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Item 1A. Risk Factors

2024-03-29 compared with 2023-03-31 · 580 added, 466 removed, 1207 unchanged (46% 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 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.

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 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;

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 regulatory and commercial success of Iomab-B;

Our business could be adversely affected by the effects of future health

Our business is subject to cybersecurity risk;

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;

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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 of

Healthcare legislative reform measures intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal regulation of the U.S.

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

We rely on third parties to conduct our clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates;

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

Any disruption in the operations of our current third-party manufacturer, or other third-party manufacturers we may engage in the future, could adversely affect our business and results of operations;

We may rely on third parties to conduct certain aspects of our clinical

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

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

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;

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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.

report, we expect that our existing resources will be 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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However, we may not be able to secure funding when we need it or on favorable terms or indeed on any terms.

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

a going-concern opinion from our auditors which can and may impair our stock market valuation and also our ability to finance on favorable

terms or indeed on any terms.

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

To raise additional capital,

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

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

to or greater than the price per share paid by investors, and investors purchasing shares or other securities in the future could have

rights superior to existing stockholders.

If we cannot raise adequate

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

studies or future operations.

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

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

to future product candidates or certain major geographic markets.

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

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

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

have rights superior to existing stockholders.

If we cannot raise adequate funds to satisfy our capital requirements,

we will have to delay, scale back or eliminate our research and development activities, clinical studies, or future operations.

also be required to obtain funds through arrangements with collaborators, which arrangements may require us to relinquish rights to certain

technologies or products that we otherwise would not consider relinquishing, including rights to future product candidates or certain

major geographic markets.

We may further have to license our technology to others.

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

Any of these actions may harm our business, financial

condition and results of operations.

This could result in sharing revenues which we might

otherwise have retained for ourselves.

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

The amount of funding we will

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the capital markets to raise funds.

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

companies and unprofitable companies such as ours.

In addition, it is generally difficult for development-stage companies to raise capital

under current market conditions.

The amount of capital that a company such as ours is able to raise often depends on variables that are

beyond our control.

The capital markets have been unpredictable in the recent past for development stage radiopharmaceutical

and other biotechnology companies and unprofitable companies such as ours.

In addition, it is generally difficult for development-stage

companies to raise capital under current market conditions.

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

on variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive to us, or at all.

If we are able to consummate

a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds are not available on acceptable

terms, or at all, our business, including our technology licenses, results of operations, financial condition and our continued viability

will be materially adversely affected.

We are highly dependent on the success of

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 able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds

are not available on acceptable terms, or at all, our business, including our technology licenses, results of operations, financial condition

and our continued viability will be materially adversely affected.

We are highly dependent on the regulatory

and commercial success of Iomab-B

We have completed patient

enrollment in the pivotal Phase 3 SIERRA trial (Study of Iomab-B in Elderly Relapsed or Refractory AML), a 153-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

trial that compared outcomes of patients who receive Iomab-B and a BMT to those of patients receiving physician’s choice of salvage

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

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.

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001) and we intend to submit a BLA with the

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

We may be unable to establish sales, marketing

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Our business could be adversely affected

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

The global health crisis caused

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

despite 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 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

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.

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 local and foreign regulatory authorities, delays in necessary interactions with IRB’s

by the effects of future health epidemics

Our business could be adversely

impacted by the effects of future pandemics, epidemics or infectious disease outbreaks.

The full impact of such an event cannot be predicted

at this time, and could depend on numerous factors, including vaccination rates among the population 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 a future pandemic

on our business.

A future pandemic could adversely

affect our 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 a future pandemic if their geography

is impacted by the pandemic.

Further, future pandemics 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, or the inability of patients

to comply with clinical trial protocols if quarantines or travel restrictions are implemented 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 a future

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, a future pandemic

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

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

in employee resources or forced furlough of government employees.

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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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.

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

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.

Product candidates

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

We are in the early stages

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

development in other types of cancer.

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

commercialization.

The FDA 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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requires substantial time and effort.

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.

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.

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.

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 have been physician IND trials at 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

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.

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.

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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of our product candidates are time-consuming and expensive.

Initiating and completing

clinical trials necessary to support FDA approval of a BLA for Iomab-B, 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

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

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.

Initiating and completing 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 of future results, and any product

candidate we advance into clinical trials may not have favorable results in later clinical trials.

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.

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

In addition to clinical data, a BLA

filing encompasses preclinical, CMC, labeling and other information.

Regardless of whether the SIERRA trial met the study’s predefined

primary endpoint, 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.

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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, 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.

For example, in February 2023 we announced that Iomab-B

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001) producing a durable Complete Response

rate of 22% compared to a 0% durable Complete Response rate in the control arm.

We may 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

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

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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.

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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we have licensed has expired or likely expired.

The key patents related to

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

It is generally possible that others

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

alpha particle drug products comprising Ac-225.

Our final drug construct, 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.

The key patents related to the humanized antibody, lintuzumab, which we

use in our Actimab-A product candidate have expired.

It is generally possible that others may be eventually able to use an antibody with

the same sequence, and we will then need to rely on additional patent protection covering alpha particle drug products comprising Ac-225.

Our final drug construct, 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 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.

We own 4 issued 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.

patents, 2 issued Canadian 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.

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.

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.

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.

Our patent portfolio includes pending applications

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

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.

Further, if approved, Iomab-B would be entitled to 12 years of market

exclusivity in the U.S.

and 10 years in Europe, during which time no generic biologic or biosimilar referencing Iomab-B can be granted

marketing approval.

Our CD33 program clinical trials are testing

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Our CD33 program is comprised

of several clinical trials including investigator-initiated trials in AML that are studying the same drug construct consisting of lintuzumab-Ac-225.

Negative results from any of these trials could negatively impact our ability to enroll or complete our other trials studying lintzumab-Ac-225.

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

of several ongoing and planned clinical trials including investigator-initiated trials in AML studying the same drug construct consisting

of lintuzumab-Ac-225.

Negative results from any of these trials could negatively impact our ability to enroll or complete our other trials

studying lintzumab-Ac-225 including future studies conducted under our CRADA with the NCI.

Additionally, negative outcomes including safety

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

We may be unable to obtain a sufficient

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drug candidate.

Our contract for supply of

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

choose to utilize in the future.

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

These suppliers

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

Our suppliers are subject to regulations

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

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

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

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

Our inability

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

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

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

candidates receive regulatory approval.

If we encounter difficulties enrolling patients

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

Our contract for supply of this isotope from the DOE must be renewed

yearly, and we renewed our contract to extend through the end of 2024.

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 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.

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

These suppliers may not perform their contracted services

or may breach or terminate their agreements with us.

Our suppliers are subject to regulations and standards that are overseen by regulatory

and government agencies and we have no control over our suppliers’ compliance to these standards.

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 sourced material in the past, this activity was

terminated due to operating cost reasons, and we currently do not have experience in manufacturing medical grade Ac-225 and may not obtain

the resources necessary to establish our own manufacturing capabilities in the future.

Our inability to build out and establish our own

manufacturing facilities would require us to continue to rely on third party suppliers as we currently do.

However, based on our current

third-party suppliers and potential future suppliers of Ac-225 we expect to have adequate isotope supply to support our current ongoing

clinical trials, current and planned preclinical R&D activities and commercialization should our drug candidates receive regulatory

If we encounter difficulties

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

The timely completion of clinical

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

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

additional information regarding the change.

Any delay or termination of

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

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

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

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

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

Lengthy delays

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

If the FDA believes

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

information regarding the change.

Any delay or termination of our current or future clinical trials as

a result of the risks summarized above, including delays in obtaining or maintaining required approvals from IRBs, delays in patient enrollment,

the failure of patients to continue to participate in a clinical trial, and delays or termination of clinical trials as a result of protocol

modifications or adverse events during the trials, may cause an increase in costs and delays in the filing of any submissions with the

FDA, delay the approval and commercialization of our product candidates or result in the failure of the clinical trial, which could adversely

affect our business, operating results and prospects.

Lengthy delays in obtaining regulatory approval for Iomab-B or completion of our

ongoing or planned clinical trials would adversely affect our business and prospects and could cause us to cease operations.

We have obtained orphan drug designation

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reimbursement is available for patients that use our products.

However, the availability of insurance coverage and reimbursement for newly

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

are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part of the

product cost by Medicare or other third-party payors.

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

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

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

Submission of applications for reimbursement approval generally

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

obtain coverage and reimbursement for these products, we or our commercialization partners may have to agree to a net sales price lower

than the net sales price we might charge in other sales channels.

The continuing efforts of government and third-party payors to contain

or reduce the costs of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may make our revenues

particularly susceptible to any cost containment or reduction efforts.

Healthcare legislative reform measures intended

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

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

However, the availability of insurance coverage and reimbursement for

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

products are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or

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

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

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

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

Submission of applications for reimbursement approval

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

order to obtain coverage and reimbursement for these products, we or our commercialization partners may have to agree to a net sales

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

The continuing efforts of government and third-party payors

to contain or reduce the costs of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may

make our revenues particularly susceptible to any cost containment or reduction efforts.

Healthcare legislative

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

the federal regulation of the U.S.

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

of operations.

In the United States, there

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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.

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

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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.

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

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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

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

More 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

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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.

drugs, with the initial list of drugs announced on August 29, 2023, and the first year of maximum price applicability to begin in 2026.

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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Risks Related to Third Parties

We rely on third parties to conduct our

clinical trials.

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

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

We may rely on third parties to conduct our clinical trials.

third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements,

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

We do not have the ability

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

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

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

and prospects would be adversely affected.

The antibodies we use in our 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 targeted radiotherapy product

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

to the BLA pathway.

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

of biosimilar and interchangeable biologic products.

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

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

to an existing brand product.

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

the original branded product was approved under a BLA.

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

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

Even if a biosimilar gets approved for one of the

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

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

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

our product candidates on a timely basis, if at all, and our business, operating results and prospects would be adversely affected.

The protection against generic competition

for our biologic drug candidates and reimbursement by CMS may be subject to future change

We are not aware of any existing or pending regulations or legislation

that pertains to generic radiopharmaceutical products such as our ARC targeted radiotherapy product candidates.

Our ARC product candidates

are regulated by the FDA as biologic products and we intend to seek approval for these products pursuant to the BLA pathway.

The Biologics

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

biologic products.

The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics,

including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product.

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

was approved under a BLA and in Europe a biosimilar product cannot be approved until 10 years after the original branded product was approved.

The law is complex and as a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

Even if a biosimilar

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

and in some cases a linker and we are not aware of any regulations that would require us to provide the final constructs or components

to third parties or potential competitors.

Therefore, based on the current regulations, we do not believe that the final drug product

of our candidates can be subject to competition from a biosimilar as outlined in BPCIA for at least 12 years in the U.S.

We are aware that generic versions of certain radiopharmaceuticals utilizing peptides have been submitted to the FDA via the

Abbreviated New Drug Application (“ANDA”) pathway, however, those products are not covered under the BPCIA and therefore that

generic pathway is not applicable to Iomab-B or Actimab-A.

We expect this would also apply to other biologic drug candidates we may seek

to develop in the future based on the current provisions of the BPCIA.

Additionally, the Inflation Reduction Act (“IRA”) that

was enacted in August 2022, states that reimbursement by the Centers for Medicare & Medicaid Services (“CMS”) for high-expenditure

single-source biologic drugs, which we expect Iomab-B and Actimab-A to be, can only be negotiated after at least 11 years following approval

compared to 7 years for non-biologic drugs with negotiated prices taking effect two years after selection.

Therefore, we currently believe

that Actinium’s ARCs are less likely than small molecules to face pricing pressure and negotiation from IRA.

Further, a drug or

biological product that has an orphan drug designation, which Iomab-B and Actimab-A both have, for only one rare disease or condition

will be excluded from the IRA's price negotiations requirements until such time the biological products has designations for more

than one rare disease or condition, or if is approved for an indication that is not within that single designated rare disease or condition,

unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for

negotiation..

In August 2023, 10 initial drugs were identified with negotiated prices expected to take effect starting in 2026.

and 2028, it is expected that CMS will establish negotiated prices for 15 additional drugs in each respective year.

We do not believe

there is a high likelihood that Iomab-B or Actimab-A would be identified by CMS for negotiated pricing under IRA but there is potential

that IRA and other additional state and federal healthcare reform measures will be adopted in the future and the implementation of cost-containment

measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or successfully commercialize

our product candidates.

Our product candidates may never achieve

market acceptance.

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.

Iomab-B, Actimab-A and future

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

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;

and the level of education and awareness

among physicians and hospitals concerning the product.

We believe that oncologists

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we may not develop additional proprietary technologies that are patentable.

Furthermore, the issuance

of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us

with adequate proprietary protection or competitive advantages against competitors with similar products.

Competitors may also be able

to design around our patents.

Other parties may develop and obtain patent protection for more effective technologies, designs or methods.

We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors,

former employees and current employees.

Patent rights are territorial,

and patent protection extends only to those countries where we have issued patents.

Filing, prosecuting and defending patents on our products

and product candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual

property rights in some countries outside the United States could be less extensive than those in the United States.

Many countries, however,

do not protect intellectual property to the same extent as the U.S.

or Europe, and their litigation processes differ.

Competitors may

successfully challenge or avoid our patents, or manufacture products in countries where we have not applied for patent protection.

in the patent laws in the U.S.

or other countries may diminish the value of our patent rights.

As a result of these and other factors,

the scope, validity, enforceability, and commercial value of our patent rights are uncertain and unpredictable.

Indeed, several companies

have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems

of some countries do not favor the enforcement of patents and other intellectual property rights, which could make it difficult for us

to stop the infringement, misappropriation or other violation of our intellectual property rights generally.

Proceedings to enforce our

intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other

aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk

of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that are initiated, and

the damages or other remedies awarded, if any, may not be commercially meaningful.

The patent positions of pharmaceutical

companies, including our patent position, involve complex legal and factual questions, and, therefore, the issuance, scope, validity and

enforceability of any patent claims that we may obtain cannot be predicted with certainty.

Patents, if issued, may be challenged, deemed

unenforceable, invalidated, or circumvented.

A third-party may submit prior art, or we may become involved in opposition, derivation,

reexamination, inter partes review, post-grant review, supplemental examination, or interference proceedings challenging our patent rights

or the patent rights of our licensors or development partners.

The costs of defending or enforcing our proprietary rights in these proceedings

can be substantial, and the outcome can be uncertain.

An adverse determination in any such submission or proceeding could reduce the scope

of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, or

reduce our ability to manufacture or commercialize products.

Furthermore, if the scope or strength of protection provided by our patents

and patent applications is threatened, it could discourage companies from collaborating with us to license, develop or commercialize current

or future products.

The ownership of our proprietary rights could also be challenged.

As a result, our owned and

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

We or our licensors have

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

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.

Furthermore, it is possible

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

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

of such patents, such preferred position would be lost.

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

could become subject to competition from the sale of generic products.

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

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

related filings, would adversely affect our business and operations.

Patents issued or licensed

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

Our ability to enforce our patent rights depends on our ability to detect

infringement.

It is difficult to detect infringers who do not advertise the components that are used in their products.

may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product, particularly

in litigation in countries other than the U.S.

that do not provide an extensive discovery procedure.

Any litigation to enforce or defend

our patent rights, if any, even if we were to prevail, could be costly and time-consuming and would divert the attention of our management

and key personnel from our business operations.

We may not prevail in any lawsuits that we initiate and the damages or other remedies

awarded if we were to prevail may not be commercially meaningful.

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

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

Further, such litigation

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

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

Further, such litigation can go

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

There has been substantial litigation and other proceedings

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to, the same or similar information.

In addition, we cannot guarantee that we have executed these agreements with each party that may

have or have had access to our trade secrets.

Furthermore, if the employees and consultants who are parties to these agreements breach

or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade

secrets through such breaches or violations.

Certain of our patent rights

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

If we are found to be infringing on patents

If we are found to be infringing patents

or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the

development or sale of our products, and/or pay damages.

We may not have identified

all patents, published applications or published literature that affect our business either by blocking our ability to commercialize our

products, by preventing the patentability of one or more aspects of our products to us or our licensors, or by covering the same or similar

technologies that may affect our ability to market our products.

For example, we (or our licensors) may not have conducted a patent clearance

search sufficient to identify potentially obstructing third party patent rights.

Moreover, patent applications in the United States are

maintained in confidence for up to 18 months after their filing.

In some cases, however, patent applications remain confidential in the

Patent and Trademark Office, or the USPTO, for the entire time prior to issuance as a U.S.

Patent applications filed in countries

outside of the United States are not typically published until at least 18 months from their first filing date.

Similarly, publication

of discoveries in the scientific or patent literature often lags behind actual discoveries.

We cannot be certain that we or our licensors

were the first to invent, or the first to file, patent applications covering our products and candidates.

We also may not know if our

competitors filed patent applications for technology covered by our pending applications or if we were the first to invent the technology

that is the subject of our patent applications.

Competitors may have filed patent applications or received patents and may obtain additional

patents and proprietary rights that block or compete with our patents.

Our manufacturing processes

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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.

Our ability to protect and enforce our

patents does not guarantee that we will secure the right to commercialize our potential products and respective patents.

A patent is a limited monopoly

right conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using its invention.

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

may be required for commercialization to occur.

For example, a drug cannot be marketed without the appropriate authorization from the

FDA, regardless of the existence of a patent covering the product.

Further, the invention, even if patented itself, cannot be commercialized

if it infringes the valid patent rights of another party.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making, using and/or selling

its invention.

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

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

For example, a drug cannot be marketed without the

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

Further, the invention, even if

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

We rely on confidentiality agreements to

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

We rely on trade secrets that

we seek to protect through 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.

We rely on trade secrets that 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.

Any remedies that may be available to us may not be adequate

to protect our business or compensate us for the damaging disclosure.

In addition, we may have to expend resources to protect our interests

from possible infringement by others.

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.

Additionally, while working for the direct competitor, Dr.

Liang continued to provide consulting services to

We also learned that Dr.

Liang was providing consulting services to another company, which was in violation of certain provisions

of her post-employment consulting agreement with Actinium.

Liang, who had access to materials containing proprietary information and

trade secrets, pursuant to actions taken by Actinium, is no longer employed by the direct competitor.

With the assistance of outside counsel

and a forensic investigator, we identified that Dr.

Liang downloaded confidential information prior to her employment at Actinium ending.

To aid in arbitration proceedings, we petitioned and were granted a Stipulated Preliminary Injunction by the Supreme Court of the State

of New York, New York County (Index No.

656841/2022) on June 28, 2022 that ordered that Dr.

Liang is enjoined from destroying or deleting

any Actinium documents or information, is enjoined from using, transmitting or transferring any Actinium Information other than to her

counsel or Actinium’s counsel, ordered to return Actinium information within 5 days of Stipulated Preliminary Injunction, ordered

to disclose to Actinium under oath, all persons and devices 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.

On April 25, 2023, a Final Award and Permanent

Injunction was granted by the Supreme Court of the State of New York, New York County (Case No.

01-22-0003-2375) 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.

Liang is permanently enjoined from using, possessing, transmitting or transferring any Actinium property, documents of business information.

Further, until April 1, 2024, Dr.

Liang shall not, either directly or indirectly, engage in any business that directly or indirectly is

developing, or plans to develop, radioimmunotherapies for cancer or any targeted conditioning therapy or agent for adoptive cell therapy

including bone marrow transplant and CAR-T.

We may be subject to damages resulting from

claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Our employees may have been

previously employed at other companies in the industry, including our competitors or potential competitors.

Although we are not aware

of any claims currently pending against us, we may be subject to claims that these employees or we have inadvertently or otherwise used

or disclosed trade secrets or other proprietary information of the former employers of our employees.

Litigation may be necessary to defend

against these claims.

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

a distraction to management.

If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual

property rights or personnel.

A loss of key personnel or their work product could hamper or prevent our ability to commercialize product(s),

which would materially adversely affect our commercial development efforts.

Obtaining and maintaining patent protection

depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case

of non-compliance with these requirements.

Periodic maintenance fees,

renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies

in several stages over the lifetime of the patents and /or applications.

The relevant patent agencies require compliance with a number

of procedural, documentary, fee payment and other provisions during the patent application process.

In many cases, an inadvertent lapse

can be cured by payment of a late fee or by other means in accordance with the applicable rules.

However, there are situations in which

the failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting

in partial or complete loss of patent rights in the relevant jurisdiction.

In such an event, our competitors might be able to use our

technologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation.

Risks Related to Our Operations

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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 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

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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.

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

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

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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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

We may undertake international operations,

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

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

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

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

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

submitting a BLA and building a commercial organization.

employment market generally.

Specific 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 as a result of general macroeconomic factors of force majeure events, 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

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.

labor shortage, lack of skilled labor, increased turnover or labor inflation, 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 personnel.

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 submitting a BLA and

building 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

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.

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.

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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to goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results of operations.

Our common stock is subject to price volatility

which could lead to losses by stockholders and potential costly security litigation.

Our common stock is subject to price volatility which could

lead to losses by stockholders and potential costly security litigation.

The trading volume of our

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results of other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and

the financial markets or other developments affecting our competitors or us.

This volatility has had a significant effect on the market

price of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our

common stock.

the financial markets or other developments affecting our competitors

This volatility has had a significant effect on the market price of securities issued by many companies for reasons unrelated to

their operating performance and could have the same effect on our common stock.

The trading price of our common

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to significant price and volume fluctuations.

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

class action litigation has often been initiated against such a company.

Litigation initiated against us, whether or not successful, could

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

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

securities class action litigation has often been initiated against such a company.

Litigation initiated against us, whether or not successful,

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

financial condition.

We do not intend to pay dividends on our

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stock will appreciate in value.

Certain provisions of our Certificate of

Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to

complete, even if such a transaction were in our stockholders’ interest.

Certain provisions of our Certificate

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

to complete, even if such a transaction were in our stockholders’ interest.

Provisions of our certificate

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In addition, we will incur substantial expenses in connection with the

preparation of registration statements and related documents with respect any offerings of our common stock.

preparation of registration statements and related documents with respect to any offerings of our common stock.

Our ability to utilize our net operating

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for us to produce reliable financial reports and are important to help prevent financial fraud.

Our compliance with Section

404 of the Sarbanes-Oxley Act requires that we incur substantial accounting expense and expend significant management efforts.

with Section 404 at December 31, 2022 and 2021 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.

Our compliance with

Section 404 of the Sarbanes-Oxley Act requires that we incur substantial accounting expense and expend significant management

We complied with Section 404 at December 31, 2023 and 2022 and while our testing did not reveal any material weaknesses in

our internal controls, any material weaknesses in our internal controls in the future would be required us to remediate in a timely

manner so as to be able to comply with the requirements of Section 404 each year.

If we are not able to comply with the requirements

of Section 404 in a timely manner each year, we could be subject to sanctions or investigations by the SEC, NYSE American or other

regulatory authorities which would require additional financial and management resources and could adversely affect the market price

of our common stock.

Furthermore, if we cannot provide reliable financial reports or prevent fraud, our business and results of

operations could be harmed, and investors could lose confidence in our reported financial information.

If securities or industry analysts do not

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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.

UNRESOLVED STAFF COMMENTS.

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