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:

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

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.

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.

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.

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

if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant

expenses and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public

announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors

perceive these results to be negative, it could have an adverse effect on the price of our common stock.

Such litigation or proceedings

could increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution

We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater

financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise

our ability to compete in the marketplace.

may spend considerable resources developing and maintaining patents, licensing agreements and other intellectual property that may later

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

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.

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.

rely on information technology networks and systems to process, transmit and store electronic and financial information;

to coordinate

our business;

and to communicate within our Company and with customers, suppliers, partners and other third-parties.

These information

technology systems may be susceptible to damage, disruptions or shutdowns, hardware or software failures, power outages, computer viruses,

cyber-attacks, telecommunication failures, user errors or catastrophic events.

If our information technology systems suffer severe damage,

disruption or shutdown, and our business continuity plans do not effectively resolve the issues in a timely manner, our operations could

be disrupted, and our business could be negatively affected.

In addition, cyber-attacks could lead to potential unauthorized access and

disclosure of confidential information, and data loss and corruption.

There is no assurance that we will not experience these service

interruptions or cyber-attacks in the future.

Related to Our Common Stock

We are under a panel monitor from Nasdaq

as we have historically failed to comply with certain listing requirements of the Nasdaq Stock Market, which could result in our Common

Stock being delisted from the Nasdaq Stock Market.

On November 21, 2023, the Company received written

notice from Nasdaq that it had regained compliance with the Public Float Rule.

On December 29, 2023, the Company received written notice

from Nasdaq that it had regained compliance with the Stockholders’ Equity Rule, but will be subject to a Mandatory Panel Monitor

for a period of one year.

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.

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.

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 more price volatility than experienced on Nasdaq.

Stockholders may not be able to sell their shares

of common stock on any such substitute market in the quantities, at the times, or at the prices that could potentially be available on

a more liquid trading market.

As a result of these factors, if our common stock is delisted from Nasdaq, the value and liquidity of our

common stock, warrants and pre-funded warrants would likely be significantly adversely affected.

A delisting of our common stock from

Nasdaq could also adversely affect our ability to obtain financing for our operations and/or result in a loss of confidence by investors,

employees and/or business partners.

do not expect to pay dividends in the foreseeable future.

do not intend to declare dividends for the foreseeable future, as we anticipate that we will reinvest any and all future earnings in

the development and growth of our business.

Therefore, investors will not receive any funds unless they sell their securities, and holders

may be unable to sell their securities on favorable terms or at all.

We cannot assure you of a positive return on your investment or

that you will not lose the entire amount of your investment.

sales or issuances of substantial 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.

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 61 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

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

of 500 shares of our common stock and a cash payment of $250,000 at a secondary closing upon the satisfaction or waiver of certain conditions

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.

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.

connection with the contemplated acquisition of Cellvera Global, we have provided secured loans to Cellvera Global in the aggregate principal

amount of $14.5 million, which amounts came due on January 31, 2022.

Although, we have agreed to forbear from exercising our rights and

remedies against Cellvera Global while we continue to work towards an initial closing under the Share Exchange Agreement, if we are unable

to complete the transactions contemplated by the Share Exchange Agreement, we cannot provide any assurance that we will be able to timely

collect such amounts from Cellvera Global, if at all.

connection with the contemplated acquisition of Cellvera Global, we entered into a Secured Credit Agreement with Cellvera Global, pursuant

to which we have provided secured loans to Cellvera Global in the aggregate principal amount of $14.5 million, which amounts became due

on January 31, 2022.

On February 14, 2022, we entered into a Forbearance Agreement with Cellvera Global, pursuant to which we agreed

to forbear from exercising our rights and remedies against Cellvera Global until the earlier of June 30, 2022 or the date of any default

under the Forbearance Agreement.

Under the Forbearance Agreement, the Company and the Borrower also agreed to certain amendments

to the Credit Agreement, including, but not limited to:

(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

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.

may engage in future acquisitions or strategic transactions, which may require us to

seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management.

described herein, we entered into a Share Exchange Agreement with Cellvera Global in December 2021.

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.

example, an acquisition or strategic transaction may entail numerous operational and financial risks, including the risks outlined above

and additionally:

to unknown liabilities;

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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.

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.

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.

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.

We direct 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 control.

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

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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.

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.

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.

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.

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

8 unchanged sentences

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.

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

11 unchanged sentences

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