What changed in this filing

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Item 1A. Risk Factors

2024-04-26 compared with 2023-11-02 · 309 added, 183 removed, 1493 unchanged (25% of the section changed)

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We are providing 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:

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

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

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

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

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

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We are highly dependent on the regulatory and commercial success of Iomab-B;

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

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

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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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.

We may rely on third parties to conduct certain aspects of 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;

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have incurred losses in each period since our inception.

As of September 30, 2023 and December 31, 2022, we had an accumulated deficit

of $328.3 million and $288.8 million, respectively.

We reported a net loss of $39.5 million and $22.4 million for the nine months ended

September 30, 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.

As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of

$346.3 million and $337.6 million, respectively.

We reported a net loss of $8.7 million and $11.0 million for the three months ended March

31, 2024 and 2023, 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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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 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

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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 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 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 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.

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.

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

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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.

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

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

In the United States, the FDA regulates pharmaceutical

and biological product candidates under the FDCA and the Public Health Service Act (“PHSA”), as well as their respective

implementing regulations.

Such products and product candidates are also subject to other federal, state, and local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes

and regulations requires the expenditure of substantial time and financial resources.

The process required by the FDA before a drug or

biological product may be marketed in the United States generally involves the following:

In the United States, the

FDA regulates pharmaceutical and biological product candidates under the FDCA and the Public Health Service Act (“PHSA”),

as well as their respective implementing regulations.

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

local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,

state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

The process required

by the FDA before a drug or biological product may be marketed in the United States generally involves the following:

completion of preclinical laboratory tests and animal studies in accordance with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;

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Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Clinical trials must

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

Clinical trials must be

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

all research subjects provide informed consent.

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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)

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 licensed.

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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

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.

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

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 trials.

Preliminary, Interim, and “top-line”

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

From time to time, we

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

From time to time, we may

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

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

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Further, others, including

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

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

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

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

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

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We own 4 issued U.S.

patents, 1 issued Canadian patent, 1 issued

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

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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.

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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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.

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

Our inability

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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.

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

Most recently, on August 16,

More recently, on August 16,

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

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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.

Medicare Part B and Part D qualified 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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or promote is eligible for reimbursement under its criteria, the payor may impose coverage limitations that preclude payment for some

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

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

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

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

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

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

than in the United States.

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

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

Commercial third-party payors often rely upon Medicare

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

Our inability to promptly obtain and maintain coverage

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

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

overall financial condition.

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

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

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

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

for other services.

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

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

at lower prices than in the United States.

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

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

Commercial third-party payors often rely

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

Our inability to promptly obtain

and maintain coverage and profitable payment rates from both government-funded programs and private payors for any approved products

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

approved products and our overall financial condition.

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.

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

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

We do not have the ability

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and prospects would be adversely affected.

The antibodies we use in our targeted radiotherapy

product candidates may be subject to generic competition.

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 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.

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

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.

and 10 years in the EU.

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.

In 2027 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

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

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

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

Further, such litigation

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

There has been substantial litigation and other proceedings

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

We may become a party to patent litigation and

other proceedings.

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

Some of our competitors

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

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.

Moreover, it 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 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.

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

We may become a party to patent litigation and other proceedings.

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

could be substantial.

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

of their substantially greater financial resources.

Litigation may also absorb significant management time.

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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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Our ability to protect and enforce our patents

does not guarantee that we will secure the right to commercialize 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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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.

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 is permanently enjoined from using, possessing, transmitting or transferring any Actinium property, documents

of business information.

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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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.

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

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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