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Item 1A. Risk Factors

2024-04-11 compared with 2023-03-09 · 2661 added, 2551 removed, 111 unchanged (98% of the section changed)

Risk Factors.

Investing in our common stock involves a high

degree of risk.

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.

The occurrence of

any of the following risks could have a material adverse effect on our business, reputation, financial condition, results of operations

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.

Risks Related to our Financial Position and Need for Capital

We are in the early stages of vaccine development and have a

very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success

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

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

such activities.

As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory

approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization

or arrange for a third party to conduct these activities on our behalf.

Consequently, any predictions about our future success or viability

may not be as accurate as they could be if we had a longer operating history.

Our current vaccine candidate pipeline includes

multiple preclinical programs.

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

in achieving our business objectives, including with respect to our vaccine candidates.

We will need to transition in the future from

a company with a research and development focus to a company capable of supporting commercial activities and may not be successful in

such a transition.

We have incurred significant net losses since inception, do not

generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve

profitability.

Investing in our common stock involves a high degree of risk.

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.

The occurrence of any of the following risks

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

Related to our Financial Position and Need for Capital

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

our future viability.

To date, we have devoted

substantially all of our resources to performing research and development, hiring personnel, licensing and developing our technology,

organizing and staffing our company, performing business planning, establishing our intellectual property portfolio, potential asset

and business acquisitions, expenditures associated with the commercial launch of ENTADFI, and raising capital to support and expand such

As an organization, we have not yet demonstrated an ability to successfully manufacture a commercial-scale product or conduct

sales and marketing activities necessary for successful commercialization or arrange for a third party to conduct these activities on

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

operating history.

may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives,

including with respect to our products.

We are in the process of transitioning from a company with a research and development focus to

a company capable of supporting commercial activities and may not be successful in such a transition.

We have incurred significant net losses

since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable

future and may never achieve profitability.

Our stock is a highly speculative investment.

We are a preclinical stage biotechnology vaccine

company that was incorporated in October 2018.

Investment in preclinical stage companies and vaccine development is highly speculative

because it entails substantial upfront capital expenditures and significant risk that any potential vaccine candidate will not gain regulatory

approval or become commercially viable.

We do not have any products approved for sale and have not generated any revenue from product

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

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

to fund research and development of, and seek regulatory approvals for, our vaccine candidates.

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

We are a commercial-stage biotechnology company that was incorporated

in October 2018.

Our net loss was $37.4 million and $13.4 million for the years ended December 31, 2023 and 2022, respectively.

December 31, 2023, we had an accumulated deficit of $56.8 million.

We also generated negative operating cash flows of $13.6 million for

the year ended December 31, 2023.

We expect to continue to

spend significant resources to commercialize our products.

We expect to incur substantial and increasing operating losses over the next

several years.

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 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.

We will require substantial additional funding to finance our

long-term operations.

If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain

of our development programs or other operations.

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,

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;

Additionally, there can be no assurance that our

current products or those that may be under development by us in the future will be commercially viable.

If we are unable to achieve

profitability, we may be unable to continue our operations.

There is substantial doubt about our ability

to continue as a “going concern,” and we will require substantial additional funding to finance our long-term operations.

If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our products or

other operations.

Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the

foreseeable future.

As of December 31, 2023, the Company had cash of approximately $4.6 million, a working capital deficit

of approximately $11.4 million and an accumulated deficit of approximately $56.8 million.

January 23, 2024, the Company issued the Debenture in exchange for $4.6 million in net cash proceeds.

The Debenture is repayable in full

upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024.

We estimate that, based on our existing cash as of the date of this

Report, we will not 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, satisfy existing and future obligations

and liabilities, and otherwise support the Company’s working capital needs and business activities, including making the remaining

payments to Veru, and the commercialization of Proclarix and ENTADFI (should we decide to resume its commercialization).

if Stockholder Approval is not obtained by January 1, 2025, the Company may be obligated to cash settle the Series B Preferred Stock.

The Company does not currently have sufficient cash to redeem the shares of Series B Preferred Stock.

Based on the closing price of $0.166

for the Company’s stock as of April 5, 2024, the Series B Preferred Stock would be redeemable for approximately $44.8 million.

Management’s plans include generating product revenue from sales of Proclarix, which may still be subject to further successful

commercialization activities within certain jurisdictions.

In addition, should we decide to resume the commercialization of ENTADFI, we

plan to also generate product sales from ENTADFI, which is subject to further successful commercialization activities.

Certain of the

commercialization activities are outside of the Company’s control, including but not limited to, securing contracts with wholesalers

and third-party payers, securing contracts with third-party logistics providers, obtaining required licensure in various jurisdictions,

as well as attempting to secure additional required funding through equity or debt financings if available.

However, there are currently

no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable

terms, if at all.

If the Company is unable to secure additional capital, it may be required to delay or curtail any future commercialization

of products, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations

and meet its obligations.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern for

a period of time within one year following the date of this Report.

Our future capital requirements will depend on many factors, including:

the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and ENTADFI (if we decide to resume its commercialization), and other products for which we have received or will 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;

the revenue, if any, received from commercial sales of Proclarix and ENTADFI (if we decide to resume its commercialization), or other products 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 our patents or other intellectual property rights;

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

on financial, economic and other factors, many of which are beyond our control.

We cannot be certain that additional funding will be available

on acceptable terms, or at all.

We have no committed source of additional capital and if we are unable to raise additional capital in

sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization

of our vaccine candidates or other research and development initiatives.

Our license agreements may also be terminated if we are unable

to meet the payment obligations or milestones under the agreements.

We could be required to seek collaborators for our vaccine candidates

at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, or relinquish

or license on unfavorable terms our rights to our vaccine candidates in markets where we otherwise would seek to pursue development or

commercialization ourselves.

We may consider strategic alternatives in order to maximize stockholder

value, including financings, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business.

be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may have an adverse impact

on our vaccine candidates.

We may consider all strategic alternatives that

may be available to us to maximize stockholder value, including financings, strategic alliances, licensing arrangements, acquisitions

or the possible sale of our business.

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.

ability to raise additional funds will depend on financial, economic, and other factors, many of which are beyond our control.

be certain that additional funding will be available on acceptable terms, or at all.

We have no committed source of additional capital

and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce

the scope of our business activities.

We owe a significant amount of money to

Veru, which funds we do not have.

Veru may take action against us to enforce its rights to payment in the future, which could have a material

adverse effect on us and our operations.

Due to recent financial constraints, the Company may be unable to timely

pay amounts due to Veru, from whom we purchased ENTADFI in April 2023.

The Company is currently in ongoing discussions with Veru to negotiate

our payment obligations in connection with our acquisition of ENTADFI.

However, no definitive terms or extensions have been agreed to,

While we are hopeful that we can come to mutually agreeable terms regarding a settlement, payment plan, and/or extension with

Veru, we may not have sufficient funds to pay amounts due to Veru in the near term, if at all, including but not limited to $10 million,

$5 million of which is due on each of April 19, 2024 and September 30, 2024, and Veru may take action against us, including filing legal

proceedings against us seeking amounts due and interest or attempting to terminate its relationship with us.

If Veru were to take legal

action against us, we may be forced to scale back our business plan and/or seek bankruptcy protection.

We may be subject to litigation

and damages for our failure to pay due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.

We are currently considering strategic options for ENTADFI and plan to seek to raise funding in the future to support our operations,

and to pay amounts due to Veru, through a combination of equity offerings, debt financing or other capital sources, including potential

collaborations, licenses, sales, and other similar arrangements, which may not be available on favorable terms, if at all.

additional equity or debt securities, if accomplished, may result in dilution to our stockholders.

Our current liabilities are significant, and if those to whom

we owe accounts payable, such as Veru, IQVIA or other vendors, were to demand payment, we would be unable to pay.

As of December 31, 2023,

we had total current liabilities of approximately $17.2 million, including accounts payable of approximately $5.3 million, accrued expenses

of approximately $2.2 million, and approximately $9.6 million (net of discount) related to the notes payable due to Veru.

As of the same

date, we had cash of only $4.6 million.

We are currently considering strategic options for ENTADFI and plan to seek to raise funding in

the future to support our operations.

If those to whom these payments are due were to demand immediate payment, as they are entitled to

do, and we are not able to make the required payments, we would be subject to liability if our creditors chose to enforce their rights,

which could result in our bankruptcy and insolvency, at worst.

Under such a scenario, our assets would be distributed to our creditors

leaving nothing to be distributed to our stockholders.

may consider strategic alternatives in order to maximize stockholder value, including financing, strategic alliances, licensing arrangements,

acquisitions or the possible sale of our business.

We may not be able to identify or consummate any suitable strategic alternatives and

any consummated strategic alternatives may not be successful.

may consider all strategic alternatives that may be available to us to maximize stockholder value, including financing, strategic alliances,

licensing arrangements, acquisitions, or the possible sale of our business.

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

seeking appropriate strategic partners, and the negotiation process is time-consuming and complex.

Moreover, we may not be successful

in our efforts to establish a strategic partnership or other alternative arrangements for our vaccine candidates because they may be deemed

to be at too early of a stage of development for collaborative effort, and third parties may not view our vaccine candidates as having

the requisite potential to demonstrate safety and efficacy.

Any delays in entering into new strategic partnership agreements related to

our vaccine candidates could delay the development and commercialization of our vaccine candidates in certain geographies for certain

indications, which would harm our business prospects, financial condition and results of operations.

If we license products or businesses, we may not

be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company

We cannot be certain that, following a strategic transaction or license, we will achieve the results, revenue or specific net

income that justifies such transaction.

Raising additional capital may cause dilution to our existing

stockholders and investors, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms

We may seek additional capital through a variety

of means, including through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing,

distribution or licensing arrangements.

To the extent that we raise additional capital through the sale of equity or convertible debt

securities, or through the issuance of shares under other types of contracts, or upon the exercise or conversion of outstanding options,

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

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

with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidates

or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings

when needed, we may need to curtail or cease our operations.

Due to the significant resources required for the development

of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates.

Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine

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 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

may subsequently also prove to be less than optimal and could cause us to miss valuable opportunities.

If we make incorrect determinations

regarding the viability or market potential of any of our vaccine candidates or misread trends in the biopharmaceutical industry, in particular

for vaccines, our business could be seriously harmed.

As a result, we may fail to capitalize on viable commercial products or profitable

market opportunities, be required to forego or delay pursuit of opportunities with other vaccine candidates that may later prove to have

greater commercial potential than those we choose to pursue or relinquish valuable rights to such vaccine candidates through collaboration,

licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain

sole development and commercialization rights.

We have identified weaknesses in our internal controls, and we

cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in

As a public company, we are subject to the reporting

requirements of the Exchange Act, and the Sarbanes-Oxley Act.

We expect that the requirements of these rules and regulations will continue

to increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and

place significant strain on our personnel, systems and resources.

The Sarbanes-Oxley Act requires, among other things,

that we maintain effective disclosure controls and procedures, and internal control over financial reporting.

We do not yet have effective disclosure controls

and procedures, or internal controls over all aspects of our financial reporting.

We are continuing to develop and refine our disclosure

controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we will

file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.

Our management

has deemed certain conditions to be material weaknesses in our internal controls.

For example, we failed to employ a sufficient number

of staff to maintain optimal segregation of duties and to provide optimal levels of oversight in order to process financial information

in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements.

In addition, we do not

yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions.

Our management

is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under

the Exchange Act.

We will be required to expend time and resources to further improve our internal controls over financial reporting,

including by expanding our staff to include financial consultants and other qualified resources, which we commenced during the fourth

quarter of 2021.

However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify

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

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

Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm

our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements

for prior periods.

Any failure to implement and maintain effective internal control over financial reporting could also adversely affect

the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting

that we will eventually be required to include in our periodic reports that will be filed with the SEC.

Ineffective disclosure controls

and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial

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

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

other tax attributes may be limited, each of which could harm our business.

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

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.

We are subject to claims in the ordinary course

These claims may involve substantial amounts of money and involve significant defense costs.

It is not possible to prevent

or detect all activities giving rise to claims and the precautions we take may not be effective in all cases.

We maintain voluntary and

required insurance coverage, including, among others, general liability, property, director and officer, business interruption, cyber

and data breach.

Our insurance coverage is expensive and maintaining or expanding our insurance coverage may have an adverse effect on

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 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

We depend entirely on the success of a limited number of product

candidates, which are in preclinical development and none of which have commenced a clinical trial.

If we do not obtain regulatory approval

for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never

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.

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

approval and, if approved, commercialization of these product candidates.

We cannot be certain that our product candidates will receive

regulatory approval or will be successfully commercialized even if they receive regulatory approval.

The research, testing, manufacturing,

safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain, subject to comprehensive

regulation by the FDA and similar foreign regulatory authorities.

Before obtaining regulatory approvals for the commercial sale of any

product candidate, we must demonstrate through pre-clinical studies and clinical trials that the product candidate is safe and effective

for use in each target indication.

Vaccine development is a long, expensive and uncertain process, and delay or failure can occur at any

stage of any of our clinical trials.

Failure to obtain regulatory approval for our product candidates in the United States will prevent

us from commercializing and marketing our product candidates.

The success of our product candidates will depend on several additional

factors, including:

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

and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future

product candidates we intend to develop, our business will be substantially harmed.

We are at a very early stage of development for

all of our product candidates.

The product candidates we intend to develop have not gained marketing approval in the U.S., and we cannot

guarantee that we will ever have marketable products.

Our business is substantially dependent on our ability to complete the development

of, obtain marketing approval for, and successfully commercialize our current and future product candidates in a timely manner.

commercialize our product candidates in the United States without first obtaining approval from the FDA to market each product candidate.

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

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

our ongoing or planned trials as providing adequate support for future clinical trials or for an application for marketing approval, for

any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results.

are unable to confirm or replicate the results of our trials in larger patient group or if negative results are obtained, we would likely

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

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

If so, the FDA or EMA may require

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

actions, or it could simply deny our applications.

In addition, even if we obtain a BLA approval or pre-market approvals in other countries,

the approval could be revoked or other restrictions imposed if post-market data demonstrate safety issues or lack of effectiveness.

cannot predict with certainty how, or when, the FDA will act.

If we are unable to obtain the necessary regulatory approvals, our financial

condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally,

even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful

commercialization or profitability.

We may encounter substantial delays in completing our clinical

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

applicable regulatory authorities.

It is impossible to predict if or when our current

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.

Clinical testing is expensive, time-consuming and uncertain as to outcome.

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;

addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process is time-consuming and

Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for

our business activities because they may be deemed to be at too early of a stage of development for collaborative effort.

in entering into new strategic partnership agreements harm our business prospects, financial condition and results of operations.

we license or acquire products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully

integrate them with our existing operations and company culture.

We cannot be certain that, following a strategic transaction, license,

or acquisition, we will achieve the results, revenue or specific net income that justifies such transaction.

Raising additional

capital may cause dilution to our existing stockholders and investors, restrict our operations or require us to relinquish rights to

our products on unfavorable terms to us.

We may seek additional capital through a variety of means, including

through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing, distribution or licensing

arrangements.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, or through the

issuance of shares under other types of contracts, or upon the exercise or conversion of outstanding options, 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.

additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties,

we may have to relinquish valuable rights to our technologies, future revenue streams or products or grant licenses on terms that may

not be favorable to us.

If we are unable to raise additional funds through equity or debt financing when needed, we may need to curtail

or cease our operations.

Due to the significant

resources required for the commercialization of our products, and depending on our ability to access capital, we must prioritize commercialization

of certain products.

Moreover, we may expend our limited resources on products that do not yield a successful product and fail to capitalize

on products 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

products, we must decide which products to pursue and advance and the number of resources to allocate to each.

Our decisions concerning

the allocation of management and financial resources toward particular products may not lead to the development of any viable commercial

products 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 products may subsequently also prove to be less than optimal and could cause us to

miss valuable opportunities.

If we make incorrect determinations regarding the viability or market potential of any of our products or

misread trends in the pharmaceutical or diagnostic industry, our business could be seriously harmed.

As a result, we may fail to capitalize

on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other products

and/or product candidates that may later prove to have greater commercial potential than those we choose to pursue or relinquish valuable

rights to such products and/or product candidates through collaboration, licensing or other royalty arrangements in cases in which it

would have been advantageous for us to invest additional resources to retain sole development and commercialization rights.

ability to use our net operating loss carryforwards and certain other tax attributes may be limited, each of which could harm our business.

As of December 31, 2023,

federal, foreign, and state net operating loss carryforwards of approximately $27.9 million, $18.0 million, and $23.8 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.

insurance coverage may be inadequate or expensive.

are subject to claims in the ordinary course of business.

These claims may involve substantial amounts of money and involve significant

defense costs.

It is not possible to prevent or detect all activities giving rise to claims and the precautions we take may not be effective

in all cases.

We maintain voluntary and required insurance coverage, including, among others, general liability, property, director and

officer, business interruption, cyber and data breach.

Our insurance coverage is expensive and maintaining or expanding our insurance

coverage may have an adverse effect on our results of operations and financial condition.

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.

entered into an asset purchase agreement and management services agreement with WraSer, which have been terminated because we believe

that a material adverse event has occurred with respect to the WraSer Assets.

However, the termination is subject to WraSer’s right

to challenge the termination and assert claims against us.

June 13, 2023, we entered into the WraSer APA and the WraSer MSA with WraSer in connection with the purchase of the WraSer Assets.

Under the WraSer APA, we paid $3.5 million in cash to WraSer at signing.

In October 2023, WraSer alerted us that its sole manufacturer

for the API for Zontivity, the key driver for the WraSer acquisition, would no longer manufacture the API for Zontivity.

that this development constituted a Material Adverse Effect under the WraSer APA enabling us to terminate the WraSer APA and the WraSer

On October 20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy Court to exercise our termination

rights under the WraSer APA, as amended.

On December 18, 2023, the Bankruptcy Court entered an Agreed Order lifting the automatic

stay to enable us to exercise our rights to terminate the WraSer APA and the WraSer MSA without prejudice to the parties’ respective

rights, remedies, claims, and defenses they had against one another under the WraSer APA and the WraSer MSA.

On December 21,

2023, we filed a Notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA.

WraSer has advised us that it does

not believe that a Material Adverse Event occurred.

Due to the WraSer bankruptcy filing and our status as an unsecured creditor of WraSer,

it is also unlikely that we will recover the $3.5 million Signing Cash or any costs and resources in connection with services provided

by the Company under the WraSer MSA.

a result of our failure to timely file our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, we are currently ineligible to

file new short form registration statements on Form S-3, which may impair our ability to raise capital on terms favorable to us,

in a timely manner or at all.

S-3 permits eligible issuers to conduct registered offerings using a short form registration statement that allows the issuer to incorporate

by reference its past and future filings and reports made under the Securities Exchange Act of 1934, as amended, or the Exchange

In addition, Form S-3 enables eligible issuers to conduct primary offerings “off the shelf” under Rule 415 of the Securities

Act of 1933, as amended, or the Securities Act.

The shelf registration process, combined with the ability to forward incorporate

information, allows issuers to avoid delays and interruptions in the offering process and to access the capital markets in a more expeditious

and efficient manner than raising capital in a standard registered offering pursuant to a Registration Statement on Form S-1.

a result of our failure to timely file our Quarterly Report on Form 10-Q for quarter ended June 30, 2023, we are currently ineligible to

file new short form registration statements on Form S-3 and we will be unable to conduct “off the shelf” offerings

under Rule 415 of the Securities Act using our currently effective Registration Statement on Form S-3 (File No.

after we file this Report.

As a result, we may be unable to conduct an “at the market” offering pursuant to our At The Market

Offering Agreement with Wainwright after such date.

In addition, if we seek to access the capital markets through a registered offering

during the period of time that we are unable to use Form S-3, we may be required to publicly disclose the proposed offering and the material

terms thereof before the offering commences, we may experience delays in the offering process due to SEC review of a Form S-1 registration

statement and we may incur increased offering and transaction costs and other considerations.

Disclosing a public offering prior to the

formal commencement of an offering may result in downward pressure on our stock price.

In addition, our inability to conduct an offering

“off the shelf” may require us to offer terms that may not be advantageous (or may be less advantageous) to us or may generally

reduce our ability to raise capital in a registered offering.

If we are unable to raise capital through a registered offering, we would

be required to conduct our financing transactions on a private placement basis, which may be subject to pricing, size and other limitations

imposed under Nasdaq rules.

operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating

results to fall below expectations or any guidance we may provide.

quarterly and annual revenue and operating results may fluctuate significantly, which makes it difficult for us to predict our future

operating results.

Our quarterly and annual operating results may fluctuate as a result of a variety of factors, many of which are outside

our control and, as a result, may not fully reflect the underlying performance of our business.

These fluctuations may occur due to a

variety of factors, including, but not limited to:

level of demand for our diagnostic tests, which may vary significantly;

timing and cost of manufacturing our diagnostic tests, which may vary depending on the quantity

of production and the terms of our agreements with third-party suppliers and manufacturers;

● expenditures

that we may incur to acquire, develop, or commercialize additional tests and technologies;

● 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

is suspended or terminated by us, by the Institutional Review Board, or IRB, or the Ethics Commission of the institutions in which such

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,

failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate

funding to continue the clinical trial.

Any inability to successfully complete pre-clinical

and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory

and commercialization milestones and royalties.

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

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

Clinical study delays could also shorten any periods

during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market

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

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.

Any of these occurrences may significantly harm our business, financial condition

and prospects.

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

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

The outcome of 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 required to change the way the product is administered;

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

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

experience damage to our reputation.

Additionally, our product candidates could potentially

cause other adverse events that have not yet been predicted.

The inclusion of ill patients in our clinical studies may result in deaths

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

As described above, any of these

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

our products.

Obtaining and maintaining regulatory approval of our vaccine

candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our vaccine candidates in

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

approval process in others.

For example, even if the FDA grants marketing approval of a vaccine candidate, comparable regulatory authorities

in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the vaccine candidate in those countries.

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.

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.

Modifications to our products may require new BLA approvals.

Once a particular product receives FDA approval,

expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals, including

additional IND and BLA submissions and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.

pricing pressures;

rate at which we grow our sales force and the speed at which newly hired salespeople become

effective, and the cost and level of investment therein;

fluctuations due to our expectation of generating future revenue from international sales,

subjecting us to risks such as currency exchange rate volatility;

● geopolitical

instability, economics problems, and other uncertainties in certain foreign countries in

which we operate;

degree of competition in our industry and any change in the competitive landscape of our

industry, including consolidation among our competitors or future partners;

and reimbursement policies with respect to cancer treatment equipment, and potential future

diagnostic tests that compete with our diagnostic tests.

cumulative effects of these factors could result in large fluctuations and unpredictability in our future financial results.

comparing our operating results on a period-to-period basis may not be meaningful.

Further, our historical results are not necessarily

indicative of results expected for any future period, and quarterly results are not necessarily indicative of the results to be expected

for the full year or any other period, and accordingly should not be relied upon as indicative of future performance.

variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors

for any period.

If our revenue or operating results fall below the expectations of analysts or investors or below any guidance we may

provide, or if the guidance we provide is below the expectations of analysts or investors, the price of our common stock and warrants

could decline substantially.

Such a stock price decline could occur even when we have met any publicly stated guidance we may provide,

and could in turn negatively impact our business, financial condition and results of operations.

Related to the Commercialization of our Products

We depend entirely on the success of a

limited number of products.

If we do not successfully commercialize our products or we experience significant delays in doing so, these

products may not be profitable.

Our business currently depends

heavily on the successful commercialization of our products.

We cannot be certain that our products will be successfully commercialized.

The manufacturing, safety, efficacy, labeling, sale, marketing, and distribution of our products are, and will remain, subject to comprehensive

regulation by the FDA and similar foreign regulatory authorities.

The success of our products will depend on several additional factors,

establishing commercial

manufacturing capabilities;

launching commercial sales,

marketing and distribution operations;

establishing relationships with partners having established distribution, marketing and sales capabilities;

the prevalence and severity of adverse events experienced with our

acceptance of our products by patients, the medical community, and third-party

a continued acceptable

safety profile following approval;

obtaining and maintaining healthcare coverage and adequate reimbursement

for our products;

competing effectively with other therapies and diagnostics, including with respect to the sales and marketing of our products;

qualifying for, maintaining,

enforcing and defending our intellectual property rights and claims.

Many of these factors are

beyond our control, including potential threats to our intellectual property rights and changes in the competitive landscape.

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

commercialize our products, which would materially harm our business, financial condition, and results of operations.

Obtaining and maintaining regulatory approval of our products

in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.

Obtaining and maintaining

regulatory approval of our products 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.

For example, even if the FDA grants marketing approval of a pharmaceutical product, comparable

regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product in those

Approval 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 product 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 countries.

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

of pharmaceutical or diagnostic products 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 product, ENTADFI, may require new FDA approvals.

Once a particular product

receives FDA approval, expanded uses or uses in new indications may require additional human clinical trials and new regulatory approvals,

including additional IND and/or NDA, and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.

If the FDA requires new approvals for a particular use or indication, we may be required to conduct additional clinical studies, which

5 unchanged sentences

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 .

Each modification to the protocol during a clinical

trial has to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the modification is evaluated.

In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the

clinical trial are not poolable because the same protocol was not used throughout the trial.

This might require the enrollment of additional

subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product.

Any such delay could have

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

There can be no assurance that the data generated from our clinical

trials using modified protocols will be acceptable to the FDA or other regulatory authorities.

There can be no assurance that the data generated

using modified protocols will be acceptable to the FDA or other regulatory authorities or that if future modifications during the trial

are necessary, that any such modifications will be acceptable to the FDA or other regulatory authorities.

If the FDA or other regulatory

authorities believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they

evaluate additional information regarding the change.

Serious injury or death resulting from a failure

of our product candidates during current or future clinical trials could also result in the FDA or other regulatory authority delaying

our clinical trials or denying or delaying approval of a product.

Even though an adverse event may not be the result

of the failure of our product candidate, the FDA or other regulatory authority could delay or halt a clinical trial for an indefinite

period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.

Any delay or termination of our current or future

clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from the FDA

or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial,

and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase

in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization

of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

We will depend on enrollment and retention of patients in our

clinical trials for our product candidates.

If we experience delays or difficulties enrolling or retaining patients in our clinical trials,

our research and development efforts and business, financial condition, and results of operations could be materially adversely affected.

Successful and timely completion of clinical trials

will require that we enroll and retain a sufficient number of patient candidates.

Any clinical trials we conduct may be subject to delays

for a variety of reasons, including as a result of patient enrollment taking longer than anticipated, patient withdrawal, or adverse events.

These types of developments could cause us to delay the trial or halt further development.

Our clinical trials will compete with other clinical

trials that are in the same therapeutic areas as our product candidates, and this competition reduces the number and types of patients

available to us, as some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by

one of our competitors.

Moreover, enrolling patients in clinical trials for diseases in which there is an approved standard of care is

challenging, as patients will first receive the applicable standard of care.

Many patients who respond positively to the standard of care

do not enroll in clinical trials.

This may limit the number of eligible patients able to enroll in our clinical trials who have the potential

to benefit from our product candidates and could extend development timelines or increase costs for these programs.

Patients who fail

to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates.

However, these

prior treatment regimens may render our therapies less effective in clinical trials.

Because the number of qualified clinical investigators

and clinical trial sites is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our

competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.

Patient enrollment depends on many factors, including:

the size and nature of the patient population;

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

eligibility criteria for the trial;

the proximity of patients to clinical sites;

the design of the clinical protocol;

the ability to obtain and maintain patient consents;

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.

Conducting successful clinical studies may require the enrollment

of large numbers of patients, and suitable patients may be difficult to identify and recruit.

Patient enrollment in clinical trials and completion

of patient participation and follow-up depends on many factors, including the size of the patient population;

the nature of the trial

the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects;

the availability

of appropriate clinical trial investigators;

support staff;

and the proximity of patients to clinical sites and ability to comply with

the eligibility and exclusion criteria for participation in the clinical trial and patient compliance.

For example, patients may be discouraged

from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up

to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are

not attractive or involve unacceptable risks or discomforts.

Patients may also not participate in our clinical trials if they choose to

participate in contemporaneous clinical trials of competitive products.

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.

Even if our clinical trials are completed as planned,

we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will agree with

our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will

be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.

trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses.

If the FDA concludes

that the clinical trials for any product for which we might seek approval, has failed to demonstrate safety and effectiveness, we would

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.

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

regulatory authorities to delay or deny approval for our products or result in product recalls that could harm our reputation, business

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.

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;

Adverse events involving ENTADFI may result

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

we or others identify undesirable side effects caused by ENTADFI, several potentially significant negative consequences could result,

regulatory authorities may suspend or withdraw approvals of such a

regulatory authorities may require additional warnings

or limitations of use in product labeling;

we may be required to change the way a product is distributed, dispensed,

or administered or conduct additional clinical trials;

we could be sued and held liable for harm caused to

our reputation may suffer.

Any of these events could prevent us from achieving

or maintaining market acceptance of our product candidates and could significantly harm our business, prospects, financial condition and

results of operations.

Once a product receives FDA approval, the agency

has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects

in design or manufacture.

The authority to require a recall must be based on an FDA finding that there is a reasonable probability that

the product would cause serious injury or death.

Manufacturers may, under their own initiative, recall a product if any material deficiency

in a product is found.

A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side

effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues.

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

Any of these events could

prevent us from achieving or maintaining market acceptance of ENTADFI and could significantly harm our business, prospects, financial

condition and results of operations.

Once a product receives FDA

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

deficiencies or defects in design or manufacture.

The authority to require a recall must be based on an FDA finding that there is a reasonable

probability that the product would cause serious injury or death.

Manufacturers may, under their own initiative, recall a product if any

material deficiency in a product is found.

A government-mandated or voluntary recall by us or one of our distributors could occur as a

result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies

Recalls of ENTADFI would divert managerial and financial resources and have an adverse effect on our financial condition and

results of operations.

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We may initiate

voluntary recalls involving our products in the future.

voluntary recalls involving ENTADFI in the future.

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

2 unchanged sentences

when they were conducted.

Even if we obtain regulatory approval of our vaccine candidates,

the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in

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;

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;

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 effectiveness of our sales and marketing efforts.

In the United States, the CDC and ACIP develop

vaccine recommendations for both children and adults, as do similar agencies around the world.

To develop its recommendations, ACIP forms

working groups that gather, analyze and prepare scientific information.

The ACIP also considers many of the factors above, as well as

myriad additional factors such as the value of vaccination for the target population regarding the outcomes, health economic data and

implementation issues.

ACIP recommendations are also made within categories, such as in an age group or a specified risk group.

the ACIP may determine that a preferred recommendation in a smaller child population may be more economical than recommending vaccinations

for a larger adult population, which could adversely impact our market opportunity.

New pediatric vaccines that receive an ACIP preferred

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.

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

to receive CDC and ACIP recommendations, or recommendations of other comparable foreign regulatory and advisory bodies, or achieve market

acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able

to generate significant revenue.

Even if our products achieve market acceptance, we may not be able to maintain that market acceptance

over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or

render our products obsolete.

Obtaining regulatory approval for clinical trials of our vaccine

candidates in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory

approval for the pediatric populations are more stringent.

Pediatric vaccine candidates’ development

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

These additional studies may require investment of significant

additional resources beyond those required for regulatory approval of the vaccines in adults.

Approval of our vaccine candidates may be

delayed due to these additional requirements and this may have an adverse effect on the commercial prospects of our vaccine candidates,

especially our pediatric vaccine candidate, BWV-201, as well as delay our ability to generate product revenue, possibly materially.

addition, as a result of COVID-19 (or other potential pandemics), there may be a smaller pool of children from which we can enroll for

our clinical trials.

We cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric

populations or the adult population.

Even if we are able to commercialize our product candidates,

such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,

If we decide to resume the commercialization

of ENTADFI, it may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors, and others

in the medical community.

If we decide to resume the

commercialization of ENTADFI, it may fail to receive recommendations for use by regulators, or gain market acceptance by physicians, patients,

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

If ENTADFI does 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 product will depend on a number of factors,

including but not limited to:

receiving governing or

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

prevalence and severity of the disease targets for which our product

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

our product as safe and effective;

the potential and perceived advantages of our product over existing

therapies, including with respect to treatment of disease;

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 products as well as competitive

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 products and alternative treatments;

the effectiveness of our

sales and marketing efforts.

If our product fails to receive

recommendations by governing or advisory bodies in either the United States or other countries, or achieve market acceptance among physicians,

healthcare providers, patients, third-party payors or others in the medical community, we will not be able to generate significant revenue.

Even if our product achieves market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies

are introduced that are more favorably received than our product, are more cost effective or render our product obsolete.

Even if we are able to commercialize our

products, they may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,

which would harm our business.

The regulations that govern marketing approvals,

pricing, coverage and reimbursement for new drugs vary widely from country to country.

In the United States, new and future legislation

may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

The regulations that govern

marketing approvals, pricing, coverage, and reimbursement for new drugs and diagnostics vary widely from country to country.

In the United

States, new and future legislation may significantly change the approval requirements in ways that could involve additional costs and

cause delays in obtaining approvals.

Some countries require approval of the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins

after marketing or product-licensing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject

to continuing governmental control even after initial marketing approval is granted.

As a result, we might obtain marketing approval for

a vaccine in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time

periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country.

Adverse pricing limitations

may hinder our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing

Our ability to commercialize our current and any

future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products

and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other

third-party payors.

Third-party payors decide which vaccines they will pay for and establish reimbursement levels.

A significant trend

In many countries,

the pricing review period begins after marketing or product-licensing approval is granted.

In some foreign markets, prescription pharmaceutical

pricing remains subject to continuing governmental control even after initial marketing approval is granted.

Our ability to commercialize our products successfully also will depend

in part on the extent to which coverage and adequate reimbursement for this product and related treatments will be available from government

health programs, private health insurers, integrated delivery networks and other third-party payors.

Third-party payors decide which drugs

they will pay for and establish reimbursement levels.

A significant trend in the U.S.

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.

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

and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved

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,

Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of payment for particular

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, our product.

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

may not be able to successfully commercialize our product.

There may be significant

delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes

for which the product is approved 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 manufacture,

sale and distribution.

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Our inability to promptly obtain coverage and profitable payment rates from both government-funded

programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our

ability to raise capital needed to commercialize our approved products and our overall financial condition.

Any product candidate for which we obtain marketing approval

could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with

regulatory requirements or if we experience unanticipated problems with our products.

Any product candidate for which we obtain marketing

approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities

for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities.

These requirements

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.

Even if marketing

approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may

be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the

safety or efficacy of the medicine.

The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are

marketed only for the approved indications and in accordance with the provisions of the approved labeling.

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

subject to enforcement actions.

In addition, later discovery of previously unknown

problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements,

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;

programs and private payors for our product could have a material adverse effect on our operating results, our ability to raise capital

needed to commercialize our product and our overall financial condition.

Our products could be subject to marketing

restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if

we experience unanticipated problems with our products.

Our products, along with

the manufacturing processes and facilities, post-approval clinical data, labeling, advertising, and promotional activities for such product,

will be subject to continual requirements of and review by the FDA and other regulatory authorities.

These requirements 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.

The FDA closely regulates

the post-approval marketing and promotion of drugs to ensure that they are marketed only for the approved indications and in accordance

with the provisions of the approved labeling.

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 subject to enforcement actions.

In addition, later discovery

of previously unknown problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory

requirements, may result in, among other things:

restrictions on our 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;

fines, restitution or disgorgement of profits or revenue;

suspension or withdrawal of marketing approvals;

withdrawal or recall of our products from the market;

refusal to approve pending

applications or supplements to approved applications that we submit;

fines, restitution or disgorgement

of profits or revenue;

suspension or withdrawal

of marketing approval;

refusal to permit the import or export of our products;

product seizure;

injunctions or the imposition of civil or criminal penalties.

Failure to obtain regulatory approvals in foreign jurisdictions

will prevent us from marketing our products internationally.

We intend to market future products in international

In order to market our future products in regions such as the European Economic Area, or EEA, Asia Pacific, or APAC, and many

other foreign jurisdictions, we must obtain separate regulatory approvals.

For example, in the EEA, medicinal products can

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 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.

injunctions or the imposition

of civil or criminal penalties.

to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

intend to market future products in international markets.

In order to market our future products in regions such as the EEA, Asia Pacific,

and many other foreign jurisdictions, we must obtain separate regulatory approvals.

example, in the EEA, medicinal products can 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.

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.

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,

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

utilization of other products or services as well as cost data which show that treatment costs using the new product are equal to or less

than what is currently covered for other products.

If our products do not receive favorable third-party reimbursement and patients are

unwilling or unable to pay for our products out-of-pocket, it could limit our revenues and harm our business.

The continuing efforts of government and insurance

companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect

our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative

partners and the availability of capital.

For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals

is subject to government control.

In the United States, recent federal and state government initiatives have been directed at lowering

the total cost of health care.

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, a sweeping

law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud

and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry

and impose additional health policy reforms.

Federal and state legislatures will likely continue to focus on health care reform, controlling

the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems.

While we cannot predict whether any such

legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially harm our business,

be able to file for regulatory approvals and even if we file, we may not receive necessary approvals to commercialize our products in

such as the Inflation Reduction Act, may impact our ability to market and commercialize ENTADFI and reduce our profitability from such

Legislation, either in the United States or in a foreign country, may

impact our ability to market and commercialize ENTADFI and may reduce our profitability from such asset.

For example, the Inflation Reduction

Act (“IRA”) was signed into law in the United States in 2022 and intended to lower out-of-pocket costs associated with pharmaceutical

Key impacts of the IRA include the following:

Medicare can now directly

negotiate lower prescription drug prices with pharmaceutical manufacturers;

the cost of insulin for

Medicare beneficiaries is now capped at $35;

all recommended adult vaccines

drug companies are required

to pay rebates if they raise prices of their products faster than the rate of inflation.

Should we decide to raise the price of ENTADFI, and raise it higher

than the rate of inflation, we may be exposed to rebates owed to Medicare.

This may affect the profitability of our product and reduce

revenues associated with it.

shareholders may not realize a benefit from the ENTADFI or Proteomedix acquisitions commensurate with the ownership dilution they

have experienced in connection with the transactions.

the Company is unable to realize the full strategic and financial benefits currently anticipated from the recent ENTADFI and Proteomedix

acquisitions, our shareholders may experience a dilution of their ownership interests in our Company without receiving any commensurate

benefit, or only receiving part of the commensurate benefit to the extent the Company is able to realize only part of the strategic and

financial benefits currently anticipated from the transactions.

We expect to rely on third-party manufacturers

for ENTADFI and Proclarix.

For the foreseeable future,

we expect to and do rely on third-party manufacturers and other third parties to produce, package and store sufficient quantities of Proclarix

and ENTADFI (if we decide to resume its commercialization) to meet demand.

ENTADFI and Proclarix are complicated and expensive to manufacture.

If our third-party manufacturers fail to deliver ENTADFI or Proclarix for commercial sale on a timely basis, with sufficient quality,

and at commercially reasonable prices, we may be required to delay or suspend commercial sales and/or production of ENTADFI and Proclarix.

While we may be able to identify replacement third-party manufacturers or develop our own manufacturing capabilities for ENTADFI and Proclarix,

this process would likely cause a delay in the availability of ENTADFI and/or Proclarix and an increase in costs.

In addition, third-party

manufacturers may have a limited number of facilities in which ENTADFI and Proclarix can be produced, and any interruption of the operation

of those facilities due to events such as equipment malfunction or failure or damage to the facility by natural disasters could result

in the cancellation of shipments, loss of product in the manufacturing process or a shortfall in ENTADFI and Proclarix.

In addition, regulatory requirements

could pose barriers to the manufacture of ENTADFI and Proclarix.

Third-party manufacturers are required to comply with the FDA’s

cGMPs for ENTADFI and to register their activities and manufactured devices in databases and for Proclarix, manufacturers and developers

(software) are required to comply with ISO 13485 and the host of the software with ISO 27001;

these parties can be then subject to audits

or inspections.

As a result, the facilities used by any manufacturers of ENTADFI, must maintain a compliance status acceptable to the

Holders of NDAs, or other forms of FDA approvals or clearances, or those distributing a regulated product under their own name, are

responsible for manufacturing even though that manufacturing is conducted by a third-party CMO.

Our third-party manufacturers will be

required to produce ENTADFI under FDA cGMPs in order to meet acceptable standards.

Our third-party manufacturers may not perform their

obligations under their agreements with us or may discontinue their business before the time required by us to commercialize our products.

In addition, our manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign

agencies for compliance with cGMPs and similar regulatory requirements.

For medical devices in United States, the contract manufacturer

will be subject to FDA inspections (while in the EU, these would be subject to Notified Body audits (on demand)).

Failure by any of our

manufacturers to comply with applicable cGMPs, ISO 13485, ISO 27001 or applicable regulations could result in sanctions being imposed

on us, including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions

in supply, recalls, withdrawals, issuance of safety alerts and criminal prosecutions, any of which could have a material adverse effect

on our business, financial condition, results of operations and prospects.

Finally, we also could experience manufacturing delays if our

CMOs give greater priority to the supply of other products over ENTADFI or Proclarix or otherwise do not satisfactorily perform according

to the terms of their agreements with us.

any supplier for ENTADFI or Proclarix experiences any significant difficulties in its manufacturing processes, does not comply with the

terms of the agreement between us or does not devote sufficient time, energy and care to providing our manufacturing needs, we could

experience significant interruptions in the supply of ENTADFI and/or Proclarix, which could impair our ability to supply ENTADFI and/or

Proclarix at the levels required for commercialization and prevent or delay its successful development and commercialization.

to or significantly increased costs associated with transportation and other distribution channels for ENTADFI and/or Proclarix may adversely

affect our margins and profitability.

expect to rely on the uninterrupted and efficient operation of third-party logistics companies to transport and deliver ENTADFI and Proclarix.

These third-party logistics companies may experience disruptions to the transportation channels used to distribute our products, increased

airport and shipping port congestion, a lack of transportation capacity, increased fuel expenses, and a shortage of manpower or capital

or due to other business interruptions.

Disruptions to the transportation channels experienced by our third-party logistics companies

may result in increased costs, including the additional use of airfreight to meet demand.

Disruptions to this business model or our relationship

with the third party if, for example, performance fails to meet our expectations, could harm our business.

may fail or elect not to commercialize our products.

may not successfully commercialize our products.

We or our collaboration partners in any potential commercial marketing efforts of our

products may not be successful in achieving widespread patient or physician awareness or acceptance of this product.

Also, we may be

subject to pricing pressures from competitive products or from governmental or commercial payors or regulatory bodies that could make

it difficult or impossible for us to commercialize our products.

Any failure to commercialize our products could have a material adverse

effect on our future revenue and our business.

In light of (i) the time and resources needed to continue pursuing

commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has determined to temporarily pause

its commercialization of ENTADFI, as it considers strategic alternatives.

The Company expects to appoint a new Chief Executive Officer

in early April 2024, after which the new CEO and the Board will reassess its ENTADFI program in light of the foregoing and other relevant

we fail to commercialize our products, our business, financial condition, results of operations and prospects may be materially adversely

affected and our reputation in the industry and in the investment community would likely be damaged.

may not be able to gain and retain market acceptance for our products.

Physicians and other authorized health care practitioners may not prescribe

our products, which would prevent our products from generating revenue.

Market acceptance of our products by healthcare providers, patients

and payors, will depend on a number of factors, many of which are beyond our control, including the following:

the clinical indications

for which our products are approved;

acceptance by healthcare providers

and payors of our products as safe and effective treatment or test;

the cost in relation to

alternative treatments or tests;

the relative convenience

and ease of administration of our products for the conditions for which they are intended;

the availability and efficacy

of competitive drugs or tests;

the effectiveness of our

sales and marketing efforts;

the extent to which our

products are approved for inclusion on formularies of hospitals and managed care organizations;

the availability of coverage

and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care

programs, including Medicare and Medicaid;

limitations or warnings

contained in a product’s FDA or other applicable regulatory agency’s approved labeling;

prevalence and severity

of adverse side effects.

Even if the medical community accepts that our products are safe and

efficacious for its approved indications, healthcare providers may not immediately be receptive to the use or may be slow to adopt such

products as an accepted treatment or test for the conditions for which it is intended.

Without head-to-head comparative data, we will

also not be able to promote our products as being superior to competing products.

If our products do not achieve an adequate level of

acceptance by healthcare providers and payors, we may not generate sufficient or any revenue from this product.

In addition, our efforts

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

be successful.

addition, even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if:

new products or technologies

are introduced that are more favorably received than our products, are more cost effective or render our products obsolete;

unforeseen complications

arise with respect to use of our products or

sufficient third-party

insurance coverage or reimbursement does not remain available.

Proclarix is subject to competition from

other prostate cancer diagnostics and larger, well-established companies with substantially greater resources than us.

The molecular diagnostics

field is intensely competitive and characterized by rapid technological changes, frequent new product introductions, changing customer

preferences, emerging competition, evolving industry standards, reimbursement uncertainty and price competition.

Moreover, recent consolidation

in the industry permits larger clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more

intense competition.

The market for assessing

men at risk for prostate cancer is large, with many competitors some of which possess substantially greater financial, selling, logistical

and laboratory resources, more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing

budgets, as well as more experience in providing diagnostic services.

Some companies and institutions are developing liquid biopsy (blood

and urine)-based tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids, or the presence of fragments of mutated

genes that are associated with prostate cancer.

These competitors could have technological, financial, reputational, and market access

advantages over us.

is subject to competition from other BPH drugs and larger, well-established companies with substantially greater resources than us.

are engaged in the marketing of a product in industries, including the pharmaceutical industry, that are highly competitive.

The pharmaceutical

industry is also characterized by extensive research and rapid technological progress.

Potential competitors with respect to ENTADFI

in North America, Europe and elsewhere include major pharmaceutical companies, specialty pharmaceutical companies and biotechnology firms,

universities and other research institutions and government agencies.

Many of our competitors have substantially greater research and

development and regulatory capabilities and experience, and substantially greater management, manufacturing, distribution, marketing,

and financial resources, than we have.

We may be unable to compete successfully against current and future competitors, and competitive

pressures could have a negative effect on our net revenues and profit margins.

Zydus Life Sciences recently

received FDA approval for a combined finasteride-tadalafil (5 mg/5 mg) capsule, pursuant to the FDA’s Competitive Generic Therapy

Program, which was designed to enhance patient access to affordable medications by encouraging the development and commercialization of

generic drugs in clinical areas with limited generic options for patients.

Pursuant to the program, Zydus has a 180 day period to be the

sole supplier of the generic version of the drug in the market and during this period, other generic manufacturers cannot enter the market

with their versions of the same drug, provided that Zydus commences marketing the drug by 75 days from approval.

As a result, there is

a risk that the Company will face additional challenges in resuming commercializing ENTADFI, if it chooses to do so.

Other parties have developed and marketed drugs for BPH that have been

accepted by the healthcare provider, patient, and payor communities.

Many of these other products have also reached the point where they

are now generic drugs, which means that they are sold at a very low price, a price which ENTADFI may not be able to meet which could limit

the reach of ENTADFI into the healthcare provider, patient and payor communities, including government payors.

may not be able to successfully implement our strategy to grow sales of ENTADFI in the U.S.

market and Proclarix in the European markets

or, if authorized, grow sales of either in any other market.

may not be able to expand sales of ENTADFI or Proclarix through partnering with telemedicine or other partners or with commercial diagnostic

providers or through our own commercialization efforts.

We may not be able to command a price with private and government payors for

ENTADFI or Proclarix that would justify our devotion of significant resources to attempting to grow sales of ENTADFI or Proclarix.

may not be able to compete efficiently or effectively in a mature market, which is heavily generic, or the prostate cancer diagnostics

market, which is highly competitive.

Failure to grow sales of ENTADFI or Proclarix would have a negative effect on our revenue and future

commercial success of our in-development and future diagnostic tests and services and our revenue growth depend upon attaining significant

market acceptance among payers, providers, clinics, patients, and biopharmaceutical companies.

Our commercial success depends, in part, on the acceptance of our diagnostic

tests and services as being safe and relatively simple for medical personnel to learn and use, clinically flexible, operationally versatile

and, with respect to providers and payers, cost effective.

We cannot predict how quickly, if at all, payers, providers, clinics, and patients

will accept future diagnostic tests and services or, if accepted, how frequently they will be used.

These constituents must believe that

our diagnostic tests offer benefits over other available alternatives.

degree of market acceptance of our current and future diagnostic tests and services depends on a number of factors, including:

there is adequate utilization of our tests by clinicians, laboratories and other target groups based on the potential and perceived advantages

of our diagnostic tests over those of our competitors;

● the convenience and ease of use of our diagnostic

tests relative to those currently on the market;

● the effectiveness of our sales and marketing

● the ability of our distribution partners to meet

sales forecasts;

● our ability to provide incremental data that

show the clinical benefits and cost effectiveness, and operational benefits, of our diagnostic tests;

● the coverage and reimbursement acceptance of

our products and services;

● pricing pressure, including from group purchasing

organizations (“GPOs”), seeking to obtain discounts on our diagnostic tests based on the collective bargaining power of the

● negative publicity regarding our or our competitors’

diagnostic tests resulting from defects or errors;

● the diagnostic sensitivity and diagnostic specificity

of our tests relative to those of our competitors.

Additionally,

even if our diagnostic tests achieve widespread market acceptance, they may not maintain that market acceptance over time if competing

diagnostic tests or technologies, which are more cost effective or are received more favorably, are introduced.

Failure to achieve or

maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on

our business, financial condition, and results of operations.

we fail to increase our sales and marketing capabilities or develop broad awareness of our diagnostic tests in a cost-effective manner,

we may not be able to generate revenue growth.

plan to dedicate significant resources to the expansion of our distribution network and to supporting their marketing efforts.

negatively affect our business, financial condition, and results of operations if our marketing efforts and expenditures do not generate

a corresponding increase in revenue.

In addition, we believe that developing and maintaining broad awareness of our diagnostic tests

in a cost-effective manner is critical to achieving broad acceptance of our diagnostic tests.

Promotional activities may not generate

patient or physician awareness or increase revenue, and even if they do, any increase in revenue may not offset the costs and expenses

we incur in building our brand.

If we fail to successfully promote, maintain and protect our brand, we may fail to attract or retain

the physician acceptance necessary to realize a sufficient return on our brand building efforts, or to achieve the level of brand awareness

that is critical for broad use of our diagnostic tests, which in turn could have a material adverse effect on our business, financial

condition and results of operations.

we cannot maintain our current relationships, or enter into new relationships, with CROs, universities, clinics, laboratories or tissue

sample banks, our revenue prospects could be reduced.

engage contract research organizations, universities, clinics, and tissue banks to enroll or access patients primarily to support clinical

The ability of our contractors to enroll patients in clinical studies may also fluctuate in the future, which could have a material

adverse effect on our product development timelines, financial condition and results of operations.

In addition, the termination of these

relationships could result in a temporary or prolonged delay in commercial launches resulting in a loss of revenue.

engage in conversations with diagnostic laboratories regarding potential commercial opportunities on an ongoing basis.

There is no assurance

that any of these conversations will result in a commercial agreement, or if an agreement is reached, that the resulting relationship

will be successful or that clinical or research studies conducted as part of the engagement will produce successful outcomes.

in the industry about our existing or potential relationships with diagnostic laboratories and biopharmaceutical companies can also be

a catalyst for adverse speculation about us, our tests and our technology, which can adversely affect our reputation and our business.

need to ensure strong product performance and quality to maintain and grow our business.

We will need to maintain and continuously improve the performance of

our diagnostic tests to maintain CE marking or other applicable market approvals and compliance with QMS (ISO 13485).

Poor product performance

and quality could lead to customer dissatisfaction, adversely affect our reputation and revenues, and increase our service and distribution

costs and working capital requirements.

Our diagnostic tests may contain errors or defects, and while we have made efforts to control

them extensively, we cannot assure that our current diagnostic tests, or those developed in the future, will not have performance problems.

Any performance issues with our diagnostic tests now or in the future will increase our costs and accordingly adversely affect our business,

financial condition, and results of operations.

Risks Related to our Business and Industry

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 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.

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

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 COVID-19, our planned project timelines may be delayed due to reduced availability of human

resources or critical supplies needed to carry out such plans.

Due to 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 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

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 the coronavirus, which has caused

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.

While the potential economic impact brought by and the duration of the pandemic may be difficult

to assess or predict, it has already caused, and is likely to result in further, significant 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 the coronavirus could materially and adversely affect our business and the value of

our common stock.

The ultimate impact of the current pandemic, 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.

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.

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,

in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

We rely on, and intend to continue to rely on third parties to

conduct our pre-clinical testing, research and clinical trials, and those third parties may not perform satisfactorily, including failing

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

of our research and pre-clinical testing.

These third parties may terminate their engagements with us at any time.

If these third parties

do not successfully carry out their duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements

or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates

and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

Furthermore, these third

parties may also have relationships with other entities, some of which may be our competitors.

If we are required to enter into alternative

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 timeframes.

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

Upon commercialization of our products, we may be dependent on

third parties to market, distribute and sell our products.

Our ability to receive revenues may be dependent

upon the sales and marketing efforts of any future co-marketing partners and third-party distributors.

At this time, we have not entered

into an agreement with any commercialization partner and only plan to do so prior to commercialization.

If we fail to reach an agreement

with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it may

have a negative impact on our business, financial condition and results of operations.

We have no experience manufacturing product candidates on a clinical

or commercial scale and will be dependent on third parties for the manufacture of our product candidates.

If we experience problems with

any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell

any approved products.

We do not have any manufacturing facilities.

expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply

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.

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.

Any product that we develop may compete with other

product candidates and products for access to these manufacturing facilities.

There are a limited number of manufacturers that operate

under cGMPs and that might be capable of manufacturing for us.

Any performance failure on the part of our manufacturers,

including a failure that may not relate specifically to our product candidates or approved products, could delay clinical development

or marketing approval or adversely impact our ability to generate commercial sales.

If our contract manufacturers cannot perform as agreed,

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

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

Furthermore, we expect to rely on third parties

to release, label, store and distribute drug supplies for our clinical trials.

Any performance failure on the part of these third parties,

including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development

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.

Our business strategy depends on our ability to

manufacture our product candidates in sufficient quantities and on a timely basis so as to meet our obligations with respect to our clinical

trials and upon marketing approval, to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements

and managing manufacturing costs.

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;

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

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 increases.

We are dependent on sole suppliers or a limited

number of suppliers for certain components that are integral to its finished products.

If these or other suppliers encounter financial,

operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish or qualify replacement

sources of supply and could face production interruptions, delays and inefficiencies.

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.

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

in sufficient quantities to support our growth.

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.

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

partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.

We may in the future have conflicts with our current

or future partners or third party providers, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement

of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual

property developed during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is

adverse to our best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent

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;

attempts by either party to terminate the agreement.

Our product candidates may face competition sooner than anticipated

from biosimilar products.

Even if we are successful in achieving regulatory

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”

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.

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 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

for biosimilars referencing our product candidates, if approved, such products may become subject to competition from such biosimilars,

with the attendant competitive pressure and potential adverse consequences.

Such competitive products may be able to immediately compete

with us in each indication for which our product candidates may have received approval.

Our primary competitors have significantly greater resources

and experience than we do, which may make it difficult for us to successfully develop our vaccine candidates, or may result in others

discovering, developing or commercializing products before or more successfully than us.

The vaccine market is intensely competitive and

is dominated by a small number of multinational, globally established pharmaceutical corporations with significant resources;

Merck, GlaxoSmithKline and Sanofi together control approximately 75% of the global vaccine market.

We may also face competition from many

different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private

research institutions.

For example, Sanofi and SK Chemicals have partnered to develop a PCV, and Affinivax and Astellas have partnered

to develop an affinity-bound pneumococcal vaccine.

Vaccine candidates that we successfully develop

and commercialize may compete with existing vaccines and new vaccines that may become available in the future.

Many of our competitors

have substantially greater financial, lobbying, technical, human and other resources than we do and may be better equipped to develop,

manufacture and market technologically superior vaccines, including the potential that our competitors may develop chemical processes

or utilize novel technologies for developing vaccines that may be superior to those we employ.

In addition, many of these competitors

have significantly greater experience than we have in undertaking preclinical testing and clinical trials of new products and in obtaining

regulatory approvals, including for many vaccine franchises.

Accordingly, our competitors may succeed in obtaining FDA approval or a preferred

recommendation for their products.

For example, Prevnar 13 obtained FDA approval for the prevention of invasive pneumococcal disease,

or IPD, in infants based on non-inferior IgG antibody responses relative to Prevnar, using the surrogate immune endpoints established

by the prior Prevnar field efficacy study.

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

channels for the commercialization of their vaccine products, whereas we have no such established channels or capabilities.

many competitors have greater name recognition, more extensive collaborative relationships or the ability to leverage a broader vaccine

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize vaccines that are safer,

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

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

and may also be more successful than we are in manufacturing and marketing their products.

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.

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.

If we cannot successfully

defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial liabilities.

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 programs;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend the related litigation;

substantial monetary awards to trial subjects or patients;

sizes of the markets for our diagnostic tests and services and any future diagnostic tests and services may be smaller than we estimate

and may decline.

estimates of the annual total addressable market for our diagnostic tests and services are based on a number of internal and third-party

estimates and assumptions, including, without limitation, the assumed prices at which we can sell our diagnostic tests and services in

While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may

not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy

of these underlying factors.

a result, our estimates of the annual total addressable market for our diagnostic tests and services in different market segments may

prove to be incorrect.

If the actual number of patients who would benefit from our diagnostic tests, the price at which we can sell them

or the annual total addressable market for them is smaller than we have estimated, it may impair our sales growth and negatively affect

our business, financial condition and results of operations.

have a significant customer concentration, with a limited number of customers accounting for a large portion or all of our revenues.

We derive a large portion

or all of our revenues from a few major customers.

For the year ended December 31, 2023, we generated 100% of our revenue from one customer,

in the context of a partnership with Immunovia AB (Sweden).

In 2022, Immunovia AB partnered with Proteomedix to leverage Proteomedix’s

research and development capabilities and to advance their research and development efforts.

There are inherent risks whenever a large percentage

of the total revenue is concentrated with a few customers.

It is not possible for us to predict the future level of demand for our products

that will be generated by these customers or the future demand for our products by these customers.

If any of these customers’ demands

decline or delayed demands due to market, economic or competitive conditions, we could be pressured to reduce our prices, which could

have an adverse effect on our financial position and could negatively affect our revenues and results of operations.

If any of our largest

customers terminate the purchase of our products, such termination would materially negatively affect our revenues, results of operations

and financial condition.

results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our

diagnostic tests and manage our inventory.

ensure adequate inventory supply, we must forecast inventory needs and manufacture our diagnostic tests based on our estimates of future

demand for our diagnostic tests.

Our ability to accurately forecast demand for them could be negatively affected by many factors, including

our failure to accurately manage our expansion strategy, product introductions by competitors, an increase or decrease in customer demand

for our diagnostic tests or for those of our competitors, our failure to accurately forecast customer acceptance of new diagnostic tests,

unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence

in future economic conditions.

Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which

would cause our gross margin to be adversely affected and could impair the strength of our brand.

Conversely, if we underestimate customer

demand for our diagnostic tests, our supply chain, manufacturing partners and/or internal manufacturing team may not be able to deliver

components and diagnostic tests to meet our requirements, and this could result in damage to our reputation, sales growth and customer

relationships.

In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing

capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient

capacity in order to meet our increased requirements, which will adversely affect our business, financial condition and results of operations.

timing of our new product offerings is uncertain.

have multiple products in various phases of development, and we intend to devote considerable future resources to research and product

development, our core business strategy.

There can be no assurance that our development activities will always produce tests with the

sensitivity and specificity necessary to be clinically and commercially competitive, or that any test will result in a commercially successful

In addition, before we can develop diagnostic tests for new cancers or other diseases and commercialize any new products,

we will need to:

conduct substantial research and development;

conduct analytical and clinical performance testing (verification and

expend significant funds.

product development process involves a high degree of risk and may take several years in some instances.

Our product development

efforts may fail for many reasons, including, but not limited to:

failure of the product at the research or development

difficulty in accessing samples, especially samples

with known clinical results;

lack of clinical performance data to support the safety and effectiveness

of the product.

research and development projects result in commercial products, and success in early clinical trials often is not replicated in later

At any point, we may abandon development of a product candidate, or we may be required to expend considerable resources

repeating clinical trials, which would adversely impact the timing for generating potential revenues from those product candidates.

addition, as we develop products, we will have to make significant investments in product development.

If a clinical validation

study fails to demonstrate the prospectively defined endpoints of the study, we might choose to abandon the development of the product

or product feature that was the subject of the clinical trial, which could harm its business.

In addition, our competitors may develop

and commercialize competing products faster than we are able to do so.

access to samples may hinder our ability to research, develop, and commercialize future products.

planned and future products are focused primarily on exploitation of blood plasma or serum as a medium for both biomarker identification

and validation and ultimately for our commercial testing applications.

Our clinical development relies on our ability to secure access

to high quality, well-characterized samples, as well as information pertaining to the samples associated clinical outcomes.

Our competitors

have demonstrated their ability to obtain these samples and often compete with us for access to such samples.

Additionally, the process

of negotiating access to samples is lengthy since it typically involves numerous parties and approval levels to resolve complex issues

such as usage rights, institutional review board (ethical) approval, privacy rights, publication rights, intellectual property ownership

and research parameters.

If we are not able to negotiate access to samples with hospitals, clinical partners, or other companies on a

timely basis, or at all, or if competitors secure access to these samples before us, then our ability to research, develop, and commercialize

future products will be limited or delayed.

to complex test protocols is required.

validate our tests in our lab in Switzerland using blood samples obtained from a variety of sources.

Tests results can be affected by a

number of variables including how the blood is extracted, how the blood is handled, the type of test tube used, the number and speed

of centrifuge spins, the temperature the blood is exposed to during processing, the concentration of the reagents, and the timing of

All of these and other variables in the process are set forth in an assay protocol that we provide to our distributor lab

partners along with training in proper compliance.

If, due to human or equipment failure, there is material deviation from the protocols,

the accuracy of our tests can be negatively impacted.

If that occurs, the reputation of our products and our revenue could be negatively

Related to our Business and Industry

reliance on third parties heightens the risks faced by our business.

We rely on suppliers, vendors, subcontractors, 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.

However, if these parties fail to meet their defined 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

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, in emerging markets

or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

We are dependent on third parties to market, distribute and sell our

Our ability to receive revenues is dependent upon the sales and marketing

efforts of co-marketing partners and third-party distributors.

If we fail to reach an agreement with any commercialization partner, or

upon reaching such an agreement that partner fails to sell a large volume of our products, it may have a negative impact on our business,

financial condition, and results of operations.

We have no experience manufacturing our products

on a commercial scale and are dependent on third parties for the manufacture of our products.

If we experience problems with any of these

third parties, they could delay our ability to sell our products.

We do not have any manufacturing

We will rely on third-party manufacturers for commercial supply of Proclarix and ENTADFI (if we resume the commercialization

may be unable to establish agreements with third-party manufacturers for commercial supply on terms favorable to us, or at

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 through quality

management system;;

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 with U.S.

cGMPs, QSR 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 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 product recalls, operating restrictions and criminal prosecutions,

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

Our products may compete with

other products and/or product candidates and products for access to these manufacturing facilities.

There are a limited number of manufacturers

that operate under cGMPs and that might be capable of manufacturing for us.

Any performance failure on the

part of our manufacturers, including a failure that may not relate specifically to our products, could adversely impact our ability to

generate commercial sales.

If our contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer.

Our anticipated future dependence

upon others for the manufacture of our products may adversely affect our future profit margins and our ability to commercialize our products

on a timely and competitive basis.

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 products.

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 manufacture our products

in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying with

regulatory requirements and managing manufacturing costs.

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

quality or reliability

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

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

implement changes in response to regulatory requirements;

Potential damage to or

destruction of our manufacturing equipment or manufacturing facility.

If demand for our products 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

Manufacturing of our products 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 products at a cost or in quantities sufficient to make these products commercially viable.

Any of these factors

may affect our ability to manufacture our product and could reduce our gross margin and profitability.

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 increases.

are dependent on sole suppliers or a limited number of suppliers for certain components that are integral to its finished products.

these or other suppliers encounter financial, operating or other difficulties or if our relationship with them changes, we may be unable

to quickly establish or qualify replacement sources of supply and could face production interruptions, delays and inefficiencies.

addition, technology changes by our vendors could disrupt access to the 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 in sufficient quantities to support our growth.

Any one of these factors could harm our

business and growth prospects.

may not be able to manage our manufacturing and supply chain effectively, which would harm our results of operations.

We must accurately forecast market demand for our products 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 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 brand

and business.

In 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 partners

or third-party providers that could delay or prevent the commercialization of our current products.

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

or third-party providers, such as conflicts concerning the achievement of milestones, the interpretation of contractual obligations, payments

for services, development obligations or the ownership of intellectual property developed during our collaboration.

If any conflicts arise

with any of our partners, such partner may act in a manner that is adverse to our best interests.

Any such disagreement could result in

one or more of the following, each of which could delay or prevent the commercialization of our current products, 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 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 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.

Product liability lawsuits against us could cause us to incur substantial

liabilities and to limit commercialization of our products.

We face an inherent risk of product

liability exposure related to the commercialization of our products.

Product liability claims may be brought against us by patients, healthcare

providers or others using, administering, or selling our product.

addition, we face an inherent risk of product liability as a result of the marketing and sale of Proteomedix’s diagnostic

tests and services.

For example, we may be sued if the diagnostic tests or services cause or are perceived to cause injury or are

found to be otherwise unsuitable during manufacturing, marketing or sale.

Any such product liability claim may include allegations

of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability,

or a breach of warranties.

In addition, we may be subject to claims against us even if the apparent injury is due to the actions of

others or the pre-existing health of the patient.

For example, medical personnel, care partners and patients collect samples for our

diagnostic tests.

If these medical personnel, care partners or patients are not properly trained, are negligent or use our

diagnostic tests incorrectly, the capabilities of such tests may be diminished, or the patient may suffer critical injury.

also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and

sub-assemblies for our diagnostic tests.

we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit

or halt the marketing and sale of our diagnostic tests and services.

Even a successful defense would require significant financial and

management resources.

Regardless of the merits or eventual outcome, liability claims may result in:

decreased demand for our products;

injury to our reputation

and significant negative media attention;

significant costs to defend

the related litigation;

substantial monetary awards to patients;

loss of revenue;

diversion of management and scientific resources from our business operations;

the inability to commercialize any products that we may develop.

Prior to engaging in future clinical trials, we

intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate

to provide us with insurance coverage for foreseeable risks;

however, we may be unable to obtain such coverage at a reasonable cost, if

If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable cost or

in an amount adequate to satisfy any liability that may arise and such insurance may not be adequate to cover all liabilities that we

Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain

regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability

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.

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.

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

on favorable terms, or at all.

Any acquisitions we make may fail to strengthen our competitive position and these transactions may be

viewed negatively by customers or investors.

We may decide to incur debt in connection with an acquisition or issue our common stock or

other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.

We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we

may obtain from the seller.

In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations

into our existing business in an effective, timely and non-disruptive manner.

Acquisitions may also divert management attention from day-to-day

responsibilities, increase our expenses and reduce our cash available for operations and other uses.

We cannot predict the number, timing

or size of future acquisitions or the effect that any such transactions might have on our operating results.

Security threats to our information technology infrastructure

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

to be secure.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security

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

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

Despite security measures, we also cannot guarantee security

of our physical buildings.

Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network

infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that are affected,

and expose us to financial liability.

Additionally, there are a number of state, federal

and international laws protecting the privacy and security of health information and personal data.

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 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.

diversion of management

and scientific resources from our business operations;

the inability to commercialize our products;

the initiation of investigations

by regulators;

product recalls, withdrawals

or labeling, marketing, or promotional restrictions.

We have product liability insurance

coverage at a level that we believe is customary for similarly situated companies and adequate to provide us with insurance coverage for

foreseeable risks.

However, we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy

any liability that may arise, and such insurance may not be adequate to cover all liabilities that we may incur.

Furthermore, we intend

to expand our insurance coverage for products to include the sale of commercial products if we obtain regulatory approval for our product

candidates in development, but we may be unable to obtain commercially reasonable product liability 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.

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.

may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.

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 on favorable terms, or at all.

Any acquisitions we make may fail to strengthen our competitive

position and these transactions may be viewed negatively by customers or investors.

We may decide to incur debt in connection with an

acquisition or issue our common stock or other equity securities to the stockholders of the acquired company, which would reduce the

percentage ownership of our existing stockholders.

We could incur losses resulting from undiscovered liabilities of the acquired business

that are not covered by the indemnification we may obtain from the seller.

In addition, we may not be able to successfully integrate

the acquired personnel, technologies, and operations into our existing business in an effective, timely and non-disruptive manner.

may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available for operations

and other uses.

We cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might have

on our operating results.

threats to our information technology infrastructure 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 to be secure.

security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.

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

Despite security measures, we also cannot guarantee the security of our physical buildings.

Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network infrastructure and our ability

to deploy our products and services, harm our relationship with customers and partners that are affected, and expose us to financial liability.

Additionally, there are a number of state, federal and international

laws governing the collection, use, processing and protection of health information and personal data.

Most states have data security

breach laws requiring data protection measures and potentially requiring notification to regulators and impacted consumers.

Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health

Act of 2009 (collectively, “HIPAA”), imposes limitations on the use and disclosure of an individual’s healthcare information

“covered entities,” which include by healthcare providers who submit certain standard transactions electronically (mostly

related to claims for payment from health insurers), healthcare clearinghouses, and health insurance plans, and also grants individuals

rights with respect to their health information.

Although we do not currently submit standard transactions electronically and therefore

are not a HIPAA covered entity, HIPAA has been in effect for over 20 years and accordingly individuals expect that providers of health

care items or services will safeguard their health information in accordance with HIPAA.

Moreover, many states’ laws impose similar

or more stringent limitations on uses and disclosures of healthcare information than does HIPAA, and such laws also provide individuals

rights to access, amend, and withhold sharing of their health information.

HIPAA also requires reporting of certain impermissible uses

and disclosures of health information, including security breaches, to affected individuals, the Office for Civil Rights of the U.S.

of Health and Human Services, and in some cases the media.

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.

Department of Health

and Human Services.

Most states also 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

Activities outside of the U.S.

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,

to protect against security breaches and hackers or to alleviate problems caused by such breaches.

We will need to grow the size of our organization in the future,

and we may experience difficulties in managing this growth.

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,

implicate local and national data protection standards, impose additional compliance requirements

and generate additional risks of enforcement for non-compliance.

We may be required to expend significant capital and other resources

to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate

problems caused by such breaches.

will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.

As of April 5, 2024, we had

12 full-time and 11 subcontracted employees.

We will need to increase the size of our organization in order to support our continued commercialization

of our products.

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

sales, marketing, financial and other resources may increase.

2 unchanged sentences

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.

Our future success depends on our ability to retain our executive

officers and to attract, retain and motivate qualified personnel.

We are highly dependent upon our personnel, including

Joseph Hernandez, our Chief Executive Officer and members of our board of directors.

The loss of Mr.

Hernandez’s services could

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

We have not obtained, do not own, nor are we the

beneficiary of, key-person life insurance.

Our future growth and success depend on our ability to recruit, retain, manage and motivate

our employees.

The loss of any member of our senior management team or the inability to hire or retain experienced management personnel

could compromise our ability to execute our business plan and harm our operating results.

Because of the specialized scientific and managerial

nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.

The competition for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract

and retain qualified personnel necessary for the development of our business.

Our Chief Executive Officer, Joseph Hernandez, and our Chief

Financial Officer, Jon Garfield, also hold certain management positions and directorships of other companies and may allocate their time

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

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

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,

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

and responsibilities to Blue Water Vaccines Inc.

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.

Pursuant to 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.

Accordingly, Mr.

Garfield 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

Each of Messrs.

Hernandez and Garfield may also

have competitive fiduciary obligations and pecuniary interests relating to their other business ventures that conflict with our interests.

Each of Messrs.

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

Blue Water Vaccines Inc.

These restrictive covenants, generally, restrict Messrs.

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.

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

businesses, which may cause conflicts of interest in their determination as to how much time to devote to our affairs and potentially

competitive fiduciary and pecuniary interests that conflict with our interests.

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.

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

experience as founders, board members, officers or executives of other companies.

As a result, certain of those persons have been and

may become involved in proceedings, investigations and litigation relating to the business affairs of the companies with which they were,

are, or may in the future be, affiliated.

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

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

agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being

developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which

the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new

products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel

and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated

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 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.

Further, in our operations

as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in

order to properly capitalize and continue our operations.

We may be adversely affected by natural disasters, pandemics

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,

consultants, vendors and clinical research organizations, or CROs, may engage in misconduct or other improper activities, including noncompliance

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.

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;

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 products 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 hire, train and integrate additional management,

manufacturing, administrative and sales and marketing personnel.

The failure to accomplish any of these tasks could prevent us from successfully

growing our company.

future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.

are highly dependent upon our personnel and executive officers.

We have not obtained, do not own, nor are we the beneficiary of, key-person

life insurance.

Our future growth and success depend on our ability to recruit, retain, manage and motivate our employees.

of any member of our senior management team or the inability to hire or retain experienced management personnel could compromise our

ability to execute our business plan and harm our operating results.

Because of the specialized scientific and managerial nature of our

business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.

The competition

for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract and retain qualified

personnel necessary for the development of our business.

Members of our management team and board

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

As a result, certain

of those people have been and may become involved in proceedings, investigations and litigation relating to the business affairs of the

companies with which they were, are, or may in the future be, affiliated.

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

and business.

the course of their careers, members of our management team and Board 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.

Inadequate funding for the FDA, the SEC and other government agencies

could hinder their ability to hire and retain key leadership and other personnel, prevent review of regulatory submissions in a timely

manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely,

which could negatively impact our business.

The ability of the FDA to review regulatory submissions can be affected

by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment

of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may rely 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 regulatory submissions to be reviewed 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.

Further, in our operations as a public company, future government

shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue

our operations.

may be adversely affected by natural disasters, pandemics 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.

A public health emergency could also affect the

operations of the FDA and other regulatory or public health authorities, resulting in delays to meetings and ultimately review of regulatory

Our employees, independent contractors, principal investigators, consultants,

and vendors and engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors,

consultants, and vendors 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 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.

Activities subject to these laws also involve

the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result

in regulatory sanctions or other actions or lawsuits stemming from a failure to comply with such laws or regulations, and serious harm

to our reputation.

In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts

and require certain contractors to maintain a code of business ethics and conduct.

If any such actions are instituted against us, we may

have to terminate employees or others involved and the impact of such termination can result in our experiencing delays and additional

costs associated with replacing the services being provided.

If we are not successful in defending ourselves or asserting our rights,

those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,

damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment,

contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could

adversely affect our ability to operate our business and our operating results.

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, patient

rebate programs, and other business arrangements.

Activities subject to these laws also involve the improper use of information obtained

in the course of clinical trials, or illegal misappropriation of drug product, which could result in regulatory sanctions or other actions

or lawsuits stemming from a failure to comply with such laws or regulations, and serious harm to our reputation.

In addition, federal

procurement laws impose substantial penalties for misconduct in connection with government contracts and require certain contractors to

maintain a code of business ethics and conduct.

If any such actions are instituted against us, we may have to terminate employees or others

involved and the impact of such termination can result in our experiencing delays and additional costs associated with replacing the services

being provided.

If we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact

on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion

from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment, contractual damages, reputational harm,

diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate

our business and our operating results.

Macroeconomic pressures in the markets in which we operate, including,

but not limited to, the effect of the COVID-19 pandemic and the current conflict between Ukraine and Russia may alter the ways in which

we conduct our business operations and manage our financial capacities.

To varying degrees, the ways in which we conduct

our business operations and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly

involved in or providing services related to the drug and biological product development.

For example, real GDP growth, business and investor

confidence, the COVID-19 pandemic, the conflict between Ukraine and Russia, inflation, employment levels, oil prices, interest rates,

tax rates, availability of consumer and business financing, housing market conditions, foreign currency exchange rate fluctuations, costs

for items such as fuel and food and other macroeconomic trends can adversely affect not only our decisions and ability to engage in research

and development and clinical trials, but also those of our management, employees, third-party contractors, manufacturers and suppliers,

competitors, stockholders and regulatory authorities.

In addition, geopolitical issues around the world and how our markets are positioned

can also impact the macroeconomic conditions and could have a material adverse impact on our financial results.

Economic uncertainty may adversely affect our access to capital,

cost of capital and ability to execute our business plan as scheduled.

Generally, worldwide economic conditions remain

but not limited to, the current conflicts in Ukraine and the Middle East may alter the ways in which we conduct our business operations

and manage our financial capacities.

To varying degrees, the ways in which we conduct our business operations

and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly involved in or providing

services related to the drug development.

For example, real GDP growth, business and investor confidence, the conflicts in Ukraine and

the Middle East, inflation, employment levels, oil prices, interest rates, tax rates, availability of consumer and business financing,

housing market conditions, foreign currency exchange rate fluctuations, costs for items such as fuel and food and other macroeconomic

trends can adversely affect not only our decisions and ability to engage in research and development and clinical trials, but also those

of our management, employees, third-party contractors, manufacturers and suppliers, competitors, stockholders and regulatory authorities.

In addition, geopolitical issues around the world and how our markets are positioned can also impact the macroeconomic conditions and

could have a material adverse impact on our financial results.

uncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled.

worldwide economic conditions remain uncertain.

Access to capital markets is critical to our ability to operate.

Traditionally, biotechnology companies have funded their research

and development expenditures through raising capital in the equity markets.

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

development efforts.

We require significant capital for research and development for our vaccine candidates and clinical trials.

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.

If economic conditions become worse, our future cost of equity or debt capital and access

to the capital markets could be adversely affected.

In addition, if we are unable to access the capital markets on favorable terms, our

ability to execute our business plan as scheduled would be compromised.

Moreover, we rely and intend to rely on third-parties, including

clinical research organizations, contract manufacturing organizations and other important vendors and consultants.

Global economic conditions

may result in a disruption or delay in the performance of our third-party contractors and suppliers.

If such third-parties are unable

to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.

Risks Related to Our Intellectual Property

It is difficult and costly to protect our proprietary rights,

and we may not be able to ensure their protection.

If our patent position does not adequately protect our product candidates, others could

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

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

companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.

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.

Changes in either the patent laws or interpretations of patent laws in the U.S.

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

and technologies that are similar, identical or competitive to ours or important to our business.

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 before

patent offices.

Traditionally, biotechnology

companies have funded their research, development and commercialization expenditures through raising capital in the equity markets.

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, development, and commercialization efforts.

We require significant capital for the commercialization

of our products.

The general 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.

If economic conditions become worse, our future cost

of equity or debt capital and access to the capital markets could be adversely affected.

In addition, if we are unable to access the

capital markets on favorable terms, our ability to execute our business plan as scheduled would be compromised.

Moreover, we rely and

intend to rely on third-parties, including CROs, CMOs and other important vendors and consultants.

Global economic conditions may result

in a disruption or delay in the performance of our third-party contractors and suppliers.

If such third-parties are unable to adequately

satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.

in the global economy may adversely affect our business, financial condition and results of operations.

demand for in vitro diagnostics is considered inelastic in developed economies, the in vitro diagnostic industry that we sell to may

be affected by material changes in supply, market prices, exchange rates and general economic conditions.

Delays or reductions in our

customers’ purchasing or shifts to lower-cost alternatives that result from tighter economic market conditions would reduce demand

for our products and services and could, consequently, have a material adverse effect on our business, financial condition, and results

of operations.

and errors by our current and former employees and our third-party service providers could cause a material adverse effect on our business

and reputation.

employees and third-party service providers are integral to our business operations, including confidential information.

information were leaked to unintended recipients due to human error, theft, malicious sabotage or fraudulent manipulation, we may be

subject to liability for loss of such information.

Further, if any of our employees or third-party service providers absconded with our

proprietary data or know-how in order to compete with us, our competitive position may be materially and adversely affected.

improper conduct or use of funds by any of our employees or third-party service providers in contravention of our protocols and

policies may lead to regulatory and disciplinary proceedings involving us.

We may be perceived to have facilitated or participated in

such conduct and we could be subject to liability, damages, penalties and reputational damage.

It is impossible to completely identify

and eradicate all risks of misconduct or human errors, and our precautionary measures may not be able to effectively detect and prevent

such risks from happening.

occurrence of any of the above risks could result in a material adverse effect on our business and results of operations, as we are exposed

to potential liability to borrowers and investors, reputational damage, regulatory intervention, financial harm.

Our ability to attract

new and retain existing borrowers and investors and operate as an ongoing concern may be impaired.

industry is subject to rapid change, which could make our solutions and the diagnostic tests we develop and services we offer, obsolete.

If we are unable to continue to innovate and improve our diagnostic tests and services, we could lose customers or market share.

industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product introductions

and enhancements and evolving industry standards, all of which could make our current diagnostic tests and others we are developing obsolete.

Our future success will depend on our ability to keep pace with the evolving needs of our customers on a timely and cost-effective basis

and to pursue new market opportunities that develop as a result of scientific and technological advances.

In recent years, there have

been numerous advances in technologies relating to the diagnosis and treatment of cancer.

There have also been advances in methods used

to analyze very large amounts of molecular information as well as new imaging-based technologies used of the early assessment and monitoring

We must continuously enhance our offerings and develop new and improved diagnostic tests to keep pace with evolving standards

If we do not leverage or scale our sample and data biobank, discover new diagnostic biomarkers or applications, or update our

diagnostic tests to reflect new scientific knowledge, including about prostate cancer biology, and information about new cancer therapies

or relevant clinical trials, our diagnostic tests could become obsolete and sales of our current diagnostic tests and any new tests we

develop could decline or fail to grow as expected.

This failure to make continuous improvements to our diagnostic tests to keep ahead

of those of our competitors could result in the loss of customers or market share that would adversely affect our business, financial

condition, and results of operations.

The development of new liquid biopsy and imaging technologies could negatively impact demand for

our products.

the event that our products are the subject of guidelines, clinical studies or scientific publications that are unhelpful or damaging,

or otherwise call into question the benefits of our products, we may have difficulty in convincing prospective customers to adopt our

Moreover, the perception by the investment community or shareholders that recommendations, guidelines, or studies will result in

decreased use of our products could adversely affect the prevailing market price for our common stock.

Similar challenges apply to all

of the products in our pipeline.

face competition from many sources, including larger companies, and we may be unable to compete successfully.

There are a number of diagnostic

solutions companies in the United States, Europe and Asia.

Notable competitors in the United States include, but are not limited to OPKO

Health, Beckman Coulter, BioTechne, MdxHealth, A3P Biomedical AB.

These competitors all provide diagnostic tests or testing services to

hospitals, researchers, clinicians, laboratories, and other medical facilities.

Many of these organizations are significantly larger with

greater financial and personnel resources than us and enjoy significantly greater market share and have greater resources than we do.

As a consequence, they may be able to spend more on product development, marketing, sales and other product initiatives than we can.

of our competitors have:

● substantially

greater name recognition;

● broader, deeper, or longer-term relations with healthcare professionals,

customers, and third-party payers;

established distribution networks;

lines of diagnostic tests and the ability to offer rebates or bundle them to offer greater

discounts or other incentives to gain a competitive advantage;

experience in conducting research and development, manufacturing, clinical trials, marketing

and obtaining regulatory clearance or approval for diagnostic tests;

financial and human resources for product development, mergers and acquisitions, sales and

marketing and possible patent litigation.

continued success depends on our ability to:

Further penetrate the diagnostic solutions market and increase utilization of our diagnostic tests;

and retain a sufficient number of qualified employees;

and widen our technology lead over competitors by continuing to innovate and deliver new

product enhancements on a continuous basis;

● cost-effectively

manufacture our diagnostic tests and their component parts as well as drive down the cost

we attain greater commercial success, our competitors are likely to develop diagnostic tests that offer features and functionality similar

to our diagnostic tests that are currently on the market.

Improvements in existing competitive diagnostic tests or the introduction of

new competitive diagnostic tests may make it more difficult for us to compete for sales, particularly if those competitive diagnostic

tests demonstrate better reliability, convenience or effectiveness or are offered at lower prices.

issues, service interruptions or price increases by our shipping carriers and warehousing providers could adversely affect our business

and harm our reputation and ability to provide our services on a timely basis.

reliable shipping and delivery services and secure warehousing are essential to our operations.

We rely heavily on providers of transport

services for reliable and secure point-to-point transport of our diagnostic tests to our customers and for tracking of these shipments,

and from time to time require warehousing for our diagnostic tests, sample collection kits and supplies.

Should a carrier encounter delivery

performance issues such as loss, damage, or destruction of any systems, it would be costly to replace such systems in a timely manner

and such occurrences may damage our reputation and lead to decreased demand for our diagnostic tests and increased cost and expense to

our business.

In addition, any significant increase in shipping or warehousing rates could adversely affect our operating margins and

results of operations.

Similarly, strikes, severe weather, natural disasters, civil unrest and disturbances or other service interruptions

affecting delivery or warehousing services we use would adversely affect our ability to process orders for our diagnostic tests on a

timely basis.

For our clinical studies, we rely on commercial courier delivery services

to transport samples to our laboratory facility in a timely and cost-efficient manner and if these delivery services are disrupted, our

business will be harmed.

Disruptions in delivery service, whether due to labor disruptions, bad weather, natural disaster, civil unrest

or disturbances, terrorist acts or threats or for other reasons could adversely affect specimen integrity and our ability to process samples

in a timely manner and to service our customers, and ultimately our reputation and our business.

In addition, if we are unable to continue

to obtain expedited delivery services on commercially reasonable terms, our operating results may be adversely affected.

rely on software hosting our online risk calculator needed to be accessed by the user to calculate the test result.

Any internet service

interruption or hardware failure could affect availability of the online resource and thus negatively impact our business.

Cost-containment

efforts of our customers, purchasing groups and governmental purchasing organizations could have a material adverse effect on our future

sales and profitability.

an effort to reduce costs, many hospitals in the United States have become members of GPOs and Integrated Delivery Networks (IDNs).

and IDNs negotiate pricing arrangements with medical device companies and distributors and then offer these negotiated prices to affiliated

hospitals and other members.

GPOs and IDNs typically award contracts on a category-by-category basis through a competitive bidding process.

Bids are generally solicited from multiple providers with the intention of driving down pricing or reducing the number of vendors.

to the highly competitive nature of the GPO and IDN contracting processes, we may not be able to obtain new contract positions with major

GPOs and IDNs.

Furthermore, the increasing leverage of organized buying groups may reduce market prices for our diagnostic tests, thereby

reducing our revenue and margins.

having a contract with a GPO or IDN for a given product category can facilitate sales to members of that GPO or IDN, such contract positions

can offer no assurance that any level of sales will be achieved, as sales are typically made pursuant to individual purchase orders.

Even when a provider is the sole contracted supplier of a GPO or IDN for a certain product category, members of the GPO or IDN are generally

free to purchase from other suppliers.

Furthermore, GPO and IDN contracts typically are terminable without cause by the GPO or IDN upon

60 to 90 days’ notice.

Accordingly, the members of such groups may choose to purchase alternative diagnostic tests due to the price

or quality offered by other companies, which could result in a decline in our revenue.

We are highly dependent on our senior management team and key personnel,

and our business could be harmed if we are unable to attract and retain the personnel necessary for our success.

We are highly dependent on our senior management and other key personnel.

Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including

sales and marketing professionals, scientists, clinical specialists, and other highly skilled personnel and to integrate current and additional

personnel in all departments.

The loss of members of our senior management, sales and marketing professionals, scientists, clinical and

regulatory specialists could result in delays in product development and harm our business.

If we are not successful in attracting and

retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition, and results of operations.

laboratory operations depend on our ability to attract and retain highly skilled scientists and technicians.

We may not be able to attract

or retain qualified scientists and technicians in the future due to the competition for qualified personnel among life science businesses,

particularly near our laboratory facility in Zurich-Schlieren, Switzerland.

We also face competition from universities and public and

private research institutions in recruiting and retaining highly qualified scientific personnel.

We may also have difficulties locating, recruiting, or retaining qualified

Recruiting and retention difficulties can limit our ability to support our research and development and sales programs.

induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued and may continue to issue

equity awards that vest over time.

Our employment arrangements with our employees provide for at-will employment, which means that any

of our employees could leave our employment at any time, with or without notice, which may lead to more difficulty in retaining qualified

salespeople and other talent.

depend on our information technology systems and any failure of these systems could harm our business.

depend on information technology and telecommunications systems, including third-party cloud computing infrastructure and operating systems,

for significant elements of our operations, including our online risk analysis software.

have installed, and expect to expand, a number of enterprise software systems that affect a broad range of business processes and functional

areas, including systems handling human resources, financial controls and reporting, contract management, regulatory compliance and other

infrastructure operations.

technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network

failures, malicious human acts (such as ransomware) and natural disasters.

Moreover, despite network security and back-up measures, some

of our external servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems.

Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our information technology and telecommunications

systems, failures or significant downtime of these systems or those used by our partners or subcontractors could prevent us from conducting

our diagnostic products development, preparing and providing reports to researchers, clinicians and our partners, billing payors, handling

enquiries, and managing the administrative aspects of our business.

Any disruption or loss of information technology or telecommunications

systems on which critical aspects of our operations depend could have an adverse effect on our business and our reputation, and we may

be unable to regain or repair our reputation in the future.

Related to Our Intellectual Property

is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.

If our patent position

does not adequately protect our products and/or product candidates, others could compete against us more directly, which would harm our

business, possibly materially.

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 products and/or product candidates is dependent upon the extent to which we have rights under valid and enforceable

patents or trade secrets that cover these activities.

patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions

for which important legal principles remain unresolved.

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.

Changes in either the patent laws or interpretations

of patent laws in the U.S.

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 products and/or product candidates or technology could be adversely affected.

Others may file patent applications covering products and technologies

that are similar, identical, or competitive to ours or important to our business.

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 before U.S.

Such proceedings are also expensive and time consuming.

The degree of future protection for our proprietary

rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain

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;

the patents of others may have an adverse effect on our business.

degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately

protect our rights or permit us to gain or keep our competitive advantage.

others may be able to make

compounds/assays that are similar to our products and/or product candidates and/or assays, 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.

We are dependent on licensed intellectual property.

to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates,

If we breach any of the agreements under which we license the use, development and commercialization rights to our product

candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license

rights that are important to our business.

We do not currently own any patents, and we are

heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important to our

business and we may need or choose to enter into additional license agreements in the future.

Our existing license agreements impose,

and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations,

payment of milestones and/or royalties and other obligations.

If we fail to comply with our obligations under these agreements, or we

are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products

covered by the license.

Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to

abide by the terms of the license, 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.

Licensing of intellectual property is of critical

importance to our business and involves complex legal, business and scientific issues.

Disputes may arise between us and our licensors

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 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;

If we were to lose

our rights to licensed intellectual property, we may not be able to continue developing or commercializing our products and/or product

candidates, if approved.

If we breach any of the agreements under which we license the use, development, and commercialization rights

to our products and/or product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines,

we could lose license rights that are important to our business.

owns the patents and patent applications detailed above in the chapter entitled “Intellectual Property”.

Apart from this we

do not currently own any further patents, and we are heavily reliant upon a number of license agreements under which we are granted rights

to intellectual property that are important to our business, and we may need or choose to enter into additional license agreements in

Our existing license agreements impose, and we expect that future license agreements will impose on us, various development,

regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations.

If we fail to comply

with our obligations under these agreements, or we are subject to a bankruptcy, the licensor may have the right to terminate the license,

in which event we would not be able to market products covered by the license.

Our business could suffer, for example, if any current

or future licenses terminate, if the licensors fail to abide by the terms of the license, 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.

Licensing of intellectual property is of critical importance to our

business and involves complex legal, business, and scientific issues.

Disputes may arise between us and our licensors regarding intellectual

property subject to a license agreement, including:

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 products and/or 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

develop and commercialize the affected product candidates.

We have entered into several licenses to support

our various programs.

Termination of any of these license agreements would have a material adverse impact on our ability to develop and

commercialize derived products under each respective agreement.

We may enter into additional licenses to third-party

intellectual property that are necessary or useful to our business.

Our current licenses and any future licenses that we may enter into

impose various royalty payment, milestone, and other obligations on us.

Under some license agreements, we may not control prosecution

of the licensed intellectual property, or may not have the first right to enforce the intellectual property.

In those cases, we may not

be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance

If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have

breached our license agreement, and may accordingly seek to terminate our license.

Termination of any of our current or future licenses

could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to

develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business

Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual

property and information related to the product candidate being developed under the license, such as regulatory information.

The agreements under which we license intellectual

property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple

interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope

of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations

under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations

and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current

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.

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

rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have

to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and

investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results

of operations and prospects could suffer.

Some of the intellectual property covered by our licenses concerns

patent applications and provisional applications.

We cannot assure investors that any of the currently pending or future patent applications

will result in granted patents, nor can we predict how long it will take for such patents to be granted.

Some of intellectual property covered by our licenses

concerns certain, specified patent rights (including patent applications, provisional patent applications and PCT patent applications).

While in some instances, the licensors have agreed to assume responsibility for the preparation, filing, prosecution and maintenance of

patent applications covered by the licensed patent rights, we cannot be certain as to when or if final patents will be issued for those

patent applications covered by the licensed patent rights.

However, the licensors may not successfully prosecute certain patent applications,

the prosecution of which they control, under which we are only a licensee and on which our business substantially depends.

Even if patents

issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability

challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may

fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability.

Moreover, it is possible that the licensed pending

patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide

a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.

Further, it is possible that, for any of the patents that may be granted in the future, others will design around the licensed patent

rights or identify methods for preventing or treating infectious diseases that do not concern the rights covered by our licenses.

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,

we will have the funds to or be successful in defending challenges made against the licensed patents and patent applications.

Any successful

third-party challenge to the licensed patents could result in the unenforceability or invalidity of such patents, or to such patents being

interpreted narrowly or otherwise in a manner adverse to our interests.

Our ability to establish or maintain a technological or competitive

advantage over our competitors may be diminished because of these uncertainties.

Even if patents are issued based on patent applications to which

we have been granted a license, because the patent positions of pharmaceutical and biotechnology products are complex and uncertain, we

cannot predict the scope and extent of patent protection for our product candidates.

Any patents that may be issued based on patent applications

that we have been granted licenses to will not ensure sufficient protection with respect to our activities for a number of reasons, including

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 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

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

could be reduced or eliminated for noncompliance with these requirements.

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.

Maintenance fees are also due for pending patent applications in some countries.

The USPTO and various foreign

governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during

the patent application process.

While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance

with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application,

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

Noncompliance events that could result in abandonment

or lapse of a patent or patent application include, but are not limited to, failure to respond to office actions within prescribed time

limits, non-payment of fees and failure to properly legalize and submit formal documents.

In such an event, our competitors might be able

to enter the market, which would have a material adverse effect on our business.

The life of patent protection is limited, and third parties could

develop and commercialize products and technologies similar or identical to ours and compete directly with us after the patent licensed

disputes over intellectual property that we own or have licensed prevent or impair our ability to maintain our patents or current licensing

arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected products and/or product candidates.

have entered into several licenses to support our various programs.

Termination of any of these license agreements would have a material

adverse impact on our ability to develop and commercialize derived products under each respective agreement.

may enter into additional licenses to third-party intellectual property that are necessary or useful to our business.

Our current licenses

and any future licenses that we may enter into impose various royalty payment, milestone, and other obligations on us.

Under some license

agreements, we may not control prosecution of the licensed intellectual property or may not have the first right to enforce the intellectual

In those cases, we may not be able to adequately influence patent prosecution or enforcement or prevent inadvertent lapses

of coverage due to failure to pay maintenance fees.

If we fail to comply with any of our obligations under a current or future license

agreement, the licensor may allege that we have breached our license agreement and may accordingly seek to terminate our license.

of any of our current or future licenses could result in our loss of the right to use the licensed intellectual property, which could

materially adversely affect our ability to develop and commercialize a product candidate or product, if approved, as well as harm our

competitive business position and our business prospects.

Under some license agreements, termination may also result in the transfer

of or granting in rights under certain of our intellectual property and information related to the product candidate being developed

under the license, such as regulatory information.

agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in

such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise

could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe

to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business,

financial condition, results of operations and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent

or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully

develop and commercialize the affected products and/or product candidates.

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.

if we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual

property rights we have, we may have to seek alternative options, such as developing new products and/or product candidates with design-around

technologies, which may require more time and investment, or abandon development of the relevant research programs or products and/or

product candidates and our business, financial condition, results of operations and prospects could suffer.

of the intellectual property owned by Proteomedix and/or covered by our licenses concerns patent applications and provisional applications.

We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we

predict how long it will take for such patents to be granted.

of intellectual property covered by our licenses concerns certain specified patent rights (including patent applications, provisional

patent applications and PCT patent applications).

While in some instances, the licensors have agreed to assume responsibility for the

preparation, filing, prosecution and maintenance of patent applications covered by the licensed patent rights, we cannot be certain as

to when or if final patents will be issued for those patent applications covered by the licensed patent rights.

However, the licensors

may not successfully prosecute certain patent applications, the prosecution of which they control, under which we are only a licensee

and on which our business substantially depends.

Even if patents issue from these applications, there is no assurance that the patents

will be free from defects or survive validity or enforceability challenges, the licensors may fail to maintain these patents, may decide

not to pursue litigation against third-party infringers, may fail to prove infringement or may fail to defend against counterclaims of

patent invalidity or unenforceability.

it is possible that the patent applications owned by Proteomedix and/or licensed pending patent applications will not result in granted

patents, and even if such pending patent applications grant as patents, they may not provide a basis for intellectual property protection

of commercially viable vaccine products or may not provide us with any competitive advantages.

Further, it is possible that, for any

of the patents that may be granted in the future, others will design around the licensed patent rights or identify methods of diagnosis

or for preventing or treating infectious diseases that do not concern the rights covered by our patents and/or licenses.

cannot assure investors that other parties will not challenge any patents granted to Proteomedix or the licensors or that courts or regulatory

agencies will hold Proteomedix and/or licensor’s patents to be valid or enforceable.

We cannot guarantee investors that, if required

to defend the covered patents, we will have the funds to or be successful in defending challenges made against the Proteomedix and/or

licensed patents and patent applications.

Any successful third-party challenge to the Proteomedix and/or licensed patents could result

in the unenforceability or invalidity of such patents, or to such patents being interpreted narrowly or otherwise in a manner adverse

to our interests.

Our ability to establish or maintain a technological or competitive advantage over our competitors may be diminished

because of these uncertainties.

if patents are issued based on patent applications to which we have been granted a license or owned by Proteomedix, because the patent

positions of diagnostic methods and/or pharmaceutical and biotechnology products are complex and uncertain, we cannot predict the scope

and extent of patent protection for our products and/or product candidates.

patents that may be issued based on patent applications that we have been granted licenses to or owned by Proteomedix will not ensure

sufficient protection with respect to our activities for a number of reasons, including without limitation the following:

any issued patents may

not be broad or strong enough to prevent competition from other diagnostic and/or vaccine products including identical or similar

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 products and/or 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

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

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

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.

Maintenance fees are also due for pending patent applications

in some countries.

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

fee payment and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be cured

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

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

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

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

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

The life of patent protection is limited, and third parties could develop

and commercialize methods, products, and technologies similar or identical to ours and compete directly with us after the patent licensed

to us expires, which could materially and adversely affect our ability to commercialize our products and technologies.

The life of a patent and the protection it affords

For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally

20 years from its earliest U.S.

life of a patent and the protection it affords is limited.

For example, in the United States, if all maintenance fees are timely paid,

the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional filing date.

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,

testing and regulatory review of new vaccine candidates, patents protecting such vaccine candidates might expire before or shortly after

such vaccine candidates are commercialized.

As a result, the patents and patent applications licensed to us may not provide us with sufficient

rights to exclude others from commercializing products similar or identical to ours.

In Europe, the expiration

of an invention patent is 20 years from its filing date.

Even if we successfully obtain patent protection for a diagnostic method and/or

an approved vaccine candidate, it may face competition, e.g., from biosimilar medications.

Diagnostic companies or 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 method/product candidate exclusively, which would materially adversely affect any potential

sales of that product.

the amount of time required for the development, testing and regulatory review of new diagnostic methods and/or vaccine candidates, patents

protecting such diagnostic methods and/or vaccine candidates might expire before or shortly after such methods or vaccine candidates

are commercialized.

As a result, the patents and patent applications owned or licensed to us may not provide us with sufficient rights

to exclude others from commercializing methods/products similar or identical to ours.

Even if we believe that the patents involved are

eligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including the

FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions

eligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including

the FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions

are available, and such authorities may refuse to grant extensions to such patents, or may grant more limited extensions than requested.

3 unchanged sentences

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

of patent protection afforded could be less than requested.

If we are unable to obtain patent term extension or term of any such extension

is less than requested, our competitors may obtain approval of competing products following our patent expiration, and our business could

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

the value of our patents or narrow the scope of our patent protection.

The patents and pending patent applications licensed

to us for our product candidates are expected to expire on various dates.

Upon the expiration, we will not be able to assert such licensed

patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations

and prospects.

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.

There may be intellectual property rights existing

now, or in the future, relevant to our product candidates that we seek to commercialize or develop, if any, that may affect our ability

to commercialize such product candidates.

Although the Company is not aware of any such intellectual property rights, a third-party may

hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product

Even if all our main product candidates are covered by patents, it may be necessary for us to use the patented or proprietary

technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these

third parties.

Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable

contractual terms.

In that event, we may be required to expend significant time and resources to redesign our technology, product candidates,

or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical

or commercial basis.

If we are unable to do so, our business could be harmed.

The licensing or acquisition of third-party intellectual

property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party

intellectual property rights that we may consider attractive or necessary.

These established companies may have a competitive advantage

over us due to their size, capital resources and greater clinical development and commercialization capabilities.

In addition, companies

that perceive us to be a competitor may be unwilling to assign or license rights to us.

We also may be unable to license or acquire third

party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all.

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.

the applicable time period or the scope of patent protection afforded could be less than requested.

If we are unable to obtain patent

term extension or term of any such extension is less than requested, our competitors may obtain approval of competing products following

our patent expiration, and our business could be harmed.

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

United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

patents and pending patent applications licensed to us for our diagnostic methods and product candidates are expected to expire on various

Upon the expiration, we will not be able to assert such licensed patent rights against potential competitors, which would materially

adversely affect our business, financial condition, results of operations and prospects.

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.

may be intellectual property rights existing now, or in the future, relevant to our methods and/or products and/or product candidates

that we seek to commercialize or develop, if any, that may affect our ability to commercialize such methods and/or products and/or product

Although the Company is not aware of any such intellectual property rights, a third-party may hold intellectual property

rights, including patent rights, that are important or necessary to the development or manufacture of our methods and/or products and/or

product candidates.

Even if all our main methods and/or products and/or product candidates are covered by patents, it may be necessary

for us to use the patented or proprietary technology of third parties to commercialize our methods and/or products and/or product candidates,

in which case we would be required to obtain a license from these third parties.

Such a license may not be available on commercially

reasonable terms, or at all, and we could be forced to accept unfavorable contractual terms.

In that event, we may be required to expend

significant time and resources to redesign our technology, methods and/or products and/or product candidates, or the methods for manufacturing

them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

unable to do so, our business could be harmed.

licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may

pursue strategies to license or acquire third party intellectual property rights that we may consider attractive or necessary.

established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development

and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license

rights to us.

We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make

an appropriate return on our investment or at all.

If we are unable to successfully obtain rights to required third party intellectual

property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program

or product candidate, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

may infringe the intellectual property rights of others, which may prevent or delay our method and/or product development efforts and

stop us from commercializing or increase the costs of commercializing our methods and/or products and/or product candidates.

success will depend in part on our ability to operate without infringing the proprietary rights of third parties.

We are not aware of

any third-party proprietary rights that our planned methods and/or products will infringe or misappropriate, but we have not conducted

any freedom to operate study as we are in the earliest stages of development.

We thus cannot guarantee that our methods and/or products

and/or product candidates, or manufacture or use of our products and/or product candidates, will not infringe third-party patents.

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 methods and/or products and/or product candidates.

These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel.

Some of these third parties may be better capitalized and have more resources than us.

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 way around the patent and may need to halt commercialization of our methods and/or products and/or product candidates.

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 our licensors and collaborators against certain intellectual property infringement claims

brought by third parties, which could require us to expend additional resources.

The diagnostic, pharmaceutical and biotechnology industries

have produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various

types of products or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation is not

always uniform.

we are sued for patent infringement, we would need to demonstrate that our products and/or product candidates or methods either do not

infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this.

Proving invalidity

is difficult.

For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption

of validity enjoyed by issued patents.

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.

If we are unable

to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights

we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on

our business, financial condition, results of operations, and prospects.

We may infringe the intellectual property rights of others, which

may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product

Our success will depend in part on our ability to

operate without infringing the proprietary rights of third parties.

We are not aware of any third party proprietary rights that our planned

products will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages of development.

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.

These lawsuits are

costly and could affect our results of operations and divert the attention of managerial and scientific personnel.

Some of these third

parties may be better capitalized and have more resources than us.

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

way around the patent and may need to halt commercialization of our product candidates.

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

our licensors and collaborators against certain intellectual property infringement claims brought by third parties, which could require

us to expend additional resources.

The pharmaceutical and biotechnology industries have produced a proliferation of patents, and it is

not always clear to industry participants, including us, which patents cover various types of products or methods of use.

of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

If we are sued for patent infringement, we would

need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the

patent claims are invalid, and we may not be able to do this.

Proving invalidity is difficult.

For example, in the U.S., proving invalidity

requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

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.

If we are unable to avoid infringing the patent rights of others, we may

be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court.

to avoid infringing the patent rights of others, we may be required to seek a license, which may not be available, defend an infringement

action or challenge the validity of the patents in court.

Patent litigation is costly and time consuming.

We may not have sufficient resources to bring these actions to a successful conclusion.

In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully

or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product

candidates to market and be precluded from manufacturing or selling our product candidates.

Some of our competitors may be able to sustain the

costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because they

have substantially greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation

could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

We may become involved in lawsuits to protect or enforce our

intellectual property, which could be expensive, time consuming and unsuccessful.

In addition to the possibility of litigation relating

to infringement claims asserted against it, we may become a party to other patent litigation and other proceedings, including inter

partes review proceedings, post-grant review proceedings, derivation proceedings declared by the USPTO and similar proceedings in

foreign countries, regarding intellectual property rights with respect to our current or future technologies or product candidates or

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial.

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

greater financial resources.

Patent litigation and other proceedings may also absorb significant management time.

Uncertainties resulting

from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.

Competitors may infringe or otherwise violate our

intellectual property, including patents that may issue to or be licensed by us.

As a result, we may be required to file claims in an

effort to stop third-party infringement or unauthorized use.

Any such claims could provoke these parties to assert counterclaims against

us, including claims alleging that we infringe their patents or other intellectual property rights, and/or that any of our intellectual

property, including licensed intellectual property, is invalid and/or unenforceable.

This can be prohibitively expensive, particularly

for a company of our size, and time-consuming, and even if we are successful, any award of monetary damages or other remedy we may receive

may not be commercially valuable.

In addition, in an infringement proceeding, a court may decide that our asserted intellectual property

is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our intellectual

property does not cover its technology.

An adverse determination in any litigation or defense proceedings could put our intellectual property

at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

If the breadth or strength of our patent or other

intellectual property rights is compromised or threatened, it could allow third parties to exploit and, in particular, commercialize our

technology or products or result in our inability to exploit and/or commercialize our technology and products without infringing third-party

intellectual property rights.

Further, third parties may be dissuaded from collaborating with us.

Interference or derivation proceedings brought by

the USPTO or its foreign counterparts may be necessary to determine the priority of inventions with respect to our patent applications,

and we may also become involved in other proceedings, such as re-examination proceedings, before the USPTO or its foreign counterparts.

Due to the substantial competition in the pharmaceutical space, the number of such proceedings may increase.

This could delay the prosecution

of our pending patent applications or impact the validity and enforceability of any future patents that we may obtain.

In addition, any

such litigation, submission or proceeding may be resolved adversely to us and, even if successful, may result in substantial costs and

distraction to our management.

If we are not able to adequately prevent disclosure of trade

secrets and other proprietary information, the value of our technology and product could be significantly diminished.

We also rely on trade secrets to protect our proprietary

technologies, especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets are difficult

We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored

researchers and other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent

disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential

We may not have sufficient

resources to bring these actions to a successful conclusion.

In addition, if we do not obtain a license, develop or obtain non-infringing

technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary

damages, encounter significant delays in bringing our methods and/or products and/or product candidates to market and be precluded from

manufacturing or selling our products and/or product candidates.

of our competitors may be able to sustain the costs of complex patent litigation more effectively than us or the third parties from whom

we license intellectual property because they have substantially greater resources.

In addition, any uncertainties resulting from the

initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue

our operations.

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

addition to the possibility of litigation relating to infringement claims asserted against it, we may become a party to other patent

litigation and other proceedings, including inter partes review proceedings, post-grant review proceedings, derivation proceedings

declared by the USPTO and similar proceedings in foreign countries, regarding intellectual property rights with respect to our current

or future technologies or methods and/or products and/or product candidates or products.

The cost to us of any patent litigation or other

proceeding, even if resolved in our favor, could be substantial.

Some of our competitors may be able to sustain the costs of such litigation

or proceedings more effectively than we can because of their substantially greater financial resources.

Patent litigation and other proceedings

may also absorb significant management time.

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

proceedings could impair our ability to compete in the marketplace.

may infringe or otherwise violate our intellectual property, including patents that may be issued to or be licensed by us.

we may be required to file claims in an effort to stop third-party infringement or unauthorized use.

Any such claims could provoke these

parties to assert counterclaims against us, including claims alleging that we infringe their patents or other intellectual property rights,

and/or that any of our intellectual property, including licensed intellectual property, is invalid and/or unenforceable.

prohibitively expensive, particularly for a company of our size, and time-consuming, and even if we are successful, any award of monetary

damages or other remedy we may receive may not be commercially valuable.

In addition, in an infringement proceeding, a court may decide

that our asserted intellectual property is not valid or is unenforceable or may refuse to stop the other party from using the technology

at issue on the grounds that our intellectual property does not cover its technology.

An adverse determination in any litigation or defense

proceedings could put our intellectual property at risk of being invalidated or interpreted narrowly and could put our patent applications

at risk of not being issued.

the breadth or strength of our patent or other intellectual property rights is compromised or threatened, it could allow third parties

to exploit and, in particular, commercialize our technology or methods and/or products or result in our inability to exploit and/or commercialize

our technology and methods and/or products without infringing third-party intellectual property rights.

Further, third parties may be

dissuaded from collaborating with us.

or derivation proceedings brought by the USPTO, or its foreign counterparts may be necessary to determine the priority of inventions

with respect to our patent applications, and we may also become involved in other proceedings, such as re-examination proceedings, before

the USPTO or its foreign counterparts.

Due to the substantial competition in the pharmaceutical space, the number of such proceedings

may increase.

This could delay the prosecution of our pending patent applications or impact the validity and enforceability of any future

patents that we may obtain.

In addition, any such litigation, submission or proceeding may be resolved adversely to us and, even if successful,

may result in substantial costs and distraction to our management.

we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and

product could be significantly diminished.

We also rely on trade secrets to protect our proprietary technologies,

especially where we do not believe patent protection is appropriate or obtainable.

However, trade secrets are difficult to protect.

rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and

other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent disclosure

of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.

In addition, others may independently discover our trade secrets and proprietary information.

For example, the FDA, as part

of its transparency initiative, is currently considering whether to make additional information publicly available on a routine basis,

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.

We may be subject to claims that our employees or consultants

have wrongfully used or disclosed alleged trade secrets.

As is common in the biotechnology and pharmaceutical

industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors

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

or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against these

If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property

rights or personnel, which could adversely impact our business.

Even if we are successful in defending against these claims, litigation

could result in substantial costs and be a distraction to management.

Our intellectual property may not be sufficient to protect our

product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.

We may be subject to competition despite the existence

of intellectual property we license or may in the future own.

We can give no assurances that our intellectual property claims will be

sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive products.

The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and

financial condition.

Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third

parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization

of our product candidates or future product candidates.

We may elect to sue a third party, or otherwise

make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or

other intellectual property rights that we either own or license from a third party.

If we do not prevail in enforcing our intellectual

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.

A third party may also challenge the validity, enforceability

or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope or claims

of or invalidate patents that are integral to our product candidates in the future.

There can be no assurance that we will be able to

successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and the high

costs associated with intellectual property litigation, amongst other factors.

Intellectual property rights may be less extensive

and enforcement more difficult in jurisdictions outside of the U.S.

Therefore, we may not be able to protect our intellectual property

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.

Risks Related to Healthcare Compliance and Other Regulations

If we fail to comply with healthcare regulations, we could face

substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be

adversely affected.

We could be subject to healthcare fraud and abuse

laws and patient privacy laws of both the federal government and the states in which we conduct our business.

For example, the FDA, as part of its transparency

initiative, is currently considering whether to make additional information publicly available on a routine basis, 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.

may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.

is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology

or pharmaceutical companies, including our competitors 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 or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against these claims.

If we fail to defend any such claims, in addition to paying monetary damages,

we could lose valuable intellectual property rights or personnel, which could adversely impact our business.

Even if we are successful

in defending against these claims, litigation could result in substantial costs and be a distraction to management.

intellectual property may not be sufficient to protect our methods and/or products and/or product candidates from competition, which

may negatively affect our business as well as limit our partnership or acquisition appeal.

may be subject to competition despite the existence of intellectual property we license or own or may in the future own.

no assurances that our intellectual property claims will be sufficient to prevent third parties from designing around patents we own

or license and developing and commercializing competitive products.

The existence of competitive products that avoid our intellectual

property could materially adversely affect our operating results and financial condition.

Furthermore, limitations, or perceived limitations,

in our intellectual property may limit the interest of third parties to partner, collaborate or otherwise transact with us, if third

parties perceive a higher than acceptable risk to commercialization of our methods and/or products and/or product candidates or future

products and/or product candidates.

may elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade dress,

copyrights, trade secrets, domain names or other intellectual property rights that we either own or license from a third party.

do not prevail in enforcing our intellectual 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.

A third party may also challenge the validity, enforceability, or scope

of the intellectual property rights that we license or own and the result of these challenges may narrow the scope or claims of or invalidate

patents that are integral to our products and/or product candidates in the future.

There can be no assurance that we will be able to successfully

defend patents we own or license in an action against third parties due to the unpredictability of litigation and the high costs associated

with intellectual property litigation, amongst other factors.

property rights may be less extensive and enforcement more difficult in jurisdictions outside of the U.S.

Therefore, we may not be able

to protect our intellectual property and third parties may be able to market competitive products that may use some or all of our intellectual

property rights do not necessarily address all potential threats to our competitive advantage and changes in patent laws or patent jurisprudence

could diminish the value of patents in general, thereby impairing our ability to protect our products.

America Invents Act (“AIA”) has been enacted in the United States, resulting in significant changes to the U.S.

patent system.

An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-to-file”

system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming

the same invention.

A third party that files a patent application in the USPTO after that date but before us could therefore be awarded

a patent covering an invention of ours even if we had made the invention before it was made by the third party.

This will require us

to be cognizant going forward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly

filing patent applications on our inventions.

Among some of the other changes introduced by the AIA are changes that

limit where a patentee may file a patent infringement suit and provide opportunities for third parties to challenge any issued patent

in the USPTO.

This applies to all of our U.S.

patents, even those issued before March 16, 2013.

Because of a lower evidentiary standard

in USPTO proceedings compared to the evidentiary standard in U.S.

federal courts necessary to invalidate a patent claim, a third party

could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence

would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party may attempt to

use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as

a defendant in a district court action.

The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution

of our patent applications and the enforcement or defense of our issued patents.

Additionally,

Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in

certain circumstances or weakening the rights of patent owners in certain situations.

This is in particular the case in the field of

diagnostic patents based on biomarkers (Mayo v.

Prometheus, 566 U.S.

66 (2012)), where Proteomedix is active.

In addition to increasing

uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect

to the value of patents, once obtained.

Depending on decisions by the U.S.

Congress, the federal courts and the USPTO, the laws and regulations

governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents

and patents that we might obtain in the future.

inability of us to protect our competitive advantage with regard to any of our product candidates may prevent us from successfully monetizing

such product candidate and this could materially adversely affect our business, prospects, financial condition and results of operations.

Related to Healthcare Compliance and Other Regulations

we fail to comply with healthcare regulations, we could face substantial enforcement actions, including administrative, civil, and criminal

penalties and our business, operations and financial condition could be adversely affected.

could be subject to healthcare fraud and abuse laws and health information privacy and security laws of both the federal government and

the states in which we conduct our business.

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.

If our operations are found to be in violation of

any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and

criminal penalties, damages, fines and the curtailment or restructuring of our operations.

Any penalties, damages, fines, curtailment

or restructuring of our operations could adversely affect our ability to operate our business and our financial results.

Although compliance

programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.

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.

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’ 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

implemented, and there have been legal and political challenges to certain aspects of the ACA.

The former Trump administration issued

certain executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA.

Concurrently,

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.

Many of the details regarding the implementation

of the ACA are yet to be determined, and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains

In particular, there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.

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.

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

federal Anti-Kickback Statute, 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;

civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced

by individuals through civil whistleblower and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting,

or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used

a false record or statement material to a false or fraudulent claim to the federal government.;

federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices,

biologics and medical supplies for which payment is available under Medicare, Medicaid or

the Children’s Health Insurance Program, with specific exceptions, to report annually

to the Centers for Medicare & Medicaid Services, or CMS, information related to payments

or other transfers of value made to physicians and teaching hospitals, and applicable manufacturers

and applicable group purchasing organizations to report annually to CMS ownership and investment

interests held by Covered Recipients, as defined at 42 CFR Part 403, Subpart I;

HIPAA which prohibits knowingly

and willfully executing a scheme to defraud any healthcare benefit program including private third-party payors and knowingly and

willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement

in connection with the delivery of or payment for healthcare benefits, items or services, and which also imposes certain requirements

relating to the privacy, security and transmission of individually identifiable health information and certain notification requirements

and criminal and civil penalties for failure to comply with those requirements;

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.

our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we may

be subject to penalties, including administrative, civil, and criminal penalties, damages, fines and the curtailment or restructuring

of our operations.

Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to

operate our business and our financial results.

Although compliance programs can mitigate the risk of investigation and prosecution for

violations of these laws, the risks cannot be entirely eliminated.

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

Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove

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

ENTADFI and our operating results.

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.

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.

2 unchanged sentences

drugs in Medicare Parts B and D.

The FDA has issued several guidance documents, but

no implementing regulations, on biosimilars.

A number of biosimilar applications have been approved over the past few years.

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

in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price

or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency

measures, and to encourage importation from other countries and bulk purchasing.

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.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine

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.

It is also possible that President Biden will further

reform the ACA and other federal programs in a manner that may impact our operations.

For example, the Biden administration has indicated

that a goal of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible and affordable.

The potential increase in patients covered by government funded insurance may impact our pricing.

Further, it is possible that the Biden

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

initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely continue

to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

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.

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

such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure

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’ 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

the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership.

be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects.

average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding

levels and statutory, regulatory and policy changes.

Our employees may engage in misconduct or other

improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us

and harm our reputation.

We are exposed to the risk of employee fraud or

other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory

authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards

we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established

and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities

Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result

in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter employee misconduct, and the

precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in

protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws

or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,

those actions could have a significant impact on our business and results of operations, including the imposition of significant civil,

criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare

and Medicaid, and integrity oversight and reporting obligations.

We may rely on government funding and collaboration with government

entities for our vaccine development, which adds uncertainty to our research and development efforts and may impose requirements that

increase the costs of development, commercialization and production of any programs developed under those government-funded programs.

Because we anticipate the resources necessary to develop our vaccine

product candidates will be substantial, we may explore funding and development collaboration opportunities with the U.S.

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.

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.

If we received such grants or agreements, we may

not have the right to prohibit the U.S.

government from using certain technologies developed by us, and we may not be able to prohibit

third-parties, including our competitors, from using those technologies in providing products and services to the U.S.

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.

employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,

which could cause significant liability for us and harm our reputation.

are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA regulations or similar

regulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign regulatory authorities,

comply with manufacturing standards we have established, comply with federal and state healthcare fraud and abuse laws and regulations

and similar laws and regulations established and enforced by comparable foreign regulatory authorities, report financial information

or data accurately or disclose unauthorized activities to us.

It is not always possible to identify and deter employee misconduct, and

the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses

or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such

laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our

rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant

civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such

as Medicare and Medicaid, and integrity oversight and reporting obligations.

may rely on government funding and collaboration with government entities for our product development, which adds uncertainty to our

research and development efforts and may impose requirements that increase the costs of development, commercialization and production

of any programs developed under those government-funded programs.

we anticipate the resources necessary to develop our products and/or product candidates will be substantial, we may explore funding and

development collaboration opportunities with the U.S.

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 products and/or 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

and grants funded by the U.S.

government 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.

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;

criminal or civil remedies under the False Claims Act, False Statements Act, and similar

remedy provisions specific to government agreements;

the government’s financial liability to amounts appropriated by the U.S.

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.

we received such grants or agreements, we may not have the right to prohibit the U.S.

government from using certain technologies developed

by us, and we may not be able to prohibit 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.

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:

(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 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

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.

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

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.

we would be subject to the U.S.

government’s exercise such march-in rights, we may receive compensation that is deemed reasonable

government in its sole discretion, which may be less than what we might be able to obtain in the open market.

Additionally,

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

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

obligations, not all of the aforementioned obligations may be applicable to us unless and only to the extent that we receive a government

grant, contract or other agreement.

However, as an organization, we are relatively new to government contracting and new to the regulatory

compliance obligations that such contracting entails.

If we were to fail to maintain compliance with those obligations, we may be subject

to potential liability and to termination of our contracts, which may have a materially adverse effect on our ability to develop our vaccine

product candidates.

We are subject to U.S.

and certain foreign export and import

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.

We are subject to export control and import laws

and regulations, including the U.S.

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

manufacturers for products covered by

such intellectual property.

we may need to comply with some of these obligations, not all of the aforementioned obligations may be applicable to us unless and only

to the extent that we receive a government grant, contract or other agreement.

However, as an organization, we are relatively new to

government contracting and new to the regulatory compliance obligations that such contracting entails.

If we were to fail to maintain

compliance with those obligations, we may be subject to potential liability and to termination of our contracts, which may have a materially

adverse effect on our ability to develop our products and/or product candidates.

are subject to U.S.

and certain foreign export and import 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.

We are subject to export control and import laws and regulations, including

Export Administration Regulations, U.S.

Customs regulations, various economic and trade sanctions

regulations administered by the U.S.

Customs regulations, various economic and trade sanctions regulations administered by

Treasury Department’s Office of Foreign Assets Controls, the U.S.

Foreign Corrupt Practices

Act of 1977, as amended, the U.S.

Foreign Corrupt Practices Act of 1977, as amended, the

domestic bribery statute contained in 18 U.S.C.

§ 201, the U.S.

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.

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 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.

Risks Related to Owning our Common Stock

The market price of our common stock has been extremely volatile

and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their

The market price of our common stock may be highly

The market price of our common stock has

been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could

lose all or part of their investment.

The market price of our common

stock may be highly volatile.

Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:

whether we achieve our anticipated corporate objectives;

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 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 against us;

regulatory and reimbursement developments in the United States and abroad;

future sales of our common stock;

● whether we achieve our anticipated

corporate objectives;

● actual or anticipated fluctuations

in our financial condition and operating results;

● changes in financial or operational

estimates or projections;

● 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 and product components, including their ability to comply with regulatory requirements;

● 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

● 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

● product liability claims;

healthcare reform measures in the United States;

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 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

● healthcare reform measures

in the United States;

● 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 February 14, 2023 and December 21, 2023, the closing

price of our common stock on Nasdaq was $1.56 and $0.18, respectively, and daily trading volume on these days was approximately 90,326,500

and 534,300 shares, respectively.

Additionally, our intraday trading prices have experienced extreme fluctuation.

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.

Additionally, these and other external factors have

caused and may continue to cause the market price and demand for our common stock to fluctuate, which may limit or prevent investors from

readily selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock.

While the market price

of our common stock may respond to developments regarding operating performance and prospects, expansion plans, developments regarding

our participation in direct contracting, the impacts of COVID-19, and developments regarding our industry, we believe that the extreme

volatility we experienced in recent periods reflects market and trading dynamics unrelated to our underlying business, our actual or expected

operating performance, our financial condition, or macro or industry fundamentals, and we do not know if these dynamics will continue

or how long they will last .

Under these circumstances, we caution you against investing in our common stock, unless you are prepared

to incur the risk of losing all or a substantial portion of your investment.

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.

Additionally, these and other external factors have caused and may continue to cause

the market price and demand for our common stock to fluctuate, which may limit or prevent investors from readily selling their shares

of common stock and may otherwise negatively affect the liquidity of our common stock.

While the market price of our common stock may

respond to developments regarding operating performance and prospects, expansion plans, developments regarding our participation in direct

contracting, and developments regarding our industry, we believe that the extreme volatility we experienced in recent periods reflects

market and trading dynamics unrelated to our underlying business, our actual or expected operating performance, our financial condition,

or macro or industry fundamentals, and we do not know if these dynamics will continue or how long they will last.

Under these circumstances,

we caution you against investing in our common stock, unless you are prepared to incur the risk of losing all or a substantial portion

of your investment.

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,

and in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class

action litigation.

The market price of our securities

may be volatile, and in the past, companies that have experienced volatility in the market price of their securities have been subject

to securities class action litigation.

We may be the target of this type of litigation in the future.

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,

to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers, other employees

or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in 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, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.

Our Amended and Restated Certificate of Incorporation

requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,

other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in

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.

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.

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

or be sustained.

Prior to the commencement of trading of our common

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.

Further, an inactive market may also impair our

ability to raise capital by selling shares of our common stock may impair our ability to enter into strategic partnerships or acquire

companies or products by using our shares of common stock as consideration.

Our principal stockholders and management own a significant percentage

of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to stockholders

for approval.

As of March 6, 2023, our officers and directors,

together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 10,403,600

shares of our common stock, which in the aggregate represents approximately 65.4% of the outstanding shares of our common stock.

result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted

to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate

of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.

These actions may be taken even if they are opposed by other stockholders.

This concentration of ownership may also have the effect of

delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could

prevent our stockholders from receiving a premium for their shares.

Some of these persons or entities who make up our principal stockholders

may have interests different from yours.

There can be no assurance that we will be able to comply with

the continued listing standards of Nasdaq.

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

its exchange for failure to meet the listing standards, we and our stockholders could face significant material adverse consequences including:

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 limited amount of analyst coverage;

a decreased ability to issue additional securities or obtain additional financing in the future.

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.

We may have violated Section 13(k) of the

Exchange Act (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.

Section 13(k) of

the Exchange Act provides that it is unlawful for a company that has a class of securities registered under Section 12 of the

Exchange Act to, directly or indirectly, including through any subsidiary, extend or maintain credit in the form of a personal loan

to or for any of its directors or executive officers.

In the fiscal year ended December 31, 2022 and the nine months ended September 30,

2023, we paid certain expenses of our former Chief Executive Officer and Chairman of the Board, which may be deemed to be personal loans

made by us to our former Chief Executive Officer and Chairman of the Board that are not permissible under Section 13(k) of the

Exchange Act.

Specifically, after a review completed by the Audit Committee, it was determined

that our former CEO and an accounting employee charged certain personal expenses on their corporate credit cards that were not recorded

as related party receivables.

The aggregate amount of such unauthorized charges ranged from approximately (i) $257,000 to $405,000 for

all of 2022, (ii) $86,000 to $122,000 for the quarter ended March 31, 2023 and (iii) $79,000 to $150,000 for the quarter ended June 30,

The accounting employee was also the CEO’s assistant and had roles in the Company’s system of internal control over

financial reporting, including controls relating to the Company’s corporate credit cards.

Issuers that are found to

have violated Section 13(k) of the Exchange Act may be subject to civil sanctions, including injunctive remedies and monetary

penalties, as well as criminal sanctions.

The imposition of any of such sanctions on us could have a material adverse effect on our business,

financial position, results of operations or cash flows.

If we fail to maintain

proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated,

or that additional material weaknesses will not occur in the future.

are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and Nasdaq rules and regulations.

Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control

over financial reporting.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports

and, together with adequate disclosure controls and procedures, is designed to prevent fraud.

We must perform system and process evaluation

and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal

controls over financial reporting in our Annual Report on Form 10-K for each year, as required by Section 404 of the Sarbanes-Oxley Act

(“Section 404”).

This requires significant management efforts and requires us to incur substantial professional fees

and internal costs to expand our accounting and finance functions.

Any failure to implement required new or improved controls, or difficulties

encountered in their implementation, could cause us to fail to meet our reporting obligations.

In addition, any testing by us, as and

when required, conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting

firm, as and when required, may reveal deficiencies in our internal controls over financial reporting that are deemed to be significant

deficiencies or material weaknesses or that may require prospective or retroactive changes to our financial statements, or may identify

other areas for further attention or improvement.

Furthermore, we cannot be certain that our efforts will be sufficient to remediate or

prevent future material weaknesses or significant deficiencies from occurring.

do not yet have effective disclosure controls and procedures, or internal controls over all aspects of our financial reporting.

Specifically,

we have identified the following control deficiencies which we believe are material weaknesses.

● We did not maintain an effective control environment as there

was an inadequate segregation of duties with respect to certain cash disbursements.

The processing and the approval for payment of credit

card transactions and certain bank wires were being handled by the former CEO and an accounting employee, and the accounting employee

was responsible for the reconciliation of credit card statements and bank statements.

This allowed these individuals to submit unauthorized

payments to unauthorized third parties.

● We do not have an effective risk assessment process or effective monitoring

of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application

of our controls.

● Our controls over the approval and reporting of expenses

paid with the Company’s credit cards and certain bank wires were not designed and maintained to achieve the Company’s objectives.

● We have insufficient accounting resources to maintain adequate segregation of duties, maintain

adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process

financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare

financial statements.

● We do not yet have adequate internal controls in place for

the timely identification, approval or reporting of related party transactions.

● The Company did not design, implement, and maintain effective controls

to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate the risks to the achievement

of IT objectives and ITGCs in the change management, logical security and computer operations domains.

Specifically, the design and implementation

of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring controls of excessive

user access and elevated privileged access to financial applications and data were not appropriately designed and maintained.

these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an IT control environment vulnerable

to breaches and social engineering persuasion.

cannot provide assurances that these weaknesses will be effectively remediated, or that additional material weaknesses will not occur

in the future.

a result of the material weaknesses in our internal controls over financial reporting described above, and other matters raised or that

may in the future be raised by the SEC, we may face for the prospect of litigation or other disputes which may include, among others,

claims invoking the federal and state securities laws, contractual claims or other claims arising from the material weaknesses in our

internal control over financial reporting and the preparation of our financial statements, any of which claims could result in adverse

effects to our business.

As of the date hereof, we have no knowledge of any such litigation or dispute.

Our Amended and Restated Certificate of

Incorporation requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors,

officers, other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery

in 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, which may have the effect of discouraging lawsuits against our directors, officers, other

employees or stockholders.

Our Amended and Restated

Certificate of Incorporation requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against

our directors, officers, other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in

the Court of Chancery in 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.

Our Amended and Restated

Certificate of Incorporation provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable

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 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.

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 or be sustained.

Prior to the commencement

of trading of our common 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.

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 ability to raise capital by selling shares of our common stock may impair our ability to enter into strategic partnerships

or acquire companies or products by using our shares of common stock as consideration.

Our principal stockholders and management

own a significant percentage of our capital stock and will be able to exert a controlling influence over our business affairs and matters

submitted to stockholders for approval.

As of April 5, 2024, our officers and directors, together with holders

of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 5,766,959 shares of our common

stock, which in the aggregate represents approximately 26.0% of the outstanding shares of our common stock.

As a result, if some of these

persons or entities act together, they will have the ability to exercise significant influence over matters submitted to our stockholders

for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate of Incorporation and

Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.

These actions may

be taken even if they are opposed by other stockholders.

This concentration of ownership may also have the effect of delaying or preventing

a change of control of our company or discouraging others from making tender offers for our shares, which could prevent our stockholders

from receiving a premium for their shares.

Some of these persons or entities who make up our principal stockholders may have interests

different from yours.

There can be no assurance that we will be

able to comply with the continued listing standards of Nasdaq.

Our continued eligibility

for listing on Nasdaq depends on our ability to comply with Nasdaq’s continued listing requirements.

On September 18, 2023, we

received notice from Nasdaq staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business

days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq,

as set forth in Nasdaq Listing Rule 5550(a)(2).

We have 180 days from September 18, 2023, or through March 16, 2024, to regain compliance

with the Bid Price Rule.

On March 13, 2024, we submitted a plan of compliance to Nasdaq to discuss our plans to evidence compliance with

the Bid Price Rule and we received an additional 180-day period, or until September 16, 2024, to regain compliance with the Bid Price Rule.

If Nasdaq delists our common

stock from trading on its exchange for failure to meet the Bid Price Rule or any other listing standards, we and our stockholders could

face significant material adverse consequences including:

● 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 limited amount of analyst

● 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

become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer

practices in connection with transactions in penny stocks.

Penny stocks are generally equity securities with a price of less than $5.00,

other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems,

provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system.

If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny

The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to

deliver a standardized risk disclosure document containing specified information.

In addition, the penny stock rules require that before

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;

The SEC has adopted rules

that regulate broker-dealer practices in connection with transactions in penny stocks.

Penny stocks are generally equity securities with

a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain

automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided

by the exchange or system.

If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common

stock will be deemed a penny stock.

The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise

exempt from those rules, to deliver a standardized risk disclosure document containing specified information.

In addition, the penny stock

rules require that before 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;

(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

our stock price to decline.

If we or our existing stockholders, directors and

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 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.

If we or our existing stockholders,

directors and 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 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 22,324,576 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 2,330,640 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 1,322,504

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.

The issuance or conversion of securities

would result in significant dilution in the equity interest of existing shareholders and adversely affect the marketplace of the securities.

The issuance or conversion

of common shares or other securities convertible into common shares would result in significant dilution in the equity interest of existing

shareholders and adversely affect the market price of the common shares.

We have issued 3,000 shares of Series A Preferred Stock to Veru

which are initially convertible one year from issuance, in the aggregate, into 5,709,935 shares of the Company’s common stock, subject

to adjustment and certain shareholder approval limitations specified in the Certificate of Designations.

We have issued 2,696,729

shares of Series B Preferred Stock to former shareholders of Proteomedix which are initially convertible, in the aggregate, into

269,672,900 shares of the Company’s common stock, subject to adjustment and certain

shareholder approval limitations specified in the Certificate of Designations.

CFIUS may delay, prevent or impose conditions

on the Conversion.

CFIUS has authority to review

certain direct or indirect foreign investments in U.S.

businesses for national security considerations.

Among other things, CFIUS is authorized

to require mandatory filings for certain foreign investments in the United States and to self-initiate national security reviews of certain

foreign direct and indirect investments in U.S.

businesses if the parties to such investments choose not to file voluntarily.

to transactions that CFIUS determines present unresolved national security concerns, CFIUS has the power to suspend transactions, impose

mitigation measures or recommend that the President of the United States block pending transactions or order divestitures of completed

transactions when national security concerns cannot be mitigated.

Whether CFIUS has jurisdiction to review an acquisition or investment

transaction depends on, among other factors, the nature and structure of the transaction, whether the target company is a U.S.

the level of beneficial ownership and voting interests acquired by foreign persons, and the nature of any information, control, access

or governance rights that the transaction affords foreign persons.

For example, any transaction that could result in foreign “control”

(as such term is defined in the CFIUS regulations) of a U.S.

business is within CFIUS’s jurisdiction.

In addition, CFIUS has jurisdiction

over certain investments that do not result in control of a U.S.

business by a foreign person but that afford a foreign person certain

access, involvement or governance rights in a “TID U.S.

business,” that is, a U.S.

business that:

(1) produces, designs, tests,

manufactures, fabricates, or develops one or more “critical technologies;” (2) owns, operates, manufactures, supplies or services

certain “critical infrastructure;” or (3) maintains or collects, directly or indirectly, “sensitive personal data”

Certain entities or individuals associated with

or otherwise involved in the transaction are, are controlled by or have substantial ties with a non-U.S.

Specifically, each of

Schiess and Mr.

Brühlmann is a “foreign person” (as such term is defined in 31 C.F.R.

CFIUS has broad discretion to interpret its regulations,

and we cannot predict whether CFIUS may seek to review the Conversion.

If CFIUS reviews the Conversion and identifies an unresolved national

security concern as part of such review, CFIUS could recommend that the President of the United States order one or more foreign persons

to divest all or a portion of the Common Stock that they acquired without first obtaining CFIUS approval.

Moreover, should CFIUS determine

that any parties to the Conversion were required to make a filing with CFIUS but failed to do so, CFIUS could impose a civil penalty not

to exceed $250,000 or the value of the relevant transaction, whichever is greater, on the parties it determines were subject to a mandatory

filing requirement.

Onconetix and Proteomedix will submit to CFIUS

a joint declaration or notice with respect to the PMX Transaction upon the request of CFIUS, but Onconetix has determined to not exercise

its right to elect to submit such a joint declaration or notice of its own initiative.

If we fail to maintain an effective

system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to

regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline.

Effective internal controls

required under Section 404 of the Sarbanes-Oxley Act are necessary for us to provide reliable financial reports and effectively prevent

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

Any failure to implement the 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.

Inferior internal

controls could also harm our reputation and cause investors to lose confidence in our reported financial information, which could have

a negative impact on the trading price of our stock.

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, 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.

We are subject to increased costs as a result of operating as

a public company, and our management is required to devote substantial time to new compliance initiatives.

As a public company, we incur significant legal,

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.

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

company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting

or internal audit staff.

The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control

over financial reporting.

We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure

that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported

within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Securities

Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive and financial officers.

Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial

reporting may be discovered in the future.

Any failure to develop or maintain effective controls when we become subject to this requirement

could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation

reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic

reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results,

cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements.

In the event that

we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived

as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating

results and the price of our common stock could decline.

In addition, if we are unable to continue to meet these requirements, we may

not be able to remain listed on Nasdaq.

The rules and regulations applicable to public companies

have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.

requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect

on our business, financial condition, and results of operations.

The increased costs will decrease our net income and may require us to

reduce costs in other areas of our business or increase the prices of our products or services.

For example, these rules and regulations

made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial

costs in the future to maintain the same or similar coverage.

We cannot predict or estimate the amount or timing of additional costs we

may incur to respond to these requirements.

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, 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

“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 a public company, and our management is required to devote substantial time to new compliance initiatives.

As a public company, we incur significant legal, 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.

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

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 company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring

new accounting or internal audit staff.

The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures

and internal control over financial reporting.

We are continuing to develop and refine our disclosure controls and other procedures that

are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed,

summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports

under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive

and financial officers.

Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal

control over financial reporting may be discovered in the future.

Any failure to develop or maintain effective controls when we become

subject to this requirement could negatively impact the results of periodic management evaluations and annual independent registered public

accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting that we may be required

to include in our periodic reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley

Act, harm our operating results, cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial

In the event that we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial

reporting is perceived as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence

in our operating results and the price of our common stock could decline.

In addition, if we are unable to continue to meet these requirements,

we may not be able to remain listed on Nasdaq.

The rules and regulations applicable to public companies have substantially

increased our legal and financial compliance costs and make some activities more time-consuming and costly.

If these requirements divert

the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business,

financial condition, and results of operations.

The increased costs will decrease our net income and may require us to reduce costs in

other areas of our business or increase the prices of our products or services.

For example, these rules and regulations made it more

difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs

in the future to maintain the same or similar coverage.

We cannot predict or estimate the amount or timing of additional costs we may

incur to respond to these requirements.

The impact of these requirements could also make it more difficult for us to attract and retain

qualified persons to serve on our board of directors, our board committees or as executive officers.

Our management team has limited experience managing a public

Most members of our management team have limited

experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws

pertaining to public companies.

Our management team may not successfully or efficiently manage our transition to being a public company

subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of

securities analysts and investors.

These new obligations and constituents require significant attention from our senior management and

could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial

Our management team has limited experience

managing a public company.

Several members of our management

team have limited experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly

complex laws pertaining to public companies.

Our management team may not successfully or efficiently manage our transition to being a

public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous

scrutiny of securities analysts and investors.

These new obligations and constituents require significant attention from our senior management

and could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial

condition and operating results.

If we fail to maintain an effective system of internal controls,

we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our

business and operating results and cause the trading price of our stock to decline.

Effective internal controls required under Section

404 of the Sarbanes-Oxley Act, are necessary for us to provide reliable financial reports and effectively prevent fraud.

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.

Inferior internal controls could also harm

our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the

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.

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.

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

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.

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.

In addition, 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.

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 or similar disruptive problems.

Proclarix is comprised of

two components:

Proclarix Assays and Proclarix Risk Calculator.

The Proclarix Risk Calculator is cloud-based software to integrate the

results from Proclarix Assays for THBS1 and CTSD together with age, total and free PSA (from third party manufacturers) to calculate the

Proclarix Risk Score.

When entering the Patient ID, a warning indicates that the Patient ID shall not contain any sensitive personal patient

After the risk report is generated, the patient data including values for THBS1, CTSD, total and free PSA together with age and

Patient ID is stored for six months and is then automatically deleted.

High-profile security breaches and incidents at other companies and

in government agencies have increased in recent years, particularly in the healthcare sector, 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 disclose 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 also may accommodate remote workers and therefore

may be more susceptible to security breaches and other security incidents.

We have experienced and may in the future experience attempted or successful

cyber-attacks of our IT systems or networks.

1 unchanged sentence

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;

or incident 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, rendered inaccessible or unavailable, corrupted, or stolen.

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, 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 patients;

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

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 liability under laws that

protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”), similar U.S.

privacy and security laws and regulations, and other regulations, as well as in legal claims, complaints, regulatory investigations or

proceedings, significant fines or other penalties, or the requirement to enter into a multi-year settlement and remediation agreement

with federal or state agencies.

We also may be required to incur significant costs in an effort to prevent, detect, and remediate 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, consultants, collaborators, and service providers also may suffer

interruptions and disruptions of systems and other breaches, incidents, or other compromises of their IT systems or data that they process

or maintain for us, which may lead to any of the foregoing.

3 unchanged sentences

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

Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control,

which may cause our stock price to decline.

application of consumer or health related data security, privacy and 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 Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent

a change in control, which may cause our stock price to decline.

Our Amended and Restated

Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire

us, even if closing such a transaction would be beneficial to our stockholders.

Our Amended and Restated Certificate of Incorporation

and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing such

a transaction would be beneficial to our stockholders.

Our Amended and Restated Certificate of Incorporation authorizes us to issue up

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

at the time of issuance by our board of directors without further action by stockholders.

The terms of any series of preferred stock may

include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion

and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially adversely affect the rights of

the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future

holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve

control by the present management.

Provisions of our Amended and Restated Certificate

of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals

or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable.

provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management.

In particular, our Amended

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;

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.

These provisions, alone or together, could delay

or prevent hostile takeovers and changes in control or changes in our management.

As a Delaware corporation, we are also subject to

provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain stockholders holding

more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of the holders of at least

two-thirds of our outstanding common stock not held by such stockholder.

Any provision of our Amended and Restated Certificate

of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing or deterring a change in control

could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the

price that some investors are willing to pay for our common stock.

We do not anticipate paying any cash dividends on our common

stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the

foreseeable future.

We have never declared or paid cash dividends on

our common stock.

authorizes us to issue up 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 at the time of issuance by our board of directors without further action by stockholders.

The terms of any

series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to

dividend, liquidation, conversion and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially

adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific

rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third

party and thereby preserve control by the present management.

Provisions of our Amended

and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging

potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder

might consider favorable.

Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management.

In particular, our Amended 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;

● 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.

These provisions, alone or

together, could delay or prevent hostile takeovers and changes in control or changes in our management.

As a Delaware corporation,

we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain

stockholders holding more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of

the holders of at least two-thirds of our outstanding common stock not held by such stockholder.

Any provision of our Amended and Restated Certificate of Incorporation,

Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing, or deterring a change in control could limit

the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the price that

some investors are willing to pay for our common stock.

We do not anticipate paying any cash dividends

on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source

of gain for the foreseeable future.

We have never declared or

paid cash dividends on our common stock.

We do not anticipate paying any cash dividends on our common stock in the foreseeable future.

We currently intend to

retain all available funds and any future earnings to fund the development and growth of our business.

In addition, and any future loan

arrangements we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our common

As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of gain for the

foreseeable future.

We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.

any future loan arrangements we enter into may contain terms prohibiting or limiting the amount of dividends that may be declared or paid

on our common stock.

As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of

gain for the foreseeable future.

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.

Investors may purchase our common stock to hedge

existing exposure in our common stock or to speculate on the price of our common stock.

Speculation on the price of our common stock may

involve long and short exposures.

To the extent aggregate short exposure exceeds the number of shares of our common stock available for

purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders

of our common stock.

Those repurchases may in turn, dramatically increase the price of our common stock until investors with short exposure

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

of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common

stock may decline.

Unresolved Staff Comments.

We are currently leasing an office located at 201

E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

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.

From time to time we may be involved in various

disputes and litigation matters that arise in the ordinary course of business.

We are currently not a party to any material legal proceedings.

Mine Safety Disclosures.

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 over time.

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.

Investors may purchase our

common stock to hedge existing exposure in our common stock or to speculate on the price of our common stock.

Speculation on the price

of our common stock may involve long and short exposures.

To the extent aggregate short exposure exceeds the number of shares of our common

stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock

for delivery to lenders of our common stock.

Those repurchases may in turn dramatically increase the price of our common stock until investors

with short exposure 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 of our company and once investors purchase the shares of common stock necessary to cover their short position the price of

our common stock may decline.

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