What changed in this filing

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Item 1A. Risk Factors

2023-05-15 compared with 2022-11-14 · 441 added, 386 removed, 1284 unchanged (39% of the section changed)

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We are providing the following

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

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

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

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

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

We encourage you to carefully review the full risk factors contained in our Annual Report on Form 10-K for the year ended December 31,

2022 in their entirety for additional information regarding the material factors that make an investment in our securities speculative

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

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

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

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

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;

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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;

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have incurred losses in each period since our inception.

As of September 30, 2022, and December 31, 2021, we had an accumulated deficit

of $278.1 million and $255.7 million, respectively.

We reported a net loss of $22.3 million and $16.8 million for the nine months ended

September 30, 2022, and 2021, respectively.

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

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

There can be no

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

Furthermore, there can

be no assurance that if such products are approved, they will be successfully commercialized, which would have an adverse effect on our

business prospects, financial condition and results of operation.

As of March 31, 2023 and December 31, 2022, we had an accumulated deficit of

$299.8 million and $288.8 million, respectively.

We reported a net loss of $11.0 million and $5.1 million for the three months ended March

31, 2023 and 2022, respectively.

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

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

There can be no assurance that the

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

Furthermore, there can be no assurance that

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

financial condition and results of operation.

If we fail to obtain additional financing,

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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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We have limited access to the capital markets

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

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

We have limited access to

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

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

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

remains uncertain and cannot be predicted with confidence.

In addition, the Omicron variants of COVID-19, including subvariants BA.4 and

BA.5, which appear to be the most transmissible variants to date, have spread globally.

The full impact of the Omicron variant, or any

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

the effectiveness of COVID-19 vaccines and boosters against the Omicron variant and the response by governmental bodies and regulators.

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

The global health crisis caused

by the novel coronavirus COVID-19 pandemic and its resurgences has had and may in the future negatively impact global economic activity.

Although the Public Health Emergency for COVID-19 declared by the U.S.

federal government has ended, there remains a risk that new variants

of COVID 19, or other infectious diseases, may still emerge.

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, 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 a future pandemic on our business.

Many countries around the

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

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

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

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

of operations.

In response to COVID-19, we implemented 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.

Certain government-imposed precautionary measures may have

been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again due to a resurgence

in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly than prior strains.

Therefore, the COVID-19 pandemic may 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.

The continuation

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

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

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

Further, the continuation and/or resurgence of the COVID-19 pandemic

could result in delays in our clinical trials due to prioritization of hospital resources toward the pandemic, restrictions in travel,

potential unwillingness of patients to enroll in trials at this time, or the inability of patients to comply with clinical trial protocols

if quarantines or travel restrictions impede patient movement or interrupt healthcare services.

In addition, we rely on independent clinical

investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise

carrying out our preclinical studies and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources

to our programs or to travel to sites to perform work for us, which may result in delays or hinder our ability to collect data from our

clinical trials.

Additionally, COVID-19 may

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

world imposed quarantines and restrictions on travel and mass gatherings in response to the COVID-19 pandemic and could reinstitute such

policies in response to future infectious disease outbreaks.

In such a scenario, our ability to continue to operate our business may also

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 infectious

disease 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 such outbreaks

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

Market disruption and volatility

following a new outbreak of infectious disease could have an adverse effect on our ability to access capital, which could in turn negatively

affect our liquidity.

In addition, a recession or market correction resulting from the spread of such disease could materially affect

our business and the value of our common stock.

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 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, 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

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

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

and financial results during 2022 will depend on, among other things, the ultimate severity and scope of the pandemic, including the new

variants of the virus, the possible imposition of governmental and private travel restrictions and public concerns about public gatherings

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

which the economy recovers.

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

2022 and beyond.

However, the ultimate impact from COVID-19 or any future pandemic

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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the same data.

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

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

such BLA will be approved by the FDA.

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

they are subject to rigorous regulatory requirements.

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

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

The clinical trial process is also lengthy and requires substantial

time and effort.

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

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

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

part because they are subject to rigorous regulatory requirements.

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

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

The clinical trial process is also lengthy and

requires substantial time and effort.

In December 2015, the FDA

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under such IND to study Iomab-B in patients 55 years of age or older with relapsed or refractory AML.

The Phase 3 trial SIERRA trial has

met its primary endpoint assuming there are no unexpected issues or delays, including with secondary endpoints, 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.

And, we have multiple Phase 1 and Phase 2 clinical trials ongoing and others that we have

planned but not-yet commenced, for our other drug candidates under our own sponsorship and multiple investigator-initiated trials ongoing.

Except for Iomab-B (for patients with AML), we expect that the clinical trials we need to conduct to be in a position to submit BLAs for

our product candidates currently in-development will take, at least, several years to complete.

Moreover, failure can occur at any stage

of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.

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

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

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

Any of the following could

delay or disrupt the clinical development of our product candidates and potentially cause our product candidates to fail to receive regulatory

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

Any of the following could delay or disrupt

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

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

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

delays by us or third parties in the collection or analysis of data from our clinical trials;

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

We may suspend, or the FDA

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

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

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

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

unforeseen safety issues;

lack of adequate funding to continue the clinical trial.

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

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

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

safety issues;

of adequate funding to continue the clinical trial.

Modifications to our product candidates

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Initiating and completing

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

and expensive process, and the outcome is inherently uncertain.

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

expensive process, and the outcome is inherently uncertain.

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

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

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

results from the trial.

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

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

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

may not be able to produce.

We have also worked with the FDA to develop a regulatory pathway for lintuzumab-Ac-225 in patients with high-risk

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

a BLA filing.

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

There can be no assurance

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

eventually support the filing or approval of a BLA.

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

the results of any future clinical trials.

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

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

Even if the clinical data from the SIERRA

trial is positive, there can be no assurances that the BLA filing we produce will meet all of the FDA’s requirements or that they

will not request additional information or studies, which may delay the FDA’s review or we may not be able to produce.

worked with the FDA to develop a regulatory pathway for lintuzumab-Ac-225 in patients with high-risk MDS that consists of a dose-confirming

Phase 1 trial that can be followed by a randomized, controlled pivotal trial that could support a BLA filing.

To date, we have not initiated

this clinical trial and we may never elect or be able to do so.

There can be no assurance that the data generated during the trial, or

any trial, will meet our chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing

or approval of a BLA.

Even if the data from this trial are favorable, the data may not be predictive of the results of any future clinical

Preliminary, Interim, and “top-line”

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

From time to time, we may publicly disclose preliminary, interim, and

top-line data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings

and conclusions are subject to change as more patient data become available or following a more comprehensive review of the data related

to the particular study or trial.

For example, in October 2022 we announced that Iomab-B met the primary endpoint of dCR in the SIERRA

trial with statistical significance (p<0.0001).

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

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

Our clinical trials may

be open label studies and certain of our clinical development and or operations staff may review interim or preliminary safety or efficacy

data during routine data collection, cleaning and analysis from time to time.

Interim or preliminary results that we report may differ

from future results of the same studies, or different conclusions or considerations may qualify such results once additional data have

been received and fully evaluated.

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

may result in the final data being materially different from the top-line, interim or preliminary data we previously published.

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 February

2023 we announced that Iomab-B met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001).

also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or

had the opportunity to fully and carefully evaluate all data.

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

clinical development and or operations staff may review interim or preliminary safety or efficacy data during routine data

collection, cleaning and analysis from time to time.

Interim or preliminary results that we report may differ from future results of

the same studies, or different conclusions or considerations may qualify such results once additional data have been received and

fully evaluated.

Preliminary, interim or top-line data also remain subject to audit and verification procedures that may result in

the final data being materially different from the top-line, interim or preliminary data we previously published.

top-line, interim and preliminary data should be viewed with caution until the final data are available.

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The key patents related to

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

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

It is generally possible that others

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We own 4 issued U.S.

patents, 1 issued European patent (validated

as a national patent in several countries) and 1 issued Japanese patent that relate to the composition of our Iomab-B product candidate.

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

patents, 1 issued Canadian patent, 1 issued

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

Iomab-B product candidate.

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

and internationally.

We have and may continue to file patents

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

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

We have pending patents related

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

This 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.

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

use in treating solid or liquid cancers.

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

candidates Actimab-A and Iomab-B.

Any competing product based on the antibody used in Iomab-B is likely to require several years of development

before achieving our product candidate’s current status and may be subject to significant regulatory hurdles but such development

by others is nevertheless a possibility that could negatively impact our business in the future.

Our CD33 program clinical trials are testing

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Our CD33 program is comprised

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

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

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

We may be unable to obtain a sufficient

supply of isotopes to support clinical development or at commercial scale.

Iodine-131 is a key component of our Iomab-B drug candidate.

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

Currently, there is sufficient supply of I-131

to support additional trials we may undertake utilizing I-131 and for commercialization of Iomab-B.

We continually evaluate I-131 manufacturers

and suppliers and intend to have multiple qualified suppliers prior to the commercial launch of Iomab-B.

While we consider I-131 to be

commoditized and obtainable through several suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131

on terms that are acceptable to us.

Actinium-225 is a key

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

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

of Energy (“DOE”).

The Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the

natural decay of thorium-229 from so-called ‘thorium-cows’ and is able to produce sufficient quantities that are several

multiples of the amount of Ac-225 we require to supply our clinical programs through to early commercialization phase.

also producing Ac-225 from a recently developed alternative route for Ac-225 production via a linear accelerator that is currently

Iodine-131 is a key component

of our Iomab-B drug candidate.

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

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

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

launch of Iomab-B.

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

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

Actinium-225 is a key component

of our Actimab-A product candidate, technology platform, preclinical R&D programs and other drug candidates that we might consider

for development with the Ac-225 payload.

There are adequate quantities of Ac-225 available today to meet our current needs via our present

supplier, the Department of Energy (“DOE”).

The Ac-225 currently supplied to Actinium’s clinical trials from the DOE

is derived from the natural decay of thorium-229 from so-called ‘thorium-cows’ and is able to produce sufficient quantities

that are several multiples of the amount of Ac-225 we require to supply our clinical programs through to early commercialization phase.

The DOE is also producing Ac-225 from a recently developed alternative route for Ac-225 production via a linear accelerator that is currently

being evaluated by Actinium.

Initial preclinical and modelling results have indicated that the linear accelerator sourced Ac-225

does not impact labelling efficiency and expected distribution.

In accordance with representations made by the DOE, the capacity of

Ac-225 from this route is expected to be sufficient to supply all of Actinium’s pipeline and commercial Ac-225 needs and

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

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

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

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

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

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

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

Initial preclinical and modelling results have indicated that the linear accelerator sourced Ac-225 does

not impact labelling efficiency and expected distribution.

In accordance with representations made by the DOE, the capacity of Ac-225

from this route is expected to be sufficient to supply all of Actinium’s pipeline and commercial Ac-225 needs and support new program

expansion by not just Actinium but also other companies that are developing Ac-225 based products.

Additional routes of Ac-225 production

are being pursued by the DOE including the generation of new thorium cows and production via a cyclotron.

The cyclotron production method

for Ac-225 production leverages Actinium’s proprietary technology and know-how and presents an additional path towards production

of high-quality Ac-225 at a scale that would be able to satisfy commercial needs.

In addition, we are aware of at least ten other government

and non-government entities globally including the U.S., Canada, Russia, Belgium, France and Japan that have, or expect to have ability

to supply Ac-225 or equipment for its production within the timeframes relevant to the potential first commercial approval of our Ac-225-based

drug candidate.

Our contract for supply of

Ac-225 from the DOE must be renewed annually and our current contract extends through the end of 2022.

While we expect this contract will

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

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

Failure to acquire sufficient quantities of medical grade Ac-225 at a cost

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

that we may develop and would materially harm our business.

this isotope from the DOE must be renewed yearly, and we renewed our contract to extend through the end of 2023.

While we expect this

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

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

Failure to acquire sufficient quantities of medical grade

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

may develop and would materially harm our business.

Our ability to conduct clinical

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

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

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

candidates receive regulatory approval.

If we encounter difficulties enrolling patients

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

the size and nature of the patient population;

the patient eligibility criteria defined in the protocol;

the size of the study

population required for analysis of the trial’s primary and secondary endpoints;

the proximity of patients to trial sites;

the design of the trial;

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

competing clinical trials for similar or alternate therapeutic treatments;

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

our ability to obtain and maintain patient consents;

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

size and nature of the patient population;

patient eligibility criteria defined in the protocol;

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

proximity of patients to trial sites;

design of the trial;

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

clinical trials for similar or alternate therapeutic treatments;

● clinician’s

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

other available therapies;

ability to obtain and maintain patient consents;

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

In addition, refractory patients,

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We have received orphan drug

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

Under the Orphan Drug Act,

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

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

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

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

Similarly, the EMA grants orphan drug designation to promote

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

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

Under the Orphan Drug Act, the FDA may

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

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

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

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

Similarly, the EMA grants orphan drug designation to promote the

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

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

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in, among other things:

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

fines, warning letters or holds on clinical trials;

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

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

injunctions or the imposition of civil or criminal penalties.

● restrictions

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

warning letters or holds on clinical trials;

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

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

● injunctions

or the imposition of civil or criminal penalties.

The FDA’s and other

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There have been significant

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

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

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

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

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

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

Affordable Care Act.

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

While Congress

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

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

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

In December 2018,

a district court in Texas held that the individual mandate is unconstitutional and that the rest of the Affordable Care Act is, therefore,

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

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

The Fifth Circuit’s

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

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

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

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

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

Act is, therefore, invalid.

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

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

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

Supreme Court.

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

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

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

district court to dismiss the case.

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

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

may have on our business.

The adoption or implementation

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

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

We cannot predict the ultimate nature, timing, or effect

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

not adversely affect our future business and financial results.

On June 17, 2021, the Supreme Court

held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing

to challenge the constitutionality of the Affordable Care Act’s individual mandate and, accordingly, vacated the Fifth Circuit’s

decision and instructed the district court to dismiss the case.

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

form for the foreseeable future;

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

the impact any such actions may have on our business.

In addition to the Affordable

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

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

reform government program reimbursement methodologies for drug products.

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

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

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

Better Act (H.R.

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

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

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

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

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

market, if ever.

In the coming years, additional

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

and the potential success of our vaccine candidates.

Most recently, on August 16,

2022, President Biden signed into law the Inflation Reduction Act of 2022 (the “IRA Act”), which, among

other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically,

the IRA Act authorizes and directs the Department of Health and Human Services (the “DHHS”) to set drug price caps for certain

high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs to be selected by September 1, 2023, and the first

year of maximum price applicability to begin in 2026.

The IRA Act 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 Act creates significant

changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning

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.

2022, President Biden signed into law the Inflation Reduction Act of 2022 (the “IRA”), which, among other

provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically, the

IRA authorizes and directs the Department of Health and Human Services (the “DHHS”) to set drug price caps for certain high-cost

Medicare Part B and Part D qualified drugs, with the initial list of drugs to be selected by September 1, 2023, and the first year of

maximum price applicability to begin 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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healthcare laws and regulations that may affect our operations, directly or indirectly, include the following, among others:

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

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

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

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

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

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

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

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

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

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

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

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

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

for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal

and state healthcare programs such as Medicare and Medicaid;

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

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

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

to pay money to the federal government;

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

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

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

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

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

or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission

of individually identifiable health information;

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

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

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

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

manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value

provided to physicians and any ownership and investment interests held by physicians or their immediate family members.

2022, applicable manufacturers also will be required to report such information regarding payments and other transfers of value to physician

assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and

certified nurse midwives during the previous year;

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

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

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

state laws that require pharmaceutical companies to comply with the

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

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

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

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

state and local laws that require

the registration of pharmaceutical sales representatives;

and state laws governing the privacy and security of health information in

certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating

compliance efforts.

Efforts to comply with applicable

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Third-party payors may not adequately reimburse

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

authorizations and step edits that affect their use.

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

prior authorizations and step edits that affect their use.

Our ability to commercialize

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practice, or cGMP, regulations.

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

which would delay the regulatory approval process.

Our failure to comply with these regulations may require us to repeat clinical trials, which would delay

the regulatory approval process.

If our consultants, contract

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We are not aware of any existing

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

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

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

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market acceptance.

Iomab-B, CD33 program candidates

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.

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

Failure of Iomab-B, CD33 program

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

financial condition and results of operations.

Failure of Iomab-B, Actimab-A

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

condition and results of operations.

We may be subject to claims that our third-party

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our collaboration.

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

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

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

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in a number of potentially significant negative consequences, including:

regulatory authorities may withdraw their approval of the product;

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

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

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

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

our reputation may suffer.

authorities may withdraw their approval of the product;

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

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

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

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

reputation may suffer.

Any of these events could

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We or our licensors have applied

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

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

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

Furthermore, it is possible that

patents issued or licensed to us may be challenged successfully.

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

such patents, such preferred position would be lost.

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

become subject to competition from the sale of generic products.

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

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

filings, would adversely affect our business and operations.

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

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

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

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

If we are found to be infringing on patents

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may have to expend resources to protect our interests from possible infringement by others.

We have learned that a former employee violated

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

This employee, who had access to materials

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

was employed by a direct competitor.

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

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

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.

continued to provide consulting services to Actinium.

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.

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.

We are currently

in arbitration with Dr.

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

provisions, to the fullest extent of our ability.

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 Ms.

Liang is permanently enjoined from using,

possessing, transmitting or transferring any Actinium property, documents of business information.

Further, until April 1, 2024, Dr.

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.

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 currently do not have a marketing or sales

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

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

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

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

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

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

We will also have to compete with other pharmaceutical and

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

Any failure or delay in the development of our

internal sales, marketing and distribution capabilities would adversely impact the commercialization of any of our product candidates

that we obtain approval to market.

To manage our anticipated future growth, we must

continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and

train additional qualified personnel.

Due to our limited financial resources and the limited experience of our management team in managing

a public company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and

train additional qualified personnel.

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

business development resources.

Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We expect to experience significant

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

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

We currently do not have a

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

regulatory approval.

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

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

may not be successful in doing so.

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

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

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

We will also have to compete

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

Any failure or

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

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

To manage our anticipated

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

continue to recruit and train additional qualified personnel.

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

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

operations or recruit and train additional qualified personnel.

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

divert our management and business development resources.

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

or disrupt our operations.

The use of hazardous materials, including

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

submit a BLA and build a commercial organization.

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 to offer.

It is particularly difficult

to recruit and hire new employees during the COVID-19 pandemic as the uncertainty created by the COVID-19 pandemic makes it less likely

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

There can be no assurance that such professionals

will be available in the market, or that we will be able to retain existing professionals or meet or continue to meet their compensation

requirements.

Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly,

which could have a material adverse effect on us.

Failure to establish and maintain an effective management team and workforce could adversely

affect our ability to operate, grow and manage our business.

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.

Managing our growth as we expand operations

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each current stockholder’s ownership interest in the Company.

Risks Related to Ownership of Our Common

Risks Related to Ownership of Our Common Stock

The sale of securities by us in any equity

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

actual or anticipated variations in our operating results;

announcements of developments by us or our competitors;

the timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

regulatory actions regarding our products;

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

adoption of new accounting standards affecting our industry;

additions or departures of key personnel;

introduction of new products by us or our competitors;

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

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

or anticipated variations in our operating results;

● announcements

of developments by us or our competitors;

timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

actions regarding our products;

● announcements

by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

of new accounting standards affecting our industry;

or departures of key personnel;

● introduction

of new products by us or our competitors;

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

or unfavorable reports from securities or industry analysts;

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

The stock market is subject

to significant price and volume fluctuations.

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

and uncertainty in recent months.

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

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

Litigation initiated against us, whether or not successful, could

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

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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Among other things, the certificate of incorporation and bylaws:

provide that the authorized number of directors may be changed by resolution of the board of directors;

provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

divide the board of directors into three classes;

provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice.

that the authorized number of directors may be changed by resolution of the board of directors;

that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote

of a majority of directors then in office, even if less than a quorum;

the board of directors into three classes;

that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at

a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content

of a stockholder’s notice;

In addition, we are governed

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a change in our control.

General Risk Factors

Compliance with the reporting requirements

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

Our ability to utilize our net operating

loss carryforwards and certain other tax attributes may be limited.

Our ability to utilize our

federal net operating loss and tax credit carryforwards may be limited under Sections 382 and 383 of the Internal Revenue Code of 1986,

as amended, or the Code.

The limitations apply if we experience an “ownership change”, generally defined as a greater

than 50 percentage point change in the ownership of our equity by certain stockholders over a rolling three-year period.

provisions of state tax law may also apply.

We have not assessed whether such an ownership change has previously occurred.

have experienced an ownership change at any time since our formation, we may already be subject to limitations on our ability to utilize

our existing net operating losses and other tax attributes to offset taxable income.

In addition, future changes in our stock ownership,

which may be outside of our control, may trigger an ownership change and, consequently, the limitations under Sections 382 and 383 of

As a result, if or when we earn net taxable income, our ability to use our pre-change net operating loss carryforwards

and other tax attributes to offset such taxable income may be subject to limitations, which could adversely affect our future cash flows.

Failure to establish and maintain adequate

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

What changed 10-Q

Item 1A. Risk Factors