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Item 1A. Risk Factors

2020-10-23 compared with 2020-08-14 · 476 added, 467 removed, 1070 unchanged (47% 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.

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.

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.

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.

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.

We are not profitable

and have incurred losses in each period since our inception.

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

deficit of $224.6 million and $208.8 million, respectively.

We reported a net loss of $15.8 million and $17.3 million for the nine

months ended September 30, 2020 and September 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,

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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

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 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.

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

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;

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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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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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.

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,”

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

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

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Currently, the Phase 3

3 SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites, with investigators

providing feedback that recruitment and enrollment will remain active because of the acute nature of the disease, the high unmet

needs of patients with relapsed or refractory AML, the potentially curative nature of BMT and the differentiated profile of Iomab-B.

Certain sites that had not been actively enrolling due to COVID-19 have resumed recruitment and enrollment, and wecurrently anticipate

that other sites that have not been actively enrolling due to COVID-19 will likely resume recruitment and enrollment in the summer

We also believe our earlier stage clinical trials for our CD33 program will also continue to recruit and enroll patients

given the acute nature of relapsed or refractory AML.

The continuation of the pandemic globally could adversely affect our planned

clinical trial operations, including our ability to conduct the trials on the expected timelines and recruit and retain patients

and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if their geography

is impacted by the pandemic.

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.

SIERRA trial for our lead program, Iomab-B, continues to remain active at a majority of our clinical trial sites and no sites are

inactive due to COVID-19, with investigators providing feedback that recruitment and enrollment will remain active because of the

acute nature of the disease, the high unmet needs of patients with relapsed or refractory AML, the potentially curative nature

of BMT and the differentiated profile of Iomab-B.

We also believe our earlier stage clinical trials for our CD33 program will also

continue to recruit and enroll patients given the acute nature of relapsed or refractory AML.

The continuation of the pandemic

globally could adversely affect our planned clinical trial operations, including our ability to conduct the trials on the expected

timelines and recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened

exposure to COVID-19 if their geography is impacted by the pandemic.

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

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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

COVID-19 has caused severe disruptions in transportation and

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

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.

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.

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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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

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 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

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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”)

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.

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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

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

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.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under

terms authorized by the FDA.

Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical

trials to begin or that, for those that have already commenced under an active IND, that issues will not arise that suspend or

terminate such trials.

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.

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

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.

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

trial can begin.

The FDA 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.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization

and then only under terms authorized by the FDA.

Accordingly, we cannot be sure that submission of an IND will result in the FDA

allowing clinical trials to begin or that, for those that have already commenced under an active IND, that issues will not arise

that suspend or terminate such trials.

Clinical trials involve

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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.

After the completion

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

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

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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,

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.

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

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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 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

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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

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:

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.

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.

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.

The FDA or comparable foreign regulatory

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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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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.

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

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’

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’

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

Even if we receive regulatory approval

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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 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

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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 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

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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”

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”).

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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

Several states and

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

of the legislation.

On July 26, 2012, the U.S.

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

constitutional.

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

as constitutional.

However, the U.S.

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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

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

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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 trials.

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

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

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.

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.

In addition, our third-party

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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.

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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

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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

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.

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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.

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.

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

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

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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 depend on vendors

with specialized operations, equipment and know-how to manufacture the respective components of our drug candidates.

We have entered

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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.

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.

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.

manufacturers may not be able to successfully increase the manufacturing capacity for any approved product in a timely or economic

manner, or at all.

Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and

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

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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:

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

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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

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,

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.

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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’

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 to do so.

Our business strategy

includes expanding our products and capabilities, and we may seek acquisitions of product candidates, antibodies or technologies

Acquisitions involve numerous risks, including substantial cash expenditures;

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;

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;

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 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

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

shares of our capital stock.

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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

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.

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

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 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.

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.

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.

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 efforts.

We complied with Section 404 at December 31, 2019 and 2018 and while our testing did not reveal any material weaknesses in our

7 unchanged sentences

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

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.

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

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.

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.

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,

13 unchanged sentences

litigation costs in pursuing any such claim.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF

DEFAULTS UPON SENIOR SECURITIES.

1 unchanged sentence

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