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Item 1A. Risk Factors

2020-08-14 compared with 2020-06-29 · 895 added, 929 removed, 642 unchanged (74% of the section changed)

In analyzing our

company, you should consider carefully the following risk factors, together with all of the other information included in this

Quarterly Report on Form 10-Q.

Factors that could cause or contribute to differences in our actual results include those discussed

in the following subsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial

Condition and Results of Operations”

In analyzing our company,

you should consider carefully the following risk factors, together with all of the other information included in this Quarterly

Report on Form 10-Q.

Factors that could cause or contribute to differences in our actual results include those discussed in

the following subsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial Condition

and Results of Operations”

and in our Annual Report filed on Form 10-K for the year ended December 31, 2019.

of the following risk factors, either alone or taken together, could adversely affect our business, operating results and financial

condition, as well as adversely affect the value of an investment in our company.

The risks and uncertainties described below are

not the only ones we face.

Additional risks not currently known to us or other factors not perceived by us to present significant

risks to our business at this time also may impair our business operations.

following risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition,

as well as adversely affect the value of an investment in our company.

The risks and uncertainties described below are not the

only ones we face.

Additional risks not currently known to us or other factors not perceived by us to present significant risks

to our business at this time also may impair our business operations.

Risks Related to Our Business

We are a clinical-stage company and have generated no

revenue from commercial sales to date.

We are a clinical-stage company and have generated no revenue

from commercial sales to date.

We are a clinical-stage

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and anticipate that we will continue to incur net losses in the future.

profitable and have incurred losses in each period since our inception.

As of March 31, 2020 and December 31, 2019, we had an

accumulated deficit of $214.4 million and $208.8 million, respectively.

We reported a net loss of $5.7 million for the three

months ended March 31, 2020 and 2019.

continue to operate at a net loss as we continue our research and development efforts, continue to conduct clinical trials

and develop manufacturing, sales, marketing and distribution capabilities.

There can be no assurance that the products under

development by us will be approved for sale in the United States or elsewhere.

Furthermore, there can be no assurance that if

such products are approved, they will be successfully commercialized, which would have an adverse effect on our business

prospects, financial condition and results of operation.

We are not profitable and

have incurred losses in each period since our inception.

As of June 30, 2020 and December 31, 2019, we had an accumulated deficit

of $219.1 million and $208.8 million, respectively.

We reported a net loss of $10.3 million and $10.7 million for the six months

ended June 30, 2020 and June 30, 2019, respectively.

We expect to continue to operate at a net loss as we continue our research

and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

There can be no assurance that the products under development by us will be approved for sale in the United States or elsewhere.

Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized, which would

have an adverse effect on our business prospects, financial condition and results of operation.

If we fail to obtain additional financing,

we will be unable to continue or complete our product development and you will likely lose your entire investment.

On April 24, 2020, we

issued and sold 210.8 million shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu

Gross proceeds from this offering to us were $31.6 million, before deducting underwriting discounts and commissions

and other offering expenses payable by us.

On June 19, 2020, we issued and sold 55.7 million shares of common stock and 21.3

million pre-funded warrants to purchase shares of common stock.

Gross proceeds from this offering to us were $25.0 million,

before deducting underwriting discounts and commissions and other offering expenses payable us.

As of the date of filing this

report, we expect that our existing resources will be more than sufficient to fund our planned operations for more than 12

months following the date of this report.

On April 24, 2020,

we issued and sold 4.3 million shares of common stock and pre-funded warrants to purchase 2.8 million shares of common stock.

proceeds from this offering to us were $31.6 million, before deducting underwriting discounts and commissions and other offering

expenses payable by us.

On June 19, 2020, we issued and sold 1.9 million shares of common stock and 0.7 million pre-funded warrants

to purchase shares of common stock.

Gross proceeds from this offering to us were $25.0 million, before deducting underwriting discounts

and commissions and other offering expenses payable us.

As of the date of filing this report, we expect that our existing resources

will be more than sufficient to fund our planned operations for more than 12 months following the date of this report.

Our business or operations

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and also our ability to finance on favorable terms or indeed on any terms.

To raise additional

capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable

for our common stock.

We cannot assure you that we will be able to sell shares or other securities in any other offering at a price

per share that is equal to or greater than the price per share paid by investors, and investors purchasing shares or other securities

in the future could have rights superior to existing stockholders.

If we cannot raise

adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development

activities, clinical studies or future operations.

We may also be required to obtain funds through arrangements with collaborators,

which arrangements may require us to relinquish rights to certain technologies or products that we otherwise would not consider

relinquishing, including rights to future product candidates or certain major geographic markets.

We may further have to license

our technology to others.

To raise additional capital,

we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common

We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share

that is equal to or greater than the price per share paid by investors, and investors purchasing shares or other securities in

the future could have rights superior to existing stockholders.

If we cannot raise adequate

funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities,

clinical studies or future operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements

may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including

rights to future product candidates or certain major geographic markets.

We may further have to license our technology to others.

This could result in sharing revenues which we might otherwise have retained for ourselves.

actions may harm our business, financial condition and results of operations.

The amount of funding

we will need depends on many factors, including the progress, timing and scope of our product development programs;

Any of these actions may harm our business,

financial condition and results of operations.

The amount of funding we

will need depends on many factors, including the progress, timing and scope of our product development programs;

the progress,

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markets and even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

We have limited access to the capital markets

to raise funds.

The capital markets have been unpredictable in the recent past for radioisotope and other oncology companies and

unprofitable companies such as ours.

Furthermore, the COVID-19 pandemic has created significant economic uncertainty and volatility

in the credit and capital markets.

A continuation or worsening of the levels of market disruption and volatility seen in the recent

past could have an adverse effect on our ability to access capital.

In addition, it is generally difficult for development-stage

companies to raise capital under current market conditions.

The amount of capital that a company such as ours is able to raise

often depends on variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive

to us, or at all.

If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future

If adequate funds are not available on acceptable terms, or at all, our business, including our technology licenses, results

of operations, financial condition and our continued viability will be materially adversely affected.

We have limited access

to the capital markets to raise funds.

The capital markets have been unpredictable in the recent past for radioisotope and other

oncology companies and unprofitable companies such as ours.

Furthermore, the COVID-19 pandemic has created significant economic

uncertainty and volatility in the credit and capital markets.

A continuation or worsening of the levels of market disruption and

volatility seen in the recent past could have an adverse effect on our ability to access capital.

In addition, it is generally

difficult for development-stage companies to raise capital under current market conditions.

The amount of capital that a company

such as ours is able to raise often depends on variables that are beyond our control.

As a result, we may not be able to secure

financing on terms attractive to us, or at all.

If we are able to consummate a financing arrangement, the amount raised may not

be sufficient to meet our future needs.

If adequate funds are not available on acceptable terms, or at all, our business, including

our technology licenses, results of operations, financial condition and our continued viability will be materially adversely affected.

We are highly dependent on the success

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marketing and commercial supply capabilities.

We do not currently

have, nor have we ever had, commercial sales and marketing capabilities.

If any of our product candidates become approved, we would

have to build and establish these capabilities in order to commercialize our approved product candidates.

We do not currently have,

nor have we ever had, commercial sales and marketing capabilities.

If any of our product candidates become approved, we would have

to build and establish these capabilities in order to commercialize our approved product candidates.

The process of establishing

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commercialize any product candidate may have material adverse impacts on our business and ability to continue operations.

Our business could be adversely

affected by the effects of health epidemics, including the global COVID-19 pandemic.

In December 2019, a

novel strain of COVID-19 was reported in China.

Our business could be adversely affected

by the effects of health epidemics, including the global COVID-19 pandemic.

In December 2019, a novel

strain of COVID-19 was reported in China.

Since then, COVID-19 has spread globally.

The spread of COVID-19 from China to other countries has resulted in the World Health Organization

(WHO) declaring the outbreak of COVID-19 as a “pandemic,”

or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the

virus and have closed non-essential businesses, and many local jurisdictions continue to have such restrictions

The spread of COVID-19 from China to other

countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,”

a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions

on travel and mass gatherings to slow the spread of the virus and have closed non-essential businesses, and many local jurisdictions

continue to have such restrictions in place.

As many local jurisdictions

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of our drug candidates.

Such government-imposed precautionary measures may have been relaxed in certain countries or states, but

there is no assurance that more strict measures will be put in place again due to a resurgence in COVID-19 cases.

Therefore, the

COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts of the medical community to

coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect on our operations.

The spread of COVID-19,

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While the ultimate economic impact brought by,

and the duration of, the COVID-19 pandemic may be difficult to assess or predict, thepandemic has resulted in significant disruptions

in the general commercial activity and the global economy and caused financial market volatility and uncertainty in significant

and unforeseen ways in the recent months.

A continuation or worsening of the levels of market disruption and volatility seen in

the recent past could have an adverse effect on our ability to access capital, which could in the future negatively affect our

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

and the value of our common stock.

and the duration of, the COVID-19 pandemic may be difficult to assess or predict, including new information which may emerge concerning

the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others, the pandemic has resulted in significant

disruptions in the general commercial activity and the global economy and caused financial market volatility and uncertainty in

significant and unforeseen ways in the recent months.

A continuation or worsening of the levels of market disruption and volatility

seen in the recent past could have an adverse effect on our ability to access capital, which could in the future negatively affect

our liquidity.

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

business and the value of our common stock.

Currently, the Phase

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is impacted by the pandemic.

Further, the COVID-19 pandemic could result in delays in our clinical trials due to prioritization

of hospital resources toward the pandemic, restrictions in travel, potential unwillingness of patients to enroll in trials at

this time, or the inability of patients to comply with clinical trial protocols if quarantines or travel restrictions impede patient

movement or interrupt healthcare services.

In addition, we rely on independent clinical investigators, contract research organizations

and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical studies

and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources to our programs or to travel

to sites to perform work for us.

Further, the continuation and/or resurgence of the COVID-19 pandemic could result in delays in our

clinical trials due to prioritization of hospital resources toward the pandemic, restrictions in travel, potential unwillingness

of patients to enroll in trials at this time, or the inability of patients to comply with clinical trial protocols if quarantines

or travel restrictions impede patient movement or interrupt healthcare services.

In addition, we rely on independent clinical investigators,

contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying

out our preclinical studies and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources

to our programs or to travel to sites to perform work for us.

Additionally, COVID-19

may also result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions

with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and

contractors due to limitations in employee resources or forced furlough of government employees.

COVID-19 has caused severe disruptions in

transportation and limited access to our facility, resulting in limited support from our staff and professional advisors.

size of our accounting staff and the additional responsibilities emanating from COVID-19 have presented difficulties to our ability

to complete our Annual Report on Form 10-K and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, resulting

in its delay, and may continue to cause a delay in our ability to complete subsequent reports in a timely manner.

The ultimate impact

from COVID-19 on our business operations and financial results during 2020 will depend on, among other things, the ultimate severity

may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with

IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors

due to limitations in employee resources or forced furlough of government employees.

COVID-19 has caused severe

disruptions in transportation and limited access to our facility, resulting in limited support from our staff and professional

The small size of our accounting staff and the additional responsibilities emanating from COVID-19 presented difficulties

to our ability to complete our Annual Report on Form 10-K and our Quarterly Report on Form 10-Q for the quarter ended March 31,

2020, resulting in the delay of filing of each of those reports.

The ultimate impact from

COVID-19 on our business operations and financial results during 2020 will depend on, among other things, the ultimate severity

and scope of the pandemic, the pace at which governmental and private travel restrictions and public concerns about public gatherings

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Our business is subject to cybersecurity risks.

Our operations are increasingly dependent

on information technologies and services.

Threats to information technology systems associated with cybersecurity risks and cyber

incidents or attacks continue to grow, and include, among other things, storms and natural disasters, terrorist attacks, utility

outages, theft, viruses, phishing, malware, design defects, human error, and complications encountered as existing systems are

maintained, repaired, replaced, or upgraded.

Our operations are increasingly

dependent on information technologies and services.

Threats to information technology systems associated with cybersecurity risks

and cyber incidents or attacks continue to grow, and include, among other things, storms and natural disasters, terrorist attacks,

utility outages, theft, viruses, phishing, malware, design defects, human error, and complications encountered as existing systems

are maintained, repaired, replaced, or upgraded.

Risks associated with these threats include, among other things:

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increased costs to prevent, respond to or mitigate cybersecurity events.

Although we utilize various procedures and

controls to mitigate our exposure to such risk, cybersecurity attacks and other cyber events are evolving and unpredictable.

we have no control over the information technology systems of third parties conducting our clinical trials, our suppliers, and

others with which our systems may connect and communicate.

As a result, the occurrence of a cyber incident could go unnoticed for

a period time.

We do not presently maintain insurance coverage

to protect against cybersecurity risks.

If we procure such coverage in the future, we cannot ensure that it will be sufficient

to cover any particular losses we may experience as a result of such cyberattacks.

Any cyber incident could have a material adverse

effect on our business, financial condition and results of operations.

Although we utilize various

procedures and controls to mitigate our exposure to such risk, cybersecurity attacks and other cyber events are evolving and unpredictable.

Moreover, we have no control over the information technology systems of third parties conducting our clinical trials, our suppliers,

and others with which our systems may connect and communicate.

As a result, the occurrence of a cyber incident could go unnoticed

for a period time.

We do not presently maintain

insurance coverage to protect against cybersecurity risks.

If we procure such coverage in the future, we cannot ensure that it

will be sufficient to cover any particular losses we may experience as a result of such cyberattacks.

Any cyber incident could

have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Regulation

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In particular, the FDA

permits commercial distribution of a new antibody radiation-conjugate product only after a BLA

for the product has received FDA approval.

permits commercial distribution of a new antibody radiation-conjugate product only after a BLA for the product has received FDA

The BLA process is costly, lengthy and inherently uncertain.

Any BLA filed by us will

have to be supported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and

labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its intended use.

lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory

approval to market our product candidates, which would significantly harm our business, results of operations and prospects.

addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more

limited indications than we request, may not approve the price we intend to charge for our products, 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.

Any of the foregoing

scenarios could materially harm the commercial prospects for our product candidates.

The approval process

in the United States and in other countries could result in unexpected and significant costs for us and consume management’s

Any BLA filed by us will have to be supported by extensive

data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to

the FDA’s satisfaction the safety and efficacy of the product for its intended use.

The lengthy approval process as well

as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our

product candidates, which would significantly harm our business, results of operations and prospects.

In addition, even if we were

to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than

we request, may not approve the price we intend to charge for our products, 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.

Any of the foregoing scenarios could materially

harm the commercial prospects for our product candidates.

The approval process in

the United States and in other countries could result in unexpected and significant costs for us and consume management’s

time and other resources.

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that are most necessary or desirable for successful commercialization or profitability.

We have not demonstrated that any of our products are

safe and effective for any indication and will continue to expend substantial time and resources on clinical development before

any of our current or future product candidates will be eligible for FDA approval, if ever.

We expect that a substantial portion of

our efforts and expenditures over the next few years will be devoted to development of our existing and contemplated biological

product candidates.

Accordingly, our business currently depends heavily on the successful development, FDA approval, and commercialization

of such candidates, which may never receive FDA approval or be successfully commercialized even if FDA approval is received.

research, testing, manufacturing, labeling, approval, sale, marketing, and distribution of our biological product candidates are,

and will remain, subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries,

as applicable.

We are currently not permitted to market any of our current or future product candidates in the United States until

we receive FDA approval (of each) via the BLA process.

To date, we have two product candidates in clinical development and

have not-yet submitted a BLA for any of our candidates and, for many such candidates, do not expect to be in a position to do so

for the foreseeable future, as there are numerous developmental steps that must be completed before we can prepare and submit a

In the United States, the FDA regulates

pharmaceutical and biological product candidates under the Federal Food, Drug and Cosmetic Act (“FDCA”) and the Public

Health Service Act (“PHSA”), as well as their respective implementing regulations.

Such products and product candidates

are also subject to other federal, state, and local statutes and regulations.

The process of obtaining regulatory approvals and

the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires the expenditure

of substantial time and financial resources.

The process required by the FDA before a drug or biological product may be marketed

in the United States generally involves the following:

We have not demonstrated that any of

our products are safe and effective for any indication and will continue to expend substantial time and resources on clinical development

before any of our current or future product candidates will be eligible for FDA approval, if ever.

We expect that a substantial

portion of our efforts and expenditures over the next few years will be devoted to development of our existing and contemplated

biological product candidates.

Accordingly, our business currently depends heavily on the successful development, FDA approval,

and commercialization of such candidates, which may never receive FDA approval or be successfully commercialized even if FDA approval

The research, testing, manufacturing, labeling, approval, sale, marketing, and distribution of our biological product

candidates are, and will remain, subject to extensive regulation by the FDA and other regulatory authorities in the United States

and other countries, as applicable.

We are currently not permitted to market any of our current or future product candidates in

the United States until we receive FDA approval (of each) via the BLA process.

To date, we have two product candidates in

clinical development and have not-yet submitted a BLA for any of our candidates and, for many such candidates, do not expect to

be in a position to do so for the foreseeable future, as there are numerous developmental steps that must be completed before we

can prepare and submit a BLA.

In the United States, the

FDA regulates pharmaceutical and biological product candidates under the Federal Food, Drug and Cosmetic Act (“FDCA”)

and the Public Health Service Act (“PHSA”), as well as their respective implementing regulations.

Such products and

product candidates are also subject to other federal, state, and local statutes and regulations.

The process of obtaining regulatory

approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires the

expenditure of substantial time and financial resources.

The process required by the FDA before a drug or biological product may

be marketed in the United States generally involves the following:

completion of preclinical laboratory tests and animal studies in accordance with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;

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FDA review and approval, or denial, of the BLA.

Before testing any biological product candidate

in humans, the product candidate enters the preclinical testing stage.

Preclinical tests include laboratory evaluations of product

chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate.

Before testing any biological

product candidate in humans, the product candidate enters the preclinical testing stage.

Preclinical tests include laboratory evaluations

of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product

The conduct of the preclinical tests must comply with federal regulations and requirements including GLPs.

The clinical trial sponsor

must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical

data or literature and a proposed clinical protocol, to the FDA as part of the IND.

Some preclinical testing may continue even

after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns

or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.

such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns

trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available

clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

Some preclinical testing may continue

even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises

concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

may also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns

or non-compliance.

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terminate such trials.

Clinical trials involve the administration

of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally

physicians not employed by or under the trial sponsor’s control.

Clinical trials are conducted under protocols detailing,

among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the

parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain

adverse events should occur.

Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Clinical trials involve

the administration of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators,

generally physicians not employed by or under the trial sponsor’s control.

Clinical trials are conducted under protocols

detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria,

and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped

if certain adverse events should occur.

Each protocol and any amendments to the protocol must be submitted to the FDA as part of

Clinical trials must be conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements,

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These clinical trials are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.

Post-approval clinical trials, sometimes

referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These clinical trials are used to gain

additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety

After the completion of clinical trials

of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product.

must include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition

of the product, proposed labeling and other relevant information.

The FDA may grant deferrals for submission of data, or full or

partial waivers.

The testing and approval processes require substantial time and effort and there can be no assurance that the

FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

Before approving

a BLA, the FDA will inspect the facilities at which the product is manufactured.

The FDA will not approve the product unless it

determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent

production of the product within required specifications.

Additionally, before approving a BLA, the FDA will typically inspect

one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP

requirements.

To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the

areas of training, record keeping, production, and quality control.

Notwithstanding the submission of relevant

data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and deny

Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret

the same data.

Our product candidates are in the earliest stages of clinical development and, therefore, a long way from BLA submission.

We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for our product candidates or whether

any such BLA will be approved by the FDA.

Human clinical trials are very expensive and difficult to design and implement, in part

because they are subject to rigorous regulatory requirements.

For example, the FDA may not agree with our proposed endpoints for

any clinical trial we propose, which may delay the commencement of our clinical trials.

The clinical trial process is also lengthy

and requires substantial time and effort.

In December 2015, the FDA cleared our IND

filing for Iomab-B (for acute myeloid leukemia or AML), and we are currently enrolling patients in a randomized, controlled, pivotal

Phase 3 clinical trial under such IND to study Iomab-B in patients 55 years of age or older with relapsed or refractory AML.

the Phase 3 trial meets its endpoints and there are no unexpected issues or delays, it will form the basis for a BLA in the reasonably

near future for Iomab-B for use in preparing and conditioning AML patients for bone marrow transplants (BMTs).

Additionally, there

are physician IND trials at the Fred Hutchinson Cancer Research Center (FHCRC) that have been conducted or are currently ongoing

at FHCRC with Iomab-B (for other target indications) and the BC8 antibody we licensed.

And, we have multiple Phase 1 and Phase

2 clinical trials ongoing and others that we have planned but not-yet commenced, for our other drug candidates under our own sponsorship

and multiple investigator-initiated trials ongoing.

Except for Iomab-B (for patients with AML), we expect that the clinical trials

we need to conduct to be in a position to submit BLAs for our product candidates currently in-development will take, at least,

several years to complete.

Moreover, failure can occur at any stage of the trials, and we could encounter problems that cause us

to abandon or repeat clinical trials.

Also, the results of early preclinical and clinical testing may not be predictive of the

results of subsequent clinical trials.

A number of companies in the biopharmaceutical industry have suffered significant setbacks

in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies.

Post-approval clinical

trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These clinical trials

are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for

long-term safety follow-up.

After the completion of

clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product.

The BLA must include results of product development, laboratory and animal studies, human trials, information on the manufacture

and composition of the product, proposed labeling and other relevant information.

The FDA may grant deferrals for submission of

data, or full or partial waivers.

The testing and approval processes require substantial time and effort and there can be no assurance

that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured.

The FDA will not approve the

product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate

to assure consistent production of the product within required specifications.

Additionally, before approving a BLA, the FDA will

typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements

and GCP requirements.

To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort

in the areas of training, record keeping, production, and quality control.

Notwithstanding the submission

of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval

and deny approval.

Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than

we interpret the same data.

Our product candidates are in the earliest stages of clinical development and, therefore, a long way

from BLA submission.

We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for our product

candidates or whether any such BLA will be approved by the FDA.

Human clinical trials are very expensive and difficult to design

and implement, in part because they are subject to rigorous regulatory requirements.

For example, the FDA may not agree with our

proposed endpoints for any clinical trial we propose, which may delay the commencement of our clinical trials.

The clinical trial

process is also lengthy and requires substantial time and effort.

In December 2015, the FDA

cleared our IND filing for Iomab-B (for acute myeloid leukemia or AML), and we are currently enrolling patients in a randomized,

controlled, pivotal Phase 3 clinical trial under such IND to study Iomab-B in patients 55 years of age or older with relapsed or

refractory AML.

Assuming the Phase 3 trial meets its endpoints and there are no unexpected issues or delays, it will form the basis

for a BLA in the reasonably near future for Iomab-B for use in preparing and conditioning AML patients for bone marrow transplants

Additionally, there are physician IND trials at the Fred Hutchinson Cancer Research Center (FHCRC) that have been conducted

or are currently ongoing at FHCRC with Iomab-B (for other target indications) and the BC8 antibody we licensed.

And, we have multiple

Phase 1 and Phase 2 clinical trials ongoing and others that we have planned but not-yet commenced, for our other drug candidates

under our own sponsorship and multiple investigator-initiated trials ongoing.

Except for Iomab-B (for patients with AML), we expect

that the clinical trials we need to conduct to be in a position to submit BLAs for our product candidates currently in-development

will take, at least, several years to complete.

Moreover, failure can occur at any stage of the trials, and we could encounter

problems that cause us to abandon or repeat clinical trials.

Also, the results of early preclinical and clinical testing may not

be predictive of the results of subsequent clinical trials.

A number of companies in the biopharmaceutical industry have suffered

significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising

results in earlier studies.

And, preclinical and clinical data are often susceptible to multiple interpretations and analyses.

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.

Success in preclinical testing and early clinical trials does not ensure that later clinical

trials, which involve many more subjects, and the results of later clinical trials may not replicate the results of prior clinical

trials and preclinical testing.

Any failure or substantial delay in our product development plans may have a material adverse effect

on our business.

We may encounter substantial delays in our clinical trials

or may not be able to conduct our trials on the timelines we expect.

We cannot predict whether we will encounter

problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities to delay, suspend, or

discontinue clinical trials or to delay the analysis of data from ongoing clinical trials.

Any of the following could delay or

disrupt the clinical development of our product candidates and potentially cause our product candidates to fail to receive regulatory

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.

Success in preclinical testing and early clinical trials

does not ensure that later clinical trials, which involve many more subjects, and the results of later clinical trials may not

replicate the results of prior clinical trials and preclinical testing.

Any failure or substantial delay in our product development

plans may have a material adverse effect on our business.

We may encounter substantial delays in

our clinical trials or may not be able to conduct our trials on the timelines we expect.

We cannot predict whether

we will encounter problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities to delay,

suspend, or discontinue clinical trials or to delay the analysis of data from ongoing clinical trials.

Any of the following could

delay or disrupt the clinical development of our product candidates and potentially cause our product candidates to fail to receive

regulatory approval:

conditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

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delays in obtaining regulatory agency authorization for the conduct of our clinical trials.

We may suspend, or the FDA or other applicable

regulatory authorities may require us to suspend, clinical trials of a product candidate at any time if we or they believe the

patients participating in such clinical trials, or in independent third-party clinical trials for drugs based on similar technologies,

are being exposed to unacceptable health risks or for other reasons.

Further, individuals involved with our clinical

trials may serve as consultants to us from time to time and receive stock options or cash compensation in connection with such

If these relationships and any related compensation to the clinical investigator carrying out the study result in perceived

or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected interpretation of the study,

the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial

itself may be jeopardized.

The delay, suspension or discontinuation of any of our clinical trials, or a delay in the analysis of

clinical data for our product candidates, for any of the foregoing reasons, could adversely affect our efforts to obtain regulatory

approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on

our financial results.

Clinical trials may also be delayed or terminated

as a result of ambiguous or negative interim results.

In addition, a clinical trial may be suspended or terminated by us, the FDA,

the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring board, or DSMB (Data Safety Monitoring

Board)/DMC (Data Monitoring Committee), overseeing the clinical trial at issue, or other regulatory authorities due to a number

of factors, including:

We may suspend, or the

FDA or other applicable regulatory authorities may require us to suspend, clinical trials of a product candidate at any time if

we or they believe the patients participating in such clinical trials, or in independent third-party clinical trials for drugs

based on similar technologies, are being exposed to unacceptable health risks or for other reasons.

Further, individuals involved

with our clinical trials may serve as consultants to us from time to time and receive stock options or cash compensation in connection

with such services.

If these relationships and any related compensation to the clinical investigator carrying out the study result

in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected interpretation

of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the

clinical trial itself may be jeopardized.

The delay, suspension or discontinuation of any of our clinical trials, or a delay in

the analysis of clinical data for our product candidates, for any of the foregoing reasons, could adversely affect our efforts

to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses and have a material

adverse effect on our financial results.

Clinical trials may also

be delayed or terminated as a result of ambiguous or negative interim results.

In addition, a clinical trial may be suspended or

terminated by us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring board, or DSMB

(Data Safety Monitoring Board)/DMC (Data Monitoring Committee), overseeing the clinical trial at issue, or other regulatory authorities

due to a number of factors, including:

failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

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Modifications to our product candidates may require federal

The BLA application is the vehicle through

which the company may formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.

a particular product candidate receives FDA approval, expanded uses or uses in new indications of our products may require additional

human clinical trials and new regulatory approvals, including additional IND and BLA submissions and premarket approvals before

we can begin clinical development, and/or prior to marketing and sales.

If the FDA requires new approvals for a particular use

or indication, we may be required to conduct additional clinical studies, which would require additional expenditures and harm

our operating results.

The BLA application is

the vehicle through which the company may formally propose that the FDA approve a new pharmaceutical for sale and marketing in

the United States.

Once a particular product candidate receives FDA approval, expanded uses or uses in new indications of our products

may require additional human clinical trials and new regulatory approvals, including additional IND and BLA submissions and premarket

approvals before we can begin clinical development, and/or prior to marketing and sales.

If the FDA requires new approvals for

a particular use or indication, we may be required to conduct additional clinical studies, which would require additional expenditures

and harm our operating results.

If the products are already being used for these new indications, we may also be subject to significant

enforcement actions.

Conducting clinical trials and obtaining

approvals is a time-consuming process, and delays in obtaining required future approvals could adversely affect our ability to

introduce new or enhanced products in a timely manner, which in turn would have an adverse effect on our business prospects, financial

condition and results of operation.

Conducting clinical trials

and obtaining approvals is a time-consuming process, and delays in obtaining required future approvals could adversely affect our

ability to introduce new or enhanced products in a timely manner, which in turn would have an adverse effect on our business prospects,

financial condition and results of operation.

The FDA or comparable foreign regulatory

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pivotal trial that could support a BLA filing.

There can be no assurance that the data generated during the trial

will meet our chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing or

approval of a BLA.

Even if the data from this trial are favorable, the data may not be predictive of the results of any future

clinical trials.

There can be no assurance that the data generated during the trial will meet our

chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing or approval of a

Even if the data from this trial are favorable, the data may not be predictive of the results of any future clinical trials.

Our clinical trials may fail to demonstrate

adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory approval and commercialization.

Even if our clinical

trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the

FDA or foreign authorities will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical trials

does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results

Even if our clinical trials

are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or

foreign authorities will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does

not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results

of prior trials and pre-clinical studies.

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are not currently part of a product candidate’s profile.

The intellectual property related

to antibodies we have licensed has expired or likely expired

The intellectual property related to

antibodies we have licensed has expired or likely expired

The key patents related

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labeled with the isotope Ac-225.

We have licensed issued patents that relate to the linker technology we use to conjugate the

isotope to the antibody.

Further, we own issued and pending patents related to methods for drug conjugation and isotope labeling

and for methods of isotope production.

In addition, we possess trade secrets and know how related to the manufacturing and use

Any competing product based on the lintuzumab antibody is likely to require several years of development before achieving

our product candidate’s current status and may be subject to significant regulatory hurdles but is nevertheless a possibility

that could negatively impact our business in the future.

We own an issued patent in the US relating to composition of the Iomab-B

product candidate.

We have licensed issued patents that relate to the linker technology we use to conjugate the isotope

to the antibody.

Further, we own issued and pending patents related to methods for drug conjugation and isotope labeling and for

methods of isotope production.

In addition, we possess trade secrets and know how related to the manufacturing and use of isotopes.

Any competing product based on the lintuzumab antibody is likely to require several years of development before achieving our product

candidate’s current status and may be subject to significant regulatory hurdles but is nevertheless a possibility that could

negatively impact our business in the future.

We own an issued patent in the US relating to composition of the Iomab-B product

Five related patents are also pending in the US and internationally.

We have and may continue to file patents

related to Iomab-B that can provide barriers to entry but there is no certainty that these patents will be granted or such granting

thereof will adequately prevent others from seeking to replicate and use the BC8 antibody or the construct.

We have pending patents

related to radioimmunoconjugate composition, formulation administration, and methods of use in solid or liquid cancers.

includes composition, administration, and methods of treatment for our products Actimab-A and Iomab-B.

Any competing product based

on the antibody used in Iomab-B is likely to require several years of development before achieving our product candidate’s

current status and may be subject to significant regulatory hurdles but is nevertheless a possibility that could negatively impact

our business in the future.

Our CD33 program clinical trials

are testing the same drug construct

Our CD33 program is

comprised of several clinical trials including several investigator-initiated trials including AML, MDS and Multiple Myeloma that

are studying the same drug construct consisting of lintuzumab-Ac-225.

Negative results from any of these trials could negatively

impact our ability to enroll or complete our other trials studying lintzumab-Ac-225.

Additionally, negative outcomes including

safety concerns, may result in the FDA discontinuing other trials utilizing lintuzumab-Ac-225.

We have and may continue to file patents related

to Iomab-B that can provide barriers to entry but there is no certainty that these patents will be granted or such granting thereof

will adequately prevent others from seeking to replicate and use the BC8 antibody or the construct.

We have pending patents related

to radioimmunoconjugate composition, formulation administration, and methods of use in solid or liquid cancers.

This matter includes

composition, administration, and methods of treatment for our products Actimab-A and Iomab-B.

Any competing product based on the

antibody used in Iomab-B is likely to require several years of development before achieving our product candidate’s current

status and may be subject to significant regulatory hurdles but is nevertheless a possibility that could negatively impact our

business in the future.

Our CD33 program clinical trials are

testing the same drug construct

Our CD33 program is comprised

of several clinical trials including several investigator-initiated trials including AML, MDS and Multiple Myeloma that are studying

the same drug construct consisting of lintuzumab-Ac-225.

Negative results from any of these trials could negatively impact our

ability to enroll or complete our other trials studying lintzumab-Ac-225.

Additionally, negative outcomes including safety concerns,

may result in the FDA discontinuing other trials utilizing lintuzumab-Ac-225.

We may be unable to obtain a sufficient

supply of isotopes to support clinical development or at commercial scale.

Iodine-131 is a key

component of our Iomab-B drug candidate.

We currently source medical grade I-131 from three suppliers including two leading global

manufacturers.

Currently, there is sufficient supply of I-131 to advance our ongoing SIERRA clinical trial, support additional

trials we may undertake utilizing I-131 and for commercialization of Iomab-B.

We continually evaluate I-131 manufacturers and suppliers

and intend to have multiple qualified suppliers prior to the commercial launch of Iomab-B.

While we consider I-131 to be commoditized

and obtainable through several suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131 on terms

that are acceptable to us.

Actinium-225 is a key

component of our CD33 ARC program, AWE platform and other drug candidates that we might consider for development with the Ac-225

There are adequate quantities of Ac-225 available today to meet our current needs via our present supplier, the Department

of Energy, or DOE.

The current Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the natural

decay of thorium-229 from so-called ‘thorium-cows’

Iodine-131 is a key component

of our Iomab-B drug candidate.

We currently source medical grade I-131 from three suppliers including two leading global manufacturers.

Currently, there is sufficient supply of I-131 to advance our ongoing SIERRA clinical trial, support additional trials we may undertake

utilizing I-131 and for commercialization of Iomab-B.

We continually evaluate I-131 manufacturers and suppliers and intend to have

multiple qualified suppliers prior to the commercial launch of Iomab-B.

While we consider I-131 to be commoditized and obtainable

through several suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131 on terms that are acceptable

Actinium-225 is a key component

of our CD33 ARC program, AWE platform and other drug candidates that we might consider for development with the Ac-225 payload.

There are adequate quantities of Ac-225 available today to meet our current needs via our present supplier, the Department of Energy,

The current Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the natural decay

of thorium-229 from so-called ‘thorium-cows’

and is able to produce sufficient quantities that are several multiples

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patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

The timely completion

of clinical trials in accordance with their protocols depends on our ability to enroll a sufficient number of patients who remain

The timely completion of

clinical trials in accordance with their protocols depends on our ability to enroll a sufficient number of patients who remain

in the trial until its conclusion.

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and could cause us to cease operations.

We have obtained orphan drug designation from FDA for

two of our current product candidates and intend to pursue such designation for other candidates and indications in the future,

but we may be unable to obtain such designations or to maintain the benefits associated with any orphan drug designations we have

received or may receive in the future.

We have received orphan drug designation

for Iomab-B and lintuzumab-CD33 ARC for treatment of AML in both the United States and the EU.

Under the Orphan Drug Act, the FDA

may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition

that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United

States, there is no reasonable expectation that the cost of developing and making available a drug or biologic for this type of

disease or condition will be recovered from sales in the United States for that drug or biologic.

Similarly, the EMA grants orphan

drug designation to promote the development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening

or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.

Orphan drug designation neither shortens

the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory

review or approval process.

In the United States, orphan drug designation entitles a party to financial incentives, such as opportunities

for grant funding towards clinical trial costs, tax advantages, and application fee waivers.

In addition, if a product candidate

receives the first FDA approval for the indication for which it has orphan designation, such product is entitled, upon approval,

to seven years of orphan-drug exclusivity, during which the FDA may not approve any other application to market the same drug for

the same indication, unless a subsequently approved product is clinically superior to orphan drug or where the manufacturer is

unable to assure sufficient product quantity in the applicable patient population.

In the EU, orphan drug designation entitles

a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or

biological product approval.

This period may be reduced to six years if the orphan drug designation criteria are no longer met,

including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Even if we obtain (or have obtained) orphan

drug designation for certain product candidates, we may not be the first to obtain marketing approval for such candidates for the

applicable indications due to the uncertainties inherent in the development of novel biologic products.

And, an orphan drug candidate

may not receive orphan-drug exclusivity upon approval if such candidate is approved for a use that is broader than the indication

for which it received orphan designation.

In addition, exclusive marketing rights in the United States may be lost if the FDA later

determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities

of the product to meet the needs of patients with the rare disease or condition.

Finally, even if we successfully obtain

orphan-drug exclusivity for an orphan drug candidate upon approval, such exclusivity may not effectively protect the product from

competition because (i) different drugs with different active moieties can be approved for the same condition;

and (ii) the FDA

or EMA can also subsequently approve a subsequent product with the same active moiety and for the same indication as the orphan

We have obtained orphan drug designation

from FDA for two of our current product candidates and intend to pursue such designation for other candidates and indications in

the future, but we may be unable to obtain such designations or to maintain the benefits associated with any orphan drug designations

we have received or may receive in the future.

We have received orphan

drug designation for Iomab-B and lintuzumab-CD33 ARC for treatment of AML in both the United States and the EU.

Under the Orphan

Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a

disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals

in the United States, there is no reasonable expectation that the cost of developing and making available a drug or biologic for

this type of disease or condition will be recovered from sales in the United States for that drug or biologic.

Similarly, the EMA

grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention, or treatment

of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.

Orphan drug designation

neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage

in the regulatory review or approval process.

In the United States, orphan drug designation entitles a party to financial incentives,

such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers.

if a product candidate receives the first FDA approval for the indication for which it has orphan designation, such product is

entitled, upon approval, to seven years of orphan-drug exclusivity, during which the FDA may not approve any other application

to market the same drug for the same indication, unless a subsequently approved product is clinically superior to orphan drug or

where the manufacturer is unable to assure sufficient product quantity in the applicable patient population.

In the EU, orphan

drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity

following drug or biological product approval.

This period may be reduced to six years if the orphan drug designation criteria

are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market

Even if we obtain (or have

obtained) orphan drug designation for certain product candidates, we may not be the first to obtain marketing approval for such

candidates for the applicable indications due to the uncertainties inherent in the development of novel biologic products.

an orphan drug candidate may not receive orphan-drug exclusivity upon approval if such candidate is approved for a use that is

broader than the indication for which it received orphan designation.

In addition, exclusive marketing rights in the United States

may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable

to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Finally, even if we successfully

obtain orphan-drug exclusivity for an orphan drug candidate upon approval, such exclusivity may not effectively protect the product

from competition because (i) different drugs with different active moieties can be approved for the same condition;

FDA or EMA can also subsequently approve a subsequent product with the same active moiety and for the same indication as the orphan

drug if the later-approved drug if deemed clinically superior to the orphan drug.

Even if we receive regulatory approval of our product

candidates, we will be subject to ongoing regulatory obligations and continued regulatory review.

Any regulatory approvals that we receive

for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate.

The FDA may also

require a risk evaluation and mitigation strategy in order to approve our product candidates, which could entail requirements for

a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods,

patient registries and other risk minimization tools.

In addition, if the FDA or a comparable foreign regulatory authority approves

our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising,

promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued

compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.

In addition, the FDA could require us to

conduct another study to obtain additional safety or biomarker information.

Later discovery of previously unknown problems with

our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party suppliers or manufacturing

processes, or failure to comply with regulatory requirements, may result in, among other things:

Even if we receive regulatory approval

of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review.

Any regulatory approvals

that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate.

The FDA may also require a risk evaluation and mitigation strategy in order to approve our product candidates, which could entail

requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted

distribution methods, patient registries and other risk minimization tools.

In addition, if the FDA or a comparable foreign regulatory

authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting,

storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing

regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports, registration,

as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.

In addition, the FDA

could require us to conduct another study to obtain additional safety or biomarker information.

Later discovery of previously unknown

problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party

suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

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injunctions or the imposition of civil or criminal penalties.

The FDA’s and other regulatory authorities’

policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval

of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future

legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing

requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose

any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

Coverage and reimbursement may be limited or unavailable

in certain market segments for our product candidates which could limit our sales of our product candidates, if approved.

The commercial success of our product candidates

in both domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement is

available for patients that use our products.

However, the availability of insurance coverage and reimbursement for newly approved

cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products

are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part

of the product cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party

payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new

drugs, and, as a result, they may not cover or provide adequate payment for these products.

Submission of applications for reimbursement

approval generally does not occur prior to the filing of a BLA for that product and may not be granted until many months after

BLA approval.

In order to obtain coverage and reimbursement for these products, we or our commercialization partners may have to

agree to a net sales price lower than the net sales price we might charge in other sales channels.

The continuing efforts of government

and third-party payors to contain or reduce the costs of healthcare may limit our revenue.

Initial dependence on the commercial

success of our products may make our revenues particularly susceptible to any cost containment or reduction efforts.

Healthcare legislative reform measures intended to increase

pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal regulation of the U.S.

healthcare system could have a material adverse effect our business, future revenue, if any, and results of operations.

In the United States, the Medicare Prescription

Drug, Improvement, and Modernization Act of 2003, also called the MMA, changed the way Medicare covers and pays for pharmaceutical

The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology

based on average sales prices for physician-administered drugs.

In addition, this legislation provided authority for limiting the

number of drugs that will be covered in any therapeutic class.

As a result of this legislation and the expansion of federal coverage

of drug products, we expect that there will be additional pressure to reduce costs.

These cost reduction initiatives and other

provisions of this legislation could decrease the scope of coverage and the price that we receive for any approved products and

could harm our business.

While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare

coverage policies and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results

from the MMA may cause a similar reduction in payments from private payors.

This legislation may pose an even greater risk to our

drug candidates as a significant portion of the target patient population for our drug candidates would likely be over 65 years

of age and, therefore, many such patients will be covered by Medicare.

On March 23, 2010, President Obama signed

the “Patient Protection and Affordable Care Act”

111-148) and on March 30, 2010, the signed the “Health

Care and Education Reconciliation Act”

The FDA’s and other

regulatory authorities’

policies may change, and additional government regulations may be enacted that could prevent, limit

or delay regulatory approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation

that may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable

to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain

regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

Coverage and reimbursement may be limited or unavailable in

certain market segments for our product candidates which could limit our sales of our product candidates, if approved.

The commercial success

of our product candidates in both domestic and international markets will be substantially dependent on whether third-party coverage

and reimbursement is available for patients that use our products.

However, the availability of insurance coverage and reimbursement

for newly approved cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even

if our products are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed

all or part of the product cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and

other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement

of new drugs, and, as a result, they may not cover or provide adequate payment for these products.

Submission of applications for

reimbursement approval generally does not occur prior to the filing of a BLA for that product and may not be granted until many

months after BLA approval.

In order to obtain coverage and reimbursement for these products, we or our commercialization partners

may have to agree to a net sales price lower than the net sales price we might charge in other sales channels.

The continuing efforts

of government and third-party payors to contain or reduce the costs of healthcare may limit our revenue.

Initial dependence on

the commercial success of our products may make our revenues particularly susceptible to any cost containment or reduction efforts.

Healthcare legislative reform measures

intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal

regulation of the U.S.

healthcare system could have a material adverse effect our business, future revenue, if any, and results

of operations.

In the United States, the

Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the MMA, changed the way Medicare covers and

pays for pharmaceutical products.

The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a

new reimbursement methodology based on average sales prices for physician-administered drugs.

In addition, this legislation provided

authority for limiting the number of drugs that will be covered in any therapeutic class.

As a result of this legislation and the

expansion of federal coverage of drug products, we expect that there will be additional pressure to reduce costs.

These cost reduction

initiatives and other provisions of this legislation could decrease the scope of coverage and the price that we receive for any

approved products and could harm our business.

While the MMA applies only to drug benefits for Medicare beneficiaries, private

payors often follow Medicare coverage policies and payment limitations in setting their own reimbursement rates, and any reduction

in reimbursement that results from the MMA may cause a similar reduction in payments from private payors.

This legislation may

pose an even greater risk to our drug candidates as a significant portion of the target patient population for our drug candidates

would likely be over 65 years of age and, therefore, many such patients will be covered by Medicare.

On March 23, 2010, President

Obama signed the “Patient Protection and Affordable Care Act”

111-148) and on March 30, 2010, the signed the

“Health Care and Education Reconciliation Act”

111-152) (collectively, the “Healthcare Reform Law”).

The Healthcare

Reform Law included a number of new rules regarding health insurance, the provision of healthcare, conditions to reimbursement

for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms.

Through the law-making

process, substantial changes have been and continue to be made to the current system for paying for healthcare in the U.S., including

changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare

costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes,

fees, and rebate obligations on pharmaceutical and medical device companies).

This legislation was one of the most comprehensive

and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed the way healthcare

is financed by both governmental and private insurers.

This legislation has impacted the scope of healthcare insurance and incentives

for consumers and insurance companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed

to encourage providers to find cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the

cost of providing care.

This environment has caused changes in the purchasing habits of consumers and providers and resulted in

specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention

may result in our current commercial products, products we may commercialize or promote in the future, and our therapeutic candidates,

being chosen less frequently or the pricing being substantially lowered.

At this stage, it is difficult to estimate the full

extent of the direct or indirect impact of the Healthcare Reform Law on us.

These structural changes could entail further

modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s

Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well

as other changes.

The Healthcare Reform Law included a number of new rules regarding health insurance, the provision of healthcare, conditions to

reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms.

the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in

the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or

reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing

additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies).

This legislation was one of the

most comprehensive and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed

the way healthcare is financed by both governmental and private insurers.

This legislation has impacted the scope of healthcare

insurance and incentives for consumers and insurance companies, among others.

Additionally, the Healthcare Reform Law’s

provisions were designed to encourage providers to find cost savings in their clinical operations.

Pharmaceuticals represent a

significant portion of the cost of providing care.

This environment has caused changes in the purchasing habits of consumers and

providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in our current commercial products, products we may commercialize or promote in the future, and our therapeutic

candidates, being chosen less frequently or the pricing being substantially lowered.

At this stage, it is difficult to estimate

the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

These structural changes

could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid,

and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some

combination of both, as well as other changes.

Restructuring the coverage of medical care in the U.S.

could impact the reimbursement for prescribed drugs and

pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently

developing or those that we may commercialize or promote in the future.

If reimbursement for the products we currently commercialize

or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or otherwise

adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material

adverse effect on our reputation, business, financial condition or results of operations.

Extending medical benefits to those who

currently lack coverage will likely result in substantial costs to the U.S.

federal government, which may force significant additional

changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be sought through cost savings.

While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive

care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased

enforcement activities.

Cost of care could be reduced further by decreasing the level of reimbursement for medical services or

products (including our current commercial products, our development or commercialization partners or any product we may commercialize

or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby, utilization)

of medical services or products.

In either case, a reduction in the utilization of, or reimbursement for our current commercial

products, any product we may commercialize or promote, or any therapeutic candidate, or for which we receive marketing approval

in the future, could have a material adverse effect on our reputation, business, financial condition or results of operations.

Several states and private entities initially

mounted legal challenges to the Healthcare Reform Law, and they continue to litigate various aspects of the legislation.

26, 2012, the U.S.

Supreme Court generally upheld the provisions of the Healthcare Reform Law at issue as constitutional.

Supreme Court held that the legislation improperly required the states to expand their Medicaid programs to cover more

As a result, the states have a choice as to whether they will expand the number of individuals covered by their respective

state Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving and

coverage measures to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution

of Medicaid-managed care programs.

The manner in which these cost-saving and coverage measures are implemented could have a material

adverse effect on our reputation, business, financial condition or results of operations.

Further, the healthcare regulatory environment

has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify, limit, replace, or repeal

the Healthcare Reform Law and judicial challenges continue, and may increase in light of the current administration and legislative

We cannot predict the impact on our business of future legislative and legal challenges to the Healthcare Reform

Law or other changes to the current laws and regulations.

could impact the reimbursement

for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization

partners are currently developing or those that we may commercialize or promote in the future.

If reimbursement for the products

we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially

reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased,

it could have a material adverse effect on our reputation, business, financial condition or results of operations.

Extending medical benefits

to those who currently lack coverage will likely result in substantial costs to the U.S.

federal government, which may force significant

additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be sought through

cost savings.

While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness

of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care

and increased enforcement activities.

Cost of care could be reduced further by decreasing the level of reimbursement for medical

services or products (including our current commercial products, our development or commercialization partners or any product we

may commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and,

thereby, utilization) of medical services or products.

In either case, a reduction in the utilization of, or reimbursement for

our current commercial products, any product we may commercialize or promote, or any therapeutic candidate, or for which we receive

marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or results

of operations.

Several states and private

entities initially mounted legal challenges to the Healthcare Reform Law, and they continue to litigate various aspects of the

On July 26, 2012, the U.S.

Supreme Court generally upheld the provisions of the Healthcare Reform Law at issue as

constitutional.

However, the U.S.

Supreme Court held that the legislation improperly required the states to expand their Medicaid

programs to cover more individuals.

As a result, the states have a choice as to whether they will expand the number of individuals

covered by their respective state Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop

other cost-saving and coverage measures to provide care to currently uninsured individuals.

Many of these efforts to date have

included the institution of Medicaid-managed care programs.

The manner in which these cost-saving and coverage measures are implemented

could have a material adverse effect on our reputation, business, financial condition or results of operations.

Further, the healthcare

regulatory environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify,

limit, replace, or repeal the Healthcare Reform Law and judicial challenges continue, and may increase in light of the current

administration and legislative environment.

We cannot predict the impact on our business of future legislative and legal challenges

to the Healthcare Reform Law or other changes to the current laws and regulations.

The financial impact of U.S.

healthcare reform legislation over the next

few years will depend on a number of factors, including the policies reflected in implementing regulations and guidance and changes

in sales volumes for therapeutics affected by the legislation.

From time to time, legislation is drafted, introduced and passed

Congress that could significantly change the statutory provisions governing coverage, reimbursement, and marketing

of pharmaceutical products.

In addition, third-party payor coverage and reimbursement policies are often revised or interpreted

in ways that may significantly affect our business and our products.

Since taking office, President Trump has

continued to support the repeal of all or portions of the Healthcare Reform Law.

President Trump has also issued an executive order

in which he stated that it is his administration’s policy to seek the prompt repeal of the Healthcare Reform Law and in which

he directed executive departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the

provisions of the Healthcare Reform Law to the maximum extent permitted by law.

Congress has enacted legislation that repeals certain

portions of the Healthcare Reform Law, including but not limited to the Tax Cuts and Jobs Act, passed in December 2017, which included

a provision that eliminates the penalty under the Healthcare Reform Law’s individual mandate, effective January 1, 2019,

as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things, repealed the Independent Payment

Advisory Board (which was established by the Healthcare Reform Law and was intended to reduce the rate of growth in Medicare spending).

Additionally, in December 2018, a district

court in Texas held that the individual mandate is unconstitutional and that the rest of the Affordable Care Act is, therefore,

On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back

to the lower court to reassess whether and how such holding affects the validity of the rest of the Affordable Care Act.

uncertainty remains as to the future of the Affordable Care Act after the U.S.

Supreme Court declined to expedite its review of

the Fifth Circuit’s holding on January 21, 2020.

It is, thus, unlikely that these issues will be resolved before the next

presidential election in November 2020.

The current administration may seek to pass additional reform measures before the upcoming

We cannot predict the outcome of the election, nor can we predict the healthcare-reform-related initiatives that the

newly elected (or re-elected, as applicable) administration will put forth thereafter.

There is no way to know whether, and to

what extent, if any, the Affordable Care Act will remain in-effect in the future, and it is unclear how judicial decisions, subsequent

appeals, election-related measures, or other efforts to repeal and replace or, possibly, to restore the Affordable Care Act will

impact the U.S.

healthcare reform

legislation over the next few years will depend on a number of factors, including the policies reflected in implementing regulations

and guidance and changes in sales volumes for therapeutics affected by the legislation.

From time to time, legislation is drafted,

introduced and passed in the U.S.

Congress that could significantly change the statutory provisions governing coverage, reimbursement,

and marketing of pharmaceutical products.

In addition, third-party payor coverage and reimbursement policies are often revised

or interpreted in ways that may significantly affect our business and our products.

Since taking office, President

Trump has continued to support the repeal of all or portions of the Healthcare Reform Law.

President Trump has also issued an executive

order in which he stated that it is his administration’s policy to seek the prompt repeal of the Healthcare Reform Law and

in which he directed executive departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation

of the provisions of the Healthcare Reform Law to the maximum extent permitted by law.

Congress has enacted legislation that repeals

certain portions of the Healthcare Reform Law, including but not limited to the Tax Cuts and Jobs Act, passed in December 2017,

which included a provision that eliminates the penalty under the Healthcare Reform Law’s individual mandate, effective January

1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things, repealed the Independent

Payment Advisory Board (which was established by the Healthcare Reform Law and was intended to reduce the rate of growth in Medicare

Additionally, in December

2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the Affordable Care Act

is, therefore, invalid.

On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded

the case back to the lower court to reassess whether and how such holding affects the validity of the rest of the Affordable Care

Substantial uncertainty remains as to the future of the Affordable Care Act after the U.S.

Supreme Court declined to expedite

its review of the Fifth Circuit’s holding on January 21, 2020.

It is, thus, unlikely that these issues will be resolved before

the next presidential election in November 2020.

The current administration may seek to pass additional reform measures before

the upcoming election.

We cannot predict the outcome of the election, nor can we predict the healthcare-reform-related initiatives

that the newly elected (or re-elected, as applicable) administration will put forth thereafter.

There is no way to know whether,

and to what extent, if any, the Affordable Care Act will remain in-effect in the future, and it is unclear how judicial decisions,

subsequent appeals, election-related measures, or other efforts to repeal and replace or, possibly, to restore the Affordable Care

Act will impact the U.S.

healthcare industry or our business.

Risks Related to Third Parties

We rely on third parties to conduct

our clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines or

comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We do not have the

ability to independently conduct our pre-clinical and clinical trials for our product candidates and we must rely on third parties,

such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such

We rely on third parties to conduct our

clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply

with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We do not have the ability

to independently conduct our pre-clinical and clinical trials for our product candidates and we must rely on third parties, such

as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials.

Our reliance on these third parties for clinical development activities results in reduced control over these activities.

Moreover, the FDA requires us to comply with regulations and standards, commonly referred to as GCPs (good clinical practices),

for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and

accurate and that the trial participants are adequately protected.

Our reliance on third parties does not relieve us of these responsibilities

and requirements.

If we or any of our third-party contractors fail to comply with applicable GCPs, 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 marketing applications.

We cannot assure you that upon inspection by a given regulatory

authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations.

our clinical trials must be conducted with product produced under current good manufacturing practice, or cGMP, regulations.

failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

If our consultants,

contract research organizations and other similar entities with which we are working do not successfully carry out their contractual

duties, meet expected deadlines, or comply with applicable regulations, we may be required to replace them.

Although we believe

that there are a number of other third-party contractors, we could engage to continue these activities, we may not be able to enter

into arrangements with alternative third-party contractors or to do so on commercially reasonable terms, which may result in a

delay of our planned clinical trials and delayed development of our product candidates.

the FDA requires us to comply with regulations and standards, commonly referred to as GCPs (good clinical practices), for conducting,

recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that

the trial participants are adequately protected.

Our reliance on third parties does not relieve us of these responsibilities and

requirements.

If we or any of our third-party contractors fail to comply with applicable GCPs, 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 marketing applications.

We cannot assure you that upon inspection by a given regulatory authority,

such regulatory authority will determine that any of our clinical trials complies with GCP regulations.

In addition, our clinical

trials must be conducted with product produced under current good manufacturing practice, or cGMP, regulations.

Our failure to

comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

If our consultants, contract

research organizations and other similar entities with which we are working do not successfully carry out their contractual duties,

meet expected deadlines, or comply with applicable regulations, we may be required to replace them.

Although we believe that there

are a number of other third-party contractors, we could engage to continue these activities, we may not be able to enter into arrangements

with alternative third-party contractors or to do so on commercially reasonable terms, which may result in a delay of our planned

clinical trials and delayed development of our product candidates.

In addition, our third-party

9 unchanged sentences

radiation-conjugate product candidates may be subject to generic competition.

We are not aware of

any existing or pending regulations or legislation that pertains to generic radiopharmaceutical products such as our antibody radiation-conjugate

We are not aware of any

existing or pending regulations or legislation that pertains to generic radiopharmaceutical products such as our antibody radiation-conjugate

product candidates.

15 unchanged sentences

to competition from a biosimilar as outlined in BPCIA.

Our product candidates may never

achieve market acceptance.

Our product candidates may never achieve

market acceptance.

Iomab-B, CD33 ARC program

24 unchanged sentences

and from long-term data, physicians may not use or continue to use, and hospitals may not purchase or continue to purchase, them.

Failure of Iomab-B,

CD33 ARC program candidates or any of our other product candidates to significantly penetrate current or new markets would negatively

Failure of Iomab-B, CD33

ARC program candidates or any of our other product candidates to significantly penetrate current or new markets would negatively

impact our business financial condition and results of operations.

We may be subject to claims that our third-party service

providers, consultants or current or former employees have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary

information from third parties.

In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical

We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise

used or disclosed confidential information of these third parties or our employees’

We may be subject to claims that our

third-party service providers, consultants or current or former employees have wrongfully used or disclosed confidential information

of third parties.

We have received confidential

and proprietary information from third parties.

In addition, we employ individuals who were previously employed at other biotechnology

or pharmaceutical companies.

We may be subject to claims that we or our employees, consultants or independent contractors have

inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’

former employers.

Litigation may be necessary

to defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial

cost and be a distraction to our management and employees.

We currently depend on a single third-party manufacturer

to produce our pre-clinical and clinical trial drug supplies.

Litigation may be necessary to defend against these claims.

Even if we are successful in defending against these claims, litigation

could result in substantial cost and be a distraction to our management and employees.

We currently depend on a single third-party manufacturer to

produce our pre-clinical and clinical trial drug supplies.

Any disruption in the operations of our current third-party manufacturer,

or other third-party manufacturers we may engage in the future, could adversely affect our business and results of operations.

We do not currently operate manufacturing

facilities for pre-clinical or clinical production of any of our product candidates.

We rely on third-party manufacturers to supply,

store, and distribute pre-clinical and clinical supply of the components of our drug product candidates including monoclonal antibodies,

linkers and radioisotopes, as well as the final construct which comprises our drug product candidates.

We expect to continue to

depend on third-party manufacturers for the foreseeable future.

Any performance failure on the part of our existing or future manufacturers

could delay clinical development, cause us to suspend or terminate development or delay or prohibit regulatory approval of our

product candidates or commercialization of any approved products.

Further avenues of disruption to our clinical or eventual commercial

supply may also occur due to the sale, acquisition, business reprioritization, bankruptcy or other unforeseen circumstances that

might occur at any of our suppliers or contract manufacturing partners including an inability to come to terms on renewal of existing

contracts or new contracts.

We currently rely on single manufacturers

to manufacture our pre-clinical and clinical trial drug supplies.

With a view to maintaining business continuity we are evaluating

alternatives and second and even third sources of supply or manufacturing for our core suppliers and manufacturing partners, however

there can be no assurances that we will be able to identify such suppliers or partners and assuming we did, that we would be able

to enter into contracts that are on favorable terms or on terms that will enable sufficient supply to ensure business continuity

and support our growth plans.

Our product candidates require precise,

high-quality manufacturing.

Failure by our current contract manufacturer or other third-party manufacturers we may engage in the

future to achieve and maintain high manufacturing standards could result in patient injury or death, product recalls or withdrawals,

delays or failures in testing or delivery, cost overruns, or other problems that could seriously hurt our business.

Contract manufacturers

may encounter difficulties involving production yields, quality control, and quality assurance.

These manufacturers are subject

to ongoing periodic and unannounced inspections by the FDA and corresponding state and foreign agencies to ensure strict compliance

with cGMPs and other applicable government regulations and corresponding foreign standards;

we do not have control over third-party

manufacturers’

We do not currently operate

manufacturing facilities for pre-clinical or clinical production of any of our product candidates.

We rely on third-party manufacturers

to supply, store, and distribute pre-clinical and clinical supply of the components of our drug product candidates including monoclonal

antibodies, linkers and radioisotopes, as well as the final construct which comprises our drug product candidates.

continue to depend on third-party manufacturers for the foreseeable future.

Any performance failure on the part of our existing

or future manufacturers could delay clinical development, cause us to suspend or terminate development or delay or prohibit regulatory

approval of our product candidates or commercialization of any approved products.

Further avenues of disruption to our clinical

or eventual commercial supply may also occur due to the sale, acquisition, business reprioritization, bankruptcy or other unforeseen

circumstances that might occur at any of our suppliers or contract manufacturing partners including an inability to come to terms

on renewal of existing contracts or new contracts.

We currently rely on single

manufacturers to manufacture our pre-clinical and clinical trial drug supplies.

With a view to maintaining business continuity

we are evaluating alternatives and second and even third sources of supply or manufacturing for our core suppliers and manufacturing

partners, however there can be no assurances that we will be able to identify such suppliers or partners and assuming we did, that

we would be able to enter into contracts that are on favorable terms or on terms that will enable sufficient supply to ensure business

continuity and support our growth plans.

Our product candidates

require precise, high-quality manufacturing.

Failure by our current contract manufacturer or other third-party manufacturers we

may engage in the future to achieve and maintain high manufacturing standards could result in patient injury or death, product

recalls or withdrawals, delays or failures in testing or delivery, cost overruns, or other problems that could seriously hurt our

Contract manufacturers may encounter difficulties involving production yields, quality control, and quality assurance.

These manufacturers are subject to ongoing periodic and unannounced inspections by the FDA and corresponding state and foreign

agencies to ensure strict compliance with cGMPs and other applicable government regulations and corresponding foreign standards;

we do not have control over third-party manufacturers’

compliance with these regulations and standards.

We depend on vendors with specialized operations,

equipment and know-how to manufacture the respective components of our drug candidates.

We have entered into manufacturing and

supply agreements with these third-parties, and in some instances, we have agreed that such vendor be the exclusive manufacturer

and supplier.

If any of the third-parties we depend on encounter difficulties in their operations, fail to comply with required

regulations or breach their contractual obligations it may be difficult, or we may be unable to identify suitable alternative third-party

manufacturers.

While we identify and evaluate third-party manufacturers from time to time, even if we do identify suitable alternative

third-parties, we may fail to reach agreement on contractual terms, it may be prohibitively expensive and there can be no assurance

that we can successfully complete technology transfer and development work necessary or complete the necessary work in a timely

We depend on vendors with

specialized operations, equipment and know-how to manufacture the respective components of our drug candidates.

We have entered

into manufacturing and supply agreements with these third-parties, and in some instances, we have agreed that such vendor be the

exclusive manufacturer and supplier.

If any of the third-parties we depend on encounter difficulties in their operations, fail

to comply with required regulations or breach their contractual obligations it may be difficult, or we may be unable to identify

suitable alternative third-party manufacturers.

While we identify and evaluate third-party manufacturers from time to time, even

if we do identify suitable alternative third-parties, we may fail to reach agreement on contractual terms, it may be prohibitively

expensive and there can be no assurance that we can successfully complete technology transfer and development work necessary or

complete the necessary work in a timely manner.

Any of which could prevent us from commencing manufacturing with third-parties.

which could cause delays or suspension

of our clinical trials and pre-clinical work that may have a negative impact on our business.

Furthermore, these third-party contractors,

whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shut downs, employee strikes, or any other

unforeseeable acts that may delay or limit production.

Our inability to adequately establish, supervise and conduct (either ourselves

or through third parties) all aspects of the formulation and manufacturing processes, and the inability of third-party manufacturers

to consistently supply quality product when required would have a material adverse effect on our ability to develop or commercialize

our products.

We have faced delays and risks associated with reliance on key third party manufacturers in the past and may be faced

with such delays and risks in the future.

Any future manufacturing interruptions or related supply issues could have an adverse

effect on our company, including delays in clinical trials.

If we are successful in obtaining marketing approval from

the FDA and/or other regulatory agencies for any of our product candidates, we anticipate continued reliance on third-party manufacturers.

To date, our product candidates have been

manufactured in small quantities for preclinical and clinical testing by third-party manufacturers.

If the FDA or other regulatory

agencies approve any of our product candidates for commercial sale, we expect that we would continue to rely, at least initially,

on third-party specialized manufacturers to produce commercial quantities of approved products.

These manufacturers may not be

able to successfully increase the manufacturing capacity for any approved product in a timely or economic manner, or at all.

scale-up of manufacturing may require additional validation studies, which the FDA must review and approve.

If third party manufacturers

are unable to successfully increase the manufacturing capacity for a product candidate, or we are unable to establish our own manufacturing

capabilities, the commercial launch of any approved products may be delayed or there may be a shortage in supply, which in turn

could have a material adverse effect on our business.

In addition, the facilities used by our

contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted

after we submit a BLA to the FDA.

We do not control the manufacturing process of, and are completely dependent on, our contract

manufacturing partners for compliance with cGMPs.

If our contract manufacturers cannot successfully manufacture material that conforms

to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, they will not be able

to secure and/or maintain regulatory approval for their manufacturing facilities.

If the FDA or a comparable foreign regulatory

authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval

in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop,

obtain regulatory approval for or market our product candidates, if approved.

We may have conflicts with our partners that could delay

or prevent the development or commercialization of our product candidates.

which could cause delays or suspension of our clinical trials and pre-clinical work that may have a negative impact on our business.

Furthermore, these third-party

contractors, whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shut downs, employee strikes,

or any other unforeseeable acts that may delay or limit production.

Our inability to adequately establish, supervise and conduct

(either ourselves or through third parties) all aspects of the formulation and manufacturing processes, and the inability of third-party

manufacturers to consistently supply quality product when required would have a material adverse effect on our ability to develop

or commercialize our products.

We have faced delays and risks associated with reliance on key third party manufacturers in the

past and may be faced with such delays and risks in the future.

Any future manufacturing interruptions or related supply issues

could have an adverse effect on our company, including delays in clinical trials.

If we are successful in obtaining marketing

approval from the FDA and/or other regulatory agencies for any of our product candidates, we anticipate continued reliance on third-party

manufacturers.

To date, our product candidates

have been manufactured in small quantities for preclinical and clinical testing by third-party manufacturers.

If the FDA or other

regulatory agencies approve any of our product candidates for commercial sale, we expect that we would continue to rely, at least

initially, on third-party specialized manufacturers to produce commercial quantities of approved products.

These manufacturers

may not be able to successfully increase the manufacturing capacity for any approved product in a timely or economic manner, or

Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve.

If third party manufacturers are unable to successfully increase the manufacturing capacity for a product candidate, or we are

unable to establish our own manufacturing capabilities, the commercial launch of any approved products may be delayed or there

may be a shortage in supply, which in turn could have a material adverse effect on our business.

In addition, the facilities

used by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that

will be conducted after we submit a BLA to the FDA.

We do not control the manufacturing process of, and are completely dependent

on, our contract manufacturing partners for compliance with cGMPs.

If our contract manufacturers cannot successfully manufacture

material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities,

they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.

If the FDA or a comparable

foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws

any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our

ability to develop, obtain regulatory approval for or market our product candidates, if approved.

We may have conflicts with our partners

such as conflicts concerning the interpretation of preclinical or clinical data, the achievement of milestones, the interpretation

of contractual obligations, payments for services, development obligations or the ownership of intellectual property developed

during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is averse to our

best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent the development

or commercialization of our product candidates, and in turn prevent us from generating revenues:

unwillingness on the part of a

partner to pay us milestone payments or royalties we believe are due under a collaboration;

uncertainty regarding ownership of

intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product

data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization

activities or to permit public disclosure of the results of those activities;

initiating litigation or alternative dispute resolution

options by either party to resolve the dispute;

or attempts by either party to terminate the agreement.

that could delay or prevent the development or commercialization of our product candidates.

We may have conflicts with

our partners, such as conflicts concerning the interpretation of preclinical or clinical data, the achievement of milestones, the

interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual property

developed during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is averse

to our best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent

the development or commercialization of our product candidates, and in turn prevent us from generating revenues:

unwillingness

on the part of a partner to pay us milestone payments or royalties we believe are due under a collaboration;

uncertainty regarding

ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into

additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including

providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress

of its development and commercialization activities or to permit public disclosure of the results of those activities;

litigation or alternative dispute resolution options by either party to resolve the dispute;

or attempts by either party to terminate

the agreement.

We face significant competition from

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Our product candidates

face, and will continue to face, intense competition from large pharmaceutical companies, as well as academic and research institutions.

We compete in an industry that is characterized by (i) rapid technological change, (ii) evolving industry standards, (iii) emerging

competition and (iv) new product introductions.

Our competitors have existing products and technologies that will compete with

our product candidates and technologies and may develop and commercialize additional products and technologies that will compete

with our product candidates and technologies.

Because several competing companies and institutions have greater financial resources

than us, they may be able to (i) provide broader services and product lines, (ii) make greater investments in research and development,

or R&D, and (iii) carry on broader R&D initiatives.

Our competitors also have greater development capabilities than we

do and have substantially greater experience in undertaking preclinical and clinical testing of product candidates, obtaining regulatory

approvals, and manufacturing and marketing pharmaceutical products.

They also have greater name recognition and better access to

customers than us.

Our product candidates may cause

undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval,

limit their commercial potential, or result in significant negative consequences

face, and will continue to face, intense competition from large pharmaceutical and biotechnology companies, as well as academic

and research institutions.

We compete in an industry that is characterized by (i) rapid technological change, (ii) evolving industry

standards, (iii) emerging competition and (iv) new product introductions.

Our competitors have existing products and technologies

that will compete with our product candidates and technologies and may develop and commercialize additional products and technologies

that will compete with our product candidates and technologies.

Because several competing companies and institutions have greater

financial resources than us, they may be able to (i) provide broader services and product lines, (ii) make greater investments

in research and development, or R&D, and (iii) carry on broader R&D initiatives.

Our competitors also have greater development

capabilities than we do and have substantially greater experience in undertaking preclinical and clinical testing of product candidates,

obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.

They also have greater name recognition

and better access to customers than us.

Our product candidates may cause undesirable

side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their

commercial potential, or result in significant negative consequences

Undesirable side effects

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our reputation may suffer.

Any of these events

could substantially increase the costs and expenses of developing, commercializing and marketing any such product candidates or

could harm or prevent sales of any approved products.

Any of these events could

substantially increase the costs and expenses of developing, commercializing and marketing any such product candidates or could

harm or prevent sales of any approved products.

Risks Related to Our Intellectual Property

We depend upon securing and protecting critical intellectual

We are dependent on

obtaining and maintaining patents, trade secrets, copyright and trademark protection of our technologies in the United States and

other jurisdictions, as well as successfully enforcing this intellectual property and defending this intellectual property against

third-party challenges.

The degree of future protection of our proprietary rights is uncertain for product candidates that are

currently in the early stages of development because we cannot predict which of these product candidates will ultimately reach

the commercial market or whether the commercial versions of these product candidates will incorporate proprietary technologies.

We are dependent on obtaining

and maintaining patents, trade secrets, copyright and trademark protection of our technologies in the United States and other jurisdictions,

as well as successfully enforcing this intellectual property and defending this intellectual property against third-party challenges.

The degree of future protection of our proprietary rights is uncertain for product candidates that are currently in the early stages

of development because we cannot predict which of these product candidates will ultimately reach the commercial market or whether

the commercial versions of these product candidates will incorporate proprietary technologies.

Our patent position is highly uncertain

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The extent to which we are unable to do so could materially harm our business.

We or our licensors

have applied for and will continue to apply for patents for certain products.

Such applications may not result in the issuance

of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.

We or our licensors have

applied for and will continue to apply for patents for certain products.

Such applications may not result in the issuance of any

patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.

it is possible that patents issued or licensed to us may be challenged successfully.

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or obtain access to, the same or similar information.

Certain of our patent

rights are licensed to us by third parties.

If we fail to comply with the terms of these license agreements, our rights to those

patents may be terminated, and we will be unable to conduct our business.

If we are found to be infringing

on patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license

to continue the development or sale of our products, and/or pay damages.

Certain of our patent rights

are licensed to us by third parties.

If we fail to comply with the terms of these license agreements, our rights to those patents

may be terminated, and we will be unable to conduct our business.

If we are found to be infringing on patents

or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue

the development or sale of our products, and/or pay damages.

Our manufacturing processes

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our financial resources and the efforts of our personnel.

Our ability to protect and enforce

our patents does not guarantee that we will secure the right to commercialize our patents.

A patent is a limited

monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious

Our ability to protect and enforce our

patents does not guarantee that we will secure the right to commercialize our patents.

A patent is a limited monopoly

right conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making and/or

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which will subject us to risks inherent with operations outside of the United States.

Although we do not

have any international operations at this time, we intend to seek market clearances in foreign markets that we believe will generate

Although we do not have

any international operations at this time, we intend to seek market clearances in foreign markets that we believe will generate

significant opportunities.

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condition may suffer and cause us to reduce or discontinue our international development and registration efforts.

We are highly dependent on our key

personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully

implement our business strategy.

Our future operations

and successes depend in large part upon the continued service of key members of our senior management team whom we are highly dependent

We are highly dependent on our key personnel,

and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement

our business strategy.

Our future operations and

successes depend in large part upon the continued service of key members of our senior management team whom we are highly dependent

upon to manage our business.

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to find a suitable replacement quickly, the departure could have a material adverse effect on our business.

Our future success

also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical,

clinical and regulatory personnel.

There can be no assurance that such professionals will be available in the market, or that we

will be able to retain existing professionals or meet or continue to meet their compensation requirements.

Furthermore, the cost

base in relation to such compensation, which may include equity compensation, may increase significantly, which could have a material

adverse effect on us.

Failure to establish and maintain an effective management team and workforce could adversely affect our ability

to operate, grow and manage our business.

Managing our growth as we expand

operations may strain our resources.

We expect to need to grow rapidly in order to support additional,

larger, and potentially international, pivotal clinical trials of our product candidates, which will place a significant strain

on our financial, managerial and operational resources.

In order to achieve and manage growth effectively, we must continue to

improve and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to train,

motivate and manage our employees.

All of these activities will increase our expenses and may require us to raise additional capital

sooner than expected.

Failure to manage growth effectively could materially harm our business, financial condition or results of

We may expand our business through

the acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also

dilute current stockholders’

Our future success also

depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical

and regulatory personnel.

There can be no assurance that such professionals will be available in the market, or that we will be

able to retain existing professionals or meet or continue to meet their compensation requirements.

Furthermore, the cost base in

relation to such compensation, which may include equity compensation, may increase significantly, which could have a material adverse

effect on us.

Failure to establish and maintain an effective management team and workforce could adversely affect our ability to

operate, grow and manage our business.

Managing our growth as we expand operations

may strain our resources.

We expect to need to grow

rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates,

which will place a significant strain on our financial, managerial and operational resources.

In order to achieve and manage growth

effectively, we must continue to improve and expand our operational and financial management capabilities.

Moreover, we will need

to increase staffing and to train, motivate and manage our employees.

All of these activities will increase our expenses and may

require us to raise additional capital sooner than expected.

Failure to manage growth effectively could materially harm our business,

financial condition or results of operations.

We may expand our business through the

acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute

current stockholders’

ownership interests in our company.

Our business strategy

includes expanding our products and capabilities, and we may seek acquisitions of product candidates, antibodies or technologies

Our business strategy includes

expanding our products and capabilities, and we may seek acquisitions of product candidates, antibodies or technologies to do so.

Acquisitions involve numerous risks, including substantial cash expenditures;

potentially dilutive issuance of equity

incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time

of acquisition;

potentially dilutive issuance of equity securities;

incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

difficulties in assimilating acquired technologies or the operations of the acquired companies;

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or common stock, which could dilute each current stockholder’s ownership interest in the Company.

Risks Related to Ownership of Our

The sale of securities by us in any

equity or debt financing could result in dilution to our existing stockholders and have a material adverse effect on our earnings.

We have financed our

operations primarily through sales of stock and warrants.

It is likely that during the next twelve months we will seek to raise

additional capital through the sales of stock and warrants in order to expand our level of operations to continue our research

and development efforts.

Any sale of common

stock by us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional

Risks Related to Ownership of Our Common

The sale of securities by us in any equity

or debt financing could result in dilution to our existing stockholders and have a material adverse effect on our earnings.

We have financed our operations

primarily through sales of stock and warrants.

It is likely that during the next twelve months we will seek to raise additional

capital through the sales of stock and warrants in order to expand our level of operations to continue our research and development

Any sale of common stock

by us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional

shares of our capital stock.

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impact our earnings and results of operations.

We received a deficiency notice from NYSE American.

may be required to effectuate a reverse stock split to be able to maintain compliance with applicable listing requirements or standards

of the NYSE American.

If we are unable to cure this deficiency and meet the NYSE American continued listing requirements, we could

be delisted from NYSE American, which would negatively impact the trading of our common stock.

On April 29, 2020, we received a deficiency

letter from the NYSE American, indicating that we are not in compliance with certain NYSE American continued listing standards.

The deficiency letter states that our shares of common stock have been selling for a low price per share for a substantial period

Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American staff determined that our continued listing is

predicated on us effecting a reverse stock split of our common stock or otherwise demonstrating sustained price improvement within

a reasonable period of time, which the staff determined to be until October 29, 2020.

In addition, the NYSE American has advised

us that its policy is to immediately suspend trading in shares of, and commence delisting procedures with respect to, a listed

company if the market price of its shares falls below $0.06 per share at any time during the trading day.

We may be required to effect a reverse split

to maintain compliance with NYSE American listing standards.

On October 18, 2019, our board of directors unanimously approved,

subject to stockholder approval, an amendment to our certificate of incorporation to effect a reverse stock split of our outstanding

common stock by combining outstanding shares of common stock into a lesser number of outstanding shares of common stock by a ratio

of not more than 1-for-75 prior to December 18, 2020, with the exact ratio to be set within this range by our board of directors

at its sole discretion.

On December 18, 2019, at our 2019 Annual Meeting of Stockholders, our stockholders approved such proposed

amendment to our certificate of incorporation.

The primary intent of effecting the reverse stock split, if our board of directors

determines to do so, would be to ensure that we are able to maintain compliance with the listing standards of the NYSE American.

If we implement a reverse stock split, although

we expect that a reverse stock split will result in an increase in the market price of our common stock, such reverse stock split

may not result in a permanent increase in the market price of our common stock, which is dependent on many factors, including general

economic, market and industry conditions and other factors detailed from time to time in the reports we file with the Securities

and Exchange Commission.

There can be no assurance that the market price per new share of our common stock after the reverse stock

split will remain unchanged or increase in proportion to the reduction in the number of old shares of our common stock outstanding

before the reverse stock split.

If our common stock is delisted by NYSE

American, our common stock may be eligible for quotation on an over-the-counter quotation system or on the pink sheets.

such delisting, our common stock would become subject to the regulations of the Securities and Exchange Commission relating to

the market for penny stocks.

The regulations applicable to penny stocks may severely affect the market liquidity for our common

stock and could limit the ability of stockholders to sell securities in the secondary market.

In such a case, an investor may find

it more difficult to dispose of or obtain accurate quotations as to the market value of our common stock, and there can be no assurance

that our common stock will be eligible for trading or quotation on any alternative exchanges or markets.

Delisting from NYSE American could adversely

affect our ability to raise additional financing through public or private sales of equity securities, would significantly affect

the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock.

could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor

interest and fewer business development opportunities.

Our common stock is subject to price

volatility which could lead to losses by stockholders and potential costly security litigation.

The trading volume

of our common stock has been and may continue to be extremely limited and sporadic.

We expect the market price of our common stock

to fluctuate substantially due to a variety of factors, including market perception of our ability to achieve our planned growth,

The trading volume of our

common stock has been and may continue to be extremely limited and sporadic.

We expect the market price of our common stock to

fluctuate substantially due to a variety of factors, including market perception of our ability to achieve our planned growth,

quarterly operating results of other companies in the same industry, trading volume in our common stock, changes in general conditions

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have the same effect on our common stock.

The trading price of

our Common Stock may be highly volatile and could fluctuate in response to factors such as:

The trading price of our

Common Stock may be highly volatile and could fluctuate in response to factors such as:

actual or anticipated variations in our operating results;

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other events or factors, many of which are beyond our control.

The stock market

is subject to significant price and volume fluctuations.

Moreover, the COVID-19 pandemic has resulted in significant

financial market volatility and uncertainty in recent months.

In the past, following periods of volatility in the market

price of a company’s securities, securities class action litigation has often been initiated against such a company.

Litigation initiated against us, whether or not successful, could result in substantial costs and diversion of our

management’s attention and our resources, which could harm our business and financial condition.

We do not intend to pay dividends

on our common stock, so any returns will be determined by the value of our common stock.

The stock market is subject

to significant price and volume fluctuations.

Moreover, the COVID-19 pandemic has resulted in significant financial market volatility

and uncertainty in recent months.

In the past, following periods of volatility in the market price of a company’s securities,

securities class action litigation has often been initiated against such a company.

Litigation initiated against us, whether or

not successful, could result in substantial costs and diversion of our management’s attention and our resources, which could

harm our business and financial condition.

We do not intend to pay dividends on

our common stock, so any returns will be determined by the value of our common stock.

We have never declared

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provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;

In addition, we are

governed by Section 203 of the Delaware General Corporation Law.

In general, Section 203 prohibits a public Delaware corporation

from engaging in a “business combination”

In addition, we are governed

by Section 203 of the Delaware General Corporation Law.

In general, Section 203 prohibits a public Delaware corporation from engaging

in a “business combination”

with an “interested stockholder”

for a period of three years

after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved

in a prescribed manner.

for a period of three years after the date

of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed

A “business combination”

includes mergers, asset sales or other transactions resulting in a

financial benefit to the stockholder.

includes mergers, asset sales or other transactions resulting in a financial benefit

to the stockholder.

An “interested stockholder”

is a person who, together with affiliates and associates,

owns, or within three years, did own, 15% or more of the corporation’s outstanding voting stock.

These provisions may have

the effect of delaying, deferring or preventing a change in our control.

is a person who, together with affiliates and associates, owns, or

within three years, did own, 15% or more of the corporation’s outstanding voting stock.

These provisions may have the effect

of delaying, deferring or preventing a change in our control.

Compliance with the reporting requirements

of federal securities laws can be expensive.

We are subject to the

information and reporting requirements of the Exchange Act and other federal securities laws, and the compliance obligations of

the Sarbanes-Oxley Act.

The costs of preparing and filing annual and quarterly reports and other information with the Securities

and Exchange Commission and furnishing audited reports to stockholders are substantial.

In addition, we will incur substantial

expenses in connection with the preparation of registration statements and related documents with respect any offerings of our

common stock.

We are subject to the information

and reporting requirements of the Exchange Act and other federal securities laws, and the compliance obligations of the Sarbanes-Oxley

The costs of preparing and filing annual and quarterly reports and other information with the Securities and Exchange Commission

and furnishing audited reports to stockholders are substantial.

In addition, we will incur substantial expenses in connection with

the preparation of registration statements and related documents with respect any offerings of our common stock.

Our ability to utilize our net operating

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adversely affect our future cash flows.

Failure to establish and maintain

adequate finance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting

and internal controls requirements for publicly traded companies.

As a public company,

we operate in an increasingly demanding regulatory environment, including with respect to more complex accounting rules.

responsibilities required by the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, include establishing and maintaining

corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures.

Effective internal

controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.

Our compliance with

Section 404 of the Sarbanes-Oxley Act requires that we incur substantial accounting expense and expend significant management

We complied with Section 404 at December 31, 2019 and 2018 and while our testing did not reveal any material weaknesses

in our internal controls, any material weaknesses in our internal controls in the future would be required us to remediate in

a timely manner so as to be able to comply with the requirements of Section 404 each year.

If we are not able to comply with the

requirements of Section 404 in a timely manner each year, we could be subject to sanctions or investigations by the SEC, NYSE

American or other regulatory authorities which would require additional financial and management resources and could adversely

affect the market price of our common stock.

Furthermore, if we cannot provide reliable financial reports or prevent fraud, our

business and results of operations could be harmed, and investors could lose confidence in our reported financial information.

If securities or industry analysts do not publish research

or publish inaccurate or unfavorable research about our business, the price of our common stock and trading volume could decline.

The trading market for our common stock

will depend in part on the research and reports that securities or industry analysts publish about us or our business.

securities and industry analysts currently cover us.

If one or more of the analysts downgrade our common stock or publish inaccurate

or unfavorable research about our business, the price of our common stock would likely decline.

If one or more of these analysts

cease coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which could cause

the price of our common stock and trading volume to decline.

Our amended and restated bylaws, as amended, designate

federal district courts as the exclusive forum for the resolution of any complaint asserting a cause

of action arising under the Securities Act of 1933, as amended.

Our amended and restated bylaws, as

amended, provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts

Failure to establish and maintain adequate

finance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting and

internal controls requirements for publicly traded companies.

As a public company, we

operate in an increasingly demanding regulatory environment, including with respect to more complex accounting rules.

Company responsibilities

required by the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, include establishing and maintaining corporate

oversight and adequate internal control over financial reporting and disclosure controls and procedures.

Effective internal controls

are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.

Our compliance with Section

404 of the Sarbanes-Oxley Act requires that we incur substantial accounting expense and expend significant management efforts.

We complied with Section 404 at December 31, 2019 and 2018 and while our testing did not reveal any material weaknesses in our

internal controls, any material weaknesses in our internal controls in the future would be required us to remediate in a timely

manner so as to be able to comply with the requirements of Section 404 each year.

If we are not able to comply with the requirements

of Section 404 in a timely manner each year, we could be subject to sanctions or investigations by the SEC, NYSE American or other

regulatory authorities which would require additional financial and management resources and could adversely affect the market

price of our common stock.

Furthermore, if we cannot provide reliable financial reports or prevent fraud, our business and results

of operations could be harmed, and investors could lose confidence in our reported financial information.

If securities or industry analysts do

not publish research or publish inaccurate or unfavorable research about our business, the price of our common stock and trading

volume could decline.

The trading market for

our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business.

Multiple securities and industry analysts currently cover us.

If one or more of the analysts downgrade our common stock or publish

inaccurate or unfavorable research about our business, the price of our common stock would likely decline.

If one or more of these

analysts cease coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which could

cause the price of our common stock and trading volume to decline.

Our amended and restated bylaws,

as amended, designate the U.S.

federal district courts as the exclusive forum for the resolution of any

complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

Our amended and restated bylaws,

as amended, provide 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 resolving any complaint asserting a cause of action arising under

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litigation costs in pursuing any such claim.

UNREGISTERED SALES OF EQUITY SECURITIES AND

USE OF PROCEEDS.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

DEFAULTS UPON SENIOR SECURITIES.

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

What changed 10-Q

Item 1A. Risk Factors