What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-30 compared with 2025-03-31 · 233 added, 157 removed, 82 unchanged (83% of the section changed)

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

The information and financial

data discussed below is derived from the audited consolidated financial statements of Actinium Pharmaceuticals, Inc.

for its fiscal years

ended December 31, 2024 and 2023.

information and financial data discussed below is derived from the audited consolidated financial statements of Actinium Pharmaceuticals,

for its fiscal years ended December 31, 2025 and 2024.

The consolidated financial statements of Actinium Pharmaceuticals, Inc.

were prepared and presented

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,

were prepared and presented 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, Inc.

contained elsewhere in this Report.

The financial statements contained elsewhere in this Report fully represent Actinium Pharmaceuticals,

Inc.’s financial condition and operations;

however, they are not indicative of the Company’s future performance.

See “Cautionary

Note Regarding Forward-Looking Statements” above for a discussion of forward-looking statements and the significance of such statements

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,

(“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.

The financial statements contained elsewhere in this Report fully

represent Actinium Pharmaceuticals, Inc.’s financial condition and operations;

however, they are not indicative of the Company’s

future performance.

See “Cautionary Note Regarding Forward-Looking Statements” above for a discussion of forward-looking

statements and the significance of such statements 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.

Pharmaceuticals, Inc.

(“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.

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

of Operations – Year Ended December 31, 2025 Compared to the Year Ended December 31, 2024

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during the year ended December 31, 2025 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.

On April 7, 2022, we entered into a License Agreement with Immedica,

(the License Agreement), 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.

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

Option Compensation Expense

On March 31, 2025, our Board of Directors approved the cancellation of

certain stock options to purchase an aggregate of 4.9 million shares of common stock held by certain current employees and directors that

were initially granted under our Amended and Restated 2013 Stock Plan and 2019 Stock Plan.

Such cancellations were subject to the consent

of the applicable holders of the stock options.

The cancellation of stock options on March 31, 2025, described above,

resulted in a significant increase in non-cash stock-based compensation for the year ended December 31, 2025 compared to its prior-year

period due to recognition of previously unrecognized stock-based compensation cost at the cancellation.

During the years ended December

31, 2025 and December 31, 2024, total non-cash stock-based compensation expense, including stock option compensation expense, was $9.2

million and $5.3 million, respectively.

No stock options or restricted stock units were granted during 2025 to existing employees or Board

and Development Expenses, net of reimbursements

Research and development 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 development expenses decreased by $8.9 million to $21.1 million for the year ended December 31, 2025, compared to $30.0 million for

the year ended December 31, 2024.

The decrease was primarily driven by a decline in outside CRO services and other preclinical R&D

expenses of $5.5 million and lower compensation of $4.3 million due to lower headcount.

In the second quarter of 2025, we conducted a

workforce optimization that reduced our headcount by approximately fourteen percent and announced a strategic pipeline prioritization.

These decreases were partially offset by higher non-cash stock-based compensation of $1.0 million, resulting from the cancellation of

stock options described above.

and Administrative Expenses

General and administrative

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

expenses increased by $3.1 million to $15.2 million for the year ended December 31, 2025, compared to $12.1 million for the year ended

December 31, 2024.

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.

Higher non-cash compensation expense of $2.9 million resulting from the cancellation of stock options described above

and higher consulting fees and legal fees of $0.7 million were partially offset by lower compensation expense of $0.5 million, due to

lower headcount.

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

Other income for the year ended December 31, 2025 was $2.4 million, a decrease of $1.5 million from $3.9 million for the year ended December

31, 2024, primarily due to a lower average cash balance during 2025 compared to the prior year.

Net loss decreased by $4.4

million to $33.9 million for the year ended December 31, 2025, compared to $38.2 million for the year ended December 31, 2024, primarily

due to lower research and development expenses of $8.9 million for the year ended December 31, 2025.

This decrease was partially offset

by higher general and administrative expenses of $3.1 million, attributable to higher non-cash stock-based compensation expense of $2.9

million resulting from the cancellation of stock options described above, along with lower other income.

and Capital Resources

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Cash used in investing activities

Cash provided by financing activities

Cash used in/provided by financing activities

Effect of foreign currency rates on cash

Net change in cash, cash equivalents and restricted cash

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.

cash used in operating activities for the year ended December 31, 2025 was $24.6 million, representing a decrease of $8.5 million compared

to $33.1 million in the prior-year period.

This reduction was primarily driven by lower cash compensation of $4.8 million due to reduced

headcount and a $5.5 million decline in outside CRO services and other preclinical R&D expenses, partially offset by lower interest

income of $1.5 million and a $1.0 million decrease in net operating assets.

cash used in investing activities was $104 thousand for the year ended December 31, 2025 as we began construction to create modular removable

manufacturing space, with an estimated cost of $1.4 million to be incurred in 2026.

For the year ended December 31, 2024, net cash used

in investing activities was $11 thousand for the purchase of equipment for our laboratory space.

Net cash used in financing activities was $217 thousand for the year ended

December 31, 2025 related to restricted stock units withheld to cover tax withholding obligations.

Net cash provided by financing activities

of $29.3 million in 2024 was primarily from the sale of shares of common stock.

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.

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 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

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 Statement”).

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 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.

There was no sale of shares of common stock during the year ended December 31, 2025, pursuant to the Amended Sales Agreement.

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 under the Amended Sales Agreement.

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

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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.

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.

We base this belief on assumptions that are subject to change, and we may

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.

entered into a lease for manufacturing space effective December 1, 2025.

The lease has a term of five years and one month, with an expiration

date in 2030, and current annual rent of $0.2 million.

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

and maintenance.

We 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.

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.

We base this belief on

assumptions that are subject to change, and we may be required to use our available cash and cash equivalent resources sooner than we

currently expect.

In the long-term, we intend to continue to fund our operations through the sales of our common stock and common stock

equivalents, noting 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

11 unchanged sentences

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 (“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.

The Company does not have any critical

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 (“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.

We base 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.

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.

The Company does not have any critical accounting estimates that are likely to have

a material impact on our financial condition or results of operation.

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.

In December 2023, the Financial Accounting Standards Board (“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 are 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 are 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 were effective January 1, 2025 to be applied on a prospective basis,

with retrospective application permitted.

We adopted ASU 2023-09 on a retrospective basis and it did not have a material impact on our

consolidated financial statements.

July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S.

The OBBBA includes significant provisions, such

as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework

and the restoration of favorable tax treatment for certain business provisions.

The legislation has multiple effective dates, with certain

provisions effective in 2025 and others implemented through 2027.

We have evaluated the impact of the OBBBA and determined that it does

not have a material impact on our consolidated financial position and results of operations.

Issued Accounting Pronouncements

In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging

(Topic 815) and Revenue from Contracts with Customers (Topic 606):

Derivatives Scope Refinements and Scope Clarification for Share-Based

Noncash Consideration from a Customer in a Revenue Contract , which excludes from derivative accounting non-exchange-traded contracts

with underlying terms that are based on operations or activities specific to one of the parties to the contract.

However, this scope exception

does not apply to (1) variables based on a market rate, market price, or market index, (2) variables based on the price or performance

of a financial asset or financial liability of one of the parties to the contract, (3) contracts (or features) involving the issuer’s

own equity that are evaluated under the guidance in Subtopic 815-40, Derivatives and Hedging—Contracts in Entity’s Own

Equity, and (4) call options and put options on debt instruments.

We can apply the amendments in AUS 2025-07 either (1) prospectively

to new contracts entered into on or after the date of adoption or (2) on a modified retrospective basis through a cumulative-effect adjustment

to the opening balance of retained earnings as of the beginning of the annual reporting period of adoption for contracts existing as of

the beginning of the annual reporting period of adoption.

The amendments in ASU 2025-07 are effective January 1, 2027, for annual reporting

periods, including interim periods within annual reporting periods.

Early adoption is permitted.

We are evaluating the impact of ASU 2025-07

on our financial statements.

May 2025, FASB issued ASU 2025-04, Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic

Clarifications to Share-Based Consideration Payable to a Customer , which revises the Master Glossary definition of the term

“performance condition” for share-based consideration payable to a customer to include conditions, such as vesting conditions,

that are based on the volume or monetary amount of a customer’s purchases or potential purchases of goods or services from the

grantor, including over a specified period of time.

The revised definition also incorporates performance targets based on purchases made

by other parties that purchase the grantor’s goods or services from the grantor’s customers.

The revised definition of the

term performance condition cannot be applied by analogy to awards granted to employees and nonemployees in exchange for goods or services

to be used or consumed in the grantor’s own operations.

ASU 2025-04 eliminates the policy election permitting a grantor to account

for forfeitures as they occur for share-based awards granted to a customer.

Separate policy elections for forfeitures remain available

for share-based payment awards with service conditions granted to employees and nonemployees in exchange for goods or services to be

used or consumed in the grantor’s own operations.

ASU 2025-04 further clarifies that a grantor should not apply the guidance in

Topic 606 on constraining estimates of variable consideration to share-based consideration payable to a customer.

ASU 2025-04 permits

a grantor to apply the new guidance on either a modified retrospective or a retrospective basis.

The amendments in ASU 2025-04 are effective

January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods.

We are evaluating the impact

of ASU 2025-04 on our financial statements.

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

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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.

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.

1, 2027 and effective for interim periods beginning January 1, 2028, either on a prospective or retrospective basis.

We are evaluating

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

Trends, Events and Uncertainties

The Company is subject to risks and uncertainties common to companies in

the biopharmaceutical industry, including but not limited to, risks associated with completing preclinical studies and clinical trials,

receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key

personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to

fund operations.

In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict between Russia and

Ukraine and the ongoing conflicts in the Middle East, including related sanctions and countermeasures, and the effects of rising global

inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute

to increased market volatility, which may in turn adversely affect our business and operations.

In the past, U.S.

federal government shutdowns,

such as the shutdown that began on October 1, 2025 and ended on November 12, 2025, have curtailed operations of key agencies such as the

FDA and the NIH, which includes the NCI.

Future shutdowns may result in delays or disrupt our ability to advance clinical development

of the current and planned clinical trials under our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants.

Additionally, changes to U.S.

policy implemented by the U.S.

Congress, the Trump administration or any new administration have impacted

and may in the future impact, among other things, the U.S.

and global economy, tariffs, international trade relations, unemployment, immigration,

healthcare, taxation, the U.S.

regulatory environment, inflation and other areas.

Although we cannot predict the impact, if any, of these

changes to our business, they could adversely affect our business.

For a further discussion of factors that may affect future operating

results see the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statement Notice.”

than as discussed above and elsewhere in this report, we are not aware of any trends, events or uncertainties that are likely to have

a material effect on our financial condition.

In February 2026, the Chief Financial Officer of our Company tendered

his resignation.

To fill this executive vacancy, our Board appointed Sandesh Seth, the current Chairman and Chief Executive Officer of

the Company, to serve as our Principal Financial Officer.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

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What changed 10-K

Item 7. Management’s Discussion and Analysis