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Item 1A. Risk Factors

2022-05-13 compared with 2021-11-12 · 564 added, 453 removed, 1087 unchanged (48% of the section changed)

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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.

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, 2021.

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.

either alone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely

affect the value of an investment in our company.

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

Additional risks

not currently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair

our business operations.

risks 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:

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.

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

We encourage you to carefully review the full risk factors contained in this Annual Report on Form 10-K in their entirety

for additional information regarding the material factors that make an investment in our securities speculative or risky.

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

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 may not be 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;

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.;

Healthcare legislative reform measures intended

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

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.

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 the demand for talent

in the biotechnology industry is highly competitive;

if we are not successful in attracting and retaining highly qualified personnel,

we may not be able to successfully implement or execute 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

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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.

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.

As of March 31, 2022 and December 31, 2021, we had an accumulated deficit of

$260.9 million and $255.7 million, respectively.

We reported a net loss of $5.1 million and $5.3 million for the three months ended March

31, 2022 and 2021, respectively.

We expect to continue to operate at a net loss as we continue our research and development efforts, continue

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

There can be no assurance that the

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

Furthermore, there can be no assurance that

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

financial condition and results of operation.

If we fail to obtain additional financing,

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In August 2020, we entered

into the Capital on Demand™ Sales Agreement with JonesTrading, pursuant to which we may sell, from time to time, through or to JonesTrading,

up to an aggregate of $200 million of our common stock.

Shares of common stock are offered pursuant to our shelf registration statement

filed with the SEC on August 7, 2020.

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

into the Capital on Demand™ Sales Agreement with JonesTrading, pursuant to which we may sell, from time to time, through or to

JonesTrading, up to an aggregate of $200 million of our common stock.

Shares of common stock are offered pursuant to our shelf registration

statement filed with the SEC on August 7, 2020.

For the year ended December 31, 2021, we sold 4.6 million shares of common stock, resulting

in net proceeds of $35.3 million.

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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

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.

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

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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 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;

the time and cost

necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative,

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will be materially adversely affected.

We are highly dependent on the success of

Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may not

result in the data necessary to receive regulatory approval.

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 are highly dependent on the success

of Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may

not result in the data necessary to receive regulatory approval.

We have 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.

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

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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

continue to operate our business may also be limited.

These restrictions may result in a period of business, supply and drug product manufacturing

disruption, and in reduced operations, any of which could materially affect our business, financial condition and results of operations.

To date, we have not experienced a significant disruption or delay in our operations as it relates to the clinical development of our

drug candidates.

Such government-imposed precautionary measures may have been relaxed in certain countries or states, but there is no

assurance that more strict measures will be put in place again due to a resurgence in COVID-19 cases, including those involving new variants

of the coronavirus, which may be more contagious and deadly than prior strains.

Therefore, the COVID-19 pandemic may continue to affect

our operation, may further divert the attention and efforts of the medical community to coping with COVID-19 and disrupt the marketplace

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

The spread of COVID-19, 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.

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 Omicron variant

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

The full impact of the Omicron variant,

or any subsequent 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 Omicron 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.

Many countries around the

world have continued to impose quarantines and restrictions on travel and mass gatherings to slow the spread of the virus.

our ability to continue to operate our business may also be limited.

Such events may result in a period of business, supply and drug

product manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and

results of operations.

In response to COVID-19, we implemented remote working and thus far have not experienced a significant disruption

or delay in our operations as it relates to the clinical development of our drug candidates.

Such government-imposed precautionary measures

may have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again

due to a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly

than prior strains.

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

of the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect

on our operations.

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.

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 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, which may result in delays or hinder our ability to collect data from our

clinical trials.

Additionally, COVID-19 may

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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.

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

operations and financial results during 2022 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

2022 and beyond.

Our business is subject to cybersecurity

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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;

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

damage to our reputation with our potential partners, patients and

exposure to litigation;

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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

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

and others with which our systems may connect and communicate.

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

a period time.

We have cybersecurity insurance

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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.

Any cyber incident could have a material adverse effect on

our business, financial condition and results of operations.

Risks Related to Regulation

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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.

Our products are subject

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

The process of seeking regulatory

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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.

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.

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.

We have not demonstrated that any of our

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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

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.

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

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as well as their respective implementing regulations.

Such products and product candidates are also subject to other federal, state, and

local statutes and 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;

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;

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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.

In December 2015, the FDA

cleared our IND filing for Iomab-B and we have completed patient enrollment of 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 is expected to form the basis for a BLA for Iomab-B for use in preparing

and conditioning AML patients for a BMT.

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 apamistamab antibody (formerly known as BC8) we licensed.

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

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

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

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

at least, several years to complete.

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

us to abandon or repeat clinical trials.

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

of subsequent clinical trials.

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

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

And, preclinical

and clinical data are often susceptible to multiple interpretations and analyses.

Many companies that have believed their product candidates

performed satisfactorily in preclinical studies and clinical trials have, nonetheless, failed to obtain marketing approval of their products.

Success in preclinical testing and early clinical trials does not ensure that later clinical trials, which involve many more subjects,

and the results of later clinical trials may not replicate the results of prior clinical trials and preclinical testing.

Any failure or

substantial delay in our product development plans may have a material adverse effect on our business.

We may encounter substantial delays in our

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

We cannot predict whether

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

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

Any of the following could delay or disrupt

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

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 collection or analysis of data from ongoing clinical trials.

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

candidates to fail to receive regulatory approval:

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

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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.

delays in obtaining regulatory agency authorization for the conduct of

our clinical trials;

delays by us or third parties in the collection or analysis

of data from our clinical trials;

delays due to COVID-19 or a similar global health pandemic.

We may suspend, or the FDA

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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:

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,

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

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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.

In June 2012, we acquired

rights to apamistamab, a clinical stage anti-CD45 monoclonal antibody with safety and efficacy data in more than 300 patients in need

Iomab-B is our product candidate that links I-131 to apamistamab that is being studied in the pivotal Phase 3 SIERRA trial.

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

We are also evaluating

Iomab-ACT, which uses a lower dose 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 r/r AML.

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

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.

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.

Clinical trials necessary to support approval

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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.

We worked with the FDA to develop the SIERRA clinical trial 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

endpoints or otherwise produce results that will eventually support the filing or approval of a BLA.

Even if the data from this trial

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

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 lintuzumab-Ac-225 in patients with high-risk

MDS 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.

To date, we have not initiated this clinical trial and we may never elect or be able to do so.

There can be no assurance

that the data generated during the trial will meet our chosen safety and effectiveness endpoints or otherwise produce results that will

eventually support the filing or approval of a BLA.

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

the results of any future clinical trials.

Preliminary, Interim, and “top-line”

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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

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.

For example, at the ASH annual meeting in December 2021,

we presented safety and feasibility data available at the time of data submission from 100% patient enrollment from the SIERRA trial.

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.

Our clinical trials may be open label studies and certain of our clinical development

and or operations staff may review interim or preliminary safety or efficacy data during routine data collection, cleaning and analysis

from time to time.

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 available.

From time to time, we may

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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

preliminary data that we report differ from final 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

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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.

If FDA concludes that the clinical trials for Iomab-B, Actimab-A, 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

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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.

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

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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.

from seeking to replicate and use the apamistamab 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

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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.

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.

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 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

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.

this isotope from the DOE must be renewed yearly, we recently renewed our contract to extend through the end of 2022.

While we expect

this contract will continue to 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 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

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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.

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

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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.

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

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

or may receive in the future.

We have received orphan drug

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

The Fifth Circuit’s

decision on the individual mandate was appealed to the U.S.

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.

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.

On June 17, 2021, the Supreme Court held that the plaintiffs

(comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality

of the Affordable Care Act’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the

district court to dismiss the case.

As a result, the Affordable Care Act will remain in-effect in its current form for the foreseeable

however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions

may have on our business.

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

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

The Biden administration also

introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

For example, on January 28, 2021, President

Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through

the Affordable Care Act marketplace, which began on February 15, 2021, and remained open through August 15, 2021.

The executive order

also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare,

including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that

create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act.

On the legislative

front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid

drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source

drugs, beginning January 1, 2024.

And, in July 2021, the Biden administration released an executive order entitled, “Promoting Competition

in the American Economy,” with multiple provisions aimed at prescription drugs.

In response, on September 9, 2021, HHS released

a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety

of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these

And, in November 2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back

Better Act (H.R.

5376) passed by the House of Representatives on November 19, 2021, which aims to lower prescription drug pricing by,

among other things, allowing Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and Part

B after the drugs have been on the market for a certain number of years and imposing tax penalties on drug manufacturers that refuse to

negotiate pricing with Medicare or increase drug prices “faster than inflation.” If enacted, this bill could have a substantial

impact on our business, particularly once we have commercially available products on the U.S.

market, if ever.

In the coming years, additional

legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies

and the potential success of our vaccine candidates.

Our relationships with customers, health

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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.

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

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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 failure to comply with these regulations may require us to repeat clinical trials,

which would delay the regulatory approval process.

If our consultants, contract

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compliance with these regulations and standards.

We may elect to build or purchase

a manufacturing facility or facilities in the future to operate for the purposes of manufacturing our own products.

We have never built,

owned or operated a manufacturing facility.

There can be no assurances that we will be able to successfully accomplish this and in doing

so we may experience delays, cost overruns, or other problems that could seriously hurt our business.

Even if we successfully build or

purchase a manufacturing facility, we may not realize the expected benefits of these efforts.

We depend on vendors with

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Furthermore, these third-party

contractors, whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shut downs, employee strikes, or

contractors, whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shutdowns, employee strikes, or

any other unforeseeable acts that may delay or limit production.

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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.

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.

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.

In addition to infringement

or other intellectual property claims against us, we may become a party to other patent litigation or proceedings before regulatory agencies,

including post-grant review, inter parties review, interference or re-examination proceedings filed with the U.S.

Patent and Trademark

Office (or similar proceedings before corresponding tribunals in other jurisdictions) that challenge our patent rights or the patent

rights of our licensors.

The costs and efforts of defending our patents or enforcing our proprietary rights in post-issuance administrative

proceedings can be substantial and the outcome can be uncertain.

An adverse determination in these proceedings could weaken or invalidate

the patent claims that cover our technology, which adverse determination could harm our business significantly and dissuade companies

from collaborating with us or permit third parties to directly compete with the same technology.

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

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protect our trade secrets.

If these agreements are breached by our employees or other parties, our trade secrets may become known to our

If these agreements are breached by our employees or other parties, our trade secrets may become known to

our competitors.

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.

we seek to protect through numerous measures, including non-compete and 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.

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.

We have learned that a former employee violated

the non-compete provision of their employment agreement by working for a direct competitor.

This employee, who had access to materials

containing proprietary information and trade secrets, may have been solicited, and until recently, pursuant to actions taken by Actinium,

was employed by a direct competitor.

We intend to fully investigate this matter and, if appropriate, pursue litigation against all parties

that may be involved to protect our confidential information and trade secrets.

Risks Related to Our Operations

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.

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

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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

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.

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.

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,

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opportunities.

However, even with the cooperating of a commercialization partner, conducting drug development in foreign countries involves

However, even with the cooperation 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;

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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.

If we were to experience any

of the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition

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.

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to manage our business.

If any member of our current senior management terminates their employment with us and we are unable to find a

If any member of our current senior management terminates his employment with us and we are unable to find a

suitable replacement quickly, the departure could have a material adverse effect on our business.

An overall tightening and increasingly

competitive labor market has been observed in the U.S.

employment market generally, especially in response to the COVID-19 pandemic.

Specific to the biotechnology industry in which we operate, there is significant demand and competition for highly specialized talent

that we require.

We have experienced high turnover rates, with approximately one third of our employee base turning over or being replaced

A sustained labor shortage or increased turnover rates within our employee base, caused by the COVID-19 pandemic, as a result

of general macroeconomic factors, or due to dynamics within our industry, could lead to increased costs, such as increased wage rates

to attract and retain employees, and could negatively affect our ability to efficiently conduct our clinical development, R&D, business

development and potential regulatory and commercial activities.

If we are unable to hire and retain employees capable of performing at

a high-level, or if mitigation measures we may take to respond to a decrease in labor availability, have unintended negative effects,

our business could be adversely affected.

An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, caused

by the COVID-19 pandemic, general macroeconomic factors or as a result of biotechnology industry dynamics could have a material adverse

impact on our operations, results of operations, liquidity or cash flows.

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.

This activity is likely to create additional demands on the time and attention of our senior management personnel as they

identify, hire, and train external and internal candidates to fill the sizable number of positions required to execute our business plans

including submit a BLA and build a commercial organization.

The market for talent in our industry is very competitive.

Many of the other

biopharmaceutical companies we compete against for qualified personnel have greater financial and other resources, more favorable risk

profiles and a longer operating history in the biopharmaceutical industry than we do.

They also may provide more diverse opportunities

and better chances for career advancement.

Some of these opportunities may be more appealing to high-quality candidates than what we

have to offer.

It is particularly difficult

to recruit and hire new employees during the COVID-19 pandemic as conducting interviews remotely makes it more difficult to ensure we

are recruiting and hiring high-quality employees, and the uncertainty created by the COVID-19 pandemic makes it less likely potential

candidates will be willing to leave a stable job to explore a new opportunity.

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

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We expect to need to grow

rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates, potential

future commercialization of our product candidates and expanded research and development activity, which will place a significant strain

on our financial, managerial and operational resources.

In order to achieve and manage growth effectively, we must continue to improve

and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to train, motivate and

manage our employees.

All of these activities will increase our expenses and may require us to raise additional capital sooner than expected.

Failure to manage growth effectively could materially harm our business, financial condition or results of operations.

We may expand our business through the acquisition

of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’

ownership interests in our company.

rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates as well

as potential commercial operations, which will place a significant strain on our financial, managerial and operational resources.

order to achieve and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to train, motivate and manage our employees.

All of these activities will increase our

expenses and may require us to raise additional capital sooner than expected.

Failure to manage growth effectively could materially harm

our business, financial condition or results of operations.

We may expand our business through the

acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current

stockholders’ ownership interests in our company.

Our business strategy includes

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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.

and the potential loss of our key employees or

key employees of the acquired companies.

We can make no assurances

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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.

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

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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

Any sale of common stock

by us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional shares

of our capital stock.

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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.

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

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common stock.

The trading price of our common

stock may be highly volatile and could fluctuate in response to factors such as:

The trading price of our

common stock may be highly volatile and could fluctuate in response to factors such as:

actual or anticipated variations in our operating results;

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;

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;

announcements by us or our competitors of significant acquisitions,

strategic partnerships, joint ventures or capital commitments;

adoption of new accounting standards affecting our industry;

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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

Litigation initiated against us, whether or not successful,

could result in substantial costs and diversion of our management’s attention and our resources, which could harm our business

and financial condition.

We do not intend to pay dividends on our

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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.

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

Among other things, the certificate of incorporation and bylaws:

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;

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;

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

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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

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with Section 404 at December 31, 2021 and 2020 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.

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.

If securities or industry analysts do not

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securities and industry analysts currently cover us.

If one or more of the analysts downgrade our common stock or publish inaccurate or

unfavorable research about our business, the price of our common stock would likely decline.

If one or more of these analysts cease coverage

of us or fail to publish reports on us regularly, demand for our common stock could decrease, which could cause the price of our common

stock and trading volume to decline.

If one or more of the analysts downgrade our common stock or publish inaccurate

or unfavorable research about our business, the price of our common stock would likely decline.

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

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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

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.

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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.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

DEFAULTS UPON SENIOR SECURITIES.

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

What changed 10-Q

Item 1A. Risk Factors