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Item 1A. Risk Factors

2022-03-21 compared with 2021-03-31 · 1526 added, 1350 removed, 376 unchanged (88% of the section changed)

investment in our securities involves a high degree of risk.

An investor should carefully consider the risks described below as

well as other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S.

Securities and

Exchange Commission (“SEC”).

An investor should carefully consider the risks described below as well

as other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S.

Securities and Exchange Commission

The risks and uncertainties described below are not the only ones we face.

risks and uncertainties not presently known to us or that we currently believe are immaterial may also impair our business operations.

If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely

affected, the value of our securities could decline, and investors in our company may lose all or part of their investment.

Additional risks and uncertainties not

presently known to us or that we currently believe are immaterial may also impair our business operations.

If any of the following risks

actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our securities

could decline, and investors in our company may lose all or part of their investment.

Relating to Our Financial Position and Capital Needs

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 focused on the development of our novel cancer immunotherapy GP2, for breast cancer

and potentially for a broad range of other HER2/ neu -expressing cancers.

Investment in biopharmaceutical product development

is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate

will fail to prove effective, gain regulatory approval or become commercially viable.

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.

As a 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 $1.9 million and $3.4 million, respectively.

As of December 31, 2020, we had an accumulated deficit of $29.0 million.

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 focused on the development of our novel cancer immunotherapy GP2, for breast cancer and

potentially for a broad range of other HER2/ neu -expressing cancers.

Investment in biopharmaceutical product development is highly

speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove

effective, gain regulatory approval or become commercially viable.

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.

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 $4.6 million and $1.9 million, respectively.

As of December 31, 2021, we had an accumulated deficit of $33.6

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

that may achieve regulatory approval.

We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown

factors that may adversely affect our business.

The size of our future net losses will depend, in part, on the rate of future growth

of our expenses and our ability to generate revenues.

Our expenses will further increase as we:

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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.

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 our existing cash as of December 31, 2020 will enable us to fund our operating expenses through and capital expenditure

requirements for at least twelve months from the date of this Annual Report on Form 10-K;

however, our existing cash

will not be sufficient to complete development and obtain regulatory approval for our product candidate, and we will need to raise

significant additional capital to help us do so.

In addition, our operating plan may change as a result of many factors currently

unknown to us, and we may need additional funds sooner than planned.

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

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

These expenditures will include costs

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

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

selling products approved for sale, if any.

believe that it may cost approximately $12 million to $15 million to complete an interim analysis of the safety and efficacy of

our Phase III trial.

Furthermore, the total cost to complete an interim analysis and file a BLA application for drug approval

could exceed $16 million, and the total cost to complete our Phase III trial as planned could exceed $30 million;

however, we believe that we have budget flexibility with respect to the design of the Phase III clinical trial.

We believe that

we may be able to alter the cost of our Phase III clinical trial by adjusting the enrollment rate, the number of patients, and/or

the number of immunological assays.

While our budget for such Phase III trial may be flexible, our ability to reduce or modify

costs may be adversely effected by, among other things, unexpected or higher costs associated with the trial, time required to

complete the trial and other factors that may be beyond our control.

Our budgets 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;

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

our product candidate.

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

programs or commercialization efforts.

expect our existing cash as of December 31, 2021 will enable us to fund our operating expenses through and capital expenditure requirements

for at least twelve months from the date of this Annual Report on Form 10-K;

however, our existing cash will not be sufficient to complete

development and obtain regulatory approval for our product candidate, and we will need to raise significant additional capital to help

In addition, our operating plan may change as a result of many factors currently unknown to us, and we may need additional

funds sooner than planned.

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

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

These expenditures will include costs associated with

research and development, potentially acquiring new product candidates or technologies, conducting preclinical studies and clinical trials

and potentially obtaining regulatory approvals and manufacturing products, as well as marketing and selling products approved for sale,

The total cost to complete an interim analysis

and file a BLA application for drug approval in the U.S.

could exceed $30 million;

however, we believe that we have budget flexibility

with respect to the design of the Phase III clinical trial.

We believe that we may be able to alter the cost of our Phase III clinical

trial by adjusting the enrollment rate, the number of patients, and/or the number of immunological assays.

While our budget for such

Phase III trial may be flexible, our ability to reduce or modify costs may be adversely effected by, among other things, unexpected or

higher costs associated with the trial, time required to complete the trial and other factors that may be beyond our control.

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 successful;

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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;

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

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

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

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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.

may consider strategic alternatives in order to maximize stockholder value, including financings, strategic alliances, acquisitions

or the possible sale of the Company.

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.

may consider strategic alternatives in order to maximize stockholder value, including financings, strategic alliances, acquisitions or

the possible sale of the Company.

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

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

alliances, acquisitions or the possible sale of the Company.

We currently have no agreements or commitments to engage in any specific

strategic transactions, and our exploration of various strategic alternatives may not result in any specific action or transaction.

To the extent that this engagement results in a transaction, our business objectives may change depending upon the nature of the

There can be no assurance that we will enter into any transaction as a result of the engagement.

Furthermore, if

we determine to engage in a strategic transaction, we cannot predict the impact that such strategic transaction might have on

our operations or stock price.

We also cannot predict the impact on our stock price if we fail to enter into a transaction.

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

to our product candidate on unfavorable terms to us.

may seek additional capital through a variety of means, including through private and public equity offerings and debt financings,

collaborations, strategic alliances and marketing, distribution or licensing arrangements.

To the extent that we raise additional

capital through the sale of equity or convertible debt securities, or through the issuance of shares under management or other

types of contracts, or upon the exercise or conversion of outstanding derivative securities, the ownership interests of our stockholders

will be diluted, and the terms of such financings may include liquidation or other preferences, anti-dilution rights, conversion

and exercise price adjustments and other provisions that adversely affect the rights of our stockholders, including rights, preferences

and privileges that are senior to those of our holders of common stock in the event of a liquidation.

In addition, debt financing,

if available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional

debt, making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security

interests in our assets, including our intellectual property.

If we raise additional funds through collaborations, strategic alliances,

or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies,

future revenue streams, product or product candidate or grant licenses on terms that may not be favorable to us.

If we are unable

to raise additional funds through equity or debt financings when needed, we may need to curtail or cease our operations.

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

acquisitions or the possible sale of the Company.

We currently have no agreements or commitments to engage in any specific strategic

transactions, and our exploration of various strategic alternatives may not result in any specific action or transaction.

To the extent

that this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction.

can be no assurance that we will enter into any transaction as a result of the engagement.

Furthermore, if we determine to engage in

a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price.

also cannot predict the impact on our stock price if we fail to enter into a transaction.

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

product candidate on unfavorable terms to us.

may seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations,

strategic alliances and marketing, distribution or licensing arrangements.

To the extent that we raise additional capital through the

sale of equity or convertible debt securities, or through the issuance of shares under management or other types of contracts, or upon

the exercise or conversion of outstanding derivative securities, the ownership interests of our stockholders will be diluted, and the

terms of such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments

and other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior

to those of our holders of common stock in the event of a liquidation.

In addition, debt financing, if available, could include covenants

limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures, entering

into licensing arrangements, or declaring dividends and may require us to grant security interests in our assets, including our intellectual

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

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

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

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

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

currently have no source of revenues.

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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 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 current

product candidate, GP2, and other product candidates that we may 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 current product candidate, GP2, and other product candidates that we may develop, in-license or acquire in the future.

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

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 either Biologics License Applications, or BLAs, or New Drug Applications, or NDAs, to the FDA and obtain

regulatory approval for indications for which there is a commercial market;

and submit either Biologics License Applications, or BLAs, or New Drug Applications, or NDAs, to the FDA and obtain U.S.

approval for indications for which there is a commercial market;

and submit applications to foreign regulatory authorities;

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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

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;

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;

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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 may not generate significant revenues from sales

of such products, even if approved.

In addition, we anticipate incurring significant costs associated with commercializing any approved

product candidate.

As a result, even if we generate revenues, we may not become profitable and may need to obtain additional funding

to continue operations.

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

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

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

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

year 2018,”

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

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

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

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

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

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

tax on foreign earnings

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

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

under the Orphan Drug Act).

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

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

In addition, it is uncertain if and to what

extent various states will conform to the Tax Act.

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 may be subject to limitations.

of December 31, 2021, we had federal net operating loss, or NOLs, carryforwards of approximately $8.8 million.

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

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.

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.

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

These NOL carryforwards could expire unused and be unavailable to

offset future income tax liabilities.

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

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

It is uncertain if and to what extent various states will

conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

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

a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the

ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change

tax attributes to offset its post-change income may be limited.

Related to the Development and Regulatory Approval of Our Product Candidate

Clinical-stage

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

may entail substantial risk.

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.

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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 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;

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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’

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;

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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

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 product during development and following approval;

and growing an organization of scientists and business people who can develop and commercialize our product and

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 given the limited number of patients who have the diseases for

which our product candidate is being studied which could delay or prevent the start of clinical trials for our product candidate.

and growing an organization of scientists and business people who can develop and commercialize our product and technology.

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 given the limited number of patients who have the diseases for which

our product candidate is being studied 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.

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

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 product candidate under study and the participation in a clinical trial generally in

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

availability and efficacy of competing therapies and clinical trials;

of other trials underway in the same patient population;

ability of clinical sites to staff sufficiently for

the start-up and conduct of our clinical trial;

of physicians to participate in our planned clinical trials;

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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 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.

may not be able to initiate or continue to support clinical trials of 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.

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.

Any of these occurrences may harm

our business, financial condition, and prospects significantly.

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

Our existing product

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

in later clinical trials or receive regulatory approval.

Our existing product candidate

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

trials or receive regulatory approval.

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

the efficacy and safety of an investigational drug.

A number of companies in the pharmaceutical and biotechnology industries,

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

seeing promising results in earlier preclinical studies or clinical trials.

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

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from those obtained from retrospective subgroup analyses.

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

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

Even if we believe that we have adequate

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

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

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

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

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

Even if we believe that we have adequate data to

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

regulatory authorities may not agree and may require that we conduct additional clinical trials.

drug development involves a lengthy and expensive process with an uncertain outcome, including the risk of a clinical trial being

placed on clinical hold.

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 GP2 administered in combination with GM-CSF.

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.

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.

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 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.

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 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.

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 GP2 administered in combination with GM-CSF.

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

patients 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 clinical hold in the future.

Clinical trials may be delayed, suspended

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

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

are able to execute;

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

that we are able to execute;

or failure in reaching agreement with the FDA, including with respect to our ongoing discussions regarding our planned Phase III

clinical trial, or a comparable foreign regulatory authority on (i) interim analysis and statistical design, (ii) a drug candidate

manufacturing plan for clinical trials or commercial use, (iii) protocol amendments, (iv) adaptive modifications to clinical trial

design upfront or after additional trial data is analyzed, (v) choice of hazard ratio, (vi) use of alpha spend (alpha-spending makes

it possible to perform sequential testing while maintaining the overall error probability of the statistical analysis of clinical

trial endpoints), (vii) statistical power assumptions, (viii) disease free survival assumptions for treated versus placebo arms of a clinical trial, (ix) number of patients or sizing of a clinical trial, including inclusion of patients

from outside of the US who may be treated with different standard of care than in the US, (x) duration of treatment and follow-up

required to demonstrate safety and efficacy of our product candidate, (xi) use of intent to treat or other patient populations as a

basis for primary and secondary endpoints, (xii) determinants of clinical meaningfulness and relevance, (xiii) subgroup analysis

whether prospectively designed or not, and (xiv) and the impact on any of the above on the timing and financeability of clinical

trials for our product candidate;

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;

regarding the scope or design of a clinical 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 clinical trial sites;

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

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

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

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

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

or dropping out of a trial;

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

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

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

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

or failure in adding new trial sites;

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

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

sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance

with regulatory requirements, or dropping out of a clinical trial;

to identify and maintain a sufficient number of clinical 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 clinical trial sites;

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

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

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

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

decision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend

or terminate clinical trials at any

for safety issues or for any other reason;

of clinical 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 clinical trial;

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

safety issues or for any other reason;

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

to demonstrate a benefit from using a product candidate;

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

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

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

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

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

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

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

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

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

and our costs will most likely increase.

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

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

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

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

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

will most likely increase.

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

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

Regulatory approval of our product

candidate may be denied for the same reasons that caused the delay.

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

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

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

may conduct future clinical trials in countries outside of the U.S.

Consequently, we may be subject to risks related to operating

in foreign countries.

Risks associated with conducting operations in foreign countries include:

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

more stringent privacy

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

, General Data Protection Regulation in the

European Union;

more stringent privacy requirements

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

, General Data Protection Regulation in the European Union;

changes in tariffs, trade barriers and regulatory requirements;

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in particular foreign economies and markets;

compliance with tax, employment, immigration and labor laws for employees living

or traveling abroad;

compliance with tax, employment, immigration and labor laws for employees living or

traveling abroad;

foreign taxes, including withholding of payroll taxes;

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

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

to doing business or operating in another country;

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.;

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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.

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.

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;

or an IRB, that approves and,

monitors biomedical research to protect the rights and welfare of human patients.

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 patients

to complete the trial or result in potential product liability claims.

Any of these occurrences may have a material adverse effect

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

Additionally,

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

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

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

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

may be forced to suspend marketing of such product;

authorities may withdraw their approvals of such product;

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

success of such product;

may be required to conduct post-marketing studies;

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

of such product;

may be required to conduct post-marketing clinical trials;

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

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

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

reputation may suffer.

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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.

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

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

and for greater periods of time.

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

However, with a limited number of subjects and limited

However, with a limited number of patients 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.

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

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.

to successfully validate and develop a companion diagnostic for our product candidate could harm our drug development strategy and operational

has informed us that we will need a companion diagnostic for HLA typing of patients.

We do not have any third-party collaborators at

this time with an approved companion diagnostic for HLA typing.

Our product development program is dependent on the validation and

development of an in vitro companion diagnostic by us or by third-party collaborators for HLA typing.

Companion diagnostics are developed in

conjunction with clinical programs for the associated product and are subject to regulation as medical devices.

The approval of a

companion diagnostic as part of the product labeling may limit the use of the product candidate to only those patients who express

the specific genetic alteration it was developed to detect.

diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and require separate

clearance or approval prior to their commercialization.

To date, the FDA has required premarket approval of all companion diagnostics

for cancer therapies, either at the time of initial drug approval, or as a post-marketing commitment.

We, and our third-party collaborators,

may encounter difficulties in developing and obtaining approval for these companion diagnostics.

Our third-party collaborators may de-prioritize,

abandon or fail to execute against our development projects.

Any delay or failure by us or third-party collaborators to develop or obtain

regulatory approval of a companion diagnostic could delay or prevent approval of our related product candidates.

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

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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.

Similarly, we cannot commercialize

our product candidate outside of the U.S.

without obtaining regulatory approval from comparable foreign regulatory authorities.

obtaining regulatory approvals for the commercial sale of our product candidate for a target indication, we must demonstrate with substantial

evidence gathered in preclinical studies and clinical trials, that the product candidate is safe and effective for use for that target

indication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate.

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

following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion

of the regulatory authorities.

In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain

approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.

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

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

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

Also, any regulatory approval of our current

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

or may be subject to burdensome post-approval clinical trial 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:

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

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

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

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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 a BLA,

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;

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

or other submission or to obtain regulatory approval;

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

commercial supplies or our own manufacturing facility;

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

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

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

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

approval or additional clinical trials, 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.

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

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

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

approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

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

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

attributable to that product candidate.

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

to that product candidate.

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

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

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

requirements.

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

approval by one regulatory authority outside the U.S.

does not ensure approval by regulatory authorities in other countries or

jurisdictions or by the FDA.

The regulatory approval process outside the U.S.

generally includes all of the risks associated with

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

procedure varies among countries and can involve additional testing.

The time required to obtain approval may differ substantially

from that required to obtain FDA approval.

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

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

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

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

outside the U.S.

does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

The regulatory

approval process outside the U.S.

generally includes all of the risks associated with obtaining FDA approval as well as risks attributable

to the satisfaction of local regulations in foreign jurisdictions.

The approval procedure varies among countries and can involve additional

The time required to obtain approval may differ substantially from that required to obtain FDA approval.

We may not be able

to obtain approvals from regulatory authorities outside the U.S.

on a timely basis, if at all.

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

Clinical trials accepted in one country

may not be accepted by regulatory authorities in other countries.

In addition, many countries outside the U.S.

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

sale in that country.

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

approval in that country.

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 candidate receive regulatory approval, it may still face future development and regulatory difficulties.

if we obtain regulatory approval for our product candidate, 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:

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

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

if we obtain regulatory approval for our product candidate, 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.

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 clinical trials

or post-market surveillance.

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

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

If we or a regulatory agency discover previously unknown

problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product

is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall

or withdrawal of the product from the market or suspension of manufacturing.

If we, our product candidate or the manufacturing facilities

for our product candidate fail to comply with applicable regulatory requirements, a regulatory agency may:

warning letters or untitled letters;

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

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

required due dates for specific actions and penalties for noncompliance;

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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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 may inhibit our ability to successfully commercialize our product and generate revenues.

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 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 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.

Violations, including actual or alleged promotion of our product

for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions

by the FDA, as well as prosecution under the federal False Claims Act.

Any actual or alleged failure to comply with labeling and promotion

requirements may have a negative impact on our business.

Related to Our Manufacturing

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We depend on these manufacturers to meet our deadlines, quality standards and specifications.

Our reliance on third parties for the manufacture of our active pharmaceutical ingredient and drug product and, in the future,

any approved products, creates a dependency that could severely disrupt our research and development, our clinical testing, and

ultimately our sales and marketing efforts if the source of such supply proves to be unreliable or unavailable.

If the contracted

manufacturing source is unreliable or unavailable, we may not be able to manufacture clinical drug supplies of our product candidate,

and our preclinical and clinical testing programs may not be able to move forward and our entire business plan could fail.

active pharmaceutical ingredient for our product candidate is currently sourced from Polypeptide Laboratories located in San Diego,

We believe this single source is currently capable of supplying all anticipated needs of our proposed clinical studies,

as well as initial commercial introduction.

reliance on third parties for the manufacture of our active pharmaceutical ingredient and drug product and, in the future, any approved

products, creates a dependency that could severely disrupt our research and development, our clinical testing, and ultimately our sales

and marketing efforts if the source of such supply proves to be unreliable or unavailable.

If the contracted manufacturing source is

unreliable or unavailable, we may not be able to manufacture clinical drug supplies of our product candidate, and our preclinical and

clinical testing programs may not be able to move forward and our entire business plan could fail.

active pharmaceutical ingredient for our product candidate is currently sourced from Polypeptide Laboratories located in San Diego, California.

We believe this single source is currently capable of supplying all anticipated needs of our proposed clinical trials, as well

as initial commercial introduction.

We will be developing a source or sources for drug product manufacturing.

able to commercialize our product in the future, there is no assurance that our manufacturers will be able to meet commercialized

scale production requirements in a timely manner or in accordance with applicable standards or cGMP.

Once the nature and scope

of additional indications and their commensurate drug product demands are established, we will seek secondary suppliers of both

the active pharmaceutical ingredient and drug product for our product candidate, but we cannot assure that such secondary suppliers

will be found on terms acceptable to us, or at all.

are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our

product candidate.

and our CMOs will need to conduct significant development work for our product candidate for each target indication for studies,

If we are able to commercialize

our product in the future, there is no assurance that our manufacturers will be able to meet commercialized scale production requirements

in a timely manner or in accordance with applicable standards or cGMP.

Once the nature and scope of additional indications and their

commensurate drug product demands are established, we will seek secondary suppliers of both the active pharmaceutical ingredient and

drug product for our product candidate, but we cannot assure that such secondary suppliers will be found on terms acceptable to us, or

are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product

and our CMOs will need to conduct significant development work for our product candidate for each target indication for studies, clinical

trials and commercial launch readiness.

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of reagents or raw materials.

The manufacturing facilities in which our product candidate will be made could be adversely affected

by earthquakes and other natural disasters, medical pandemics, equipment failures, labor shortages, power failures, and numerous

other factors.

The manufacturing facilities in which our product candidate will be made could be adversely affected by

earthquakes and other natural disasters, medical pandemics, equipment failures, labor shortages, power failures, and numerous other factors.

Additionally,

the process of manufacturing our product candidate is complex, highly regulated and subject to several risks, including but not

the process of manufacturing our product candidate is complex, highly regulated and subject to several risks, including but not limited

loss due to contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error;

production yields, product defects, and other supply disruptions due to deviations, even minor, from normal manufacturing

and distribution processes;

production yields, product defects, and other supply disruptions due to deviations, even minor, from normal manufacturing and distribution

product defects;

viral, or other contaminations in our product candidate or in the manufacturing facilities in which our product candidate

is made, which may result in the closure of such manufacturing facilities for an extended period of time to allow for the

investigation and remediation of the contamination.

viral, or other contaminations in our product candidate or in the manufacturing facilities in which our product candidate is made,

which may result in the closure of such manufacturing facilities for an extended period of time to allow for the investigation and

remediation of the contamination.

adverse developments affecting manufacturing operations for our product candidate may result in shipment delays, inventory shortages,

lot failures, withdrawals or recalls or other interruptions in the supply of our drug substance and drug product, which could

delay the development of our product candidate.

We may also have to write off inventory, incur other charges and expenses for

supply of drug product that fails to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing

alternatives.

Inability to meet the demand for our product candidate could damage our reputation and the reputation of our product

among physicians, healthcare payors, patients or the medical community, and cancer treatment centers, which could adversely affect

our ability to operate our business and our results of operations.

the clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer,

which may or may not reliably provide GM-CSF, thus jeopardizing the completion of the trials.

lot failures, withdrawals or recalls or other interruptions in the supply of our drug substance and drug product, which could delay the

development of our product candidate.

We may also have to write off inventory, incur other charges and expenses for supply of drug product

that fails to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives.

meet the demand for our product candidate could damage our reputation and the reputation of our product among physicians, healthcare

payors, patients or the medical community, and cancer treatment centers, which could adversely affect our ability to operate our business

and our results of operations.

the clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer, which may

or may not reliably provide GM-CSF, thus jeopardizing the completion of the trials.

is administered in combination with GM-CSF which is available in both liquid and lyophilized forms exclusively from one manufacturer.

We will continue to be dependent on such manufacturer for our supply of GM-CSF in combination with GP2 in the ongoing GP2 trials

and upon the potential commercialization of GP2.

We have not entered into a supply agreement with the manufacturer for GM-CSF,

and instead rely on purchase orders to meet our supply needs.

Any temporary interruptions or discontinuation of the availability

of GM-CSF could have a material adverse effect on our operations.

any of our CMOs’

clinical manufacturing facilities are damaged or destroyed or production at such facilities is otherwise

interrupted, our business and prospects would be negatively affected.

our CMOs’

manufacturing facilities or the equipment in them is damaged or destroyed, we may not be able to quickly or inexpensively

We will continue to be dependent on such manufacturer for our supply of GM-CSF in combination with GP2 in the ongoing GP2 trials and

upon the potential commercialization of GP2.

We have not entered into a supply agreement with the manufacturer for GM-CSF, and instead

rely on purchase orders to meet our supply needs.

Any temporary interruptions or discontinuation of the availability of GM-CSF could

have a material adverse effect on our operations.

any of our CMOs’ clinical manufacturing facilities are damaged or destroyed or production at such facilities is otherwise interrupted,

our business and prospects would be negatively affected.

our CMOs’ manufacturing facilities or the equipment in them is damaged or destroyed, we may not be able to quickly or inexpensively

replace our manufacturing capacity or replace it at all.

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we might not be able to transfer manufacturing to another CMO.

Even if we could transfer manufacturing to another CMO, the shift

would likely be expensive and time-consuming, particularly because the new facility would need to comply with the necessary regulatory

requirements and we would need FDA approval before selling any products manufactured at that facility.

Such an event could delay

our clinical trials or reduce our product sales.

we do not currently maintain insurance coverage against damage to our property and to cover business interruption and research

and development restoration expenses, any insurance coverage we obtain in the future may not reimburse us, or may not be sufficient

to reimburse us, for any expenses or losses we may suffer.

We may be unable to meet our requirements for our product candidate

if there were a catastrophic event or failure of our current manufacturing facility or processes.

Even if we could transfer manufacturing to another CMO, the shift would

likely be expensive and time-consuming, particularly because the new facility would need to comply with the necessary regulatory requirements

and we would need FDA approval before selling any products manufactured at that facility.

Such an event could delay our clinical trials

or reduce our product sales.

we do not currently maintain insurance coverage against damage to our property and to cover business interruption and research and development

restoration expenses, any insurance coverage we obtain in the future may not reimburse us, or may not be sufficient to reimburse us,

for any expenses or losses we may suffer.

We may be unable to meet our requirements for our product candidate if there were a catastrophic

event or failure of our current manufacturing facility or processes.

Related to Our Dependence on Third Parties and Our License Agreements

rely on third parties to conduct our preclinical studies and clinical trials.

If these third parties do not successfully carry

out their contractual duties or meet expected deadlines, or if we lose any of our CROs or other key third-party vendors, we may

not be able to obtain regulatory approval for or commercialize our current or future product candidates on a timely basis, if

If these third parties do not successfully carry out their

contractual duties or meet expected deadlines, or if we lose any of our CROs or other key third-party vendors, we may not be able to

obtain regulatory approval for or commercialize our current or future product candidates on a timely basis, if at all.

internal capacity for clinical trial execution and management is limited and therefore we rely heavily on third parties.

relied upon and plan to continue to rely upon third-party CROs, vendors and contractors to monitor and manage data for our ongoing

preclinical and clinical programs.

For example, our collaborating investigators along with their clinical and clinical operations

teams may manage the conduct of any future clinical trials for GP2 as well as perform the analysis, publication and presentation

of data and results related to this program.

plan to rely on CROs and other third-party vendors for all currently contemplated clinical studies.

We have relied

upon and plan to continue to rely upon third-party CROs, vendors and contractors to monitor and manage data for our ongoing preclinical

and clinical programs.

For example, our collaborating investigators along with their clinical and clinical operations teams may manage

the conduct of any future clinical trials for GP2 as well as perform the analysis, publication and presentation of data and results related

to this program.

plan to rely on CROs and other third-party vendors for all currently contemplated clinical trials.

We rely on these parties for

the execution of our preclinical studies and clinical trials, including the proper and timely conduct of our clinical trials,

and we control only some aspects of their activities.

Outsourcing these functions involves risk that third parties may not perform

to our standards, may not produce results or data in a timely manner or may fail to perform at all.

we may have agreements governing the commitments of our third-party vendor services, we will have limited influence over their

actual performance.

Nevertheless, we will be responsible for ensuring that each of our trials is conducted in accordance with

the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs will not relieve us of our

regulatory responsibilities.

our Company, or any of our partners or CROs, fail to comply with applicable regulations and good clinical practices, the clinical

data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require

us to perform additional clinical trials before approving our regulatory applications.

We cannot assure you that upon inspection

by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable

requirements.

In addition, our clinical trials must be conducted with product produced under cGMP and other requirements.

also required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored

database, clinicaltrials.gov , within a specified timeframe.

Failure to comply also would violate federal requirements in

and could result in other penalties, which would delay the regulatory approval process and result in adverse publicity.

CROs, third-party vendors and contractors are not and will not be our employees, and except for remedies available to us under

our agreements with such CROs, third-party vendors and contractors, we cannot control whether or not they devote sufficient time

and resources, including experienced staff, to our ongoing clinical, nonclinical and preclinical programs.

They may also have

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

If CROs, third-party vendors and contractors do not successfully

carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data

they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons,

our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully

commercialize our current or future product candidates.

CRO, vendor or contractor errors could cause our results of operations

and the commercial prospects for our current or future product candidates to be harmed, our costs to increase and our ability

to generate revenues to be delayed.

addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which

could increase the risk that this information will be misappropriated.

To the extent we are unable to identify and successfully

manage the performance of third-party service providers in the future, our business may be adversely affected.

Though, once engaged,

we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges

or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial

condition and prospects.

the execution of our preclinical studies and clinical trials, including the proper and timely conduct of our clinical trials, and we

control only some aspects of their activities.

Outsourcing these functions involves risk that third parties may not perform to our standards,

may not produce results or data in a timely manner or may fail to perform at all.

we may have agreements governing the commitments of our third-party vendor services, we will have limited influence over their actual

Nevertheless, we will be responsible for ensuring that each of our trials is conducted in accordance with the applicable

protocol and legal, regulatory and scientific standards, and our reliance on the CROs will not relieve us of our regulatory responsibilities.

our Company, or any of our partners or CROs, fail to comply with applicable regulations and good clinical practices, the clinical data

generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to

perform additional clinical trials before approving our regulatory applications.

We cannot assure you that upon inspection by a given

regulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable requirements.

addition, our clinical trials must be conducted with product produced under cGMP and other requirements.

We are also required to register

ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, clinicaltrials.gov ,

within a specified timeframe.

Failure to comply also would violate federal requirements in the U.S.

and could result in other penalties,

which would delay the regulatory approval process and result in adverse publicity.

CROs, third-party vendors and contractors are not and will not be our employees, and except for remedies available to us under our agreements

with such CROs, third-party vendors and contractors, we cannot control whether or not they devote sufficient time and resources, including

experienced staff, to our ongoing clinical, nonclinical and preclinical programs.

They may also have relationships with other entities,

some of which may be our competitors.

If CROs, third-party vendors and contractors do not successfully carry out their contractual duties

or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure

to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated

and we may not be able to obtain regulatory approval for or successfully commercialize our current or future product candidates.

vendor or contractor errors could cause our results of operations and the commercial prospects for our current or future product candidates

to be harmed, our costs to increase and our ability to generate revenues to be delayed.

addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could

increase the risk that this information will be misappropriated.

To the extent we are unable to identify and successfully manage the

performance of third-party service providers in the future, our business may be adversely affected.

Though, once engaged, we intend to

carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future

or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

are dependent on technologies we license, and if we lose the right to license such technologies or we fail to license new technologies

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currently are dependent on a license from HJF for technologies relating to our product candidate.

The license imposes, and any

future licenses we enter into are likely to impose, various development, funding, royalty, diligence, sublicensing, insurance

and other obligations on us.

If our license with respect to any of these technologies is terminated for any reason, the development

of the products contemplated by the licenses would be delayed, or suspended altogether, while we seek to license similar technology

or develop new non-infringing technology which could have a material adverse effect on our business.

The license imposes, and any future

licenses we enter into are likely to impose, various development, funding, royalty, diligence, sublicensing, insurance and other obligations

If our license with respect to any of these technologies is terminated for any reason, the development of the products contemplated

by the licenses would be delayed, or suspended altogether, while we seek to license similar technology or develop new non-infringing

technology which could have a material adverse effect on our business.

operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic, war

or other catastrophic event.

depend on our employees, consultants, CMOs, CROs, as well as regulatory agencies and other parties, for the continued operation of our

Despite any precautions we take for natural disasters or other catastrophic events, these events, including terrorist attacks,

pandemics, hurricanes, fires, floods and ice and snowstorms, could result in significant disruptions to our research and development,

preclinical studies, clinical trials, and, ultimately, commercialization of our products.

Long-term disruptions in the infrastructure

caused by events, such as natural disasters, the outbreak of war (including expansion of the current armed conflict between Russia and

Ukraine), the escalation of hostilities and acts of terrorism or other “acts of God,” particularly involving cities in which

we have offices, manufacturing or clinical trial sites, could adversely affect our businesses.

Although we carry business interruption

insurance policies and typically have provisions in our contracts that protect us in certain events, our coverage might not include or

be adequate to compensate us for all losses that may occur.

Any natural disaster or catastrophic event affecting us, our CMOs, our CROs,

regulatory agencies or other parties with which we are engaged could have a material adverse effect on our operations and financial performance.

may not realize the benefits of our strategic alliances that we may form in the future.

may form strategic alliances, create joint ventures or collaborations or enter into licensing arrangements with third parties

that we believe will complement or augment our existing business.

These relationships, or those like them, may require us to incur

nonrecurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders

or disrupt our management and business.

In addition, we face significant competition in seeking appropriate strategic alliances

and the negotiation process is time-consuming and complex.

Moreover, we may not be successful in our efforts to establish a strategic

alliance or other alternative arrangements for or current product candidate or any future product candidates and programs because

our research and development pipeline may be insufficient, our current product candidate and future product candidates and programs

may be deemed to be at too early a stage of development for collaborative effort and third parties may not view such product candidates

and programs as having the requisite potential to demonstrate safety and efficacy.

If we license products or acquire businesses,

we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing

operations and company culture.

We cannot be certain that, following a strategic transaction or license, we will achieve the revenues

or specific net income that justifies such transaction.

Any delays in entering into new strategic alliances agreements related

to our current product candidate or future product candidates could also delay the development and commercialization of such product

candidates and reduce their competitiveness even if they reach the market.

may form strategic alliances, create joint ventures or collaborations or enter into licensing arrangements with third parties that we

believe will complement or augment our existing business.

These relationships, or those like them, may require us to incur nonrecurring

and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our

management and business.

In addition, we face significant competition in seeking appropriate strategic alliances and the negotiation

process is time-consuming and complex.

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

arrangements for or current product candidate or any future product candidates and programs because our research and development pipeline

may be insufficient, our current product candidate and future product candidates and programs may be deemed to be at too early a stage

of development for collaborative effort and third parties may not view such product candidates and programs as having the requisite potential

to demonstrate safety and efficacy.

If we license products or acquire businesses, we may not be able to realize the benefit of such transactions

if we are unable to successfully integrate them with our existing operations and company culture.

We cannot be certain that, following

a strategic transaction or license, we will achieve the revenues or specific net income that justifies such transaction.

Any delays in

entering into new strategic alliances agreements related to our current product candidate or future product candidates could also delay

the development and commercialization of such product candidates and reduce their competitiveness even if they reach the market.

business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental,

health and safety laws and regulations, which can be expensive and restrict how we do business.

third-party manufacturers’

and suppliers’

activities involve the controlled storage, use and disposal of hazardous

We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage,

handling and disposal of these hazardous materials even after we sell or otherwise dispose of the products.

In some cases, these

hazardous materials and various wastes resulting from their use will be stored at our contractors or manufacturers’

pending use and disposal.

We cannot completely eliminate the risk of contamination, which could cause injury to our employees

and others, environmental damage resulting in costly cleanup and liabilities under applicable laws and regulations governing the

use, storage, handling and disposal of these materials and specified waste products.

Although we expect that the safety procedures

utilized by our third-party contractors and manufacturers for handling and disposing of these materials will generally comply

with the standards prescribed by these laws and regulations, we cannot guarantee that this will be the case or eliminate the risk

of accidental contamination or injury from these materials.

In such an event, we may be held liable for any resulting damages

and such liability could exceed our resources.

We do not currently carry biological or hazardous waste insurance coverage and

any future property and casualty, and general liability insurance policies may exclude coverage for damages and fines arising

from biological or hazardous waste exposure or contamination.

may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize

our product candidate.

third-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials.

We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal

of these hazardous materials even after we sell or otherwise dispose of the products.

In some cases, these hazardous materials and various

wastes resulting from their use will be stored at our contractors or manufacturers’ facilities pending use and disposal.

completely eliminate the risk of contamination, which could cause injury to our employees and others, environmental damage resulting

in costly cleanup and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials

and specified waste products.

Although we expect that the safety procedures utilized by our third-party contractors and manufacturers

for handling and disposing of these materials will generally comply with the standards prescribed by these laws and regulations, we cannot

guarantee that this will be the case or eliminate the risk of accidental contamination or injury from these materials.

In such an event,

we may be held liable for any resulting damages and such liability could exceed our resources.

We do not currently carry biological or

hazardous waste insurance coverage and any future property and casualty, and general liability insurance policies may exclude coverage

for damages and fines arising from biological or hazardous waste exposure or contamination.

may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize our

product candidate.

expect to depend on collaborators, partners, licensees, CROs and other third parties to formulate our product candidate, to manufacture

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We cannot guarantee that we will be able to successfully

negotiate agreements for or maintain relationships with collaborators, partners, licensees, clinical investigators, vendors and

other third parties on favorable terms, if at all.

Our ability to successfully negotiate such agreements will depend on, among

other things, potential partners’

evaluation of the superiority of our technology over competing technologies and the quality

of the preclinical and clinical data that we have generated, and the perceived risks specific to developing our product candidate.

If we are unable to obtain or maintain these agreements, we may not be able to clinically develop, formulate, manufacture, obtain

regulatory approvals for or commercialize our product candidate.

We cannot necessarily control the amount or timing of resources

that our contract partners will devote to our product candidate, and we cannot guarantee that these parties will fulfill their

obligations to us under these arrangements in a timely fashion.

We may not be able to readily terminate any such agreements with

contract partners even if such contract partners do not fulfill their obligations to us.

addition, we may receive notices from third parties from time to time alleging that our technology or product candidate infringes

upon the intellectual property rights of those third parties.

Any assertion by third parties that our activities or product candidate

infringes upon the intellectual property rights of third parties may adversely affect our ability to secure strategic partners

or licensees for our technology or product candidate or our ability to secure or maintain manufacturers for our compounds.

negotiate agreements for or maintain relationships with collaborators, partners, licensees, clinical investigators, vendors and other

third parties on favorable terms, if at all.

Our ability to successfully negotiate such agreements will depend on, among other things,

potential partners’ evaluation of the superiority of our technology over competing technologies and the quality of the preclinical

and clinical data that we have generated, and the perceived risks specific to developing our product candidate.

If we are unable to obtain

or maintain these agreements, we may not be able to clinically develop, formulate, manufacture, obtain regulatory approvals for or commercialize

our product candidate.

We cannot necessarily control the amount or timing of resources that our contract partners will devote to our

product candidate, and we cannot guarantee that these parties will fulfill their obligations to us under these arrangements in a timely

We may not be able to readily terminate any such agreements with contract partners even if such contract partners do not fulfill

their obligations to us.

addition, we may receive notices from third parties from time to time alleging that our technology or product candidate infringes upon

the intellectual property rights of those third parties.

Any assertion by third parties that our activities or product candidate infringes

upon the intellectual property rights of third parties may adversely affect our ability to secure strategic partners or licensees for

our technology or product candidate or our ability to secure or maintain manufacturers for our compounds.

Related to Our Intellectual Property

rely on an exclusive license granted to us by HJF with respect to GP2, and if HJF does not adequately defend such license, our

business may be harmed.

rely on an exclusive license granted to us by HJF with respect to GP2, and if HJF does not adequately defend such license, our business

may be harmed.

have been granted an exclusive license to GP2, our product candidate, from HJF.

The GP2 patent rights were assigned to HJF by

certain third parties including the Uniformed Services University of the Health Sciences.

We rely on HJF to maintain the patents

already issued with respect to GP2, to continue to pursue patent applications pending in certain countries with respect to GP2,

and otherwise protect the intellectual property covered by our exclusive license agreement.

We have limited control over the activities

of HJF or over any other intellectual property that may be related to GP2.

For example, we cannot be certain that activities by

HJF have been or will be conducted in compliance with applicable laws and regulations and/or any agreements between HJF and the

third party assignors.

We have no control or input over whether, and in what manner, HJF may enforce or defend the patents against

a third-party.

HJF may enforce or defend the patent less vigorously than if we had enforced or defended the patents ourselves.

Further, HJF may not necessarily seek enforcement in scenarios in which we would feel that enforcement was in our best interests.

For example, HJF may not enforce the patents against a competitor of ours who is not a direct competitor of HJF.

If our in-licensed

intellectual property is found to be invalid or unenforceable, then HJF may not be able to enforce the patents against a competitor

If we fail to meet our obligations under our exclusive license agreement with HJF, then HJF may terminate such agreement.

Although we may choose to terminate our license agreement with HJF, doing so would allow a third party to seek and obtain an exclusive

license to GP2.

If a third party obtains an exclusive license to intellectual property with respect to GP2, then the third party

may seek to enforce the intellectual property against us which may have a material adverse effect on our business.

The GP2 patent rights were assigned to HJF by certain

third parties including the Uniformed Services University of the Health Sciences.

We rely on HJF to maintain the patents already issued

with respect to GP2, to continue to pursue patent applications pending in certain countries with respect to GP2, and otherwise protect

the intellectual property covered by our exclusive license agreement.

We have limited control over the activities of HJF or over any

other intellectual property that may be related to GP2.

For example, we cannot be certain that activities by HJF have been or will be

conducted in compliance with applicable laws and regulations and/or any agreements between HJF and the third party assignors.

no control or input over whether, and in what manner, HJF may enforce or defend the patents against a third-party.

HJF may enforce or

defend the patent less vigorously than if we had enforced or defended the patents ourselves.

Further, HJF may not necessarily seek enforcement

in scenarios in which we would feel that enforcement was in our best interests.

For example, HJF may not enforce the patents against

a competitor of ours who is not a direct competitor of HJF.

If our in-licensed intellectual property is found to be invalid or unenforceable,

then HJF may not be able to enforce the patents against a competitor of ours.

If we fail to meet our obligations under our exclusive

license agreement with HJF, then HJF may terminate such agreement.

Although we may choose to terminate our license agreement with HJF,

doing so would allow a third party to seek and obtain an exclusive license to GP2.

If a third party obtains an exclusive license to intellectual

property with respect to GP2, then the third party may seek to enforce the intellectual property against us which may have a material

adverse effect on our business.

is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.

If our patent position

does not adequately protect our product candidate, others could compete against us more directly, which would harm our business,

possibly materially.

commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current

product candidate and future product candidates, the processes used to manufacture them and the methods for using them, as well

as successfully defending these patents against third-party challenges.

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

we only have licensed rights from HJF to certain issued patents as well as patent applications which are currently pending in

certain countries with respect to GP2.

Our ability to stop third parties from making, using, selling, offering to sell or importing

our product candidate is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets

that cover these activities.

does not adequately protect our product candidate, others could compete against us more directly, which would harm our business, possibly

commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current product

candidate and future product candidates, the processes used to manufacture them and the methods for using them, as well as successfully

defending these patents against third-party challenges.

As of the date of this Annual Report on Form 10-K, we only have licensed rights

from HJF to certain issued patents as well as patent applications which are currently pending in certain countries with respect to GP2.

Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidate is dependent upon

the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions

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and other countries may diminish the value of our intellectual property.

Accordingly, we cannot predict

the breadth of claims that may be enforced in the patents that may be issued from the applications we currently or may in the

future own or license from third parties.

Further, if any patents we obtain or license are deemed invalid and unenforceable, our

ability to commercialize or license our technology could be adversely affected.

Accordingly, we cannot predict the

breadth of claims that may be enforced in the patents that may be issued from the applications we currently or may in the future own

or license from third parties.

Further, if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize

or license our technology could be adversely affected.

have filed, and in the future are likely to file, patent applications covering products and technologies that are similar, identical

or competitive to ours or important to our business.

We cannot be certain that any patent application owned by a third party will

not have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference,

We cannot be certain that any patent application owned by a third party will not

have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference,

opposition, reexamination, review, reissue, post grant review or invalidity proceedings before U.S.

patent offices.

degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may

not adequately protect our rights or permit us to gain or keep our competitive advantage.

may be able to make compounds that are similar to our product candidate, but that are not covered by the claims of our licensed

degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately

protect our rights or permit us to gain or keep our competitive advantage.

may be able to make compounds that are similar to our product candidate, but that are not covered by the claims of our licensed patents;

might not have been the first to make the inventions covered by its pending patent applications;

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pending patent applications may not result in issued patents;

claims of HJF’s issued patents or patent applications when issued may not cover our product or product candidate;

patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;

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patents of others may have an adverse effect on our business.

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.

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.

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

These 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 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 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.

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

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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;

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 us.

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

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 our product candidate, which could harm our business significantly.

may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property

we choose to commence a proceeding or litigation to prevent another party from infringing HJF’s patents, that party will

have the right to ask the examiner or court to rule that such patents are invalid or should not be enforced against them.

is a risk that the examiner or court will decide that HJF’s patents are not valid and that HJF does not have the right to

stop the other party from using the related inventions.

There is also the risk that, even if the validity of such patents is upheld,

the examiner or court will refuse to stop the other party on the ground that such other party’s activities do not infringe

our rights to such patents.

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 our product candidate, which could harm our business significantly.

may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights.

we choose to commence a proceeding or litigation to prevent another party from infringing HJF’s patents, that party will have the

right to ask the examiner or court to rule that such patents are invalid or should not be enforced against them.

There is a risk that

the examiner or court will decide that HJF’s patents are not valid and that HJF does not have the right to stop the other party

from using the related inventions.

There is also the risk that, even if the validity of such patents is upheld, the examiner or court

will refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to such patents.

In addition, the U.S.

Supreme Court has recently modified some tests used by the U.S.

Patent and Trademark

Office (the “USPTO”) in granting patents over the past 20 years, which may decrease the likelihood that we or HJF

will be able to obtain patents and increase the likelihood of challenge to any patents we obtain or license.

Any proceedings or

litigation to enforce our intellectual property rights or defend ourselves against claims of infringement of third-party intellectual

property rights could be costly and divert the attention of managerial and scientific personnel, regardless of whether such litigation

is ultimately resolved in our favor.

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

if we are unable to successfully defend against claims that we have infringed the intellectual property rights of others, we may

be prevented from using certain intellectual property and may be liable for damages, which in turn could materially adversely

affect our business, financial condition or results of operations.

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 candidate.

Patent and Trademark Office (the “USPTO”)

in granting patents over the past 20 years, which may decrease the likelihood that we or HJF will be able to obtain patents and increase

the likelihood of challenge to any patents we obtain or license.

Any proceedings or litigation to enforce our intellectual property rights

or defend ourselves against claims of infringement of third-party intellectual property rights could be costly and divert the attention

of managerial and scientific personnel, regardless of whether such litigation is ultimately resolved in our favor.

We may not have sufficient

resources to bring these actions to a successful conclusion.

Moreover, if we are unable to successfully defend against claims that we

have infringed the intellectual property rights of others, we may be prevented from using certain intellectual property and may be liable

for damages, which in turn could materially adversely affect our business, financial condition or results of operations.

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 candidate.

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

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that our product candidate, or manufacture or use of our product candidate, will not infringe third-party patents.

a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop

us from engaging in our normal operations and activities, including making or selling our product candidate.

These lawsuits are

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

Some of these

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

There is a risk that a court would decide that we are

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

In that event, we

may not have a viable way around the patent and may need to halt commercialization of our product 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.

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 product candidate or methods either do not infringe

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

Proving invalidity

is difficult.

For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the

presumption of validity enjoyed by issued patents.

Even if we are successful in these proceedings, we may incur substantial costs

and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on

If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, which may not be available,

defend an infringement action or challenge the validity of the patents in court.

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 candidate.

These lawsuits are costly and could affect

our results of operations and divert the attention of managerial and scientific personnel.

Some of these third parties may be better

capitalized and have more resources than us.

There is a risk that a court would decide that we are infringing the third party’s

patents and would order us to stop the activities covered by the patents.

In that event, we may not have a viable way around the patent

and may need to halt commercialization of our product 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.

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 product candidate or methods either do not infringe the patent

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

Proving invalidity is difficult.

For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity

enjoyed by issued patents.

Even if we are successful in these proceedings, we may incur substantial costs and 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, defend an infringement action or challenge

the validity of the patents in court.

Patent litigation is costly and time consuming.

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

In addition, if we do not obtain a license,

develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared

invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product candidate to market and

be precluded from manufacturing or selling our product candidate.

cannot be certain that others have not filed patent applications for technology covered by HJF’s pending applications, or

that HJF the first to invent the technology, because:

We may not have sufficient resources to bring these

actions to a successful conclusion.

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

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

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

cannot be certain that others have not filed patent applications for technology covered by HJF’s pending applications, or that

HJF the first to invent the technology, because:

patent applications in the U.S.

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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 HJF’s patent applications, which could require us to obtain rights to issued patents

covering such technologies.

Any such patent application

may have priority over HJF’s patent applications, which could require us to obtain rights to issued patents covering such technologies.

If another party has filed U.S.

patent applications on inventions similar to HJF that claims priority

to any applications filed prior to the priority dates of HJF’s applications, HJF may have to participate in an interference

proceeding declared by the USPTO to determine priority of invention in the U.S.

It is possible that such efforts would be unsuccessful

if, unbeknownst to HJF, the other party had independently arrived at the same or similar inventions prior to HFJ’s inventions,

resulting in a loss of HFJ’s U.S.

patent position with respect to such inventions which could in turn have a material adverse

effect on our operations.

Other countries have similar laws that permit secrecy of patent applications, and 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 us or the third parties

from whom we license intellectual property because they have substantially greater resources.

In addition, any uncertainties resulting

from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds

necessary to continue our operations.

we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology

and product could be significantly diminished.

patent applications on inventions similar to HJF that claims priority to any applications filed prior

to the priority dates of HJF’s applications, HJF may have to participate in an interference proceeding declared by the USPTO to

determine priority of invention in the U.S.

It is possible that such efforts would be unsuccessful if, unbeknownst to HJF, the other

party had independently arrived at the same or similar inventions prior to HFJ’s inventions, resulting in a loss of HFJ’s

patent position with respect to such inventions which could in turn have a material adverse effect on our operations.

Other countries

have similar laws that permit secrecy of patent applications, and 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 us or the third parties from whom

we license intellectual property because they have substantially greater resources.

In addition, any uncertainties resulting from the

initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue

our operations.

we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and

product could be significantly diminished.

also rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate

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However, trade secrets are difficult to protect.

We rely in part on confidentiality agreements with our employees,

consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other

proprietary information.

These agreements may not effectively prevent disclosure of confidential information and may not provide

an adequate remedy in the event of unauthorized disclosure of confidential information.

Furthermore, any license agreements we

enter into in the future may require us to notify, and in some cases license back to the licensor, certain additional proprietary

information or intellectual property that we developed using the rights licensed to us under these agreements.

Any such licenses

back to the licensor could allow our licensors to use that proprietary information or intellectual property in a manner that could

harm our business.

In addition, others may independently discover our trade secrets and proprietary information.

the FDA, as part of its transparency initiative, is currently considering whether to make additional information publicly available

on a routine basis, including information that we may consider to be trade secrets or other proprietary information, and it is

not clear at the present time how the FDA’s disclosure policies may change in the future, if at all.

Costly and time-consuming

litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain

trade secret protection could adversely affect our competitive business position.

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

trade secrets.

We rely in part on confidentiality agreements with our employees, consultants,

outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information.

These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event

of unauthorized disclosure of confidential information.

Furthermore, any license agreements we enter into in the future may require us

to notify, and in some cases license back to the licensor, certain additional proprietary information or intellectual property that we

developed using the rights licensed to us under these agreements.

Any such licenses back to the licensor could allow our licensors to

use that proprietary information or intellectual property in a manner that could harm our business.

In addition, others may independently

discover our trade secrets and proprietary information.

For example, the FDA, as part of its transparency initiative, is currently considering

whether to make additional information publicly available on a routine basis, including information that we may consider to be trade

secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change

in the future, if at all.

Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary

rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

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 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 product candidate from competition, which may negatively affect our

business as well as limit our partnership or acquisition appeal.

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 product candidate from competition, which may negatively affect our business

as well as limit our partnership or acquisition appeal.

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

We can give no assurances that

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

developing and commercializing competitive products.

The existence of competitive products that avoid our intellectual property

could materially adversely affect our operating results and financial condition.

Furthermore, limitations, or perceived limitations,

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

third parties perceive a higher than acceptable risk to commercialization of our product candidate or future product candidates.

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

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

If we do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:

We can give no assurances that our intellectual

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

competitive products.

The existence of competitive products that avoid our intellectual property could materially adversely affect our

operating results and financial condition.

Furthermore, limitations, or perceived limitations, in our intellectual property may limit

the interest of third parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable

risk to commercialization of our product candidate or future product candidates.

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

copyrights, trade secrets, domain names or other intellectual property rights that we either own or license from a third party.

do not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:

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 product;

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

condition, and the commercial viability of our product;

restructuring

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

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

competitiveness.

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

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

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 candidate

in the future.

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

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

other factors.

the result of these challenges may narrow the scope or claims of or invalidate patents that are integral to our product candidate in

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

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

property rights and enforcement may be less extensive in jurisdictions outside of the U.S.;

thus, we may not be able to protect

our intellectual property and third parties may be able to market competitive products that may use some or all of our intellectual

to patent law, including 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, may substantially change the regulations and procedures surrounding patent applications,

issuance of patents, and prosecution of patents.

We can give no assurances that the patents of our licensor can be defended or

will protect us against future intellectual property challenges, particularly as they pertain to changes in patent law and future

patent law interpretations.

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

submission, fee payment and other requirements imposed by the USPTO, courts and foreign government patent agencies, and HJF’s

patent protection could be reduced or eliminated for non-compliance with these requirements which may have a material adverse

effect on our business.

thus, we may not be able to protect our intellectual

property and third parties may be able to market competitive products that may use some or all of our intellectual property.

to patent law, including 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, may substantially change the regulations and procedures surrounding patent applications, issuance of patents,

and prosecution of patents.

We can give no assurances that the patents of our licensor can be defended or will protect us against future

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

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

fee payment and other requirements imposed by the USPTO, courts and foreign government patent agencies, and HJF’s patent protection

could be reduced or eliminated for non-compliance with these requirements which may have a material adverse effect on our business.

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 current product candidate or any future product candidates, the products may not gain market

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

Market acceptance

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

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

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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;

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

any future product candidates;

cost of treatment in relation to alternative treatments;

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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.

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

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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

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.

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 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.

Coverage and reimbursement may 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 may not be able to successfully commercialize any product candidate for which we obtain regulatory approval.

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

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

Moreover, eligibility for coverage and

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

manufacture, sale and distribution.

Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our

costs and may only be temporary.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is

used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other

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.

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.

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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.

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.

and certain international jurisdictions, there have been a number of legislative and regulatory changes

to the health care system that could impact our ability to sell our product profitably.

In particular, in 2010, the Affordable Care Act

(“ACA”) was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars,

addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that

are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid

Drug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed

care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives

to programs that increase the federal government’s comparative effectiveness research.

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.

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 may be adopted in the future.

The continuing

efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain

or reduce costs of healthcare and/or impose price controls may adversely affect:

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;

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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

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 approved.

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, particularly member states of the European Union, 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.

Political, economic and regulatory developments may further complicate pricing negotiations,

and pricing negotiations may continue after reimbursement has been obtained.

Reference pricing used by various European Union member

states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

some countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness

of our product candidate to other available therapies in order to obtain or maintain reimbursement or pricing approval.

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

country of publication and other countries.

If reimbursement of our product is unavailable or limited in scope or amount, or if

pricing is set at unsatisfactory levels, our business could be adversely affected.

Publication 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.

and reimbursement may be limited or unavailable in certain market segments for our product candidate, which could make it difficult for

us to sell our product candidates, if licensed, profitably.

commercialization of our product candidate will depend in part on the extent to which reimbursement for those drug products will be available

from government health administration authorities, private health insurers, and other organizations.

Government authorities and third-party

payors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish

reimbursement levels.

The availability and extent of reimbursement by governmental and private payors is essential for most patients

to be able to afford a drug product.

Sales of drug products depend substantially, both domestically and abroad, on the extent to which

the costs of drugs products are paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations,

or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors.

uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval.

product candidate for which we seek regulatory approval and reimbursement will need to meet or surpass our target product profile to be deemed a viable alternative to currently approved therapies.

payors decide which drugs and treatments they will cover and the amount of reimbursement.

Reimbursement by a third-party payor may depend

upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:

covered benefit under its health plan;

effective and medically necessary;

for the specific patient;

cost-effective;

experimental nor investigational.

coverage and reimbursement of a product from a government or other third-party payor is a time-consuming and costly process that could

require us to provide the payor with supporting scientific, clinical and cost-effectiveness data for the use of our products, if licensed.

In the U.S., the principal decisions about reimbursement for new drug products are typically made by the Centers for Medicare

and Medicaid Services, or CMS, an agency within the U.S.

Department of Health and Human Services, or HHS.

CMS decides whether and to

what extent a new drug product will be covered and reimbursed under Medicare, and private payors tend to follow CMS to a substantial

However, no uniform policy of coverage and reimbursement for drug products exists among third-party payors and coverage and reimbursement

levels for drug products can differ significantly from payor to payor.

Further, one payor’s determination to provide coverage for

a product does not assure that other payors will also provide coverage for the product.

Adequate third-party reimbursement may not be

available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

if we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product

for use in their facility or third-party payors may require co-payments that patients find unacceptably high.

Patients are unlikely to

use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our

product candidates.

Separate reimbursement for the product itself may or may not be available.

Instead, the hospital or administering

physician may be reimbursed only for providing the treatment or procedure in which our product is used.

Further, from time to time, CMS

revises the reimbursement systems used to reimburse health care providers, including the Medicare Physician Fee Schedule and Outpatient

Prospective Payment System, which may result in reduced Medicare payments.

In some cases, private third-party payors rely on all or portions

of Medicare payment systems to determine payment rates.

Changes to government healthcare programs that reduce payments under these programs

may negatively impact payments from private third-party payors, and reduce the willingness of physicians to use our product candidates.

marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other

third-party payors fail to provide coverage and adequate reimbursement.

We expect downward pressure on pharmaceutical pricing to continue.

Further, coverage policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status

is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates

may be implemented in the future.

expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to

Biologics Price Competition and Innovation Act of 2009, or BPCIA, was enacted as part of the Patient Protection and Affordable Care Act,

as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, to establish an abbreviated pathway for the

approval of biosimilar and interchangeable biological products.

The regulatory pathway establishes legal authority for the FDA to review

and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity

to a licensed biologic.

Under the BPCIA, an application for a biosimilar product cannot be licensed by the FDA until 12 years after the

reference product was licensed under a BLA.

The law is complex and is still being interpreted and implemented by the FDA.

believe that any of the product candidates we develop that is licensed in the U.S.

as a biological product under a BLA should

qualify for the 12-year period of exclusivity.

However, there is a risk that this exclusivity could be shortened due to congressional

action or otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products,

potentially creating the opportunity for generic competition sooner than anticipated.

Moreover, the extent to which a biosimilar, once

licensed, will be substituted for any one of the reference products in a way that is similar to traditional generic substitution for

non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

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 may 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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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’

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

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:

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 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 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 preempted by HIPAA, thus complicating compliance efforts.

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 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 may 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 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 preempted 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.

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

employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,

which could cause significant liability for us and harm our reputation.

are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA regulations or

similar regulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign

regulatory authorities, comply with manufacturing standards we have established, comply with federal and state healthcare fraud

and abuse laws and regulations and similar laws and regulations established and enforced by comparable foreign regulatory authorities,

report financial information or data accurately or disclose unauthorized activities to us.

Employee misconduct could also involve

the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious

harm to our reputation.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect

and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental

investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions

could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal

and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare

and Medicaid, and integrity oversight and reporting obligations.

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

we may develop.

face an inherent risk of product liability exposure related to the testing of our current product candidate or future product

candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop.

Product liability claims may be brought against us by subjects enrolled in our clinical trials, patients, healthcare providers

or others using, administering or selling our product.

If we cannot successfully defend ourselves against claims that our product

candidate or product caused injuries, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability

claims may result in:

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.

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

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 patients 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;

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costs to defend the related litigation;

monetary awards to trial subjects or patients;

monetary awards to clinical trial patients;

of management and scientific resources from our business operations;

inability to commercialize any products that we may develop.

to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is

customary for similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks;

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

If we are able to obtain product liability insurance,

we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that

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

Furthermore, we intend to expand

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

candidate in development, but we may be unable to obtain commercially reasonable product liability insurance for any products

that receive regulatory approval.

Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated

side effects.

A successful product liability claim or series of claims brought against us, particularly if judgments exceed our

insurance coverage, could decrease our cash and adversely affect our business.

to engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is customary

for similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks;

however, we may be unable

to obtain such coverage at a reasonable cost, if 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

and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling

certain products outside of the U.S.

and require us to develop and implement costly compliance programs.

we expand our operations outside of the U.S., we must dedicate additional resources to comply with numerous laws and regulations

in each jurisdiction in which we plan to operate.

The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S.

individual or business

from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political

party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business

in obtaining or retaining business.

The FCPA also obligates companies whose securities are listed in the U.S.

to comply with

certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions

of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls

for international operations.

with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem.

In addition, the FCPA

presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government,

and doctors and other hospital employees are considered foreign officials.

Certain payments to hospitals in connection with clinical

trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

laws, regulations and Executive Orders also restrict the use and dissemination outside of the U.S., or the sharing with certain

nationals, of information classified for national security purposes, as well as certain products and technical data relating

to those products.

If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply

with these laws, and these laws may preclude us from developing, manufacturing, marketing or selling certain products and product candidates

outside of the U.S., which could limit our growth potential and increase our development costs.

failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension

or debarment from government contracting.

The SEC also may suspend or bar issuers from trading securities on U.S.

exchanges for violations

of the FCPA’s accounting provisions.

Related to our Business Operations

face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

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 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 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 noncompetitive before we can recover the expenses of development and commercialization.

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 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 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 of

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.

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 candidate.

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 noncompetitive

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.

The coronavirus has spread to many regions of the world.

The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain

and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the

coronavirus or treat its impact, among others.

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 nonperformance 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.

For instance, our clinical

trials may be affected by the pandemic.

Site initiation, participant recruitment and enrollment, participant dosing, distribution of

clinical trial materials, clinical trial 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 clinical trial 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 nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully recoverable

or adequately covered by insurance.

and deaths related to the pandemic may disrupt the healthcare and healthcare regulatory systems in the U.S..

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 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 any third-party parties in the supply chain for

materials used in the production of our product candidates are adversely impacted by restrictions resulting from the coronavirus outbreak,

our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research and

development operations.

a result of the shelter-in-place order and other mandated local travel restrictions, our employees conducting research and development

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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 restrictions on travel and quarantine policies put into

place by businesses and governments, may have a material economic effect on our business.

While the potential economic impact brought

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

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

In addition, a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus could materially

and adversely affect our business and the value of our common stock.

ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet

know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems

or the global economy as a whole.

However, these effects could have a material impact on our operations, and we will continue

to monitor the situation closely.

disruptions of information technology systems, computer system failures or breaches of information security could adversely affect

our business.

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.

Data collection

is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

are subject to stringent privacy and data protection requirements and these requirements may become more complex as we grow our business

and begin to operate in other jurisdictions.

For example, the collection, use, storage, disclosure, transfer, or other processing of

personal data, including health-related information, regarding individuals in the European Economic Area, or EEA, is governed by the

European General Data Protection Regulation, or the GDPR, which became effective on May 25, 2018.

The GDPR applies to any business, regardless

of its location, that provides goods or services to residents in the EU or monitors the behavior of individuals within the European Union.

The GDPR is wide ranging in scope and imposes stringent operational requirements for processors and controllers of personal data, including,

for example, special protections for “sensitive information” which includes health and genetic information, expanded disclosures

to individuals about how their personal data is to be used, limitations on retention of information, increased requirements pertaining

to health data and pseudonymized ( i.e.

, key-coded) data, implementing safeguards to protect the security and confidentiality of

personal data, mandatory data breach notification requirements and higher standards for controllers to demonstrate that they have obtained

valid consent for certain data processing activities.

The GDPR grants individuals the opportunity to object to the processing of their

personal information, allows them to request deletion of personal information in certain circumstances, and provides the individual with

an express right to seek legal remedies in the event the individual believes his or her rights have been violated.

Further, the GDPR

imposes strict rules on the transfer of personal data out of the European Union to the U.S.

and other jurisdictions that have

not been deemed to offer “adequate” privacy protections.

addition to the requirement of the GDPR, European Union Member States may make their own further laws and regulations in relation to

the processing of genetic, biometric or health data, which could result in differences between Member States, limit our ability to

use and share personal data or could cause our costs to increase, and harm our business and financial condition.

Should we commence

clinical trial activity within the member states of the European Union, such activity will be regulated by the GDPR as well as

applicable member state laws.

In addition, we are subject to evolving and strict rules on the transfer of personal data out of the

European Union to the U.S..

For example, evolution of laws governing the cross-border transfer of data, such as the

invalidation of the EU–U.S.

Privacy Shield, creates additional uncertainty around the legality and mechanics of such

Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or

require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and

penalties, litigation, and reputational harm in connection with any future European activities.

We could be adversely affected if we

fail to comply fully with all of these requirements.

Failure to comply with European Union data protection laws may result in fines

(for example, of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year

(whichever is higher) under the GDPR) and other administrative penalties, which may be onerous and adversely affect our business,

financial condition, results of operations and prospects.

addition, further to the United Kingdom’s (UK) exit from the EU on January 31, 2020, the GDPR ceased to apply in the UK at the

end of the transition period on December 31, 2020.

However, as of January 1, 2021, the UK’s European Union (Withdrawal) Act 2018

incorporated the GDPR (as it existed on December 31, 2020 but subject to certain UK specific amendments) into UK law (referred to as

the ‘UK GDPR’).

The UK GDPR and the UK Data Protection Act 2018 set out the UK’s data protection regime, which is independent

from but aligned to the EU’s data protection regime.

Non-compliance with the UK GDPR may result in monetary penalties of up to

£17.5 million or 4% of worldwide revenue, whichever is higher.

Although the UK is regarded as a third country under the EU’s

GDPR, the European Commission has now issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore,

transfers of personal data originating in the EU to the UK remain unrestricted.

Like the EU GDPR, the UK GDPR restricts personal data

transfers outside the UK to countries not regarded by the UK as providing adequate protection.

The UK government has confirmed that personal

data transfers from the UK to the EEA remain free flowing.

lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, uncertainty,

complexity and cost to our handling of EU personal information and our privacy and data security compliance programs.

It is possible

that over time the UK Data Protection Act could become less aligned with the EU General Data Protection Regulation, or GDPR, which could

require us to implement different compliance measures for the UK and the European Union and result in potentially enhanced compliance

obligations for EU personal data.

the U.S., there has been a flurry of activity at the state level.

In California, the California Consumer Privacy Act, or CCPA,

was enacted in June 2018, became effective on January 1, 2020, and became subject to enforcement by the California Attorney General’s

office on July 1, 2020.

The CCPA broadly defines personal information, and creates new individual privacy rights and protections for

California consumers (as defined in the law), places increased privacy and security obligations on entities handling personal data of

consumers or households, and provides for civil penalties for violations and a private right of action for data breaches.

The CCPA requires

covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected

California residents with ways to opt-out of certain sales or transfers of personal information.

While there is an exception for protected

health information that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become

a “Business” regulated by the scope of the CCPA.

addition to the CCPA, new privacy and data security laws have been proposed in more than half of the states in the U.S.

and in the U.S.

Congress, reflecting a trend toward more stringent privacy legislation in the U.S., which trend may accelerate depending on the new U.S.

presidential administration.

The effects of the CCPA, and other similar state or federal laws, are potentially significant and may require

us to modify our data processing practices and policies and to incur substantial costs and potential liability in an effort to comply

with such legislation.

various jurisdictions around the world continue to propose new laws that regulate the privacy and/or security of certain types of personal

Complying with these laws, if enacted, would require significant resources and leave us vulnerable to possible fines and penalties

if we are unable to comply.

The regulatory framework governing the collection, processing, storage, use and sharing of certain information

is rapidly evolving and is likely to continue to be subject to uncertainty and varying interpretations.

It is possible that these laws

may be interpreted and applied in a manner that is inconsistent with our existing data management practices or the features of our services

and platform capabilities.

Any failure or perceived failure by us, or any third parties with which we do business, to comply with our

posted privacy policies, evolving laws, rules and regulations, industry standards, or contractual obligations to which we or such third

parties are or may become subject, may result in actions or other claims against

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.

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 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 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 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 21, 2022, we had 3 full-time employee and 3 part-time employees.

We will need to grow the size of

our organization in order to support our continued development and potential commercialization of our product candidate.

development and commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing,

sales, marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not

be adequate to support this future growth.

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

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

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

our clinical trials effectively;

recruiting, maintaining, motivating and integrating additional employees;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees,

contractors and other third parties;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors

and other third parties;

our managerial, development, operational, information technology, and finance systems;

our facilities.

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

third parties.

Our future financial performance and our ability to commercialize our product candidate and to compete effectively

will depend, in part, on our ability to manage any future growth effectively, as well as our ability to develop a sales and marketing

force when appropriate for our company.

To that end, we must be able to manage our development efforts and preclinical studies

and clinical trials effectively and hire, train and integrate additional management, research and development, manufacturing,

administrative and sales and marketing personnel.

The failure to accomplish any of these tasks could prevent us from successfully

growing our company.

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

Our future financial performance and our ability to commercialize our product candidate and to compete effectively will depend,

in part, on our ability to manage any future growth effectively, as well as our ability to develop a sales and marketing force when appropriate

for our company.

To that end, we must be able to manage our development efforts and preclinical studies and clinical trials effectively

and hire, train and integrate additional management, research and development, manufacturing, administrative and sales and marketing

The failure to accomplish any of these tasks could prevent us from successfully growing our company.

future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.

are highly dependent upon our personnel, including Snehal Patel, our Chief Executive Officer and member of our board of directors.

The loss of Mr.

Patel’s services could impede the achievement of our research, development and commercialization objectives.

We have not obtained, do not own, nor are we the beneficiary of, key-person life insurance.

Our future growth and success depend

on our ability to recruit, retain, manage and motivate our employees.

The loss of any member of our senior management team or

the inability to hire or retain experienced management personnel could compromise our ability to execute our business plan and

harm our operating results.

Because of the specialized scientific and managerial nature of our business, we rely heavily on our

ability to attract and retain qualified scientific, technical and managerial personnel.

The competition for qualified personnel

in the pharmaceutical field is intense and as a result, we may be unable to continue to attract and retain qualified personnel

necessary for the development of our business.

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

Patel’s services could impede the achievement of our research, development and commercialization objectives.

not obtained, do not own, nor are we the beneficiary of, key-person life insurance.

Our future growth and success depend on our ability

to recruit, retain, manage and motivate our employees.

The loss of any member of our senior management team or the inability to hire

or retain experienced management personnel could compromise our ability to execute our business plan and harm our operating results.

Because of the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified

scientific, technical and managerial personnel.

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

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

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 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

agencies, which would adversely affect our business.

For example, over the last several years, including beginning on December

22, 2018, the U.S.

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

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

If a prolonged government shutdown

occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could

have a material adverse effect on our business.

Further, in our operations as a public company, future government shutdowns could

impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our

In addition, government funding of the SEC and other

government agencies on which our operations may rely, including those that fund research and development activities is subject to the

political process, which is inherently fluid and unpredictable.

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

which would adversely affect our business.

For example, over the last several years, including beginning on December 22, 2018, the U.S.

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

SEC and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact

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

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

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

Related to Owning our Common Stock

price of our common stock may fluctuate substantially.

should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand

a significant loss and wide fluctuations in the market value of your investment.

Some factors that may cause the market price

of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors”

section and elsewhere

in this Annual Report on Form 10-K, are:

should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand a

significant loss and wide fluctuations in the market value of your investment.

Some factors that may cause the market price of our common

stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section and elsewhere in this Annual

Report on Form 10-K, are:

of our common stock by our stockholders, executives and directors;

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;

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical

trials, and other business activities;

delays in the expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;

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;

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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in the development status of our product candidate;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical

and clinical trials;

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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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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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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.

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.

and economic conditions may negatively impact our business, financial condition and share price.

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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 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 relies 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 may be adversely affected by any such economic downturns (including the 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

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 relies 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.

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

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own approximately 70% of our outstanding shares of common stock.

As a result, these stockholders, acting together, 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,

have the ability to control the management and affairs of our company.

Accordingly, this concentration of ownership might harm

the market price of our common stock by:

As a result, these stockholders, acting together, 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, have the ability to control the

management and affairs of our company.

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

deferring or preventing a change in corporate control;

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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 product, and continuing activities as an operating public company.

To the extent we raise additional

capital by issuing equity securities, our stockholders may experience substantial dilution.

We may sell common stock, convertible securities

or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock,

convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing

stockholders.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not

anticipate declaring or paying any cash dividends for the foreseeable future.

Any return to stockholders will therefore be limited

to the increase, if any, of our share price.

are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable

to emerging growth companies, which could make our common stock less attractive to investors.

are an “emerging growth company,”

as defined in the JOBS Act and we intend to take advantage of certain exemptions

from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”

including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act,

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from

the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved.

In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company”

we intend to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying

with new or revised accounting standards.

In other words, an “emerging growth company”

can delay the adoption of certain

accounting standards until those standards would otherwise apply to private companies.

We 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.

advantage of these reporting exemptions until we are no longer an “emerging growth company.”

We will remain an “emerging

growth company”

until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of

$1.07 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our

initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

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.

are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging

growth companies, which could make our common stock less attractive to investors.

are an “emerging growth company,” as defined in the JOBS Act and we intend to take advantage of certain exemptions from various

reporting requirements that are applicable to other public companies that are not “emerging growth companies” including not

being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations

regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding

advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we intend to take advantage of the extended transition

period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.

In other words,

an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise

apply to private companies.

We 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.

We may take advantage of these reporting exemptions until we are no longer an “emerging growth

company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in

which we have total annual gross revenues of $1.07 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary

of the date of the completion of our initial public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible

debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the

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.

common stock is currently listed on The Nasdaq

Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock exchange, our stock price could

be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more

difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s

minimum listing requirements or those of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid

market for our common stock does not develop or is sustained, our common stock may remain thinly traded.

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.

common stock is currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any

stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could

be impaired and it may be more difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum

listing requirements or those of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid market for

our common stock does not develop or is sustained, our common stock may remain thinly traded.

listing rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

for any reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from

trading on its exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all

of the following may occur, each of which could have a material adverse effect on our stockholders:

reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its

exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may

occur, each of which could have a material adverse effect on our stockholders:

liquidity of our common stock;

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number of broker-dealers willing to execute trades in shares of our common stock.

second amended and restated certificate of incorporation (“Amended and Restated Certificate of Incorporation”) and

our second amended and restated bylaws (the “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.

Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law could make it more difficult

for a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders.

We are authorized

to issue up to 10 million shares of preferred stock.

This preferred stock may be issued in one or more series, the terms of which

may be determined at the time of issuance by our board of directors without further action by stockholders.

The terms of any series

of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to

dividend, liquidation, conversion and redemption rights and sinking fund provisions.

The issuance of any preferred stock could

materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with,

or sell our assets to, a third party and thereby preserve control by the present management.

of our Amended and Restated 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 management.

In particular, the certificate of incorporation and bylaws and Delaware law, as applicable,

among other things:

second amended and restated certificate of incorporation (“Amended and Restated Certificate of Incorporation”) and our second

amended and restated bylaws (the “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.

Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law could make it more difficult for

a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders.

We are authorized to issue up

to 10 million shares of preferred stock.

This preferred stock may be issued in one or more series, the terms of which may be determined

at the time of issuance by our board of directors without further action by stockholders.

The terms of any series of preferred stock

may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion

and redemption rights and sinking fund provisions.

The issuance of any preferred stock could materially adversely affect the rights of

the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights granted to future

holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve

control by the present management.

of our Amended and Restated 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 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 Amended and Restated 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;

advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon

at stockholder meetings;

that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

reporting obligations of being a public company in the U.S.

are expensive and time-consuming, and our management is required to

devote substantial time to compliance matters.

are expensive and time-consuming, and our management is 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 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 Nasdaq Capital Market.

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.

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.”

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.

Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum

for substantially all disputes between the Company and its stockholders, which could limit stockholders’

ability to obtain

a favorable judicial forum for disputes with the Company or its directors, officers or employees.

Amended and Restated Bylaws provides that unless we consent in writing to the selection of an alternative forum, the State of

Delaware is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of us, (ii) any action

asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders,

(iii) any action asserting a claim against us, our directors, officers or employees arising pursuant to any provision of the Delaware

General Corporation Law (the “DGCL”) or our Amended and Restated Certificate of Incorporation or our Amended and Restated

Bylaws, or (iv) any action asserting a claim against us, our directors, officers, employees or agents governed by the internal

affairs doctrine, except for, as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that

there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not

consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), which is vested in

the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery does not have

subject matter jurisdiction.

This exclusive forum provision would not apply to suits brought to enforce any liability or duty

created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal

jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations

22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty

or liability created by the Securities Act or the rules and regulations thereunder.

However, our Amended and Restated Bylaws contain

a federal forum provision which provides that unless we consent in writing to the selection of an alternative forum, the federal

district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause

of action arising under the Securities Act.

Any person or entity purchasing or otherwise acquiring any interest in shares of our

capital stock are deemed to have notice of and consented to this provision.

choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable

for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors,

officers and other employees.

Alternatively, if a court were to find our choice of forum provisions contained in either our Amended

and Restated Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving

such action in other jurisdictions, which could harm our business, results of operations, and financial condition.

The obligations of being a public company

require significant expenditures and 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 Nasdaq Capital Market.

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.” 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.

Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially

all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum

for disputes with the Company or its directors, officers or employees.

Amended and Restated Bylaws provides that unless we consent in writing to the selection of an alternative forum, the State of Delaware

is the sole and exclusive forum for:

(i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim

of breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders, (iii) any action

asserting a claim against us, our directors, officers or employees arising pursuant to any provision of the Delaware General Corporation

Law (the “DGCL”) or our Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws, or (iv) any

action asserting a claim against us, our directors, officers, employees or agents governed by the internal affairs doctrine, except for,

as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable party not

subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the

Court of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum other

than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction.

This exclusive forum provision

would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim

for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon federal law claims, Section

27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the

Exchange Act or the rules and regulations thereunder.

22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability

created by the Securities Act or the rules and regulations thereunder.

However, our Amended and Restated Bylaws contain a federal forum

provision which provides that unless we consent in writing to the selection of an alternative forum, the U.S.

federal district

courts will be the exclusive forum for the resolution of any complaint asserting a cause of action arising

under the Securities Act.

Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock are deemed

to have notice of and consented to this provision.

choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes

with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and

other employees.

Alternatively, if a court were to find our choice of forum provisions contained in either our Amended and Restated Bylaws

to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions,

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

we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately

2 unchanged sentences

controls and procedures.

We are required to furnish a report by management on, among other things, the effectiveness of internal

control over financial reporting.

This assessment will include disclosure of any material weaknesses identified by management

in our internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal

control over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or

interim financial statements will not be prevented or detected on a timely basis.

Section 404 of the Sarbanes-Oxley Act also generally

requires an attestation from an issuer’s independent registered public accounting firm on the effectiveness of its internal

We are required to furnish a report by management on, among other things, the effectiveness of internal control

over financial reporting.

This assessment will include disclosure of any material weaknesses identified by management in our internal

control over financial reporting.

However, for as long as we remain an emerging growth company under the JOBS Act, we may take

advantage of the exemption permitting us not to comply with the independent registered public accounting firm attestation requirement.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial

reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will

not be prevented or detected on a timely basis.

Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from an

issuer’s independent registered public accounting firm on the effectiveness of its internal control over financial reporting.

for as long as we remain an emerging growth company under the JOBS Act, we may take advantage of the exemption permitting us not to comply

with the independent registered public accounting firm attestation requirement.

compliance with Section 404 of the Sarbanes-Oxley Act may require that we incur substantial accounting expense and expend significant

1 unchanged sentence

We may not be able to complete our evaluation, testing and any required remediation in a timely fashion.

the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting,

we may be unable to assert that our internal control over financial reporting is effective.

In connection with management’s

assessment of internal controls over financial reporting for the quarter ended September 30, 2020, we identified a material weakness

due to inadequate segregation of duties within our accounting processes due to limited personnel and insufficient written policies

and procedures for accounting, IT and financial reporting and record keeping.

Although we are developing a plan to remediate the

material weaknesses, we cannot assure you that we will be able to remediate such weaknesses or that there will not be new material

weaknesses or significant deficiencies in our internal control over financial reporting in the future.

Any failure to maintain

internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results

of operations or cash flows.

If we are unable to conclude that our internal control over financial reporting is effective, we

could lose investor confidence in the accuracy and completeness of our financial reports, the value of our common stock could

decline, and we could be subject to sanctions or investigations by regulatory authorities.

Failure to remedy any material weakness

in our internal control over financial reporting, or to implement or maintain other effective control systems required of public

companies, could also restrict our future access to the capital markets.

evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we may

be unable to assert that our internal control over financial reporting is effective.

In connection with management’s assessment

of internal controls over financial reporting for the quarter ended September 30, 2020, we identified a material weakness due to inadequate

segregation of duties within our accounting processes due to limited personnel and insufficient written policies and procedures for accounting,

IT and financial reporting and record keeping.

Although we are developing a plan to remediate the material weaknesses, we cannot assure

you that we will be able to remediate such weaknesses or that there will not be new material weaknesses or significant deficiencies in

our internal control over financial reporting in the future.

Any failure to maintain internal control over financial reporting could

severely inhibit our ability to accurately report our financial condition, results of operations or cash flows.

If we are unable to conclude

that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of

our financial reports, the value of our common stock could decline, and we could be subject to sanctions or investigations by regulatory

Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other

effective control systems required of public companies, could also restrict our future access to the capital markets.

UNRESOLVED STAFF COMMENTS

sublease a facility to support our clinical trial operations and contract research and development.

sublease a facility to support our clinical trial operations and research and development.

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