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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-25 · 450 added, 390 removed, 1223 unchanged (41% of the section changed)

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

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 elsewhere throughout this Annual Report on Form 10-K.

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

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

subsection, as well as those discussed below in “Management’s Discussion and Analysis of Financial Condition and Results

of Operations” and elsewhere throughout this Annual Report on Form 10-K.

The following are material factors that make an investment

in our company speculative or risky.

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.

Additional risks not

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

our business operations.

Summary of Risk Factors

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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;

If we fail to obtain additional financing, we will be unable to continue

or complete our product development or product commercialization 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;

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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;

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;

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

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 year ended December 31, 2021, we sold 4.6 million shares of common stock, resulting in net

proceeds of $35.3 million.

As of the date of filing this report, we expect that our existing resources will be more than sufficient to

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

As of the date of filing this

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

the date of this report.

Our business or operations

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We have limited access to the capital markets

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

and even if we can raise additional funding, we may be required to do so on unfavorable terms.

We have limited access to

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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.

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

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chemotherapy, defined as conventional care, as no standard of care exists for this patient population.

We have announced that Iomab-B

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001).

The SIERRA trial may be unsuccessful

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

The global health crisis

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

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

In addition, the 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.

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 vaccination efforts, remains uncertain and cannot be predicted with confidence.

In addition, highly transmissible new variants

of COVID-19 have spread globally.

The full impact of such variants cannot be predicted at this time, and could depend on numerous factors,

including vaccination rates among the population, the effectiveness of COVID-19 vaccines and boosters against the COVID-19 variants 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.

world have imposed quarantines and restrictions on travel and mass gatherings and could reinstitute such policies in response to future

COVID-19 outbreaks.

In such a scenario, 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 hybrid working for our office-based

staff, while our research staff has been actively working in our laboratory throughout the pandemic and thus far have not experienced

a significant disruption or delay in our operations as it relates to the clinical development, preclinical development of manufacturing

of our drug candidates.

Although we are adhering to health and safety protocols, an outbreak of COVID-19 at our facilities could nonetheless

cause shutdowns of facilities and a reduction in our workforce, which could cause a disruption or delay in such operations.

New outbreaks

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

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

A continuation or worsening

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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.

We believe our earlier

stage CD33 clinical trials will continue to recruit and enroll patients given the acute nature of relapsed or refractory AML.

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 are reinstated that 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

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

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

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

We continue to monitor the

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

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

operations and financial results during 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.

result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s

or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources or forced furlough of government employees.

We continue to monitor

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

However, the ultimate impact from COVID-19 on our

business operations and financial results during 2023 will depend on, among other things, the ultimate severity and scope of the

pandemic, including the new variants of the virus, and whether governmental and private travel restrictions and public concerns

about public gatherings are reinstated.

We are not able to fully quantify the impact that these factors had on our financial

results during 2022 and will have in 2023.

Our business is subject to cybersecurity

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

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 CD33 Alpha program studying Actimab-A (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.

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

We are in the

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

and clinical development in other types of cancer.

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

for successful commercialization.

The FDA 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.

The approval process in the

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

We expect that a substantial portion of our efforts

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

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

which may never receive FDA approval or be successfully commercialized even if FDA approval is received.

The research, testing, manufacturing,

labeling, approval, sale, marketing, and distribution of our biological product candidates are, and will remain, subject to extensive

regulation by the FDA and other regulatory authorities in the United States and other countries, as applicable.

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.

We expect that a substantial

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

product candidates.

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

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

The research,

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

subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, as applicable.

are currently not permitted to market any of our current or future product candidates in the United States until we receive FDA approval

(of each) via the BLA process.

To date, we have two product candidates in clinical development and have not-yet submitted a BLA for any

of our candidates and, for many such candidates, do not expect to be in a position to do so for the foreseeable future, as there are numerous

developmental steps that must be completed before we can prepare and submit a BLA.

In the United States, the

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the same data.

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

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

such BLA will be approved by the FDA.

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

they are subject to rigorous regulatory requirements.

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

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

The clinical trial process is also lengthy and requires substantial

time and effort.

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

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

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

part because they are subject to rigorous regulatory requirements.

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

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

The clinical trial process is also lengthy and

requires substantial time and effort.

In December 2015, the FDA

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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.

The Phase 3 SIERRA trial met its

primary endpoint with high statistical significance with positive results for secondary endpoints and exploratory endpoints and 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.

We have other clinical trials ongoing and others that we have planned

but not-yet commenced, for our other drug candidate Actimab-A under our own sponsorship and investigator-initiated trials ongoing.

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

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condition and results of operation.

The FDA or comparable foreign regulatory

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

In June 2012, we acquired

rights to apamistamab, 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 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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Initiating and completing

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

and expensive process, and the outcome is inherently uncertain.

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

expensive process, and the outcome is inherently uncertain.

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

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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.

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.

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

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.

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, or

any 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

Preliminary, Interim, and “top-line”

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

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.

For example, in October 2022 we announced that Iomab-B

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001).

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

If the interim, top-line or preliminary data that we report differ

from 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 results, prospects or financial

If the interim, top-line or

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

results, prospects or financial condition.

Our clinical trials may fail to demonstrate

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The key patents related to

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

the humanized antibody, lintuzumab, which we use in our Actimab-A product candidate have expired.

It is generally possible that others

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alpha particle drug products comprising Ac-225.

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

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

we own issued and pending patents related to methods for drug conjugation and isotope labeling and for methods of isotope production.

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

Any competing product based on the

lintuzumab antibody is likely to require several years of development before achieving our product candidate’s current status and

may be subject to significant regulatory hurdles but such development by others is nevertheless a possibility that could negatively impact

our business in the future.

Our final drug construct, Actimab A, consists of the lintuzumab antibody labeled with

the isotope Ac-225.

We currently own issued and pending patents relating to methods of manufacturing Actimab-A, methods of treatment using

Actimab-A and production of the Ac-225 isotope.

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

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

our product candidate’s current status and may be subject to significant regulatory hurdles but such development by others is nevertheless

a possibility that could negatively impact our business in the future.

We own 4 issued U.S.

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

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

Several patent applications relating to

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

patents, 1 issued Canadian patent, 1 issued

European patent (validated as a national patent in several countries) and 1 issued Japanese patent that relate to the composition of our

Iomab-B product candidate.

Patent applications relating to Iomab-B are also pending in the U.S.

and internationally.

We have and may continue to file patents related to Iomab-B that can provide

barriers to entry but there is no certainty that these patents will be granted or such granting thereof will adequately prevent others

from seeking to replicate and use the apamistamab 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.

We have and may continue

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

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

patent portfolio includes pending applications related to radioimmunoconjugate composition, formulation administration, and methods of

use in treating solid or liquid cancers.

This subject matter includes composition, administration, and methods of treatment for our product

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

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

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

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

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

While we consider I-131 to be commoditized and obtainable through several

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

Currently, there is sufficient supply of I-131 to support additional trials we may undertake utilizing I-131 and for commercialization

We continually evaluate I-131 manufacturers and suppliers and intend to have multiple qualified suppliers prior to the commercial

launch of Iomab-B.

While we consider I-131 to be commoditized and obtainable through several suppliers, there can be no guarantee that

we will be able to secure I-131 or obtain I-131 on terms that are acceptable to us.

Actinium-225 is a key component

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

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

The current Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the natural decay of thorium-229

from so-called ‘thorium-cows’ and is able to produce sufficient quantities that are several multiples of the amount of Ac-225

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

The DOE is also producing Ac-225 from a recently

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

Initial preclinical

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

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.

of our Actimab-A product candidate, technology platform, preclinical R&D programs 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 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 at a scale that would be able to satisfy commercial needs.

In addition, we are aware of at least ten 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-based

drug candidate.

Our contract for supply of

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 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, and we renewed our contract to extend through the end of 2023.

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

Failure to acquire sufficient quantities of medical grade

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

may develop and would materially harm our business.

Our ability to conduct clinical

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

may choose to utilize in the future.

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

choose to utilize in the future.

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

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

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

to support our current ongoing clinical trials, current and planned preclinical R&D activities and commercialization should our drug

candidates receive regulatory approval.

If we encounter difficulties enrolling patients

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the patient eligibility criteria defined in the protocol;

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

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

the proximity of patients to trial sites;

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We have received orphan drug

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

Under the Orphan Drug Act,

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

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

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

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

Similarly, the EMA grants orphan drug designation to promote

the development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating

designation for Iomab-B and Actimab-A for treatment of AML in both the United States and the EU.

Under the Orphan Drug Act, the FDA may

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

fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no

reasonable expectation that the cost of developing and making available a drug or biologic for this type of disease or condition will

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

Similarly, the EMA grants orphan drug designation to promote the

development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating

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

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quality reporting system and feedback program.

There have been significant ongoing judicial, administrative, executive,

and legislative initiatives to modify, limit, replace, or repeal the Affordable Care Act.

For example, former President Trump issued several

Executive Orders and other directives designed to delay the implementation of certain provisions of the Affordable Care Act or otherwise

circumvent some of the requirements for health insurance mandated by the Affordable Care Act.

Concurrently, Congress considered legislation

that would repeal or replace all or part of the Affordable Care Act.

While Congress has not passed comprehensive repeal legislation, several

bills affecting the implementation the Affordable Care Act have been passed.

For example, the Tax Cuts and Jobs Act of 2017 eliminated

the Affordable Care Act provision requiring individuals to purchase and maintain health coverage, or the “individual mandate,”

by reducing the associated penalty to zero, beginning in 2019.

In December 2018, a district court in Texas held that the individual mandate

is unconstitutional and that the rest of the Affordable Care Act is, therefore, invalid.

On appeal, the Fifth Circuit Court of Appeals

affirmed the holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding

affects the validity of the rest of the Affordable Care Act.

The Fifth Circuit’s decision on the individual mandate was appealed

There have been significant

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

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

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

Affordable Care Act.

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

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

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

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

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

Care Act is, therefore, invalid.

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

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

The Fifth Circuit’s decision on the individual mandate was appealed to the U.S.

Supreme Court.

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.

the Affordable Care Act will remain in-effect in its current form for the foreseeable future;

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

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

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

reform government program reimbursement methodologies for drug products.

Pharmaceutical product prices have been the focus of increased

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

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

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

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 principles.

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.

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 future;

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.

In addition to the Affordable Care Act, there have been numerous other

Congressional initiatives and proposed and enacted federal and state legislation designed to, among other things, bring more transparency

to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement

methodologies for drug products.

Pharmaceutical product prices have been the focus of increased scrutiny by the government, including

certain state attorneys general, members of Congress and the United States Department of Justice.

State or federal healthcare reform measures

or other social or political pressure to lower the cost of pharmaceutical products could have a material adverse impact on our business,

results of operations and financial condition.

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 principles.

Most recently, on August 16, 2022, President Biden signed into law

the Inflation Reduction Act of 2022 (the “IRA”), which, among other provisions, included several measures

intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically, the IRA authorizes and directs the Department

of Health and Human Services (the “DHHS”) to set drug price caps for certain high-cost Medicare Part B and Part D qualified

drugs, with the initial list of drugs to be selected by September 1, 2023, and the first year of maximum price applicability to begin

The IRA further authorizes the DHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part

B and Part D drugs faster than the rate of inflation.

Finally, the IRA creates significant changes to the Medicare Part D benefit design

by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.

We cannot be sure whether additional

or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on the profitability of

any of our drug candidates, if approved for commercial use, in the future.

Our relationships with customers, health

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

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

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

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

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

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

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Third-party payors may not adequately reimburse

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

authorizations and step edits that affect their use.

customers for any product candidates that we may commercialize or promote, and may impose coverage restrictions or limitations such as

prior authorizations and step edits that affect their use.

Our ability to commercialize

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the regulatory approval process.

If our consultants,

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

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

Although we believe that

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

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

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

If our consultants, contract

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

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

Although we believe that there are a number

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

third-party contractors or to do so on commercially reasonable terms, which may result in a delay of our planned clinical trials and delayed

development of our product candidates.

In addition, our third-party

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and prospects would be adversely affected.

The antibodies we use in our antibody radiation-conjugate

The antibodies we use in our targeted radiotherapy

product candidates may be subject to generic competition.

We are not aware of any existing

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

or pending regulations or legislation that pertains to generic radiopharmaceutical products such as our targeted radiotherapy product

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

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market acceptance.

Iomab-B, CD33 ARC program

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

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

effectiveness and reliability of the product;

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

the availability,

relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product

are approved for reimbursement by public and private insurers;

the strength of our marketing and distribution infrastructure;

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

Iomab-B, Actimab-A

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

medical community.

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

and perceived effectiveness and reliability of the product;

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

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

the degree to which

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

the strength of our marketing and

distribution infrastructure;

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

We believe that oncologists

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

Failure of Iomab-B, CD33 ARC

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

business financial condition and results of operations.

Failure of Iomab-B, Actimab-A

or any of our other product candidates to significantly penetrate current or new markets would negatively impact our business financial

condition and results of operations.

We may be subject to claims that our third-party

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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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our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is averse to our best interests.

If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to our best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent the development or commercialization

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or attempts by either party to terminate the agreement.

If in the future we are unable to establish

or global sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates,

we may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue.

We currently do not have a

marketing or sales team for the marketing, sales and distribution of any of our product candidates that may receive regulatory approval.

In order to commercialize any product candidates after approval, we must build on a territory-by-territory basis marketing, sales, distribution,

managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful

If our product candidates receive regulatory approval, we may decide to establish an internal sales or marketing team with

technical expertise and supporting distribution capabilities to commercialize our product candidates, which will be expensive and time-consuming

and will require significant attention of our executive officers to manage.

Any failure or delay in the development of our internal sales,

marketing and distribution capabilities would adversely impact the commercialization of any of our product candidates that we obtain approval

With respect to the commercialization

of all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with

third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution

systems or in lieu of our own sales force and distribution systems.

In particular, we have and expect to continue to partner with third

parties to commercialize Iomab-B outside the United States.

In April 2022, we entered into a licensing agreement with Immedica, in

which Immedica acquired the product rights for commercialization of Iomab-B for certain territories outside the U.S.

If we are unable

to enter into or maintain such arrangements when needed on acceptable terms, or at all, we may not be able to successfully commercialize

any of our product candidates that receive regulatory approval or any such commercialization may experience delays or limitations.

we are not successful in commercializing our product candidates, either on our own or through collaborations with one or more third parties,

our future product revenue will suffer and we may incur significant additional losses.

We face significant competition from other

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we may not develop additional proprietary technologies that are patentable.

As a result, our owned

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

the full commercial extent of our technology.

As a result, our owned and

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

full commercial extent of our technology.

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

We or our licensors have applied

for and will continue to apply for patents for certain products.

Such applications may not result in the issuance of any patents, and

any patents now held or that may be issued may not provide us with adequate protection from competition.

Furthermore, it is possible that

patents issued or licensed to us may be challenged successfully.

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

such patents, such preferred position would be lost.

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

become subject to competition from the sale of generic products.

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

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

filings, would adversely affect our business and operations.

We or our licensors have

applied for and will continue to apply for patents for certain products and methods.

Such applications may not result in the issuance of any

patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.

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

In that event, if we have a preferred

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

If we are unable to secure or to continue to

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

Failure to receive,

inability to protect, or expiration of our patents for medical use, manufacture, conjugation and labeling of Ac-225, the antibodies

that we license from third parties, or subsequent related filings, would adversely affect our business and operations.

Patents issued or licensed

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If we fail to comply with the terms of these license agreements, our rights to those patents may

be terminated, and we will be unable to conduct our business.

be terminated, and we may be unable to conduct our business.

If we are found to be infringing on patents

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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.

For instance, we learned that a former employee,

Qing Liang, Ph.D., who was employed by Actinium in the position of Vice President, Head of Radiation Sciences, violated the non-compete

provision of her employment agreement by working for a direct competitor.

Liang, who had access to materials containing proprietary

information and trade secrets, is no longer employed by the direct competitor (who terminated her employment after learning of her actions).

With the assistance of outside counsel and a forensic investigator, we also identified that Dr.

Liang downloaded confidential information

prior to the end of her employment with Actinium.

We petitioned for and were granted a Stipulated Preliminary Injunction by the Supreme

Court of the State of New York, New York County (Index No.

656841/2022) that ordered that Dr.

Liang be enjoined from destroying or deleting

any Actinium documents or information, enjoined from using, transmitting or transferring any Actinium Information (as defined in the injunction)

other than to her counsel or Actinium’s counsel, ordered to return all Actinium information within 5 days of the Stipulated Preliminary

Injunction, ordered to disclose to Actinium, under oath, all persons and devices to whom she transferred or disclosed Actinium Information,

and ordered to allow a qualified forensic examiner selected by Actinium to remove and permanently delete all Actinium Information from

any electronic devices, systems, email accounts, or other electronic or physical storage sites belonging to Dr.

We also filed an

arbitration proceeding against Dr.

Liang and we intend to enforce the terms of her employment agreement, especially the non-compete and

confidentiality provisions, to the fullest extent of our ability.

Risks Related to Our Operations

We expect to expand our development and

regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and, as a result, we may encounter difficulties

in managing our growth, which could disrupt our operations.

We expect to experience significant

growth in the number of our employees and the scope of our operations, particularly in the areas of product candidate development, regulatory

affairs and, if any of our product candidates receives marketing approval, sales, marketing and distribution.

We currently do not have a

marketing or sales team for the marketing, sales and distribution of any of our product candidates that are potentially able to obtain

regulatory approval.

In order to commercialize any product candidates, we must build on a territory-by-territory basis marketing, sales,

distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we

may not be successful in doing so.

If our product candidates receive regulatory approval, we intend to establish an internal sales or

marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates, which will be

expensive and time consuming and will require significant attention of our executive officers to manage.

We will also have to compete

with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

Any failure or

delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of

any of our product candidates that we obtain approval to market.

To manage our anticipated

future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and

continue to recruit and train additional qualified personnel.

Due to our limited financial resources and the limited experience of our

management team in managing a public company with such anticipated growth, we may not be able to effectively manage the expansion of our

operations or recruit and train additional qualified personnel.

The expansion of our operations may lead to significant costs and may

divert our management and business development resources.

Any inability to manage growth could delay the execution of our business plans

or disrupt our operations.

The use of hazardous materials, including

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to manage our business.

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.

If any member of our current senior management terminates his or her 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 during 2021.

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

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

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

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.

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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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.

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.

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each current stockholder’s ownership interest in the Company.

Risks Related to Ownership of Our Common

Risks Related to Ownership of Our Common Stock

The sale of securities by us in any equity

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sales of our common stock or other securities in the open market;

inaccurate or unfavorable reports from securities or industry analysts;

other events or factors, many of which are beyond our control.

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to significant price and volume fluctuations.

Moreover, the COVID-19 pandemic has resulted in significant financial market volatility

and uncertainty in recent months.

In the past, following periods of volatility in the market price of a company’s securities, securities

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a change in our control.

General Risk Factors

Compliance with the reporting requirements

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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-K

Item 1A. Risk Factors