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Item 1A. Risk Factors

2023-03-09 compared with 2022-03-31 · 1180 added, 1179 removed, 1482 unchanged (61% of the section changed)

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You should carefully consider the following information about these risks, together with the other information appearing

elsewhere in this Report, including our financial statements, the notes thereto and the section entitled “Management’s Discussion

and Analysis of Financial Condition and Results of Operations,”

before deciding to invest in our common stock.

elsewhere in this Report, including our financial statements, the notes thereto and the section entitled “Management’s Discussion

and Analysis of Financial Condition and Results of Operations,” before deciding to invest in our common stock.

The occurrence of

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and future growth prospects, as well as our ability to accomplish our strategic objectives.

As a result, the trading price of our

common stock could decline and you could lose all or part of your investment.

Additional risks and uncertainties not presently known to

us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

As a result, the trading price of our common

stock could decline and you could lose all or part of your investment.

Additional risks and uncertainties not presently known to us or

that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risks Related to our Financial Position and Need for Capital

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of our business to date and to assess our future viability.

To date, we have devoted substantially all of our

resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support of

our product development efforts, hiring personnel, licensing and developing our technology and vaccine candidates, organizing and staffing

To date, we have devoted substantially all of

our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support

of our product development efforts, hiring personnel, licensing and developing our technology and vaccine candidates, organizing and staffing

our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand

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Our current vaccine candidate pipeline includes

four preclinical programs.

multiple preclinical programs.

We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors

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As a result, we are not profitable and have incurred losses in each year since inception.

Our net losses were $3.4 million

and $1.6 million for the years ended December 31, 2021 and 2020, respectively.

As of December 31, 2021, we had an

accumulated deficit of $6.0 million.

Our net loss was $13.4 million and $3.4

million for the years ended December 31, 2022 and 2021, respectively.

As of December 31, 2022, we had an accumulated deficit of $19.4

We also generated negative operating cash flows of $8.7 million for the year ended December 31, 2022.

We expect to continue to spend significant resources

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We expect to incur substantial and increasing

operating losses over the next several years as our research, development, manufacturing, preclinical testing and clinical trial

activities increase.

operating losses over the next several years as our research, development, manufacturing, preclinical testing and clinical trial activities

As a result, our accumulated deficit will also increase significantly.

Additionally, there can be no assurance that

the product candidates currently under development or that may be under development by us in the future will be approved for sale in the

Additionally, there can be no assurance that the product

candidates currently under development or that may be under development by us in the future will be approved for sale in the U.S.

or elsewhere.

Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized,

and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve profitability,

we may be unable to continue our operations.

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 will require substantial additional funding to finance our

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of our development programs or other operations.

As of December 31, 2021, we had cash and cash

equivalents of $1.9 million.

As of February 28, 2022, we had cash and cash equivalents of $19.3 million as a result of the net proceeds

received from the initial public offering.

We estimate that, based on our existing cash as of December 31, 2021, together with the net

proceeds received from the initial public offering, we have cash on hand sufficient to fund our operations into the second quarter of

We will need to raise additional capital prior to commencing additional pivotal trials for certain of our vaccine candidates.

believe that we will need to raise substantial additional capital to fund our continuing operations and the development and commercialization

of our current product candidates and future product candidates in the long-term.

Our business or 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.

We expect to finance our subsequent

cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution

arrangements, as well as other collaborations, strategic alliances and licensing arrangements or any combination of these approaches.

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 and we may not be able to raise sufficient funds to commercialize our current and future product candidates

we intend to develop.

Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions

and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including the

trading price of common stock, resulting from the ongoing COVID-19 pandemic.

As of December 31, 2022, we had cash of $25.8

As of December 31, 2021, we had cash of $1.9 million.

On April 19, 2022, we closed the April Private Placement from which we

received aggregate net proceeds of approximately $6.9 million, after deducting placement agent fees and other offering expenses.

11, 2022, we closed the August Private Placement from which we received approximately $8.7 million in net proceeds, after deducting placement

agent fees and other offering expenses.

We estimate that, based on our existing cash as of the date of this Report, we will have cash

on hand sufficient to fund our operations for at least the 12 months following the date of this Report.

We believe that we will need to

raise substantial additional capital to fund our continuing operations and the development and commercialization of our current product

candidates and future product candidates in the long-term.

Our business or 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.

We expect to finance our subsequent cash needs through public

or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well

as other collaborations, strategic alliances and licensing arrangements or any combination of these approaches.

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

However, we may not be able to secure funding

when we need it or on favorable terms and we may not be able to raise sufficient funds to commercialize our current and future product

candidates we intend to develop.

Our ability to raise additional capital may be adversely impacted by potential worsening global economic

conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including

the trading price of common stock, resulting from the ongoing COVID-19 pandemic.

Our future capital requirements will depend on many factors,

● the timing, scope, progress, results and costs of research

and development, testing, screening, manufacturing, preclinical development and clinical trials;

● the outcome, timing and cost of seeking and obtaining regulatory

approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we

perform field efficacy studies for our vaccine candidates, require more studies than those that we currently expect or change their requirements

regarding the data required to support a marketing application;

● the cost of building a sales force in anticipation of any

product commercialization;

● the costs of future commercialization activities, including

product manufacturing, marketing, sales, royalties and distribution, for any of our vaccine candidates for which we receive marketing

● our ability to maintain existing, and establish new, strategic

collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any

future milestone, royalty or other payments due under any such agreement;

● any product liability or other lawsuits related to our products;

● the expenses needed to attract, hire and retain skilled personnel;

● the revenue, if any, received from commercial sales, or sales

to foreign governments, of our vaccine candidates for which we may receive marketing approval;

● the costs to establish, maintain, expand, enforce and defend

the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that

we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing of any patents or other intellectual

property rights;

● the expenses needed to attract, hire and retain skilled personnel;

● the costs of operating as a public company;

● the impact of the COVID-19 pandemic, which may exacerbate

the magnitude of the factors discussed above.

timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical development and

clinical trials;

outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including

the potential for such authorities to require that we perform field efficacy studies for our vaccine candidates, require more studies

than those that we currently expect or change their requirements regarding the data required to support a marketing application;

cost of building a sales force in anticipation of any product commercialization;

costs of future commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for any

of our vaccine candidates for which we receive marketing approval;

ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of

any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

product liability or other lawsuits related to our products;

expenses needed to attract, hire and retain skilled personnel;

revenue, if any, received from commercial sales, or sales to foreign governments, of our vaccine candidates for which we may receive

marketing approval;

costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing

of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending

and enforcing of any patents or other intellectual property rights;

expenses needed to attract, hire and retain skilled personnel;

costs of operating as a public company;

impact of the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.

Our ability to raise additional funds will depend

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or the possible sale of our business.

We currently have no agreements or commitments to engage in any specific strategic transactions,

and our exploration of various strategic alternatives may not result in any specific action or transaction.

To the extent that this engagement

results in a transaction, our business objectives may change depending upon the nature of the transaction.

There can be no assurance that

we will enter into any transaction as a result of the engagement.

Furthermore, if we determine to engage in a strategic transaction, we

cannot predict the impact that such strategic transaction might have on our operations or stock price.

We also cannot predict the impact

on our stock price if we fail to enter into a transaction.

Our exploration of various strategic alternatives may not result in any specific action or transaction.

To the extent that this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction.

There can be no assurance that we will enter into any transaction as a result of the engagement.

Furthermore, if we determine to engage

in a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price.

We also cannot predict the impact on our stock price if we fail to enter into a transaction.

In addition, we face significant competition in

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warrants, convertible debt or other similar securities, the ownership interests of our stockholders will be diluted, and the terms of

such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and

other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to

those of our holders of common stock in terms of the payment of dividends or in the event of a liquidation.

In addition, debt financing,

if available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt,

making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security interests

in our assets.

such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and other

provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to those

of our holders of common stock in terms of the payment of dividends or in the event of a liquidation.

In addition, debt financing, if

available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making

capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security interests in our

If we raise additional funds through collaborations, strategic alliances, or marketing, distribution or licensing arrangements

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candidates that may be more profitable or for which there is a greater likelihood of success.

Due to the significant resources required for the

development of our vaccine candidates, we must decide which vaccine candidates to pursue and advance and the amount of resources to allocate

Our decisions concerning the allocation of research, development, management and financial resources toward particular vaccine

candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.

Due to the significant resources required for

the development of our vaccine candidates, we must decide which vaccine candidates to pursue and advance and the amount of resources to

allocate to each.

Our decisions concerning the allocation of research, development, management and financial resources toward particular

vaccine candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.

Similarly, our potential decisions to delay, terminate, license or collaborate with third parties in respect of certain vaccine candidates

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or avoid material weaknesses in the future.

Our current controls and any new controls that we

develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international

Our current controls and any new controls that

we develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international

Further, weaknesses in our disclosure controls or our internal control over financial reporting may be discovered in the future.

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and other information, which would likely have a negative effect on the market price of our common stock.

We are not currently required to comply with the

SEC rules that implement Section 404 of the Sarbanes-Oxley Act, and are therefore not required to make a formal assessment of the

effectiveness of our internal control over financial reporting for that purpose.

We will be required to provide an annual management report

on the effectiveness of our internal control over financial reporting commencing with our second annual report on Form 10-K.

independent registered public accounting firm is not required to audit the effectiveness of our internal control over financial reporting

until after we are no longer an “emerging growth company”

as defined in the JOBS Act.

At such time, our independent registered

public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control

over financial reporting is documented, designed or operating.

We are required to comply with the SEC rules that

implement Section 404 of the Sarbanes-Oxley Act, and are therefore required to make a formal assessment of the effectiveness of our internal

control over financial reporting for that purpose.

We are required to provide an annual management report on the effectiveness of our

internal control over financial reporting in our annual report on Form 10-K.

Our independent registered public accounting firm is not

required to audit the effectiveness of our internal control over financial reporting until after we are no longer an “emerging growth

company” as defined in the JOBS Act.

At such time, our independent registered public accounting firm may issue a report that is

adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed

or operating.

Our ability to use our net operating loss carryforwards and certain

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As of December 31, 2022, we had U.S.

and state net operating loss carryforwards of approximately $4.9 million and $5.1 million, respectively.

Under Sections 382

and 383 of the Internal Revenue Code, or the Code, if a corporation undergoes an “ownership change,”

the corporation’s

ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research

tax credits, to offset its post-ownership change income and taxes may be limited.

In general, an ownership change will occur when the

percentage of the Corporation’s ownership (by value) of one or more “5-percent stockholders”

(as defined in the Code)

has increased by more than 50 percent over the lowest percentage owned by such stockholders at any time during the prior three years

(calculated on a rolling basis).

Similar rules may apply under state tax laws.

An entity that experiences an ownership change generally

will be subject to an annual limitation on its pre-ownership change tax loss and credit carryforwards equal to the equity value of the

corporation immediately before the ownership change, multiplied by the long-term, tax-exempt rate posted monthly by the U.S.

Revenue Service (subject to certain adjustments).

The annual limitation would be increased each year to the extent that there is an unused

limitation in a prior year.

In the event that it is determined that we have in the past experienced an ownership change as a result of

transactions in our stock, or if we experience one or more ownership changes as a result of future transactions in our stock, then we

may be limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable

income that we earn.

Any limitations on the ability to use our net operating loss carryforwards and other tax assets could harm our business.

federal and state

net operating loss carryforwards of approximately $12.5 million and $12.1 million, respectively.

Under Sections 382 and 383 of the Internal

Revenue Code, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-ownership

change net operating loss carryforwards and other pre-ownership change tax attributes, such as research tax credits, to offset its post-ownership

change income and taxes may be limited.

In general, an ownership change will occur when the percentage of the Corporation’s ownership

(by value) of one or more “5-percent stockholders” (as defined in the Code) has increased by more than 50 percent over the

lowest percentage owned by such stockholders at any time during the prior three years (calculated on a rolling basis).

Similar rules may

apply under state tax laws.

An entity that experiences an ownership change generally will be subject to an annual limitation on its pre-ownership

change tax loss and credit carryforwards equal to the equity value of the corporation immediately before the ownership change, multiplied

by the long-term, tax-exempt rate posted monthly by the U.S.

Internal Revenue Service (subject to certain adjustments).

The annual limitation

would be increased each year to the extent that there is an unused limitation in a prior year.

In the event that it is determined that

we have in the past experienced an ownership change as a result of transactions in our stock, or if we experience one or more ownership

changes as a result of future transactions in our stock, then we may be limited in our ability to use our net operating loss carryforwards

and other tax assets to reduce taxes owed on the net taxable income that we earn.

Any limitations on the ability to use our net operating

loss carryforwards and other tax assets could harm our business.

Our insurance coverage may be inadequate or expensive.

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our results of operations and financial condition.

Our insurance coverage may be insufficient to protect

us against all losses and costs stemming from operational and technological failures and we cannot be certain that such insurance will

continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any future

The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence of

changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance requirements,

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

Our insurance coverage may be insufficient to

protect us against all losses and costs stemming from operational and technological failures and we cannot be certain that such insurance

will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any

future claim.

The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence

of changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance

requirements, could have an adverse effect on our business, financial condition and results of operations.

Risks Related to the Development of our Product Candidates

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become profitable.

We do not have any products that have received regulatory

approval and may never be able to develop marketable product candidates.

We expect that a substantial portion of our efforts and expenses

over the next few years will be devoted to the development of our product candidates;

specifically, the commencement of Phase I

clinical trials for our vaccine candidates.

We do not have any products that have received

regulatory approval and may never be able to develop marketable product candidates.

We expect that a substantial portion of our efforts

and expenses over the next few years will be devoted to the development of our product candidates;

specifically, the commencement of Phase

I clinical trials for our vaccine candidates.

As a result, our business currently depends heavily on the successful development, regulatory

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factors, including:

● completing clinical trials that demonstrate their efficacy

● receiving marketing approvals from applicable regulatory

● completing any post-marketing studies required by applicable

regulatory authorities;

● establishing commercial manufacturing capabilities;

● launching commercial sales, marketing and distribution operations;

● the prevalence and severity of adverse events experienced

with our product candidates;

● acceptance of our product candidates by patients, the medical

community and third-party payors;

● a continued acceptable safety profile following approval;

● obtaining and maintaining healthcare coverage and adequate

reimbursement for our product candidates;

● competing effectively with other therapies, including with

respect to the sales and marketing of our product candidates, if approved;

● qualifying for, maintaining, enforcing and defending our

intellectual property rights and claims.

Many of these factors are beyond our control, including

the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual property

rights and changes in the competitive landscape.

It is possible that none of our product candidates will ever obtain regulatory approval,

even if we expend substantial time and resources seeking such approval.

If we do not achieve one or more of these factors in a timely

manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory approval

or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and results of operations.

clinical trials that demonstrate their efficacy and safety;

marketing approvals from applicable regulatory authorities;

any post-marketing studies required by applicable regulatory authorities;

● establishing

commercial manufacturing capabilities;

commercial sales, marketing and distribution operations;

prevalence and severity of adverse events experienced with our product candidates;

of our product candidates by patients, the medical community and third-party payors;

continued acceptable safety profile following approval;

and maintaining healthcare coverage and adequate reimbursement for our product candidates;

effectively with other therapies, including with respect to the sales and marketing of our product candidates, if approved;

for, maintaining, enforcing and defending our intellectual property rights and claims.

Many of these factors are beyond our control,

including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual

property rights and changes in the competitive landscape.

It is possible that none of our product candidates will ever obtain regulatory

approval, even if we expend substantial time and resources seeking such approval.

If we do not achieve one or more of these factors in

a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory

approval or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and results

of operations.

The marketing approval process of the FDA is lengthy, time consuming

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Our product candidates could fail to receive marketing approval for many reasons, including among others:

● the FDA may disagree with the design or implementation of

our clinical trials;

● Our clinical trials for our product candidate(s) must

be successful if we are to seek and obtain regulatory marketing application through the submission of a new Biological License Application

(BLA) and marketing authorization application (MAA) with the U.S.

Food and Drug Administration (FDA) and the European Medicines

Agency (EMA), respectively.

Advanced clinical trials are often not successful even if prior trials were successful, and even if we are

able to conduct advanced clinical trials and those trials are successful, we may not obtain necessary regulatory approvals for our product

candidate(s) or we may be unable to successfully commercialize our products even if we receive the necessary regulatory approvals

In addition, the process of seeking regulatory approval

to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort and expense incurred,

approval is never guaranteed.

If we are not successful in obtaining timely approval of our product candidates from the FDA, we may never

be able to generate significant revenue and may be forced to cease operations.

The new Biological License Application, or BLA, process

is costly, lengthy and uncertain.

Any BLA application filed by us will have to be supported by extensive data, including, but not limited

to, technical, pre-clinical, clinical, manufacturing and labelling data, to demonstrate to the FDA’s satisfaction the safety and

efficacy of the product for its intended use.

In order to commence a clinical trial in the United States,

we will be required to seek FDA acceptance of an IND for each of our product candidates.

We cannot be sure any IND we submit to the FDA,

or any similar clinical trial application we submit in other countries, will be accepted.

If we will be required by regulatory authorities

to conduct additional preclinical testing prior to filing an IND or similar application to clinically evaluate any of our product candidates,

this may result in delay in our product candidate development.

The results of any such preclinical testing may not be positive and may

not support an application to study any of our product candidates in additional clinical trials.

FDA may disagree with the design or implementation of our clinical trials;

clinical trials for our product candidate(s) must be successful if we are to seek and obtain regulatory marketing application through

the submission of a new Biological License Application (BLA) and marketing authorization application (MAA) with the U.S.

Food and Drug

Administration (FDA) and the European Medicines Agency (EMA), respectively.

Advanced clinical trials are often not successful even if

prior trials were successful, and even if we are able to conduct advanced clinical trials and those trials are successful, we may not

obtain necessary regulatory approvals for our product candidate(s) or we may be unable to successfully commercialize our products even

if we receive the necessary regulatory approvals

In addition, the process of seeking regulatory

approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort and expense

incurred, approval is never guaranteed.

If we are not successful in obtaining timely approval of our product candidates from the FDA,

we may never be able to generate significant revenue and may be forced to cease operations.

The new Biological License Application, or

BLA, process is costly, lengthy and uncertain.

Any BLA application filed by us will have to be supported by extensive data, including,

but not limited to, technical, pre-clinical, clinical, manufacturing and labelling data, to demonstrate to the FDA’s satisfaction

the safety and efficacy of the product for its intended use.

In order to commence a clinical trial in the United

States, we will be required to seek FDA acceptance of an IND for each of our product candidates.

We cannot be sure any IND we submit to

the FDA, or any similar clinical trial application we submit in other countries, will be accepted.

If we will be required by regulatory

authorities to conduct additional preclinical testing prior to filing an IND or similar application to clinically evaluate any of our

product candidates, this may result in delay in our product candidate development.

The results of any such preclinical testing may not

be positive and may not support an application to study any of our product candidates in additional clinical trials.

It is possible that the FDA or EMA will not view

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be further delayed or prevented from advancing further clinical development any of our product candidates.

Additionally, the FDA or EMA may disagree with the

sufficiency of our proposed reliance upon the preclinical, manufacturing or clinical data generated by third-party academic-sponsored

Additionally, the FDA or EMA may disagree with

the sufficiency of our proposed reliance upon the preclinical, manufacturing or clinical data generated by third-party academic-sponsored

trials, or our interpretation of preclinical, manufacturing or clinical data from our ongoing trials.

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us to obtain and submit additional preclinical, manufacturing or clinical data.

Obtaining approvals from the FDA and from the regulatory

agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome.

The FDA and other agencies could

ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming

Obtaining approvals from the FDA and from the

regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome.

The FDA and other agencies

could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming

actions, or it could simply deny our applications.

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or future 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.

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.

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

Events that may prevent successful or timely completion of clinical development

● delays in reaching, or failing to reach, a consensus with

regulatory agencies on study design;

● delays in reaching, or failing to reach, agreement on acceptable

terms with a sufficient number of prospective contract research organizations, or 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 recruiting a sufficient number of suitable patients

to participate in our clinical studies;

● imposition of a clinical hold by regulatory agencies, after

an inspection of our clinical study operations or study sites;

● failure by our CROs, other third parties or us to adhere

to clinical study, regulatory or legal requirements;

● failure to perform in accordance with the FDA’s good

clinical practices, or GCPs, 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 its potential benefits;

● changes in regulatory requirements and guidance that require

amending or submitting new clinical protocols.

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.

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,

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

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

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

to perform in accordance with the FDA’s good clinical practices, or GCPs, or applicable regulatory guidelines in other countries;

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

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 its potential benefits;

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

We could also encounter delays if a clinical trial

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trials are being conducted, by an independent Safety Review Board, or SRB, for such trial or by the FDA 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 or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects,

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 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

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In addition, any delays in completing

our clinical trials will increase our costs, slow down our product candidates’

development and approval process and jeopardize

our ability to commence product sales and generate revenues.

our clinical trials will increase our costs, slow down our product candidates’ 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

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also ultimately lead to the denial of regulatory approval of our product candidates.

The outcome of pre-clinical 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, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many companies

that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless failed

to obtain marketing approval.

The outcome of pre-clinical 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, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many

companies that have believed their product candidates performed satisfactorily in pre-clinical 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 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 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;

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.

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other jurisdictions.

Obtaining and maintaining regulatory approval of

our vaccine candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other

jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory

Obtaining and maintaining regulatory approval

of our vaccine candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any

other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory

approval process in others.

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procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those

in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction

may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a vaccine

candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we

intend to charge for our products is also subject to approval.

in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may

not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a vaccine candidate

must be approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we intend to

charge for our products is also subject to approval.

We may also submit marketing applications in other

Regulatory authorities in jurisdictions outside of the United States have requirements for approval of vaccine candidates

with which we must comply prior to marketing in those jurisdictions.

Obtaining foreign regulatory approvals and compliance with foreign

regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction

of our products in certain countries.

If we fail to comply with the regulatory requirements in international markets and/or receive applicable

marketing approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates

will be harmed.

Regulatory authorities in jurisdictions outside of the United States have requirements for approval of vaccine candidates with

which we must comply prior to marketing in those jurisdictions.

Obtaining foreign regulatory approvals and compliance with foreign regulatory

requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products

in certain countries.

If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing

approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates will be harmed.

Modifications to our products may require new BLA approvals.

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a timely manner, which in turn would harm our future growth.

Additional delays to the completion of clinical

studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or

required by the occurrences in the given trial .

Additional delays to the completion of clinical studies may result

from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences

in the given trial .

Each modification to the protocol during a clinical

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the size and nature of the patient population;

● the severity of the disease, condition or infection under

investigation;

the severity of the disease, condition or infection under investigation;

eligibility criteria for the trial;

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the ability to obtain and maintain patient consents;

● perceived risks and benefits of the product candidate under

● the ability to recruit clinical trial investigators with

the appropriate competencies and experience;

● the risk that patients enrolled in clinical trials will drop

out of the trials before the administration of our product candidates or trial completion;

perceived risks and benefits of the product candidate under evaluation;

the ability to recruit clinical trial investigators with the appropriate competencies and experience;

the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion;

the availability of competing clinical trials;

the availability of such patients during the COVID-19 pandemic;

● the availability of new drugs approved for the indication

the clinical trial is investigating;

● clinicians’

and patients’

perceptions as to the

potential advantages of the drug being studied in relation to other available therapies.

These factors may make it difficult for us to enroll

enough patients to complete our clinical trials in a timely and cost-effective manner.

Delays in the completion of any clinical trial

of our product candidates will increase our costs, slow down our product candidate development and approval process, and delay or potentially

jeopardize our ability to commence product sales and generate revenue.

In addition, some 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 availability of new drugs approved for the indication the clinical trial is investigating;

clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies.

These factors may make it difficult for us to

enroll enough patients to complete our clinical trials in a timely and cost-effective manner.

Delays in the completion of any clinical

trial of our product candidates will increase our costs, slow down our product candidate development and approval process, and delay or

potentially jeopardize our ability to commence product sales and generate revenue.

In addition, some 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.

Conducting successful clinical studies may require the enrollment

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The results of our future clinical trials may not support our

product candidates’

claims or may result in the discovery of unexpected adverse side effects.

product candidates’ claims or may result in the discovery of unexpected adverse side effects.

Even if our clinical trials are completed as planned,

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not receive FDA approval to market that product in the United States for the indications sought.

In addition, such an outcome could cause us to abandon

a product candidate and might delay development of others.

Any delay or termination of our clinical trials will delay the filing of any

product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.

possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of our product candidates’

In addition, such an outcome could cause us to

abandon a product candidate and might delay development of others.

Any delay or termination of our clinical trials will delay the filing

of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.

is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of our product

candidates’ profiles.

Adverse events involving our products may lead the FDA or other

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and financial results.

Additionally, if any of our product candidates receives

marketing approval, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, and other non-U.S.

authorities could impose other specific obligations as a condition of approval to ensure that the benefits outweigh its risks, which may

include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan

to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used.

Furthermore, if we or

others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences

could result, including:

● regulatory authorities may suspend or withdraw approvals

of such a product candidate;

● regulatory authorities may require additional warnings or

limitations of use in product labeling;

● we may be required to change the way a product candidate

is distributed, dispensed, or administered or conduct additional clinical trials;

Additionally, if any of our product candidates

receives marketing approval, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, and other non-U.S.

regulatory authorities could impose other specific obligations as a condition of approval to ensure that the benefits outweigh its risks,

which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication

plan to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used.

Furthermore, if

we or others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative

consequences could result, including:

regulatory authorities may suspend or withdraw approvals of such a product candidate;

regulatory authorities may require additional warnings or limitations of use in product labeling;

we may be required to change the way a product candidate is distributed, dispensed, or administered or conduct additional clinical trials;

we could be sued and held liable for harm caused to patients;

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results of operations.

The FDA requires that certain classifications of recalls be reported to FDA within ten working days after

the recall is initiated.

The FDA requires that certain classifications of recalls be reported to FDA within ten working days after the recall

is initiated.

Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.

may initiate voluntary recalls involving our products in the future.

A future recall announcement could harm our reputation with customers

and negatively affect our sales.

In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report

the recalls when they were conducted.

We may initiate

voluntary recalls involving our products in the future.

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

affect our sales.

In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report the recalls

when they were conducted.

Even if we obtain regulatory approval of our vaccine candidates,

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the medical community.

Even if any of our vaccine candidates receive marketing

approval, they may fail to receive recommendations for use by regulators or advisory boards that recommend vaccines, or gain market acceptance

by physicians, patients, third-party payors and others in the medical community.

If such vaccine candidates do not achieve an adequate

level of acceptance, we may not generate significant product revenue and may not become profitable.

The degree of market acceptance of

any vaccine candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

● receiving CDC and ACIP recommendations for use, as well as

recommendations of comparable foreign regulatory and advisory bodies;

● prevalence and severity of the disease targets for which

our vaccine candidates are approved;

● physicians, hospitals, third-party payors and patients considering

our vaccine candidates as safe and effective;

● the potential and perceived advantages of our vaccine candidates

over existing vaccines, including with respect to spectrum coverage or immunogenicity;

Even if any of our vaccine candidates receive

marketing approval, they may fail to receive recommendations for use by regulators or advisory boards that recommend vaccines, or gain

market acceptance by physicians, patients, third-party payors and others in the medical community.

If such vaccine candidates do not achieve

an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.

The degree of market acceptance

of any vaccine candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

receiving CDC and ACIP recommendations for use, as well as recommendations of comparable foreign regulatory and advisory bodies;

prevalence and severity of the disease targets for which our vaccine candidates are approved;

physicians, hospitals, third-party payors and patients considering our vaccine candidates as safe and effective;

the potential and perceived advantages of our vaccine candidates over existing vaccines, including with respect to spectrum coverage or immunogenicity;

the prevalence and severity of any side effects;

● product labeling or product insert requirements of the FDA

or comparable foreign regulatory and advisory bodies;

● limitations or warnings contained in the labeling approved

by the FDA or comparable foreign regulatory and advisory bodies;

● the timing of market introduction of our vaccine candidates

as well as competitive products;

product labeling or product insert requirements of the FDA or comparable foreign regulatory and advisory bodies;

limitations or warnings contained in the labeling approved by the FDA or comparable foreign regulatory and advisory bodies;

the timing of market introduction of our vaccine candidates as well as competitive products;

the cost of treatment in relation to alternative treatments;

● the availability of coverage and adequate reimbursement and

pricing by third-party payors, including government authorities;

● the willingness of patients to pay out-of-pocket in

the absence of coverage and adequate reimbursement by third-party payors, including government authorities;

● relative convenience and ease of administration, including

as compared to competitive vaccines and alternative treatments;

the availability of coverage and adequate reimbursement and pricing by third-party payors, including government authorities;

the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including government authorities;

relative convenience and ease of administration, including as compared to competitive vaccines and alternative treatments;

the effectiveness of our sales and marketing efforts.

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recommendation are almost universally adopted, and adult vaccines that receive a preferred recommendations are widely adopted.

in 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults ages 65 years and older against pneumococcal

disease, which caused Prevnar 13 to become the standard of care along with continued use of Pneumovax 23.

ACIP can also modify its preferred

recommendation.

For instance, in June 2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend Prevnar

13 for adults 65 and older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation,

which means the decision to vaccinate should be made at the individual level between health care providers and their patients.

recently noted that this revised recommendation is expected to have a negative effect on Prevnar 13 revenue for future periods.

in 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults ages 65 years and older against pneumococcal disease,

which caused Prevnar 13 to become the standard of care along with continued use of Pneumovax 23.

ACIP can also modify its preferred recommendation.

For instance, in June 2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend Prevnar 13 for adults 65 and

older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation, which means

the decision to vaccinate should be made at the individual level between health care providers and their patients.

Pfizer recently noted

that this revised recommendation is expected to have a negative effect on Prevnar 13 revenue for future periods.

If our vaccine candidates are approved but fail

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approval for the pediatric populations are more stringent.

Pediatric vaccine candidates’

Pediatric vaccine candidates’ development

may require additional studies to determine safe dosing and long-term monitoring.

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healthcare industry and elsewhere is cost containment.

Government authorities and third-party payors have attempted to

control costs by limiting coverage and the amount of payment for particular vaccines.

Increasingly, third-party payors are requiring that

drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products.

and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement

may not be sufficient for commercial success.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate

for which we obtain marketing approval.

If coverage and reimbursement is not available or is available only to limited levels, we may

not be able to successfully commercialize any product candidate for which we obtain marketing approval.

Government authorities and third-party payors have attempted to control

costs by limiting coverage and the amount of payment for particular vaccines.

Increasingly, third-party payors are requiring that drug

companies provide predetermined discounts from list prices and are challenging the prices charged for medical products.

Coverage and reimbursement

may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient

for commercial success.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain

marketing approval.

If coverage and reimbursement is not available or is available only to limited levels, we may not be able to successfully

commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining coverage

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by the FDA or similar regulatory authorities outside the United States.

Moreover, eligibility for coverage and reimbursement does

not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,

Moreover, eligibility for coverage and reimbursement does not

imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,

sale and distribution.

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include submissions of promotional materials and safety and other post-marketing information and reports, registration and listing requirements,

current Good Manufacturing Practice (“cGMP”) requirements for product facilities, quality assurance and corresponding maintenance

of records and documents and requirements regarding the distribution of samples to physicians and related recordkeeping.

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However, companies may share

truthful and not misleading information that is otherwise consistent with the product’s FDA approved labeling.

The FDA imposes stringent

restrictions on manufacturers’

communications regarding off-label use and if we do not comply with these restrictions, we may be

restrictions on manufacturers’ communications regarding off-label use and if we do not comply with these restrictions, we may be

subject to enforcement actions.

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may result in, among other things:

● restrictions on such products, manufacturers or manufacturing

processes or facilities;

● restrictions on the labeling, marketing, distribution or

use of a product;

● requirements to conduct post-approval clinical trials, other

studies or other post-approval commitments;

restrictions on such products, manufacturers or manufacturing processes or facilities;

restrictions on the labeling, marketing, distribution or use of a product;

requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;

warning or untitled letters;

withdrawal or recall of the products from the market;

● refusal to approve pending applications or supplements to

approved applications that we submit;

refusal to approve pending applications or supplements to approved applications that we submit;

fines, restitution or disgorgement of profits or revenue;

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only be commercialized after obtaining a Marketing Authorization, or MA.

Before granting the MA, the European Medicines Agency or

the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of

scientific criteria concerning its quality, safety and efficacy.

In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA,

of the Ministry of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug

product may be marketed in Japan.

We have had limited interactions with foreign regulatory

The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain

approval may differ from that required to obtain FDA approval.

Moreover, clinical studies conducted in one country may not be accepted

by regulatory authorities in other countries.

Approval by the FDA does not ensure approval by regulatory authorities in other countries,

and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries

or by the FDA.

However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory

process in others.

Before granting the MA, the European Medicines Agency or the

competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific

criteria concerning its quality, safety and efficacy.

In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA, of the Ministry

of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug product may

be marketed in Japan.

We have had limited interactions with foreign

regulatory authorities.

The approval procedures vary among countries and can involve additional clinical testing, and the time required

to obtain approval may differ from that required to obtain FDA approval.

Moreover, clinical studies conducted in one country may not be

accepted by regulatory authorities in other countries.

Approval by the FDA does not ensure approval by regulatory authorities in other

countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign

countries or by the FDA.

However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the

regulatory process in others.

The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.

not obtain foreign regulatory approvals on a timely basis, if at all.

We may not be able to file for regulatory approvals and even if

we file we may not receive necessary approvals to commercialize our products in any market.

We may not obtain foreign regulatory approvals on a timely basis, if at all.

We may not be able to file for regulatory approvals and even

if we file we may not receive necessary approvals to commercialize our products in any market.

If our products do not receive favorable third-party reimbursement,

or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not generate significant revenues.

Our ability to commercialize our products will depend

in part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations and products and related treatments

are obtained by governmental authorities, private health insurers and other organizations, such as Health Maintenance Organizations, or

Our ability to commercialize our products will

depend in part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations and products and related

treatments are obtained by governmental authorities, private health insurers and other organizations, such as Health Maintenance Organizations,

Reimbursement from third parties depends greatly on our ability to present data which demonstrate positive outcomes and reduced

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We may be adversely affected by the ongoing coronavirus pandemic.

The outbreak of the novel coronavirus COVID-19 (“COVID-19”)

has evolved into a global pandemic.

The outbreak of the novel coronavirus COVID-19

(“COVID-19”) has evolved into a global pandemic.

The coronavirus has spread to many regions of the world.

The extent to which the coronavirus impacts

our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including

new information that may emerge concerning the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

The extent to which

the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be

accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus

or treat its impact, among others.

As a result of the continuing spread of COVID-19,

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possibly for an extended period of time.

Moreover, our clinical trials may be affected by

the COVID-19 pandemic.

Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of clinical

trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal,

state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the COVID-19 pandemic.

If the coronavirus continues to spread, some participants and clinical investigators may not be able to execute clinical trial protocols

per the expected timelines.

The new mutations of the virus may also make it harder for us to predict the exact impact (if any) on the

progression of COVID-19 on our development programs.

For example, quarantines or other travel limitations (whether voluntary or required)

may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable to conduct

our clinical trials.

Further, if the spread of the COVID-19 pandemic continues and our operations are adversely impacted, we risk a delay,

default and/or nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully recoverable

or adequately covered by insurance.

Infections and deaths related to the pandemic may

disrupt the United States’

healthcare and healthcare regulatory systems.

Moreover, our clinical trials may be affected

by the COVID-19 pandemic.

Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of

clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,

federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the COVID-19

If the coronavirus continues to spread, some participants and clinical investigators may not be able to execute clinical trial

protocols per the expected timelines.

The new mutations of the virus may also make it harder for us to predict the exact impact (if any)

on the progression of COVID-19 on our development programs.

For example, quarantines or other travel limitations (whether voluntary or

required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable

to conduct our clinical trials.

Further, if the spread of the COVID-19 pandemic continues and our operations are adversely impacted, we

risk a delay, default and/or nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully

recoverable or adequately covered by insurance.

Infections and deaths related to the pandemic

may disrupt the United States’ healthcare and healthcare regulatory systems.

Such disruptions could divert healthcare resources

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It is unknown how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical

trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product

Any elongation or de-prioritization of our clinical trials

or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

The spread of the coronavirus, which has caused

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could have a material impact on our operations, and we will continue to monitor the situation closely.

We may be adversely affected by the ongoing monkeypox outbreak.

The monkeypox outbreak of 2022 has spread to many

regions of the world, including the United States.

The extent to which the monkeypox outbreak impacts our business and operating results

will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge,

if the outbreak is ultimately upgraded to a pandemic, and the actions to contain monkeypox or treat its impact, among others.

2022, it is still classified as an outbreak by the World Health Organization, but this may be upgraded to a pandemic in the event of future

spread of the disease.

As a result of the continuing spread of monkeypox

infections, our business operations could be delayed or interrupted.

Currently, we operate virtually, i.e., our program activities are

and will continue to be carried out on our behalf, by competent contract research organizations (CROs) with expertise in pre-clinical,

clinical and/or chemistry and manufacturing areas.

Due to monkeypox, our planned project timelines may be delayed due to reduced availability

of human resources or critical supplies needed to carry out such plans.

In the event of any future shelter-in-place/stay-at-home orders

and other government restrictions, our employees conducting research and development or manufacturing activities at external vendor locations

across the globe may not be able to access their laboratory or manufacturing space which may result in our core activities being significantly

limited or curtailed, possibly for an extended period of time.

Moreover, our clinical trials may be affected

by the monkeypox outbreak.

Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution

of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,

federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the outbreak.

If monkeypox continues to spread and regulations are developed and enacted, some participants and clinical investigators may not be able

to execute clinical trial protocols per the expected timelines.

Further, if the spread of the monkeypox outbreak continues and our operations

are adversely impacted, we risk a delay, default and/or nonperformance under existing agreements which may increase our costs.

increases may not be fully recoverable or adequately covered by insurance.

Infections and deaths related to this outbreak

may disrupt the United States’ healthcare and healthcare regulatory systems.

Such disruptions could divert healthcare resources

away from, or materially delay FDA review or review by other regulatory agencies and/or approval with respect to, our clinical trials.

It is unknown how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials

or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

The spread of monkeypox, which may cause a broad

impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material

economic effect on our business in the event of continued spread of the virus.

While the potential economic impact brought by and the

duration may be difficult to assess or predict, it may result in disruption of global financial markets, which may reduce our ability

to access capital either at all or on favorable terms.

In addition, a recession, depression or other sustained adverse market event resulting

from the spread of monkeypox could materially and adversely affect our business and the value of our common stock.

The ultimate impact of the current outbreak, or

any other health epidemic, is highly uncertain and subject to change.

We do not yet know the full extent of potential delays or impacts

on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole.

However, these effects

could have a material impact on our operations, and we will continue to monitor the situation closely.

Our reliance on third parties heightens the risks faced by our

We rely on suppliers, vendors and partners for certain

key aspects of our business, including support for information technology systems and certain human resource functions.

We do not control

these partners, but we depend on them in ways that may be significant to us.

If these parties fail to meet our expectations or fulfill

their obligations to us, we may fail to receive the expected benefits.

In addition, if any of these third parties fails to comply with

applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible for

such violations as well.

This risk is particularly serious in emerging markets, where corruption is often prevalent and where many of

the third parties on which we rely do not have internal compliance resources comparable to our own.

We rely on suppliers, vendors and partners for

certain key aspects of our business, including support for information technology systems and certain human resource functions.

not control these partners, but we depend on them in ways that may be significant to us.

If these parties fail to meet our expectations

or fulfill their obligations to us, we may fail to receive the expected benefits.

In addition, if any of these third parties fails to

comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible

for such violations as well.

This risk is particularly serious in emerging markets, where corruption is often prevalent and where many

of the third parties on which we rely do not have internal compliance resources comparable to our own.

Any such failures by third parties,

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to meet deadlines for the completion of such trials, research or testing.

We have been relying on third parties for our preclinical

studies, and we expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical data

management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects

We have been relying on third parties for our

preclinical studies, and we expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical

data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects

of our research and pre-clinical testing.

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arrangements, it could delay our product development activities.

Our reliance on third parties for research and development

activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we will remain

responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols

for the trial.

Moreover, the FDA and other international regulatory authorities require us to comply with GCP standards for conducting,

recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the

rights, integrity and confidentiality of trial participants are protected.

We also are required to register ongoing clinical trials and

post the results of completed clinical trials on a government-sponsored database, available at www.clinicaltrials.gov , within certain

Our reliance on third parties for research and

development activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we

will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan

and protocols for the trial.

Moreover, the FDA and other international regulatory authorities require us to comply with GCP standards

for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate

and that the rights, integrity and confidentiality of trial participants are protected.

We also are required to register ongoing clinical

trials and post the results of completed clinical trials on a government-sponsored database, available at www.clinicaltrials.gov ,

within certain timeframes.

Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

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of any product candidate for which we obtain marketing approval.

We may be unable to establish agreements with third-party

manufacturers for clinical or commercial supply on terms favorable to us, or at all.

Even if we are able to establish agreements with

third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

● reliance on the third party for regulatory compliance and

quality assurance;

● the possible breach of the manufacturing agreement by the

third party, including the inability to supply sufficient quantities or to meet quality standards or timelines;

● the possible termination or nonrenewal of the agreement by

the third party at a time that is costly or inconvenient for us.

We may be unable to establish agreements with

third-party manufacturers for clinical or commercial supply on terms favorable to us, or at all.

Even if we are able to establish agreements

with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

reliance on the third party for regulatory compliance and quality assurance;

the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines;

the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to comply

cGMPs or similar regulatory requirements outside the United States.

Our failure, or the failure of our third-party

manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates

or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties,

delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and

criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.

Our failure, or the failure of our third-party manufacturers,

to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates or approved

products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension

or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions,

any of which could adversely affect supplies of our product candidates and harm our business and results of operations.

Any product that we develop may compete with other

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we may be required to replace that manufacturer.

Our anticipated future dependence upon others for

the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability

Our anticipated future dependence upon others

for the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability

to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

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or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue.

Moreover, our manufacturers and suppliers may experience

difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of supply of our

product candidates.

Manufacturing risks may adversely affect our ability to

manufacture our product and could reduce our gross margin and profitability.

Moreover, our manufacturers and suppliers may

experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of

supply of our product candidates.

Manufacturing risks may adversely affect our ability to manufacture

our product and could reduce our gross margin and profitability.

Our business strategy depends on our ability to

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We are subject to numerous risks relating to our manufacturing capabilities, including:

● quality or reliability defects in product components that

we source from third-party suppliers, including manufacturing compliance with federal and state regulations;

● our inability to secure product components in a timely manner,

in sufficient quantities or on commercially reasonable terms;

quality or reliability defects in product components that we source from third-party suppliers, including manufacturing compliance with federal and state regulations;

our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;

our failure to increase production of products to meet demand;

● our inability to modify production lines to enable us to

efficiently produce future products or implement changes in current products in response to regulatory requirements;

● Potential damage to or destruction of our manufacturing equipment

or manufacturing facility.

If demand for our product candidates increases in

the future, we will have to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes.

If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins

could fluctuate or decline.

In addition, although we expect some of our product candidates in development to share product features and

components, manufacturing of some of our product candidates may require the modification of our production lines, the hiring

of specialized employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies.

It may not be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates

commercially viable.

our inability to modify production lines to enable us to efficiently produce future products or implement changes in current products in response to regulatory requirements;

Potential damage to or destruction of our manufacturing equipment or manufacturing facility.

If demand for our product candidates increases

in the future, we will have to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing

If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating

margins could fluctuate or decline.

In addition, although we expect some of our product candidates in development to share product features

and components, manufacturing of some of our product candidates may require the modification of our production lines, the hiring of specialized

employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies.

be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates commercially

Any of these factors may affect our ability to manufacture our product and could reduce our gross margin and profitability.

We maintain single supply relationships for certain key components,

and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its manufacturing process

and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its manufacturing

process increases.

We are dependent on sole suppliers or a limited

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In addition, technology changes by our vendors could

disrupt access to required manufacturing capacity or require expensive, time consuming development efforts to adapt and integrate

new equipment or processes.

disrupt access to required manufacturing capacity or require expensive, time consuming development efforts to adapt and integrate new

equipment or processes.

Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipment and materials

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Any one of these factors could harm our business and growth prospects.

We may not be able to manage our manufacturing and

supply chain effectively, which would harm our results of operations.

We must accurately forecast our clinical trial obligations,

and, in the future, market demand, for our product candidates in order to have adequate product inventory available to fulfil our timeline

and customer orders timely.

Our forecasts will be based on multiple assumptions that may cause our estimates to be inaccurate, and thus

affect our ability to ensure adequate manufacturing capability to satisfy product candidate needs or market demand.

Any material delay

in our ability to obtain timely product inventories from our manufacturing facility and our ingredient suppliers could prevent us from

satisfying increased consumer demand for our products, resulting in material harm to our clinical trials, brand and business.

we will need to continuously monitor our inventory and product mix against forecasted demand to avoid having inadequate product inventory

or having too much product inventory on hand.

If we are unable to manage our supply chain effectively, our operating costs may increase

We may not be able to manage our manufacturing and supply chain

effectively, which would harm our results of operations.

We must accurately forecast our clinical trial

obligations, and, in the future, market demand, for our product candidates in order to have adequate product inventory available to fulfil

our timeline and customer orders timely.

Our forecasts will be based on multiple assumptions that may cause our estimates to be inaccurate,

and thus affect our ability to ensure adequate manufacturing capability to satisfy product candidate needs or market demand.

delay in our ability to obtain timely product inventories from our manufacturing facility and our ingredient suppliers could prevent us

from satisfying increased consumer demand for our products, resulting in material harm to our clinical trials, brand and business.

addition, we will need to continuously monitor our inventory and product mix against forecasted demand to avoid having inadequate product

inventory or having too much product inventory on hand.

If we are unable to manage our supply chain effectively, our operating costs may

increase materially.

We may in the future have conflicts with our current or future

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the development or commercialization of our current and future product candidates, and in turn prevent us from generating revenues:

● unwillingness on the part of a partner to pay us milestone

payments or royalties we believe are due to us under a collaboration;

● uncertainty regarding ownership of intellectual property

rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

● unwillingness by the partner to cooperate in the development

or manufacture of the product, including providing us with product data or materials;

● unwillingness on the part of a partner to keep us informed

regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;

● initiating of litigation or alternative dispute resolution

options by either party to resolve the dispute;

unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;

initiating of litigation or alternative dispute resolution options by either party to resolve the dispute;

attempts by either party to terminate the agreement.

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approval to commercialize a product candidate faster than our competitors, our product candidates may face competition from biosimilar

In the United States, our product candidates are regulated by the FDA as biologic products and we intend to seek approval

for these product candidates pursuant to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA,

created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway

establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar

as “interchangeable”

In the United States, our product candidates are regulated by the FDA as biologic products and we intend to seek approval for

these product candidates pursuant to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an

abbreviated pathway for the approval of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway establishes

legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable”

based on its similarity to an existing brand product.

Under the BPCIA, an application for a biosimilar

product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA.

complex and is still being interpreted and implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning

are subject to uncertainty.

There is a risk that any exclusivity we may be afforded

if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action, the results

of recent litigation, or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products,

potentially creating the opportunity for generic or biosimilar competition sooner than anticipated.

Moreover, the extent to which a biosimilar

product, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution

for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA after completing its own preclinical

studies and clinical trials.

In such cases, any exclusivity to which we may be eligible under the BPCIA would not prevent the competitor

from marketing its product as soon as it is approved.

Under the BPCIA, an application for a biosimilar product cannot be approved by the

FDA until 12 years after the original branded product was approved under a BLA.

The law is complex and is still being interpreted and

implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

There is a risk that any exclusivity we may be

afforded if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action,

the results of recent litigation, or otherwise, or that the FDA will not consider our product candidates to be reference products for

competing products, potentially creating the opportunity for generic or biosimilar competition sooner than anticipated.

Moreover, the

extent to which a biosimilar product, once approved, will be substituted for any one of our reference products in a way that is similar

to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory

factors that are still developing.

In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA

after completing its own preclinical studies and clinical trials.

In such cases, any exclusivity to which we may be eligible under the

BPCIA would not prevent the competitor from marketing its product as soon as it is approved.

In addition, critics of the 12-year exclusivity

period in the biosimilar pathway law will likely continue to seek to shorten the data exclusivity period and/or to encourage the FDA to

interpret narrowly the law’s provisions regarding which new products receive data exclusivity.

In December 2019, the US agreed

to remove from the United States-Mexico-Canada Agreement a requirement for at least 10 years of data exclusivity for biologic

Also, the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference

product’s original 12-year exclusivity period (a concept known in the generic drug context as “umbrella exclusivity”).

If the FDA were to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the

exclusivity period, this could expose us to biosimilar competition at an earlier time.

There also have been, and may continue to be, legislative

and regulatory efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization,

including efforts to lower standards for demonstrating biosimilarity or interchangeability, limit patents that may be litigated and/or

patent settlements and implement preferential reimbursement policies for biosimilars.

interpret narrowly the law’s provisions regarding which new products receive data exclusivity.

In December 2019, the US agreed to

remove from the United States-Mexico-Canada Agreement a requirement for at least 10 years of data exclusivity for biologic products.

the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference product’s

original 12-year exclusivity period (a concept known in the generic drug context as “umbrella exclusivity”).

If the FDA were

to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the exclusivity period,

this could expose us to biosimilar competition at an earlier time.

There also have been, and may continue to be, legislative and regulatory

efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization, including efforts

to lower standards for demonstrating biosimilarity or interchangeability, limit patents that may be litigated and/or patent settlements

and implement preferential reimbursement policies for biosimilars.

If competitors are able to obtain marketing approval

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Pfizer is currently implementing a similar approach to development of its 20-valent PCV vaccine

candidate, and may have a more efficient path to regulatory approval given Pfizer’s and the FDA’s previous experience with

Many of our competitors have established distribution

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more effective, more convenient, less expensive or with a more favorable label than any vaccine candidates that we may develop.

As a result of these factors, our competitors may

obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine

As a result of these factors, our competitors

may obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine

Our competitors may also develop vaccines that are safer, more effective, more widely accepted or less expensive than ours,

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These advantages could render our vaccine candidates

obsolete or non-competitive before we can recover the costs of such vaccine candidates’

development and commercialization.

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 early-stage

companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing

clinical trial sites and subject enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for,

our programs.

obsolete or non-competitive before we can recover the costs of such vaccine candidates’ development and commercialization.

Mergers and acquisitions in the pharmaceutical

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

early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established

These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel,

establishing clinical trial sites and subject enrollment for clinical trials, as well as in acquiring technologies complementary to, or

necessary for, our programs.

Product liability lawsuits against us could cause us to incur

substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure

related to the testing of our current product candidates or future product candidates in human clinical trials and will face an even greater

risk if we commercially sell any products that we may develop.

Product liability claims may be brought against us by subjects enrolled

in our clinical trials, patients, healthcare providers or others using, administering or selling our product.

We face an inherent risk of product liability

exposure related to the testing of our current product candidates or future product candidates in human clinical trials and will face

an even greater risk if we commercially sell any products that we may develop.

Product liability claims may be brought against us by subjects

enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product.

If we cannot successfully

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of merit or eventual outcome, liability claims may result in:

● decreased demand for any product candidates or products that

we may develop;

● termination of clinical trial sites or entire clinical trial

decreased demand for any product candidates or products that we may develop;

termination of clinical trial sites or entire clinical trial programs;

injury to our reputation and significant negative media attention;

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loss of revenue;

● diversion of management and scientific resources from our

business operations;

diversion of management and scientific resources from our business operations;

the inability to commercialize any products that we may develop.

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insurance for any products that receive regulatory approval.

Large judgments have been awarded in class action lawsuits based on

drugs that had unanticipated side effects.

A successful product liability claim or series of claims brought against us, particularly if

judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

Large judgments have been awarded in class action lawsuits based on drugs

that had unanticipated side effects.

A successful product liability claim or series of claims brought against us, particularly if judgments

exceed our insurance coverage, could decrease our cash and adversely affect our business.

We may engage in acquisitions that could disrupt our business,

cause dilution to our stockholders or reduce our financial resources.

In the future, we may enter into transactions to

acquire other businesses, products or technologies.

In the future, we may enter into transactions

to acquire other businesses, products or technologies.

If we do identify suitable candidates, we may not be able to make such acquisitions

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and/or our physical buildings could expose us to liability and damage our reputation and business.

It is essential to our business strategy that our

technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners

It is essential to our business strategy that

our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners

to be secure.

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We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products

and services, misappropriate our or our customers’

and partners’

proprietary information, which may include personally identifiable

and services, misappropriate our or our customers’ and partners’ proprietary information, which may include personally identifiable

information, or cause interruptions of our internal systems and services.

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For example, the Health Insurance

Portability and Accountability Act of 1996, or HIPAA, imposes limitations on the use and disclosure of an individual’s

healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities,

and also grants individuals rights with respect to their health information.

HIPAA also imposes compliance obligations and corresponding

penalties for non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.

As part of the American Recovery and Reinvestment Act of 2009, or ARRA, the privacy and security provisions of HIPAA were amended.

ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s health information under

HIPAA and extended enforcement authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted

in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been inappropriately

accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national

Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance

with encryption or other standards developed by the U.S.

Portability and Accountability Act of 1996, or HIPAA, imposes limitations on the use and disclosure of an individual’s healthcare

information by healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities, and also

grants individuals rights with respect to their health information.

HIPAA also imposes compliance obligations and corresponding penalties

for non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.

As part of the

American Recovery and Reinvestment Act of 2009, or ARRA, the privacy and security provisions of HIPAA were amended.

ARRA also made significant

increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement

authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted in 2013, HIPAA also imposes

notification requirements on covered entities in the event that certain health information has been inappropriately accessed or disclosed,

notification requirements to individuals, federal regulators, and in some cases, notification to local and national media.

is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance with encryption

or other standards developed by the U.S.

Department of Health and Human Services.

Most states have laws requiring

notification of affected individuals and/or state regulators in the event of a breach of personal information, which is a broader class

of information than the health information protected by HIPAA.

Many state laws impose significant data security requirements, such

as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.

Most states have laws requiring notification of affected

individuals and/or state regulators in the event of a breach of personal information, which is a broader class of information than the

health information protected by HIPAA.

Many state laws impose significant data security requirements, such as encryption or mandatory

contractual terms, to ensure ongoing protection of personal information.

Activities outside of the U.S.

local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.

implicate local and national data

protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.

be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws,

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and we may experience difficulties in managing this growth.

As of March 15, 2022, we had 5 full-time and

6 subcontracted employees.

We will need to grow the size of our organization in order to support our continued development and potential

commercialization of our product candidates.

As our development and commercialization plans and strategies continue to develop, our need

for additional managerial, operational, manufacturing, sales, marketing, financial and other resources may increase.

Our management, personnel

and systems currently in place may not be adequate to support this future growth.

Future growth would impose significant added responsibilities

on members of management, including:

As of March 6, 2023, we had 12 employees.

We will need to grow the

size of our organization in order to support our continued development and potential commercialization of our product candidates.

development and commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing,

sales, marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not be adequate

to support this future growth.

Future growth would impose significant added responsibilities on members of management, including:

managing our clinical trials effectively;

● identifying, recruiting, maintaining, motivating and integrating

additional employees;

● managing our internal development efforts effectively while

complying with our contractual obligations to licensors, licensees, contractors and other third parties;

● improving our managerial, development, operational, information

technology, and finance systems;

identifying, recruiting, maintaining, motivating and integrating additional employees;

managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

improving our managerial, development, operational, information technology, and finance systems;

expanding our facilities.

If our operations expand, we will also need to manage

additional relationships with various strategic partners, suppliers and other third parties.

Our future financial performance and our

ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth

effectively, as well as our ability to develop a sales and marketing force when appropriate.

To that end, we must be able to manage our

development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management, research

and development, manufacturing, administrative and sales and marketing personnel.

The failure to accomplish any of these tasks could prevent

us from successfully growing our company.

If our operations expand, we will also need to

manage additional relationships with various strategic partners, suppliers and other third parties.

Our future financial performance and

our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future

growth effectively, as well as our ability to develop a sales and marketing force when appropriate.

To that end, we must be able to manage

our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,

research and development, manufacturing, administrative and sales and marketing personnel.

The failure to accomplish any of these tasks

could prevent us from successfully growing our company.

Our future success depends on our ability to retain our executive

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The loss of Mr.

Hernandez’s services could

impede the achievement of our research, development and commercialization objectives.

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could have a negative impact on our ability to implement our plan of operation.

Our Chief Executive Officer, Joseph Hernandez is

engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest

Our Chief Executive Officer, Joseph Hernandez

is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest

in allocating his time between our operations and his other businesses.

Pursuant to Mr.

Hernandez’s employment agreement, Mr.

shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business activities.

Subject to our Board’s prior approval, Mr.

Hernandez may serve as an officer, stakeholder, or member of the board of directors

or advisory board (or the equivalent in the case of a non-corporate entity) of non-competing for-profit businesses and charitable organizations,

Subject to our Board’s prior approval, Mr.

Hernandez may serve as an officer, stakeholder, or member of the board of directors or

advisory board (or the equivalent in the case of a non-corporate entity) of non-competing for-profit businesses and charitable organizations,

provided, however, that such activities do not materially interfere, individually or in the aggregate, with the performance of his duties

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Accordingly, although Mr.

Hernandez’s primary occupation is his service to

Blue Water Vaccines Inc., he also holds certain management positions and directorships of other companies, and may allocate his time to

such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.

Additionally, our Chief Financial Officer, Jon Garfield,

is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest

in allocating his time between our operations and his other businesses.

Hernandez’s primary occupation is his service to Blue

Water Vaccines Inc., he also holds certain management positions and directorships of other companies, and may allocate his time to such

other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.

Additionally, our Chief Financial Officer, Jon

Garfield, is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict

of interest in allocating his time between our operations and his other businesses.

Pursuant to Mr.

Garfield’s employment agreement, Mr.

shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business activities,

subject to the restrictions imposed on Mr.

Garfield’s employment agreement,

Garfield shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business

activities, subject to the restrictions imposed on Mr.

Hernandez as described above.

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Each of Messrs.

Hernandez and Garfield’s employment agreement contains certain restrictive covenants while they are employed at

Blue Water Vaccines Inc.

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Hernandez and Garfield from engaging in any other business

or occupation that (x) conflicts with the interests of the Company, (y) interferes with the proper and efficient performance

of his duties for the Company, or (z) interferes with his exercise of judgment in the Company’s best interests.

and Garfield are further subject to general restrictions regarding the solicitation of employees, certain customers, as well as the use

or disclosure of any confidential information, of the business of Blue Water Vaccines Inc.

Notwithstanding the foregoing, to the extent

that these additional activities may have a conflict between their interests and ours, this could have a negative impact on our ability

to implement our plan of operations.

or occupation that (x) conflicts with the interests of the Company, (y) interferes with the proper and efficient performance of his duties

for the Company, or (z) interferes with his exercise of judgment in the Company’s best interests.

Hernandez and Garfield

are further subject to general restrictions regarding the solicitation of employees, certain customers, as well as the use or disclosure

of any confidential information, of the business of Blue Water Vaccines Inc.

Notwithstanding the foregoing, to the extent that these additional

activities may have a conflict between their interests and ours, this could have a negative impact on our ability to implement our plan

of operations.

Certain significant personnel may allocate their time to other

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competitive fiduciary and pecuniary interests that conflict with our interests.

Our executive officers are supported by Ronald Cobb,

Brian Price and Andrew Skibo, who provide valuable technical and strategic capabilities to us.

They are not currently required to commit

their full time to our affairs.

executive officers are supported by Ali Fattom and Andrew Skibo, who provide valuable technical and strategic capabilities to us.

are not currently required to commit their full time to our affairs.

As such, they may allocate their time to other businesses.

From time to time, those other commitments

may limit the nature of services that Messrs.

Cobb, Price and Skibo provide to our Company, for instance, where such activities may involve

overlapping industries and products.

If these individuals’

other business affairs require them to devote substantial amounts of

time to such affairs in excess of their current commitment levels, it could limit their ability to devote time or resources to our affairs,

which may have a negative impact on our ability to complete our plan of operations.

to time, those other commitments may limit the nature of services that Messrs.

Fattom and Skibo provide to our Company, for instance,

where such activities may involve overlapping industries and products.

If these individuals’ other business affairs require them

to devote substantial amounts of time to such affairs in excess of their current commitment levels, it could limit their ability to devote

time or resources to our affairs, which may have a negative impact on our ability to complete our plan of operations .

Members of our management team and board of directors have significant

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This may have an adverse effect on us, could damage our reputation and business.

During the course of their careers, members of our

management team and board of directors have had significant experience as founders, board members, officers or executives of other companies.

As a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become, involved

in litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered into by

such companies.

Any such litigation, investigations or other proceedings may divert our management team’s and board’s attention

and resources away from our affairs and may negatively affect our reputation and our business.

During the course of their careers, members of

our management team and board of directors have had significant experience as founders, board members, officers or executives of other

As a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become,

involved in litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered

into by such companies.

Any such litigation, investigations or other proceedings may divert our management team’s and board’s

attention and resources away from our affairs and may negatively affect our reputation and our business.

Inadequate funding for the FDA, the SEC and other government

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in recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may

rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and

unpredictable.

Disruptions at the FDA and other agencies may also

slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our

In addition, government funding of the SEC and other government agencies on which our operations may rely,

including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may

also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect

our business.

For example, over the last several years, including beginning on December 22, 2018, the U.S.

government has shut

down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government

employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA

to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

government has shut down several

times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees

and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely

review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, in our operations

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We may be adversely affected by natural disasters, pandemics

and other catastrophic events, some possible related to the increasing effects of climate change, and by man-made problems such as terrorism

and acts of war, that could disrupt our business operations and our business continuity and disaster recovery plans may not adequately

protect us from a serious disaster.

We are vulnerable to the increasing impact of climate

change and other natural disasters.

If a disaster, power outage or other event occurred that prevented us from using all or a significant

portion of our headquarters, that damaged critical infrastructure, such as enterprise financial systems, manufacturing resource planning

or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to

continue our business for a substantial period of time.

Our contract manufacturers’

and suppliers’

facilities are located

in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes, fires, explosions or large-scale

accidents or power outages, and other public health emergencies could severely disrupt our operations and have a material adverse effect

on our business, financial condition, operating results and prospects.

For example, the recent COVID-19 pandemic may cause significant

disruption to our business operations, the operations of our third-party contractors and suppliers and the operations of our clinical

trials, including as a result of significant restrictions or bans on travel into and within the geographic areas in which our manufacturers

product our product candidates or where we conduct our clinical trials.

A public health emergency could also affect the operations of

the FDA and other regulatory or public health authorities, resulting in delays to meetings related to planned or completed clinical trials

and ultimately of reviews and approvals of our product candidates.

Such disruption could impede, delay, limit or prevent our employees

and third-party contractors from beginning or continuing research and development or clinical trial-related activities, which may impede,

delay, limit or prevent initiation or completion of our ongoing clinical trials and preclinical research and ultimately lead to the delay

or denial of regulatory approval of our product candidates, which could seriously harm our operations and financial condition.

and other catastrophic events, and by man-made problems such as terrorism and acts of war, that could disrupt our business operations

and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

If a disaster, power outage or other event occurred

that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as enterprise

financial systems, manufacturing resource planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult

or, in certain cases, impossible for us to continue our business for a substantial period of time.

Our contract manufacturers’ and

suppliers’ facilities are located in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes,

fires, explosions or large-scale accidents or power outages, and other public health emergencies could severely disrupt our operations

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

For example, the recent COVID-19

pandemic may cause significant disruption to our business operations, the operations of our third-party contractors and suppliers and

the operations of our clinical trials, including as a result of significant restrictions or bans on travel into and within the geographic

areas in which our manufacturers product our product candidates or where we conduct our clinical trials.

A public health emergency could

also affect the operations of the FDA and other regulatory or public health authorities, resulting in delays to meetings related to planned

or completed clinical trials and ultimately of reviews and approvals of our product candidates.

Such disruption could impede, delay, limit

or prevent our employees and third-party contractors from beginning or continuing research and development or clinical trial-related activities,

which may impede, delay, limit or prevent initiation or completion of our ongoing clinical trials and preclinical research and ultimately

lead to the delay or denial of regulatory approval of our product candidates, which could seriously harm our operations and financial

Our employees, independent contractors, principal investigators,

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with regulatory standards and requirements.

We are exposed to the risk that our employees, independent

contractors, principal investigators, consultants, vendors and CROs may engage in fraudulent or other illegal activity.

Misconduct by

these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates:

laws or regulations, including

those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities;

manufacturing

We are exposed to the risk that our employees,

independent contractors, principal investigators, consultants, vendors and CROs may engage in fraudulent or other illegal activity.

by these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates:

laws or regulations,

including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities;

manufacturing standards;

federal, state and foreign healthcare fraud and abuse laws and data privacy;

or laws that require the true, complete and accurate

reporting of financial information or data.

In particular, sales, marketing and other business arrangements in the healthcare industry

are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices.

These laws may restrict

or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and

promotion, sales commission, customer incentive programs and other business arrangements.

or laws that require the true, complete

and accurate reporting of financial information or data.

In particular, sales, marketing and other business arrangements in the healthcare

industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices.

These laws may

restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing

and promotion, sales commission, customer incentive programs and other business arrangements.

Activities subject to these laws also involve

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Declines and uncertainties in these markets in the past have

severely restricted raising new capital and have affected companies’

ability to continue to expand or fund existing research and

severely restricted raising new capital and have affected companies’ ability to continue to expand or fund existing research and

development efforts.

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economic and capital market conditions, both in the U.S.

and worldwide, have been volatile in the past and at times have adversely

affected our access to capital and increased the cost of capital.

There is no certainty that the capital and credit markets will be available

to raise additional capital on favorable terms.

and worldwide, have been volatile in the past and at times have adversely affected

our access to capital and increased the cost of capital.

There is no certainty that the capital and credit markets will be available to

raise additional capital on favorable terms.

If economic conditions become worse, our future cost of equity or debt capital and access

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compete against us more directly, which would harm our business, possibly materially.

Our commercial success will depend in part on obtaining

and maintaining patent protection and trade secret protection of our current product candidates and future product candidates, the processes

used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party challenges.

Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent upon

the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

Our commercial success will depend in part on

obtaining and maintaining patent protection and trade secret protection of our current product candidates and future product candidates,

the processes used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party

Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent

upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

The patent positions of biotechnology and pharmaceutical

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No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S.

or in foreign

jurisdictions outside of the U.S.

or in foreign jurisdictions

outside of the U.S.

Changes in either the patent laws or interpretations of patent laws in the U.S.

countries may diminish the value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be enforced

in the patents that may be issued from the applications we currently license or may in the future own or license from third parties.

if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates

or technology could be adversely affected.

and other countries may diminish the

value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be enforced in the patents that may

be issued from the applications we currently license or may in the future own or license from third parties.

Further, if any patents we

obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates or technology could

be adversely affected.

Others may file patent applications covering products

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We cannot be certain that any patent

application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our

licensors will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings

application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors

will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings before

patent offices.

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or keep our competitive advantage.

● others may be able to make compounds that are similar to

our product candidates, but that are not covered by the claims of our licensed patents;

● any patents that we obtain from licensing or otherwise may

not provide us with any competitive advantages;

● any granted patents that we rely upon may be held invalid

or unenforceable as a result of legal challenges by third parties;

others may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;

any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;

any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties;

the patents of others may have an adverse effect on our business.

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regarding intellectual property subject to a license agreement, including:

● the scope of rights granted under the license agreement and

other interpretation-related issues;

● whether and the extent to which our technology and processes

infringe on intellectual property of the licensor that is not subject to the licensing agreement;

● our right to sublicense patent and other rights to third

● our diligence obligations with respect to the use of the

licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those

diligence obligations;

● our obligation to pursue or license others to pursue development

of indications we are not currently pursuing;

● the ownership of inventions and know-how resulting from the

joint creation or use of intellectual property by our licensors and us and our partners;

the scope of rights granted under the license agreement and other interpretation-related issues;

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our right to sublicense patent and other rights to third parties;

our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;

our obligation to pursue or license others to pursue development of indications we are not currently pursuing;

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;

our right to transfer or assign the license;

the effects of termination.

If disputes over intellectual property that we have

licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully

If disputes over intellectual property that we

have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully

develop and commercialize the affected product candidates.

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licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product

In addition, if our licensors fail to abide by the

terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are found

to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.

our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims,

regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor’s rights.

In addition, if our licensors fail to abide by

the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are

found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.

Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject

to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor’s rights.

Similarly, if we are unable to successfully obtain

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we cannot assure investors that other parties will not challenge any patents granted to the licensors or that courts or regulatory agencies

will hold licensor’s patents to be valid or enforceable.

We cannot guarantee investors that, if required to defend the covered patents,

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without limitation the following:

● any issued patents may not be broad or strong enough to prevent

competition from other vaccine products including identical or similar products;

● if patents are not issued or if issued patents expire, there

would be no protections against competitors making generic equivalents;

● there may be prior art of which we are not aware that may

affect the validity or enforceability of a patent claim;

● there may be other patents existing, now or in the future,

in the patent landscape for our product candidates that we seek to commercialize or develop, if any, that will affect our freedom to

● if patents that we have been granted licenses to are challenged,

a court could determine that they are not valid or enforceable;

● a court could determine that a competitor’s technology

or product does not infringe patents that we have been granted licenses to;

● patents to which we have been granted licenses could irretrievably

lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing;

● if we encounter delays in our development or clinical trials,

the period of time during which we could market our products under patent protection would be reduced.

any issued patents may not be broad or strong enough to prevent competition from other vaccine products including identical or similar products;

if patents are not issued or if issued patents expire, there would be no protections against competitors making generic equivalents;

there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;

there may be other patents existing, now or in the future, in the patent landscape for our product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;

if patents that we have been granted licenses to are challenged, a court could determine that they are not valid or enforceable;

a court could determine that a competitor’s technology or product does not infringe patents that we have been granted licenses to;

patents to which we have been granted licenses could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing;

if we encounter delays in our development or clinical trials, the period of time during which we could market our products under patent protection would be reduced.

Obtaining and maintaining patent protection depends on compliance

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Periodic maintenance fees on any issued patent are

due to be paid to the United States Patent and Trademark Office (USPTO) and foreign Intellectual Property Offices in several stages

over the term of the patent.

due to be paid to the United States Patent and Trademark Office (USPTO) and foreign Intellectual Property Offices in several stages over

the term of the patent.

Maintenance fees are also due for pending patent applications in some countries.

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non-provisional filing date.

In Europe, the expiration of an invention patent is 20 years

from its filing date.

Even if we successfully obtain patent protection for an approved vaccine candidate, it may face competition from

biosimilar medications.

Manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying

our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual

property rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materially

adversely affect any potential sales of that product.

In Europe, the expiration of an invention patent is 20 years from its filing

Even if we successfully obtain patent protection for an approved vaccine candidate, it may face competition from biosimilar medications.

Manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying our technology in court

or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual property rights and,

as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materially adversely affect

any potential sales of that product.

Given the amount of time required for the development,

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one or more of the U.S.

patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition

and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent extension term of

up to five years as compensation for patent term lost during the FDA regulatory review process.

A patent term extension cannot extend

the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and

only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.

However, we may

not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process,

failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy

applicable requirements.

patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition and

Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent extension term of up to

five years as compensation for patent term lost during the FDA regulatory review process.

A patent term extension cannot extend the remaining

term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering

the approved drug, a method for using it, or a method for manufacturing it may be extended.

However, we may not be granted an extension

because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within

applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements.

Moreover, the applicable time period or the scope

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We may need to license intellectual property from third parties,

and such licenses may not be available or may not be available

on commercially reasonable terms or at all.

and such licenses may not be available or may not be available on commercially reasonable terms or at all.

There may be intellectual property rights existing

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We thus cannot guarantee that our product candidates, or manufacture or use of our product candidates, will not infringe third-party patents.

Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court

to stop us from engaging in our normal operations and activities, including making or selling our product candidates.

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There is a risk that a court would decide that we are infringing the

third party’s patents and would order us to stop the activities covered by the patents.

In that event, we may not have a viable

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In addition, there is a risk that a court will

order us to pay the other party damages for having violated the other party’s patents.

In addition, we may be obligated to indemnify

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Even if we are

successful in these proceedings, we may incur substantial costs and diversion of management’s time and attention in pursuing these

proceedings, which could have a material adverse effect on us.

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including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time

how the FDA’s disclosure policies may change in the future, if at all.

Costly and time-consuming litigation could be necessary

to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely

affect our competitive business position.

how the FDA’s disclosure policies may change in the future, if at all.

Costly and time-consuming litigation could be necessary to

enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect

our competitive business position.

We may be subject to claims that our employees or consultants

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or potential competitors.

Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of

others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used

Although we try to ensure that our employees and consultants do not use the proprietary information or know-how

of others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used

or disclosed trade secrets or other proprietary information of their former employers.

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property rights in this type of litigation, we may be subject to:

● paying monetary damages related to the legal expenses of

the third party;

● facing additional competition that may have a significant

adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product;

● restructuring our company or delaying or terminating select

business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due

to a potential deterioration of our financial condition or market competitiveness.

paying monetary damages related to the legal expenses of the third party;

facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product;

restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

A third party may also challenge the validity, enforceability

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and third parties may be able to market competitive products that may use some or all of our intellectual property.

Changes to patent law, including the Leahy-Smith America

Invests Act of 2011 and the Patent Reform Act of 2009 and other future article of legislation, may substantially change

the regulations and procedures surrounding patent applications, issuance of patents and prosecution of patents.

We can give no assurances

that the patents of our licensor can be defended or will protect us against future intellectual property challenges, particularly as they

pertain to changes in patent law and future patent law interpretations.

Changes to patent law, including the Leahy-Smith

America Invests Act of 2011 and the Patent Reform Act of 2009 and other future article of legislation, may substantially change the regulations

and procedures surrounding patent applications, issuance of patents and prosecution of patents.

We can give no assurances that the patents

of our licensor can be defended or will protect us against future intellectual property challenges, particularly as they pertain to changes

in patent law and future patent law interpretations.

Risks Related to Healthcare Compliance and Other Regulations

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The laws include:

● the federal healthcare program anti-kickback law, which prohibits,

among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral

of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal

healthcare programs such as the Medicare and Medicaid programs;

● federal false claims laws which prohibit, among other things,

individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party

payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;

● HIPAA which prohibits executing a scheme to defraud any healthcare

benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the

privacy, security and transmission of individually identifiable health information;

● the FDCA which among other things, strictly regulates drug

manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates

the distribution of drug samples;

● state law equivalents of each of the above federal laws,

such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial

insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from

each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;

HIPAA which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;

the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

If our operations are found to be in violation of

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Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal

expenses and divert management’s attention from the operation of our business.

Moreover, achieving and sustaining compliance with

applicable federal and state privacy, security and fraud laws may prove costly.

Healthcare reform in the United States has been implemented

in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry.

Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.

In the United States, there have been, and

continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future

results of pharmaceutical manufactures’

In particular, there have been and continue to be a number of initiatives at

the federal and state levels that seek to reduce healthcare costs.

For example, the Affordable Care Act, or the ACA, which was originally

enacted in March 2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both

governmental and private insurers.

Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry

are the following:

● an annual, nondeductible fee on any entity that manufactures

or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in

certain government healthcare programs;

● implementation of the federal physician payment transparency

requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

Healthcare reform in the United States has been implemented in

the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry.

of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.

In the United States, there have been, and continue

to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future results

of pharmaceutical manufactures’ operations.

In particular, there have been and continue to be a number of initiatives at the federal

and state levels that seek to reduce healthcare costs.

For example, the Affordable Care Act, or the ACA, which was originally enacted

in March 2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both governmental

and private insurers.

Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry are the

an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for follow-on biologic products;

● a new Patient-Centered Outcomes Research Institute to oversee,

identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

● establishment of a Center for Medicare Innovation at the

Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid

spending, potentially including prescription drug spending;

● an increase in the statutory minimum rebates a manufacturer

must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs,

respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;

● a new methodology by which rebates owed by manufacturers

under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled,

infused, instilled, implanted or injected;

● extension of manufacturers’

Medicaid rebate liability

to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

● expansion of eligibility criteria for Medicaid programs by,

among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories

for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’

rebate liability;

● a new Medicare Part D coverage gap discount program,

in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible

beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare

● expansion of the entities eligible for discounts under the

Public Health program.

a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;

a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;

extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

expansion of the entities eligible for discounts under the Public Health program.

Some of the provisions of the ACA have yet to be

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Congress considered legislation that would repeal or repeal and replace all or part of the ACA.

While Congress has not passed repeal

legislation, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared

responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a

year that is commonly referred to as the “individual mandate.”

Congress may consider other legislation to repeal or replace

elements of the ACA.

While Congress has not passed repeal legislation,

the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment

imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred

to as the “individual mandate.” Congress may consider other legislation to repeal or replace elements of the ACA.

Many of the details regarding the implementation

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This uncertainty

is heightened by President Biden’s January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act,

which indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump

administration.

is heightened by President Biden’s January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act, which

indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump administration.

In August 2022, President Biden signed the Inflation Reduction Act, which extended enhanced subsidies, passed as part of the American

Rescue Plan Act in 2021, and prevented insurance companies from imposing significant increases in healthcare premiums for low income exchange

customers through 2025.

In addition, under this legislation, Medicare will have the ability to negotiate drug prices for a select list

of pharmaceuticals in Medicare Part D drugs, with the list of included drugs expected to increase over the coming years and incorporate

drugs in Medicare Parts B and D.

The FDA has issued several guidance documents, but

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A number of biosimilar applications have been approved over the past few years.

regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical

manufacturers conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly

similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically

meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

The regulations

that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers

conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly similar to an

approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences

between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

Individual states have become increasingly aggressive

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Legally mandated price controls on payment amounts by

third-party payors or other restrictions could harm a pharmaceutical manufacturer’s business, results of operations, financial condition

and prospects.

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what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical manufacturer’s

business, results of operations, financial condition and prospects.

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Further, it is possible that the Biden

administration may further increase the scrutiny on drug pricing.

administration may further increase the scrutiny on drug pricing, including a recent provision of the 2023 Inflation Reduction Act, allowing

Medicare to negotiate pharmaceutical prices directly with drug manufacturers.

In addition, given recent federal and state government

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example, there have been several recent U.S.

congressional inquiries and proposed federal and proposed and enacted state legislation

designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient

programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

in July 2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug

products including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts

for plans, pharmacies, and pharmaceutical benefit managers.

No assurance can be given whether these orders will remain in effect under

the Biden administration.

congressional inquiries and proposed federal and proposed and enacted state legislation designed

to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs,

reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

Further, in July

2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug products including

one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts for plans, pharmacies,

and pharmaceutical benefit managers.

No assurance can be given whether these orders will remain in effect under the Biden administration.

While no one can predict the full outcome of any

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to reduce prescription drug prices.

This could harm a pharmaceutical manufacturer’s ability to generate revenue.

Increases in importation

or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure

on a pharmaceutical manufacturer’s ability to profitably price products, which, in turn, could adversely affect business, results

of operations, financial condition and prospects.

A pharmaceutical manufacturer might elect not to seek approval for or market products

in foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated from

product sales.

It is also possible that other legislative proposals having similar effects will be adopted.

Furthermore, regulatory authorities’

or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure on a pharmaceutical

manufacturer’s ability to profitably price products, which, in turn, could adversely affect business, results of operations, financial

condition and prospects.

A pharmaceutical manufacturer might elect not to seek approval for or market products in foreign jurisdictions

in order to minimize the risk of re-importation, which could also reduce the revenue generated from product sales.

It is also possible

that other legislative proposals having similar effects will be adopted.

Furthermore, regulatory authorities’ assessment

of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as

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product candidates will be substantial, we may explore funding and development collaboration opportunities with the U.S.

and its agencies.

For example, we may apply for certain grant funding from BARDA, the NIH or other government agencies to further the

research, development, manufacture, testing, and regulatory approval of our vaccine product candidates.

We have no control or input over

whether an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide

investors with any assurances that we will receive such funding.

government and

its agencies.

For example, we may apply for certain grant funding from BARDA, the NIH or other government agencies to further the research,

development, manufacture, testing, and regulatory approval of our vaccine product candidates.

We have no control or input over whether

an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide investors

with any assurances that we will receive such funding.

Contracts and grants funded by the U.S.

and its agencies, contain provisions that reflect the government’s substantial rights and remedies, many of which are not typically

found in commercial contracts, including powers of the government to:

● reduce or modify the government’s obligations under

such agreements without the consent of the other party;

● claim rights, including Intellectual Property rights, in

products and data developed under such agreements;

● audit contract-related costs and fees, including allocated

indirect costs;

● suspend the contractor or grantee from receiving new contracts

pending resolution of alleged violations of procurement laws or regulations.

● impose U.S.

manufacturing requirements for products

that embody inventions conceived or first reduced to practice under such agreements;

● suspend or debar the contractor or grantee from doing future

business with the government;

reduce or modify the government’s obligations under such agreements without the consent of the other party;

claim rights, including Intellectual Property rights, in products and data developed under such agreements;

audit contract-related costs and fees, including allocated indirect costs;

suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations.

manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;

suspend or debar the contractor or grantee from doing future business with the government;

control and potentially prohibit the export of products;

● pursue criminal or civil remedies under the False Claims

Act, False Statements Act, and similar remedy provisions specific to government agreements;

● limit the government’s financial liability to amounts

appropriated by the U.S.

Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding

for a program even after it has been funded for an initial period.

pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements;

limit the government’s financial liability to amounts appropriated by the U.S.

Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.

If we received such grants or agreements, we may

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third-parties, including our competitors, from using those technologies in providing products and services to the U.S.

Further, under such agreements we could be subject to obligations to and the rights of the U.S.

government set forth in the Bayh-Dole

Act of 1980, meaning the U.S.

government may have rights in certain inventions developed under these government-funded

agreements, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

under such agreements we could be subject to obligations to and the rights of the U.S.

government set forth in the Bayh-Dole Act of 1980,

meaning the U.S.

government may have rights in certain inventions developed under these government-funded agreements, including a non-exclusive,

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

In addition, the U.S.

government could have the right to require us to grant exclusive, partially exclusive, or nonexclusive licenses

to any of these inventions to a third party if it determines that:

government could

have the right to require us to grant exclusive, partially exclusive, or nonexclusive 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.”

Although the U.S.

government’s

historic restraint with respect to these rights indicates they are unlikely to be used, any exercise of the march-in rights could harm

our competitive position, business, financial condition, results of operations, and prospects.

In the event we would be subject to the

government’s exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S.

in its sole discretion, which may be less than what we might be able to obtain in the open market.

(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.” Although the U.S.

government’s historic restraint with respect to these rights

indicates they are unlikely to be used, any exercise of the march-in rights could harm our competitive position, business, financial condition,

results of operations, and prospects.

In the event we would be subject to the U.S.

government’s exercise such march-in rights, we

may receive compensation that is deemed reasonable by the U.S.

government in its sole discretion, which may be less than what we might

be able to obtain in the open market.

Additionally, the U.S.

government requires

that any products embodying any invention generated through the use of U.S.

government funding 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

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

manufacturers for products covered by such intellectual

government requires that

any products embodying any invention generated through the use of U.S.

government funding be manufactured substantially in the United

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 U.S.

manufacturers

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

manufacturers for products covered by such intellectual property.

Although we may need to comply with some of these

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controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations.

Compliance with these legal

standards could impair our ability to compete in domestic and international markets.

We can face criminal liability and other serious

consequences for violations, which can harm our business.

Compliance with these legal standards

could impair our ability to compete in domestic and international markets.

We can face criminal liability and other serious consequences

for violations, which can harm our business.

We are subject to export control and import laws

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Export Administration Regulations, U.S.

Customs regulations, various economic and trade

sanctions regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Controls, the U.S.

Corrupt Practices Act of 1977, as amended, the U.S.

Customs regulations, various economic and trade sanctions

regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Controls, the U.S.

Foreign Corrupt Practices

Act of 1977, as amended, the U.S.

domestic bribery statute contained in 18 U.S.C.

§ 201, the U.S.

Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct

Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other

collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value

to recipients in the public or private sector.

We may engage third parties for clinical trials outside of the United States,

to sell our products abroad once we enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations,

and other regulatory approvals.

We have direct or indirect interactions with officials and employees of government agencies or government-affiliated

hospitals, universities and other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents,

contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities.

Any violations

of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of

export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Travel Act, the USA PATRIOT Act

and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities.

Anti-corruption

laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing,

promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private

We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a commercialization

phase and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

We have direct or indirect interactions

with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations.

held liable for the corrupt or other illegal activities of our employees, agents, contractors and other collaborators, even if we do not

explicitly authorize or have actual knowledge of such activities.

Any violations of the laws and regulations described above may result

in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments,

breach of contract and fraud litigation, reputational harm and other consequences.

Risks Related to Owning our Common Stock

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whether we achieve our anticipated corporate objectives;

● actual or anticipated fluctuations in our financial condition

and operating results;

actual or anticipated fluctuations in our financial condition and operating results;

changes in financial or operational estimates or projections;

● the development status of our product candidates and when

our products receive regulatory approval;

● our execution of our sales and marketing, manufacturing and

other aspects of our business plan;

● performance of third parties on whom we rely to manufacture

our products, product components and product candidates, including their ability to comply with regulatory requirements;

the development status of our product candidates and when our products receive regulatory approval;

our execution of our sales and marketing, manufacturing and other aspects of our business plan;

performance of third parties on whom we rely to manufacture our products, product components and product candidates, including their ability to comply with regulatory requirements;

the results of our clinical studies and clinical trials;

● results of operations that vary from those of our competitors

and the expectations of securities analysts and investors;

● changes in expectations as to our future financial performance,

including financial estimates by securities analysts and investors;

● our announcement of significant contracts, acquisitions or

capital commitments;

● announcements by our competitors of competing products or

other initiatives;

● announcements by third parties of significant claims or proceedings

● regulatory and reimbursement developments in the United States

results of operations that vary from those of our competitors and the expectations of securities analysts and investors;

changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;

our announcement of significant contracts, acquisitions or capital commitments;

announcements by our competitors of competing products or other initiatives;

announcements by third parties of significant claims or proceedings against us;

regulatory and reimbursement developments in the United States and abroad;

future sales of our common stock;

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additions or departures of key personnel;

● general economic or political conditions in the United States

or elsewhere.

In addition, the stock market in general, and

the stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have

often been unrelated or disproportionate to the operating performance of the issuer.

For example, on March 15, 2022 and March 18, 2022,

the closing price of our common stock on Nasdaq was $67.90 and $39.90, respectively, and daily trading volume on these days was approximately

general economic or political conditions in the United States or elsewhere.

In addition, the stock market in general, and the

stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often

been unrelated or disproportionate to the operating performance of the issuer.

For example, on March 15, 2022 and November 9, 2022, the

closing price of our common stock on Nasdaq was $67.90 and $0.92, respectively, and daily trading volume on these days was approximately

12,500 and 236,500 shares, respectively.

Additionally, our intraday trading prices have experienced extreme fluctuation.

For example, on

March 16, 2022, the difference between our high and low trading price was $46.49 and on February 22, 2022, the difference between our

high and low trading price was $40.80.

These broad market fluctuations may adversely affect the trading price of our common stock.

particular, a proportion of our common stock has been and may continue to be traded by short sellers which may put pressure on the supply

On April 7, 2022,

the difference between our high and low trading price was $52.10.

These broad market fluctuations may adversely affect the trading price

of our common stock.

In particular, a proportion of our common stock may be traded by short sellers which may put pressure on the supply

and demand for our common stock, further influencing volatility in its market price.

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We may be subject to securities litigation, which is expensive

and could divert our management’s attention.

The market price of our securities may be volatile,

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Securities litigation against us could result in substantial

costs and divert our management’s attention from other business concerns, which could seriously harm our business.

Our Amended and Restated Certificate of Incorporation requires,

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and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service of process on such

stockholder’s counsel, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.

Our Amended and Restated Certificate of Incorporation

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the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service

of process on such stockholder’s counsel except any action (A) as to which the Court of Chancery in the State of Delaware 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), (B) which is vested in

the exclusive jurisdiction of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have

subject matter jurisdiction, or (D) any action arising under the Securities Act, as to which the Court of Chancery and the federal

district court for the District of Delaware shall have concurrent jurisdiction.

Any person or entity purchasing or otherwise acquiring

any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our Amended and

Restated Certificate of Incorporation.

This choice of forum provision may make it more costly for a stockholder to bring a claim, and

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

of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders

cannot waive our compliance with federal securities laws and the rules and regulations thereunder.

Alternatively, if a court were to find

the choice of forum provision contained in our Amended and Restated Certificate of Incorporation 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,

operating results and financial condition.

to the personal jurisdiction of the Court of Chancery within ten days following such determination), (B) which is vested in the exclusive

jurisdiction of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have subject matter jurisdiction,

or (D) any action arising under the Securities Act, as to which the Court of Chancery and the federal district court for the District

of Delaware shall have concurrent jurisdiction.

Any person or entity purchasing or otherwise acquiring any interest in shares of our capital

stock shall be deemed to have notice of and consented to the forum provisions in our Amended and Restated Certificate of Incorporation.

This choice of forum provision may make it more costly for a stockholder to bring a claim, and it may also limit a stockholder’s

ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees

or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders cannot waive our compliance with

federal securities laws and the rules and regulations thereunder.

Alternatively, if a court were to find the choice of forum provision

contained in our Amended and Restated Certificate of Incorporation 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, operating results and financial condition.

Our Amended and Restated Certificate of Incorporation

provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law.

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.

As a result, the exclusive forum provision will not apply to suits brought to enforce any duty

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

our Amended and Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum,

the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum

for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the

rules and regulations promulgated thereunder.

We note, however, that there is uncertainty as to whether a court would enforce this provision

and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

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

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

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.

As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability

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

In addition, our Amended and

Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum, the federal

district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution

of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the rules and regulations promulgated

We note, however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive

compliance with the federal securities laws and the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrent

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

rules and regulations thereunder.

An active trading market for our common stock may not develop

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stock on February 18, 2022, no public market for our common stock existed.

Although our common stock is listed on The Nasdaq Capital

Market, an active trading market for our common stock may not develop, or if developed, be sustained.

The lack of an active market may

impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable.

The lack of an active

market may also reduce the fair value of your shares.

Although our common stock is listed on The Nasdaq Capital Market,

an active trading market for our common stock may not develop, or if developed, be sustained.

The lack of an active market may impair

your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable.

The lack of an active market

may also reduce the fair value of your shares.

Further, an inactive market may also impair our

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Our continued eligibility for listing on Nasdaq

depends on our ability to comply with Nasdaq’s continued listing requirements.

If Nasdaq delists the common stock from trading on

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a limited availability of market quotations for our securities;

● a determination that our common stock is a “penny stock,”

which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading

activity in the secondary trading market for our common stock;

a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;

a limited amount of analyst coverage;

● a decreased ability to issue additional securities or obtain

additional financing in the future.

a decreased ability to issue additional securities or obtain additional financing in the future.

If our shares become subject to the penny stock rules, it would

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effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination

that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the

receipt of a risk disclosure statement;

that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt

of a risk disclosure statement;

(ii) a written agreement to transactions involving penny stocks;

and (iii) a signed

and dated copy of a written suitability statement.

These disclosure requirements may have the effect of reducing the trading activity

in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

and (iii) a signed and dated copy of

a written suitability statement.

These disclosure requirements may have the effect of reducing the trading activity in the secondary market

for our common stock, and therefore stockholders may have difficulty selling their shares.

Future sales of our shares by existing stockholders could cause

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officers sell, or indicate an intent to sell, substantial amounts of our common stock or securities convertible into our common stock

in the public market after February 17, 2023 in the case of the Company and after August 16, 2022 in the case of directors, officers and

stockholders, contractual lock-up and other legal restrictions on resale in connection with our initial public offering lapse, the trading

price of our common stock could decline significantly.

Based on 11,048,587 shares of common stock outstanding as of March 15, 2022, 2,222,222

shares of common stock are freely tradable, without restriction, in the public market.

If our existing stockholders sell substantial amounts

of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on

the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

intend to register all shares of common stock that we may issue under our equity compensation plan.

Once we register these shares, they

can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

After the lock-up agreements pertaining to our initial

public offering expire, an additional 8,826,365 shares will be eligible for sale in the public market.

In addition, upon issuance, the

780,640 shares subject to outstanding options under our stock option plan and the shares reserved for future issuance under our stock

option plan will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.

our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales

could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such

sales and the performance of our business.

We are an “emerging growth company”

and the reduced

in the public market after contractual lock-up and other legal restrictions on resale lapse, the trading price of our common stock could

decline significantly and could decline below the initial public offering price.

We have outstanding 15,911,868 shares of common stock

as of the date hereof, assuming no exercise of outstanding options or warrants, are or will be freely tradable, without restriction, in

the public market.

If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives

that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship

between such sales and the performance of our business.

We have previously registered 2,600,000 shares of common stock under our equity

compensation plans.

These shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates

and lock-up agreements.

Upon issuance, the 1,470,040 shares subject to outstanding

options under our stock option plan and the shares reserved for future issuance under our stock option plan will become eligible for sale

in the public market in the future, subject to certain legal and contractual limitations.

If our existing stockholders sell substantial

amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact

on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

We are an “emerging growth company” and the reduced

disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

We are an “emerging growth company,”

as defined in the JOBS Act.

We may remain an “emerging growth company”

until as late as December 31, 2027 (the fiscal

year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an “emerging

growth company”

earlier under certain circumstances, including (1) if the market value of our common stock that is held by

nonaffiliates exceeds $700 million as of any June 30, in which case we would cease to be an “emerging growth company”

We may remain an “emerging growth company” until as late as December 31, 2027 (the fiscal year-end

following the fifth anniversary of the completion of our initial public offering, which closed during February 2022), though we may cease

to be an “emerging growth company” earlier under certain circumstances, including (1) if the market value of our common stock

that is held by nonaffiliates exceeds $700 million as of any June 30, in which case we would cease to be an “emerging growth company”

as of the following December 31, or (2) if our gross revenue exceeds $1.235 billion in any fiscal year.

“Emerging

growth companies”

may take advantage of certain exemptions from various reporting requirements that are applicable to other public

companies, including not being required to comply with the auditor attestation requirements of Section 404 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 stockholder approval of any golden parachute payments

not previously approved.

Investors could 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.

In addition, Section 102 of the JOBS Act also

provides that an “emerging growth company”

can 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.

An “emerging growth company”

can therefore delay

the adoption of certain accounting standards until those standards would otherwise apply to private companies.

“Emerging growth companies”

may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies, including

not being required to comply with the auditor attestation requirements of Section 404 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 stockholder approval of any golden parachute payments not previously approved.

Investors could

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.

In addition, Section 102 of the JOBS Act also provides

that an “emerging growth company” can 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.

An “emerging growth company” can therefore delay the

adoption of certain accounting standards until those standards would otherwise apply to private companies.

We are subject to increased costs as a result of operating as

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accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements.

The Sarbanes-Oxley Act of 2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The

Nasdaq Capital Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including

requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.

Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted.

significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional

rules and regulations in these areas, such as “say on pay”

and proxy access.

Emerging growth companies may implement many

of these requirements over a longer period of up to five years from the pricing of their initial public offering.

We intend to take

advantage of these extended transition periods but cannot guarantee that we will not be required to implement these requirements sooner

than budgeted or planned and thereby incur unexpected expenses.

Stockholder activism, the current political environment and the current

high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which

may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.

Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company

reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines

prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote

additional time and costs to comply with such compliance programs and rules.

These rules and regulations will cause us to incur significant

legal and financial compliance costs and will make some activities more time-consuming and costly.

The Sarbanes-Oxley Act of 2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The Nasdaq Capital

Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment

and maintenance of effective disclosure and financial controls and changes in corporate governance practices.

Further, in July 2010, the

Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted.

There are significant corporate governance

and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in

these areas, such as “say on pay” and proxy access.

Emerging growth companies may implement many of these requirements over

a longer period of up to five years from the pricing of their initial public offering.

We intend to take advantage of these extended transition

periods but cannot guarantee that we will not be required to implement these requirements sooner than budgeted or planned and thereby

incur unexpected expenses.

Stockholder activism, the current political environment and the current high level of government intervention

and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs

and impact the manner in which we operate our business in ways we cannot currently anticipate.

Our management and other personnel will

devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and as a result

of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and

further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply

with such compliance programs and rules.

These rules and regulations will cause us to incur significant legal and financial compliance

costs and will make some activities more time-consuming and costly.

To comply with the requirements of being a public

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404 of the Sarbanes-Oxley Act, are necessary for us to provide reliable financial reports and effectively prevent fraud.

If we cannot provide

reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed.

We have discovered, and may

in the future discover, areas of our internal controls that need improvement.

We cannot be certain that the measures we have taken or

intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future.

Any failure to

implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,

provide reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed.

We have discovered,

and may in the future discover, areas of our internal controls that need improvement.

We cannot be certain that the measures we have taken

or intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future.

to implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,

harm our business and operating results or cause us to fail to meet our reporting obligations.

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trading price of our stock.

If securities or industry analysts do not

publish research, or publish inaccurate or unfavorable research, about our business, our stock price and our trading volume could decline.

If securities or industry analysts do not publish research, or

publish inaccurate or unfavorable research, about our business, our stock price and our trading volume could decline.

The trading market for our common stock depends,

in part, on the research and reports that securities or industry analysts publish about us or our business.

Securities and industry analysts

may never publish research on us.

If no or few securities or industry analysts commence coverage of us, the price for our common stock

could be negatively impacted.

In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover

us downgrade our common stock or publish inaccurate or unfavorable research about our business, our stock price could decline.

if our operating results fail to meet the forecast of analysts, our stock price could decline.

If one or more of these analysts cease

coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price

and trading volume to decline.

While we currently have certain

analyst coverage, if one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research

about our business, our stock price could decline.

In addition, if our operating results fail to meet the forecast of analysts, our stock

price could decline.

If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our

common stock could decrease, which might cause our stock price and trading volume to decline.

Our stock repurchase program may adversely affect our liquidity

and cause fluctuations in our stock price.

On November 8, 2022, our Board authorized a stock

repurchase program pursuant to which the Company may repurchase up to 5 million shares of our common stock, with a maximum price of $1.00

per share, with discretion to management to make purchases subject to market conditions.

On November 18, 2022, our Board approved an increase

to the maximum price to $2.00 per share.

Potential future stock repurchases under the stock

share repurchase program could be funded by operating cash flow or excess cash balances.

The maximum number of shares of the Company’s

common stock that may yet be repurchased under the share repurchase program is 4.5 million.

Repurchases under the stock repurchase program

may adversely affect our liquidity, which in turn could impact our profitability, financial condition and results of operations.

repurchases under the stock repurchase program will reduce the number of shares of our common stock available for purchase and sale in

the public market, which could affect the market price of our common stock.

Furthermore, the Inflation Reduction Act of 2022, which was

signed into law in August 2022, imposes a non-deductible 1% excise tax on the fair market value of stock repurchases after December 31,

2022 that exceed $1.0 million in a taxable year, which may impact the tax efficiency of our stock repurchase program.

Failure in, or security breaches or incidents impacting, our

information technology or storage systems could significantly disrupt our operations and our research and development efforts.

Our ability to execute our business strategy will

depend, in part, on the continued and uninterrupted performance of our information technology, or IT, systems, which support our operations,

including at our proposed clinical laboratories, and our research and development efforts.

We are dependent on our IT systems for many

aspects of our business, including our needs to retain and store our confidential and proprietary business information and to receive

and process test orders, securely store patient health records and deliver the results of our tests.

The integrity and protection of our

own data, and that of our customers and employees, is critical to our business.

The regulatory environment governing information, security

and privacy and data protection laws is increasingly demanding and continues to evolve.

IT systems are vulnerable to damage from a variety

of sources, including telecommunications or network failures, cyberattacks (including ransomware attacks) and other malicious human acts

from criminal hackers, hacktivists, state-sponsored intrusions and other attacks, industrial espionage and employee malfeasance, breaches

and incidents due to employee error or negligence, and natural disasters.

Moreover, despite network security and back-up measures, some

of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and other malicious code similar disruptive

High-profile security breaches and incidents at

other companies and in government agencies have increased in recent years, and security industry experts and government officials have

warned about the risks of hackers and cyber-attacks targeting businesses such as ours.

Cyber-attacks are becoming more sophisticated and

frequent, and in some cases have caused significant harm.

Computer hackers and others routinely attempt to breach the security of technology

products, services and systems, and to fraudulently induce employees, customers, or others to disclosure information or unwittingly provide

access to systems or data.

Much of our workforce currently works remotely rather than in our offices, and we may be more susceptible to

security breaches and incidents as a result.

Our service providers may be more susceptible to security breaches and other security incidents

while social distancing measures restrict the ability of their employees to work at offices to combat the COVID-19 pandemic.

We may in the future experience attempted or successful

cyber-attacks of our IT systems or networks.

To date, we have not experienced any material cyber-attacks.

However, any security breach

or incident impacting, or interruption could compromise our networks and the information stored therein, including algorithms relating

to our products, could be accessed by unauthorized parties, publicly disclosed, lost, inaccessible or unavailable, corrupted, or stolen.

Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, unauthorized access

to our systems, or disruptions or other security breaches impacting our IT systems, and any unauthorized access to, or, loss, inaccessibility,

unavailability, corruption, theft or disclosure could also disrupt our operations, including our ability to:

process tests, provide test results, bill payors or patients;

process claims and appeals;

provide customer assistance services;

conduct research and development activities;

collect, process and prepare company financial information;

provide information about our tests and other patient and healthcare provider education and outreach efforts through our website;

and manage the administrative aspects of our business and damage our reputation.

Any such breach, incident, or other compromise of

IT systems or data, or the perception that any of these has occurred, could result in legal claims or proceedings, liability under laws

that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996, or HIPAA, similar

state data protection regulations, and other regulations, the breach of which could result in claims, complaints, regulatory investigations

and other proceedings, and significant fines, penalties, and other liability.

We also may be required to incur significant costs in an

effort to detect and prevent security breaches and other security-related incidents.

Additionally, information obtained by third parties

in connection with past or future cyberattacks or other security breaches or incidents could be used in ways that adversely affect our

company or our stockholders.

Further, third-party service providers who support

our operations, and our independent contractors (including CROs), consultants, collaborators, and service providers also may suffer interruptions

and disruptions of systems and other breaches, incidents, or other compromises of or impacting their IT systems or data that they process

or maintain for us, which may lead to any of the foregoing.

We and our third-party service providers may not have the resources or technical

sophistication to anticipate or prevent all cyberattacks or other sources of security breaches or incidents, and we or they may face difficulties

or delays in identifying and responding to cyberattacks and data security breaches and incidents.

In addition, the interpretation and

application of consumer, health related and security, privacy and data protection laws in the United States, Europe and elsewhere are

often uncertain, contradictory and in flux, such as in the area of international transfers of personal data.

Complying with these various

laws, and satisfying healthcare providers’ and patients’ evolving expectations with respect to data protection, could cause

us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business.

We do not maintain insurance policies for cybersecurity-related

matters, data handling or data security liabilities.

The successful assertion of one or more large claims against us could have a material

adverse effect on our business, including our financial condition, operating results, and reputation

Our Amended and Restated Certificate of Incorporation and our

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Our Amended and Restated Certificate of Incorporation authorizes us to issue up

to 10,000,000 shares of preferred stock.

to 10 million shares of preferred stock.

This preferred stock may be issued in one or more series, the terms of which may be determined

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and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:

● provide the board of directors with the ability to alter

the bylaws without stockholder approval;

provide the board of directors with the ability to alter the bylaws without stockholder approval;

place limitations on the removal of directors;

● establish advance notice requirements for nominations for

election to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

● provide that vacancies on the board of directors may be filled

by a majority of directors in office, although less than a quorum.

establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

These provisions, alone or together, could delay

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foreseeable future.

A possible “short squeeze”

due to a sudden increase

Environmental, social and governance matters may impact our business

and reputation.

Increasingly, in addition to the importance of their

financial performance, companies are being judged by their performance on a variety of environmental, social and governance (“ESG”)

matters, which are considered to contribute to the long-term sustainability of companies’ performance.

A variety of organizations measure the performance

of companies on such ESG topics, and the results of these assessments are widely publicized.

In addition, investment in funds that specialize

in companies that perform well in such assessments are increasingly popular, and major institutional investors have publicly emphasized

the importance of such ESG measures to their investment decisions.

Topics taken into account in such assessments include, among others,

the company’s efforts and impacts on climate change and human rights, ethics and compliance with law, and the role of the company’s

board of directors in supervising various sustainability issues.

In addition to the topics typically considered in such assessments, in

the healthcare industry, issues of the public’s ability to access our medicines are of particular importance.

In light of investors’ increased focus on

ESG matters, there can be no certainty that we will manage such issues successfully, or that we will successfully meet society’s

expectations as to our proper role.

Any failure or perceived failure by us in this regard could have a material adverse effect on our

reputation and on our business, share price, financial condition, or results of operations, including the sustainability of our business

A possible “short squeeze” due to a sudden increase

in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

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are able to purchase additional common shares to cover their short position.

This is often referred to as a “short squeeze.”

A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects

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E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

All of our research and development is performed

on the premises of our third-party providers.

We also lease office space located at 150 Worth

Avenue, Palm Beach, FL 33480, which lease expires on April 30, 2023.

All of our research and development is performed on the premises

of our third-party providers.

Legal Proceedings.

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Mine Safety Disclosures.

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