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Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-03-29 · 193 added, 315 removed, 46 unchanged (92% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The information and financial

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in accordance with generally accepted accounting principles in the United States.

The information and financial data discussed below is

only a summary and should be read in conjunction with the historical financial statements and related notes of Actinium Pharmaceuticals,

The information and financial data discussed below

is only a summary and should be read in conjunction with the historical financial statements and related notes of Actinium Pharmaceuticals,

contained elsewhere in this Report.

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in the context of this Report.

See also “Risk Factors” in Part I, Item 1A of this Report for a discussion of risks and

uncertainties that could impact Actinium Pharmaceuticals, Inc.’s future financial condition, operations and performance.

Actinium Pharmaceuticals,

is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and clinical experience to develop novel

targeted radiotherapies for patients with unmet needs.

Our targeted radiotherapies combine the cell-killing ability of radiation via a

radioisotope payload with a targeting agent, such as a monoclonal antibody, to deliver radiation in a precise manner inside the body to

specific, targeted cells such as cancer cells, to potentially achieve greater efficacy with lower toxicity than with cytotoxic chemotherapy

or external beam radiation.

Targeted radiotherapies also enable broader application of radiation than external beam radiation as they

can be used in the treatment of both solid tumors and blood cancers, which generally cannot be treated with external radiation given their

diffuse nature.

Results of Operations – Year Ended December

31, 2023 Compared to the Year Ended December 31, 2022

The following table sets forth,

for the periods indicated, data derived from our statements of operations:

(“Actinium”, the “Company”, or “we”) is a pioneer in the development of targeted radiotherapies

intended to meaningfully improve outcomes for patients with relapsed or refractory cancer who have failed existing therapies.

as a single operating segment focused on research, discovery, and clinical development of targeted radiotherapies.

of Operations – Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023

following table sets forth, for the periods indicated, data derived from our statements of operations:

For the years ended

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Total other income

We recorded no commercial

revenues for the years ended December 31, 2023 and 2022, respectively.

Other revenue

We determined that certain

collaborations with a third-party were within the scope of Topic ASC 606, Revenue Recognition from Contracts with Customers, or

The collaboration agreement was made up of multiple modules related to various research activities.

While the third party has

the option to terminate the agreement at the conclusion of any module, we identified a single performance obligation to provide research

services within each module for which we receive monetary consideration.

The consideration was recognized as revenue over each module

and revenue of $0.9 million was recognized during the year ended December 31, 2022.

There was no corresponding revenue recognized from

a collaboration during the year ended December 31, 2023.

The National Institutes of

Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan

Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve

lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.

We recognized other revenue during the

years ended December 31, 2023 and December 31, 2022 of $0.1 million in each year from this grant.

On April 7, 2022, we entered

into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product rights

for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra, Bahrain,

Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia,

Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.

Upon signing, we were entitled

to an upfront payment of $35 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement, we are eligible

to receive regulatory and commercial milestone payments and are entitled to receive royalties in the mid-20 percent range on net sales

of the product in certain countries that may result from the License Agreement.

We will continue to be responsible for certain clinical

development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S.

recorded no commercial revenues for the years ended December 31, 2024 and 2023, respectively.

National Institutes of Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration

with Memorial Sloan Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeting Antibody Radio-Conjugate, for targeted conditioning

to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.

We recognized other revenue

during the year ended December 31, 2023 of $0.1 million from this grant.

April 7, 2022, we entered into a License Agreement with Immedica, pursuant to which Immedica licensed the exclusive product rights for

commercialization of Iomab-B in certain countries in the EUMENA region.

Upon signing, we were entitled to an upfront, non-refundable

payment of $35.0 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement, we are eligible to

receive certain regulatory and commercial milestone payments and royalties on net sales of the product in certain countries that may

result from the License Agreement.

We continue to retain commercialization rights in the U.S.

and rest of the world.

Our contract liabilities are

recorded within Other revenue deferred – current liability or Long-term license revenue deferred in our condensed consolidated balance

sheets depending on the short-term or long-term nature of the payments to be recognized.

Our contract liabilities primarily consist of

advanced payments from licensees.

Long-term license revenue deferred was $35.0 million at both December 31, 2023 and December 31, 2022,

resulting from the receipt from Immedica.

This deferred revenue will be recognized upon European Union regulatory approval of Iomab-B.

Research and Development Expense, net of reimbursements

contract liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue deferred in our

condensed consolidated balance sheets depending on the short-term or long-term nature of the payments to be recognized.

liabilities primarily consist of advanced payments from licensees.

Long-term license revenue deferred was $35.0 million at December 31,

2024 and December 31, 2023, resulting from the receipt from Immedica;

this deferred revenue will be recognized upon the European Union’s

regulatory approval of Iomab-B or provision of definitive feedback that Iomab-B will not receive approval in the European Union.

and Development Expenses, net of reimbursements

Research and development expenses

increased by $15.6 million to $38.7 million for the year ended December 31, 2023 compared to $23.1 million for the year ended December

Higher expenses were primarily due to increased CMC activity related to the planned BLA and MAA-enabling work for Iomab-B.

addition, increased compensation of $4.3 million resulting from higher headcount, primarily to support BLA and MAA-enabling activity.

General and Administrative Expenses

decreased by $8.6 million to $30.0 million for the year ended December 31, 2024, compared to $38.7 million for the year ended December

This decrease was primarily due to CMC expenses declining by $12.0 million and consulting expenses declining by $1.7 million

due to lower CMC activity related to Iomab-B.

These declines were partially offset by increased preclinical expenses of $5.0 million.

the third quarter of 2024, our overall headcount was reduced by approximately twenty percent, with a majority of these former employees

being from our clinical and CMC groups.

As a result of these departures, we expect our personnel expenses to be reduced by approximately

$3.7 million in 2025, which may be offset by additional hires or consultants.

We do not expect these departures to have a material impact

on our operations or ability to execute our operating plan.

and Administrative Expenses

General and administrative

expenses increased by $1.3 million to $13.3 million for the year ended December 31, 2023 compared to $12.0 million for the year ended

expenses decreased by $1.3 million to $12.1 million for the year ended December 31, 2024, compared to $13.3 million for the year ended

December 31, 2023.

Higher expenses were primarily due to increased compensation of $0.9 million resulting from higher headcount and increased

non-cash equity compensation of $0.8 million, partially offset by lower consulting fees and legal fees.

Other income is comprised

of net interest income in both reporting periods.

Other income of $3.1 million for the year ended December 31, 2023 increased from $1.1

million for the year ended December 31, 2022 primarily due to higher interest rates.

Net loss increased by $15.8

million to $48.8 million for the year ended December 31, 2023 compared to $33.0 million for the year ended December 31, 2022, primarily

due to higher research and development expenses largely attributed to increased CMC activity and headcount to support the planned BLA

and MAA-enabling activity and general and administrative expenses, partially offset by other income, as discussed above.

Liquidity and Capital Resources

Historically, we have financed

our operations primarily through sales of our common stock and common stock equivalents.

The following tables sets forth selected cash

flow information for the periods indicated:

Lower expenses were primarily the result of lower consulting fees and legal fees of $1.6 million and lower compensation

expense of $0.6 million due to lower headcount, partially offset by higher non-cash compensation expense of $1.2 million.

income is comprised of net interest income in both reporting periods.

Other income of $3.9 million for the year ended December 31, 2024

increased from $3.1 million for the year ended December 31, 2023 primarily due to higher average interest rates.

loss decreased by $10.6 million to $38.2 million for the year ended December 31, 2024, compared to $48.8 million for the year ended December

31, 2023 due to lower research and development expenses, lower general and administrative expenses and a higher level of other income.

and Capital Resources

Historically,

we have financed our operations primarily through sales of our common stock and common stock equivalents.

The following tables sets forth

selected cash flow information for the periods indicated:

For the years ended

(amounts in thousands)

Cash (used in)/provided by operating activities

Cash used in operating activities

Cash used in investing activities

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Net change in cash, cash equivalents and restricted cash

Net cash used in operating

activities for the year ended December 31, 2023 was $47.3 million, a decrease of $56.0 million from $8.6 million of net cash provided

by operating activities in the prior-year period, primarily as a result of the higher net loss of $15.8 million and the receipt in the

prior-year period of the $35.0 million up-front payment from Immedica.

Net cash used in investing

activities was $0.2 million and $0.4 million for the years ended December 31, 2023 and December 31, 2022, respectively, primarily due

to the purchase of equipment for our laboratory space.

In August 2020, we entered into the Capital on Demand™ Sales

Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we are able to sell, from time to time, through

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

On June 28, 2022, we entered into an Amendment and Restated

Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and B.

cash used in operating activities for the year ended December 31, 2024 was $33.1 million, a decrease of $14.2 million from $47.3 million

in the prior-year period, primarily as a result of a lower net loss of $10.8 million and a decrease in net operating assets and liabilities of $2.2 million.

cash used in investing activities was $11 thousand and $153 thousand for the years ended December 31, 2024 and December 31, 2023, respectively,

primarily due to the purchase of equipment for our laboratory space.

August 2020, we entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading,

pursuant to which we are able to sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common

On June 28, 2022, we entered into an Amendment and Restated Capital on Demand™ Sales Agreement, or the Amended Sales Agreement,

with JonesTrading and B.

Riley Securities, Inc.

The Amended Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B.

Riley as an additional sales

agent thereunder.

Shares of common stock are offered pursuant to a shelf registration statement on Form S-3 (File No.

333-242322) filed

with the SEC on August 7, 2020 (the “Prior Shelf Registration Statement”).

On August 11, 2023, we filed a new registration

statement on Form S-3 (File No.

333-273911), and amended on February 2, 2024, which was declared effective on February 5, 2024, to replace

the Prior Shelf Registration Statement, including a base prospectus which covers the offering, issuance and sale of up to $500 million

of common stock, preferred stock, warrants, units and/or subscription rights;

and a sales agreement prospectus covering the offering,

issuance and sale of up to a maximum aggregate offering price of $200 million of common stock that may be issued and sold under the Amended

Sales Agreement.

For the year ended December 31, 2023, we sold 1.9 million shares of common stock, resulting in gross proceeds of $15.1

million and net proceeds of $14.6 million.

For the year ended December 31, 2022, we sold 3.5 million shares of common stock, resulting

in gross proceeds of $23.9 million and net proceeds of $23.2 million.

We entered into a lease

for corporate office space effective June 1, 2022.

The lease has a term of five years two months, with an expiration date in 2027, and

current annual rent of $0.6 million.

We are also responsible for certain other costs, such as insurance, utilities and maintenance.

issued a letter of credit in connection with the lease and as of December 31, 2023 maintain a $0.3 million certified deposit as collateral

for the letter of credit.

We will require

additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals,

The Amended Sales Agreement modifies the original Capital on

Demand™ Sales Agreement to include B.

Riley as an additional sales agent thereunder.

Shares of common stock were offered pursuant

to a shelf registration statement on Form S-3 (File No.

333-242322) filed with the SEC on August 7, 2020 (the “Prior Shelf Registration

On August 11, 2023, we filed a registration statement on Form S-3 (File No.

333-273911), and amended on February 2,

2024, which was declared effective on February 5, 2024, to replace the Prior Shelf Registration Statement, including a base prospectus

which covers the offering, issuance and sale of up to $500 million of common stock, preferred stock, warrants, units and/or subscription

and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $200

million of common stock that may be issued and sold under the Amended Sales Agreement.

For the year ended December 31, 2024, we sold

3.5 million shares of common stock, resulting in gross proceeds of $29.9 million and net proceeds of $29.3 million.

For the year ended

December 31, 2023, we sold 1.9 million shares of common stock, resulting in gross proceeds of $15.1 million and net proceeds of $14.6

entered into a lease for corporate office space effective June 1, 2022.

The lease has a term of five years and two months, with an expiration

date in 2027, and current annual rent of $0.6 million.

We are also responsible for certain other costs, such as insurance, utilities

and maintenance.

We issued a letter of credit in connection with the lease and as of December 31, 2024 maintain a $0.3 million certified

deposit as collateral for the letter of credit.

will require additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals,

commercially launch our product candidates, and will need to secure additional financing in the future to support our operations.

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be required to use our available cash and cash equivalent resources sooner than we currently expect.

Our actual future capital

requirements will depend on many factors, including the progress and results of our ongoing clinical trials, the duration and cost

of discovery and preclinical development, laboratory testing and clinical trials for our pipeline candidates, the timing and outcome

of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending, and

enforcing patent claims and other intellectual property rights, the number and development requirements of other pipeline candidates

that we pursue, and the costs of commercialization activities, including product marketing, sales, and distribution.

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.

Our ability to obtain additional capital may depend on prevailing economic conditions and financial,

business, and other factors beyond our control.

Current economic conditions have been, and continue to be, volatile.

Continued instability

in these market conditions may limit our ability to access the capital necessary to fund and grow our business.

Off-Balance Sheet Arrangements

We do not have any off-balance

Our actual future capital requirements

will depend on many factors, including the progress and results of our ongoing clinical trials, the duration and cost of discovery and

preclinical development, laboratory testing and clinical trials for our pipeline candidates, the timing and outcome of regulatory review

of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims

and other intellectual property rights, the number and development requirements of other pipeline candidates that we pursue, and the

costs of commercialization activities, including product marketing, sales, and distribution.

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.

Our ability to obtain additional capital may depend on prevailing

economic conditions and financial, business, and other factors beyond our control.

Current economic conditions have been, and continue

to be, volatile.

Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow

our business.

Sheet Arrangements

Critical Accounting Estimates

do not have any off-balance sheet arrangements.

Accounting Estimates

Our management’s discussion

and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared

in accordance with accounting principles generally accepted in the United States, or GAAP.

The preparation of these financial statements

requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of

contingent assets and liabilities in our consolidated financial statements during the reporting periods.

These items are monitored and

analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.

estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent

from other sources.

in accordance with accounting principles generally accepted in the United States (“GAAP”).

The preparation of these financial

statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure

of contingent assets and liabilities in our consolidated financial statements during the reporting periods.

These items are monitored

and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.

our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the

circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not

readily apparent from other sources.

Changes in estimates are reflected in reported results for the period in which they become known.

Actual results may

differ materially from these estimates under different assumptions or conditions.

Fair Value Measurement

Fair value is defined as the

price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants.

A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for

identical assets or liabilities and the lowest priority to unobservable inputs.

Revenue Recognition

We recognize revenue in accordance

with ASC 606.

Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects

the consideration that we expect to receive in exchange for those goods or services.

To determine revenue recognition for arrangements

within the scope of ASC 606, we perform the following five steps:

(i) identify the contract(s) with a customer;

(ii) identify the performance

obligations in the contract;

(iii) determine the transaction price, including variable consideration, if any;

(iv) allocate the transaction

price to the performance obligations in the contract;

and (v) recognize revenue as we satisfy a performance obligation.

We only apply

the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the

goods or services we transfer to the customer.

At contract inception,

once the contract is determined to be within the scope of ASC 606, we assess whether the promised goods or services promised within

each contract are distinct and, therefore, represent a separate performance obligation.

Goods and services that are determined

not to be distinct are combined with other promised goods and services until a distinct bundle is identified.

In determining whether

goods or services are distinct, we evaluate certain criteria, including whether (i) the customer can benefit from the good or

service either on its own or together with other resources that are readily available to the customer (capable of being distinct)

and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context

of the contract).

ASC 606 requires us to allocate

the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction

price of the contract and identifying the performance obligations to which that amount should be allocated.

The relative standalone selling

price is defined in the new revenue standard as the price at which an entity would sell a promised good or service separately to a customer.

We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance

obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input

Collaborative Arrangements

We follow the accounting guidance

for collaboration agreements, which requires that certain transactions between us and collaborators be recorded in our consolidated statements

of operations on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced

disclosure of collaborative relationships.

We evaluate our collaboration agreements for proper classification in our consolidated statements

of operations based on the nature of the underlying activity.

When we conclude that we have a customer relationship with one of our collaborators,

we follow the guidance of ASC 606 .

Grant Revenue

We have a grant from a government-sponsored

entity for research and development related activities that provides for payments for reimbursed costs, which included overhead and general

and administrative costs as well as an administrative fee.

We recognize revenue from the grant as we perform services under this arrangement.

Associated expenses are recognized when incurred as research and development expense.

Revenue and related expenses are presented gross

in the consolidated statements of operations.

License Revenue

We entered into a product

licensing agreement whereby we allowed a third party to commercialize a certain product in specified territories using our trademarks.

The terms of this arrangement includes payment to us for a combination of one or more of the following:

upfront license fees;

regulatory and sales-based milestone payments;

and royalties on net sales of licensed products.

We use judgment to determine whether milestones

or other variable consideration should be included in the transaction price.

Upfront license fees :

If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement,

we will recognize revenue from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee

is able to use and benefit from the license.

For licenses that are bundled with other promises, we determine whether the combined performance

obligation is satisfied over time or at a point in time.

Development, regulatory

or commercial milestone payments :

At the inception of each arrangement that includes payments based on the achievement of certain

development, regulatory and sales-based or commercial events, we evaluate whether the milestones are considered probable of being achieved

and estimate the amount to be included in the transaction price using the most likely amount method.

If it is probable that a significant

revenue reversal would not occur, the associated milestone value is included in the transaction price.

Milestone payments that are not

within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until regulatory

approval is received.

At the end of each subsequent reporting period, we will re-evaluate the probability of achieving such development

and regulatory milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price.

adjustments are recorded on a cumulative catch-up basis and recorded as part of license revenues during the period of adjustment.

Sales-based milestone

payments and royalties :

For arrangements that include sales-based royalties, including milestone payments based on the volume of

sales, we will determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones

relate and if such is the case, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the

performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Upfront payments and fees

may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements or when it is

probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with

any variable consideration is subsequently resolved.

Amounts payable to us are recorded as accounts receivable when our right to consideration

is unconditional.

Research and Development Costs

Research and development costs

are expensed as incurred.

These costs include the costs of manufacturing drug components and final drug product, the costs of clinical

trials, costs of employees and associated overhead, and depreciation and amortization costs related to facilities and equipment.

and development reimbursements are recorded by us as a reduction of research and development costs.

Share-Based Payments

We estimate the fair value

of each stock option award at the grant date by using the Black-Scholes option pricing model.

The fair value determined represents the

cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the

We account for forfeitures of stock options as they occur.

We use the asset and liability

method to calculate deferred taxes.

Deferred taxes are recognized based on the differences between the financial reporting and income

tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.

We review deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred tax asset will

be fully realized.

A valuation allowance, if necessary, is provided against deferred tax assets, based upon our assessment as to their

We recognize tax when the

positions meet a “more-likely-than-not” recognition threshold.

There were no tax positions for which it is considered reasonably

possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year.

interest related to unrecognized tax benefits in interest expense and penalties in operating expenses.

Recently Issued Accounting Pronouncements

In December 2023, FASB issued

ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures , to enhance the transparency and decision usefulness

of income tax disclosures.

The amendments in ASU 2023-09 provide improvements primarily related to the rate reconciliation and income

taxes paid information included in income tax disclosures.

We would be required to disclose additional information regarding reconciling

items equal to or greater than five percent of the amount computed by multiplying pretax income (loss) by the applicable statutory tax

Similarly, we would be required to disclose income taxes paid (net of refunds received) equal to or greater than five percent of

total income taxes paid (net of refunds received).

The amendments in ASU 2023-09 are

effective January 1, 2025, including interim periods.

Early adoption is permitted for annual financial statements that have not yet been

issued or made available for issuance.

Actual results may differ materially from these estimates under different assumptions or conditions.

The Company does not have any critical

accounting estimates.

Adopted Accounting Pronouncements

In November 2023, the Financial

Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU 2023-07, Segment Reporting (Topic 280), Improvements

to Reportable Segment Disclosures , which provides improvements to reportable segment disclosure requirements, primarily through enhanced

disclosures around segment expenses.

ASU 2023-07 requires us to disclose significant segment expenses that are regularly provided to the

chief operating decision maker, or CODM, and included within each reported measure of segment profit or loss.

ASU 2023-07 also requires

that we disclose an amount for other segment items by reportable segment, a description of their composition and provide all annual disclosures

about a reportable segment’s profit or loss and assets pursuant to Topic 280 during interim periods.

We must also disclose the CODM’s

title and position, as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the reported

measures in assessing segment performance and deciding how to allocate resources.

For public entities with a single reportable segment,

such as us, the entity must provide all the disclosures required pursuant to ASU 2023-07 and all existing segment disclosures under Topic

The amendments of ASU 2023-07 are effective for annual periods beginning January 1, 2024, and effective for interim periods beginning

January 1, 2025.

We adopted this standard effective January 1, 2024 and reported on it in this Annual Report on Form 10-K for the year

ended December 31, 2024.

Issued Accounting Pronouncements

November 2024, FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic

220-40), to improve the disaggregation of expenses within the consolidated statement of operations.

The amendments in ASU 2024-03 require

disclosures in the notes to the consolidated financial statements and specified information about certain costs and expenses.

The amendments

require that at each interim and annual reporting period an entity disclose (a) employee compensation, (b) depreciation, and (c) intangible

asset amortization included in each relevant expense caption;

include certain amounts that are already required to be disclosed under

current GAAP in the same disclosure as the other disaggregation requirements;

and disclose a qualitative description of the amounts remaining

in relevant expense captions that are not separately disaggregated quantitatively.

The amendments in ASU 2024-03 are effective January

1, 2027 and effective for interim periods beginning January 1, 2028.

We will evaluate the impact of ASU 2024-03 on our financial statements.

In November 2023, FASB

issued ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures , which provides

improvements to reportable segment disclosure requirements, primarily through enhanced disclosures around segment expenses.

2023-07 requires us to disclose significant segment expenses that are regularly provided to the chief operating decision maker, or

CODM, and included within each reported measure of segment profit or loss.

ASU 2023-07 also requires that we disclose an amount for

other segment items by reportable segment, a description of their composition and provide all annual disclosures about a reportable

segment’s profit or loss and assets pursuant to Topic 280 during interim periods.

We must also disclose the CODM’s title

and position, as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the

reported measures in assessing segment performance and deciding how to allocate resources.

For public entities with a single

reportable segment, the entity must provide all the disclosures required by pursuant to ASU 2023-07 and all existing segment

disclosures under Topic 280.

The amendments of ASU 2023-07 are effective for us for annual

periods beginning January 1, 2024, and effective for interim periods beginning January 1, 2025.

Early adoption is permitted for

annual financial statements that have not yet been issued or made available for issuance.

will evaluate the impact of ASU 2023-07 on our financial statements.

In October 2021, FASB issued

ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers,

which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance

with ASC 606.

To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue

Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities

consistent with how they were recognized and measured in the acquiree’s financial statements.

The amendments of ASU 2021-08 are

effective January 1, 2023, including interim periods.

We will evaluate the impact of ASU 2021-08 on any future business combinations

we may enter in the future.

Subsequent Event

Since December 31, 2023, we

have sold 1.8 million shares of common stock under our Amended Sales Agreement, resulting in net proceeds of $14.7 million.

December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures , to enhance the

transparency and decision usefulness of income tax disclosures.

The amendments in ASU 2023-09 provide improvements primarily related

to the rate reconciliation and income taxes paid information included in income tax disclosures.

We will be required to disclose additional

information regarding reconciling items equal to or greater than five percent of the amount computed by multiplying pretax income (loss)

by the applicable statutory tax rate.

Similarly, we will be required to disclose income taxes paid (net of refunds received) equal to

or greater than five percent of total income taxes paid (net of refunds received).

The amendments in ASU 2023-09 are effective for fiscal

years beginning January 1, 2025, including interim periods.

We will evaluate the impact of ASU 2023-09 on our financial statements.

Subsequent Events

On March 27, 2025, a putative

class action complaint (the “Complaint”) was filed by alleged stockholder Nihil Kohil against the Company and executives Sandesh

Seth, Avinash Desai, Madhuri Vusirikala, and Sergio Giralt, styled Kohil v.

Actinium Pharmaceuticals, Inc., et al ., Case No.

1:25-cv-02553 in the Southern District of New York, wherein, the Complaint alleges that the defendants made material misrepresentations

and omissions concerning the Iomab-B Phase 3 Sierra Trial and the plaintiff asserts claims against all defendants pursuant to section

10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, as well

as additional claims against the individual defendants pursuant to Section 20(a) of the Exchange Act.

The Complaint purports to

assert class action claims on behalf of all persons and entities that purchased or otherwise acquired Actinium securities between October

31, 2022 and August 2, 2024.

Plaintiff seeks unspecified damages.

The defendants have not yet

responded to the complaint, and they intend to vigorously defend themselves against the plaintiff’s allegations however, there can

be no assurances as to the outcome.

On March 31, 2025, our Board

of Directors of approved the cancellation of certain stock options to purchase 5,149,944 shares of common stock held by certain current

employees and directors that were initially granted under the Company’s Amended and Restated 2013 Stock Plan and 2019 Amended and

Restated Stock Plan.

Such cancellation is subject to the consent of the applicable holder of the stock options, which the Company is expecting

to receive shortly following the filing of this Annual Report on Form 10-K.

Our Compensation Committee intends to conduct an analysis

of our equity compensation plan and develop an equity compensation strategy that satisfies the purpose of the 2019 Plan to attract and

retain the best available personnel who can make meaningful contributions towards achieving the business objectives of the Company.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required

under this item.

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

What changed 10-K

Item 7. Management’s Discussion and Analysis