What changed in this filing

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Item 1A. Risk Factors

2021-11-12 compared with 2021-07-30 · 1464 added, 1410 removed, 76 unchanged (97% of the section changed)

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, 2020.

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

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 Risk Factors

are providing the following summary of the risk factors contained in this Quarterly Report on Form 10-Q to enhance the readability and

accessibility of our risk factor disclosures.

We encourage you to carefully review the full risk factors contained in our Annual Report

on Form 10-K for the year ended December 31, 2020 in their entirety for additional information regarding the material factors that make

an investment in our securities speculative or risky.

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, 2020.

Each 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.

Summary of Risk Factors

We are providing the following

summary of the risk factors contained in this Quarterly Report on Form 10-Q to enhance the readability and accessibility of our risk factor

We encourage you to carefully review the full risk factors contained in our Annual Report on Form 10-K for the year ended

December 31, 2020 in their entirety for additional information regarding the material factors that make an investment in our securities

speculative or risky.

These risks and uncertainties include, but are not limited to, the following:

are a clinical-stage company and have generated no revenue from commercial sales to date;

have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future;

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;

are highly dependent on the success of Iomab-B and the SIERRA trial and we many not able to complete the necessary clinical development

or our development efforts may not result in the data necessary to receive regulatory approval;

business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic;

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,

clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay

regulatory approval and commercialization;

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;

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;

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;

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;

patent position is highly uncertain and involves complex legal and factual questions;

use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain

compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials;

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;

provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us

and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest;

ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

Related to Our Business

are a clinical-stage company and have generated no revenue from commercial sales to date.

are a clinical-stage biopharmaceutical company with a limited operating history.

We have no products approved for commercial sale and

have not generated any revenue from product sales to date.

We will encounter risks and difficulties frequently experienced by early-stage

companies in rapidly evolving fields.

If we do not address these risks successfully, our business will suffer.

have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.

are not profitable and have incurred losses in each period since our inception.

As of June 30, 2021 and December 31, 2020, we had an

accumulated deficit of $241.3 million and $231.0 million, respectively.

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

June 30, 2021 and $10.3 million for the six months ended June 30, 2020.

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.

We are a clinical-stage company and have generated no revenue from commercial sales to date;

We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future;

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;

We are highly dependent on the success of Iomab-B and the SIERRA trial and we many not able to complete the necessary clinical development or our development efforts may not result in the data necessary to receive regulatory approval;

Our business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic;

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;

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;

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;

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 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;

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 patent position is highly uncertain and involves complex legal and factual questions;

The use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials;

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;

Certain provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest;

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

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 biopharmaceutical

company with a limited operating history.

We have no products approved for commercial sale and have not generated any revenue from product

sales to date.

We will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields.

we do not address these risks successfully, our business will suffer.

We have incurred net losses in every year

since our inception 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 September 30, 2021 and December 31, 2020, we had an accumulated deficit

of $247.7 million and $231.0 million, respectively.

We reported a net loss of $16.8 million for the nine months ended September 30, 2021

and $15.8 million for the nine months ended September 30, 2020.

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 fail to obtain additional financing, we will be unable to continue or complete our product development and you will likely lose your

entire investment.

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.

In August 2020, we entered

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filed with the SEC on August 7, 2020.

For the six months ended June 30, 2021, we sold 3.5 million shares of common stock, resulting in

net proceeds of $28.7 million.

For the nine months ended September 30, 2021, we sold 4.5 million shares of common stock, resulting

in net proceeds of $34.5 million.

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.

business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional

funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business

or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a

change in preferred cancer treatment modalities.

However, we may not be able to secure funding when we need it or on favorable terms

or indeed on any terms.

In addition, from time to time, we may not be able to secure enough capital in a timely enough manner which may

cause the generation of a going-concern opinion from our auditors which can and may impair our stock market valuation and also our ability

to finance on favorable terms or indeed on any terms.

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.

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.

Our business or operations

may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required

to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or

otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred

cancer treatment modalities.

However, we may not be able to secure funding when we need it or on favorable terms or indeed on any terms.

In addition, from time to time, we may not be able to secure enough capital in a timely enough manner which may cause the generation of

a going-concern opinion from our auditors which can and may impair our stock market valuation 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.

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.

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

the progress, timing and scope of our preclinical studies and clinical trials;

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;

the progress, timing and scope

of our preclinical studies and clinical trials;

the time and cost necessary to obtain regulatory approvals;

the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into

and maintain collaborative, licensing and other commercial relationships;

and our partners’ commitment of time and resources to

the development and commercialization of our products.

have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on terms that are

dilutive to you.

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.

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.

the time and cost necessary

to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative,

licensing and other commercial relationships;

and our partners’ commitment of time and resources to the development and commercialization

of our products.

We have limited access to the capital 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.

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.

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.

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 of

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result in the data necessary to receive regulatory approval.

which we licensed from the Fred Hutchinson Cancer Research Center (“FHCRC”) in June 2012 is our lead program to which we

allocate a significant portion of our resources.

We are currently enrolling patients in the pivotal Phase 3 SIERRA trial (Study of Iomab-B

in Elderly Relapsed or Refractory AML), a 150-patient multi-center randomized trial that will compare outcomes of patients who receive

Iomab-B and a BMT to those patients receiving physician’s choice of salvage chemotherapy, defined as conventional care, as no standard

of care exists for this patient population.

The SIERRA trial may be unsuccessful and fail to demonstrate a safety and efficacy profile

that is necessary to receive favorable regulatory approval.

The DMC may recommend that the trial be stopped early for safety or

efficacy concerns, which could prevent us from completing the SIERRA trial.

Even if Iomab-B receives favorable regulatory approval, we

may not be successful in securing adequate reimbursement or establishing successful commercial operations.

Any or all of these factors

could have a material adverse impact on our business and ability to continue operations.

may be unable to establish sales, marketing and commercial supply capabilities.

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

commercial capabilities will be expensive and time consuming.

Even if we are successful in building sales and marketing capabilities,

we may not be successful in commercializing any of our product candidates.

Any delays in commercialization or failure to successfully

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

business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic.

The global health crisis caused by the novel coronavirus COVID-19 pandemic

and its resurgences has and may continue to negatively impact global economic activity, which, despite progress in vaccination efforts,

remains uncertain and cannot be predicted with confidence.

In addition, a new Delta variant of COVID-19, which appears to be the most

transmissible variant to date, has begun to spread globally.

The impact of the Delta variant cannot be predicted at this time, and could

depend on numerous factors, including vaccination rates among the population, the effectiveness of COVID-19 vaccines against the Delta

variant and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult

to predict the impact of the COVID-19 pandemic on our business.

Iomab-B, which we licensed

from the Fred Hutchinson Cancer Research Center (“FHCRC”) in June 2012 is our lead program to which we allocate a significant

portion of our resources.

In September 2021, we completed patient enrollment in the pivotal Phase 3 SIERRA trial (Study of Iomab-B in

Elderly Relapsed or Refractory AML), a 150-patient multi-center randomized trial that will compare outcomes of patients who receive Iomab-B

and a BMT to those patients receiving physician’s choice of salvage chemotherapy, defined as conventional care, as no standard of

care exists for this patient population.

The SIERRA trial may be unsuccessful and fail to demonstrate a safety and efficacy profile that

is necessary to receive favorable regulatory approval.

The DMC may recommend that the trial be stopped early for safety or efficacy concerns,

which could prevent us from completing the SIERRA trial.

Even if Iomab-B receives favorable regulatory approval, we may not be successful

in securing adequate reimbursement or establishing successful commercial operations.

Any or all of these factors could have a material

adverse impact on our business and ability to continue operations.

We may be unable to establish sales, 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.

The process of establishing commercial

capabilities will be expensive and time consuming.

Even if we are successful in building sales and marketing capabilities, we may not

be successful in commercializing any of our product candidates.

Any delays in commercialization or failure to successfully 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.

The global health crisis

caused by the novel coronavirus COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic

activity, which, despite progress in vaccination efforts, remains uncertain and cannot be predicted with confidence.

In addition,the

Delta variant of COVID-19, which appears to be the most transmissible variant to date, has spread globally.

The full impact of the

Delta variant cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among the

population, the effectiveness of COVID-19 vaccines against the Delta variant and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our

Accordingly, our ability to

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in which we operate and may have a material adverse effect on our operations.

spread of COVID-19, which has caused a broad impact globally, may materially affect us economically.

While the ultimate economic impact

brought by, 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

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.

the Phase 3 SIERRA trial for our lead program, Iomab-B, remains 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.

sites that had not been actively enrolling due to COVID-19 at the initial outbreak of the pandemic resumed recruitment and enrollment

in mid-2020, and we currently do not have any sites that are not recruiting and enrolling due to COVID-19.

We also believe our earlier

stage CD33 clinical trials will 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 may result in delays in receiving approvals from domestic and foreign regulatory authorities, delays in necessary interactions

with Institutional Review Boards (“IRBs”), domestic and foreign regulators, ethics committees and other important agencies

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

continue to monitor the impacts of COVID-19 on the global economy and on our business operations.

However, the ultimate impact from

COVID-19 on our business operations and financial results during 2021 will depend on, among other things, the ultimate severity and

scope of the pandemic, including the new variants of the virus, the pace at which governmental and private travel restrictions and

public concerns about public gatherings will ease, the rate at which historically large increases in unemployment rates will

decrease, if at all, and whether, and the speed with which the economy recovers.

We are not able to fully quantify the impact that

these factors will have on our financial results during 2021 and beyond, but developments related to COVID-19 may materially affect

business is subject to cybersecurity risks.

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.

The spread of COVID-19, which

has caused a broad impact globally, may materially affect us economically.

While the ultimate economic impact brought by, 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.

The Phase 3 SIERRA trial for

our lead program, Iomab-B, remained active at a majority of our clinical trial sites, with investigators providing feedback that recruitment

and enrollment would 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 at the initial outbreak of the pandemic resumed recruitment and enrollment in mid-2020, and we were able to complete patient

enrollment in September 2021.

We believe our earlier stage CD33 clinical trials will 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 may

result in delays in receiving approvals from domestic and foreign regulatory authorities, delays in necessary interactions with Institutional

Review Boards (“IRBs”), domestic and foreign regulators, ethics committees and other important agencies and contractors due

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

We continue to monitor the

impacts of COVID-19 on the global economy and on our business operations.

However, the ultimate impact from COVID-19 on our business operations

and financial results during 2021 will depend on, among other things, the ultimate severity and scope of the pandemic, including the new

variants of the virus, the pace at which governmental and private travel restrictions and public concerns about public gatherings will

ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with which

the economy recovers.

We are not able to fully quantify the impact that these factors will have on our financial results during 2021 and

beyond, but developments related to COVID-19 may materially affect us in 2021 and beyond.

Our business is subject to cybersecurity

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:

or misappropriation of funds;

corruption, or misappropriation of intellectual property, or other proprietary, confidential or personally identifiable information

(including supplier, clinical data or employee data);

or impairment of our and our business operations and safety procedures;

to our reputation with our potential partners, patients and the market;

to litigation;

costs to prevent, respond to or mitigate cybersecurity events.

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.

have cybersecurity insurance coverage in the event we become subject to various cybersecurity attacks, however, 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.

Related to Regulation

FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval

of our product candidates.

products are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities.

of seeking regulatory approval to market an antibody radiation-conjugate product is expensive and time-consuming, and, notwithstanding

the effort and expense incurred, approval is never guaranteed.

If we are not successful in obtaining timely approval of our products

from the FDA, we may never be able to generate significant revenue and may be forced to cease operations.

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.

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, chemistry, manufacturing and controls (“CMC”) 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.

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.

The FDA and other foreign regulatory agencies could ask us to supplement our submissions, collect non-clinical

data, conduct additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

even if we obtain approval to market our products in the United States or in other countries, the approval could be revoked, or other

restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or

when, the FDA or other regulatory authorities will act.

If we are unable to obtain the necessary regulatory approvals, our financial

condition and cash flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally, even if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited

indications that we request.

The Company’s products may not be approved for the specific indications that are most necessary or

desirable for successful commercialization or profitability.

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.

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.

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.

the United States, the FDA regulates pharmaceutical and biological product candidates under the 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

The process required by the FDA before a drug or biological product may be marketed in the United States generally involves

the following:

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;

to the FDA of an Investigational New Drug (“IND”), which must become effective before human clinical trials in the United

States may begin;

of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, GCPs, and any additional requirements

for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed

biological product for its intended use;

to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency

of the product that is the subject of the BLA based on results of preclinical testing and clinical trials;

completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess compliance

with cGMPs and assure that the facilities, methods and controls are adequate to preserve the biological product’s identity,

strength, quality and purity;

FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

review and approval, or denial, of the BLA.

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.

theft or misappropriation of funds;

loss, corruption, or misappropriation of intellectual property, or other proprietary, confidential or personally identifiable information (including supplier, clinical data or employee data);

disruption or impairment of our and our business operations and safety procedures;

damage to our reputation with our potential partners, patients and the market;

exposure to litigation;

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

We have cybersecurity insurance

coverage in the event we become subject to various cybersecurity attacks, however, 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

The FDA or comparable foreign regulatory

authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates.

Our products are subject to

rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities.

The process of seeking regulatory

approval to market an antibody radiation-conjugate product is expensive and time-consuming, and, notwithstanding the effort and expense

incurred, approval is never guaranteed.

If we are not successful in obtaining timely approval of our products from the FDA, we may never

be able to generate significant revenue and may be forced to cease operations.

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.

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, chemistry, manufacturing and controls (“CMC”) 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

The FDA and other foreign regulatory agencies could ask us to supplement our submissions, collect non-clinical data, conduct

additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

In addition, even if we

obtain approval to market our products in the United States or in other countries, the approval could be revoked, or other restrictions

imposed if post-market data demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or when, the FDA

or other regulatory authorities will act.

If we are unable to obtain the necessary regulatory approvals, our financial condition and cash

flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally, even

if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications that we

The Company’s products may not be approved for the specific indications 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.

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.

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 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;

submission to the FDA of an Investigational New Drug (“IND”), which must become effective before human clinical trials in the United States may begin;

performance of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

submission to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the BLA based on results of preclinical testing and clinical trials;

satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess compliance with cGMPs and assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

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.

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.

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.

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.

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 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.

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

that all research subjects provide informed consent.

Clinical trials must be

conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements, including the requirement that

all research subjects provide informed consent.

Further, each clinical trial must be reviewed and approved by an independent institutional

7 unchanged sentences

The biological product is initially introduced into healthy human subjects and tested for safety.

In the case of some products

for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy

volunteers, the initial human testing is often conducted in subjects.

The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to

preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage

and dosing schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population

at geographically dispersed clinical trial sites.

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 follow-up.

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.

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.

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 BMTs.

Additionally,

there are physician IND trials at the 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.

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

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.

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

to receive regulatory approval:

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

in receiving, or the inability to obtain, required approvals from IRBs or other reviewing entities at clinical sites selected for

participation in our clinical trials;

in enrolling patients into clinical trials;

lower than anticipated retention rate of patients in clinical trials;

need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing

or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;

supply, delays in distribution, deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other

materials necessary to conduct our clinical trials;

FDA or other foreign regulatory inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not

observed in earlier trials or only observed in a limited number of participants;

finding that the trial participants are being exposed to unacceptable health risks;

placement by the FDA or a foreign regulatory authority of a clinical hold on a trial;

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

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 including but not limited to unacceptable or suboptimal

factors related to toxicity, clinical efficacy, imbalances in safety and efficacy profiles or for other reasons.

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

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:

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

of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical

interpretation of data by the FDA or similar foreign regulatory authorities;

to achieve primary or secondary endpoints or other failure to demonstrate efficacy;

safety issues;

of adequate funding to continue the clinical trial.

Modifications

to our product candidates may require federal approvals.

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.

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.

FDA or comparable foreign regulatory authorities may disagree with our regulatory plans, and we may fail to obtain regulatory approval

of our product candidates.

In June 2012, we acquired

rights to BC8 (Iomab), a clinical stage monoclonal antibody with safety and efficacy data in more than 300 patients in need of a BMT.

Iomab-B is our product candidate that links I-131 to the BC8 antibody that is being studied in an ongoing Phase 3 pivotal trial.

candidates utilizing this antibody would require BLA approval before they can be marketed in the United States.

We are also evaluating

a lower dose of the BC8 antibody and I-131 for lymphodepletion prior to CAR-T or adoptive cell therapy.

We are currently evaluating clinical

trials that would use our construct for lymphodepletion.

Our lintuzumab-Ac-225 product candidate is also being studied in several Phase

1 trials under our sponsorship and investigator-initiated trials in patients with AML and has been studied in other hematologic malignancies.

Product candidates utilizing the lintuzumab antibody would require BLA approval before they can be marketed in the United States.

in the early stages of evaluating other product candidates consisting of conjugates of Ac-225 with human or humanized antibodies for pre-clinical

and clinical development in other types of cancer.

The FDA may not approve these products for the indications that are necessary or desirable

for successful commercialization.

The FDA may fail to approve any BLA we submit for new product candidates or for new intended uses or

indications for approved products or future product candidates.

Failure to obtain FDA approval for our products in the proposed indications

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

trials necessary to support approval of our product candidates are time-consuming and expensive.

and completing clinical trials necessary to support FDA approval of a BLA for Iomab-B, CD33 program candidates, and other product candidates,

is a time-consuming and expensive process, and the outcome is inherently uncertain.

Moreover, the results of early clinical trials are

not necessarily predictive of future results, and any product candidate we advance into clinical trials may not have favorable results

in later clinical trials.

We have worked with the FDA to develop a clinical trial designed to test the safety and efficacy of Iomab-B

in patients with relapsed or refractory AML who are age 55 and above prior to a BMT.

This trial is designed to support a BLA filing for

marketing approval by the FDA, pending results from the trial.

In addition to clinical data, a BLA filing encompasses preclinical, CMC,

labeling and other information.

Even if the clinical data from the SIERRA trial is positive, there can be no assurances that the BLA

filing we produce will meet all of the FDA’s requirements or that they will not request additional information or studies, which

may delay the FDA’s review or we may not be able to produce.

We have also worked with the FDA to develop a regulatory pathway for

our Actimab-MDS trial that consists of a dose-confirming Phase 1 trial that can be followed by a randomized, controlled pivotal trial

that could support a BLA filing.

In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in subjects.

The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites.

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 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.

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

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.

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 BMTs.

Additionally, there are physician IND trials at the

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.

In addition, 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

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;

delays in receiving, or the inability to obtain, required approvals from IRBs or other reviewing entities at clinical sites selected for participation in our clinical trials;

delays in enrolling patients into clinical trials;

a lower than anticipated retention rate of patients in clinical trials;

the need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;

inadequate supply, delays in distribution, deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;

unfavorable FDA or other foreign regulatory inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

serious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;

a finding that the trial participants are being exposed to unacceptable health risks;

the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial;

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 including but not limited to unacceptable or suboptimal factors related to toxicity, clinical

efficacy, imbalances in safety and efficacy profiles 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;

inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

varying interpretation of data by the FDA or similar foreign regulatory authorities;

failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy;

unforeseen safety issues;

lack of adequate funding to continue the clinical trial.

Modifications to our product candidates

may require federal approvals.

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

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

authorities may disagree with our regulatory plans, and we may fail to obtain regulatory approval of our product candidates.

In June 2012, we acquired rights

to apamistamab (BC8), a clinical stage monoclonal antibody with safety and efficacy data in more than 300 patients that we utilize in

Iomab-B and Iomab-ACT.

Iomab-B is our product candidate that links I-131 to the apamistamab antibody that is being studied in the Phase

3 pivotal SIERRA trial, which completed patient enrollment in September 2021.

Product candidates utilizing this antibody would require

BLA approval before they can be marketed in the United States.

We are also evaluating Iomab-ACT, a lower dose of I-131 with apamistamab

for lymphodepletion prior to CAR-T or adoptive cell therapy.

We are currently evaluating clinical trials that would use our construct

for lymphodepletion.

Our lintuzumab-Ac-225 product candidate is also being studied in several Phase 1 trials under our sponsorship and

investigator-initiated trials in patients with AML and has been studied in other hematologic malignancies.

Product candidates utilizing

the lintuzumab antibody would require BLA approval before they can be marketed in the United States.

We are in the early stages of evaluating

other product candidates consisting of conjugates of Ac-225 with human or humanized antibodies for pre-clinical and clinical development

in other types of cancer.

The FDA may not approve these products for the indications that are necessary or desirable for successful commercialization.

The FDA or comparable foreign regulatory authorities may fail to approve any BLA or other regulatory filing we submit for new product

candidates or for new intended uses or indications for approved products or future product candidates.

Failure to obtain FDA approval

for our products in the proposed indications would have a material adverse effect on our business prospects, financial condition and results

of operations.

Clinical trials necessary to support approval

of our product candidates are time-consuming and expensive.

Initiating and completing

clinical trials necessary to support FDA approval of a BLA for Iomab-B, CD33 program candidates, and other product candidates, is a time-consuming

and expensive process, and the outcome is inherently uncertain.

Moreover, the results of early clinical trials are not necessarily predictive

of future results, and any product candidate we advance into clinical trials may not have favorable results in later clinical trials.

We have worked with the FDA to develop a clinical trial designed to test the safety and efficacy of Iomab-B in patients with relapsed

or refractory AML who are age 55 and above prior to a BMT.

This trial is designed to support a BLA filing for marketing approval by the

FDA, pending results from the trial.

In addition to clinical data, a BLA filing encompasses preclinical, CMC, labeling and other information.

Even if the clinical data from the SIERRA trial is positive, there can be no assurances that the BLA filing we produce will meet all of

the FDA’s requirements or that they will not request additional information or studies, which may delay the FDA’s review or

we may not be able to produce.

There can be no assurance that the data generated during the trial will meet our chosen safety and effectiveness

2 unchanged sentences

are favorable, the data may not be predictive of the results of any future clinical trials.

Interim, and “top-line” data from our clinical trials that we announce or publish from time to time may change as more patient

data become available and are subject to audit and verification procedures that could result in material changes in the final data.

time to time, we may publicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a

preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change as more

patient data become available or following a more comprehensive review of the data related to the particular study or trial.

example, on February 10, 2021, interim safety, and feasibility data from 75% patient enrollment from the SIERRA trial was presented

at the TCT Annual Meeting.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and

we may not have received or had the opportunity to fully and carefully evaluate all data.

Interim or preliminary results that we

report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once

additional data have been received and fully evaluated.

Preliminary, interim or top-line data also remain subject to audit and

verification procedures that may result in the final data being materially different from the top-line, interim or preliminary data

we previously published.

As a result, top-line, interim and preliminary data should be viewed with caution until the final data are

time to time, we may also disclose interim data from our preclinical studies and clinical trials.

Interim data from clinical trials that

we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues

and more patient data become available.

Adverse differences between interim data and final data could significantly harm our business

Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our common stock.

others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses

or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability

or commercialization of the particular product candidate or product and our company in general.

In addition, the information we choose

to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others

may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities,

disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which

could harm our business, operating results, prospects or financial condition.

clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory

approval and commercialization.

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.

The clinical trial process may fail to demonstrate that our product candidates are

safe and effective for the proposed indicated uses.

If FDA concludes that the clinical trials for Iomab-B, lintzumab-Ac-225, or any other

product candidate for which we might seek approval, have failed to demonstrate safety and effectiveness, we would not receive FDA approval

to market that product candidate in the United States for the indications sought.

In addition, such an outcome could cause us to abandon

the product candidate and might delay development of others.

Any delay or termination of our clinical trials will delay or preclude the

filing of any submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.

is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of a product

candidate’s profile.

intellectual property related to antibodies we have licensed has expired or likely expired.

key patents related to the humanized antibody, lintuzumab, which we use in our CD33 program product candidates have expired.

It is generally

possible that others may be eventually able to use an antibody with the same sequence, and we will then need to rely on additional patent

protection covering alpha particle drug products comprising Ac-225.

Our final drug construct consists of the lintuzumab antibody 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

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

isotope production.

Preliminary, Interim, and “top-line”

data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject

to audit and verification procedures that could result in material changes in the final data.

From time to time, we may

publicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a preliminary analysis of then-available

data, and the results and related findings and conclusions are subject to change as more patient data become available or following a

more comprehensive review of the data related to the particular study or trial.

For example, on February 10, 2021, interim safety, and

feasibility data from 75% patient enrollment from the SIERRA trial was presented at the TCT Annual Meeting.

We also make assumptions,

estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully

and carefully evaluate all data.

Interim or preliminary results that we report may differ from future results of the same studies, or

different conclusions or considerations may qualify such results once additional data have been received and fully evaluated.

interim or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different

from the top-line, interim or preliminary data we previously published.

As a result, top-line, interim and preliminary data should be

viewed with caution until the final data are available.

From time to time, we may

also disclose interim data from our preclinical studies and clinical trials.

Interim data from clinical trials that we may complete are

subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data

become available.

Adverse differences between interim data and final data could significantly harm our business prospects.

Further, disclosure

of interim data by us or by our competitors could result in volatility in the price of our common stock.

Further, others, including

regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or

weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization

of the particular product candidate or product and our company in general.

In addition, the information we choose to publicly disclose

regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with

what we determine is material or otherwise appropriate information to include in our disclosure.

If the interim, top-line or

preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions

reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating

results, prospects or financial condition.

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 of prior trials

and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the

proposed indicated uses.

If FDA concludes that the clinical trials for Iomab-B, lintzumab-Ac-225, or any other product candidate for which

we might seek approval, have failed to demonstrate safety and effectiveness, we would not receive FDA approval to market that product

candidate in the United States for the indications sought.

In addition, such an outcome could cause us to abandon the product candidate

and might delay development of others.

Any delay or termination of our clinical trials will delay or preclude the filing of any submissions

with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.

It is also possible that patients

enrolled in clinical trials will experience adverse side effects that 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 key patents related to

the humanized antibody, lintuzumab, which we use in our CD33 program product candidates have expired.

It is generally possible that others

may be eventually able to use an antibody with the same sequence, and we will then need to rely on additional patent protection covering

alpha particle drug products comprising Ac-225.

Our final drug construct consists of the lintuzumab antibody labeled with the isotope

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

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 2 issued patents in the US and 1 in Europe relating to composition of the Iomab-B product candidate.

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.

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.

CD33 program clinical trials are testing the same drug construct.

CD33 program is comprised of several clinical trials including investigator-initiated trials in AML 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.

may be unable to obtain a sufficient supply of isotopes to support clinical development or at commercial scale.

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 payload.

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

we require to supply our clinical programs through to early commercialization phase.

The DOE is also producing Ac-225 from a recently

developed alternative route for Ac-225 production via a linear accelerator that is currently being evaluated by Actinium.

Initial preclinical

and modelling results have indicated that the linear accelerator sourced Ac-225 does not impact labelling efficiency and expected distribution.

Per representations made by the DOE, the capacity of Ac-225 from this route is expected to be sufficient to supply all of Actinium’s

pipeline and commercial Ac-225 needs and support new program expansion by not just Actinium but also other companies that are developing

Ac-225 based products.

Additional routes of Ac-225 production are being pursued by the DOE including the generation of new thorium cows

and production via a cyclotron.

The cyclotron production method for Ac-225 production leverages Actinium’s proprietary technology

and know-how and presents an additional path towards production of high-quality Ac-225 that would be able to satisfy commercial needs.

In addition, we are aware of at least six other government and non-government entities globally including the U.S., Canada, Russia, Belgium,

France and Japan that have, or expect to have ability to supply Ac-225 or equipment for its production within the timeframes relevant

to the potential first commercial approval of our Ac-225 ARC.

contract for supply of this isotope from the DOE must be renewed yearly, and the current contract extends through the end of 2021.

we expect this contract will be renewed at the end of its term as it has since 2009, there can be no assurance that the DOE will renew

the contract or that change its policies that allow for the sale of isotope to us.

Failure to acquire sufficient quantities of medical

grade Ac-225 would make it impossible to effectively complete clinical trials and to commercialize any Ac-225 based drug candidates that

we may develop and would materially harm our business.

ability to conduct clinical trials to advance our ARC drug candidates is dependent on our ability to obtain the radioisotopes I-131,

Ac-225 and other isotopes we may choose to utilize in the future.

Currently, we are dependent on third party manufacturers and suppliers

for our isotopes.

These suppliers may not perform their contracted services or may breach or terminate their agreements with us.

suppliers are subject to regulations and standards that are overseen by regulatory and government agencies and we have no control over

our suppliers’ compliance to these standards.

Failure to comply with regulations and standards may result in their inability to

supply isotope could result in delays in our clinical trials, which could have a negative impact on our business.

We have developed intellectual

property, know-how and trade secrets related to the manufacturing process of Ac-225.

While we have manufactured medical grade Ac-225

of a purity compared to the cyclotron sourced material in the past, this activity was terminated due to operating cost reasons and we

currently do not have experience in manufacturing medical grade Ac-225 and may not obtain the resources necessary to establish our own

manufacturing capabilities in future.

Our inability to build out and establish our own manufacturing facilities would require us to continue

to rely on third party suppliers as we currently do.

However, based on our current third-party suppliers and potential future suppliers

of Ac-225 we expect to have adequate isotope supply to support our current ongoing clinical trials, current AWE program activities and

commercialization should our drug candidates receive approval.

we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise

adversely affected.

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.

We may experience difficulties in patient enrollment in our clinical trials for a variety

of reasons, including:

size and nature of the patient population;

patient eligibility criteria defined in the protocol;

size of the study population required for analysis of the trial’s primary endpoints;

proximity of patients to trial sites;

design of the trial;

ability to recruit clinical trial investigators with the appropriate competencies and expertise;

clinical trials for similar or alternate therapeutic treatments;

and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation

to other available therapies;

ability to obtain and maintain patient consents;

risk that patients enrolled in clinical trials will not complete a clinical trial.

addition, refractory patients, which several of our trials are enrolling, participating in clinical trials are seriously and often terminally

ill and therefore may not complete the clinical trial due to reasons including comorbid conditions or occurrence of adverse medical events

related or unrelated to the investigational products, or death.

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

clinical trials, delays in patient enrollment will result in increased costs or affect the timing of our planned trials, which could

adversely affect our ability to advance the development of our product candidates.

may take actions that would prolong, delay, suspend, or terminate clinical trials of our product candidates, which may delay or prevent

us from commercializing our product candidates on a timely basis.

can be no assurance that the data generated in our clinical trials will be acceptable to FDA or that if future modifications during the

trial are necessary, that any such modifications will be acceptable to FDA.

Certain modifications to a clinical trial protocol made during

the course of the clinical trial have to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the

modification is evaluated.

In addition, depending on the quantity and nature of the changes made, FDA could take the position that some

or all of the data generated by the clinical trial is not usable because the same protocol was not used throughout the trial.

require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying approval

of a product candidate.

If the FDA believes that its prior approval is required for a particular modification, it can delay or halt a

clinical trial while it evaluates additional information regarding the change.

delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining

or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical

trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause

an increase in costs and delays in the filing of any submissions with the FDA, delay the approval and commercialization of our product

candidates or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

Lengthy delays in the completion of our Iomab-B clinical trials would adversely affect our business and prospects and could cause us

to cease operations.

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.

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.

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

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.

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.

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.

if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory

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

The FDA may also require a REMS 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:

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

product recalls;

warning letters or holds on clinical trials;

by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license

seizure or detention, or refusal to permit the import or export of our product candidates;

or the imposition of civil or criminal penalties.

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.

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.

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.

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.

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.

the United States, there have been a number of legislative and regulatory initiatives focused on containing the cost of healthcare.

Affordable Care Act, for example, substantially changed the way healthcare is financed by both governmental and private insurers.

Affordable Care Act contains a number of provisions that could impact our business and operations, primarily, once we obtain FDA approval

to commercialize one of our product candidates in the United States, if ever, and may also affect our operations in ways we cannot currently

Affordable Care Act provisions that may affect our business include, among others, those governing enrollment in federal healthcare

programs, reimbursement changes, rules regarding prescription drug benefits under health insurance exchanges, expansion of the 340B program,

expansion of state Medicaid programs, fees and increased discount and rebate obligations, transparency and reporting requirements, and

fraud and abuse enforcement.

Such changes may impact existing government healthcare programs, industry competition, formulary composition,

and may result in the development of new programs, including Medicare payment for performance initiatives, health technology assessments,

and improvements to the physician quality reporting system and feedback program.

have been significant ongoing judicial, administrative, executive, and legislative initiatives to modify, limit, replace, or repeal the

Affordable Care Act.

For example, former President Trump issued several Executive Orders and other directives designed to delay the implementation

of certain provisions of the Affordable Care Act or otherwise circumvent some of the requirements for health insurance mandated by the

Affordable Care Act.

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 such development by others is nevertheless a possibility that could negatively impact

our business in the future.

We own 2 issued U.S.

patents, 1 issued European patent (validated as a national patent in several countries)

and 1 issued Japanese patent that relate to the composition of our Iomab-B product candidate.

Several patent applications relating to

Iomab-B are also pending in the U.S.

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 apamistamab (formerly 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 such development by others 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 investigator-initiated trials in AML 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 payload.

There are adequate quantities of Ac-225 available

today to meet our current needs via our present supplier, the Department of Energy (“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 of the amount of Ac-225 we require to supply our clinical programs

through to early commercialization phase.

The DOE is also producing Ac-225 from a recently developed alternative route for Ac-225 production

via a linear accelerator that is currently being evaluated by Actinium.

Initial preclinical and modelling results have indicated that

the linear accelerator sourced Ac-225 does not impact labelling efficiency and expected distribution.

In accordance with representations

made by the DOE, the capacity of Ac-225 from this route is expected to be sufficient to supply all of Actinium’s pipeline and commercial

Ac-225 needs and support new program expansion by not just Actinium but also other companies that are developing Ac-225 based products.

Additional routes of Ac-225 production are being pursued by the DOE including the generation of new thorium cows and production via a

The cyclotron production method for Ac-225 production leverages Actinium’s proprietary technology and know-how and presents

an additional path towards production of high-quality Ac-225 that would be able to satisfy commercial needs.

In addition, we are aware

of at least six other government and non-government entities globally including the U.S., Canada, Russia, Belgium, France and Japan that

have, or expect to have ability to supply Ac-225 or equipment for its production within the timeframes relevant to the potential first

commercial approval of our Ac-225 ARC.

Our contract for supply of

this isotope from the DOE must be renewed yearly, and the current contract extends through the end of 2021.

While we expect this contract

will be renewed at the end of its term as it has since 2009, there can be no assurance that the DOE will renew the contract or that change

its policies that allow for the sale of isotope to us.

Failure to acquire sufficient quantities of medical grade Ac-225 would make it

impossible to effectively complete clinical trials and to commercialize any Ac-225 based drug candidates that we may develop and would

materially harm our business.

Our ability to conduct clinical

trials to advance our ARC drug candidates is dependent on our ability to obtain the radioisotopes I-131, Ac-225 and other isotopes we

may choose to utilize in the future.

Currently, we are dependent on third party manufacturers and suppliers for our isotopes.

These suppliers

may not perform their contracted services or may breach or terminate their agreements with us.

Our suppliers are subject to regulations

and standards that are overseen by regulatory and government agencies and we have no control over our suppliers’ compliance to these

Failure to comply with regulations and standards may result in their inability to supply isotope could result in delays in

our clinical trials, which could have a negative impact on our business.

We have developed intellectual property, know-how and trade secrets

related to the manufacturing process of Ac-225.

While we have manufactured medical grade Ac-225 of a purity compared to the cyclotron

sourced material in the past, this activity was terminated due to operating cost reasons and we currently do not have experience in manufacturing

medical grade Ac-225 and may not obtain the resources necessary to establish our own manufacturing capabilities in future.

Our inability

to build out and establish our own manufacturing facilities would require us to continue to rely on third party suppliers as we currently

However, based on our current third-party suppliers and potential future suppliers of Ac-225 we expect to have adequate isotope supply

to support our current ongoing clinical trials, current AWE program activities and commercialization should our drug candidates receive

If we encounter difficulties enrolling 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 in the trial until

its conclusion.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

the size and nature of the patient population;

the patient eligibility criteria defined in the protocol;

the size of the study population required for analysis of the trial’s primary endpoints;

the proximity of patients to trial sites;

the design of the trial;

our ability to recruit clinical trial investigators with the appropriate competencies and expertise;

competing clinical trials for similar or alternate therapeutic treatments;

clinician’s and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies;

our ability to obtain and maintain patient consents;

the risk that patients enrolled in clinical trials will not complete a clinical trial.

In addition, refractory patients,

which several of our trials are enrolling, participating in clinical trials are seriously and often terminally ill and therefore may not

complete the clinical trial due to reasons including comorbid conditions or occurrence of adverse medical events related or unrelated

to the investigational products, or death.

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

in patient enrollment will result in increased costs or affect the timing of our planned trials, which could adversely affect our ability

to advance the development of our product candidates.

FDA may take actions that would prolong,

delay, suspend, or terminate clinical trials of our product candidates, which may delay or prevent us from commercializing our product

candidates on a timely basis.

There can be no assurance

that the data generated in our clinical trials will be acceptable to FDA or that if future modifications during the trial are necessary,

that any such modifications will be acceptable to FDA.

Certain modifications to a clinical trial protocol made during the course of the

clinical trial have to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the modification is evaluated.

In addition, depending on the quantity and nature of the changes made, FDA could take the position that some or all of the data generated

by the clinical trial is not usable because the same protocol was not used throughout the trial.

This might require the enrollment of

additional subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product candidate.

the FDA believes that its prior approval is required for a particular modification, it can delay or halt a clinical trial while it evaluates

additional information regarding the change.

Any delay or termination of

our current or future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required

approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays

or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase in

costs and delays in the filing of any submissions with the FDA, delay the approval and commercialization of our product candidates or

result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

Lengthy delays

in the completion of our Iomab-B clinical trials would adversely affect our business and prospects and could cause us to cease operations.

We have obtained orphan drug designation

in the United States and European Union 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 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.

also require a REMS 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

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

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;

fines, warning letters or holds on clinical trials;

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

product seizure or detention, or refusal to permit the import or export of our product candidates;

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.

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

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

In the United States, there

have been a number of legislative and regulatory initiatives focused on containing the cost of healthcare.

The Affordable Care Act, for

example, substantially changed the way healthcare is financed by both governmental and private insurers.

The Affordable Care Act contains

a number of provisions that could impact our business and operations, primarily, once we obtain FDA approval to commercialize one of our

product candidates in the United States, if ever, and may also affect our operations in ways we cannot currently predict.

Affordable Care

Act provisions that may affect our business include, among others, those governing enrollment in federal healthcare programs, reimbursement

changes, rules regarding prescription drug benefits under health insurance exchanges, expansion of the 340B program, expansion of state

Medicaid programs, fees and increased discount and rebate obligations, transparency and reporting requirements, and fraud and abuse enforcement.

Such changes may impact existing government healthcare programs, industry competition, formulary composition, and may result in the development

of new programs, including Medicare payment for performance initiatives, health technology assessments, and improvements to the physician

quality reporting system and feedback program.

There have been significant

ongoing judicial, administrative, executive, and legislative initiatives to modify, limit, replace, or repeal the Affordable Care Act.

For example, former President Trump issued several Executive Orders and other directives designed to delay the implementation of certain

provisions of the Affordable Care Act or otherwise circumvent some of the requirements for health insurance mandated by the Affordable

Concurrently, Congress considered legislation that would repeal or replace all or part of the Affordable Care Act.

While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation the Affordable Care Act have

For example, the Tax Cuts and Jobs Act of 2017 eliminated the Affordable Care Act provision requiring individuals to purchase

and maintain health coverage, or the “individual mandate,” by reducing the associated penalty to zero, beginning in 2019.

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 Act.

Supreme Court is currently reviewing the case.

While Congress

has not passed comprehensive repeal legislation, several bills affecting the implementation the Affordable Care Act have been passed.

For example, the Tax Cuts and Jobs Act of 2017 eliminated the Affordable Care Act provision requiring individuals to purchase and maintain

health coverage, or the “individual mandate,” by reducing the associated penalty to zero, beginning in 2019.

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.

Supreme Court

is currently reviewing the case.

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

There is no way to predict whether, and to what extent, if any, the Affordable Care Act will remain in-effect in the future, and it is

unclear how these decisions, subsequent appeals, or other efforts to repeal and replace the Affordable Care Act will impact the United

States healthcare industry or our business.

we cannot predict what reform measures the Biden administration will implement in connection with the Affordable Care Act or otherwise.

The adoption or implementation of new or amended legislation at the federal or state level could affect our ability to obtain regulatory

approval for any of our vaccine candidates and the commercial viability of our future approved products, if any.

We cannot predict the

ultimate nature, timing, or effect of any changes to the Affordable Care Act or other federal and state reform efforts, and there is

no assurance that such efforts will not adversely affect our future business and financial results.

addition to the Affordable Care Act, there have been several recent Congressional inquiries and proposed and enacted federal and state

legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer

patient programs, and reform government program reimbursement methodologies for drug products.

Pharmaceutical product prices have been

the focus of increased scrutiny by the government, including certain state attorneys general, members of Congress and the United States

Department of Justice.

State or federal healthcare reform measures or other social or political pressure to lower the cost of pharmaceutical

products could have a material adverse impact on our business, results of operations and financial condition.

relationships with customers, health care professionals and third-party payors may be subject to applicable healthcare laws, which could

expose us to penalties, including administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion from participation

in federal healthcare programs such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of our operations and

diminished future profits and earnings.

professionals and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which

we obtain marketing approval.

Our current and future arrangements with customers, healthcare professionals and third-party payors may

expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial

arrangements and relationships through which we conduct research, market, sell and distribute any products for which we obtain marketing

Federal and state healthcare laws and regulations that may affect our operations, directly or indirectly, include the following,

among others:

federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting,

offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral

of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment

may be made under federal and state healthcare programs such as Medicare and Medicaid;

federal false claims laws, including civil whistleblower or qui tam actions under the federal False Claims Act, which impose criminal

and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to

the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal

an obligation to pay money to the federal government;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for

Economic and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing

a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations,

including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare

clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health

information for or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy,

security and transmission of individually identifiable health information;

federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare

or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection

of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an

exception applies;

federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires

certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid

or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments

or other transfers of value provided to physicians and any ownership and investment interests held by physicians or their immediate

family members.

Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and

other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified

registered nurse anesthetists and certified nurse midwives during the previous year;

state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices,

including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or

services reimbursed by any third-party payor, including private insurers;

state laws that require pharmaceutical companies to comply

with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the

United States federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral

state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information

and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities;

and local laws that require the registration of pharmaceutical sales representatives;

and state laws governing the privacy and security

of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted

by federal law, thus complicating compliance efforts.

to comply with applicable healthcare laws and regulations will involve substantial costs.

Interpretations of standards of compliance

under these laws and regulations are rapidly changing and subject to varying interpretations and it is possible that governmental authorities

will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable

fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of these laws or any

other laws that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion

from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations

and oversight (if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with

these laws), and the curtailment or restructuring of our operations, any of which could diminish our future profits or earnings.

of the physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable

laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

payors may not adequately reimburse customers for any of our products that we may commercialize or promote, and may impose coverage restrictions

or limitations such as prior authorizations and step edits that affect their use.

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

for these products and related treatments will be available from government health programs, private health insurers, integrated delivery

networks and other third-party payors.

There is no way to predict

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

subsequent appeals, or other efforts to repeal and replace the Affordable Care Act will impact the United States healthcare industry or

our business.

Furthermore, we cannot predict

what reform measures the Biden administration will implement in connection with the Affordable Care Act or otherwise.

The adoption or

implementation of new or amended legislation at the federal or state level could affect our ability to obtain regulatory approval for

any of our vaccine candidates and the commercial viability of our future approved products, if any.

We cannot predict the ultimate nature,

timing, or effect of any changes to the Affordable Care Act or other federal and state reform efforts, and there is no assurance that

such efforts will not adversely affect our future business and financial results.

In addition to the Affordable

Care Act, there have been several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among

other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and

reform government program reimbursement methodologies for drug products.

Pharmaceutical product prices have been the focus of increased

scrutiny by the government, including certain state attorneys general, members of Congress and the United States Department of Justice.

State or federal healthcare reform measures or other social or political pressure to lower the cost of pharmaceutical products could have

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

Our relationships with customers, health

care professionals and third-party payors may be subject to applicable healthcare laws, which could expose us to penalties, including

administrative, civil or criminal penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs

such as Medicare and Medicaid, reputational harm, the curtailment or restructuring of our operations and diminished future profits and

Healthcare professionals and

third-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing

Our current and future arrangements with customers, healthcare professionals and third-party payors may expose us to broadly

applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships

through which we conduct research, market, sell and distribute any products for which we obtain marketing approval.

Federal and state

healthcare laws and regulations that may affect our operations, directly or indirectly, include the following, among others:

the federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;

the federal false claims laws, including civil whistleblower or qui tam actions under the federal False Claims Act, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

the federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value provided to physicians and any ownership and investment interests held by physicians or their immediate family members.

Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year;

analogous state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the United States federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities;

state and local laws that require the registration of pharmaceutical sales representatives;

and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance efforts.

Efforts to comply with applicable

healthcare laws and regulations will involve substantial costs.

Interpretations of standards of compliance under these laws and regulations

are rapidly changing and subject to varying interpretations and it is possible that governmental authorities will conclude that our business

practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare

laws and regulations.

If our operations are found to be in violation of any of these laws or any other laws that may apply to us, we may

be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs,

such as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations and oversight (if we become subject to

a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws), and the curtailment or restructuring

of our operations, any of which could diminish our future profits or earnings.

If any of the physicians or other providers or entities

with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative

sanctions, including exclusions from government funded healthcare programs.

Third-party payors may not adequately reimburse

customers for any of our products that we may commercialize or promote, and may impose coverage restrictions or limitations such as prior

authorizations and step edits that affect their use.

Our ability to commercialize

any product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products

and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other

third-party payors.

Third-party payors decide which medications they will pay for and establish reimbursement levels.

A significant trend in the United States healthcare industry and elsewhere is cost containment.

Government authorities and third-party

payors have attempted to control costs by limiting coverage and the amount of payment for particular medications.

Increasingly, third-party

payors are requiring that drug companies provide predetermined discounts from list prices and are challenging the prices charged for

medical products.

Coverage and reimbursement may not be available for any product that we commercialize and, if reimbursement is available,

the level of reimbursement may not be sufficient for commercial success.

Coverage and reimbursement may impact the demand for, or the

price of, any product candidate for which we obtain marketing approval.

If coverage and reimbursement is not available or is available

only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

reimbursement approval for any product candidate for which we obtain marketing approval from any government or other third-party payor

is a time-consuming and costly process.

There may be significant delays in obtaining coverage and adequate reimbursement for newly approved

Moreover, eligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a

rate that covers our costs, including research, development, manufacture, sale and distribution.

Even when a payor determines that a

product that we may commercialize or promote is eligible for reimbursement under its criteria, the payor may impose coverage limitations

that preclude payment for some uses that are approved by the FDA, or may impose restrictions, such as prior authorization requirements,

or may simply deny coverage altogether.

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

our costs and may not be made permanent.

Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances

under which it is used may be based on reimbursement levels already set for lower cost products or procedures or may be incorporated

into existing payments for other services.

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

healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where

they may be sold at lower prices than in the United States.

Furthermore, the Centers for Medicare and Medicaid Services frequently change

product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values.

Commercial third-party

payors often rely upon Medicare coverage policies and payment limitations in setting their own reimbursement policies.

Our inability

to promptly obtain and maintain coverage and profitable payment rates from both government-funded programs and private payors for any

approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed

to commercialize our approved products and our overall financial condition.

Related to Third Parties

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.

do not have the ability to independently conduct our 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.

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.

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.

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.

addition, our third-party contractors are not our employees, and except for remedies available to us under our agreements with such third-party

contractors, we cannot control whether or not they devote sufficient time and resources to our programs.

If these third parties do not

successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of

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

our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able

to obtain regulatory approval for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business,

operating results and prospects would be adversely affected.

antibodies we use in our antibody radiation-conjugate product candidates may be subject to generic competition.

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.

Our product candidates are regulated by the FDA as biologic products and we intend to

seek approval for these products pursuant to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created

an abbreviated pathway for the approval of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway establishes

legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable”

based on its similarity to an existing brand product.

Under the BPCIA, an application for a biosimilar product cannot be approved by

the FDA until 12 years after the original branded product was approved under a BLA.

The law is complex and is still being interpreted

and implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

Even if a biosimilar

gets approved for one of the antibodies that we use, the final constructs of our drug candidates consist of an antibody, radioisotope

and in some cases a linker.

Therefore, we do not believe that the final drug product of our candidates can be subject to competition

from a biosimilar as outlined in BPCIA.

product candidates may never achieve market acceptance.

CD33 ARC program candidates and future product candidates that we may develop may never gain market acceptance among physicians, patients

and the medical community.

The degree of market acceptance of any of our products will depend on a number of factors, including the actual

and perceived effectiveness and reliability of the product;

A significant trend

in the United States healthcare industry and elsewhere is cost containment.

Government authorities and third-party payors have attempted

to control costs by limiting coverage and the amount of payment for particular medications.

Increasingly, third-party payors are requiring

that drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products.

and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement

may not be sufficient for commercial success.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate

for which we obtain marketing approval.

If coverage and reimbursement is not available or is available only to limited levels, we may

not be able to successfully commercialize any product candidate for which we obtain marketing approval.

Obtaining reimbursement approval

for any product candidate for which we obtain marketing approval from any government or other third-party payor is a time-consuming and

costly process.

There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products.

eligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our

costs, including research, development, manufacture, sale and distribution.

Even when a payor determines that a product that we may commercialize

or promote is eligible for reimbursement under its criteria, the payor may impose coverage limitations that preclude payment for some

uses that are approved by the FDA, or may impose restrictions, such as prior authorization requirements, or may simply deny coverage altogether.

Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under which it is used may be

based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing payments for other

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private

payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices

than in the United States.

Furthermore, the Centers for Medicare and Medicaid Services frequently change product descriptors, coverage

policies, product and service codes, payment methodologies and reimbursement values.

Commercial third-party payors often rely upon Medicare

coverage policies and payment limitations in setting their own reimbursement policies.

Our inability to promptly obtain and maintain coverage

and profitable payment rates from both government-funded programs and private payors for any approved products that we develop could have

a material adverse effect on our operating results, our ability to raise capital needed to commercialize our approved products and our

overall financial condition.

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 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.

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.

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

contractors are not our employees, and except for remedies available to us under our agreements with such third-party contractors, we

cannot control whether or not they devote sufficient time and resources to our programs.

If these third parties do not successfully carry

out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain

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

development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory

approval for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results

and prospects would be adversely affected.

The antibodies we use in our antibody 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 product

Our product candidates are regulated by the FDA as biologic products and we intend to seek approval for these products pursuant

to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated pathway for the approval

of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway establishes legal authority for the FDA to review

and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity

to an existing brand product.

Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after

the original branded product was approved under a BLA.

The law is complex and is still being interpreted and implemented by the FDA.

a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

Even if a biosimilar gets approved for one of the

antibodies that we use, the final constructs of our drug candidates consist of an antibody, radioisotope and in some cases a linker.

we do not believe that the final drug product of our candidates can be subject to competition from a biosimilar as outlined in BPCIA.

Our product candidates may never achieve

market acceptance.

Iomab-B, CD33 ARC program

candidates and future product candidates that we may develop may never gain market acceptance among physicians, patients and the medical

The degree of market acceptance of any of our products will depend on a number of factors, including the actual and perceived

effectiveness and reliability of the product;

the results of any long-term clinical trials relating to use of the product;

the availability, relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments

using the product are approved for reimbursement by public and private insurers;

the availability,

relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product

are approved for reimbursement by public and private insurers;

the strength of our marketing and distribution infrastructure;

and the level of education and awareness among physicians and hospitals concerning the product.

believe that oncologists and other physicians will not widely adopt a product candidate unless they determine, based on experience, clinical

data, and published peer-reviewed journal articles, that the use of that product candidate provides an effective alternative to other

means of treating specific cancers.

Patient studies or clinical experience may indicate that treatment with our product candidates does

not provide patients with sufficient benefits in extension of life or quality of life.

We believe that recommendations and support for

the use of each product candidate from influential physicians will be essential for widespread market acceptance.

Our product candidates

are still in the development stage and it is premature to attempt to gain support from physicians at this time.

We can provide no assurance

that such support will ever be obtained.

If our product candidates do not receive such support from these physicians and from long-term

data, physicians may not use or continue to use, and hospitals may not purchase or continue to purchase, them.

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.

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.

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.

currently depend on single third-party manufacturers to produce our pre-clinical and clinical trial drug supplies.

Any disruption in

the operations of our current third-party manufacturers, or other third-party manufacturers we may engage in the future, could adversely

affect our business and results of operations.

do not currently operate manufacturing facilities for pre-clinical or clinical production of any of our product candidates.

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.

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.

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.

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;

level of education and awareness among physicians and hospitals concerning the product.

We believe that oncologists

and other physicians will not widely adopt a product candidate unless they determine, based on experience, clinical data, and published

peer-reviewed journal articles, that the use of that product candidate provides an effective alternative to other means of treating specific

Patient studies or clinical experience may indicate that treatment with our product candidates does not provide patients with

sufficient benefits in extension of life or quality of life.

We believe that recommendations and support for the use of each product candidate

from influential physicians will be essential for widespread market acceptance.

Our product candidates are still in the development stage

and it is premature to attempt to gain support from physicians at this time.

We can provide no assurance that such support will ever be

If our product candidates do not receive such support from these physicians 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 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 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 single third-party

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

Any disruption in the operations of our current third-party

manufacturers, 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’

compliance with these regulations and standards.

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.

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.

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.

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.

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

commercial product may require financial commitment or investment by us, which we may not have sufficient capital for or may elect not

to undertake.

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.

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.

may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.

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 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

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

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.

Significant scale-up of manufacturing may

require additional validation studies, which the FDA must review and approve.

Scale-up for commercial product may require financial commitment

or investment by us, which we may not have sufficient capital for or may elect not to undertake.

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.

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 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;

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.

face significant competition from other biotechnology and pharmaceutical companies.

product candidates 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

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.

side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and

could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.

The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in

potential product liability claims.

We face significant competition from other

biotechnology and pharmaceutical companies.

Our product candidates 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 caused

by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more

restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.

The drug-related side

effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability

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

Even if any of our product candidates receives marketing approval, as greater numbers of patients use a product following its approval,

an increase in the incidence of side effects or the incidence of other post-approval problems that were not seen or anticipated during

pre-approval clinical trials could result in a number of potentially significant negative consequences, including:

authorities may withdraw their approval of the product;

authorities may require the addition of labeling statements, such as warnings or contraindications;

may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

may elect, or we may be required, to recall or withdraw product from the market;

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

reputation may suffer.

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.

Related to Our Intellectual Property

depend upon securing and protecting critical intellectual property.

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.

patent position is highly uncertain and involves complex legal and factual questions.

we cannot predict the breadth of claims that may be allowed or enforced under our patents or in third-party patents.

For example, we

or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents;

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

others may independently develop

similar or alternative technologies or duplicate any of our technologies;

it is possible that none of our pending patent applications

or the pending patent applications of our licensors will result in issued patents;

our issued patents and issued patents of our licensors

may not provide a basis for commercially viable technologies, or may not provide us with any competitive advantages, or may be challenged

and invalidated by third parties;

and, we may not develop additional proprietary technologies that are patentable.

a result, our owned and licensed patents may not be valid, and we may not be able to obtain and enforce patents and to maintain trade

secret protection for the full commercial extent of our technology.

The extent to which we are unable to do so could materially harm

our business.

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.

Furthermore, it is possible that patents issued or licensed to us may be challenged successfully.

In that event, if we have a preferred

competitive position because of such patents, such preferred position would be lost.

If we are unable to secure or to continue to maintain

a preferred position, we could become subject to competition from the sale of generic products.

Failure to receive, inability to protect,

or expiration of our patents for medical use, manufacture, conjugation and labeling of Ac-225, the antibodies that we license from third

parties, or subsequent related filings, would adversely affect our business and operations.

issued or licensed to us may be infringed by the products or processes of others.

The cost of enforcing our patent rights against infringers,

if such enforcement is required, could be significant, and we do not currently have the financial resources to fund such litigation.

Further, such litigation can go on for years and the time demands could interfere with our normal operations.

There has been substantial

litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry.

We may become

a party to patent litigation and other proceedings.

The cost to us of any patent litigation, even if resolved in our favor, could be

Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their

substantially greater financial resources.

Even if any of our product candidates

receives marketing approval, as greater numbers of patients use a product following its approval, an increase in the incidence of side

effects or the incidence of other post-approval problems that were not seen or anticipated during pre-approval clinical trials could result

in a number of potentially significant negative consequences, including:

regulatory authorities may withdraw their approval of the product;

regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

we may elect, or we may be required, to recall or withdraw product from the market;

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

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.

Risks Related to Our Intellectual Property

We depend upon securing and protecting critical

intellectual property.

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

and involves complex legal and factual questions.

Accordingly, we cannot predict

the breadth of claims that may be allowed or enforced under our patents or in third-party patents.

For example, we or our licensors might

not have been the first to make the inventions covered by each of our pending patent applications and issued patents;

we or our licensors

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

others may independently develop similar or alternative

technologies or duplicate any of our technologies;

it is possible that none of our pending patent applications or the pending patent applications

of our licensors will result in issued patents;

our issued patents and issued patents of our licensors may not provide a basis for commercially

viable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties;

we may not develop additional proprietary technologies that are patentable.

As a result, our owned and

licensed patents may not be valid, and we may not be able to obtain and enforce patents and to maintain trade secret protection for the

full commercial extent of our technology.

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.

Furthermore, it is possible that

patents issued or licensed to us may be challenged successfully.

In that event, if we have a preferred competitive position because of

such patents, such preferred position would be lost.

If we are unable to secure or to continue to maintain a preferred position, we could

become subject to competition from the sale of generic products.

Failure to receive, inability to protect, or expiration of our patents

for medical use, manufacture, conjugation and labeling of Ac-225, the antibodies that we license from third parties, or subsequent related

filings, would adversely affect our business and operations.

Patents issued or licensed

to us may be infringed by the products or processes of others.

The cost of enforcing our patent rights against infringers, if such enforcement

is required, could be significant, and we do not currently have the financial resources to fund such litigation.

Further, such litigation

can go on for years and the time demands could interfere with our normal operations.

There has been substantial litigation and other proceedings

regarding patent and other intellectual property rights in the pharmaceutical industry.

We may become a party to patent litigation and

other proceedings.

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

Some of our competitors

may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financial resources.

Litigation may also absorb significant management time.

trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial

Although we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret

laws and the use of confidentiality agreements with our partners, collaborators, employees and consultants and other appropriate means,

these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently,

or obtain access to, the same or similar information.

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.

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.

manufacturing processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors,

universities or others, or the trade secrets of those persons and entities.

As the pharmaceutical industry expands and more patents are

issued, the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade

secrets of others.

These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing,

manufacturing and marketing of the affected product or process.

If any of these actions are successful, in addition to any potential

liability for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market

the affected product or use the affected process.

Required licenses may not be available on acceptable terms, if at all, and the results

of litigation are uncertain.

If we become involved in litigation or other proceedings, it could consume a substantial portion of our

financial resources and the efforts of our personnel.

ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents.

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 invention.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others

from making and/or using its invention.

While a patent gives the holder this right to exclude others, it is not a license to commercialize

the invention where other permissions may be required for commercialization to occur.

For example, a drug cannot be marketed without

the appropriate authorization from the FDA, regardless of the existence of a patent covering the product.

Further, the invention, even

if patented itself, cannot be commercialized if it infringes the valid patent rights of another party.

rely on confidentiality agreements to protect our trade secrets.

If these agreements are breached by our employees or other parties,

our trade secrets may become known to our competitors.

rely on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties.

If these agreements

are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us.

We may not have any remedies

against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate us for

the damaging disclosure.

In addition, we may have to expend resources to protect our interests from possible infringement by others.

use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain compliance

costs on us and may subject us to liability for claims arising from the use or misuse of these materials.

research, development and manufacturing activities involve the controlled use of hazardous materials, including chemicals, radioactive

and biological materials, such as radioactive isotopes.

We are subject to federal, state, local and foreign environmental laws and regulations

governing, among other matters, the handling, storage, use and disposal of these materials and some waste products.

We cannot completely

eliminate the risk of contamination or injury from these materials and we could be held liable for any damages that result, which could

exceed our financial resources.

Unpatented trade secrets,

improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success.

we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of

confidentiality agreements with our partners, collaborators, employees and consultants and other appropriate means, these measures may

not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, 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.

Our manufacturing processes

and potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities or others,

or the trade secrets of those persons and entities.

As the pharmaceutical industry expands and more patents are issued, the risk increases

that our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others.

persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the

affected product or process.

If any of these actions are successful, in addition to any potential liability for damages, we could be required

to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process.

Required licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain.

If we become involved

in litigation or other proceedings, it could consume a substantial portion of 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 invention.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using its invention.

While a patent gives the holder this right to exclude others, it is not a license to commercialize the invention where other permissions

may be required for commercialization to occur.

For example, a drug cannot be marketed without the appropriate authorization from the

FDA, regardless of the existence of a patent covering the product.

Further, the invention, even if patented itself, cannot be commercialized

if it infringes the valid patent rights of another party.

We rely on confidentiality agreements to

protect our trade secrets.

If these agreements are breached by our employees or other parties, our trade secrets may become known to our

We rely on trade secrets that

we seek to protect through confidentiality agreements with our employees and other parties.

If these agreements are breached, our competitors

may obtain and use our trade secrets to gain a competitive advantage over us.

We may not have any remedies against our competitors and

any remedies that may be available to us may not be adequate to protect our business or compensate us for the damaging disclosure.

addition, we may have to expend resources to protect our interests from possible infringement by others.

The use of hazardous materials, including

radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us

to liability for claims arising from the use or misuse of these materials.

Our research, development

and manufacturing activities involve the controlled use of hazardous materials, including chemicals, radioactive and biological materials,

such as radioactive isotopes.

We are subject to federal, state, local and foreign environmental laws and regulations governing, among

other matters, the handling, storage, use and disposal of these materials and some waste products.

We cannot completely eliminate the

risk of contamination or injury from these materials and we could be held liable for any damages that result, which could exceed our financial

We currently maintain insurance coverage for injuries resulting from the hazardous materials we use;

however, future claims may exceed the amount of our coverage.

however, future claims

may exceed the amount of our coverage.

Also, we do not have insurance coverage for pollution cleanup and removal.

Currently the costs of complying with such federal, state, local and foreign environmental regulations are not significant, and consist

primarily of waste disposal expenses.

However, they could become expensive, and current or future environmental laws or regulations may

impair our research, development, production and commercialization efforts.

may undertake international operations, which will subject us to risks inherent with operations outside of the United States.

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.

However, even with the cooperating of a commercialization partner, conducting drug development in

foreign countries involves inherent risks, including, but not limited to difficulties in staffing, funding and managing foreign operations;

unexpected changes in regulatory requirements;

Currently the costs

of complying with such federal, state, local and foreign environmental regulations are not significant, and consist primarily of waste

disposal expenses.

However, they could become expensive, and current or future environmental laws or regulations may impair our research,

development, production and commercialization efforts.

We may undertake international operations,

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 significant

opportunities.

However, even with the cooperating of a commercialization partner, conducting drug development in foreign countries involves

inherent risks, including, but not limited to difficulties in staffing, funding and managing foreign operations;

unexpected changes in

regulatory requirements;

export restrictions;

tariffs and other trade barriers;

difficulties in protecting, acquiring,

enforcing and litigating intellectual property rights;

difficulties in protecting, acquiring, enforcing and litigating

intellectual property rights;

fluctuations in currency exchange rates;

and potentially adverse tax consequences.

we were to experience any of the difficulties listed above, or any other difficulties, any international development activities and our

overall financial condition may suffer and cause us to reduce or discontinue our international development and registration efforts.

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.

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.

If any member of our current senior management terminates their employment with us

and we are unable to find a suitable replacement quickly, the departure could have a material adverse effect on our business.

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.

our growth as we expand operations may strain our resources.

If we were to experience any

of the difficulties listed above, or any other difficulties, any international development activities and our overall financial 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 upon

to manage our business.

If any member of our current senior management terminates their employment with us and we are unable 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

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

8 unchanged sentences

Failure to manage growth effectively could materially harm our business, financial condition or results of operations.

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.

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 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;

diverting our management’s

attention away from other business concerns;

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.

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;

difficulties in assimilating

acquired technologies or the operations of the acquired companies;

diverting our management’s attention away from other business

risks of entering markets in which we have limited or no direct experience;

and the potential

loss of our key employees or key employees of the acquired companies.

can make no assurances that any acquisition will result in short-term or long-term benefits to us.

We may incorrectly judge the value

or worth of an acquired product, company or business.

In addition, our future success would depend in part on our ability to manage the

rapid growth associated with some of these acquisitions.

We cannot assure that we will be able to make the combination of our business

with that of acquired products, businesses or companies work or be successful.

Furthermore, the development or expansion of our business

or any acquired products, business or companies may require a substantial capital investment by us.

We may not have these necessary funds,

or they might not be available to us on acceptable terms or at all.

We may also seek to raise funds by selling shares of our preferred

or common stock, which could dilute each current stockholder’s ownership interest in the Company.

Related to Ownership of Our Common Stock

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.

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.

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.

In addition, our business strategy may include expansion through internal growth or by establishing

strategic relationships with targeted customers and vendors.

In order to do so, or to finance the cost of our other activities, we may

issue additional equity securities that could dilute our stockholders’ stock ownership.

We may also assume additional debt and

incur impairment losses related to goodwill and other tangible assets if we acquire another company and this could negatively impact

our earnings and results of operations.

common stock is subject to price volatility which could lead to losses by stockholders and potential costly security litigation.

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

in the economy and the financial markets or other developments affecting our competitors or us.

This volatility has had a significant

effect on the market price of securities issued by many companies for reasons unrelated to their operating performance and could have

the same effect on our common stock.

trading price of our common stock may be highly volatile and could fluctuate in response to factors such as:

or anticipated variations in our operating results;

announcements

of developments by us or our competitors;

timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

actions regarding our products;

announcements

by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

of new accounting standards affecting our industry;

or departures of key personnel;

of new products by us or our competitors;

of our common stock or other securities in the open market;

events or factors, many of which are beyond our control.

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.

do not intend to pay dividends on our common stock, so any returns will be determined by the value of our common stock.

have never declared or paid any cash dividends on our common stock.

For the foreseeable future, it is expected that earnings, if any,

generated from our operations will be used to finance the growth of our business, and that no dividends will be paid to holders of our

and the potential loss of our key employees or key

employees of the acquired companies.

We can make no assurances

that any acquisition will result in short-term or long-term benefits to us.

We may incorrectly judge the value or worth of an acquired

product, company or business.

In addition, our future success would depend in part on our ability to manage the rapid growth associated

with some of these acquisitions.

We cannot assure that we will be able to make the combination of our business with that of acquired products,

businesses or companies work or be successful.

Furthermore, the development or expansion of our business or any acquired products, business

or companies may require a substantial capital investment by us.

We may not have these necessary funds, or they might not be available

to us on acceptable terms or at all.

We may also seek to raise funds by selling shares of our preferred 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 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.

In addition, our business strategy may include expansion through internal growth or by establishing strategic relationships

with targeted customers and vendors.

In order to do so, or to finance the cost of our other activities, we may issue additional equity

securities that could dilute our stockholders’ stock ownership.

We may also assume additional debt and incur impairment losses related

to goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results of operations.

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, quarterly operating

results of other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and

the financial markets or other developments affecting our competitors or us.

This volatility has had a significant effect on the market

price of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our

common stock.

As a result, the success of an investment in our common stock will depend upon any future appreciation in its value.

is no guarantee that our common stock will appreciate in value.

provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and

make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest.

of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control

or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions

that our stockholders might otherwise deem to be in their best interests.

Therefore, these provisions could adversely affect the price

of our stock.

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;

announcements of developments by us or our competitors;

the timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

regulatory actions regarding our products;

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

adoption of new accounting standards affecting our industry;

additions or departures of key personnel;

introduction of new products by us or our competitors;

sales of our common stock or other securities in the open market;

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

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 or

paid any cash dividends on our common stock.

For the foreseeable future, it is expected that earnings, if any, generated from our operations

will be used to finance the growth of our business, and that no dividends will be paid to holders of our common stock.

As a result, the

success of an investment in our common stock will depend upon any future appreciation in its value.

There is no guarantee that our common

stock will appreciate in value.

Certain provisions of our Certificate of

Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to

complete, even if such a transaction were in our stockholders’ interest.

Provisions of our certificate

of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our

management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our

stockholders might otherwise deem to be in their best interests.

Therefore, these provisions could adversely affect the price of our stock.

Among other things, the certificate of incorporation and bylaws:

that the authorized number of directors may be changed by resolution of the board of directors;

that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative

vote of a majority of directors then in office, even if less than a quorum;

the board of directors into three classes;

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;

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.

A “business combination” 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.

with the reporting requirements of federal securities laws can be expensive.

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.

ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

ability to utilize our federal net operating loss and tax credit carryforwards may be limited under Sections 382 and 383 of the Internal

Revenue Code of 1986, as amended, or the Code.

The limitations apply if we experience an “ownership change”, generally

defined as a greater than 50 percentage point change in the ownership of our equity by certain stockholders over a rolling three-year

Similar provisions of state tax law may also apply.

We have not assessed whether such an ownership change has previously

If we have experienced an ownership change at any time since our formation, we may already be subject to limitations on

our ability to utilize our existing net operating losses and other tax attributes to offset taxable income.

In addition, future changes

in our stock ownership, which may be outside of our control, may trigger an ownership change and, consequently, the limitations under

Sections 382 and 383 of the Code.

As a result, if or when we earn net taxable income, our ability to use our pre-change net operating

loss carryforwards and other tax attributes to offset such taxable income may be subject to limitations, which could adversely affect

our future cash flows.

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.

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.

internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.

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, 2020 and 2019 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.

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.

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.

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.

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.

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.

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 the Securities Act of 1933, as amended.

In addition, our amended and restated bylaws, as amended, state that

any person purchasing or otherwise acquiring any interest in our security shall be deemed to have notice of and to have consented to

such provision.

Such choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds

favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits, if successful, might

benefit our stockholders.

Stockholders who do bring a claim in the federal district courts of the United States of America could face

additional litigation costs in pursuing any such claim.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

provide that the authorized number of directors may be changed by resolution of the board of directors;

provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

divide the board of directors into three classes;

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” 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.

A “business combination” 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.

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.

Our ability to utilize our net operating

loss carryforwards and certain other tax attributes may be limited.

Our ability to utilize our

federal net operating loss and tax credit carryforwards may be limited under Sections 382 and 383 of the Internal Revenue Code of 1986,

as amended, or the Code.

The limitations apply if we experience an “ownership change”, generally defined as a greater

than 50 percentage point change in the ownership of our equity by certain stockholders over a rolling three-year period.

provisions of state tax law may also apply.

We have not assessed whether such an ownership change has previously occurred.

have experienced an ownership change at any time since our formation, we may already be subject to limitations on our ability to utilize

our existing net operating losses and other tax attributes to offset taxable income.

In addition, future changes in our stock ownership,

which may be outside of our control, may trigger an ownership change and, consequently, the limitations under Sections 382 and 383 of

As a result, if or when we earn net taxable income, our ability to use our pre-change net operating loss carryforwards

and other tax attributes to offset such taxable income may be subject to limitations, which could 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.

with Section 404 at December 31, 2020 and 2019 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

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 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 the Securities

Act of 1933, as amended.

In addition, our amended and restated bylaws, as amended, state that any person purchasing or otherwise acquiring

any interest in our security shall be deemed to have notice of and to have consented to such provision.

Such choice of forum provision

may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors,

officers or other employees, which may discourage such lawsuits, if successful, might benefit our stockholders.

Stockholders who do bring

a claim in the federal district courts of the United States of America could face additional litigation costs in pursuing any such claim.

UNREGISTERED SALES OF EQUITY SECURITIES

AND USE OF PROCEEDS.

DEFAULTS UPON SENIOR SECURITIES.

1 unchanged sentence

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What changed 10-Q

Item 1A. Risk Factors