What changed in this filing

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Item 1A. Risk Factors

2022-03-31 compared with 2021-03-25 · 1075 added, 935 removed, 75 unchanged (96% of the section changed)

Risk Factors.

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.

Related to Our Financial Position and Need for Capital

have generated no 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.

Our net loss for the years ended December 31, 2020 and 2019 was $9,149,227 and $5,827,728, respectively, and our

accumulated deficit as of December 31, 2020 was $20,879,178.

There can be no assurance that the products under development by

us will be approved for sale in the U.S.

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,

2021 and 2020 was $46,371,364 and $9,149,227, respectively, and our accumulated deficit as of December 31, 2021 was $67,352,809.

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

or elsewhere.

Furthermore, there can be no assurance that if such products are approved,

they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.

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.

Our current cash position, we expect to be sufficient to satisfy our capital requirements sufficient to fund our operations

for the foreseeable future.

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.

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.

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.

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

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

ability to enter into and maintain collaborative, licensing and other commercial relationships;

and our partners’

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 revenues.

For the years ended

December 31, 2020 and 2019, the Company had a net loss of $9,149,227 and $5,827,728, 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.

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.

working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire

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.

expect that our current cash position will be sufficient to fund our current operations for at least the next 18 months.

However, 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

In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, our product

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

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

and this would require additional capital.

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

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

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.

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

The amount of capital we may

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

the progress, timing and scope

of our preclinical studies and clinical trials;

the 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, 2021

and 2020, the Company had a net loss of $46,371,364 and $9,149,227, 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.

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.

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.

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.

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.

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.

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 for marketing approval;

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 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 all.

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

If adequate funds are

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

viability will be materially adversely affected.

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, if

We will not be permitted to

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

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;

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

for marketing approval;

FDA or foreign regulator may disagree with the number, design, size, conduct or implementation of our clinical trials;

1 unchanged sentence

FDA or foreign regulator may not approve the formulation, labeling or specifications of our product candidates;

contract research organizations (CROs) and other contractors that we may retain to conduct our clinical trials may take actions

outside of our control that materially adversely impact our clinical trials;

FDA or foreign regulator may find the data from preclinical studies and clinical trials insufficient to demonstrate that our

product candidate(s) are safe and effective for their proposed indications;

contract research organizations (CROs) and other contractors that we may retain to conduct our clinical trials may take actions outside

of our control that materially adversely impact our clinical trials;

FDA or foreign regulator may find the data from preclinical studies and clinical trials insufficient to demonstrate that our product

candidate(s) are safe and effective for their proposed indications;

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;

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

minimization strategies to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of

approval or post-approval;

FDA or other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party

manufacturers with which we contract;

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

strategies to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of approval or post-approval;

FDA or other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party manufacturers

with which we contract;

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

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 approval.

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 at all.

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

may prevent successful or timely completion of clinical development include:

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:

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 study site;

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;

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

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

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

study operations or study sites;

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;

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

in having patients’

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

study sites or patients dropping out of a study;

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

unanticipated

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

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

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

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

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.

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

candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.

these occurrences may significantly harm our business, financial condition and prospects.

In addition, many of the factors that

cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory

approval of our product candidates.

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,

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

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

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

required to change the way the product is administered;

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

regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified

risk evaluation and mitigation strategy;

damage to our reputation.

Additionally,

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

The inclusion of ill patients

in our clinical studies may result in deaths or other adverse medical events due to other therapies or medications that such patients

may be using.

As described above, any of these events could prevent us from achieving or maintaining market acceptance of our

product candidates and impair our ability to commercialize our products.

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.

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 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

of clinical safety and efficacy;

convenience, dosing burden and ease of administration;

prevalence and severity of any adverse effects;

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

of our product candidates compared to competing products;

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

may be approved;

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

and cost-effectiveness;

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

effectiveness of our own or any future collaborators’

sales and marketing strategies;

or warnings contained in approved labeling from regulatory authorities;

ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including

Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals

from government bodies regulating the pricing and usage of therapeutics;

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

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.

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

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.

the FDA or applicable foreign regulatory agency concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS;

● failure to perform in accordance with the FDA’s

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

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

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

clinical study sites or patients dropping out of a study;

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

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

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

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

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.

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

and approval process and jeopardize our ability to commence product sales and generate revenues.

Any of these occurrences may significantly

harm our business, financial condition and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement

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:

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

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

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

be required to change the way the product is administered;

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

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

experience damage to our reputation.

Additionally, our product candidates

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

The inclusion of ill patients in our clinical studies may

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

As described above,

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

to commercialize our products.

If our future pre-clinical development and

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

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:

demonstration of clinical safety and efficacy;

relative convenience, dosing burden and ease of administration;

the prevalence and severity of any adverse effects;

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

efficacy of our product candidates compared to competing products;

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

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

pricing and cost-effectiveness;

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

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

limitations or warnings contained in approved labeling from regulatory authorities;

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

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

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

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.

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.

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 ongoing revenues.

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

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

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

ongoing revenues.

This can be a costly and resource draining activity.

to be promising technologies when we license them may not lead to viable technologies or products, or to commercial success.

What appear to be promising technologies when we license them may

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

Complying with numerous regulations pertaining

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

To renew this certificate, we are

subject to survey and inspection every two years.

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

outside of the renewal process.

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

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

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

We must maintain CLIA compliance and certification to be eligible

to bill for assays provided to Medicare beneficiaries.

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

to sanctions, our business and reputation could be harmed.

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

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

To renew this certificate, we are subject

to survey and inspection every two years.

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

the renewal process.

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

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

civil injunctive suit and/or criminal penalties.

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

provided to Medicare beneficiaries.

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

our business and reputation could be harmed.

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

significant expenses and potentially lose revenue in doing so.

Additionally, certain states

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

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.

Related to the Company and our Business

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.

Without these licenses, we may not be able to continue to develop

our product candidates.

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.

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

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.

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

Additional Milestone Deadlines include:

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

application to initiate first-in-human clinical trials on or before March 31, 2022, (ii) the completion of first-in-human (phase I/II)

clinical trials by March 31, 2024, (iii) the completion of Phase III clinical trials by March 31, 2026 and (iv) biologic licensing approval

(BLA) by the FDA by March 31, 2027.

If the LLU License Agreement were to be terminated by LLU, we would lose our most significant asset

and may no longer be able to develop our product candidates, which would have a material adverse effect on our operations.

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);

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, 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;

(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.

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.

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.

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.

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:

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 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.

Our technologies and products under development,

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

Successful development of technologies

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

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

quantities at acceptable costs while also preserving product quality.

Difficulties often encountered in scaling up production include

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

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

These risks include the possibility that

any of our technologies or future products may:

found unsafe;

8 unchanged sentences

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

may not adopt our products quickly, or at all.

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 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 than we do.

As a result, they may be able to devote greater resources to the manufacture, promotion or sale of their products,

receive greater resources and support from market partners and independent distributors, initiate or withstand substantial price

competition or more readily take advantage of acquisition or other opportunities.

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.

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.

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.

We rely on third parties for the distribution

of our current and future products, including our AditxtScore™

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™

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.

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:

reduced control over delivery schedules, yields and product reliability;

price increases;

manufacturing deviations from internal and regulatory specifications;

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

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

misappropriation of our intellectual property;

other risks in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct customers and end users.

If we need to enter into

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

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.

anticipate relying on independent market partners and distributors to distribute and assist us with the marketing and sale of

our products.

Our future revenue generation and growth will depend in large part on our success in establishing and maintaining

this sales and distribution channel.

If our market partners and distributors are unable to sell our products, or receive negative

feedback from end users, they may not continue to purchase or market our products.

In addition, there can be no assurance that

our market partners and distributors will focus adequate resources on selling our products to end users or will be successful

in selling them.

Many of our potential market partners and distributors are in the business of distributing and sometimes manufacturing

other, possibly competing, products.

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 products.

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

to us, including the following:

control over delivery schedules, yields and product reliability;

● manufacturing

deviations from internal and regulatory specifications;

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

● difficulties

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

● misappropriation

of our intellectual property;

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

customers and end users.

If we need to enter into agreements

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

If we 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.

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.

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

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 Mr.

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

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

We anticipate relying on independent

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

Our future revenue generation

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

If our market

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

or market our products.

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

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

Many of our potential market partners and distributors are

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

As a result, these market partners

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

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

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

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

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 Mr.

Amro Albanna and 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.

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.

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.

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,

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.

may impact our operations.

January 30, 2020 the World Health Organization declared the COVID-19 coronavirus outbreak a “Public Health Emergency of

International Concern”

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

Actions taken around the world to help mitigate

the spread of the coronavirus include restrictions on travel, and quarantines in certain areas, and forced closures for certain

types of public places and businesses.

The COVID-19 coronavirus and actions taken to mitigate it have had and are expected to

continue to have an adverse impact on the economies and financial markets of many countries, including the geographical area in

which the Company operates.

While it is unknown how long these conditions will last and what the complete financial effect will

be to the Company, capital raise efforts and additional development of our technologies may be negatively affected.

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 effectively.

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:

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;

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.

The COVID-19 coronavirus

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

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

While it is unknown how long these conditions will last

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

be negatively affected.

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

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

may be subject to interference proceedings;

8 unchanged sentences

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 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;

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.

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.

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.

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.

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.

However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of

our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect

on our business and financial condition.

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) or the patent rights of others.

An adverse determination in any such submission, proceeding

or litigation could reduce the scope of, or invalidate, our patent rights (whether licensed or otherwise held), allow third parties

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

manufacture or commercialize products without infringing third-party patent rights.

In addition, if the breadth or strength of

protection provided by our patents and patent applications (whether licensed or otherwise held) is threatened, it could dissuade

companies from collaborating with us to license, develop or commercialize current or future product candidates.

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.

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

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

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.

However, the Leahy-Smith Act and its implementation

could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our

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

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

or the patent rights of others.

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

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

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

third-party patent rights.

In addition, if the breadth or strength of protection provided by our patents and patent applications (whether

licensed or otherwise held) is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize

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.

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.

We may become involved in lawsuits to protect

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

Competitors may infringe our

intellectual property.

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

and time-consuming.

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

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

In addition, in a patent infringement

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

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

not cover that technology.

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

and ultimately unsuccessful.

may infringe our intellectual property.

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

which can be expensive and time-consuming.

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

counterclaims against us alleging that we infringe their intellectual property or that our intellectual property is invalid or

unenforceable.

In addition, in a patent infringement proceeding, a court may decide that a licensed or owned patent of ours is

invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from

using the technology at issue on the grounds that our patents do not cover that technology.

Moreover, lawsuits to protect or enforce

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

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.

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.

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.

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 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.

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.

of our 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

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.

of the intellectual property rights we own or have licensed have been generated through the use of United States government funding

and may therefore be subject to certain federal regulations.

As a result, the United States government may have certain rights

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

These United States government rights in certain inventions developed under a government-funded program include a non-exclusive,

non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

In addition, the United States

government has the right to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions

to a third party if it determines that:

(i) adequate steps have not been taken to commercialize the invention;

(ii) government

action is necessary to meet public health or safety needs;

or (iii) government action is necessary to meet requirements for

public use under federal regulations (also referred to as “march-in rights”).

The United States government also has

the right to take title to these inventions if we fail to disclose the invention to the government and fail to file an application

to register the intellectual property within specified time limits.

In addition, the United States government may acquire title

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

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 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

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

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

and other similar provisions during the patent application process.

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

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

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

Noncompliance

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

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

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

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.

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

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.

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.

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;

or (iii) government

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

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

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

In addition, the United States government

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

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

us to expend substantial resources.

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

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

The manufacturing

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

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

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

This preference for United

States manufacturers may limit our ability to contract with non-U.S.

product manufacturers for products covered by such intellectual

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.

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.

We may 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.

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.

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

are currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock

exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could

be impaired and it may be more difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s

minimum listing requirements or those of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid

market for our common stock does not develop or is sustained, our common stock may remain thinly traded.

listing rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

for any reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from

trading on its exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all

of the following may occur, each of which could have a material adverse effect on our stockholders:

liquidity of our common stock;

market price of our common stock;

ability to obtain financing for the continuation of our operations;

number of institutional and general investors that will consider investing in our common stock;

number of investors in general that will consider investing in our common stock;

number of market makers in our common stock;

availability of information concerning the trading prices and volume of our common stock;

number of broker-dealers willing to execute trades in shares of our common stock.

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.

dissolution of our Company, you may not recoup all or any portion of your investment.

the event of a liquidation, 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.

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, we received

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

Based upon the closing bid price for

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

However, the Nasdaq Listing Rules also provide us a compliance

period of 180 calendar days in which to regain compliance.

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

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

confirmation of compliance and the matter will be closed.

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

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

To qualify, we would be required to meet all other

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

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

to cure the deficiency during the second compliance period.

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

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

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

If we are not able to obtain a listing

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

their shares.

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

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

However, there can be no assurance that the

reverse stock split would be approved by our stockholders.

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

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

of our common stock outstanding before the reverse stock split.

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

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

with other Nasdaq listing rules.

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 acquisition transaction with Cellvera Global f/k/a AiPharma Global,

could result in significant dilution.

On December 28, 2021, we entered

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

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

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

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

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

of certain conditions to closing.

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

considerations.

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

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

While we have entered into a Share Exchange

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

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

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

We can provide no assurance that

the conditions to the initial closing will be satisfied.

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

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

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

we will recognize the anticipated benefits of the transaction.

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

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

We may need to acquire additional financing to fund our obligations

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

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

Obtaining financing through the issuance

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

to our current stockholders.

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

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

affect our operations and financial results.

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

financial risks, including the risks outlined above and additionally:

to unknown liabilities;

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

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

● higher than expected acquisition and integration costs;

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

● increased amortization expenses;

● difficulty and cost in combining the operations and personnel

of any acquired businesses with our operations and personnel;

● impairment of relationships with key suppliers or customers

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

● inability to retain key employees of any acquired businesses.

Accordingly, although there

can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transactions

that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects.

Upon dissolution of our Company, you may

not recoup all or any portion of your investment.

In the event of a liquidation,

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.

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

of Liability and Indemnification of Management.

Delaware General Corporation Law and the Company’s Amended and Restated Certificate of Incorporation provide for the limitation

of the liability of directors for monetary damages.

Such provisions may discourage shareholders from bringing a lawsuit against

directors for breaches of fiduciary duty and may also have the effect of reducing the likelihood of derivative litigation against

directors and officers even though such action, if successful, might otherwise be a benefit to the Company’s shareholders.

addition, a shareholder’s investment in the Company may be adversely affected to the extent that costs of settlement and

damage awards against the Company’s officers or directors are paid by the Company pursuant to such provisions.

Additionally,

in accordance with Delaware law and the Company’s Amended and Restated Certificate of Incorporation, the Company shall indemnify,

hold harmless and provide advancement of expenses, to the fullest extent permitted by applicable law, directors, officers, employees,

and agents that are made a party or threatened to be made a party to legal proceedings by reason of the fact that such parties

were working at the request of the Company.

We direct you to the Company’s Amended and Restated Certificate of Incorporation

for more information.

Anti-takeover

provisions under Delaware law could discourage, delay or prevent a change in control of our Company and could affect the trading

price of our securities.

are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent

a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three

years after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders.

management team is required to devote substantial time to public company compliance initiatives.

a publicly reporting company, 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.

to develop our internal controls over financial reporting as we grow could have an adverse impact on us.

our Company matures, we will need to develop our current internal control systems and procedures to manage our growth.

required to establish and maintain appropriate internal controls over financial reporting.

Failure to establish appropriate controls,

or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial

condition or results of operations.

In addition, management’s assessment of internal controls over financial reporting may

identify weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters

that may raise concerns for investors.

Any actual or perceived weaknesses and conditions that need to be addressed in our internal

control over financial reporting, disclosure of management’s assessment of our internal controls over financial reporting

or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal

controls over financial reporting may have an adverse impact on the price of our common stock.

could issue “blank check”

preferred stock without stockholder approval with the effect of diluting interests

of then-current stockholders and impairing their voting rights, and provisions in our charter documents and under Delaware law

could discourage a takeover that stockholders may consider favorable.

Amended and Restated Certificate of Incorporation provides for the authorization to issue up to 3,000,000 shares of “blank

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.

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

Amended and Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole

and exclusive forum for substantially all disputes between the Company and its stockholders, which could limit stockholders’

ability to obtain a favorable judicial forum for disputes with the Company or its directors, officers or employees.

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

22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty

or liability created by the Securities Act or the rules and regulations thereunder.

However, our Amended and Restated Bylaws contain

a federal forum provision which provides that unless the Company consents in writing to the selection of an alternative forum,

the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting

a cause of action arising under the Securities Act.

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 is enforceable.

There may be uncertainty, however, as to whether

courts of other jurisdictions would enforce such a provision, if applicable.

choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable

for disputes with the Company or its directors, officers or other employees, which may discourage such lawsuits against us and

our directors, officers and other employees.

Alternatively, if a court were to find our choice of forum provisions contained in

either our Amended and Restated Certificate of Incorporation or Amended and Restated Bylaws to be inapplicable or unenforceable

in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our

business, results of operations, and financial condition.

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.

are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),

and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public

companies that are not “emerging growth companies”

including not being required to comply with the auditor attestation

requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation

in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive

compensation and shareholder approval of any golden parachute payments not previously approved.

In addition, pursuant to Section 107

of the JOBS Act, as an “emerging growth company”

we intend to take advantage of the extended transition period provided

in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.

In other words, an “emerging

growth company”

can delay the adoption of certain accounting standards until those standards would otherwise apply to private

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.

cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.

If some investors

find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock

price may be more volatile.

We may take advantage of these reporting exemptions until we are no longer an “emerging growth

company.”

We will remain an “emerging growth company”

until the earliest of (i) the last day of the fiscal

year in which we have total annual gross revenues of $1.07 billion or more;

(ii) the last day of our fiscal year following

the fifth anniversary of the date of the completion of our initial public offering;

(iii) the date on which we have issued

more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are deemed

to be a large accelerated filer under the rules of the SEC.

Limitation of Liability and Indemnification

of Management.

The Delaware General Corporation

Law and the Company’s Amended and Restated Certificate of Incorporation provide for the limitation of the liability of directors

for monetary damages.

Such provisions may discourage shareholders from bringing a lawsuit against directors for breaches of fiduciary

duty and may also have the effect of reducing the likelihood of derivative litigation against directors and officers even though such

action, if successful, might otherwise be a benefit to the Company’s shareholders.

In addition, a shareholder’s investment

in the Company may be adversely affected to the extent that costs of settlement and damage awards against the Company’s officers

or directors are paid by the Company pursuant to such provisions.

Additionally, in accordance with Delaware law and the Company’s

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

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

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

We direct you to

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

Anti-takeover provisions under Delaware

law could discourage, delay or prevent a change in control of our Company and could affect the trading price of our securities.

We are a Delaware corporation

and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting

us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested

stockholder, even if a change in control would be beneficial to our existing stockholders.

Our management team is required to devote

substantial time to public company compliance initiatives.

As a publicly reporting company,

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.

Failure to develop our internal controls

over financial reporting as we grow could have an adverse impact on us.

As our Company matures, we

will need to develop our current internal control systems and procedures to manage our growth.

We are required to establish and maintain

appropriate internal controls over financial reporting.

Failure to establish appropriate controls, or any failure of those controls once

established, could adversely impact our public disclosures regarding our business, financial condition or results of operations.

management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed

in our internal controls over financial reporting or other matters that may raise concerns for investors.

Any actual or perceived weaknesses

and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment

of our internal controls over financial reporting or disclosure of our public accounting firm’s attestation to or report on management’s

assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.

We could issue “blank check” preferred

stock without stockholder approval with the effect of diluting interests of then-current stockholders and impairing their voting

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

Our Amended and Restated Certificate

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

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

Our board of directors is empowered,

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

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

The issuance of a series of preferred stock

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

For example, it would be possible for our board

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

control of our company.

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

Our Amended and Restated Certificate of

Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially

all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum

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

Our Amended and Restated Certificate

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

is the sole and exclusive forum for:

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

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

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

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

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

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

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

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

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

matter jurisdiction.

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

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

To the extent that any such claims

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

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

Section 22 of the Securities

Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the

Securities Act or the rules and regulations thereunder.

However, our Amended and Restated Bylaws contain a federal forum provision which

provides that unless the Company consents in writing to the selection of an alternative forum, the federal district courts of the United

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.

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

is enforceable.

There may be uncertainty, however, as to whether courts of other jurisdictions would enforce such a provision, if applicable.

These choice of forum provisions

may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or

its directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees.

Alternatively, if a court were to find our choice of forum provisions contained in either our Amended and Restated Certificate of Incorporation

or Amended and Restated Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving

such action in other jurisdictions, which could harm our business, results of operations, and financial condition.

We are an “emerging growth company”

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

stock less attractive to investors.

We are an “emerging growth

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

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

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

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

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

not previously approved.

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

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

or revised accounting standards.

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

standards until those standards would otherwise apply to private companies.

As a result, our financial statements may not be comparable

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

We cannot predict if investors

will find our common stock less attractive because we may rely on these exemptions.

If some investors find our common stock less attractive

as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

We may take advantage

of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth

company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion

(ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Unresolved Staff Comments.

lease property consisting of office and laboratory space located at 2569 Wyandotte, St., Suite 101 Mountain View, CA 94043.

expires on August 31, 2024, subject to extension.

Not applicable.

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