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Item 1A. Risk Factors

2021-03-26 compared with 2020-03-25 · 1492 added, 537 removed, 162 unchanged (93% of the section changed)

1 unchanged sentence

the notes thereto, should be considered by investors.

Related to Business

Related to Our Financial Resources and Capital Needs

are engaged in early-stage research and as such may not be successful in our efforts to develop a portfolio of commercially viable

8 unchanged sentences

research methodology used may not be successful in identifying potential product candidates;

however, the Company has identified

two promising lead candidate compounds which have activity in animal models, one of which, LB-100, has completed a Phase 1

clinical trial;

however, we have identified two

promising lead candidate compounds which have activity in animal models, one of which, LB-100, has completed a Phase 1 clinical

candidates for drugs may on further study be shown to have harmful side effects or other characteristics that indicate they

2 unchanged sentences

programs or in-license suitable products or delivery technologies on acceptable business terms, our business prospects will suffer.

auditors have included a going concern modification in their opinion;

we do not expect to obtain any significant revenues for

several years and there is no assurance that we will ever generate any revenues or be profitable.

Company’s consolidated financial statements have been presented on the basis that it is a going concern, which contemplates

the realization of assets and satisfaction of liabilities in the normal course of business.

The Company has not generated any

revenues from operations to date and does not expect to do so in the foreseeable future.

The Company has experienced recurring

losses and negative operating cash flows since inception and has financed its working capital requirements during this period

primarily through the recurring sale of its equity securities and the exercise of outstanding common stock options and purchase

a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern

within one year of the date that the consolidated financial statements were issued.

In addition, the Company’s independent

registered public accounting firm, in their report on the Company’s consolidated financial statements for the year ended

December 31, 2019, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund

its research and development activities and to ultimately achieve sustainable operating revenues and profits.

The Company’s

consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

December 31, 2019, the Company had cash and cash equivalents of $2,598,864 available to fund its operations.

Because the Company

is currently engaged in Phase 2 clinical trials, it is expected that it will take a significant amount of time to develop any

product or intellectual property capable of generating sustainable revenues.

Accordingly, the Company’s business is unlikely

to generate any sustainable operating revenues in the next several years and may never do so.

In addition, to the extent that

the Company is able to generate revenues through licensing its technologies or through product sales, there can be no assurance

that the Company will be able to achieve positive earnings and operating cash flows.

Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical

companies with major programs in cancer.

The Company expects that it will need to begin to raise additional capital no later than

the fourth quarter of 2020.

amount and timing of future cash requirements will depend on the pace and design of the Company’s clinical trial program.

As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances

that the Company will be able to secure additional financing on acceptable terms, or at all, as and when necessary to continue

to conduct operations.

The impact of the coronavirus on capital markets may affect the availability, amount and type of financing

available to the Company in the future.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale

back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although

there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its compounds,

or to discontinue its operations entirely.

we were to materially breach any existing or future license or collaboration agreements, we could lose our ability to commercialize

the related technologies, and our business could be materially and adversely affected.

intend to enter into intellectual property licenses and agreements, all of which we expect would be integral to our business.

These licenses and agreements would impose various research, development, commercialization, sublicensing, royalty, indemnification,

insurance and other obligations on us.

If we or our collaborators fail to perform under these agreements or otherwise breach obligations

imposed by them, we could lose intellectual property rights that are important to our business.

may not be successful in establishing additional strategic collaborations, which could adversely affect our ability to develop

and commercialize products.

the future, we may seek opportunities to establish new collaborations, joint ventures and strategic collaborations for the development

and commercialization of products we discover.

We face significant competition in seeking appropriate collaborators and the negotiation

process is time-consuming and complex.

We may not be successful in our efforts to establish additional strategic collaborations

or other alternative arrangements.

Even if we are successful in our efforts to establish a collaboration or agreement, the terms

that we establish may not be favorable to us.

Finally, such strategic alliances or other arrangements may not result in successful

products and associated revenue.

life sciences industry is highly competitive and subject to rapid technological change.

life sciences industry is highly competitive and subject to rapid and profound technological change.

Our present and potential

competitors include major pharmaceutical companies, as well as specialized biotechnology and life sciences firms in the United

States and in other countries.

Most of these companies have considerably greater financial, technical and marketing resources

Additional mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources

being concentrated in our competitors.

Our existing or prospective competitors may develop processes or products that are more

effective than ours or be more effective at implementing their technologies to develop commercial products faster.

Our competitors

may succeed in obtaining patent protection and/or receiving regulatory approval for commercializing products before us.

by our competitors may render our product candidates obsolete or non-competitive.

also experience competition from universities and other research institutions, and we are likely to compete with others in acquiring

technology from those sources.

There can be no assurance that others will not develop technologies with significant advantages

over those that we are seeking to develop.

Any such development could harm our business.

may be unable to compete successfully with our competitors.

compete with universities and other research institutions engaged in research in these areas.

Many of our competitors have greater

technical and financial resources than we do.

ability to compete successfully is based on numerous factors, including:

cost-effectiveness of any product we ultimately commercialize relative to competing products;

ease of use and ready availability of any product we bring to market;

relative speed with which we are able to bring any product resulting from our research to market in our target markets.

we are unable to distinguish our products from competing products, or if competing products reach the market first, we may be

unable to compete successfully with current or future competitors.

This could affect our ability to achieve revenues and profitability.

have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing

losses for the foreseeable future.

are a clinical stage biopharmaceutical company that uses biomarker technology to identify enzyme targets associated with serious

common diseases and then designs novel compounds to attack those threats.

We do not have any products approved by regulatory authorities

and have not generated any revenues from collaboration and licensing agreements or product sales to date, and have incurred significant

research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses.

result, we have not been profitable and have incurred significant operating losses since our inception.

For the years ended December

31, 2020 and 2019, we reported a net loss of $3,264,882 and $2,440,343, respectively.

As of December 31, 2020 and December 31,

2019, we had an accumulated deficit of $30,353,768 and $27,088,886, respectively.

do not expect to generate revenues for many years, if at all.

We expect to continue to incur significant expenses and operating

losses for the foreseeable future.

We anticipate these losses to increase as we continue to research, develop and seek regulatory

approvals for our product candidate and any additional product candidates we may acquire, and potentially begin to commercialize

product candidates that may achieve regulatory approval.

We may also encounter unforeseen expenses, difficulties, complications,

delays and other unknown factors that may adversely affect our business.

The size of our future net losses will depend, in part,

on the rate of future growth of our expenses and our ability to generate revenues.

Our expenses will further increase as we:

clinical trials of our lead product candidate, LB-100;

or acquire the rights to, and pursue development of, other products, product candidates or technologies;

additional clinical, manufacturing, quality control, quality assurance and scientific personnel;

marketing approval for any product candidates that successfully complete clinical trials;

our outsourced manufacturing and commercial activities and establish sales, marketing and distribution capabilities, if we

receive, or expect to receive, marketing approval for any product candidates;

expand and protect our intellectual property portfolio;

operational, financial and management information systems and personnel.

need significant additional financing to fund our operations and complete the development and, if approved, the commercialization

of our product candidate.

If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our

product development programs or commercialization efforts.

expect that our existing cash resources as of December 31, 2020, combined with the proceeds from our registered direct equity

offering completed in March 2021, will provide sufficient working capital resources to fund our operations, including our clinical

trial program with respect to the development of our lead anti-cancer clinical compound LB-100, through mid-2022.

existing cash resources will not be sufficient to complete development of and obtain regulatory approval for our product candidate,

and we will need to raise significant additional capital to help us do so.

The Company estimates that it will need to raise additional

capital to fund its operations, including its various clinical trial commitments, by no later than June 30, 2022.

our operating plan may change as a result of many factors currently unknown to us, including possible additional clinical trials,

and we may need additional funds sooner than planned.

expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our

product candidate and the advancement and expansion of our preclinical research pipeline.

These expenditures will include costs

associated with research and development, potentially acquiring new product candidates or technologies, conducting preclinical

studies and clinical trials and potentially obtaining regulatory approvals and manufacturing products, as well as marketing and

selling products approved for sale, if any.

and future capital requirements depend on many factors, including:

scope, progress, results and costs of our ongoing and planned development programs for our product candidate, as well as any

additional clinical trials we undertake to obtain data sufficient to seek marketing approval for our product candidate;

timing of, and the costs involved in, obtaining regulatory approvals for our product candidate if our clinical trials are

cost of commercialization activities for our product candidate, if our product candidate is approved for sale, including marketing,

sales and distribution costs;

cost of manufacturing our product candidate for clinical trials in preparation for regulatory approval, including the cost

and timing of process development, manufacturing scale-up and validation activities;

ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;

costs to in-license future product candidates or technologies;

costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including

litigation costs and the outcome of such litigation;

costs in defending and resolving future derivative and securities class action litigation;

operating expenses;

emergence of competing technologies or other adverse market developments.

funds may not be available when we need them on terms that are acceptable to us, or at all.

We have no committed source of additional

If adequate funds are not available to us on a timely basis, we may not be able to continue as a going concern or we

may be required to delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for

our product candidate or target indications, or delay, limit, reduce or terminate our establishment of sales and marketing capabilities

or other activities that may be necessary to commercialize our product candidate.

currently have no source of revenues.

We may never generate revenues or achieve profitability.

we do not generate any revenues from product sales or otherwise.

Even if we are able to successfully achieve regulatory approval

for our product candidate, we do not know when we will generate revenues or become profitable, if at all.

Our ability to generate

revenues from product sales and achieve profitability will depend on our ability to successfully commercialize products, including

our primary product candidate, LB-100, and any other product candidates that we may develop, in-license or acquire in the future.

Our ability to generate revenues and achieve profitability also depends on a number of additional factors, including our ability

complete development activities, including the necessary clinical trials;

and submit New Drug Applications, or NDAs, to the FDA and obtain U.S.

regulatory approval for indications for which there

is a commercial market;

and submit applications to foreign regulatory authorities;

regulatory approval in territories with viable market sizes;

coverage and adequate reimbursement from third parties, including government and private payors;

commercially viable prices for our product, if any;

and maintain supply and manufacturing relationships with reliable third parties and/or build our own manufacturing facility

and ensure adequate, legally globally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

distribution processes for our product candidate;

commercial quantities of our product candidate, once approved, at acceptable cost levels;

obtain additional funding, if required

to develop and commercialize our product candidate;

a commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves, in the

markets in which we choose to commercialize on our own;

market acceptance of our product;

hire and retain qualified personnel;

our rights in our intellectual property portfolio.

revenues for any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the

markets in the territories for which it gains regulatory approval, the accepted price for the product, the ability to get reimbursement

at any price, and whether we own the commercial rights for that territory.

If the number of our addressable disease patients is

not as significant as our estimates, the indication approved by regulatory authorities is narrower than we expect, or the reasonably

accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant

revenues from sales of such products, even if approved.

In addition, we anticipate incurring significant costs associated with

commercializing any approved product candidate.

As a result, even if we generate revenues, we may not become profitable and may

need to obtain additional funding to continue operations.

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.

Tax Cuts and Jobs Act could adversely affect our business and financial condition.

1, “An Act to provide for reconciliation pursuant to title II and V of the concurrent resolution on the budget for fiscal

year 2018,”

informally entitled the Tax Cuts and Jobs Act (“Tax Act”) enacted on December 22, 2017, among other

things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal

rate of 35% to a single rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted taxable income (except

for certain small businesses), limitation of the deduction for net operating losses carried forward from taxable years beginning

after December 31, 2017 to 80% of current year taxable income and elimination of net operating loss carrybacks, one time taxation

of offshore earnings at reduced rates regardless of whether they are repatriated, elimination of U.S.

tax on foreign earnings

(subject to certain important exceptions), providing immediate deductions for certain new investments instead of deductions for

depreciation expense over time, and modifying or repealing many business deductions and credits (including reduction of tax credits

under the Orphan Drug Act).

Notwithstanding the reduction in the corporate income tax rate, the overall impact of the Tax Act

is uncertain and our business and financial condition could be adversely affected.

In addition, it is uncertain if and to what

extent various states will conform to the Tax Act.

ability to use net operating losses to offset future taxable income may be subject to limitations.

of December 31, 2020, we had federal net operating loss, or NOL, carryforwards of approximately $5,477,000.

Our NOLs generated

in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

tax laws, and will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused and be unavailable

to offset future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017

may be carried forward indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent

various states will conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could

minimize its applicability.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding

provisions of state law, if a corporation undergoes an “ownership change,”

which is generally defined as a greater

than 50% change, by value, in the ownership of its equity over a three-year period, the corporation’s ability to use its

pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited.

Related to the Development and Regulatory Approval of Our Product Candidate

Clinical-stage

biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which

may entail substantial risk.

are a clinical-stage biopharmaceutical company with a product candidate in clinical development.

The success of our product candidate

will depend on several factors, including the following:

conducting and successfully completing preclinical development activities, including preclinical efficacy and IND-enabling

studies, for our product candidate or product candidates we may, in the future, in-license or acquire;

conducting and completing clinical trials for our product candidate with positive results;

of regulatory approvals from applicable authorities;

and maintaining patent and trade secret protection and regulatory exclusivity for our product candidate;

arrangements with third-party manufacturers, receiving regulatory approval of our manufacturing processes and our third-party

manufacturers’

facilities from applicable regulatory authorities and ensuring adequate supply of drug product;

manufacturing

our product candidate at an acceptable cost;

launching commercial sales of our product candidate, if approved, whether alone or in collaboration with others;

acceptance of our product candidate, if approved, by patients, the medical community and third-party payors;

competing with other therapies;

our product candidate is approved, obtaining and maintaining coverage and adequate reimbursement by third-party payors, including

government payors, for our product candidate;

with all applicable regulatory requirements, including FDA current Good Clinical Practices (“GCP”), current Good

Manufacturing Practices (“cGMP”), and standards, rules and regulations governing promotional and other marketing

a continued acceptable safety profile of the product during development and following approval.

we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability

to successfully develop and commercialize our product candidate, which could materially harm our business.

may find it difficult to enroll patients in our clinical trials which could delay or prevent the start of clinical trials for

our product candidate.

and qualifying patients to participate in clinical trials of our product candidate is essential to our success.

The timing of

our clinical trials depends in part on the rate at which we can recruit patients to participate in clinical trials of our product

candidate, and we may experience delays in our clinical trials if we encounter difficulties in enrollment.

If we experience delays

in our clinical trials, the timeline for obtaining regulatory approval of our product candidate will most likely be delayed.

factors may affect our ability to identify, enroll and maintain qualified patients, including the following:

criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical

of the clinical trial;

and nature of the patient population;

patients’

perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally

in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

availability and efficacy of competing therapies and clinical trials;

of other trials underway in the same patient population;

of physicians to participate in our planned clinical trials;

of the disease under investigation;

of patients to clinical sites;

who do not complete the trials for personal reasons;

with CROs and/or with other vendors that handle our clinical trials.

may not be able to initiate or continue to support clinical trials of LB-100, our product candidate, for one or more indications,

or any future product candidates if we are unable to locate and enroll a sufficient number of eligible participants in these trials

as required by the FDA or other regulatory authorities.

Even if we are able to enroll a sufficient number of patients in our clinical

trials, if the pace of enrollment is slower than we expect, the development costs for our product candidate may increase and the

completion of our trials may be delayed or our trials could become too expensive to complete.

we experience delays in the completion of, or termination of, any clinical trials of our product candidate, the commercial prospects

of our product candidate could be harmed, and our ability to generate product revenue from any of our product candidate could

be delayed or prevented.

In addition, any delays in completing our clinical trials would likely increase our overall costs, impair

product candidate development and jeopardize our ability to obtain regulatory approval relative to our current plans.

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

results of preclinical studies or earlier clinical trials are not necessarily predictive of future results.

Our existing product

candidate in clinical trials, and any other product candidates that may advance into clinical trials, may not have favorable results

in later clinical trials or receive regulatory approval.

in preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate

the efficacy and safety of an investigational drug.

A number of companies in the pharmaceutical and biotechnology industries,

including those with greater resources and experience than us, have suffered significant setbacks in clinical trials, even after

seeing promising results in earlier preclinical studies or clinical trials.

the results reported in earlier preclinical studies or clinical trials for our product candidate, we do not know whether the clinical

trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidate

for a particular indication, in any particular jurisdiction.

Efficacy data from prospectively designed trials may differ significantly

from those obtained from retrospective subgroup analyses.

If later-stage clinical trials do not produce favorable results, our

ability to achieve regulatory approval for our product candidate may be adversely impacted.

Even if we believe that we have adequate

data to support an application for regulatory approval to market our current product candidate or any future product candidates,

the FDA or other regulatory authorities may not agree and may require that we conduct additional clinical trials.

drug development involves a lengthy and expensive process with an uncertain outcome.

testing is expensive and can take many years to complete, with the outcome inherently uncertain.

Failure can occur at any time

during the clinical trial process.

Before obtaining approval from regulatory authorities for the sale of our product candidate,

we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans.

initiating clinical trials, a sponsor must complete extensive preclinical testing of a product candidate, including, in most cases,

preclinical efficacy experiments as well as IND-enabling toxicology studies.

These experiments and studies may be time-consuming

and expensive to complete.

The necessary preclinical testing may not be completed successfully for a preclinical product candidate

and a potentially promising product candidate may therefore never be tested in humans.

Once it commences, clinical testing is

expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome.

A failure of one

or more clinical trials can occur at any stage of testing.

The outcome of preclinical testing and early clinical trials may not

be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final

Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies

that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless

failed to obtain marketing approval of their products.

We may experience numerous unforeseen events during drug development that

could delay or prevent our ability to receive marketing approval or commercialize our product candidate.

In particular, clinical

trials of our product candidate may produce inconclusive or negative results.

We have limited data regarding the safety, tolerability

and efficacy of our product candidate.

Clinical trials also require the review and oversight of an institutional review board

(“IRB”).

An inability or delay in obtaining IRB approval could prevent or delay the initiation and completion of clinical

trials, and the FDA may decide not to consider any data or information derived from a clinical investigation not subject to initial

and continuing IRB review and approval.

may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trials will begin

or enroll subjects on time, will need to be redesigned or will be completed on schedule, if at all.

There can be no assurance

that the FDA will not put clinical trials of our product candidate on hold in the future.

Clinical trials may be delayed, suspended

or prematurely terminated for a variety of reasons, such as:

or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that

we are able to execute;

or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority

regarding the scope or design of a trial;

or failure in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can

be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

or failure in obtaining IRB approval or the approval of other reviewing entities, including comparable foreign regulatory

authorities, to conduct a clinical trial at each site;

of clinical trial sites from our clinical trials or the ineligibility of a site to participate in our clinical trials;

or failure in recruiting and enrolling suitable subjects to participate in a trial;

or failure in subjects completing a trial or returning for post-treatment follow-up;

sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements,

or dropping out of a trial;

to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial

programs, including some that may be for the same indication;

of our third-party clinical trial managers, CROs, clinical trial sites, contracted laboratories or other third-party vendors

to satisfy their contractual duties, meet expected deadlines or return trustworthy data;

or failure in adding new trial sites;

results or data that are ambiguous or negative or are inconsistent with earlier results or data;

of trial design necessitated by re-evaluation of design assumptions based upon observed data;

from the FDA, the IRB or a comparable foreign regulatory authority, or results from earlier stage or concurrent preclinical

studies and clinical trials, that might require modification to the protocol for a trial;

decision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend or terminate clinical trials at

any time for safety issues or for any other reason;

risk-benefit profile, unforeseen safety issues or adverse side effects;

to demonstrate a benefit from using a product candidate;

in manufacturing or obtaining from third parties sufficient quantities of a product candidate to start or to use in clinical

of adequate funding to continue a trial, including the incurrence of unforeseen costs due to enrollment delays, requirements

to conduct additional studies or increased expenses associated with the services of our CROs and other third parties;

in governmental regulations or administrative actions or lack of adequate funding to continue a clinical trial.

we experience delays in the completion or termination of any clinical trial of our product candidate, the approval and commercial

prospects of our product candidate will be harmed, delaying our ability to generate product revenues from such product candidate

and our costs will most likely increase.

The required regulatory approvals may also be delayed, thereby jeopardizing our ability

to commence product sales and generate revenues and the period of commercial exclusivity for our product may be decreased.

approval of our product candidate may be denied for the same reasons that caused the delay.

associated with operating in foreign countries could materially adversely affect our product development.

may conduct future studies in countries outside of the U.S.

Consequently, we may be subject to risks related to operating in foreign

Risks associated with conducting operations in foreign countries include:

regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;

more stringent privacy requirements

for data to be supplied to our operations in the U.S., e.g.

, General Data Protection Regulation in the European Union;

changes in tariffs, trade barriers and regulatory requirements;

economic weakness, including inflation, or political instability

in particular 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;

payor reimbursement regimes, governmental payors or patient self-pay systems and price controls;

currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident

to doing business or operating in another country;

uncertainty in countries where labor unrest is more common than in the U.S.;

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

interruptions resulting from geopolitical actions, including war and terrorism.

current and future product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects

or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label

or result in significant negative consequences following any regulatory approval.

side effects caused by our current or future product candidates, their delivery methods or dosage levels could cause us or regulatory

authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of

regulatory approval or termination of clinical trials by the FDA or other comparable foreign regulatory authorities;

that approves and, monitors biomedical research to protect the rights and welfare of human subjects.

As a result of safety or

toxicity issues that we may experience in our clinical trials, or negative or inconclusive results from the clinical trials of

others for drug candidates similar to our own, we may not receive approval to market our current product candidate or any product

candidates we may pursue, which could prevent us from ever generating revenues or achieving profitability.

Results of our trials

could reveal an unacceptably high severity and incidence of side effects.

In such an event, our trials could be suspended or terminated,

and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our

current or any future product candidates for any or all targeted indications.

The drug-related side effects could also affect

patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.

Any of these occurrences may have a material adverse effect on our business, results of operations, financial condition, cash

flows and future prospects.

Additionally,

if our product candidate receives regulatory approval, and we or others later identify undesirable side effects caused by such

product, a number of potentially significant negative consequences could result, including that:

may be forced to suspend marketing of such product;

authorities may withdraw their approvals of such product;

authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success

of such product;

may be required to conduct post-marketing studies;

may be required to change the way the product is administered;

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

reputation may suffer.

of these events could prevent us from achieving or maintaining market acceptance of our product candidate, if approved.

product development program may not uncover all possible adverse events that patients who take our product candidate may experience.

The number of subjects exposed to our product candidate and the average exposure time in the clinical development program may

be inadequate to detect rare adverse events or chance findings that may only be detected once the product is administered to more

patients and for greater periods of time.

trials by their nature utilize a sample of the potential patient population.

However, with a limited number of subjects and limited

duration of exposure, we cannot be fully assured that rare and severe side effects of our product candidate will be uncovered.

Such rare and severe side effects may only be uncovered with a significantly larger number of patients exposed to our product

If such safety problems occur or are identified after our product candidate reaches the market, the FDA may require

that we amend the labeling of the product or recall the product, or may even withdraw approval for the product.

future success is dependent on the regulatory approval of our product candidate.

business is dependent on our ability to obtain regulatory approval for our product candidate in a timely manner.

We cannot commercialize

our product candidate in the U.S.

without first obtaining regulatory approval for the product from the FDA.

Similarly, we cannot

commercialize our product candidate outside of the U.S.

without obtaining regulatory approval from comparable foreign regulatory

Before obtaining regulatory approvals for the commercial sale of our product candidate for a target indication, we

must demonstrate with substantial evidence gathered in preclinical studies and clinical trials, that the product candidate is

safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate

with respect to such product candidate.

time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes

many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including

the substantial discretion of the regulatory authorities.

In addition, approval policies, regulations, or the type and amount

of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and

may vary among jurisdictions.

if a product candidate were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval

might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications,

or may be subject to burdensome post-approval study or risk management requirements.

Also, any regulatory approval of our current

product candidate or any future product candidates we may pursue, once obtained, may be withdrawn.

current product candidate and future product candidates could fail to receive regulatory approval from the FDA.

have not obtained regulatory approval for our product candidate and it is possible that our existing product candidate or any

future product candidates will not obtain regulatory approval, for many reasons, including:

with the regulatory authorities regarding the scope, design or implementation of our clinical trials;

to demonstrate that a product candidate is safe and effective for our proposed indication;

of clinical trials to meet the level of statistical significance required for approval;

to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

with our interpretation of data from preclinical studies or clinical trials;

insufficiency of data collected from clinical trials of our product candidate to support the submission and filing of an NDA

or other submission or to obtain regulatory approval;

to obtain approval of our manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical

and commercial supplies or our own manufacturing facility;

in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.

FDA or a comparable foreign regulatory authority may require more information, including additional preclinical or clinical data

to support approval or additional studies, which may delay or prevent approval and our commercialization plans, or we may decide

to abandon the development program.

If we were to obtain approval, regulatory authorities may approve our current product candidate

and any future product candidates we may pursue for fewer or more limited indications than we request (including failing to approve

the most commercially promising indications), may grant approval contingent on the performance of costly post-marketing clinical

trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the

successful commercialization of that product candidate.

we are unable to obtain regulatory approval for our product candidate in one or more jurisdictions, or any approval contains significant

limitations, we may not be able to obtain sufficient funding to continue the development of that product or generate revenues

attributable to that product candidate.

to obtain regulatory approval in international jurisdictions would prevent our product candidate from being marketed abroad.

addition to regulations in the U.S., to market and sell our product candidate in the European Union, United Kingdom, many Asian

countries and other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory

requirements.

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

approval by one regulatory authority outside the U.S.

does not ensure approval by regulatory authorities in other countries or

jurisdictions or by the FDA.

The regulatory approval process outside the U.S.

generally includes all of the risks associated with

obtaining FDA approval as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.

procedure varies among countries and can involve additional testing.

The time required to obtain approval may differ substantially

from that required to obtain FDA approval.

We may not be able to obtain approvals from regulatory authorities outside the U.S.

on a timely basis, if at all.

Clinical trials accepted in one country may not be accepted by regulatory authorities in other countries.

In addition, many countries outside the U.S.

require that a product be approved for reimbursement before it can be approved for

sale in that country.

A product candidate that has been approved for sale in a particular country may not receive reimbursement

approval in that country.

may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our product in any market.

If we are unable to obtain approval of any of our current product candidate or any future product candidates we may pursue by

regulatory authorities in the European Union, United Kingdom, Asia or elsewhere, the commercial prospects of that product candidate

may be significantly diminished, our business prospects could decline and this could materially adversely affect our business,

results of operations and financial condition.

if our current primary product candidate received regulatory approval, it may still face future development and regulatory difficulties.

if we obtain regulatory approval for our primary product candidate, LB-100, that approval would be subject to ongoing requirements

by the FDA and comparable foreign regulatory authorities governing the manufacture, quality control, further development, labeling,

packaging, storage, distribution, adverse event reporting, safety surveillance, import, export, advertising, promotion, recordkeeping

and reporting of safety and other post-marketing information.

These requirements include submissions of safety and other post-marketing

information and reports, registration, as well as continued compliance by us and/or our CMOs and CROs for any post-approval clinical

trials that we may conduct.

The safety profile of any product will continue to be closely monitored by the FDA and comparable

foreign regulatory authorities after approval.

If the FDA or comparable foreign regulatory authorities become aware of new safety

information after approval of our product candidate, they may require labeling changes or establishment of a risk evaluation and

mitigation strategy, impose significant restrictions on such product’s indicated uses or marketing or impose ongoing requirements

for potentially costly post-approval studies or post-market surveillance.

addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the

FDA and other regulatory authorities for compliance with cGMP, GCP, and other regulations.

If we or a regulatory agency discover

previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the

facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility

or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we, our product

candidate or the manufacturing facilities for our product candidate fail to comply with applicable regulatory requirements, a

regulatory agency may:

warning letters or untitled letters;

modifications to promotional materials or require us to provide corrective information to healthcare practitioners;

us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required

due dates for specific actions and penalties for noncompliance;

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

or withdraw regulatory approval;

any ongoing clinical trials;

to approve pending applications or supplements to applications filed by us;

or impose restrictions on operations, including costly new manufacturing requirements;

or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.

occurrence of any event or penalty described above may inhibit our ability to successfully commercialize our product and generate

and promotion of any product candidate that obtains approval in the U.S.

is heavily scrutinized by the FDA, the Department of

Justice, the Office of Inspector General of Health and Human Services, state attorneys general, members of Congress and the public.

A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance

with the provisions of the approved label.

Additionally, advertising and promotion of any product candidate that obtains approval

outside of the U.S.

is heavily scrutinized by comparable foreign regulatory authorities.

Violations, including actual or alleged

promotion of our product for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and

civil and criminal sanctions by the FDA, as well as prosecution under the federal False Claims Act.

Any actual or alleged failure

to comply with labeling and promotion requirements may have a negative impact on our business.

Related to Our Dependence on Third Parties

depend on certain key scientific personnel for our success who do not work full time for us.

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success depends on the continued availability and contributions of our founder and Chief Executive Officer, Dr.

Kovach is 83 years old.

Kovach is 84 years old and is being treated for recurrent asymptomatic prostate cancer.

The loss of services of Dr.

Kovach could delay or reduce our product development and commercialization

efforts and would require that we hire a qualified replacement to fill the position of the Chief Executive Officer.

recruiting and retaining qualified scientific personnel to perform future research and development work will be critical to our

The loss of members of our scientific personnel, or our inability to attract or retain other qualified personnel or advisors,

could significantly weaken our management, harm our ability to compete effectively and harm our business.

could delay or reduce our product development and commercialization efforts and would require that we hire a qualified replacement

to fill the position of the Chief Executive Officer.

Furthermore, recruiting and retaining qualified scientific personnel to perform

future research and development work will be critical to our success.

The loss of members of our scientific personnel, or our

inability to attract or retain other qualified personnel or advisors, could significantly weaken our management, harm our ability

to compete effectively and harm our business.

The competition for qualified personnel in the pharmaceutical field is intense and,

as a result, we may be unable to attract and retain qualified personnel necessary for the development of our business.

September 2015, we entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which we engaged BioPharmaWorks to

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suspended and resumed;

effective March 1, 2019, the Company and BioPharmaWorks agreed to resume services under this Collaboration

Agreement, and the Collaboration Agreement is currently in effect.

We believe that this Collaboration Agreement mitigates, to

a certain extent, our reliance on the services of Dr.

effective March 1, 2019, we and BioPharmaWorks agreed to resume services under this Collaboration Agreement,

and the Collaboration Agreement is currently in effect.

Additionally,

we have recently hired Dr.

Miser as Chief Medical Officer.

For the foreseeable future, Dr.

Miser will be working with

us on a half-time basis.

We believe that this Collaboration Agreement with BioPharmaWorks and the hiring of Dr.

Miser mitigate,

to a certain extent, our reliance on the services of Dr.

Kovach, and would allow us the time to replace Dr.

Kovach in the event that

such a need arose.

Kovach in the event

that such a need arose.

expect to rely heavily on third parties for the conduct of clinical trials of our product candidates.

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Cancer Institute Phase 1 clinical trial contract for ten years at the Mayo Clinic, Rochester, Minnesota.

However, the Company

has no experience in conducting clinical trials and expects to rely heavily on collaborative partners and contract research organizations

for their performance and management of clinical trials of our product candidates.

However, we have no experience

in conducting clinical trials and expects to rely heavily on collaborative partners and contract research organizations for their

performance and management of clinical trials of our product candidates.

products under development may not be effective in treating any of our targeted disorders or may prove to have undesirable or

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operating revenues and sustainable profitability, as a result of which our stock price could decline substantially.

if our products are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience

unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data and promotional

activities for such product, will be subject to continual review and periodic inspections by the FDA and other regulatory bodies.

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

the product may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor the safety or

efficacy of the product.

Later discovery of previously unknown problems with our products, including unanticipated adverse events

or adverse events of unanticipated severity or frequency, manufacturer or manufacturing processes, or failure to comply with regulatory

requirements, may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market,

voluntary or mandatory recall, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil

or criminal penalties.

to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad.

intend to market our products in international markets.

In order to market our products in the European Union and many other foreign

jurisdictions, we must obtain separate regulatory approvals.

The approval procedure varies among countries and can involve additional

testing, and the time required to obtain approval may differ from that required to obtain FDA approval.

The foreign regulatory

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

We may not obtain foreign regulatory approvals

on a timely basis, if at all.

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

by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.

We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any

are subject to uncertainty relating to health care reform measures and reimbursement policies which, if not favorable to our product

candidates, could hinder or prevent commercial success of our product candidates.

continuing efforts of the government, insurance companies, managed care organizations and other payors of health care costs to

contain or reduce costs of health care may adversely affect:

ability to generate revenues and achieve profitability;

future revenues and profitability of our potential customers, suppliers and collaborators;

availability of capital.

certain foreign markets, the pricing of prescription pharmaceuticals is subject to government control.

In the United States, given

recent federal and state government initiatives directed at lowering the total cost of health care, the United States Congress

and state legislatures will likely continue to focus on health care reform, the cost of prescription pharmaceuticals and on the

reform of the Medicare and Medicaid systems.

While we cannot predict the effects of the implementation of any new legislation

or whether any current legislative or regulatory proposals affecting our business will be adopted, the implementation of new legislation

or the announcement or adoption of current proposals could have a material and adverse effect on our business, financial condition

and results of operations.

ability to commercialize our product candidates successfully will depend in part on the extent to which governmental authorities,

private health insurers and other organizations establish appropriate reimbursement levels for the cost of our products and related

Third-party payors are increasingly challenging the prices charged for medical products and services.

Also, the trend

toward managed health care in the United States, which could significantly influence the purchase of health care services and

products, as well as legislative efforts to implement health care reforms such as the Patient Protection and Affordable Care Act

(the “ACA”), which became law in 2010, and other measures, may result in lower prices for our product candidates or

exclusion of our product candidates from reimbursement programs.

The cost containment measures that health care payors and providers

are instituting, and the effect of the ACA and other health care reform, could materially and adversely affect our results of

product candidates that we may develop may not gain market acceptance among physicians, healthcare payors, patients and the medical

If physicians and patients do not accept the products that we may develop, our ability to generate product revenue

in the future will be adversely affected.

Market acceptance of and demand for any product that we may develop will depend on many

factors, including:

ability to provide acceptable evidence of safety and efficacy;

and ease of administration;

and severity of adverse side effects;

of alternative treatments;

effectiveness;

effectiveness

of our marketing strategy and the pricing of any product that we may develop;

concerning our products or competitive products;

ability to obtain third-party coverage or insurance reimbursement.

face the risk of product liability claims and may not be able to obtain insurance.

business exposes us to the risk of product liability claims that is inherent in the testing, manufacturing, and marketing of drugs.

Although we will obtain product liability and clinical trial liability insurance when appropriate, this insurance is subject to

deductibles and coverage limitations.

We may not be able to obtain or maintain adequate protection against potential liabilities.

In addition, if any of our product candidates are approved for marketing, we may seek additional insurance coverage at that time.

If we are unable to obtain insurance at acceptable cost or on acceptable terms with adequate coverage or otherwise protect against

potential product liability claims, we will be exposed to significant liabilities, which may harm our business.

These liabilities

could prevent or interfere with our product commercialization efforts.

Defending a suit, regardless of merit, could be costly,

could divert management attention, and might result in adverse publicity or reduced acceptance of our products in the market.

interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses.

operations, and those of our directors, advisors, contractors, consultants, CROs, and collaborators, could be adversely affected

by earthquakes, floods, hurricanes, typhoons, extreme weather conditions, fires, water shortages, power failures, business systems

failures, medical epidemics and other natural and man-made disaster or business interruptions.

Our phones, electronic devices

and computer systems and those of our directors, advisors, contractors, consultants, CROs, and collaborators are vulnerable to

damages, theft and accidental loss, negligence, unauthorized access, terrorism, war, electronic and telecommunications failures,

and other natural and man-made disasters.

Operating as a virtual company, our employees conduct business outside of our headquarters

and leased or owned facilities.

These locations may be subject to additional security and other risk factors due to the limited

control of our employees.

If such an event as described above were to occur in the future, it may cause interruptions in our operations,

delay research and development programs, clinical trials, regulatory activities, manufacturing and quality assurance activities,

sales and marketing activities, hiring, training of employees and persons within associated third parties, and other business

For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our

regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

we will rely on third parties to manufacture our product candidates and conduct clinical trials, and similar events as those described

in the prior paragraph relating to their business systems, equipment and facilities could also have a material adverse effect

on our business.

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications,

or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and

commercialization of our product candidate could be delayed or altogether terminated.

failure to find third party collaborators to assist or share in the costs of product development could materially harm our business,

financial condition and results of operations.

strategy for the development and commercialization of our proprietary product candidates may include the formation of collaborative

arrangements with third parties.

We have entered into a number of agreements with third parties as described below under “Business,”

including a clinical trial research agreement with Moffitt Cancer Center, a collaboration agreement with the Spanish Sarcoma Group,

a cooperative research and development agreement with the National Cancer Institute, a clinical trial research agreement with

City of Hope National Medical Center, an agreement with Theradex Systems, Inc., a patent assignment and exploitation agreement

with Inserm Transfert, SA, a consulting agreement with Liberi Life Sciences Consultancy BV, an exclusive license agreement with

Moffitt, a material cooperative research and development agreement with the National Institutes of Health, a collaboration agreement

with BioPharmaWorks and a consulting agreement with NDA Consulting Corp.

Existing and future collaborators have significant discretion

in determining the efforts and resources they apply and may not perform their obligations as expected.

Potential third-party collaborators

include biopharmaceutical, pharmaceutical and biotechnology companies, academic institutions and other entities.

Third-party collaborators

may assist us in:

research, preclinical development, clinical trials and manufacturing;

and obtaining regulatory approvals;

commercializing any future product candidates.

we are not able to establish further collaboration agreements, we may be required to undertake product development and commercialization

at our own expense.

Such an undertaking may limit the number of product candidates that we will be able to develop, significantly

increase our capital requirements and place additional strain on our internal resources.

Our failure to enter into additional

collaborations could materially harm our business, financial condition and results of operations.

addition, our dependence on licensing, collaboration and other agreements with third parties may subject us to a number of risks.

These agreements may not be on terms that prove favorable to us and may require us to relinquish certain rights in our product

To the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate

with other entities could be curtailed.

Lengthy negotiations with potential new collaborators may lead to delays in the research,

development or commercialization of product candidates.

The decision by our collaborators to pursue alternative technologies or

the failure of our collaborators to develop or commercialize successfully any product candidate to which they have obtained rights

from us could materially harm our business, financial condition and results of operations.

Related to Our Intellectual Property

cannot be certain we will be able to obtain patent protection to protect our product candidates and technology.

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If a third party has also filed a patent application relating to

an invention claimed by us or our licensors, we may be required to participate in an interference proceeding declared by the United

States Patent and Trademark Office to determine priority of invention, which could result in substantial uncertainties and cost

for us, even if the eventual outcome is favorable to us.

The degree of future protection for our proprietary rights is uncertain.

an invention claimed by us or one or more of our licensors, we may be required to participate in an interference or derivation

proceeding declared or instituted by the United States Patent and Trademark Office, which could result in substantial uncertainties

and cost for us, even if the eventual outcome is favorable to us.

The degree of future protection for our proprietary rights is

or our licensors might not have been the first to make the inventions covered by our pending or future patent applications;

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for example, if a competitor independently develops duplicative, similar, or alternative technologies.

we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar

legislation, thereby potentially extending the term of our marketing exclusivity for any product candidates we may develop, our

business may be materially harmed.

the United States, the patent term of a patent that covers an FDA-approved drug may be eligible for limited patent term extension,

which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process.

Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, permits a patent term extension

of up to five years beyond the expiration of the patent.

The length of the patent term extension is related to the length of time

the drug is under clinical development and regulatory review.

Patent term extension cannot extend the remaining term of a patent

beyond a total of 14 years from the date of product approval, and only one patent that is applicable to and covers an approved

drug may be extended.

Similar provisions are available in Europe, such as supplementary protection certificates, and in certain

other non-United States jurisdictions to extend the term of a patent that covers an approved drug.

While, in the future, if and

when our product candidates receive FDA approval, we expect to apply for patent term extensions on patents covering those product

candidates, there is no guarantee that the applicable authorities will agree with our assessment of whether such extensions should

be granted, and even if granted, the length of such extensions.

We may not be granted patent term extension either in the United

States or in any foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory

review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise

failing to satisfy applicable requirements.

Moreover, the length of a patent term extension, as well as the scope of patent protection

during any such extension, afforded by the governmental authority could be less than we request.

If we are unable to obtain any

patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing

products following the expiration of our patent rights, and our business, financial condition, results of operations and prospects

could be materially harmed.

is possible that we will not obtain patent term extension under the Hatch-Waxman Act for a U.S.

patent covering any of our product

candidates that we may identify even where that patent is eligible for patent term extension, or if we obtain such an extension,

it may be for a shorter period than we had sought.

we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties

or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important

to our business.

have entered and may be required to enter into intellectual property license agreements that are important to our business.

license agreements may impose various diligence, milestone payment, royalty and other obligations on us.

For example, we may enter

into exclusive license agreements with various third parties (for example, universities and research institutions), we may be

required to use commercially reasonable efforts to engage in various development and commercialization activities with respect

to licensed products, and may need to satisfy specified milestone and royalty payment obligations.

If we fail to comply with any

obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole

increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which

case our ability to develop or commercialize products covered by the license agreement will be impaired.

addition, disputes may arise regarding intellectual property subject to a license agreement, including:

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

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

licensing agreement;

diligence obligations under the license agreement and what activities satisfy those obligations;

a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license

agreements, we may be required to sublicense rights in that area to a third party, and that sublicense could harm our business;

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

disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates.

may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all.

In that event, we would be unable

to further develop and commercialize one or more of our product candidates, which could harm our business significantly.

may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us

from commercializing or increase the costs of commercializing our product candidates.

success will depend in part on our ability to operate without infringing the proprietary rights of third parties.

We cannot guarantee

that our products or product candidates, or manufacture or use of our products or product candidates, will not infringe third-party

Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and

may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.

These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel.

Some of these third parties may be better capitalized and have more resources than us.

There is a risk that a court would decide

that we are infringing the third party’s patents and would order us to stop the activities covered by the patents.

event, we may not have a viable way around the patent and may need to halt commercialization of the relevant product candidate.

In addition, there is a risk that a court will order us to pay the other party damages for having violated the other party’s

In addition, we may be obligated to indemnify our licensors and collaborators against certain intellectual property infringement

claims brought by third parties, which could require us to expend additional resources.

The pharmaceutical and biotechnology industries

have produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover

various types of products or methods of use.

The coverage of patents is subject to interpretation by the courts, and the interpretation

is not always uniform.

we are sued for patent infringement, we would need to demonstrate that our products or products or methods either do not infringe

the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do

Proving invalidity is difficult.

For example, in the United States, proving invalidity requires a showing of clear and convincing

evidence to overcome the presumption of validity enjoyed by issued patents.

Even if we are successful in these proceedings, we

may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a

material adverse effect on us.

If we are unable to avoid infringing the patent rights of others, we may be required to seek a

license, which may not be available, and then we will have to defend an infringement action or challenge the validity of the patents

Patent litigation is costly and time consuming.

We may not have sufficient resources to bring these actions to a successful

In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement

action successfully or have infringed patents declared invalid or unenforceable, we may incur substantial monetary damages, encounter

significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.

cannot be certain that others have not filed patent applications for technology covered by our pending applications, or that we

were the first to invent the technology, because:

patent applications in the United States may be maintained in secrecy until the patents are issued;

applications in the United States are typically not published until 18 months after the priority date;

in the scientific literature often lag behind actual discoveries.

competitors may have filed, and may in the future file, patent applications covering technology similar to ours.

Any such patent

application may have priority over our patent applications, which could further require us to obtain rights to issued patents

covering such technologies.

If another party has filed US patent applications on inventions similar to ours that claims priority

to any applications filed prior to the priority dates of our applications, we may have to participate in an interference proceeding

declared or a derivation proceed instituted by the USPTO to determine priority of invention in the United States.

these proceedings could be substantial, and it is possible that such efforts would be unsuccessful if, unbeknownst to us, the

other party had independently arrived at the same or similar inventions prior to our own inventions, resulting in a loss of our

patent position with respect to such inventions.

Other countries have similar laws that permit secrecy of patent applications,

and thus the third party’s patent or patent application may be entitled to priority over our applications in such jurisdictions.

of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have

substantially greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation

could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged

trade secrets.

is common in the biotechnology and pharmaceutical industries, we employ, and may employ in the future, individuals who were previously

employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

Although we try

to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others

in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently

or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary

to defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages, we could lose

valuable intellectual property rights or personnel, which could adversely impact our business.

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management.

intellectual property may not be sufficient to protect our products from competition, which may negatively affect our business

as well as limit our partnership or acquisition appeal.

may be subject to competition despite the existence of intellectual property we license or own.

We can give no assurances that

our intellectual property claims will be sufficient to prevent third parties from designing around patents we own or license and

developing and commercializing competitive products.

The existence of competitive products that avoid our intellectual property

could materially adversely affect our operating results and financial condition.

Furthermore, limitations, or perceived limitations,

in our intellectual property may limit the interest of third parties to partner, collaborate or otherwise transact with us, if

third parties perceive a higher than acceptable risk to commercialization of our products or future products.

approach involves the filing of patent applications covering new methods of use and/or new formulations of previously known, studied

and/or marketed drugs.

Although the protection afforded by our patent applications may be significant, when looking at our patents’

ability to block competition, the protection offered by our patents may be, to some extent, more limited than the protection provided

by patents claiming the composition of matter of entirely new chemical structures previously unknown.

If a competitor were able

to successfully design around any method of use and formulation patents we may have in the future, our business and competitive

advantage could be significantly affected.

may elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade

dress, copyrights, trade secrets, domain names or other intellectual property rights that we either own or license.

prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:

monetary damages related to the legal expenses of the third party;

additional competition that may have a significant adverse effect on our product pricing, market share, business operations,

financial condition, and the commercial viability of our products;

restructuring

our company or delaying or terminating select business opportunities, including, but not limited to, research and development,

clinical trials, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

third party may also challenge the validity, enforceability or scope of the intellectual property rights that we license or own;

and, the result of these challenges may narrow the scope or claims of or invalidate patents that are integral to our product candidates

in the future.

There can be no assurance that we will be able to successfully defend patents we own in an action against third

parties due to the unpredictability of litigation and the high costs associated with intellectual property litigation, amongst

other factors.

laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations

in the United States and Europe, and many companies have encountered significant difficulties in protecting and defending such

rights in such jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor

the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult for us to

stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.

to enforce our patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert our

efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly

and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.

We may not prevail

in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial

advantage from the intellectual property that we develop or license.

Furthermore, while we intend to protect our intellectual

property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts

in all jurisdictions in which we may wish to market our products or product candidates.

Accordingly, our efforts to protect our

intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully

commercialize our product candidates in all of our expected significant foreign markets.

If we or our licensors encounter difficulties

in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business

in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those

jurisdictions.

to patent law, for example the Leahy-Smith America Invests Act, AIA or Leahy-Smith Act, of 2011 and the Patent Reform Act of 2009

and other future article of legislation in the U.S., may substantially change the regulations and procedures surrounding patent

applications, issuance of patents, prosecution of patents, challenges to patent validity, and patent enforcement.

no assurances that our patents and those of our licensor(s) can be defended or will protect us against future intellectual property

challenges, particularly as they pertain to changes in patent law and future patent law interpretations.

addition, enforcing and maintaining our intellectual property protection depends on compliance with various procedural, document

submission, fee payment and other requirements imposed by the U.S.

Patent and Trademark Office and courts, and foreign government

patent agencies and courts, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we may suffer

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However, trade secrets are difficult to protect.

will attempt to protect our trade secrets and unpatented know-how by requiring our employees, consultants and advisors to execute

a confidentiality and non-use agreement.

We cannot guarantee that these agreements will provide meaningful protection, that these

agreements will not be breached, that we will have an adequate remedy for any such breach, or that our trade secrets will not

otherwise become known or independently developed by a third party.

Our trade secrets, and those of our present or future collaborators

that we utilize by agreement, may become known or may be independently discovered by others, which could adversely affect the

competitive position of our product candidates.

will attempt to protect our trade secrets and unpatented know-how by requiring our employees, consultants, collaborators, and

advisors to execute a confidentiality and non-use agreement.

We cannot guarantee that these agreements will provide meaningful

protection, that these agreements will not be breached, that we will have an adequate remedy for any such breach, or that our

trade secrets will not otherwise become known or independently developed by a third party.

Our trade secrets, and those of our

present or future collaborators that we utilize by agreement, may become known or may be independently discovered by others, which

could adversely affect the competitive position of our product candidates.

may incur substantial costs enforcing our patents, defending against third-party patents, invalidating third-party patents or

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property rights.

may be unaware of or unfamiliar with prior art and/or interpretations of prior art that could potentially impact the validity

or scope of our patents or pending patent applications, or patent applications that we will file.

We may have elected, or elect

now or in the future, not to maintain or pursue intellectual property rights that, at some point in time, may be considered relevant

to or enforceable against a competitor.

take efforts and enter into agreements with employees, consultants, collaborators, and advisors to confirm ownership and chain

of title in intellectual property rights.

However, an inventorship or ownership dispute could arise that may permit one or more

third parties to practice or enforce our intellectual property rights, including possible efforts to enforce rights against us.

may not have rights under some patents or patent applications that may cover technologies that we use in our research, drug targets

that we select, or product candidates that we seek to develop and commercialize.

Third parties may own or control these patents

and patent applications in the United States and elsewhere.

These third parties could bring claims against us or our collaborators

that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages.

if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research,

development, manufacturing or sales of the product or product candidate that is the subject of the suit.

We or our collaborators

therefore may choose to seek, or be required to seek, a license from the third-party and would most likely be required to pay

license fees or royalties or both.

These licenses may not be available on acceptable terms, or at all.

Even if we or our collaborators

were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual

Ultimately, we could be prevented from commercializing a product, or forced to cease some aspect of our business operations,

as a result of patent infringement claims, which could harm our business.

that we select, product candidates and particular uses thereof that we seek to develop and commercialize, as well as synthesis

of our product candidates.

Third parties may own or control these patents and patent applications in the United States and elsewhere.

These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and,

if successful against us, could cause us to pay substantial damages.

Further, if a patent infringement suit were brought against

us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product

or product candidate that is the subject of the suit.

We or our collaborators therefore may choose to seek, or be required to

seek, a license from the third-party and would most likely be required to pay license fees or royalties or both.

These licenses

may not be available on acceptable terms, or at all.

Even if we or our collaborators were able to obtain a license, the rights

may be nonexclusive, which would give our competitors access to the same intellectual property.

Ultimately, we could be prevented

from commercializing a product or product candidate, or forced to cease some aspect of our business operations, as a result of

patent infringement claims, which could harm our business.

has been substantial litigation and other legal proceedings regarding patent and other intellectual property rights in the pharmaceutical

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Although we are not currently a party to any patent litigation or any other adversarial proceeding,

including any interference proceeding declared before the United States Patent and Trademark Office, regarding intellectual property

rights with respect to our products and technology, it is possible that we may become so in the future.

We are not currently aware

of any actual or potential third-party infringement claim involving our products.

The cost to us of any patent litigation or other

proceeding, even if resolved in our favor, could be substantial.

The outcome of patent litigation is subject to uncertainties

that cannot be adequately quantified in advance, including the demeanor and credibility of witnesses and the identity of the adverse

party, especially in biotechnology related patent cases that may turn on the testimony of experts as to technical facts upon which

experts may reasonably disagree.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more

effectively than we can because of their substantially greater financial resources.

If a patent or other proceeding is resolved

against us, we may be enjoined from researching, developing, manufacturing or commercializing our products without a license from

the other party and we may be held liable for significant damages.

We may not be able to obtain any required license on commercially

acceptable terms or at all.

including any interference or derivation proceeding declared or instituted before the United States Patent and Trademark Office,

regarding intellectual property rights with respect to our products, product candidates and technology, it is possible that we

may become so in the future.

We are not currently aware of any actual or potential third-party infringement claim involving our

product candidates.

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial.

The outcome of patent litigation is subject to uncertainties that cannot be adequately quantified in advance, including the demeanor

and credibility of witnesses and the identity of the adverse party, especially in pharmaceutical and biotechnology related patent

cases that may turn on the testimony of experts as to technical facts upon which experts may reasonably disagree.

competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially

greater financial resources.

If a patent or other proceeding is resolved against us, we may be enjoined from researching, developing,

manufacturing or commercializing our products or product candidates without a license from the other party and we may be held

liable for significant damages.

We may not be able to obtain any required license on commercially acceptable terms or at all.

Uncertainties

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be predicted with certainty.

Patents, if issued, may be challenged, invalidated or circumvented.

United States patents and patent

applications may also be subject to interference proceedings, and United States patents may be subject to reexamination proceedings

in the United States Patent and Trademark Office and foreign patents may be subject to opposition or comparable proceedings in

corresponding foreign patent offices, which proceedings could result in either loss of the patent or denial of the patent application

or loss or reduction in the scope of one or more of the claims of the patent or patent application.

In addition, such interference,

reexamination and opposition proceedings may be costly.

Thus, any patents that we own or license from others may not provide any

protection against competitors.

Furthermore, an adverse decision in an interference proceeding can result in a third-party receiving

the patent rights sought by us, which in turn could affect our ability to market a potential product to which that patent filing

was directed.

Our pending patent applications, those that we may file in the future, or those that we may license from third parties

may not result in patents being issued.

If issued, they may not provide us with proprietary protection or competitive advantages

against competitors with similar technology.

Furthermore, others may independently develop similar technologies or duplicate any

technology that we have developed.

Many countries, including certain countries in Europe, have compulsory licensing laws under

which a patent owner may be compelled to grant licenses to third parties.

For example, compulsory licenses may be required in

cases where the patent owner has failed to “work”

the invention in that country, or the third-party has patented improvements.

Patents may be challenged, invalidated, found unenforceable, or circumvented.

United States patents

and patent applications may be subject to interference and derivation proceedings, United States patents may also be subject to

post grant proceedings, including re-examination, derivation, Inter Partes Review and Post Grant Review, in the United

States Patent and Trademark Office and foreign patents may be subject to opposition or comparable proceedings in corresponding

foreign patent offices, which could result in either loss of the patent or denial of the patent application or loss or reduction

in the scope of one or more of the claims of the patent or patent application.

In addition, such interference, derivation, post

grant and opposition proceedings may be costly.

Thus, any patents that we own or license from others may not provide any protection

against competitors.

Furthermore, an adverse decision in an interference or derivation proceeding can result in a third-party

receiving the patent rights sought by us, which in turn could affect our ability to market a potential product to which that patent

filing was directed.

Our pending patent applications, those that we may file in the future, or those that we may license from

third parties may not result in patents being issued.

If issued, they may not provide us with proprietary protection or competitive

advantages against competitors with similar technology.

Furthermore, others may independently develop similar technologies or

duplicate any technology that we have developed.

Many countries, including certain countries in Europe, have compulsory licensing

laws under which a patent owner may be compelled to grant licenses to third parties.

For example, compulsory licenses may be required

in cases where the patent owner has failed to “work”

the invention in that country, or the third-party has patented

improvements.

In addition, many countries limit the enforceability of patents against government agencies or government contractors.

countries, the patent owner may have limited remedies, which could materially diminish the value of the patent.

Moreover, the

legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of patent

and other intellectual property protection, which makes it difficult to stop infringement.

In these countries, the patent owner may have limited remedies, which could materially diminish the value of our patents.

the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of

patents and other intellectual property protection, which makes it difficult to stop infringement.

addition, our ability to enforce our patent rights depends on our ability to detect infringement.

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We will seek to protect this information by entering into confidentiality agreements with parties that have access to it, such

as strategic partners, collaborators, employees and consultants.

Any of these parties may breach these agreements and disclose

our confidential information or our competitors might learn of the information in some other way.

If any trade secret, know-how

or other technology not protected by a patent were disclosed to, or independently developed by, a competitor, our business, financial

condition and results of operations could be materially adversely affected.

our third-party manufacturers’

facilities do not follow current good manufacturing practices, our product development and

commercialization efforts may be harmed.

are a limited number of manufacturers that operate under the FDA’s and European Union’s good manufacturing practices

regulations and are capable of manufacturing products.

Third-party manufacturers may encounter difficulties in achieving quality

control and quality assurance and may experience shortages of qualified personnel.

A failure of third-party manufacturers to follow

current good manufacturing practices or other regulatory requirements and to document their adherence to such practices may lead

to significant delays in the availability of products for commercial use or clinical study, the termination of, or hold on, a

clinical study, or may delay or prevent filing or approval of marketing applications for our products.

In addition, we could be

subject to sanctions being imposed on us, including fines, injunctions and civil penalties.

Changing manufacturers may require

additional clinical trials and the revalidation of the manufacturing process and procedures in accordance with FDA mandated current

good manufacturing practices and would require FDA approval.

This revalidation may be costly and time consuming.

If we are unable

to arrange for third-party manufacturing of our products, or to do so on commercially reasonable terms, we may not be able to

complete development or marketing of our products.

we fail to obtain an adequate level of reimbursement for our products by third-party payors, there may be no commercially viable

markets for our products or the markets may be much smaller than expected.

availability and levels of reimbursement by governmental and other third-party payors affect the market for our products.

efficacy, safety and cost-effectiveness of our products, as well as the efficacy, safety and cost-effectiveness of any competing

products, will determine the availability and level of reimbursement.

These third-party payors continually attempt to contain

or reduce the costs of healthcare by challenging the prices charged for healthcare products and services.

In certain countries,

particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations with governmental authorities can take six to twelve months or longer after the receipt

of regulatory marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required

to conduct clinical trials that compare the cost-effectiveness of our products to other available therapies.

If reimbursement

for our products is unavailable, limited in scope or amount, or if pricing is set at unsatisfactory levels, our potential revenues

would be reduced, and our results of operations would be negatively impacted.

development that may affect the pricing of drugs is regulatory action regarding drug re-importation into the United States.

Medicare Prescription Drug, Improvement and Modernization Act of 2003, which became law in December 2003, requires the Secretary

of the United States Department of Health and Human Services to promulgate regulations allowing drug re-importation from Canada

into the United States under certain circumstances.

These provisions will become effective only if the Secretary certifies that

such imports will pose no additional risk to the public’s health and safety and result in significant cost savings to consumers.

To date, the Secretary has made no such finding, but he could do so in the future.

Proponents of drug re-importation may also

attempt to pass legislation that would remove the requirement for the Secretary’s certification or allow re-importation

under circumstances beyond those anticipated under current law.

If legislation is enacted, or regulations issued, allowing the

re-importation of drugs, it could decrease the reimbursement we would receive for any products that we may commercialize, negatively

affecting our anticipated revenues and prospects for profitability.

Related to Common Stock

Company is a “smaller reporting company”

and it has elected to comply with certain reduced reporting and disclosure

requirements which could make its common stock less attractive to investors.

as strategic partners, collaborators, employees, contractors and consultants.

Any of these parties may breach these agreements

and disclose our confidential information or our competitors might learn of the information in some other way.

If any trade secret,

know-how or other technology not protected by a patent were disclosed to, or independently developed by, a competitor, our business,

financial condition and results of operations could be materially adversely affected.

Related to Commercialization of Our Current Product Candidate and Future Product Candidates

commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates,

if approved, among physicians, patients, healthcare payors and cancer treatment centers.

if we obtain regulatory approval for our current product candidate or any future product candidates, the products may not gain

market acceptance among physicians, healthcare payors, patients or the medical community, including cancer treatment centers.

Market acceptance of any product candidates for which we receive approval depends on a number of factors, including:

efficacy and safety of such product candidates as demonstrated in clinical trials;

clinical indications and patient populations for which the product candidate is approved;

by physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;

adoption of novel immunotherapies by physicians, hospitals and third-party payors;

potential and perceived advantages of product candidates over alternative treatments;

safety of product candidates seen in a broader patient group, including our use outside the approved indications;

restrictions on use together with other medications;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities;

timing of market introduction of our product as well as competitive products;

development of manufacturing and distribution processes for commercial scale manufacturing for our current product candidate

and any future product candidates;

cost of treatment in relation to alternative treatments;

availability of coverage and adequate reimbursement from third-party payors and government authorities;

convenience and ease of administration;

effectiveness of our sales and marketing efforts and those of our collaborators.

our current product and any future product candidates are approved but fail to achieve market acceptance among physicians, patients,

healthcare payors or cancer treatment centers, we will not be able to generate significant revenues, which would compromise our

ability to become profitable.

if we are able to commercialize our current product candidate or any future product candidates, the products may not receive coverage

and adequate reimbursement from third-party payors in the U.S.

and in other countries in which we seek to commercialize our products,

which could harm our business.

ability to commercialize any product successfully will depend, in part, on the extent to which coverage and adequate reimbursement

for such product and related treatments will be available from third-party payors, including government health administration

authorities, private health insurers and other organizations.

payors determine which medications they will cover and establish reimbursement levels.

A primary trend in the healthcare industry

is cost containment.

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for

particular medications.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts

from list prices and are challenging the prices charged for medical products.

Third-party payors may also seek additional clinical

evidence, beyond the data required to obtain regulatory approval, demonstrating clinical benefit and value in specific patient

populations before covering our product for those patients.

We cannot be sure that coverage and adequate reimbursement will be

available for any product that we commercialize and, if coverage is available, what the level of reimbursement will be.

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

reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any product

candidate for which we obtain regulatory approval.

may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than

the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities.

Moreover, eligibility for

coverage and reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including

research, development, manufacture, sale and distribution.

Interim reimbursement levels for new drugs, if applicable, may also

not be sufficient to cover our costs and may only be temporary.

Reimbursement rates may vary according to the use of the drug

and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be

incorporated into existing payments for other services.

Net prices for drugs may be reduced by mandatory discounts or rebates

required by third-party payors and by any future relaxation of laws that presently restrict imports of drugs from countries where

they may be sold at lower prices than in the U.S.

No uniform policy for coverage and reimbursement exists in the U.S., and coverage

and reimbursement can differ significantly from payor to payor.

Third-party payors often rely upon Medicare coverage policy and

payment limitations in setting their own reimbursement policies, but also have their own methods and approval process apart from

Medicare determinations.

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

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

to raise capital needed to commercialize our product and overall financial condition.

legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.

payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling

healthcare costs.

In both the U.S.

and certain international jurisdictions, there have been a number of legislative and regulatory

changes to the health care system that could impact our ability to sell our product profitably.

In particular, in 2010, the Affordable

Care Act (“ACA”) was enacted, which, among other things, subjected biologic products to potential competition by lower-cost

biosimilars, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated

for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by most manufacturers

under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals

enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription

drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts

by the current U.S.

administration to repeal or repeal and replace certain aspects of the ACA.

On December 14, 2018, a U.S.

Court Judge in the Northern District of Texas, or the Texas District Court Judge, ruled that the individual mandate is a critical

and inseverable feature of the ACA, and therefore, because it was repealed as a part of the Tax Act, the remaining provisions

of the ACA are invalid as well.

While the Texas District Court Judge, as well as the Trump Administration and CMS, have stated

that the ruling will have no immediate effect, it is unclear how this decision, subsequent appeals and other efforts to repeal

and replace the ACA will impact the ACA.

Until there is more certainty concerning the future of the ACA, it will be difficult

to predict its full impact and influence on our business.

addition, other legislative changes have been proposed and adopted in the U.S.

since the ACA was enacted.

In August 2011, the

Budget Control Act of 2011, among other things, created measures for spending reductions by Congress.

A Joint Select Committee

on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through

2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government

This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in

2013, and will remain in effect through 2027 unless additional Congressional action is taken.

The American Taxpayer Relief Act

of 2012 further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, and increased

the statute of limitations period for the government to recover overpayments to providers from three to five years.

have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed

at containing or lowering the cost of healthcare.

We cannot predict the initiatives that may be adopted in the future.

The continuing

efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain

or reduce costs of healthcare and/or impose price controls may adversely affect:

demand for our product candidate, if we obtain regulatory approval;

ability to receive or set a price that we believe is fair for our product;

ability to generate revenue and achieve or maintain profitability;

level of taxes that we are required to pay;

availability of capital.

expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions

in Medicare and other healthcare funding, more rigorous coverage criteria, lower reimbursement and new payment methodologies.

This could lower the price that we receive for any approved product.

Any denial in coverage or reduction in reimbursement from

Medicare or other government-funded programs may result in a similar denial or reduction in payments from private payors, which

may prevent us from being able to generate sufficient revenue, attain profitability or commercialize our product candidate, if

controls may be imposed in foreign markets, which may adversely affect our future profitability.

some countries, particularly member states of the European Union, the pricing of prescription drugs is subject to governmental

In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory

approval for a product.

In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement

levels, including as part of cost containment measures.

Political, economic and regulatory developments may further complicate

pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.

Reference pricing used by various

European Union member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further

reduce prices.

some countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness

of our product candidate to other available therapies in order to obtain or maintain reimbursement or pricing approval.

of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the

country of publication and other countries.

If reimbursement of our product is unavailable or limited in scope or amount, or if

pricing is set at unsatisfactory levels, our business could be adversely affected.

Related to Healthcare Compliance Regulations

relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare

laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and

diminished profits and future earnings.

If we or they are unable to comply with these provisions, we may become subject to civil

and criminal investigations and proceedings that could have a material adverse effect on our business, financial condition and

providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates

for which we obtain regulatory approval.

Our current and future arrangements with healthcare providers, healthcare entities, third-party

payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain

the business or financial arrangements and relationships through which we research, develop and will market, sell and distribute

As a pharmaceutical company, even though we do not and will not control referrals of healthcare services or bill

directly to Medicare, Medicaid or other third-party payors, federal and state healthcare laws and regulations pertaining to fraud

and abuse and patients’

rights are applicable to our business.

Restrictions under applicable federal and state healthcare

laws and regulations that may affect our ability to operate include the following:

federal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and

willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash

or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation

of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

civil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower

or qui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing

to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment or approval that

are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal

federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil

liability for executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit

knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statements in

connection with the delivery of or payment for healthcare benefits, items or services, as amended by the Health Information

Technology for Economic and Clinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory

contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health

information on entities subject to the law, such as certain healthcare providers, health plans, and healthcare clearinghouses,

known as covered entities, and their respective business associates that perform services for them that involve the creation,

use, maintenance or disclosure of, individually identifiable health information;

federal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and

medical supplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of

value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians

and other healthcare providers and their immediate family members and applicable group purchasing organizations;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including

private insurers;

some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s

voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require

drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare

providers, marketing expenditures or pricing information;

and certain state and local laws which require the registration

of pharmaceutical sales representatives;

and foreign laws govern the privacy and security of health information in specified circumstances, many of which differ from

each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with

current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us,

we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion

from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and

the curtailment or restructuring of our operations.

If any physicians or other healthcare providers or entities with whom we expect

to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative

sanctions, including exclusions from government funded healthcare programs.

employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,

which could cause significant liability for us and harm our reputation.

are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA regulations or

similar regulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign

regulatory authorities, comply with manufacturing standards we have established, comply with federal and state healthcare fraud

and abuse laws and regulations and similar laws and regulations established and enforced by comparable foreign regulatory authorities,

report financial information or data accurately or disclose unauthorized activities to us.

Employee misconduct could also involve

the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious

harm to our reputation.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect

and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental

investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions

could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal

and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare

and Medicaid, and integrity oversight and reporting obligations.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that

we may develop.

face an inherent risk of product liability exposure related to the testing of our current product candidate or future product

candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop.

Product liability claims may be brought against us by subjects enrolled in our clinical trials, patients, healthcare providers

or others using, administering or selling our product.

If we cannot successfully defend ourselves against claims that our product

candidate or product caused injuries, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability

claims may result in:

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

of clinical trial sites or entire clinical trial programs;

to our reputation and significant negative media attention;

of clinical trial participants;

costs to defend the related litigation;

monetary awards to trial subjects or patients;

of management and scientific resources from our business operations;

inability to commercialize any products that we may develop.

to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is

customary for similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks;

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

If we are able to obtain product liability insurance,

we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that

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

Furthermore, we intend to expand

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

candidate in development, but we may be unable to obtain commercially reasonable product liability insurance for any products

that receive regulatory approval.

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

side effects.

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

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

Related to our Business Operations

face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

will face competition from numerous pharmaceutical and biotechnology enterprises, as well as from academic institutions, government

agencies and private and public research institutions for our current product candidate.

Our commercial opportunities will be

reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects

or are less expensive than any products that we may develop.

Competition could result in reduced sales and pricing pressure on

our current product candidate, if approved, which in turn would reduce our ability to generate meaningful revenues and have a

negative impact on our results of operations.

In addition, significant delays in the development of our product candidate could

allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidate.

The biotechnology industry, including the cancer immunotherapy market, is intensely competitive and involves a high degree of

We compete with other companies that have far greater experience and financial, research and technical resources than us.

Potential competitors in the U.S.

and worldwide are numerous and include pharmaceutical and biotechnology companies, educational

institutions and research foundations, many of which have substantially greater capital resources, marketing experience, research

and development staffs and facilities than ours.

Some of our competitors may develop and commercialize products that compete directly

with those incorporating our technology or may introduce products to market earlier than our product or on a more cost-effective

Our competitors compete with us in recruiting and retaining qualified scientific and management personnel as well as in

acquiring technologies complementary to our technology.

We may face competition with respect to product efficacy and safety, ease

of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory approvals,

availability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions

An inability to successfully complete our product development or commercializing our product candidate could result

in our having limited prospects for establishing market share or generating revenue.

of our competitors or potential competitors have significantly greater established presence in the market, financial resources

and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory

approvals and marketing approved products than we do, and as a result may have a competitive advantage over us.

Mergers and acquisitions

in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number

of our competitors.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific

and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring

technologies and technology licenses complementary to our programs or potentially advantageous to our business.

a result of these factors, these competitors may obtain regulatory approval of their products before we are able to obtain patent

protection or other intellectual property rights, which will limit our ability to develop or commercialize our current product

Our competitors may also develop drugs that are safer, more effective, more widely used and cheaper than ours, and

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

These appreciable advantages could render our

product candidate obsolete or non-competitive before we can recover the expenses of development and commercialization.

business may be adversely affected by the ongoing coronavirus pandemic.

outbreak of the novel coronavirus (COVID-19) has evolved into a global pandemic.

The coronavirus has spread to many regions of

The extent to which the coronavirus impacts our business and operating results will depend on future developments that

are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the coronavirus

and the actions to contain the coronavirus or treat its impact, among others.

a result of the continuing spread of the coronavirus, our business operations could be delayed or interrupted.

For instance, our

clinical trials may be affected by the pandemic.

Site initiation, participant recruitment and enrollment, participant dosing,

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

or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or

other reasons related to the pandemic.

If the coronavirus continues to spread, some participants and clinical investigators may

not be able to comply with clinical trial protocols.

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

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

be unable to conduct our clinical trials.

Further, if the spread of the coronavirus pandemic continues and our operations are

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

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

and deaths related to the pandemic may disrupt the United States’

healthcare and healthcare regulatory systems.

Such disruptions

could divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

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

Any elongation or de-prioritization of our clinical

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

product candidates.

currently utilize third parties to, among other things, manufacture raw materials.

If either any third-party parties in the supply

chain for materials used in the production of our product candidates are adversely impacted by restrictions resulting from the

coronavirus outbreak, our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical

trials and research and development operations.

a result of the shelter-in-place order and other mandated local travel restrictions, our employees conducting research and development

or manufacturing activities may not be able to access their laboratory or manufacturing space which may result in our core activities

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

spread of the coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies

put into place by businesses and governments, may have a material economic effect on our business.

While the potential economic

impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely

to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either

at all or on favorable terms.

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

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

ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet

know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems

or the global economy as a whole.

However, these effects could have a material impact on our operations, and we will continue

to monitor the situation closely.

disruptions of information technology systems, computer system failures or breaches of information security could adversely affect

our business.

rely to a large extent upon sophisticated information technology systems to operate our business.

In the ordinary course of business,

we collect, store and transmit large amounts of confidential information (including, but not limited to, personal information

and intellectual property).

The size and complexity of our information technology and information security systems, and those

of our third-party vendors with whom we may contract, make such systems potentially vulnerable to service interruptions or to

security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties.

Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives

(including, but not limited to, industrial espionage and market manipulation) and expertise.

While we intend to invest in the

protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or

security breaches.

internal computer systems, and those of our CROs, our CMOs, and other business vendors on which we may rely, are vulnerable to

damage from computer viruses, unauthorized access, natural disasters, fire, terrorism, war and telecommunication and electrical

We exercise little or no control over these third parties, which increases our vulnerability to problems with their

If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of

our drug development programs.

Any interruption or breach in our systems could adversely affect our business operations and/or

result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial,

legal, business and reputational harm to us or allow third parties to gain material, inside information that they use to trade

in our securities.

For example, the loss of clinical trial data from completed or ongoing clinical trials could result in delays

in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any

disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential

or proprietary information, we could incur liability, the further development of our current and future product candidates could

be delayed and our business could be otherwise adversely affected.

will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.

of March 12, 2021, we had three full-time employees and one part-time employee.

We will need to grow the size of our organization

in order to support our continued development and potential commercialization of our product candidate.

As our development and

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

marketing, financial and other resources may increase.

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

to support this future growth.

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

our clinical trials effectively;

recruiting, maintaining, motivating and integrating additional employees;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors

and other third parties;

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

our facilities.

our operations expand, we will also need to manage additional relationships with various strategic partners, suppliers and other

third parties.

Our future financial performance and our ability to commercialize our product candidate and to compete effectively

will depend, in part, on our ability to manage any future growth effectively, as well as our ability to develop a sales and marketing

force when appropriate for our company.

To that end, we must be able to manage our development efforts and preclinical studies

and clinical trials effectively and hire, train and integrate additional management, research and development, manufacturing,

administrative and sales and marketing personnel.

The failure to accomplish any of these tasks could prevent us from successfully

growing our company.

funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other

personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those

agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact

our business.

ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and

funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the

SEC and other government agencies on which our operations may rely, including those that fund research and development activities

is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government

agencies, which would adversely affect our business.

For example, over the last several years, including beginning on December

22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had

to furlough critical FDA, SEC and other government employees and stop critical activities.

If a prolonged government shutdown

occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could

have a material adverse effect on our business.

Further, in our operations as a public company, future government shutdowns could

impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our

Related to Owning our Common Stock

are a “smaller reporting company”

and we have elected to comply with certain reduced reporting and disclosure requirements

which could make its common stock less attractive to investors.

are a “smaller reporting company,”

as defined in the Regulation S-K of the Securities Act of 1933, as amended, which

17 unchanged sentences

active trading market for our common stock and/or the market price of our common stock may be more volatile.

Company does not intend to pay cash dividends to its stockholders for the foreseeable future, so you may not receive any return

on your investment in the Company prior to selling your interest in the Company.

have never paid any dividends to our common stockholders and do not foresee doing so as a public company.

We currently intend

to retain any future earnings for funding growth and, therefore, do not expect to pay any cash dividends in the foreseeable future.

If we determine that we will pay cash dividends to the holders of our common stock, we cannot assure that such cash dividends

will be paid on a regular basis.

The success of an investment in the Company will likely depend entirely upon any future appreciation.

As a result, an investor will not receive any return on their investment prior to selling their shares in the Company and, for

the other reasons discussed in this “Risk Factors”

section, an investor may not receive any return on their investment

even when they sell their shares in the Company.

recent outbreak of the novel coronavirus (COVID-19) could negatively impact our business operations, including the conduct and

cost of our ongoing clinical trials, and our future capital-raising efforts.

light of the uncertain and rapidly evolving situation relating to the spread of the novel coronavirus (COVID-19), this pandemic

could pose a risk to our business.

The extent to which the coronavirus may impact our business operations will depend on future

developments, which are highly uncertain and cannot be predicted at this time.

We intend to continue to monitor the situation

and may adjust our current business plans as more information and guidance become available.

coronavirus pandemic presents a challenge to medical facilities worldwide.

Even though our clinical trials are conducted on an

outpatient basis, it is not currently possible to predict the impact of this developing health crisis on such clinical trials,

but it is possible that our clinical trials could be delayed and our costs could increase.

Company expects that it will need to begin to raise additional capital no later than the fourth quarter of 2020.

The impact of

the coronavirus on capital markets may affect the availability, amount and type of financing.

Company will require additional capital in the future to support its operations.

will require additional capital to fund our operations, likely through the sale of our equity securities, but also possibly through

the sale of debt securities.

The uncertainties surrounding our novel compounds makes it difficult to evaluate our current business

model and future prospects.

Accordingly, investors should consider our prospects in light of the costs, uncertainties, delays

and difficulties frequently encountered by companies in Phase 2 clinical trials, as we have, in fact, encountered.

Potential investors

should carefully consider the risks and uncertainties that a company with limited funds will face.

In particular, potential investors

should consider that there is a significant risk that we will not be able to raise sufficient funds in the capital markets on

a timely basis and under acceptable terms to effectuate our business plan.

we raise additional funds through further issuances of equity or convertible debt securities, our existing shareholders could

suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to

those of holders of our existing capital stock.

Any debt financing secured by us in the future could involve restrictive covenants

relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us

to obtain additional capital.

In addition, 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, our ability to continue

to support our current operations and to respond to business challenges would be significantly limited.

If we cannot access the

capital necessary to support our business, we would be forced to curtail our business activities or even shut down or liquidate

our operations.

If we cannot execute any one of the foregoing or similar matters relating to our business, the business may fail,

in which case you would lose the entire amount of your investment in the Company.

have identified certain material weaknesses in our internal control over financial reporting.

Failure to maintain effective internal

controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock.

internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.

are subject to the reporting requirements of the Exchange Act, and the Sarbanes-Oxley Act.

The Exchange Act requires that we file

annual, quarterly and current reports with respect to our business and financial condition, proxy statement, and other information.

The Sarbanes-Oxley Act requires, among other things, that we establish and maintain effective internal controls and procedures

for financial reporting.

Our Chief Executive Officer and Chief Accounting Officer (who is the same person) needs to certify that

our disclosure controls and procedures are effective in ensuring that material information we are required to disclose in reports

that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified

in the SEC’s rules and forms.

internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner.

In connection

with the preparation of our financial statements for the year ended December 31, 2019, we concluded that there were material weaknesses

in our internal control over financial reporting.

A material weakness is a significant deficiency, or a combination of significant

deficiencies, in internal control over financial reporting such that it is reasonably possible that a material misstatement of

the annual or interim financial statements will not be prevented or detected on a timely basis.

We have identified certain material

weaknesses in our internal controls resulting from:

Chief Executive Officer having almost complete responsibility for the processing of invoices and the preparation of checks;

finance department not having adequate internal staff to process the accounting information and prepare periodic financial

statements and footnotes.

we have designed and implemented measures and systems that we believe address and mitigate these control weaknesses, through expanded

bookkeeping and review procedures and the services of qualified outside consultants with expertise to perform specific accounting

and finance functions, we may not be successful in such efforts, which may undermine our ability to provide accurate, timely and

reliable reports on our financial and operating results.

In addition, if we identify additional material weaknesses in our internal

control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated.

Moreover, in the future we may engage in business activities or transactions that could negatively affect our internal control

over financial reporting and result in additional material weaknesses.

management and independent registered public accounting firm were not required to and therefore did not perform a formal evaluation

of our internal control over financial reporting during any period in accordance with the provisions of the Sarbanes-Oxley Act.

Had we and our independent registered public accounting firm performed an evaluation of our internal control over financial reporting

in accordance with the provisions of the Sarbanes-Oxley Act, additional control deficiencies amounting to material weaknesses

may have been identified.

If we identify new material weaknesses in our internal control over financial reporting, if we are unable

to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, if we are unable to assert that our

internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express

an opinion as to the effectiveness of our internal control over financial reporting, we may be late with the filing of our periodic

reports, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our

common stock could be negatively affected.

As a result of such failures, we could also become subject to investigations by the

stock exchange on which our securities are listed, the SEC, or other regulatory authorities, and become subject to litigation

from investors and stockholders, which could harm our reputation, financial condition or divert financial and management resources

from our core business.

the Company fails to establish and maintain an effective system of internal controls, it may not be able to report its financial

results accurately or prevent fraud.

Any inability to report and file its financial results accurately and timely could harm the

Company’s reputation and adversely impact the trading price of its common stock.

internal controls are necessary for us to provide reliable financial reports and prevent fraud.

If we cannot provide reliable

financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control

environment existed, and our business and reputation with investors may be harmed.

Notwithstanding our diligence, certain internal

controls deficiencies may not be detected.

As a result, any internal control deficiencies may adversely affect our financial condition,

results of operations and access to capital.

We may in the future discover areas of our internal controls that need remediation

or improvement.

of the Company’s preferred stock or exercise of the Company’s outstanding options and warrants which may cause significant

dilution to its shareholders.

have common shares issuable upon conversion of preferred stock and exercise of outstanding options and warrants.

These preferred

shares and options and warrants provide the right to acquire additional shares of common stock at a price that may be less than

the then prevailing market price per share of common stock, which therefore may cause additional dilution to our shareholders.

company compliance may make it more difficult to attract and retain officers and directors.

Sarbanes Oxley Act and rules implemented by the SEC have required changes in corporate governance practices of public companies.

As a public company, these rules and regulations increase our compliance costs and make certain activities more time consuming

As a public company, these rules and regulations may make it more difficult and expensive for us to maintain our directors

and officer’s liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially

higher costs to obtain the same or similar coverage.

As a result, it may be more difficult for us to attract and retain qualified

persons to serve on our Board of Directors or as executive officers, and to maintain insurance at reasonable rates, or at all.

Company’s stock price may be volatile, and you may not be able to resell your shares at or above the purchase price.

our common stock is registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and our

stock is traded on the OTCQB operated by the OTC Markets, an active trading market for the securities does not yet exist and may

not exist or be sustained in the future.

The OTCQB is an over-the-counter market that provides significantly less liquidity than

the Nasdaq Stock Market.

Quotes for stocks included on the OTCQB are not listed in the financial sections of newspapers as are

those for the Nasdaq Stock Market.

Therefore, prices for securities traded solely on the OTCQB may be difficult to obtain and

holders of common stock may be unable to resell their securities at or near their original offering price or at any price.

is no assurance that an established public trading market for our common stock will ultimately develop, and if it does develop,

that it will be sustainable, which would adversely affect the ability of our investors to sell their shares of common stock in

the public market.

addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated

to the operating performance of particular companies.

These market fluctuations may also materially and adversely affect the market

price of our common stock.

market price of our common stock is volatile and could fluctuate widely in price in response to various factors, many of which

are beyond our control, including the following:

ability to execute our business plan;

in our industry;

pricing pressures and other competitive developments;

ability to obtain working capital financing;

or departures of key personnel and management;

of our common stock in financing transactions;

results that fall below expectations;

developments;

and other external factors;

period-to-period

fluctuations in our financial results;

public’s response to press releases or other public announcements by us or third parties, including filings with the

in financial estimates or ratings by any securities analysts who follow our common stock, our failure to meet these estimates

or failure of those analysts to initiate or maintain coverage of our common stock;

development and sustainability of an active trading market for our common stock;

future sales of our common stock by our officers, directors and significant stockholders.

eligible for future sale may adversely affect the market price of our common stock, as the future sale of a substantial amount

of outstanding stock in the public marketplace could reduce the price of our common stock.

John Kovach, our founder and Chief Executive Officer, is currently eligible to sell his shares of common stock by means of ordinary

brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended, subject

to certain limitations.

Rule 144 also permits the sale of securities, without any limitations, by a non-affiliate that has satisfied

a six-month holding period.

Any substantial sale of common stock pursuant to Rule 144 may have an adverse effect on the market

price of our common stock by creating an excessive supply.

common stock is considered a “penny stock”

and may be difficult to sell.

common stock is considered to be a “penny stock”

since it meets one or more of the definitions in Rules 15g-2 through

15g-6 promulgated under Section 15(g) of the Exchange Act.

These include but are not limited to the following:

(i) the stock trades

at a price less than $5.00 per share;

(ii) it is NOT traded on a “recognized”

national exchange;

(iii) it is NOT quoted

on the NASDAQ Stock Market, or even if so, has a price less than $5.00 per share;

or (iv) it is issued by a company with net tangible

assets less than $2.0 million, if in business more than a continuous three years, or with average revenues of less than $6.0 million

for the past three years.

The principal result or effect of being designated a “penny stock”

is that securities broker-dealers

cannot recommend the stock but must trade in it on an unsolicited basis.

Additionally,

Section 15(g) of the Exchange Act and Rule 15g-2 promulgated thereunder by the Securities and Exchange Commission require broker-dealers

dealing in penny stocks to provide potential investors with a document disclosing the risks of penny stocks and to obtain a manually

signed and dated written receipt of the document before effecting any transaction in a penny stock for the investor’s account.

investors in our common stock are urged to obtain and read such disclosure carefully before purchasing any shares that are deemed

to be “penny stock”.

Moreover, Rule 15g-9 requires broker-dealers in penny stocks to approve the account of any investor

for transactions in such stocks before selling any penny stock to that investor.

This procedure requires the broker-dealer to:

(i) obtain from the investor information concerning his or her financial situation, investment experience and investment objectives;

(ii) reasonably determine, based on that information, that transactions in penny stocks are suitable for the investor and that

the investor has sufficient knowledge and experience as to be reasonably capable of evaluating the risks of penny stock transactions;

(iii) provide the investor with a written statement setting forth the basis on which the broker-dealer made the determination

in (ii) above;

and (iv) receive a signed and dated copy of such statement from the investor, confirming that it accurately reflects

the investor’s financial situation, investment experience and investment objectives.

Compliance with these requirements

may make it more difficult for holders of our common stock to resell their shares to third parties or to otherwise dispose of

them in the market or otherwise.

principal stockholder has significant influence over our company.

John Kovach, our principal stockholder and our Chief Executive Officer, beneficially owns 13.6% of our outstanding common stock

(the Company’s only voting security currently issued and outstanding).

As a result of the combination of these factors,

Kovach possesses significant influence on the operations and corporate governance of the Company, giving him substantial influence

over the election of the members of the Board of Directors and the approval of significant corporate transactions.

Such influence

may also have the effect of delaying or preventing a future change in control transaction, impeding a merger, consolidation, takeover

or other business combination or discourage a potential acquirer from making a tender offer or otherwise attempting to obtain

control of us.

Warrants are speculative in nature.

Warrants offered in our November 2020 public offering do not confer any rights of common stock ownership on their holders, such

as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at

a fixed price.

Specifically, holders of the Warrants may exercise their right to acquire the common stock and pay an exercise

price of $5.70 per share.

Furthermore, each Warrant will expire five (5) years from the original issuance date.

In the event our

common stock price does not exceed the exercise price of the Warrants during the period when the Warrants are exercisable, the

Warrants may not have any value.

of the Warrants will have no rights as a common stockholder until they acquire our common stock.

the acquisition of shares of our common stock upon exercise of the Warrants, a holder will have no rights with respect to shares

of our common stock issuable upon exercise of the Warrant.

Upon exercise of a Warrant, a holder will be entitled to exercise the

rights of a common stockholder as to the security exercised only as to matters for which the record date occurs after the exercise.

is a limited market for the Warrants to purchase shares of our common stock.

the Warrants are currently trading on The Nasdaq Capital Market, there can be no assurance that there will be an active trading

market for the Warrants.

Without an active trading market, the liquidity of the Warrants will be limited.

of the Warrants could discourage an acquisition of us by a third party.

provisions of the Warrants could make it more difficult or expensive for a third party to acquire us.

The Warrants prohibit us

from engaging in certain transactions constituting “fundamental transactions”

unless, among other things, the surviving

entity assumes our obligations under the Warrants.

These and other provisions of the Warrants could prevent or deter a third party

from acquiring us even where the acquisition could be beneficial to you.

price of our common stock or Warrants may fluctuate substantially.

should consider an investment in our common stock and Warrants to be risky.

Some factors that may cause the market price of our

common stock or Warrants to fluctuate, in addition to the other risks mentioned in this “Risk Factors”, are:

of our common stock by our stockholders, executives, and directors and our stockholders

and limitations in trading volumes of our shares of common stock;

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our

clinical trials, and other business activities;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics

of our industry, including consolidation among competitors, customers or strategic partners;

outages or security breaches;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement,

enrollment or results of our clinical trials for our product candidate or any future clinical trials we may conduct;

in the development status of our product candidate;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical

and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our product candidate;

unanticipated

safety concerns related to the use of our product candidate;

to meet external expectations or management guidance;

in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our

stockholders;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

inability to enter into new markets or develop new products;

from existing technologies and products or new technologies and products that may emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or

our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial

condition and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us

to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.

sale or perceived sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

connection with our recent public offering of shares of our common stock and Warrants, all of our executive officers and directors

and certain of our stockholders and warrant holders have agreed not to sell shares of our common stock for a period of 180 days

(until May 30, 2021), subject to extension under specified circumstances.

Common stock subject to these lock-up agreements will

become eligible for sale in the public market upon expiration of these lock-up agreements, subject to limitations imposed by Rule

144 under the Securities Act of 1933, as amended.

If our stockholders sell substantial amounts of our common stock in the public

market, the market price of our common stock could fall.

Moreover, the perceived risk of this potential dilution could cause stockholders

to attempt to sell their shares and investors to short our common stock.

These sales also may make it more difficult for us to

sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

and economic conditions may negatively impact our business, financial condition and share price.

over medical epidemics, energy costs, geopolitical issues, the U.S.

mortgage market and a deteriorating real estate market, unstable

global credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability,

diminished liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations

for the global economy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults

in recent years.

Our general business strategy may be adversely affected by any such economic downturns (including the current

downturn related to the current COVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic

and market conditions.

If these conditions continue to deteriorate or do not improve, it may make any necessary debt or equity

financing more difficult to complete, more costly, and more dilutive.

Failure to secure any necessary financing in a timely manner

and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price and

could require us to delay or abandon development or commercialization plans.

securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business,

our stock price and trading volume may decline.

trading market for our common stock will rely in part on the research and reports that industry or financial analysts publish

about us, our business, our markets and our competitors.

We do not control these analysts.

If securities analysts do not cover

our common stock, the lack of research coverage may adversely affect the market price of our common stock.

Furthermore, if one

or more of the analysts who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or

our business, our stock price would likely decline.

If one or more of these analysts cease coverage of us or fails to regularly

publish reports on us, we could lose visibility in the market and interest in our stock could decrease, which in turn could cause

our stock price or trading volume to decline and may also impair our ability to expand our business with existing customers and

attract new customers.

certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions

requiring stockholder approval.

directors, executive officers and principal stockholders, and their respective affiliates, currently beneficially own approximately

75% of our outstanding shares of common stock, based on 13,538,259 shares of common stock currently issued and outstanding.

percentage increases to approximately 76% in the event that the shares of our Series A Preferred Stock are converted into shares

of common stock.

As a result, these stockholders, acting together, would have the ability to control the outcome of matters submitted

to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially

all of our assets.

In addition, these stockholders, acting together, would have the ability to control the management and affairs

of our company.

Accordingly, this concentration of ownership might harm the market price of our common stock by:

deferring or preventing a change in corporate control;

a merger, consolidation, takeover or other business combination involving us;

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and

could cause our share price to fall.

expect that significant additional capital will be needed in the future to continue our planned operations, including increased

marketing, hiring new personnel, commercializing our product, and continuing activities as an operating public company.

extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.

sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we

determine from time to time.

If we sell common stock, convertible securities or other equity securities in more than one transaction,

investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing stockholders,

and new investors could gain rights superior to our existing stockholders.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not

anticipate declaring or paying any cash dividends for the foreseeable future.

Any return to stockholders will therefore be limited

to the increase, if any, of our share price.

may be at risk of securities class action litigation.

In the past, biotechnology and pharmaceutical companies have experienced

significant stock price volatility, particularly when associated with binary events such as clinical trials and product approvals.

If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources,

which could harm our business and results in a decline in the market price of our common stock.

Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law may have anti-takeover effects that could discourage,

delay or prevent a change in control, which may cause our stock price to decline.

Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law could make it more difficult for a third party

to acquire us, even if closing such a transaction would be beneficial to our stockholders.

We are authorized to issue up to 10,000,000

shares of preferred stock.

This preferred stock may be issued in one or more series, the terms of which may be determined at the

time of issuance by our Board of Directors without further action by stockholders.

The terms of any series of preferred stock

may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation,

conversion and redemption rights and sinking fund provisions.

As of March 12, 2021, we have designated 350,000 shares of preferred

stock as Series A Convertible Preferred Stock, all of which are issued and outstanding.

The issuance of any preferred stock could

materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with,

or sell our assets to, a third party and thereby preserve control by the present management.

of our Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging

potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder

might consider favorable.

Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our

In particular, the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:

the Board of Directors with the ability to alter the bylaws without stockholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted

upon at stockholder meetings;

that vacancies on the Board of Directors may be filled by a majority of directors in office, although less than a quorum.

reporting obligations of being a public company in the U.S.

are expensive and time-consuming, and our management will be required

to devote substantial time to compliance matters.

a publicly traded company we incur significant additional legal, accounting and other expenses.

The obligations of being a public

company in the U.S.

require significant expenditures and will place significant demands on our management and other personnel,

including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding

corporate governance practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection

Act, and the listing requirements of the stock exchange on which our securities are listed.

These rules require the establishment

and maintenance of effective disclosure and financial controls and procedures, internal control over financial reporting and changes

in corporate governance practices, among many other complex rules that are often difficult to implement, monitor and maintain

compliance with.

Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations

will make some activities more time-consuming and costly, particularly after we are no longer an “emerging growth company”.

In addition, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and

officer liability insurance.

Our management and other personnel will need to devote a substantial amount of time to ensure that

we comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk

becoming subject to litigation or being delisted, among other potential problems.

we fail to comply with the rules under Sarbanes-Oxley related to accounting controls and procedures in the future, or, if we discover

material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly

and raising capital could be more difficult.

404 of Sarbanes-Oxley requires annual management assessments of the effectiveness of our internal control over financial reporting.

If we fail to comply with the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we

discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline

significantly and raising capital could be more difficult.

If material weaknesses or significant deficiencies are discovered or

if we otherwise fail to achieve and maintain the adequacy of our internal control, we may not be able to ensure that we can conclude

on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal controls are necessary for us to produce reliable financial reports and are important to helping

prevent financial fraud.

If we cannot provide reliable financial reports or prevent fraud, our business and operating results

could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock

could drop significantly.

UNRESOLVED STAFF COMMENTS

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What changed 10-K

Item 1A. Risk Factors