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Item 1A. Risk Factors

2022-03-21 compared with 2021-03-26 · 1520 added, 1374 removed, 280 unchanged (91% of the section changed)

following risk factors, together with the other information presented in this document, including the financial statements and

the notes thereto, should be considered by investors.

following risk factors, together with the other information presented in this document, including the financial statements and the notes

thereto, should be considered by investors.

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

key element of our strategy is to discover, develop and commercialize a portfolio of new drugs.

We are seeking to do so through

our internal research programs.

A significant portion of the research that we are conducting involves new and unproven technologies.

Research programs to identify new disease targets and product candidates require substantial technical, financial and human resources

whether or not any candidates or technologies are ultimately identified.

Our research programs may initially show promise in identifying

potential product candidates, yet fail to yield product candidates for clinical development for the following reasons:

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

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

are unlikely to be effective drugs.

we are unable to discover suitable potential product candidates, develop additional delivery technologies through internal research

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

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.

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

key element of our strategy is to discover new product candidates and develop LB-100 as a monotherapy or combination therapy to treat

We are seeking to do so through our internal research programs or strategic partnerships.

A significant portion of the research

or development that we are conducting involves new and unproven technologies.

Research programs to identify new disease targets and product

candidates or to develop them require substantial technical, financial and human resources whether or not any candidates or technologies

are ultimately identified or proven successful.

Our research programs might initially show promise in identifying potential product candidates,

yet fail to yield product candidates for clinical development for the following reasons:

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

however, we have identified several

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

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

unlikely to be effective drugs.

we are unable to discover suitable potential product candidates, develop additional delivery technologies through internal research programs

or strategic partnerships, or in-license suitable products or delivery technologies on acceptable business terms, our business prospects

Even if we discover additional product candidates, and even though LB-100 has completed a Phase 1 clinical trial, subsequent

clinical trials of LB-100 or new clinical trials of one or more additional drug candidates may show that these product candidates are

unsafe or ineffective.

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 design novel compounds to attack those threats.

We do not have any products approved by a regulatory authority and

have not generated any revenue from collaboration or 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.

As a result, we have

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

For the years ended December 31, 2021 and 2020,

we reported a net loss of $6,728,396 and $3,264,882, respectively.

As of December 31, 2021 and December 31, 2020, we had an accumulated

deficit of $37,082,164 and $30,353,768, 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.

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 one or more of our product candidates and any additional product candidates we might acquire, and potentially begin to commercialize

product candidates that might achieve regulatory approval.

We might also encounter unforeseen expenses, difficulties, complications,

delays and other unknown factors that could 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;

or acquire 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;

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.

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

our lead product candidate, LB-100.

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,

expect that our existing cash resources as of December 31, 2021, 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 programs

with respect to the development of our lead anti-cancer clinical compound LB-100, through approximately September 30, 2022.

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

capital to fund its operations, including its various clinical trial commitments, during the quarter ending September 30, 2022.

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

we might need additional funds sooner than planned.

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

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.

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;

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

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

timing of, and the costs involved in, obtaining regulatory approvals for our lead drug candidate if our clinical trials are successful;

cost of commercialization activities for our lead product candidate, if it is approved for sale, including marketing, sales and distribution

cost of manufacturing our lead 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 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;

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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.

funds might 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.

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

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

candidates 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 lead product candidate.

currently have no source of revenues.

We may never generate revenues or achieve profitability.

We might 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.

Even if we are able to successfully achieve regulatory approval for

our lead 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 lead product

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

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

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

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;

regulatory approval for indications for which there is a commercial

and submit applications to foreign regulatory authorities;

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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;

commercially viable prices for our intended product, if any;

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

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

distribution processes for our lead product candidate;

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

additional funding, if required to develop and commercialize our lead 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 one or more of our intended products;

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.

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 might 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 might not become profitable and might 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 might be

unable to continue our operations at planned levels and might 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.

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

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 might be subject to limitations.

of December 31, 2021, we had federal net operating loss, or NOL, carryforwards of approximately $6,723,000.

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

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 might be limited.

Related to the Development and Regulatory Approval of Our Product Candidates

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;

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

substantial risk.

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

The success of our lead 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 lead product candidate or product candidates that we might, in the future, in-license or acquire;

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

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’

and maintaining patent and trade secret protection and regulatory exclusivity for our lead 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;

our lead product candidate at an acceptable cost;

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

acceptance of our lead 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

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

government payors, for our lead 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 activities;

a continued acceptable safety profile of the lead product candidate 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 lead product candidate, which could materially harm our business.

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

and qualifying patients to participate in clinical trials of our lead 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 lead product candidate,

and we might 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 lead product candidate will most likely be delayed.

factors might 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 trials;

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;

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

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

availability and efficacy of competing therapies and clinical trials;

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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.

who are noncompliant or do not otherwise complete the trials;

with contract research organizations (each being a “CRO”) and/or with other vendors that handle our clinical trials.

might not be able to initiate or continue to support clinical trials of LB-100, our lead 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 one or more 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 lead product candidate might increase

and the completion of our trials might 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 lead product candidate, the commercial prospects

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

Any of these occurrences

might 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.

Our lead product candidate

in clinical trials, and any other product candidates that might advance into clinical trials, might 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.

A number of companies in the pharmaceutical and biotechnology industries, including

those with greater resources and experience than we have, 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 lead product candidate, we do not know whether the clinical

trials that we might conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our lead product

candidate for a particular indication, in any particular jurisdiction.

Efficacy data from prospectively designed trials might 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 lead product candidate might be adversely impacted.

Even if we believe that we have

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

the FDA or other regulatory authorities might not agree and might 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;

Failure can occur at any time during

the clinical trial process.

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

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

Prior to 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 might be time-consuming and expensive

The necessary preclinical testing might not be completed successfully for a preclinical product candidate and a potentially

promising product candidate might 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 might not be predictive of the success of later

clinical trials, and interim results of a clinical trial do not necessarily predict final results.

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.

might experience numerous unforeseen events during drug development that could delay or prevent our ability to receive marketing approval

or commercialize our lead product candidate.

In particular, clinical trials of our lead product candidate might produce inconclusive

or negative results.

We have limited data regarding the safety, tolerability and efficacy of our lead 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 might decide not to consider any data or information

derived from a clinical investigation not subject to initial and continuing IRB review and approval.

might 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 lead product candidate on hold in the future.

Clinical trials might be delayed, suspended or prematurely

terminated for a variety of reasons, such as:

or failure in reaching agreement with the FDA or a 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;

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;

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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;

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;

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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;

from the FDA, the IRB or a 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 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 manufacturing or obtaining from one or more 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

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

prospects of our lead 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.

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 intended product may be shortened.

Regulatory approval

of our lead 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.

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

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

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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.

stringent privacy requirements for data to be supplied to our operations in the U.S., but generated outside 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;

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

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

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;

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.

interruptions resulting from geopolitical actions or events, including civil or political unrest (such as the ongoing conflict between

Ukraine and Russia), sanctions, 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, our collaborators

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 foreign regulatory authorities;

or an IRB, 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 might experience in our clinical trials, or negative or inconclusive results from the clinical trials of others for drug candidates

that might be similar to our own, we might not receive approval to market our current lead 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 or incidence of side effects.

In such an event, our trials or those or our collaborators could be suspended

or terminated, and the FDA or foreign regulatory authorities could order us or our collaborators to cease further development of or deny

approval of our current or any future product candidates for any or all targeted indications.

Any drug-related side effects could also

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

Any of these occurrences could 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:

if our lead 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

authorities might withdraw their approvals of such product;

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

of such product;

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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.

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

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

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

be inadequate to detect rare adverse events or chance findings that might 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.

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 lead product candidate will be uncovered.

and severe side effects might only be uncovered with a significantly larger number of patients exposed to our lead product candidate.

If such safety problems occur or are identified after our lead product candidate reaches the market, the FDA might require that we amend

the labeling of the product or recall the product, or might even withdraw approval for the product.

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

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

We cannot commercialize

our product candidate in the U.S.

our lead 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

commercialize our lead product candidate outside of the U.S.

without obtaining regulatory approval from one or more foreign regulatory

Before obtaining regulatory approvals for the commercial sale of our lead 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 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 one or more 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:

Also, any regulatory approval of our lead product

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

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

have not obtained regulatory approval for our lead product candidate, and it is possible that our lead 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;

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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

insufficiency of data collected from clinical trials of our lead 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;

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

FDA or a foreign regulatory authority might require more information, including additional preclinical or clinical data to support approval

or additional studies, which might delay or prevent approval or our commercialization plans, or we might decide to abandon the development

If we were to obtain approval, regulatory authorities might approve our lead product candidate and any future product candidates

we might pursue for fewer or more limited indications than we request (including failing to approve the most commercially promising indications),

might grant approval contingent on the performance of costly post-marketing clinical trials, or might 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 lead product candidate in one or more jurisdictions, or if any approval contains

significant limitations, we might 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

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

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

Asian countries and in 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.

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

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

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.

The approval procedure varies among

countries and can require additional data or involve additional testing.

The time required to obtain foreign 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.

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

timely basis, if at all.

Clinical trials accepted in one country might 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:

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 might not receive reimbursement approval

in that country.

might not be able to file for regulatory approvals and might not receive necessary approvals to commercialize our intended product in

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

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

might 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 might still face future development and regulatory difficulties.

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

FDA and 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 can 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 or our collaborators

might conduct.

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

after approval.

If the FDA or foreign regulatory authorities become aware of new safety information after approval of our lead product

candidate, they might 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, a collaborator 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 might 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 lead product candidate or the

manufacturing facilities for our lead product candidate fail to comply with applicable regulatory requirements, a regulatory agency might:

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;

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;

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any ongoing clinical trials;

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

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

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

occurrence of any event or penalty described above might inhibit our ability to successfully commercialize our intended 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.

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.

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

is heavily scrutinized by foreign regulatory authorities.

Violations, including actual or alleged promotion of our intended 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 can 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.

The loss of any such personnel could

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

The loss of any such personnel could adversely

affect our business, financial condition and results of operations.

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

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

is 85 years old and is being treated for recurrent asymptomatic prostate cancer.

The loss of services of Dr.

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

perform certain services for us.

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.

Furthermore, recruiting and retaining qualified scientific personnel to perform future research and development

work is 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.

competition for qualified personnel in the pharmaceutical field is intense and, as a result, we might 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 perform

certain services for us.

Those services include, among other things:

(a) assisting us to (i) commercialize our products

and strengthen our patent portfolio, (ii) identify large pharmaceutical companies with potential interest in our product pipeline,

and (iii) prepare and deliver presentations concerning our products;

(b) at the request of the Board of Directors, serving as

backup management for up to three months should our Chief Executive Officer and scientific leader be temporarily unable to carry

out his duties;

and (d) identifying providers and overseeing

tasks relating to clinical use and commercialization of new compounds.

BioPharmaWorks was founded in 2015 by former Pfizer scientists

with extensive multi-disciplinary research and development and drug development experience.

The Collaboration Agreement automatically

renews annually unless either party elects to terminate it.

Services under this Collaboration Agreement have been periodically

suspended and resumed;

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

and the Collaboration Agreement is currently in effect.

(a) assisting us to (i) commercialize our intended products and

strengthen our patent portfolio, (ii) identify pharmaceutical companies with potential interest in our product pipeline, and (iii) prepare

and deliver presentations concerning our product candidates;

(b) at the request of the Board of Directors, serving as backup management

for up to three months should our Chief Executive Officer and scientific leader be temporarily unable to carry out his duties;

available for consultation in drug discovery and development;

and (d) identifying providers and overseeing tasks relating to clinical

use and commercialization of new compounds.

BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary

research and development and drug development experience.

The Collaboration Agreement automatically renews annually unless either party

elects to terminate it.

Services under this Collaboration Agreement have been periodically suspended and resumed;

effective March 1,

2019, we and BioPharmaWorks agreed to resume services under this Collaboration Agreement, and the Collaboration Agreement is currently

Additionally,

we have recently hired Dr.

we have hired Dr.

Miser as Chief Medical Officer.

For the foreseeable future, Dr.

Miser will be working with

us on a half-time basis.

Miser will be working with us on a half-time

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.

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.

If these clinical trials

are not successful, or if we or our collaborators are not able to obtain the necessary regulatory approvals, we will not be able

to commercialize our product candidates.

order to obtain regulatory approval for the commercial sale of our product candidates, we and our collaborators will be required

to complete extensive preclinical studies as well as clinical trials in humans to demonstrate to the FDA and foreign regulatory

authorities that our product candidates are safe and effective.

Kovach is experienced in the design and conduct of early clinical cancer trials, having been the lead investigator for a National

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

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

unintended side effects, toxicities or other characteristics that may prevent or limit their commercial use.

If these clinical trials are not

successful, or if we or our collaborators are not able to obtain the necessary regulatory approvals, we will not be able to commercialize

our product candidates.

order to obtain regulatory approval for the commercial sale of our product candidates, we or our collaborators will be required to complete

extensive preclinical studies as well as clinical trials in humans to demonstrate to the FDA and foreign regulatory authorities that

our product candidates are safe and effective.

Kovach is experienced in the design and conduct of early clinical cancer trials, having been the lead investigator for a National Cancer

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

However, we have no experience in conducting

clinical trials and expect to rely heavily on collaborative partners and CROs for their performance and management of clinical trials

of our product candidates.

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

or unintended side effects, toxicities or other characteristics that might prevent or limit their commercial use.

Institutional review

boards or regulators, including the FDA, may hold, suspend or terminate our clinical research or the clinical trials of our product

candidates for various reasons, including non-compliance with regulatory requirements or if, in their opinion, the participating

subjects are being exposed to unacceptable health risks.

Additionally, the failure of third parties conducting or overseeing the

operation of the clinical trials to perform their contractual or regulatory obligations in a timely fashion could delay the clinical

Failure of clinical trials can occur at any stage of testing.

Any of these events would adversely affect our ability to

market a product candidate.

boards or regulators, including the FDA, might hold, suspend or terminate our clinical research or the clinical trials of our product

candidates for various reasons, including non-compliance with regulatory requirements or if, in their opinion, the participating subjects

are being exposed to unacceptable health risks.

Additionally, failure of third parties conducting or overseeing the operation of the

clinical trials to perform their contractual or regulatory obligations in a timely fashion could delay the clinical trials.

clinical trials can occur at any stage.

Any of these events would adversely affect our ability to market a product candidate.

development process necessary to obtain regulatory approval is lengthy, complex and costly.

If we and our collaborative partners

do not obtain necessary regulatory approvals at each stage of development, then our business would not be successful, and the

market price of our common stock could decline substantially.

the extent that we, or our collaborative partners, are able to successfully advance a product candidate through the clinic, we,

or such partner, will be required to obtain regulatory approval prior to marketing and selling such product.

The process of obtaining

FDA and other required regulatory approvals is costly and lengthy.

The time required for FDA and other approvals is uncertain

and can typically take a number of years, depending on the complexity and novelty of the product.

regulatory approval to market a product may be subject to limitations on the indicated uses for which we, or our collaborative

partners, may market the product.

These limitations may restrict the size of the market for the product and affect reimbursement

by third-party payors.

In addition, regulatory agencies may not grant approvals on a timely basis or may revoke or significantly

modify previously granted approvals.

If we or our collaborative partners do not

obtain necessary regulatory approvals, then our business would not be successful, and the market price of our common stock could decline

substantially.

the extent that we, or our collaborative partners, are able to successfully advance a product candidate through the clinic, we, or such

partner, will be required to obtain regulatory approval prior to marketing and selling such product.

The process of obtaining FDA and

other required regulatory approvals is costly and lengthy.

The time required for FDA and other approvals is uncertain and can typically

take several or many years, depending on the complexity and novelty of the product.

regulatory approval to market a product might be subject to limitations on the indicated uses for which we, or our collaborative partners,

may market the product.

These limitations might restrict the size of the market for the product and affect reimbursement by third-party

In addition, regulatory agencies might not grant approvals on a timely basis or might revoke or significantly modify previously

granted approvals.

or our collaborative partners, also are subject to numerous foreign regulatory requirements governing the manufacturing and marketing

of our potential future products outside of the United States.

The approval procedure varies among countries, additional testing

may be required in some jurisdictions, and the time required to obtain foreign approvals often differs from that required to obtain

FDA approvals.

The approval procedure varies among countries, additional testing might

be required in some jurisdictions, and the time required to obtain foreign approvals often differs from that required to obtain FDA approvals.

Moreover, approval by the FDA does not ensure approval by regulatory authorities in other countries, and vice versa.

a result of these factors, we, or our collaborative partners, may not successfully complete clinical trials in the time periods

estimated, if at all.

Moreover, if we, or our collaborative partners, incur unanticipated costs and/or delays in development programs

or if we fail to successfully develop and commercialize products based upon our technologies, we may not be able to generate significant

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

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.

a result of these factors, we, or our collaborative partners, might not successfully complete clinical trials in the time periods estimated,

Moreover, if we, or our collaborative partners, incur unanticipated costs and/or delays in development programs or if we fail

to successfully develop and commercialize products based upon our technologies, we might not be able to generate significant operating

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

interruptions could adversely affect future operations, revenues, and financial conditions, and might 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

might 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 might 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 activities.

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.

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

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

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

of our lead 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

financial condition or results of operations.

strategy for the development and commercialization of our proprietary product candidates might 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:

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

including a clinical trial research agreement with H.

Lee Moffitt Cancer Center and Research Institute, Inc.

a collaboration agreement with the Spanish Sarcoma Group;

a cooperative research and development agreement with the National Cancer Institute;

a clinical research support agreement with City of Hope National Medical Center;

an agreement with Theradex Systems, Inc.;

a patent assignment

and exploitation agreement with Inserm Transfert SA;

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 might not perform their obligations as expected.

Potential third-party collaborators include biopharmaceutical, pharmaceutical

and biotechnology companies, academic institutions, government agencies and other entities.

Third-party collaborators may assist us in:

research, preclinical development, clinical trials and manufacturing;

1 unchanged sentence

commercializing any future product candidates.

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

we are not able to establish further collaboration agreements, we might 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.

Such an undertaking might 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 might subject us to a number of risks.

we fail to comply with our obligations under these agreements, of if one or more third parties allege that we fail to comply, then one

or more third parties might terminate the agreements.

In this event, we might not be able to develop, manufacture or market our product

This would materially adversely affect our business prospects.

agreements might not be on terms that prove favorable to us and might require us to relinquish certain rights in our product candidates.

To the extent we agree to work exclusively with one collaborator in a particular territory, research area, or therapeutic field of use,

our opportunities to collaborate with other entities could be curtailed.

Lengthy negotiations with potential new collaborators might

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.

addition, our agreements might not be assignable by us without the consent of the respective other party or parties, which might limit

or delay our ability to consummate transactions, adversely impact the value of those transactions, or limit our ability to pursue research,

development or other activities.

might be subject to claims by third parties asserting that our employees, consultants, collaborators contractors or we have misappropriated

their intellectual property, or claiming ownership of what we regard as our own intellectual property.

employees, consultants, collaborators or contractors have been previously employed at universities or third-party pharmaceutical companies,

including our actual or possible competitors, and received confidential and proprietary information from them.

Although we try to ensure

that our employees, consultants, collaborators or contractors do not use the proprietary information or know-how of others in their work

for us, we may be subject to claims that these employees, consultants, collaborators or contractors, or we, have used or disclosed intellectual

property, including trade secrets or other proprietary information, of any former employer.

We might also be subject to claims that former

employers or other third parties have an ownership interest in our patents.

Litigation may be necessary to defend against these claims.

We might not be successful in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages,

we could lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property.

Even if we are successful, litigation could result in substantial cost and reputational loss and be a distraction to our business.

addition, while it is our policy to require our employees, consultants, collaborators and contractors who may be involved in the development

of intellectual property to execute agreements assigning such intellectual property to us, we might be unsuccessful in executing such

an agreement with each party who in fact develops intellectual property that we regard as our own.

Such assignment agreements might not

be self-executing or may be breached, and we might be forced to bring claims against third parties, or defend claims that third parties

might bring against us, to determine the ownership of what we regard as our intellectual property.

Related to Our Intellectual Property

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

patents and patent applications are owned solely by our subsidiary Lixte Biotechnology, Inc., or jointly by Lixte Biotechnology, Inc.,

and one of our collaborators.

patent prosecution process is expensive and time-consuming, and we might not be able to file or prosecute all necessary or desirable

patent applications at a reasonable cost or in a timely manner.

It is also possible that we will fail to identify patentable aspects

of our research or development before it is too late to obtain patent protection.

Therefore, these patents and applications might not

be prosecuted and enforced in a manner consistent with the best interests of our business.

patent position of pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent

years been the subject of much litigation.

In addition, the laws of foreign countries might not protect our rights to the same extent

as the laws of the United States.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and

patent applications in the United States and other jurisdictions are typically not published until after filing, or in some cases not

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our solely owned or jointly

owned patents or pending patent applications, or that we were the first inventors to file for patent protection of such inventions.

a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and

future patent applications might not result in patents being issued that protect our technology or products, in whole or in part, or

that effectively prevent others from commercializing competitive technologies and products.

Changes in the patent laws or their interpretation

by courts or patent offices might diminish the value of our patents or patent applications, or narrow their scope.

issuance of a patent is not conclusive as to its inventorship, scope, term, validity or enforceability, and our solely or jointly owned

patents might be challenged in a U.S.

court or patent office.

Such challenges might result in loss of exclusivity or in patent

claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using

or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and

Given the amount of time required for research, development, testing or regulatory review of product candidates, patents protecting

such candidates might expire before or shortly after such candidates are approved or commercialized.

As a result, our solely or jointly

owned patents might not provide us with sufficient rights to exclude others from commercializing intended products similar or identical

cannot be certain that all patents applied for will be issued.

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

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;

or our licensors might not have been the first to file patent applications for these inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies;

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

claimed by us, solely or jointly with one of our collaborators, we might 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 uncertain.

solely or jointly with our collaborators, might not have been the first to make the inventions covered by our pending or future patent

applications;

solely or jointly with our collaborators, might not have been the first to file patent applications for these inventions;

might independently develop identical, similar or alternative technologies;

is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted

by any patents arising from our patent applications will be significantly narrower than expected;

patents under which we hold ultimate rights may not provide us with a basis for commercially-viable products, may not provide

us with any competitive advantages or may be challenged by third parties as not infringed, invalid, or unenforceable under

United States or foreign laws;

patent issued to us in the future or under which we hold rights may not be valid or enforceable;

may develop additional proprietary technologies that are not patentable and which may not be adequately protected through

trade secrets;

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.

might be unaware of prior art that renders one or more of our patent applications unpatentable or one or more of our patents invalid;

court might determine that we failed to disclose to a patent office prior art that we were aware of and that is material to patentability

and, therefore, conclude that one or more of our patents are unenforceable;

patents under which we hold rights might not cover commercially viable products, might not provide us with any competitive advantages

or might be challenged by one or more third parties as being not infringed, being invalid, or being unenforceable under United States

or foreign laws;

court or patent office might determine that two or more of our patents claim patentably indistinct subject matter, which could adversely

affect one or more of the patents’ the term, validity or enforceability;

court or patent office might determine that one or more patents issued to us in the future or under which we hold rights are invalid

or unenforceable;

might develop additional proprietary technologies that are not patentable and which might not be adequately protected through trade

secrets or know-how.

addition, we solely or jointly own patents or patent applications in jurisdictions having, or that might in the future have, geopolitical

disputes, including over sovereignty.

We cannot guarantee that patents granted in these jurisdictions will be enforceable.

to enforce patents in these jurisdictions could have a material adverse effect on our business.

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

our business might be materially harmed.

the United States, the term of a patent that covers an FDA-approved drug, its method for use or method for manufacture, can be eligible

for patent term extension.

law provides a patent term extension of up to five years beyond the expiration of the patent for time

during which the drug is under regulatory review.

Patent term extension cannot extend the term of a patent beyond a total of 14 years

from the date of regulatory approval;

only one patent can be extended for the same regulatory review period;

and the scope of a patent’s

enforceability during a patent term extension is limited to the scope of FDA approval.

There is no guarantee that the relevant agencies,

including the United States Patent and Trademark Office (“USPTO”), will agree with our assessment of whether such extensions

should be granted, and even if granted, the term of these extensions.

We might not be granted patent term extension in the United States

or in any foreign country because of, for example, expiration of our patents before obtaining regulatory approval, 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 if the term of any such extension is less than we request, our competitors might

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:

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 agreements under which we have licensed or, might license, intellectual property rights from

third parties, or if we otherwise experience disruptions to our business relationships with our licensors, we could lose rights that

are important to our business.

have entered into, and might in the future enter into, one or more intellectual property license agreements that are important to our

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

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

to licensed products, and might 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 might be subject to termination of the license agreement in whole or in part, 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 might 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.

our technology, product candidates or processes infringe intellectual property rights that are owned by the licensor, but that are

not subject to the licensing agreement;

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

we are required to sublicense to a third party rights that the license grants to us, but that we do not commercially pursue;

ownership of inventions, data and know-how resulting from joint creation or use of intellectual property by our licensors and us.

disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain

our licensing arrangements on acceptable terms, we may be unable to successfully develop or commercialize the affected product candidates.

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

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

Other companies

might have a competitive advantage over us due to their larger size or cash resources or greater clinical development and commercialization

capabilities.

We might be unable to further develop or commercialize one or more of our product candidates, which could harm our business

significantly.

might 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

that our intended products or our product candidates, or manufacture or use of our intended products or our product candidates, will

not infringe third-party patents.

Furthermore, a third party might claim that we are using without permission one or more inventions

covered by the third party’s patent rights and might go to court to stop us from engaging in our normal operations and activities,

including making, offering to sell or selling our product candidates.

Still further a third party might go to court seeking judgment

that our patents are invalid or unenforceable.

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 might be better capitalized and have more resources than us.

is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities

covered by the patents.

In that event, we might not have a viable way around the patent and might 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 patents.

There is also a risk that a court would decide that one or more of our patents are invalid or unenforceable.

In addition, we might be obligated to indemnify our licensors and collaborators against 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.

cannot guarantee that we have identified all third-party patents or pending patent applications that are or might be necessary for the

commercialization of our intended products and technologies in any jurisdiction.

Patent applications in the United States and elsewhere

are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date

being commonly referred to as the priority date.

Therefore, patent applications covering our technologies and intended products could

have been filed by others without our knowledge.

Additionally,

pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover

our technologies or intended products.

The scope of a patent claim is determined by the interpretation of the law, the words of a patent

claim, the written disclosure in a patent and the patent’s prosecution history.

Our interpretation of the relevance or the scope

of a patent or a pending patent application may be incorrect, which may negatively impact our ability to market our intended products.

We might incorrectly determine that our technologies or intended products are not covered by a third-party patent or might incorrectly

predict whether a third party’s pending patent application will issue with claims of relevant scope.

Our determination of the expiration

date of any patent in the United States or abroad that we consider relevant might be incorrect, and we might incorrectly conclude that

a third-party patent does not cover our technology or intended products, is invalid or is unenforceable.

Our inability to identify or

correctly interpret relevant patents might negatively impact our ability to develop or market our technologies or intended products.

If we fail to identify or correctly interpret relevant patents, we might be subject to infringement claims.

We cannot guarantee that

we will be able to successfully settle or otherwise resolve such infringement claims.

If we fail in any such dispute, in addition to

being liable for damages, we might be temporarily or permanently enjoined or otherwise prohibited from commercializing any of technologies

or intended products that are held to be infringing.

We might, if possible, also be forced to redesign intended products or product formulations

so that we no longer infringe the third-party intellectual property rights.

Any of these events, even if we were ultimately to prevail,

could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

the pharmaceutical or biotechnology industry expands and more patents are issued, the risk increases that our product candidates or intended

products give rise to claims of infringement of the patent rights of others.

There may be third-party patents of which we are currently

unaware with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of

our product candidates.

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

infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, negotiate and obtain a license

under reasonable terms to us or discontinue performing the allegedly infringing activities.

We might not be able to do any of these.

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

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 might 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 might be required to seek a license, which might not be available,

and then we will have to defend an infringement action, challenge the validity of the patents in the USPTO or in court, or discontinue

performing the allegedly infringing activities.

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;

We might not have sufficient resources

to bring these actions to a successful conclusion.

In addition, if we do not obtain a license, develop or obtain non-infringing technology,

fail to defend an infringement action successfully or fail to have infringed patents declared invalid or unenforceable, we might 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, that we were the

first to invent the technology or that we were the first to file patent applications covering our technology, because:

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

applications in the United States are typically not published until 18 months after their earliest claimed 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

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

such patent applications might dominate 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 that cover inventions similar or identical to ours and claim priority

to any applications filed prior to the priority dates of our applications, we might 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

The costs of these

proceedings could be substantial, and it is possible that such efforts would be unsuccessful if the other party had independently arrived

at the same or similar inventions before us, possibly resulting in a loss of our U.S.

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

Other countries might have similar laws that permit secrecy of patent applications.

Either way, the third party’s patents or patent

applications might be entitled to priority over our applications in such jurisdictions.

of our competitors might be able to sustain the costs of a patent challenge more effectively than we can because they have substantially

greater resources.

In addition, uncertainties regarding the outcome of the challenge could have a material adverse effect on our ability

to raise the funds necessary to continue our operations.

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

secrets of one or more third parties.

is common in the biotechnology and pharmaceutical industries, we employ, and might 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

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 might 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 might 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 might not be sufficient to protect our intended products from competition, which might 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:

might 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, any actual or perceived limitations, in our intellectual

property might lessen 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 intended products or future products.

approach includes filing patent applications covering combination therapy with known, studied and/or marketed drugs.

Although the protection

afforded by our patent applications might be significant, when looking at our patents’ ability to block competition, the protection

offered by our patents might be, to some extent, more limited than protection provided by patents claiming a composition of matter that

is entirely new and previously unknown.

If a competitor were able to successfully design around any combination therapy patents we have

or might have in the future, our business and competitive advantage could be significantly affected.

might 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.

We might alternatively elect

to sue a third party, or otherwise make a claim, alleging that we don’t infringe a third party’s patents or that the third

party’s patents are invalid or unenforceable.

Any claims that we assert against a third party could provoke the third party to

assert one or more counterclaims against us, for example, alleging that we infringe their patents.

In addition, in a patent infringement

proceeding, a court might decide that a patent of ours is invalid or unenforceable, in whole or in part;

construe the patent’s

claims narrowly;

or refuse to stop the other party from using the technology at issue.

Any litigation proceeding could put one or more

of our patents at risk of being invalidated, held unenforceable or interpreted narrowly.

Even if we prevail in a lawsuit, a court might

not award remedies that sufficiently compensate us for our losses.

we do not prevail in either type of litigation, we might 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;

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

financial condition, and the commercial viability of our intended 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

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 might also challenge the validity, enforceability or scope of the intellectual property rights that we license or own, and

the result of these challenges might 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

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, among other factors.

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

United States, and many companies have encountered significant difficulties in protecting and defending such rights in non-U.S.

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

competitive harm.

also rely on proprietary trade secrets and unpatented know-how to protect our research and development activities, particularly

when we do not believe that patent protection is appropriate or available.

The legal systems of some countries are less supportive of enforcement of patents, trade secrets and other intellectual property protection,

than the United States.

This could make it difficult for us to enforce our patents or market competing products outside the United States,

in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in non-U.S.

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 might not prevail in any lawsuits that we initiate, and the damages or other remedies awarded,

if any, might not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights in all jurisdictions

where we have the rights might be inadequate to obtain a significant commercial advantage from the intellectual property that we develop

Furthermore, while we seek to protect our intellectual property rights in significant markets, we cannot ensure that we will

be able to initiate or maintain similar efforts in all jurisdictions in which we might wish to market our intended products or our product

Accordingly, our efforts to protect our intellectual property rights in such countries might be inadequate, which might 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 might be diminished, and we might 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., might substantially change the regulations and procedures surrounding patent applications,

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

We can give no assurances that our

patents or 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.

prosecuting and defending patents covering our product candidates in all countries throughout the world would be prohibitively expensive,

and our intellectual property rights in some jurisdictions outside the United States can be less extensive than those in the United States.

And filing, prosecuting and defending patents even in only those jurisdictions in which we develop or commercialize our product candidates

might be prohibitively expensive or impractical.

Competitors might use our technologies in jurisdictions where we have not obtained patent

protection to develop their own products or technologies and, further, may export otherwise infringing products or technologies to territories

where we and have patent protection, but where enforcement is not as strong as that in the United States.

These third-party products

or technologies might compete with our product candidates, and our intellectual property rights may not be effective or sufficient to

prevent third parties from competing.

addition, we might decide to abandon national or regional patent applications while they are still pending or to abandon granted patents.

This might invite or encourage third parties to develop their products or technologies in jurisdictions where we abandon patent applications

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

also rely on proprietary trade secrets and unpatented know-how to protect our research and development activities, particularly when

we do not believe that patent protection is appropriate or available.

However, trade secrets are difficult to protect.

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

licensing third-party intellectual property, as a result of litigation or other proceedings relating to patent and other intellectual

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, 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.

We 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, by, e.g., a misappropriating or disclosing our confidential information;

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, might become known or might be independently discovered

by others, which could adversely affect the competitive position of our product candidates.

might incur substantial costs prosecuting our patent applications, maintaining our patents and patent applications, enforcing our patents,

defending against third-party patent infringement suits, seeking invalidation of third-party patents or in-licensing third-party intellectual

property, as a result of litigation or other proceedings relating to patent and other intellectual property rights.

might 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 might have elected, or elect now or in the

future, not to maintain or pursue intellectual property rights that, at some point in time, might be considered relevant to or enforceable

against a competitor.

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

title in intellectual property rights.

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

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

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

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

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

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 might 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 might not be available on acceptable terms, or

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

maintenance fees on issued U.S.

patents are due to be paid to the USPTO, and periodic maintenance fees on issued non-U.S.

pending non-U.S.

patent applications are due to be paid to non-U.S.

patent offices.

The patent offices require compliance with many procedural,

documentary, fee payment and other requirements during the patent application process and after a patent issues or grants.

While an inadvertent

lapse can in some cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations

in which non-compliance, for example, caused by geopolitical events such as civil or political unrest (including the ongoing conflict

between Ukraine and Russia), can result in abandonment or lapse of the patent or patent application, resulting in partial or complete

loss of a patent or patent rights in the relevant jurisdiction.

Non-compliance events that could result in abandonment or lapse of a

patent or patent application include, but are not limited to, failure to respond to patent office actions within prescribed time limits,

non-payment of fees and failure to properly legalize and submit formal documents.

In such an event, our competitors might be able to

enter the market, which would have a material adverse effect on our business.

USPTO and various non-U.S.

government agencies require compliance with certain foreign filing requirements during the patent application

For example, in some countries, including the United States, a foreign filing license is required before certain patent applications

are filed outside that country.

The foreign filing license requirements can vary by country.

In some cases, a foreign filing license

may be obtained retroactively in accordance with the applicable rules.

There are situations, however, in which non-compliance can result

in abandonment of a pending patent application or can be grounds for revoking or invalidating an issued patent, resulting in the loss

of patent rights in the relevant jurisdiction.

In such an event, potential competitors might be able to enter the relevant markets with

similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results

of operations, and prospects.

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

and biotechnology industries.

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

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.

Although we are not currently a party to any patent litigation or any other adversarial proceeding, 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 intended products, our product candidates and our technology, it is possible that we might become

one in the future.

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

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.

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

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

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

Some of our competitors

might 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 might be enjoined from researching, developing, manufacturing

or commercializing our intended products or our product candidates without a license from the other party and we might be held liable

for significant damages.

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

Uncertainties

resulting from the initiation and continuation of patent litigation or other proceedings could harm our ability to compete in

the marketplace.

Patent litigation and other proceedings may also absorb significant management time.

we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features

that may reduce demand for our potential products.

resulting from the initiation and continuation of patent litigation or other proceedings could harm our ability to compete in the marketplace.

Patent litigation or other proceedings might also absorb significant management time.

we are unable to protect our intellectual property rights, our competitors might develop and market products with similar or identical

features that might reduce demand for our potential products.

following factors are important to our success:

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our patent rights and trade secrets.

will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only

to the extent that such intellectual property rights are covered by valid and enforceable patents or are effectively maintained

as trade secrets.

issues of patentability involve complex legal and factual questions, the issuance, scope and enforceability of patents cannot

be predicted with certainty.

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.

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.

will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to

the extent that such intellectual property rights are covered by valid and enforceable patents or are effectively maintained as trade

secrets and we enforce these rights.

issues of patentability involve complex legal and factual questions, the issuance, scope or enforceability of patents cannot be predicted

with certainty.

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

United States patents and patent applications

can be subject to interference or derivation proceedings.

United States patents can 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.

patents can be subject to opposition or comparable proceedings in corresponding foreign patent offices.

Any of these challenges might

result in loss of the patent, rejection 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, these proceedings can be costly.

Thus, any patents that we own or license from others might

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 might file in the future, or those that we might license

from third parties might not result in patents being issued.

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

advantages against competitors with similar or identical technology.

Furthermore, others might independently develop similar technologies

or duplicate any technology that we have developed.

Some countries have compulsory licensing laws under which a patent owner might be

compelled to grant licenses to third parties.

For example, compulsory licenses might be required in cases such as where the patent owner

has failed to “work” the invention in that country or where a third-party has patented improvements.

In addition, some countries

might limit the enforceability of patents against government agencies or government contractors.

In these countries, we might have limited

infringement remedies, which could materially diminish the value of our patents.

Moreover, the legal systems of some countries are less

supportive of enforcement of patents, trade secrets and other intellectual property protection, than the United States, which might make

it difficult to stop infringement in these countries.

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

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who do not advertise or otherwise promote the compounds that are used in their products.

Any litigation to enforce or defend our

patent rights, even if we prevail, could be costly and time-consuming and would divert the attention of management and key personnel

from business operations.

Any litigation to enforce or defend our patent

rights, even if we prevail, could be costly and time-consuming and would divert the attention of management and key personnel from business

will also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position.

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, 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.

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

partners, collaborators, employees, contractors and consultants.

Any of these parties might breach these agreements and misappropriate

or 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

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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:

if we obtain regulatory approval for our lead product candidate or any future product candidates, the products might 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;

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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;

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

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

future product candidates;

cost of treatment in relation to alternative treatments;

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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,

our lead product candidate 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 lead product candidate or any future product candidates, the products might not receive coverage

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

and in other countries in which we seek to commercialize our intended 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.

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

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

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 might 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 intended 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.

Coverage and reimbursement might impact

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

If reimbursement is not available or

is available only at limited levels, we might not be able to successfully commercialize any product candidate for which we obtain regulatory

might be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage might 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.

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, might also not be sufficient

to cover our costs and might only be temporary.

Reimbursement rates might vary according to the use of the drug and the clinical setting

in which it is used, might be based on reimbursement levels already set for lower cost drugs and might be incorporated into existing

payments for other services.

Net prices for drugs might 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 might be sold at lower prices than

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 can 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 intended product and overall

financial condition.

legislative measures aimed at reducing healthcare costs might 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

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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.

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 intended 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.

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.

Since 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.

District 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.

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 programs.

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 might 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;

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 might adversely affect:

demand for our lead product candidate, if we obtain regulatory approval;

ability to receive or set a price that we believe is fair for our intended product;

ability to generate revenue and achieve or maintain profitability;

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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

expect that the ACA, as well as other healthcare reform measures that might be adopted in the future, might 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

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 might result in a similar denial or reduction in payments from private payors, which might prevent us from

being able to generate sufficient revenue, attain profitability or commercialize our product candidate, if approved.

controls might be imposed in foreign markets, which might adversely affect our future profitability.

some countries, the pricing of prescription drugs is subject to governmental control.

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.

economic and regulatory developments might further complicate pricing negotiations, and pricing negotiations might 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 might 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.

Publication of

discounts by third-party payors or authorities might lead to further pressure on the prices or reimbursement levels within the country

of publication and other countries.

If reimbursement of our intended 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

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 might become subject to civil and criminal

investigations and proceedings that could have a material adverse effect on our business, financial condition and prospects.

providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates

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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.

payors and customers might expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that might constrain

the business or financial arrangements and relationships through which we research, develop and will market, sell and distribute our

intended product.

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 might 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 might 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 government;

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 might apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private

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 might 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,

It is possible that governmental authorities will conclude that our business practices might 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 might apply to us, we might 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 might be subject to criminal, civil or administrative sanctions, including exclusions from government

funded healthcare programs.

employees might 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;

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 might not be effective

in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits

stemming from a failure to be in compliance with such laws or regulations.

If any such actions are instituted against us, and we are

not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results

of operations, including the imposition of significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion

from government funded healthcare programs, such as Medicare and Medicaid, and integrity oversight and reporting obligations.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we

might develop.

face an inherent risk of product liability exposure related to the testing of our lead 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 might develop.

Product liability

claims might be brought against us by subjects enrolled in our clinical trials, patients, healthcare providers or others using, administering

or selling our intended product.

If we cannot successfully defend ourselves against claims that our lead product candidate or product

caused injuries, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims might result in:

demand for any product candidates or products that we might develop;

of clinical trial sites or entire clinical trial programs;

4 unchanged sentences

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.

inability to commercialize any products that we might 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;

however, we might be unable

to obtain such coverage at a reasonable cost, if at all.

If we are able to obtain product liability insurance, we might not be able to

maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that might arise and such insurance

might not be adequate to cover all liabilities that we might 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 lead product candidate in development, but we might

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.

face substantial competition, which might 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 lead 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 might develop.

Competition could result in reduced sales and pricing pressure on our lead 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 lead product candidate could allow our competitors to bring products to market

before we do and impair our ability to commercialize our lead product candidate.

The biotechnology industry, including the cancer immunotherapy

market, is intensely competitive and involves a high degree of risk.

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.

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 might develop and commercialize

products that compete directly with those incorporating our technology or might introduce products to market earlier than our intended

product or on a more cost-effective basis.

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 might 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 lead 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 might have a competitive advantage over us.

Mergers and acquisitions in the pharmaceutical

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

or early-stage companies might 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 might 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 lead product candidate.

Our competitors

might also develop drugs that are safer, more effective, more widely used and cheaper than ours, and might also be more successful than

us in manufacturing and marketing their products.

These appreciable advantages could render our lead product candidate obsolete or non-competitive

before we can recover the expenses of development and commercialization.

business might be adversely affected by the ongoing coronavirus pandemic.

outbreak of the novel coronavirus (SARS-CoV-2) has evolved into a global pandemic.

The coronavirus has spread to many regions of the

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 might 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 and emergence of new variants, our business operations could be delayed or interrupted.

For instance, our clinical trials might be affected by the pandemic.

Site initiation, participant recruitment and enrollment, participant

dosing, distribution of clinical trial materials, study monitoring and data analysis might 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 might not be able to comply

with clinical trial protocols.

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

movement, affect sponsor access to study sites, or interrupt healthcare services, and we might 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 might increase our costs.

These cost increases might not be fully recoverable or adequately

covered by insurance.

and deaths related to the pandemic might 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.

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 might 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

or manufacturing activities might not be able to access their laboratory or manufacturing space which might 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.

spread of the coronavirus, which has caused a broad impact globally, including travel restrictions and quarantine policies put into place

by businesses and governments, might have a material adverse effect on our business.

While the potential economic impact brought by and

the duration of the pandemic might be difficult to assess or predict, it has already caused, and is likely to result in further, significant

disruption of global financial markets, which might reduce our ability to access capital either at all or on favorable terms.

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.

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

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.

we collect, store and transmit large amounts of confidential information (including, but not limited to, personal information and intellectual

The size and complexity of our information technology and information security systems, and those of our third-party vendors

with whom we might 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 might rely, are vulnerable to damage

from computer viruses, unauthorized access, natural disasters, fire, terrorism, war and telecommunication and electrical failures.

exercise little or no control over these third parties, which increases our vulnerability to problems with their systems.

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 misappropriation or disclosure of confidential or proprietary information, we could incur liability, the further

development of our lead and future product candidates could be delayed and our business could be otherwise adversely affected.

might need to grow the size of our organization in the future, and we might experience difficulties in managing this growth.

of March 11, 2022, we had three full-time officer/employees and one part-time officer/employee.

The Company relies to a significant extent

on outside consultants and advisors with various technical skills and expertise that the Company can draw on as necessary to conduct

its research and development and clinical trial programs.

We might need to grow the size of our organization in order to support our

continued development and potential commercialization of our lead 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 might increase.

Our management, personnel and systems currently in place might not be adequate to support this future growth.

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

5 unchanged sentences

our facilities.

our operations expand, we will also need to manage additional relationships with various strategic partners, suppliers and other

our operations expand, we will likely 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

Our future financial performance and our ability to commercialize our lead 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

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 might 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 changes.

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the

SEC and other government agencies on which our operations may rely, including those that fund research and development activities

is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government

In addition, government funding of the SEC and other

government agencies on which our operations might 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 might 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,

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

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

FDA, SEC and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly

impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on

our business.

Further, in our operations as a public company, future government shutdowns could impact our ability to access the public

markets and obtain necessary capital in order to properly capitalize and continue our operations.

Related to Owning our Securities

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

allows us to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies

that are not smaller reporting companies, including (1) not being required to comply with the auditor attestation requirements

of Section 404 of the Sarbanes-Oxley Act of 2002, and (2) reduced disclosure obligations regarding executive compensation in our

periodic reports and proxy statements.

In addition, as an emerging growth company, we are only required to provide two years of

audited financial statements in this document.

As a result of these reduced reporting and disclosure requirements our financial

statements may not be comparable to SEC registrants not classified as emerging growth companies.

cannot predict if investors will find our common stock less attractive because we may rely on these exemptions.

If some investors

find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock

price may be more volatile.

independent registered public accounting firm is not be required to formally attest to the effectiveness of our internal control

over financial reporting until we are no longer a “smaller reporting company”.

We cannot assure you that there will

not be material weaknesses or significant deficiencies in our internal controls in the future.

may find our common stock less attractive as a result of our election to utilize these exemptions, which could result in a less

active trading market for our common stock and/or the market price of our common stock may be more volatile.

are a “smaller reporting company,” as defined in the Regulation S-K of the Securities Act of 1933, as amended (the “Securities

Act”), which allows us to take advantage of certain exemptions from various reporting requirements that are applicable to other

public companies that are not smaller reporting companies, including (1) not being required to comply with the auditor attestation requirements

of Section 404 of the Sarbanes-Oxley Act of 2002, and (2) reduced disclosure obligations regarding executive compensation in our periodic

reports and proxy statements.

In addition, as an emerging growth company, we are only required to provide two years of audited financial

statements in this document.

As a result of these reduced reporting and disclosure requirements our financial statements might not be

comparable to SEC registrants not classified as emerging growth companies.

cannot predict if investors will find our common stock less attractive because we might rely on these exemptions.

If some investors find

our common stock less attractive as a result, there might be a less active trading market for our common stock and our stock price might

be more volatile.

independent registered public accounting firm is not be required to formally attest to the effectiveness of our internal control over

financial reporting until we are no longer a “smaller reporting company”.

We cannot assure you that there will not be material

weaknesses or significant deficiencies in our internal controls in the future.

might find our common stock less attractive as a result of our election to utilize these exemptions, which could result in a less active

trading market for our common stock and/or the market price of our common stock might be more volatile.

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.

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.

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 might 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.

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.

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.

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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.

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 might 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:

Some factors that might 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;

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;

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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

enrollment or results of our clinical trials for our lead product candidate or any future clinical trials we might conduct;

in the development status of our lead 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;

approval for our lead product candidate;

unanticipated

safety concerns related to the use of our product candidate;

safety concerns related to the use of our lead 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;

in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

cash position;

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inability to enter into new markets or develop new products;

from existing technologies and products or new technologies and products that may emerge;

from existing technologies and products or new technologies and products that might emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or

our competitors;

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;

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in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

events or factors, many of which might 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.

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 might expose us to lawsuits that,

even if unsuccessful, could be costly to defend and a distraction to management.

Company’s failure to meet the continued listing standards of Nasdaq could result in a delisting of its common stock.

In order to meet the continued

listing standards of the Nasdaq Capital Market (“Nasdaq”), the Company is required to meet various requirements, including

that it has stockholders’ equity of at least $2,500,000 and that its common stock have a minimum closing bid price of $1.00 per

If we fail to satisfy

the continued listing standards of Nasdaq in the future, Nasdaq may take steps to delist our common stock.

Such a delisting would

likely have a negative effect on the price of our common stock and would impair your ability to buy or sell our common stock when you

wish to do so.

A delisting would adversely affect the liquidity, trading volume and likely the price of our common stock, causing

the value of an investment in us to decrease, would adversely affect our ability to raise capital, and would have an adverse effect on

our business, financial condition and results of operations.

sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline.

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 might 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 might 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.

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 might 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.

these conditions continue to deteriorate or do not improve, it might 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 might 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

If securities analysts do not cover our common stock,

the lack of research coverage might 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 might 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 might have effective control over actions

requiring stockholder approval.

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of our outstanding shares of common stock, based on 13,746,593 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.

This percentage

decreases to approximately 22% 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

Accordingly, this concentration of ownership might harm the market price of our common stock by:

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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.

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 intended product, and continuing activities as an operating public company.

To the extent we

raise additional capital by issuing equity securities, our stockholders might experience substantial dilution.

We might 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 might be materially

diluted by subsequent sales.

Such sales might 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:

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.

might 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 might have anti-takeover effects that could discourage,

delay or prevent a change in control, which might 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 might be issued in one or more series, the terms of which might 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 might 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 11, 2022, 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

Such provisions might also prevent or frustrate attempts by our stockholders to replace or remove our management.

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.

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 might 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.

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.

The obligations of being a public company

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 might 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

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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.

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 might 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.

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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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors