What changed in this filing

/stocks — the workspaceLOADING

Item 5. Market for Registrant’s Common Equity

2023-03-09 compared with 2022-03-31 · 61 added, 625 removed, 7 unchanged (99% of the section changed)

Market for Registrant’s Common

Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock began trading

on Nasdaq under the symbol “BWV”

on February 18, 2022.

Prior to that date, there was no established public trading market

for our common stock.

As of March 15, 2022, there

were approximately 7 holders of record of our common stock.

This number does not include stockholders who are beneficial owners, but whose

shares are held in street name by brokers and other nominees.

This number of holders of record also does not include stockholders whose

shares may be held in trust by other entities.

Our common stock is traded on Nasdaq under the symbol

As of March 6, 2023, there were approximately 29 holders

of record of our common stock.

This number does not include stockholders who are beneficial owners, but whose shares are held in street

name by brokers and other nominees.

This number of holders of record also does not include stockholders whose shares may be held in trust

by other entities.

Recent Sales of Unregistered Securities

Since October 2018 (our date of inception), we have

made the following sales of unregistered securities:

(1) We granted to certain employees, consultants and directors

options to purchase an aggregate of 780,640 shares (net of certain forfeitures of grants) of our common stock at an exercise price

of $0.01 per share.

(2) We issued an aggregate of 1,146,138 shares of Series

Seed Preferred Stock in July 2019 to 5 accredited investors at a price of $6.09 per share for an aggregate purchase price of $6,979,980,

which converted into 5,626,365 shares of common stock upon the consummation of our initial public offering.

The offers, sales and issuances of the securities

described in paragraph (1) were deemed to be exempt from registration under Rule 701 promulgated under the Securities Act as transactions

under compensatory benefit plans and contracts relating to compensation, or under Section 4(a)(2) of the Securities Act as a transaction

by an issuer not involving a public offering.

The recipients of such securities were our directors, employees or bona fide consultants

and received the securities under our equity incentive plans.

Appropriate legends were affixed to the securities issued in these transactions.

Each of the recipients of securities in these transactions had adequate access, through employment, business or other relationships, to

information about us.

The offers, sales and issuances of the securities

described in paragraph (2) were deemed to be exempt under Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D under

the Securities Act as a transaction by an issuer not involving a public offering.

The recipients of securities in each of these transactions

acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate

legends were affixed to the securities issued in these transactions.

Each of the recipients of securities in these transactions was an

accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act and had adequate access, through employment,

business or other relationships, to information about us.

No underwriters were involved in these transactions.

There are no transactions

that have not been previously included in a Current Report on Form 8-K, aside from the following:

As discussed above, on

October 9, 2022, the Company and Boustead entered into a Settlement Agreement pursuant to which Boustead agreed to waive certain obligations

of the Company under the Underwriting Agreement that was entered into between the two parties in connection with the Company’s IPO

in February 2022.

Pursuant to this agreement, the Company issued to Boustead 93,466 shares of restricted common stock in exchange for

the cancellation of 111,111 warrants issued to Boustead in connection with the IPO.

In addition, the Company and Boustead Capital also

entered into the Advisory Agreement for which consideration equal to 200,000 shares of restricted common stock, with no vesting provisions,

was issued to Boustead Capital upon execution of the Advisory Agreement.

Dividend Policy

As of the date of this Annual

Report on Form 10-K, we have not paid any cash dividends to stockholders.

The declaration of any future cash dividend will be at the discretion

of our board of directors and will depend upon our earnings, if any, our capital requirements and financial position, the general economic

conditions, and other pertinent conditions.

It is our present intention not to pay any cash dividends in the foreseeable future, but rather

to reinvest earnings, if any, in our business operations.

Use of Proceeds from Initial Public Offering

As of the date of this Annual Report on Form 10-K,

we have not paid any cash dividends to stockholders.

The declaration of any future cash dividend will be at the discretion of our board

of directors and will depend upon our earnings, if any, our capital requirements and financial position, the general economic conditions,

and other pertinent conditions.

It is our present intention not to pay any cash dividends in the foreseeable future, but rather to reinvest

earnings, if any, in our business operations.

Issuer Purchases of Equity Securities

On November 10, 2022, the Company’s Board

of Directors approved a share repurchase program to allow for the Company to repurchase up to 5 million shares of common stock, with discretion

to management to make purchases subject to market conditions.

The maximum purchase price is $2.00 per share and there is no expiration

date for this program.

Below is a summary of stock

repurchases for the three months ended December 31, 2022.

See Note 6 of our Notes to Financial Statements for information regarding

our stock repurchase program.

Total Number of Shares

Maximum Number of Shares

Beginning repurchase authority

November 1 – November 30, 2022

Shares repurchased

December 1 - December 31, 2022

Shares repurchased

(1) On November 10, 2022, the Board approved a share repurchase program to allow for the Company

to repurchase up to 5 million shares of the Company’s common stock at a price of $1.00 per share, with discretion to management

to make purchases subject to market conditions.

On November 18, 2022 the Board approved an increase in the price to $2.00 per share.

Initial Public Offering

On February 23, 2022, we completed our initial public

1 unchanged sentence

received net proceeds of $17.1 million, after deducting underwriting discounts and commissions and other offering costs.

use the net proceeds of our IPO to fund our research and development activities, clinical trials and the regulatory review process for

our product candidates, and the remainder for working capital and other general corporate purposes.

The foregoing expected use

of net proceeds from our initial public offering represents our intentions based upon our current plans and business conditions.

the nature, amounts and timing of our actual expenditures may vary significantly depending on numerous factors.

For example, we may also

elect to use proceeds from the initial public offering to acquire complimentary technologies, products or businesses, although we are

not a party to any letters of intent or definitive agreements for any such acquisition.

As a result, our management has and will retain

broad discretion over the allocation of the net proceeds.

We may find it necessary or advisable to use the net proceeds for other purposes,

and we will have broad discretion in the application of net proceeds.

Management’s Discussion and Analysis

of Financial Condition and Results of Operations.

The following discussion

and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the

related notes to those statements included elsewhere in this Annual Report on Form 10-K.

In addition to historical financial information,

the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions.

the numbers included herein have been rounded for the convenience of presentation.

Our actual results may differ materially from those

anticipated in these forward-looking statements as a result of many factors, including those discussed under Part I.

“Item 1A.

Factors”

and elsewhere in this Annual Report on Form 10-K.

We are a biotechnology company focused on the research

and development of transformational vaccines to prevent infectious diseases worldwide.

Our versatile vaccine platform has unique molecular

properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines.

Our lead influenza

(flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins of antigens, with cross-reactive properties,

that enable the potential development of a universal flu vaccine.

We are focused on developing novel vaccines that induce durable and

long-term immunity.

We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines

to improve both health outcomes and quality of life globally.

Since our inception in October 2018, 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, acquiring 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.

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

To date, we have financed our operations primarily with proceeds from our sale of preferred securities to seed investors and the close

of our initial public offering.

We will continue to require additional capital to develop our vaccine candidates and fund operations beyond

the second quarter of 2023.

Accordingly, until such time as we can generate significant revenue from sales of our vaccine candidates,

if ever, we expect to finance our 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.

We have incurred net losses since inception and

expect to continue to incur net losses in the foreseeable future.

Our net losses may fluctuate significantly from quarter-to-quarter and

year-to-year, depending in large part on the timing of our preclinical studies, clinical trials and manufacturing activities, and our

expenditures on other research and development activities.

As of December 31, 2021, the Company had working capital of approximately

$1.4 million and an accumulated deficit of approximately $6.0 million.

We will need to raise additional capital to fund our

planned operations beyond the second quarter of 2023.

While we believe that we can raise additional capital

to fund our planned operations, until we generate revenue sufficient to support self-sustaining cash flows, if ever, we will need to raise

additional capital to fund our continued operations to execute our long-term business plan, including our product development and commercialization

activities related to our current and future products.

There can be no assurance that additional capital will be available to us on acceptable

terms, or at all, or that we will ever generate revenue sufficient to provide for self-sustaining cash flows.

We do not expect to generate any revenue from commercial

product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our vaccine candidates,

which we expect will take a number of years.

We expect our expenses will increase substantially in connection with our ongoing activities,

● advance vaccine candidates through preclinical studies and

clinical trials;

● require the manufacture of supplies for our preclinical studies

and clinical trials;

● pursue regulatory approval of vaccine candidates;

● hire additional personnel;

● operate as a public company;

● acquire, discover, validate and develop additional vaccine

● obtain, maintain, expand and protect our intellectual property

We rely and will continue to rely on third parties

in the conduct of our preclinical studies and clinical trials and for manufacturing and supply of our vaccine candidates.

We have no internal

manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for

our preclinical and clinical trial materials.

Given our stage of development, we do not yet have a marketing or sales organization or

commercial infrastructure.

Accordingly, if we obtain regulatory approval for any of our vaccine candidates, we also expect to incur significant

commercialization expenses related to product sales, marketing, manufacturing and distribution.

Because of the numerous risks and uncertainties

associated with vaccine development, we are unable to predict the timing or amount of increased expenses or when or if we will be able

to achieve or maintain profitability.

Even if we are able to generate revenue from the sale of our vaccines, we may not become profitable.

If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations

at planned levels and may be forced to reduce our operations.

Certain Significant Relationships

We have entered into grant, license and collaboration

arrangements with various third parties as summarized below.

For further details regarding these and other agreements, see the section

titled “Business —

Intellectual Property”

and Note 5 to each of our audited financial statements and

unaudited financial statements included elsewhere in this Report.

Ology Agreement

In July 2019, we entered into a development

and manufacturing master services agreement with Ology Bioservices (which was later acquired by National Resilience, Inc.) (“Ology”),

which we refer to as the Ology Agreement, pursuant to which Ology is obligated to perform manufacturing process development and clinical

manufacture and supply of components.

Under the Ology Agreement, we will pay Ology agreed

upon fees for Ology’s performance of manufacturing services, and we will reimburse Ology for its out-of-pocket costs associated

with purchasing raw materials, plus a customary handling fee.

For additional details regarding our relationship

with Ology, see the section entitled “Business —

Manufacturing and Supply”

and Note 5 to our financial

statements included elsewhere in this Report.

Cincinnati Children’s Hospital Medical Center Agreement

On June 1, 2021, we entered into an exclusive,

worldwide license agreement with Children’s Hospital Medical Center, d/b/a Cincinnati Children’s Hospital Medical Center,

or CHMC, which we refer to as the CHMC Agreement, pursuant to which we obtained the right to develop and commercialize certain CHMC patents

and related technology directed at a virus-like particle (VLP) vaccine platform that utilizes nanoparticle delivery technology, which

may have potential broad application to develop vaccines for multiple infectious diseases.

Under the CHMC Agreement, we agreed to pay CHMC

certain license fees, deferred license fees, development milestone fees, and running royalties beginning on the first net sale (among

For additional details regarding our relationship with CHMC, see the section entitled “Business —

Property —

Exclusive License Agreement with Children’s Hospital Medical Center, d/b/a Cincinnati Children’s

Hospital Medical Center”

included elsewhere in this Report.

The CHMC license includes:

Application No.

Granted Claim Type

Compositions of the vaccine/vaccine platform

Method of treatment

Compositions of the vaccine platform

Pending applications

in Canada, China,

(filed 2/16/2021)

[February 2042] #

(filed 3/17/2021)

[March 2042] #

* Projected expiration if patent issues:

20 years from

earliest non-provisional application filing date.

# Non-provisional application not yet filed.

Expiration projected

21 years from provisional application filing date.

Dependent on timely conversion to non-provisional application and issuance of

** This is a pending application.

Claim type will be determined

prosecution is complete.

The claim type sought includes compositions of the vaccine and vaccine platform.

Oxford University Innovation Limited Agreement

On July 16, 2019, we entered into an exclusive,

worldwide license agreement with Oxford University Innovation Limited, which we refer to as the OUI Agreement, pursuant to which we obtained

the right to develop and commercialize certain licensed technology entitled “Immunogenic Composition.”

Under the OUI Agreement, we agreed to fund three years’

worth of salaries for Dr.

Craig Thompson in the University’

Department of Zoology through a sponsored research agreement with

Oxford University, as well as royalties on all net sales of licensed products, along with certain development and milestone payments (among

For additional details regarding our relationship with OUI, see the section entitled “Business —

Property —

License Agreement Between Oxford University Innovation Limited and Blue Water Vaccines Inc.”

elsewhere in this Report.

The OUI license includes:

Application No.

Granted Claim Type

Compositions and method of treatment

Pending applications in Australia, Canada, China, EU and Japan

* Projected expiration if patent issues:

20 years from

earliest non-provisional application filing date.

** This is a pending application.

Claim type will be determined

prosecution is complete.

The claim type sought includes compositions of the compositions and method of treatment.

Jude Children’s Research Hospital, Inc.

On January 27, 2020, we entered into an exclusive,

worldwide license agreement with St.

Jude Children’s Research Hospital, Inc., which we refer to as the St.

Jude Agreement, pursuant

to which we acquired the right to develop certain licensed products and produce vaccines for use in humans.

Under the St.

Jude Agreement, we agreed to pay an

initial license fee, an annual maintenance fee, milestone payments, patent reimbursement, and running royalties based on the net sales

of licensed products.

For additional details regarding our relationship with St.

Jude, see the section entitled “Business —

Property —

Exclusive License Agreement between St.

Jude Children’s Research Hospital, Inc.

Vaccines”

included elsewhere in this Report.

Jude license includes:

Patent Application No.

Granted Claim Type

Compositions and method of treatment

Pending Applications in:

Australia, Brazil, Canada, China, Europe, Hong Kong, Japan and Korea

* Projected expiration if patent issues:

20 years from

earliest non-provisional application filing date.

National stage entry of WO 2020/183420 (PCT/IB2020/052250).

** This is a pending application.

Claim type will be determined

prosecution is complete.

The claim type sought includes compositions of the compositions and method of treatment.

COVID-19 Impacts

We are continuing to closely monitor the impact

of the global COVID-19 pandemic on our business and are taking proactive efforts designed to protect the health and safety of our employees

and to maintain business continuity.

We believe that the measures we are implementing are appropriate, and we will continue to monitor

and seek to comply with guidance from governmental authorities and adjust our activities as appropriate.

Based on guidance issued by federal,

state and local authorities, we transitioned to a remote work model for a vast majority of our employees in March 2020.

pandemic has resulted in an impact to our development timelines, as the pandemic continues, we could continue to see an impact on our

ability to advance our programs, obtain supplies from our contract manufacturer or interact with regulators, ethics committees or other

important agencies due to limitations in regulatory authority, employee resources or otherwise.

In any event, if the COVID-19 pandemic

continues and persists for an extended period of time, we could experience significant disruptions to our development timelines, which

would adversely affect our business, financial condition, results of operations and growth prospects.

In addition, while the potential economic impact

brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, the pandemic could result in significant

and prolonged disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect

our liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business

and the potential value of our common stock.

The extent of the impact of the COVID-19 pandemic

on our development and regulatory efforts, our ability to raise sufficient additional capital on acceptable terms, if at all, and the

future value of and market for our common stock will depend on future developments that are highly uncertain and cannot be predicted with

confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business

closure requirements in the U.S.

and in other countries, and the effectiveness of actions taken globally to contain and treat COVID-19.

For additional information about risks and uncertainties related to the COVID-19 pandemic that may impact our business, financial condition

and results of operations, see the section titled “Risk Factors.”

Components of Results of Operations

Research and Development Expenses

Substantially all of our research and development

expenses consist of expenses incurred in connection with the development of our product candidates.

These expenses include fees paid to

third parties to conduct certain research and development activities on our behalf, consulting costs, costs for laboratory supplies, product

acquisition and license costs, certain payroll and personnel-related expenses, including salaries and bonuses, employee benefit costs

and stock-based compensation expenses for our research and product development employees and allocated overheads, including information

technology costs and utilities.

We expense both internal and external research and development expenses as they are incurred.

We do not allocate our costs by product candidate,

as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, laboratory

supplies and allocated overhead, and external costs, such as fees paid to third parties to conduct research and development activities

on our behalf, are not tracked by product candidate.

We expect our research and development expenses

to increase substantially for at least the next few years, as we seek to initiate additional clinical trials for our product candidates,

complete our clinical programs, pursue regulatory approval of our product candidates and prepare for the possible commercialization of

such product candidates.

Predicting the timing or cost to complete our clinical programs or validation of our commercial manufacturing

and supply processes is difficult and delays may occur because of many factors, including factors outside of our control.

if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, we

could be required to expend significant additional financial resources and time on the completion of clinical development.

we are unable to predict when or if our product candidates will receive regulatory approval with any certainty.

General and Administrative Expenses

General and administrative expenses consist principally

of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for

legal, consulting, accounting and tax services, including information technology costs, and other general operating expenses not otherwise

classified as research and development expenses.

We anticipate that our general and administrative

expenses will increase as a result of increased personnel costs, expanded infrastructure and higher consulting, legal and accounting services

costs associated with complying with the applicable stock exchange and the SEC requirements, investor relations costs and director and

officer insurance premiums associated with being a public company.

Other income consists primarily of interest income.

Results of Operations

Comparison of the Years Ended December 31, 2021 and

The following table summarizes our statements of

operations and comprehensive loss for the periods indicated:

Operating costs and expenses

General and administrative

Research and development

Total operating expenses

Loss from operations

Interest income

Total other income

$ (3,417,334 )

$ (1,599,466 )

General and Administrative Expenses

For the year ended December 31, 2021, general

and administrative expenses increased by $1.0 million compared to 2020.

The increase was mainly due to an increase in discretionary

bonus compensation of approximately $0.5 million, an increase in audit and accounting services of $0.3 million, and increases

in other business activities and expenses such as public relations, travel expenses, and franchise tax fees, which each increased $0.1 million.

These increases were partially offset by a decrease in wages and stock-based compensation of approximately $0.1 million.

Research and Development Expenses

For the year ended December 31, 2021, research

and development expenses increased by approximately $0.8 million compared to 2020.

The increase was primarily attributable to an

increase in licensing fees and patent reimbursements of approximately $0.3 million related mainly to BWV-301 and BWV-302, an

increase in preclinical development activities of approximately $0.4 million mainly related to BWV-201, and an increase in research

and development personnel costs of approximately $0.2 million.

These increases were partially offset by a decrease in stock-based

compensation of approximately $0.2 million.

For the year ended December 31, 2021, other

income decreased by $23,000 compared to 2020.

The decrease was primarily due to decrease in interest income after transitioning our bank

account from a money market account to a business checking account.

Liquidity and Capital Resources

Since inception, we have devoted substantially all

of our efforts to research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product

development efforts, hiring personnel, acquiring 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.

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

We have incurred net losses in each

year since inception and expect to continue to incur net losses in the foreseeable future.

Our net loss was $3.4 million for the

year ended December 31, 2021.

As of December 31, 2021, we had an accumulated deficit of $6.0 million.

We also generated

negative operating cash flows of $2.0 million for the year ended December 31, 2021.

On February 23, 2022, we completed our IPO

in which we received approximately $17.2 million in net proceeds, after deducting the underwriting discount, and estimated offering

We believe the existing cash at December 31,

2021, together with the net proceeds received upon the close of our initial public offering, will be sufficient to continue operations,

satisfy our obligations and fund the future expenditures that will be required to conduct the clinical and regulatory work to develop

our product candidates into the second quarter of 2023.

However, we will require significant amounts of

additional capital to continue to fund our operations in the long term and complete our research and development activities.

We will continue

seeking additional financing sources to meet our working capital requirements, make continued investment in research and development and

make capital expenditures needed for us to maintain and expand our business.

We may not be able to obtain additional financing on terms

favorable to us, if at all.

If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it,

or if we expend capital on projects that are not successful, our ability to continue to support our business growth and to respond to

business challenges could be significantly limited, or we may even have to cease our operations.

If we raise additional funds through

further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity

securities we issue could have rights, preferences and privileges superior to those of holders of our common stock.

Future Funding Requirements

Our primary uses of cash are to fund our operations,

which consist primarily of research and development expenditures related to our programs and general and administrative expenditures.

We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance our vaccine candidates,

expand our corporate infrastructure, including the costs associated with being a public company and further our research and development

initiatives for our vaccine candidates.

We are subject to all of the risks typically related to the development of new drug candidates,

and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our

We anticipate that we will need substantial additional funding in connection with our continuing operations in order to execute

our long term business plan.

We estimate that, based on our existing cash as

of December 31, 2021, together with the net proceeds received from the initial public offering, we have cash on hand sufficient to fund

our operations into the second quarter of 2023.

We will need to raise additional capital prior to commencing additional pivotal trials

for certain of our vaccine candidates.

Until we can generate a sufficient amount of revenue from the commercialization of our vaccine

candidates or from collaboration agreements with third parties, if ever, we expect to finance our future 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.

The future sale of equity

or convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible

debt, those securities could provide for rights, preferences or privileges senior to those of our common stock.

Debt financings may subject

us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt, making capital

expenditures or declaring dividends.

Our ability to raise additional funds may be adversely impacted by deteriorating global economic

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

from the ongoing COVID-19 pandemic.

There can be no assurance that we will be successful in acquiring additional funding at levels sufficient

to fund our operations or on terms favorable or acceptable to us.

If we are unable to obtain adequate financing when needed or on terms

favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development

Our future capital requirements will depend on many

factors, including:

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

and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials, including any impacts related

to the COVID-19 pandemic;

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

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

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

regarding the data required to support a marketing application;

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

product commercialization;

● the costs of future commercialization activities, including

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

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

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

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

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

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

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

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

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

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

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

property rights;

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

● the costs of operating as a public company;

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

the magnitude of the factors discussed above.

A change in the outcome of any of these or other

variables could significantly change the costs and timing associated with the development of our vaccine candidates.

Furthermore, our

operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated

with such change.

The following table summarizes our cash flows for

the periods indicated:

Net cash used in operating activities

Net cash used in investing activities

Net cash used in financing activities

Net decrease in cash

Cash Flows from Operating Activities

Net cash used in operating activities for the year

ended December 31, 2021 was $2.0 million, which primarily resulted from a net loss of $3.4 million, and was partially offset

by a net change in our operating assets and liabilities of $1.2 million and stock-based compensation of $0.1 million.

Net cash used in operating activities for the year

ended December 31, 2020 was $1.7 million, which primarily resulted from a net loss of $1.6 million and a net change in

our operating assets and liabilities of $0.5 million, partially offset by stock-based compensation of $0.3 million.

Cash Flows from Investing Activities

Net cash used in investing activities for the years

ended December 31, 2021 and 2020 was $2,000 and $12,000, respectively, which resulted from purchases of property and equipment.

Cash Flows from Financing Activities

Net cash used in financing activities for the year

ended December 31, 2021 and 2020, was $0.3 million related to payments of deferred offering costs and $0, respectively.

Legal Contingencies

From time to time, we may become involved in legal

proceedings arising from the ordinary course of business.

We record a liability for such matters when it is probable that future losses

will be incurred and that such losses can be reasonably estimated.

Off-Balance Sheet Arrangements

During the periods presented we did not have, nor

do we currently have, any off-balance sheet arrangements as defined in the rules and regulations of the SEC.

Recent Accounting Pronouncements Not Yet Adopted

See Note 3 to our financial statements included

elsewhere in this Report for more information.

Critical Accounting Policies and Estimates

Our financial statements have been prepared in accordance

generally accepted accounting principles (“U.S.

GAAP”).

The preparation of these financial statements

requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of

contingent assets and liabilities in our financial statements.

On an ongoing basis, we evaluate our estimates and judgments, including

those related to accrued research and development expenses fair value of common stock and stock-based compensation.

We base our estimates

on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent

from other sources.

Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described

in more detail in Note 3 to our financial statements included elsewhere in this Report, we believe the following accounting policies

and estimates to be most critical to the judgments and estimates used in the preparation of our financial statements.

Accrued Research and Development Expenses

We have entered into various agreements with contract

manufacturing organizations, or CMOs, and may enter into contracts with clinical research organizations, or CROs, in the future.

of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses as of

each balance sheet date.

This process involves reviewing open contracts and purchase orders, communicating with our personnel and third

parties to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost

incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost.

We make estimates of our accrued

research and development expenses as of each balance sheet date based on facts and circumstances known to us at that time.

We periodically

confirm the accuracy of our estimates with the service providers and make adjustments, if necessary.

The significant estimates in our

accrued research and development expenses include the costs incurred for services performed by our vendors in connection with research

and development activities for which we have not yet been invoiced.

We accrue for costs related to research and development activities

based on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors, including CMOs, that

conduct research and development on our behalf.

The financial terms of these agreements are subject to negotiation, vary from contract

to contract and may result in uneven payment flows.

There may be instances in which payments made to our vendors will exceed the level

of services provided and result in a prepayment of the research and development expense.

Advance payments for goods and services that

will be used in future research and development activities are expensed when the activity has been performed or when the goods have been

We make significant judgments and estimates in determining accrued research and development liabilities as of each reporting

period based on the estimated time period over which services will be performed and the level of effort to be expended.

If the actual

timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense accordingly.

Although we do not expect our estimates to be materially

different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status

and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period.

there have been no material differences between our estimates of such expenses and the amounts actually incurred.

Stock-Based Compensation

The Company expensed stock-based compensation to

employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards.

awards to employees with graded-vesting schedules are recognized, using the accelerated attribution method, on a straight-line basis over

the requisite service period for each separately vesting portion of the award.

The Company estimates the fair value of stock option

grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent

management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

Expected Term —

The expected term of options represents the period

that the Company’s stock-based awards are expected to be outstanding based on the simplified method, which is the half-life

from vesting to the end of its contractual term.

Expected Volatility —

The Company computes stock price volatility over

expected terms based on comparable companies historical common stock trading prices.

Common Stock Fair Value —

The fair value of the common stock

underlying the Company’s stock options was estimated at each grant date and was determined with the assistance of an

independent third-party valuation expert.

The assumptions underlying these valuations represented management’s best estimates,

which involved inherent uncertainties and the application of significant levels of management judgment.

Risk-Free Interest Rate —

The Company bases the risk-free interest

rate on the implied yield available on U.S.

Treasury securities with a remaining term commensurate with the estimated expected

Expected Dividend —

The Company has never declared or paid any cash

dividends on its common shares and does not plan to pay cash dividends in the foreseeable future, and, therefore, uses an expected

dividend yield of zero in its valuation models.

The Company recognizes forfeitures of equity awards

as they occur.

Fair value of common stock

In order to determine the fair value of shares of

common stock of the Company when issuing stock options and computing their estimated stock-based compensation expense, its board of directors

considered with input from third party valuations, among other things, contemporaneous valuations of the Company’s common stock.

Given the absence of a public trading market of the Company’s capital stock to date, its board of directors has exercised reasonable

judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of our common and

preferred stock, including:

● the prices, rights, preferences and privileges of our preferred

stock relative to our common stock;

● our business, financial condition and results of operations,

including related industry trends affecting our operations;

● the likelihood of achieving a liquidity event, such as an

initial public offering, or IPO, or sale of our company, given prevailing market conditions;

● the lack of marketability of our common stock;

● the market performance of comparable publicly traded companies;

and global economic and capital market conditions

● Common stock valuation methodology.

In estimating the fair market value of common stock

of the Company, its board of directors first determined the equity value of its business using accepted valuation methods.

The Company engaged a third party valuation specialist

to conduct a valuation, which used its recent preferred stock financing as a starting point and determined the equity value of the company

based on the Backsolve method using an Option Pricing Method (OPM) to calculate the implied value based on a market approach.

The Company’s

equity value was allocated using OPM to estimate the fair market value of the Company’s classes of equity.

Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by

Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.

Section 107 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.

In other words, an “emerging growth company”

delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies.

We have elected

to avail ourselves of this extended transition period.

For as long as we remain an “emerging growth

company”

under the recently enacted JOBS Act, we will, among other things:

● be exempt from the provisions of Section 404(b) of

the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness

of our internal control over financial reporting;

● be permitted to omit the detailed compensation discussion

and analysis from proxy statements and reports filed under the Exchange Act and instead provide a reduced level of disclosure concerning

executive compensation;

● be exempt from any rules that may be adopted by the Public

Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial

Although we are still evaluating the JOBS Act, we

currently intend to take advantage of some or all of the reduced regulatory and reporting requirements that will be available to us so

long as we qualify as an “emerging growth company,”

including the extension of time to comply with new or revised financial

accounting standards available under Section 102(b) of the JOBS Act.

Among other things, this means that our independent registered

public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial

reporting so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal

control over financial reporting go undetected.

Likewise, so long as we qualify as an emerging growth company, we may elect not to provide

you with certain information, including certain financial information and certain information regarding compensation of our executive

officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for

investors and securities analysts to evaluate our company.

As a result, investor confidence in our company and the market price of our

common stock may be materially and adversely affected.

Quantitative and Qualitative Disclosures

About Market Risk

As a smaller reporting company, we are not required to provide the

information required by this item.

Financial Statements and Supplementary

Reference is made to pages F-1 through F-24 comprising

a portion of this report, which are incorporated herein by reference.

Changes in and Disagreements With Accountants

on Accounting and Financial Disclosure.

the net proceeds of our IPO to fund our research and development activities, clinical trials and the regulatory review process for our

product candidates, and the remainder for working capital and other general corporate purposes.

The foregoing expected use of net proceeds from

our initial public offering represents our intentions based upon our current plans and business conditions.

However, the nature, amounts

and timing of our actual expenditures may vary significantly depending on numerous factors.

For example, we may also elect to use proceeds

from the initial public offering to acquire complimentary technologies, products or businesses, although we are not a party to any letters

of intent or definitive agreements for any such acquisition.

As a result, our management has and will retain broad discretion over the

allocation of the net proceeds.

We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad

discretion in the application of net proceeds.

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 5. Market for Registrant’s Common Equity