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Item 1A. Risk Factors

2023-03-29 compared with 2022-03-23 · 532 added, 753 removed, 868 unchanged (60% of the section changed)

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Operations.” The occurrence of any of the events discussed below could significantly and adversely affect our business, prospects,

results of operations, financial condition, and cash flows.

results of operations, financial condition, and cash flow.

business is subject to numerous risks and uncertainties that you should consider before investing in our common stock.

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is a summary of the principal risk factors we face:

We have incurred significant

losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability.

We have no history of commercializing

We will need additional

funding to pursue our business objectives, including to eventually commercialize our product candidates if we complete research and

development efforts and receive the required regulatory approvals for a product candidate in the future.

We allocated a significant

amount of time and resources into developing a treatment for COVID-19, and these efforts may ultimately be unfruitful.

Our business and operations

may be adversely affected by the evolving and ongoing COVID-19 pandemic.

The regulatory approval

processes of the FDA and other government authorities are lengthy, time consuming and inherently unpredictable.

If we are unable to successfully

develop, receive regulatory approval for and commercialize our product candidates, our business will be harmed.

Even if we do commercialize

one or more products, most pharmaceutical products that achieve commercialization still do not recoup their cost of capital.

We face uncertainties with

respect to the potential for new United States healthcare legislation which may lead to reduced pricing, among other things.

The cost of our research

and development programs may be higher than expected, and there is no assurance that such efforts will be successful in a timely

manner or at all.

Success in preclinical

studies or earlier clinical trials may not be indicative of results in future clinical trials or an ability to ultimately receive

approval from the FDA.

We may not be successful

in our efforts to research, develop, or in-license or acquire product candidates.

We face intense competition,

which may limit or eliminate our commercial prospects with respect to product candidates.

We rely on third parties

to research, develop and commercialize certain product candidates, and such third parties may not perform satisfactorily or act in

our best interests.

If we are unable to obtain

or protect intellectual property rights related to any of our product candidates, we may not be able to compete effectively in the

We may become subject to

expensive intellectual property litigation to enforce our intellectual property rights or defend against claims asserted by others.

Our common stock may be

delisted if we fail to meet and maintain Nasdaq’s minimum bid price requirement, including regaining compliance in connection

with our current closing bid price deficiency which we are required to remedy by May 16, 2022 absent an extension.

The trading price and volume

of our common stock may be volatile, and could decline in which case investors could lose all or part of their investment.

have incurred significant losses since our inception, expect to incur losses over the next several years and may never achieve or

maintain profitability.

have no history of commercializing products.

will need additional funding to pursue our business objectives, including to eventually commercialize our product candidates if we

complete research and development efforts and receive the required regulatory approvals for a product candidate in the future.

allocated a significant amount of time and resources into developing a treatment for COVID-19, and these efforts may ultimately be

regulatory approval processes of the FDA and other government authorities are lengthy, time consuming and inherently unpredictable.

we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, our business will

if we do commercialize one or more products, most pharmaceutical products that achieve commercialization still do not recoup their

cost of capital.

face uncertainties with respect to the potential for new United States healthcare legislation which may lead to reduced pricing,

among other things.

cost of our research and development programs may be higher than expected, and there is no assurance that such efforts will be successful

in a timely manner or at all.

in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials or an ability to ultimately

receive approval from the FDA.

may not be successful in our efforts to research, develop, or in-license or acquire product candidates.

face intense competition, which may limit or eliminate our commercial prospects with respect to product candidates.

rely on third parties to research, develop and commercialize certain product candidates, and such third parties may not perform satisfactorily

or act in our best interests.

we are unable to obtain or protect intellectual property rights related to any of our product candidates, we may not be able to compete

effectively in the market.

may become subject to expensive intellectual property litigation to enforce our intellectual property rights or defend against claims

asserted by others.

trading price and volume of our common stock may be volatile and could decline in which case investors could lose all or part of

their investment.

RELATED TO OUR BUSINESS

business has been and may continue to be affected by the COVID-19 pandemic, and the full extent of such impact remains uncertain.

United States and global impact from the COVID-19 virus has had and/or will have a material adverse effect on us in a number of ways

If our scientists

and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage in ongoing research

the third parties on whom we rely have been and may in the future be adversely impacted, which can materially adversely affect our

operations and financial condition.

For example, beginning in 2021 our CROs have experienced serious operational issues due to the

spread of the Omicron variant, and throughout the pandemic in general we have experienced delays with our CROs and CMOs arising from

challenges such as facility shutdowns, personnel illness, shortages of trained scientists, local COVID-19 policies and safety measures,

and supply chain issues including with animals for preclinical studies, which in each case has resulted in material delays and/or

cost increases in our research and development efforts;

If these third parties

continue to be affected by COVID-19, they may focus on other activities which they may devote their limited time to other priorities

rather than to our joint research;

We have experienced and

may in the future experience supply chain disruptions, including shortages, delays and price increases in laboratory equipment and

supplies, which would impact our research activities.

For example, supply shortages caused by the pandemic delayed the development

of our Influenza A virus program and may impact our COVID-19 programs;

As a result of the continuing

impact of the virus, we may fail to get access to third party laboratories which would impact our research activities;

We may face challenges

related to restrictions and efforts to avoid further spread of the virus, in our efforts to conduct our planned clinical trials consistent

with normally applicable approaches and good clinical practice standards, and although regulators including the FDA have offered

guidance applicable during the COVID-19 pandemic allowing for flexibility of standards in certain areas and alternate methods of

meeting trial oversight obligations (for example, via remote monitoring), the potential impact of these challenges cannot be fully

predicted at this time.

CROs we contract

with may encounter difficulties enrolling patients for our Phase 1 clinical trials or in conducting that trial due to government

actions to contain the outbreak or general public concern;

We may fail to appropriately

allocate resources or adapt to the rapidly evolving market and regulatory environment caused by the pandemic, including with respect

to our efforts to develop a treatment for COVID-19;

As the FDA continues to

focus its efforts on the pandemic, there may be material delays in our IND application for our planned Phase 1 studies;

We may sustain problems

due to the serious short-term and possible longer term economic disruptions and market volatility as the U.S.

and global economy

faces unprecedented uncertainty.

have never generated revenue from product sales and all of our product candidates are currently in the pre-clinical and early clinical

have never generated revenue from product sales and all of our product candidates are currently in the preclinical and early clinical

stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales.

are a pre-clinical and early stage clinical, biopharmaceutical discovery and development company.

We have initiated a Phase 1

clinical trial for our Influenza A product candidate in the first quarter of 2022, which has been delayed due to challenges with

CROs arising from the recent Omicron variant of COVID-19.

We also plan to commence two COVID-19 clinical trials in 2022 for product candidates.

An IND is required by the FDA in order to proceed from pre-clinical to clinical trials for a product candidate.

of the need to complete clinical trials, establish safety and efficacy and obtain regulatory approval, which is an expensive and time-consuming

process, we do not anticipate generating revenue from product sales for at least five years and will continue to sustain considerable

We may develop a partnership that could generate income sooner, but there is no guarantee that will be achievable.

are a preclinical and early stage clinical, biopharmaceutical discovery and development company.

We completed a Phase 1 clinical trial

for our Influenza A lead oral candidate CC-42344 in December 2022.

We also plan to commence a COVID-19 clinical trial in 2023 for our

lead oral candidate CDI-988.

Because of the need to complete clinical trials, establish safety and efficacy and obtain regulatory approval,

which is an expensive and time-consuming process, we do not anticipate generating revenue from product sales for at least five years

and will continue to sustain considerable losses.

We may develop a partnership that could generate income sooner, but there is no guarantee

that will be achievable.

had an accumulated deficit of $297,930,000 from inception through December 31, 2022 and expect to continue losing money in the future.

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revenue and achieve profitability will depend on, among other things, the following:

identifying and validating

new therapeutic strategies;

entering into collaborations

with large pharmaceutical or biotechnology companies, similar to our Collaboration Agreement with Merck;

completing our research

and preclinical development of pharmaceutical product candidates;

initiating and completing

clinical trials for pharmaceutical product candidates;

seeking and obtaining regulatory

marketing approvals for pharmaceutical product candidates that successfully complete clinical trials;

establishing and maintaining

supply and manufacturing relationships with third parties;

launching and commercializing

pharmaceutical product candidates for which we obtain regulatory marketing approval with a partner or, if launched independently,

successfully establishing a sales force, marketing and distribution infrastructure;

maintaining, protecting,

enforcing, defending and expanding our intellectual property portfolio;

attracting, hiring and

retaining qualified personnel.

and validating new therapeutic strategies;

into collaborations with large pharmaceutical or biotechnology companies, similar to our Collaboration Agreement with Merck;

our research and preclinical development of pharmaceutical product candidates;

and completing clinical trials for pharmaceutical product candidates;

and obtaining regulatory marketing approvals for pharmaceutical product candidates that successfully complete clinical trials;

and maintaining supply and manufacturing relationships with third parties;

and commercializing pharmaceutical product candidates for which we obtain regulatory marketing approval with a partner or, if launched

independently, successfully establishing a sales force, marketing and distribution infrastructure;

protecting, enforcing, defending and expanding our intellectual property portfolio;

hiring and retaining qualified personnel.

of the numerous risks and uncertainties associated with pharmaceutical product development, we cannot predict the timing or amount of

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capital or form strategic partnerships to support our research and development activities in the future.

are still in the early stages of development of our product candidates and have no products approved for commercial sale or presently

in clinical trials.

As stated earlier, we initiated a Phase 1 clinical trial for our Influenza A product and also plan to initiate

two COVID-19 product candidates in 2022.

However, our ability to conduct clinical trials in a cost-effective manner and within the

desired timeframes remains subject to uncertainties arising from COVID-19 (including the pandemic’s effect on third parties on

which we rely), supply chain shortages, and potential difficulties in obtaining adequate participant enrollments.

Further, developing

pharmaceutical products, including conducting preclinical studies and clinical trials, is capital-intensive.

As a rule, research and

development expenses increase substantially as we advance our product candidates toward clinical programs.

If we are able to advance

our products through clinical trials, we may need to raise additional capital to support our operations and/or form partnerships, in

addition to our existing collaborative alliances, which may give substantial rights to a partner.

Such funding or partnerships may not

be available to us on acceptable terms, or at all.

are still in the early stages of preclinical and clinical development of our product candidates and have no products approved for commercial

sale or presently in clinical trials.

However, our ability to conduct clinical trials in a cost-effective manner and within the desired

timeframes remains subject to uncertainties arising from COVID-19 (including the pandemic’s effect on third parties on which we

rely), supply chain shortages, and potential difficulties in obtaining adequate participant enrollments.

Further, developing pharmaceutical

products, including conducting preclinical studies and clinical trials, is capital-intensive.

As a rule, research and development expenses

increase substantially as we advance our product candidates toward clinical programs.

If we are able to advance our products through

clinical trials, we may need to raise additional capital to support our operations and/or form partnerships, in addition to our existing

collaborative alliances, which may give substantial rights to a partner.

Such funding or partnerships may not be available to us on acceptable

terms, or at all.

Moreover, any future financing may be very dilutive to our existing stockholders.

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acceptable terms, we may be required to:

accept terms that restrict

our ability to issue securities, incur indebtedness, or otherwise raise capital in the future, or restrict our ability to pay dividends

or engage in acquisitions;

significantly delay, scale

back or discontinue the development or commercialization of any product candidates;

seek strategic alliances

for research and development programs at an earlier stage than otherwise would be desirable or on terms less favorable than might

otherwise be available;

relinquish or license on

unfavorable terms, our rights to technologies or any product candidates we otherwise would seek to develop or commercialize ourselves.

terms that restrict our ability to issue securities, incur indebtedness, or otherwise raise capital in the future, or restrict our

ability to pay dividends or engage in acquisitions;

significantly

delay, scale back or discontinue the development or commercialization of any product candidates;

strategic alliances for research and development programs at an earlier stage than otherwise would be desirable or on terms less

favorable than might otherwise be available;

or license on unfavorable terms, our rights to technologies or any product candidates we otherwise would seek to develop or commercialize

we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be prevented from pursuing development

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virus, our business and future prospects could be materially and adversely affected.

we plan to commence IND-enabling studies for two COVID-19 products in 2022, our COVID-19 programs are still in the preclinical stage.

We may be unable to produce an effective therapy in a timely manner or at all.

Additionally, we are committing substantial financial

and other resources to our COVID-19 program, which may negatively impact our other programs.

Further, in the wake of the global COVID-19

pandemic a number of third parties, including large biotechnology and pharmaceutical companies and academic institutions have developed

vaccines, at least two of which have FDA approval.

Some competitors have also received FDA approval or emergency use authorization for

the treatment of COVID-19.

Some of these large pharmaceutical companies, including Pfizer, Moderna and Janssen

Biotech, Inc., have obtained FDA approval for vaccines which have demonstrated high efficacy rates and are currently being distributed

to the general population above the age of five, with the FDA currently reviewing applications for reducing the age for which certain

vaccines are approved to six months and older.

While our COVID-19 program is focused on treatment rather than prevention, widespread

vaccination limits our prospects with respect to any therapeutic product candidate we develop.

we plan to commence a Phase 1 clinical study of our COVID-19 lead oral candidate CDI-988 in the first half of 2023, we may be unable

to produce an effective therapy in a timely manner or at all.

Additionally, we are committing substantial financial and other resources

to our COVID-19 program, which may negatively impact our other programs.

Further, in the wake of the global COVID-19 pandemic a number

of third parties, including large biotechnology and pharmaceutical companies and academic institutions have developed vaccines, at least

two of which have FDA approval.

Some competitors have also received FDA approval or emergency use authorization for the treatment of

Some of these large pharmaceutical companies, including Pfizer, Moderna and Janssen Biotech, Inc., have obtained FDA approval

for vaccines which have demonstrated high efficacy rates and are currently being distributed to the general population, with the permitted

age of use for certain vaccines as low as six months and older.

While our COVID-19 program is focused on treatment rather than prevention,

widespread vaccination limits our prospects with respect to any therapeutic product candidate we develop.

some of our competitors that are also developing treatments for the virus have substantially more resources, including government funding,

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For example, the FDA approved remdesivir,

an investigational antiviral agent developed by Gilead for the treatment of patients with COVID-19

requiring hospitalization.

In addition, the FDA has issued an emergency use authorization for the investigational monoclonal antibody

therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

At least one other competitor is conducting a

combination Phase 2/3 clinical trials for a treatment using cannabidiol to treat COVID-19 for patients with heart issues.

Another competitor

is conducting Phase 2 clinical trials for the treatment of “long” COVID, also known as post-COVID syndrome, for patients

who experience symptoms for more than four weeks.

Even if we do obtain FDA authorization for a therapeutic product, the FDA may subsequently

rescind or limit such authorization as more information about the product, including its efficacy and side effects, becomes available.

Further, this virus is highly mutative and a number of variants have already arisen, and any treatment we are able to develop and commercialize

will therefore remain subject to the risk that a mutation will occur that produces a strain or strains of the virus to which such treatment

has a diminished effect or is ineffective.

For example, the recent Omicron variant of the virus is more resistant to treatments that

were effective against prior variants of the virus.

If we do develop a treatment that is effective against a current variant, a later

variant may arise that reduces or eliminates the product’s efficacy before we are able to commercialize it.

Further, if this occurs,

one or more competitors’ products may be more effective against new variants than ours, resulting in a diminished market for our

For example, on February 11, 2022, the FDA announced its emergency use authorization for bebtelovimab, a new monoclonal antibody

for the treatment of COVID-19 by non-hospitalized patients, that retains activity against the Omicron variant.

If we are unable to timely

advance our COVID-19 program, or if we fail to gain or maintain a market share as a result of our competitors developing and successfully

commercializing vaccines and effective COVID-19 therapies more quickly than we do, our business and future prospects could be materially

and adversely affected.

an investigational antiviral agent developed by Gilead for the treatment of patients with COVID-19 requiring hospitalization.

the FDA has issued an emergency use authorization for the investigational monoclonal antibody therapy for the treatment of mild-to-moderate

COVID-19 in adult and pediatric patients.

At least one other competitor is conducting a combination Phase 2/3 clinical trials for a treatment

using cannabidiol to treat COVID-19 for patients with heart issues.

Another competitor is conducting Phase 2 clinical trials for the

treatment of “long” COVID, also known as post-COVID syndrome, for patients who experience symptoms for more than four weeks.

Even if we do obtain FDA authorization for a therapeutic product, the FDA may subsequently rescind or limit such authorization as more

information about the product, including its efficacy and side effects, becomes available.

Further, this virus is highly mutative and

a number of variants have already arisen, and any treatment we are able to develop and commercialize will therefore remain subject to

the risk that a mutation will occur that produces a strain or strains of the virus to which such treatment has a diminished effect or

is ineffective.

For example, the Omicron variant of the virus is more resistant to treatments that were effective against prior variants

of the virus.

If we do develop a treatment that is effective against a current variant, a later variant may arise that reduces or eliminates

the product’s efficacy before we are able to commercialize it.

Further, if this occurs, one or more competitors’ products

may be more effective against new variants than ours, resulting in a diminished market for our products.

For example, on February 11,

2022, the FDA announced its emergency use authorization for bebtelovimab, a new monoclonal antibody for the treatment of COVID-19 by

non-hospitalized patients, that retains activity against the Omicron variant.

If we are unable to timely advance our COVID-19 program,

or if we fail to gain or maintain a market share as a result of our competitors developing and successfully commercializing vaccines

and effective COVID-19 therapies more quickly than we do, our business and future prospects could be materially and adversely affected.

will depend on Merck for the successful research, development and commercialization of our Influenza A/B product candidates.

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On January 19, 2021, the Company announced that it had completed all research obligations under the Collaboration

Agreement with Merck, and Merck is now solely responsible for further development of the Influenza A/B antiviral compounds, and will

also be solely responsible for the commercialization of any products derived therefrom.

Agreement with Merck, and Merck is now solely responsible for further development of the Influenza A/B antiviral compounds and will also

be solely responsible for the commercialization of any products derived therefrom.

See “Item 1 – Business – Collaborations

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out to be unsuccessful and are subject to certain risks, including the following risks:

disagreements with Merck

resulting in delays or termination of the research, development or commercialization of product candidates, or litigation;

change the focus by Merck

of its development and commercialization efforts;

failure by Merck to commit

sufficient resources to the testing, marketing, distribution or development of product candidates;

development by Merck of

alternative products either on its own or in collaboration with others, or conflicts of interest or changes in business strategy

or other business issues, which could adversely affect its willingness or ability to fulfill their obligations to us.

disagreements

with Merck resulting in delays or termination of the research, development or commercialization of product candidates, or litigation;

the focus by Merck of its development and commercialization efforts;

by Merck to commit sufficient resources to the testing, marketing, distribution or development of product candidates;

by Merck of alternative products either on its own or in collaboration with others, or conflicts of interest or changes in business

strategy or other business issues, which could adversely affect its willingness or ability to fulfill their obligations to us.

our collaboration with Merck is unsuccessful for these or other reasons, or is otherwise terminated for any reason, we would not receive

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receives required regulatory approvals, is commercialized and net sales exceed the thresholds set forth in the Collaboration Agreement.

Achieving the milestones may be difficult and time-consuming.

If some or all of these goals are not achieved, we may not receive some

or all of the milestone payments under the Collaboration Agreement.

Achieving milestones may be difficult and time-consuming.

If some or all of these goals are not achieved, we may not receive some or

all of the milestone payments under the Collaboration Agreement.

As of the date of this Report, none of the milestones under the Collaboration

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by several factors including:

a partner may shift its

priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing

of its company or business unit;

a partner may cease development

in therapeutic areas which are the subject of our strategic alliances;

a partner may change the

success criteria for a program or product candidate delaying or ceasing development of such program or candidate;

a significant delay in

initiation of certain development activities by a partner could also delay payment of milestones tied to such activities, impacting

our ability to fund our own activities;

a partner could develop

a product that competes, either directly or indirectly, with an alliance product;

a partner with commercialization

obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;

a partner with manufacturing

responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

a partner may exercise

its rights under the agreement to terminate a strategic alliance, including termination without cause;

a dispute may arise between

us and a partner concerning the research, development or commercialization of a program or product candidate resulting in a delay

in milestones, royalty payments or termination of a program and possibly resulting in costly litigation or arbitration which may

divert management attention and resources;

a partner may use our proprietary

information or intellectual property to invite litigation from a third-party or fail to maintain or prosecute intellectual property

rights possibly jeopardizing our rights in such property.

partner may shift its priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition,

sale or downsizing of its company or business unit;

partner may cease development in therapeutic areas which are the subject of our strategic alliances;

partner may change the success criteria for a program or product candidate delaying or ceasing development of such program or candidate;

significant delay in initiation of certain development activities by a partner could also delay payment of milestones tied to such

activities, impacting our ability to fund our own activities;

partner could develop a product that competes, either directly or indirectly, with an alliance product;

partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution

or sale of a product;

partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

partner may exercise its rights under the agreement to terminate a strategic alliance, including termination without cause;

dispute may arise between us and a partner concerning the research, development or commercialization of a program or product candidate

resulting in a delay in milestones, royalty payments or termination of a program and possibly resulting in costly litigation or arbitration

which may divert management attention and resources;

partner may use our proprietary information or intellectual property to invite litigation from a third-party or fail to maintain

or prosecute intellectual property rights possibly jeopardizing our rights in such property.

of a strategic alliance may require us to seek out and establish alternative strategic alliances with third-party partners.

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our product candidates ourselves, including:

the ongoing supply chain

the inability to meet any

product specifications and quality requirements consistently;

a delay or inability to

procure or expand sufficient manufacturing capacity;

discontinuation or recall

of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization of products;

manufacturing and product

quality issues related to scale-up of manufacturing;

costs and validation of

new equipment and facilities required for scale-up;

a failure to comply with

cGMP and similar foreign standards;

the inability to negotiate

manufacturing agreements with third parties under commercially reasonable terms;

the possibility of breach

or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly or damaging to us;

the reliance on a few sources,

and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply of these product components, we

cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities or under acceptable terms;

the lack of qualified backup

suppliers for any raw materials currently purchased from a single source supplier;

operations of our third-party

manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of

the manufacturer or supplier;

carrier disruptions or

increased costs beyond our control;

misappropriation of our

proprietary technology for the purpose of manufacturing a “generic” version of our product or sale of our product to

organizations that distribute and sell counterfeit goods, including drugs;

failing to deliver products

under specified storage conditions and in a timely manner.

ongoing supply chain shortages;

inability to meet any product specifications and quality requirements consistently;

delay or inability to procure or expand sufficient manufacturing capacity;

discontinuation

or recall of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization

manufacturing

and product quality issues related to scale-up of manufacturing;

and validation of new equipment and facilities required for scale-up;

failure to comply with cGMP and similar foreign standards;

inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

possibility of breach or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly or damaging

reliance on a few sources, and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply of

these product components, we cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities or under

acceptable terms;

lack of qualified backup suppliers for any raw materials currently purchased from a single source supplier;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including

the bankruptcy of the manufacturer or supplier;

disruptions or increased costs beyond our control;

misappropriation

of our proprietary technology for the purpose of manufacturing a “generic” version of our product or sale of our product

to organizations that distribute and sell counterfeit goods, including drugs;

to deliver products under specified storage conditions and in a timely manner.

events could lead to clinical study delays or failure to obtain regulatory approval or impact our ability to successfully commercialize

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of supply may cause a delay in developing and commercializing these product candidates.

intend to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, the drug substance,

and the drug product of any product candidate for which we are responsible for preclinical or clinical development.

Each supplier may

require licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

As part of any

marketing approval, a manufacturer and its processes must be qualified by the FDA or foreign regulatory authorities prior to commercialization.

intend to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, drug substances, and

the drug product of any product candidate for which we are responsible for preclinical or clinical development.

Each supplier may require

licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

As part of any marketing

approval, a manufacturer and its processes must be qualified by the FDA or foreign regulatory authorities prior to commercialization.

If supply from the approved vendor is interrupted, there could be a significant disruption in commercial supply.

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candidates for clinical development for several reasons, including:

our research methodology

or that of our partners may be unsuccessful in identifying potential product candidates;

potential product candidates

may have harmful side effects or may have other characteristics that make the products unmarketable or unlikely to receive marketing

we or our partners may

change their development profiles for potential product candidates or abandon a therapeutic area.

research methodology or that of our partners may be unsuccessful in identifying potential product candidates;

product candidates may have harmful side effects or may have other characteristics that make the products unmarketable or unlikely

to receive marketing approval;

or our partners may change their development profiles for potential product candidates or abandon a therapeutic area.

events may force us to abandon our development efforts for a program or programs, which would have a material adverse effect on our business

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on the type, complexity, and novelty of the product candidates involved.

Our ability to generate revenues would be adversely affected

Our ability to generate revenue would be adversely affected

if we are delayed or unable to successfully develop our products.

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in doing so, our business will be materially harmed.

intend to invest a significant portion of our efforts and financial resources in the identification and preclinical development of product

candidates that target viral replication enzymes.

Our ability to generate product revenues, which we do not expect will occur for many

years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidates.

have invested and intend to continue to invest a significant portion of our efforts and financial resources in the identification and

preclinical development of product candidates that target viral replication enzymes.

Our ability to generate product revenues, which

we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization

of our product candidates.

commercial success of our product candidates will depend on several factors, including:

successful completion of

preclinical studies and clinical trials;

receipt of marketing and

pricing approvals from regulatory authorities;

obtaining and maintaining

patent and trade secret protection for product candidates;

establishing and maintaining

manufacturing relationships with third parties or establishing our own manufacturing capability;

commercializing our products,

if and when approved, whether alone or in collaboration with others.

completion of preclinical studies and clinical trials;

of marketing and pricing approvals from regulatory authorities;

and maintaining patent and trade secret protection for product candidates;

and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability;

commercializing

our products, if and when approved, whether alone or in collaboration with others.

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

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that may cause a delay or unsuccessful completion of clinical development include, among other things:

delays in agreeing with

the FDA or other regulatory authorities on final clinical trial design;

imposition of a clinical

hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;

delays in agreeing on acceptable

terms with prospective contract research organizations, or CROs, and clinical trial sites;

delays in obtaining required

institutional review board approval at each clinical trial site;

delays in recruiting suitable

patients to participate in a trial;

delays in the testing,

validation, manufacturing and delivery of the product candidates to the clinical sites;

delays in having patients

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

delays caused by patients

dropping out of a trial due to product side effects or disease progression;

clinical sites dropping

out of a trial to the detriment of enrollment;

negative or inconclusive

results of clinical trials of our product candidates;

time and expenses required

to add new clinical sites;

delays by our contract

manufacturers in producing and delivering sufficient supply of clinical trial materials.

in agreeing with the FDA or other regulatory authorities on final clinical trial design;

of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;

in agreeing on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;

in obtaining required institutional review board approval at each clinical trial site;

in recruiting suitable patients to participate in a trial;

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

in having patients complete participation in a trial or return for post-treatment follow-up;

caused by patients dropping out of a trial due to product side effects or disease progression;

sites dropping out of a trial to the detriment of enrollment;

or inconclusive results of clinical trials of our product candidates;

and expenses required to add new clinical sites;

by our contract manufacturers in producing and delivering sufficient supply of clinical trial materials.

we or our partners must conduct additional clinical trials or other testing of any product candidates beyond those that are contemplated,

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trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our partners may:

be delayed in obtaining

marketing approval for our product candidates;

not obtain marketing approval

obtain approval for indications

or patient populations not as broad as intended or desired;

obtain approval with labeling

that includes significant use or distribution restrictions or safety warnings;

be subject to additional

post-marketing testing requirements;

remove the product from

the market after obtaining marketing approval.

delayed in obtaining marketing approval for our product candidates;

obtain marketing approval at all;

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

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

subject to additional post-marketing testing requirements;

FDA or foreign regulator will remove the product from the market after obtaining marketing approval.

product development costs will also increase if we experience delays in testing or in obtaining marketing approvals.

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authorities may withdraw prior approval of the product or impose restrictions on its distribution in the form of a modified risk

evaluation and mitigation strategy (“REMS”) which may restrict the manner in which the product can be distributed

or administered;

we may be required to add

labeling statements, such as warnings or contraindications;

we may be required to change

the way the product is administered or conduct additional clinical trials;

we may decide or be forced

to temporarily or permanently remove the affected product from the marketplace;

we could be sued and held

liable for harm caused to patients;

our reputation may suffer.

evaluation and mitigation strategy (“REMS”) which may restrict the manner in which the product can be distributed or

administered;

may be required to add labeling statements, such as warnings or contraindications;

may be required to change the way the product is administered or conduct additional clinical trials;

may decide or be forced to temporarily or permanently remove the affected product from the marketplace;

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

reputation may suffer.

events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially

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of the United States.

holder of an approved NDA must monitor and report AEs and SAEs and any failure of a product to meet the specifications in the NDA.

holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved

product, product labeling or manufacturing process.

Advertising and promotional materials must comply with FDA rules and other applicable

federal and state laws and are subject to FDA review.

holder of an approved new drug application, or NDA must monitor and report AEs and SAEs and any failure of a product to meet the specifications

The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes

to the approved product, product labeling or manufacturing process.

Advertising and promotional materials must comply with FDA rules

and other applicable federal and state laws and are subject to FDA review.

product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA

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we or our partners fail to comply with regulatory requirements following approval of our product candidates, a regulatory agency may:

issue a warning letter

asserting we are in violation of the law;

impose a REMS or other

restrictions on the manufacturing, marketing or use of the product;

seek an injunction or impose

civil or criminal penalties or monetary fines;

suspend or withdraw regulatory

suspend any ongoing clinical

refuse to approve a pending

NDA or supplements to an NDA submitted by us;

seize product;

refuse to allow us to enter

into supply contracts, including government contracts.

a warning letter asserting we are in violation of the law;

a REMS or other restrictions on the manufacturing, marketing or use of the product;

an injunction or impose civil or criminal penalties or monetary fines;

or withdraw regulatory approval;

any ongoing clinical trials;

to approve a pending NDA or supplements to an NDA submitted by us;

to allow us to enter into supply contracts, including government contracts.

defense of any government investigation of alleged violations of law, or any lawsuit alleging such violations, could require us to expend

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products, we may be required to:

cease our development efforts

for a product candidate;

cause a partner to terminate

its support of a product candidate;

cause a potential partner

to terminate discussions about a potential license.

our development efforts for a product candidate;

a partner to terminate its support of a product candidate;

a potential partner to terminate discussions about a potential license.

of these events may occur after we have spent substantial sums in connection with the clinical research of one or more product candidates.

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efforts to develop our product candidates are at an early stage.

To date, with two exceptions, including recently initiating a Phase

1 trial for our Influenza A product candidate in the first quarter of 2022, we have not entered other compounds into

human clinical trials,

We may be unable to progress our other product candidates undergoing preclinical testing into clinical trials.

Success in preclinical

testing and early clinical trials does not ensure that later clinical trials will succeed, and favorable initial results from a clinical

trial do not determine outcomes in subsequent clinical trials.

The indications of use for which we are pursuing development may have

clinical effectiveness endpoints not previously reviewed or validated by the FDA or foreign regulatory authorities, which may complicate

or delay our effort to obtain marketing approval.

To date, with two exceptions, including recently completing a Phase

1 trial for our Influenza A product candidate in late 2022, we have not entered other compounds into human clinical trials.

advance the Influenza A product to a Phase 2a trial, and to commence a Phase 1 trial for a COVID-19 product candidate, in 2023.

be unable to progress our product candidates undergoing preclinical testing into clinical trials.

Success in preclinical testing and

early clinical trials does not ensure that later clinical trials will succeed, and favorable initial results from a clinical trial do

not determine outcomes in subsequent clinical trials.

The indications of use for which we are pursuing development may have clinical

effectiveness endpoints not previously reviewed or validated by the FDA or foreign regulatory authorities, which may complicate or delay

our effort to obtain marketing approval.

We cannot guarantee that our clinical trials will succeed.

In fact, most compounds

fail in clinical trials, even at companies far larger and more experienced than us.

In fact, most compounds fail in clinical

trials, even at companies far larger and more experienced than us.

have not obtained marketing approval or commercialized any of our product candidates.

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actions taken at the international level.

For example, a proposal has been advanced and is being considered by the World Trade Organization

beginning in late 2020, which is supported by multiple countries across the globe, including the U.S., which would implement a multi-jurisdictional

waiver of patent and other intellectual property rights with respect to vaccines and therapeutic products that target COVID-19 in an

effort to fight the pandemic and allow for a more equal distribution of resources towards that goal.

If the proposed waiver is implemented

or similar actions are taken with respect to COVID-19-related products or other products in which we are or may become involved, our

ability to protect the underlying intellectual property rights we rely on for such products, including those licensed from third parties,

could be materially diminished or eliminated, and as a result any potential competitive advantage would be lost.

If we are unable to

prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no guarantee

we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage in our

market, which could materially adversely affect our business, results of operations and financial condition.

For example, in June 2022 member countries of the World Trade Organization (“WTO”)

agreed to implement a multi-jurisdictional five-year waiver of patent protection with respect to vaccines that target COVID-19 in an

effort to fight the pandemic and allow for a more equal distribution of resources, particularly for developing countries, towards that

This resulted from ongoing discussions among WTO member countries which began in 2020 with a proposal for a more extensive waiver

that would have covered patents for COVID-19 related diagnostics and therapeutics as well as vaccines, and the WTO is still under discussions

to potentially extend the waiver to such products.

Similarly, some have argued that the WTO should also extend the waiver to apply to

other types of intellectual property such as know-how related to the development and distribution of the COVID-19 related products.

as of March 15, 2023 no definitive action has been taken on expanding upon the WTO waiver that is currently in effect.

The WTO waiver,

together with similar actions that may be taken with respect to COVID-19-related products or other products in which we are or may become

involved could materially diminish or eliminate our ability to protect the underlying intellectual property rights we rely on for such

products, including those licensed from third parties, and as a result any potential competitive advantage would be lost.

If we are unable

to prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, and there is no

guarantee we will have any such enforceable trade secret protection, we may not be able to establish or maintain a competitive advantage

in our market, which could materially adversely affect our business, results of operations and financial condition.

third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization

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and monetary expenditure.

of the costs involved in defending patent litigation, we may in the future lack the capital to defend our intellectual

property rights.

of the costs involved in defending patent litigation, we may in the future lack the capital to defend our intellectual property rights.

may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive,

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An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being

invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

invalidated or interpreted narrowly and could put our patent applications at risk of not being issued.

proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions regarding our patents

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disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including those relating

the scope of rights, if

any, granted under the license agreement and other interpretation-related issues;

whether and to what extent

our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;

whether our licensor or

its licensor had the right to grant the license agreement;

whether third parties are

entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization;

our right to sublicense

patent and other rights to third parties under collaborative development relationships;

whether we are complying

with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of product

our involvement in the

prosecution and enforcement of the licensed patents and our licensors’ overall patent prosecution and enforcement strategy;

the allocation of ownership

of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and any future

partners or collaborators;

the amounts of royalties,

milestones or other payments due under the license agreement.

scope of rights, if any, granted under the license agreement and other interpretation-related issues;

and to what extent our technology and processes infringe on intellectual property of the licensor that is not subject to the license

our licensor or its licensor had the right to grant the license agreement;

third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without

their authorization;

right to sublicense patent and other rights to third parties under collaborative development relationships;

we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization

of product candidates;

involvement in the prosecution and enforcement of the licensed patents and our licensors’ overall patent prosecution and enforcement

allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors

and by us and any future partners or collaborators;

amounts of royalties, milestones or other payments due under the license agreement.

resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the

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to leverage our experience in drug discovery and development to:

discover and develop therapeutics

superior to other products in the market;

attract and retain qualified

scientific, product development and commercial personnel;

obtain patent and/or other

proprietary protection for our technology platform and product candidates;

obtain required regulatory

successfully collaborate

with pharmaceutical companies in the discovery, development and commercialization of new therapeutics.

and develop therapeutics superior to other products in the market;

and retain qualified scientific, product development and commercial personnel;

patent and/or other proprietary protection for our technology platform and product candidates;

required regulatory approvals;

collaborate with pharmaceutical companies in the discovery, development and commercialization of new therapeutics.

availability of our competitors’ products could limit the demand, and the price we can charge, for any products we may develop

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candidates will depend on several factors, including:

demonstration of clinical

safety and efficacy compared to other products;

the relative convenience,

ease of administration and acceptance by physicians, patients and healthcare payors;

the prevalence and severity

of any adverse effects or serious adverse effects;

limitations or warnings

in the label approved by FDA and/or foreign regulatory authorities for such products;

the timing of market introduction

of our products relative to competitive products and the availability of alternative treatments;

pricing and cost-effectiveness;

the execution and effectiveness

of our or any partners’ sales and marketing strategies;

our ability to obtain hospital

formulary approval;

our ability to obtain and

maintain sufficient third-party payor coverage or reimbursement.

demonstration

of clinical safety and efficacy compared to other products;

relative convenience, ease of administration and acceptance by physicians, patients and healthcare payors;

prevalence and severity of any adverse effects or serious adverse effects;

or warnings in the label approved by FDA and/or foreign regulatory authorities for such products;

timing of market introduction of our products relative to competitive products and the availability of alternative treatments;

and cost-effectiveness;

execution and effectiveness of our or any partners’ sales and marketing strategies;

ability to obtain hospital formulary approval;

ability to obtain and maintain sufficient third-party payor coverage or reimbursement.

we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues, and as

such, the failure of these products to find market acceptance would adversely affect our results of operations.

such, the failure of such product to find market acceptance would adversely affect our results of operations.

insurance and/or government coverage and adequate reimbursement are not available for our product candidates, it could impair our ability

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our business.

President Biden, we expect that the FDA, the Centers

for Disease Control and other agencies which affect our business may increase their regulatory efforts.

At the senior administrative

level, new regulators with a regulatory zeal may tighten existing regulations and that approach may also be taken in the routine interactions

between staff and our scientists and others.

For example, in late calendar year 2021 the White House Office of Management and Budget

issued the Fall 2021 Agency Rule List which contains 85 proposed and final rules that the agency plans to issue under the FDA’s

These rules or other regulatory developments which may occur in the future could have an adverse impact, directly or indirectly,

on our operations or on the operations of our collaborators.

Increased regulation and enforcement may lead to increased costs and further

delays in getting approvals, which may adversely affect our business.

President Biden, we expect that the FDA, the Centers for Disease Control and other agencies which affect our business may increase their

regulatory efforts.

At the senior administrative level, new regulators with a regulatory zeal may tighten existing regulations and that

approach may also be taken in the routine interactions between staff and our scientists and others.

For example, since taking office

in 2021, the Biden Administration has forwarded proposed rules and budget allocations intended to expand the FDA’s purview and

regulatory capabilities.

These rules or other regulatory developments which may occur in the future could have an adverse impact, directly

or indirectly, on our operations or on the operations of our collaborators.

Increased regulation and enforcement may lead to increased

costs and further delays in getting approvals, which may adversely affect our business.

pressures on our drug candidates, including as the result of proposed legislative changes, may negatively impact our future results of

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Among other things, such a system may seek to:

lower prescription prices

by permitting Medicare to negotiate prices;

limit price increases;

set prices for drugs which

do not have competition;

permit consumers to buy

prescriptions from other countries.

prescription prices by permitting Medicare to negotiate prices;

price increases;

prices for drugs which do not have competition;

consumers to buy prescriptions from other countries.

Additionally,

in 2021 the Biden administration proposed legislation to implement a number of regulatory changes to make affordable healthcare

available for a larger number of Americans, including by lowering the costs of prescription drugs.

The proposal includes measures that

would allow the government to negotiate prices of certain prescription drugs under Medicare and would redesign the Medicare Part D benefit

to limit patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

These changes are subject

to Congressional approval and we cannot predict what, if any, of these broad proposals or other legislation will pass.

in 2022 the Biden administration proposed legislation to implement a number of regulatory changes to make affordable healthcare available

for a larger number of Americans, including by lowering the costs of prescription drugs.

The proposal includes measures that would allow

the government to negotiate prices of certain prescription drugs under Medicare and would redesign the Medicare Part D benefit to limit

patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

Following the proposal, the Inflation Reduction Act was enacted later in

2022 which provides for lower cost prescription drugs and vaccines in Medicare and other federal programs, including by establishing a

$2,000 annual cap on out-of-pocket drug costs for Medicare participants beginning in 2025.

In a similar vein, in October 2022, President

Biden issued an executive order to address concerns about the high costs of prescription drugs in the U.S., wherein the Secretary of the

Department of Health and Human Services (“HHS”) was tasked with evaluating potential new health care payment and delivery

models designed to lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid

programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality

In its responsive report, the HHS indicated that it was “full steam ahead in delivering cost savings” and identified

three potential price-reducing models for further consideration, as well as other areas for further research.

Like the Inflation Reduction

Act, certain of the recent or newly proposed regulatory changes will be subject to Congressional approval, and we cannot predict what,

if any, of these broad proposals or other legislation or regulation will pass or otherwise be implemented, particularly with a divided

the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control

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any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing

arrangements for our products.

arrangements for our products, if any are approved.

Historically, products launched in the EU do not follow price structures of the U.S.

and tend to be priced

significantly lower.

and tend to be priced significantly lower.

we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product

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To market any products that may be approved, we must

build our sales, marketing, managerial and other non-technical capabilities or arrange with third parties to perform these services.

build our sales, marketing, managerial and other non-technical capabilities or arrange with third parties to provide these services.

current and future partners may not dedicate sufficient resources to the commercialization of our product candidates or may otherwise

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business relationships, including:

different regulatory requirements

for drug approvals in foreign countries;

reduced protection for

intellectual property rights;

unexpected changes in tariffs,

trade barriers and regulatory requirements;

economic weakness, including

inflation, or political instability in foreign economies and markets;

compliance with tax, employment,

immigration and labor laws for employees living or traveling abroad;

foreign taxes, including

withholding of payroll taxes;

foreign currency fluctuations,

which could cause increased operating expenses and reduced revenues, and other obligations incident to doing business in another

workforce uncertainty in

countries where labor unrest is endemic;

production shortages resulting

from any events affecting raw material supply or manufacturing capabilities abroad;

business interruptions

resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and

regulatory requirements for drug approvals in foreign countries;

protection for intellectual property rights;

changes in tariffs, trade barriers and regulatory requirements;

weakness, including inflation, or political instability in foreign economies and markets;

with tax, employment, immigration and labor laws for employees living or traveling abroad;

taxes, including withholding of payroll taxes;

currency fluctuations, which could cause increased operating expenses and reduced revenues, and other obligations incident to doing

business in another country;

uncertainty in countries where labor unrest is endemic;

impact of any war or hostilities such as the Russian invasion of Ukraine;

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons,

floods and fires.

we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience

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the loss of whose services may adversely impact the achievement of our

We are highly dependent on our President and co-Interim Chief Executive Officer, Dr.

Sam Lee and our Chief Financial Officer

and co-Interim Chief Executive Officer, James Martin, particularly following the passing away of our former Chief Executive Officer and

Chairman of the Board, Dr.

Gary Wilcox, in May 2021.

We may be unable to locate a new Chief Executive Officer capable of running our

company effectively, and any such individual will require high compensation in a competitive market for experienced and qualified personnel

within our industry.

We are highly dependent on our President and Co-Chief Executive Officer, Dr.

Sam Lee and our Chief Financial Officer and

Co-Chief Executive Officer, James Martin.

We may be unable to locate a new Chief Executive Officer capable of running our company effectively,

and any such individual will require high compensation in a competitive market for experienced and qualified personnel within our industry.

We do not carry “key-man” life insurance on any of our employees or advisors.

Furthermore, our future

success will also depend in part on the continued service of our key scientific and management personnel and our ability to identify,

hire, and retain additional personnel.

We may not be able to attract and retain personnel on acceptable terms, as there is significant

competition among numerous pharmaceutical companies for individuals with similar skill sets.

Because of this competition, our compensation

costs may increase significantly.

Furthermore, our future success will also depend

in part on the continued service of our key scientific and management personnel and our ability to identify, hire, and retain additional

We may not be able to attract and retain personnel on acceptable terms, as there is significant competition among numerous

pharmaceutical companies for individuals with similar skill sets.

Because of this competition, our compensation costs may increase significantly.

If we lose key employees, our business may suffer.

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Also, our management may need to divert a disproportionate amount of

its attention away from our day-to-day activities and to managing these growth activities.

its attention away from our day-to-day activities and to manage these growth activities.

We may not be able to effectively manage the

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The laws that may affect our ability to operate include:

the federal Anti-Kickback

Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,

directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an

item or service for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil and criminal

false claims laws and civil monetary penalty 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;

the federal Health Insurance

Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme

to defraud any healthcare benefit program and making false statements relating to healthcare matters;

HIPAA, as amended by the

Health Information Technology and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which imposes certain

requirements relating to the privacy, security and transmission of individually identifiable health information;

state and foreign 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 and foreign laws governing the privacy and security of health information

in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating

compliance efforts.

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering

or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase

or recommendation of an item or service for which payment may be made under a federal healthcare program, such as the Medicare and

Medicaid programs;

civil and criminal false claims laws and civil monetary penalty 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;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit

executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

as amended by the Health Information Technology and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which

imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;

and foreign 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 and foreign laws governing the privacy

and security of health information in certain circumstances, many of which differ from each other in significant ways and may not

have the same effect, thus complicating compliance efforts.

our operations are found to violate any of the laws described above or any other governmental regulations that apply to us, we may be

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Regardless of merit or eventual outcome, product liability claims may cause:

impairment of our business

withdrawal of clinical

trial participants;

costs due to related litigation;

distraction of management’s

attention from our primary business;

substantial monetary awards

to patients or other claimants;

regulatory scrutiny and

product recalls, withdrawals or labeling, marketing or promotional restrictions;

the inability to commercialize

our product candidates;

decreased demand for our

product candidates, if approved for commercial sale.

of our business reputation;

of clinical trial participants;

due to related litigation;

of management’s attention from our primary business;

monetary awards to patients or other claimants;

scrutiny and product recalls, withdrawals or labeling, marketing or promotional restrictions;

inability to commercialize our product candidates;

demand for our product candidates, if approved for commercial sale.

coverage is becoming increasingly expensive and we may not be able to maintain insurance coverage at a reasonable cost or in sufficient

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We also maintain a small finance and accounting

office in Miami, Florida.

In addition, while we do not have offices in Australia, our Influenza A Phase 1 clinical trial in

Australia will depend on one or more CROs and their facilities located in Australia for the furtherance of our research and development

efforts as to that product.

We will also use CROs for our two planned COVID-19 clinical trials.

We and third parties on which we rely

are vulnerable to natural disasters such as earthquakes, tornados, severe storms, hurricanes, tsunamis, and fires, as well as

other events that could disrupt our operations and cause delays in research and development of our product candidates.

We do not carry

insurance for natural disasters or similar events, and we may not carry sufficient business interruption insurance to compensate us for

losses that may occur.

office in Miami, Florida and an administrative office in Australia.

In addition, our Influenza A Phase 1 clinical trial depends on one

or more CROs and their facilities located in Australia for Phase 1 and the United Kingdom for Phase 2a for the furtherance of our research

and development efforts as to that product.

We also plan use Australian CROs for our planned COVID-19 clinical trial in 2023.

third parties on which we rely are vulnerable to natural disasters such as earthquakes, tornados, severe storms, hurricanes, tsunamis,

and fires, as well as other events that could disrupt our operations and cause delays in research and development of our product candidates.

We do not carry insurance for natural disasters or similar events, and we may not carry sufficient business interruption insurance to

compensate us for losses that may occur.

Any losses or damages we incur could have a material adverse effect on our operations.

What changed 10-K

Item 1A. Risk Factors