Item 8. Financial Statements and Supplementary Data
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors of
Actinium
Pharmaceuticals, Inc.
Opinion
on the Financial Statements
We have audited the accompanying consolidated balance
sheet of Actinium Pharmaceuticals, Inc. (the “Company”) as of December 31, 2025, the related consolidated statements of operations,
comprehensive loss, changes in stockholders’ equity, and cash flows for the year ended December 31, 2025, and the related notes
(collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows
for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
As discussed in Notes 1 and 8 to the financial statements,
the Company adopted Accounting Standards Update (ASU) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU
2023-09”). We have also audited the adjustments to the 2024 financial statements to retrospectively adjust the disclosures for the
adoption of ASU 2023-09 in 2025. In our opinion, such retrospective adjustments are appropriate and have been properly applied. We were
not engaged to audit, review, or apply any procedures to the 2024 financial statements of the Company other than with respect to these
retrospective adjustments, and accordingly, we do not express an opinion or any other form of assurance on the 2024 financial statements
taken as a whole.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the
current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective,
or complex judgments. We determined that there are no critical audit matters.
/s/ CBIZ CPAS P.C .
CBIZ CPAs P.C.
We have served as the Company’s auditor since
2012 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective November 1, 2024).
Houston, Texas
March 30, 2026
F- 1
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Actinium Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited, before the effects of the retrospective
adjustments to the disclosures for the adoption of Accounting Standards Update (ASU) 2023-09, Income Taxes (Topic 740): Improvements to
Income Tax Disclosures (“ASU 2023-09”) as discussed in Notes 1 and 8 to the consolidated financial statements, the accompanying
consolidated balance sheet of Actinium Pharmaceuticals, Inc. (the “Company”) as of December 31, 2024, the related consolidated
statements of operations, changes in stockholders’ equity and cash flows for the year ended December 31, 2024, and the related notes
(collectively referred to as the “financial statements”) (the 2024 financial statements before the effects of the adjustments
discussed in Notes 1 and 8 to the financial statements are not presented herein). In our opinion, the financial statements, before the
effects of the retrospective adjustments to the disclosures for the adoption of ASU 2023-09 as discussed in Notes 1 and 8 to the financial
statements, present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of
its operations and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in
the United States of America.
We were not engaged to audit, review, or apply any
procedures to the retrospective adjustments to the disclosures for the adoption of ASU 2023-09 as discussed in Notes 1 and 8 to the financial
statements and, accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are appropriate
and have been properly applied. Those retrospective adjustments were audited by CBIZ CPAs P.C.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the
current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective,
or complex judgments. We determined that there are no critical audit matters.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor from
2012 through 2025.
Houston, Texas
March 31, 2025
F- 2
Actinium
Pharmaceuticals, Inc.
Consolidated Balance Sheets
(amounts
in thousands, except share and per share data)
December 31,
2025
December 31,
2024
Assets
Current Assets:
Cash and cash equivalents
$ 47,998
$ 72,904
Prepaid expenses and other current assets
1,383
1,602
Total Current Assets
49,381
74,506
Property and equipment, net of accumulated depreciation of $ 1,064 and $ 891
295
364
Restricted cash – long term
335
324
Operating lease right-of-use assets
1,754
1,685
Finance leases right-of-use assets
10
20
Total Assets
$ 51,775
$ 76,899
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,247
$ 7,568
Operating leases current liability
711
569
Finance leases current liability
11
11
Total Current Liabilities
7,969
8,148
Long-term license revenue deferred
35,000
35,000
Long-term operating lease obligations
972
984
Long-term finance lease obligations
-
9
Total Liabilities
43,941
44,141
Commitments and contingencies
Stockholders’ Equity:
Preferred stock, $ 0.001 par value; 50,000,000 shares authorized, 0 shares issued and outstanding
-
-
Common stock, $ 0.001 par value; 1,000,000,000 shares authorized; 31,195,891 shares issued and outstanding at December 31, 2025 and 2024, respectively
31
31
Additional paid-in capital
417,536
408,553
Accumulated other comprehensive loss
( 20 )
-
Accumulated deficit
( 409,713 )
( 375,826 )
Total Stockholders’ Equity
7,834
32,758
Total Liabilities and Stockholders’ Equity
$ 51,775
$ 76,899
See
accompanying notes to the consolidated financial statements.
F- 3
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Operations
(amounts
in thousands, except share and per share data)
For the Year ended
December 31,
2025
2024
Revenue
Revenue
$ -
$ -
Other Revenue
90
-
Total revenue
90
-
Operating expenses:
Research and development, net of reimbursements
21,124
30,045
General and administrative
15,213
12,076
Total operating expenses
36,337
42,121
Loss from operations
( 36,247 )
( 42,121 )
Other income:
Interest income – net
2,360
3,878
Total other income
2,360
3,878
Net loss
$ ( 33,887 )
$ ( 38,243 )
Net loss per common share – basic and diluted
$ ( 1.09 )
$ ( 1.27 )
Weighted average common shares outstanding – basic and diluted
31,195,891
30,070,028
See
accompanying notes to the consolidated financial statements.
F- 4
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Loss
(amounts
in thousands)
For the Year ended
December 31,
2025
2024
Net loss
$ ( 33,887 )
( 38,243 )
Other comprehensive loss:
Foreign currency translation adjustment
( 20 )
-
Comprehensive loss
$ ( 33,907 )
$ ( 38,243 )
See
accompanying notes to the consolidated financial statements.
F- 5
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
For the Years Ended December 31, 2025 and 2024
(amounts in thousands, except share amounts)
Accumulated
Additional
Other
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balance, January 1, 2024
27,634,213
$ 28
$ 373,934
$ -
$ ( 337,583 )
$ 36,379
Stock-based compensation
13,394
-
5,292
-
-
5,292
Sale of common stock, net of offering costs
3,538,136
3
29,252
-
-
29,255
Issuance of common stock from exercise of stock options
10,148
-
75
-
75
Net loss
-
-
-
-
( 38,243 )
( 38,243 )
Balance, December 31, 2024
31,195,891
$ 31
$ 408,553
$ -
$ ( 375,826 )
$ 32,758
Stock-based compensation
-
-
9,190
-
-
9,190
Restricted stock units withheld to cover tax obligations
-
-
( 207 )
-
-
( 207 )
Net loss
-
-
-
-
( 33,887 )
( 33,887 )
Unrealized loss on foreign currency translation
-
-
-
( 20 )
-
( 20 )
Balance, December 31, 2025
31,195,891
$ 31
$ 417,536
$ ( 20 )
$ ( 409,713 )
$ 7,834
See
accompanying notes to the consolidated financial statements.
F- 6
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(amounts
in thousands)
For the Year ended
December 31,
2025
2024
Cash Flows from Operating Activities:
Net loss
$ ( 33,887 )
$ ( 38,243 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
9,190
5,292
Depreciation expense
173
197
Amortization of right-of-use assets
648
614
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
219
( 15 )
Accounts payable and accrued expenses
( 346 )
( 387 )
Operating lease liabilities
( 577 )
( 530 )
Net Cash Used In Operating Activities
( 24,580 )
( 33,072 )
Cash Flows Used in Investing Activities:
Purchase of property and equipment
( 104 )
( 11 )
Net Cash Used In Investing Activities
( 104 )
( 11 )
Cash Flows From Financing Activities:
Payments on finance leases
( 10 )
( 9 )
Proceeds from sales of shares of common stock, net of offering costs
-
29,255
Restricted stock units withheld to cover tax obligations
( 207 )
-
Proceeds from the exercise of stock options
-
75
Net Cash (Used In) Provided By Financing Activities
( 217 )
29,321
Effect of foreign currency rates on cash
6
-
Net Change in Cash, Cash Equivalents and Restricted Cash
( 24,895 )
( 3,762 )
Cash, cash equivalents and restricted cash at beginning of year
73,228
76,990
Cash, Cash Equivalents and Restricted Cash at End of Year
$ 48,333
$ 73,228
Supplemental Disclosure of Non-cash Investing and Financing Activities:
Right-of-use assets obtained in exchange for lease liabilities
$ 708
$ -
See
accompanying notes to the consolidated financial statements.
F- 7
Actinium
Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
Note
1 - Description of Business and Summary of Significant Accounting Policies
Nature
of Business - Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing ARCs and other targeted radiotherapies to
deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.
Principles
of Consolidation - The consolidated financial statements include the Company’s accounts and those of the Company’s wholly
owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.
Use
of Estimates in Financial Statement Presentation - The preparation of these consolidated financial statements in conformity with
accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses
during the reporting period. Actual results could differ from those estimates.
Segment
Information - The Company operates as a single operating and reportable segment for the purposes of assessing performance and allocating
resources. The Company’s chief operating decision maker is its Chief Executive Officer, who reviews total assets in the consolidated
balance sheets and net loss and its components in the consolidated statements of operations: research and development expenses, general
and administrative expenses, and interest income, for the purposes of making operating decisions, assessing financial performance, and
allocating resources. All assets are in the United States.
Cash
and Cash Equivalents and Restricted Cash - The Company considers all highly liquid accounts with original maturities of three months
or less to be cash equivalents. The Company holds most of its cash equivalents in a Money Market account comprised of U.S. Treasury notes.
Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation insured limits.
Following
is a summary of cash, cash equivalents and restricted cash at December 31, 2025 and December 31, 2024:
(in thousands)
December 31,
2025
December 31,
2024
Cash and cash equivalents
$ 47,998
$ 72,904
Restricted cash – long-term
335
324
Cash, cash equivalents and restricted cash
$ 48,333
$ 73,228
Restricted
cash relates to certificates of deposit held as collateral for letters of credit issued in connection with the Company’s leases
of corporate office spaces.
Property
and Equipment - Machinery and equipment are recorded at cost and depreciated on a straight-line basis over estimated useful lives
of three to five years . Furniture and fixtures are recorded at cost and depreciated on a straight-line basis over estimated useful lives
of seven years. When assets are retired, the cost and related accumulated depreciation are removed from the accounts, and any related
gain or loss is reflected in operations. Repairs and maintenance expenditures are charged to operations when incurred. Capitalized lease
assets are recorded at the lesser of the present value of minimum lease payments or fair value and amortized over the estimated useful
life of the related property or term of the lease. Construction in progress represents costs incurred for assets that are not yet ready
for their intended use. These costs include construction-related expenditures and are not depreciated until the asset is placed in service.
Upon completion, construction in progress is reclassified to the appropriate property and equipment category and depreciation begins.
F- 8
Leases
- The Company has an operating lease for corporate office space, an operating lease for manufacturing space and a finance lease
for office equipment located at the corporate office space. Leases with an initial term of 12 months or less are not recorded on the
balance sheet; lease expense for these leases is recognized on a straight-line basis over the lease term.
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 - The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From
Contracts With Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of
promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods
or services. To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs 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 the entity satisfies a performance obligation. The Company only applies the five-step model to contracts
when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers
to the customer.
At
contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses 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, the Company evaluates 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).
The
Company then determines the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange
for the promised goods or services for each performance obligation and recognizes the associated revenue as each performance obligation
is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which it
expects to be entitled. Variable consideration includes payments in the form of collaboration milestone payments. If an arrangement includes
collaboration milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates
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.
ASC
606 requires the Company 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 revenue standard as the price at which an entity would sell a promised
good or service separately to a customer. The Company then recognizes 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 method.
Collaborative Arrangements
- The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain transactions
between the Company and collaborators be recorded in its 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.
The Company evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the
nature of the underlying activity. When the Company has concluded that it has a customer relationship with one of its collaborators,
the Company follows the guidance of ASC 606 . There was no revenue from collaborative arrangements for the years ended December
31, 2025 and December 31, 2024, respectively.
F- 9
Grant
Revenue - The Company has 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. The Company recognizes revenue from grants as it performed services under this arrangement. Associated
expenses are recognized when incurred as research and development expense. The Company concluded that payments received under these grants
represent conditional, nonreciprocal contributions, as described in ASC 958, Not-for-Profit Entities, and that the grants are not within
the scope of ASC 606, Revenue from Contracts with Customers, as the organizations providing the grants do not meet the definition of a
customer. Revenue and related expenses are presented gross in the consolidated statements of operations. Grant revenue is recorded as
Other Revenue in the statement of operations and was $ 90 thousand for the year ended December 31, 2025, there was no grant revenue recognized
for the year ended December 31, 2024.
License
Revenue - The Company entered into a product licensing agreement whereby the Company allowed a third party to commercialize a certain
product in specified territories using the Company’s trademarks. The terms of this arrangement include payment to the Company for
a combination of one or more of the following: upfront license fees; development, regulatory and sales-based milestone payments; and
royalties on net sales of licensed products. The Company uses its judgment to determine whether milestones or other variable consideration
should be included in the transaction price. There was no license revenue recognized for the years ended December 31, 2025 and December
31, 2024, respectively.
Upfront
license fees : If the license to the Company’s intellectual property is determined
to be distinct from the other performance obligations identified in the arrangement, the Company 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, the Company determines whether the combined performance obligation is satisfied over
time, in which case the customer will simultaneously receive and consume the benefit from the license as the performance occurs, 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, the Company evaluates whether the milestones are considered
probable of being achieved and estimates 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 the Company’s 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, the Company will re-evaluate
the probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjust the Company’s
estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis and recorded as part of license
revenue 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, the Company 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, the Company 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 the Company performs its obligations under these
arrangements or when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when
the uncertainty associated with any variable consideration is subsequently resolved. Amounts payable to the Company are recorded as accounts
receivable when the Company’s 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
product, the costs of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to
facilities and equipment. Research and development reimbursements are recorded by the Company as a reduction of research and development
costs.
Share-Based
Payments - The Company estimates 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 award. The Company accounts for forfeitures of stock options as they occur.
Income
Taxes - The Company accounts for income taxes in accordance with ASC 740 Income Taxes , which requires 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. The Company reviews 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.
F- 10
ASC
740 prescribes guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions. Tax positions
must meet a “more-likely-than-not” recognition threshold to be recognized. 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.
The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses.
Net
Loss Per Common Share - Basic loss per common share is computed by dividing the net loss available to common stockholders by the
weighted average number of common shares outstanding during the reporting period. For periods of net loss, diluted loss per share is
calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive.
For
the years ended December 31, 2025 and 2024, the Company’s potentially dilutive shares, which include outstanding common stock options,
restricted stock units and warrants, have not been included in the computation of diluted net loss per share as the result would have
been anti-dilutive.
(in thousands)
December 31,
2025
December 31,
2024
Stock Options
99
5,137
Restricted Stock Units
-
300
Vested unissued shares of common stock
179
-
Warrants
7
7
Total
285
5,444
Subsequent
Events - The Company’s management reviewed all material events through the date the consolidated financial statements were
issued for subsequent event disclosure consideration.
Recently
Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board, (the “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. The Company is 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, the Company is 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 to be applied on a prospective basis, with retrospective application permitted. The Company adopted ASU 2023-09 on a retrospective
basis and it did not have a material impact on the Company’s consolidated financial statements.
In
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 expected to be implemented through 2027. The Company has evaluated the impact of the OBBBA and
determined that it does not have a material impact on the Company’s consolidated financial position and results of operations.
F- 11
Recently
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. The Company 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. The Company is evaluating the impact
of ASU 2025-07 on its financial statements.
In
May 2025, FASB issued ASU 2025-04, Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic
606): 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 non-employees 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 non-employees 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. The Company is evaluating the
impact of ASU 2025-04 on its financial statements.
In
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, either on a prospective or retrospective basis. The Company is evaluating
the impact of ASU 2024-03 on its financial statements.
Note
2 - Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following at December 31, 2025 and 2024:
December 31,
December 31,
2025
2024
Prepaid insurance
$ 591
$ 608
Prepaid clinical trial expenses
624
637
Other prepaid expenses and other current assets
168
357
Total prepaid expenses and other current assets
$ 1,383
$ 1,602
F- 12
Note
3 - Property and Equipment
Property
and equipment consisted of the following at December 31, 2025 and 2024:
December 31,
December 31,
(in thousands)
Lives
2025
2024
Construction in Progress
$ 104
$ -
Lab equipment
5 years
817
817
Office equipment and furniture
3 - 7 years
438
438
Less: accumulated depreciation
( 1,064 )
( 891 )
Property and equipment, net
$ 295
$ 364
The Company entered into an agreement with a contractor for equipment
in newly leased manufacturing space, effective December 1, 2025 and construction in progress was $ 104 thousand at December 31, 2025.
Depreciation
expense consisted of the following for the years ended December 31, 2025 and 2024, respectively:
December 31,
December 31,
(in thousands)
2025
2024
Research and development
$ 139
$ 161
General and administrative
34
36
Total depreciation expense
$ 173
$ 197
Note
4 - Leases
The
Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys
to the Company the right to control the use of a fixed asset for a period of time in exchange for consideration. Control of an underlying
asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic
benefits from using the underlying asset. The Company has lease agreements which include lease and non-lease components, which the Company
has elected to account for as a single lease component for all classes of underlying assets. Lease expense for variable lease components
are recognized when the obligation is probable. The Company made an accounting policy election to exclude from balance sheet reporting
those leases with initial terms of 12 months or less.
Right-of-use
assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ASC 842
requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily
determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s leases,
the incremental borrowing rate was used based on the information available at commencement date in determining the present value of lease
payments.
The
lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered
by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option
to extend (or not to terminate) the lease controlled by the lessor. Options for lease renewals have been excluded from the lease term
(and lease liability) for the Company’s leases as the reasonably certain threshold is not met.
F- 13
As
of December 31, 2025, the Company has three leases which have been capitalized in accordance with ASC 842, one for corporate office space,
one for manufacturing space and one for office equipment. The Company entered into a lease for corporate office space effective June
1, 2022. The lease has a term of 5 years and 2 months , with an expiration date on July 30, 2027 and current annual rent of $ 0.6 million.
The Company is also responsible for certain other costs, such as insurance, utilities and maintenance. As noted above, the Company 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 of December 31, 2030 and current annual rent of $ 0.2 million. The Company is also responsible for certain other costs, such as insurance,
utilities and maintenance.
The
components of lease expense are as follows:
(in thousands)
Year ended
December 31,
2025
Year ended
December 31,
2024
Operating lease expense
$ 707
$ 691
Finance lease cost
Amortization of right-to-use assets
$ 10
$ 10
Interest on lease liabilities
$ 1
$ 2
Total finance lease cost
11
$ 12
Supplemental
cash flow information related to leases are as follows:
Year ended
(in thousands)
December 31,
2025
December 31,
2024
Cash flow information:
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 645
$ 618
Operating cash flow use from finance leases
$ 11
$ 11
Financing cash flow use from finance leases
$ 10
$ 9
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 707
$ -
Finance leases
$ -
$ -
Weighted
average remaining lease terms are as follows at December 31, 2025:
Weighted average remaining lease term:
Operating leases 2.9 years
Finance leases 1.0 years
As
the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its
incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s
incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company
would have had to pay to borrow on a secured basis. Below is information on the weighted average discount rates used at the time that
the leases were evaluated:
Weighted average discount rates:
Operating leases
6.0 %
Finance leases
6.2 %
F- 14
Maturities
of lease liabilities are as follows:
Year
ending December 31,
Operating
Leases
Finance
Leases
2026
814
11
2027
557
-
2028
182
-
2029
187
-
2030
193
-
Total
lease payments
$ 1,933
$ 11
Less
imputed interest
( 250 )
(- )
Present
value of lease liabilities
$ 1,683
$ 11
Note
5 - Other Revenue
The
Company has a grant from a government-sponsored entity for research and development related activities that provides for payments for
reimbursed costs, which includes overhead and general and administrative costs as well as an administrative fee. The Company recognized
revenue from grants as it performed services under this arrangement. Associated expenses are recognized when incurred as research and
development expense. Other revenue recognized from this grant during the year ended December 31, 2024 was $ 0.1 million.
On
April 7, 2022, the Company entered into a license and supply agreement (the “License Agreement”) with Immedica Pharma AB
(“Immedica”), pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab)
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, the Company was entitled to
an upfront, non-refundable payment of $ 35 million from Immedica, which was received in May 2022. Under the terms of the License Agreement,
the Company is 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. The Company continues to retain commercialization rights in the U.S. and
rest of the world.
The Company’s contract
liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue deferred in its consolidated
balance sheets, depending on the short-term or long-term nature of the payments to be recognized. The Company’s contract liabilities
primarily consist of advanced payments from licensees. Long-term license revenue deferred was $ 35.0 million at December 31, 2025 and
December 31, 2024; this deferred revenue will be recognized upon European Union’s regulatory approval of Iomab-B or provision of
definitive feedback that Iomab-B will not receive approval in the European Union.
Note
6 - Commitments and Contingencies
On
June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”)
to build upon previous and ongoing clinical trials with apamistamab (licensed antibody). FHCRC has completed both a Phase 1 and Phase
2 clinical trial with apamistamab. The Company has been granted exclusive rights to the antibody and related master cell bank developed
by FHCRC. A milestone payment of $ 1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed antibody.
Upon commercial sale of the drug, royalty payments of 2 % of net sales will be due to FHCRC.
As
of December 31, 2025, the Company had contractual commitments of approximately $ 1.5 million related to the construction of its modular
removable manufacturing space in its newly leased manufacturing space, with $ 1.4 million expected to be incurred in 2026.
On
March 27, 2025, a putative class action complaint (the “Securities Complaint”) was filed by alleged stockholder Nitin Kohil
against the Company and executives Sandesh Seth, Avinash Desai, Madhuri Vusirikala, and Sergio Giralt (the “Defendants”),
styled Kohil v. Actinium Pharmaceuticals, Inc., et al ., Case No. 1:25-cv-02553 in the United States District Court for the
Southern District of New York, (“the Court”). The Securities Complaint alleges that the Defendants made material misrepresentations
and omissions concerning the Iomab-B Phase 3 Sierra Trial during a proposed class period of October 31, 2022 to August 2, 2024 and asserts
claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. Plaintiff sought unspecified damages. On June 24, 2025,
the court in the securities action appointed lead plaintiffs pursuant to the Private Securities Litigation Reform Act of 1995 and re-captioned
the case as In re Actinium Pharmaceuticals, Inc. Securities Litigation . Lead Plaintiffs filed an amended complaint on August 25,
2025. On October 27, 2025, Defendants moved to dismiss the amended complaint; on December 19, 2025, Lead Plaintiffs filed their opposition;
and on February 2, 2026, Defendants filed their reply in support. The parties are currently awaiting the Court’s decision on Defendants’
motion
F- 15
On
May 5, 2025, a shareholder complaint captioned Georges v. Seth et al. , Case No. 1:25-cv-03738-JPO was filed against certain of
the Company’s directors and officers, alleging derivative liability based on the same factual allegations made in the securities
class action. On May 13, 2025, a second substantially identical derivative complaint captioned Robinson v. Seth et al ., Case No.
1:25-cv-04012-JPO was filed. On June 24, 2025, the Court consolidated the derivative cases and, on July 29, 2025, the parties to the derivative
cases filed a stipulation with the Court to stay those matters pending resolution of the motion that defendants will file in the securities
class action. The Court so-ordered that stipulation on July 30, 2025, and re-captioned the case as In re Actinium Pharmaceuticals,
Inc. Derivative Litigation.
On
June 17, 2025, a purported shareholder served Actinium with a demand for books and records pursuant to Section 220 of the Delaware General
Corporation Law. In general, the demand seeks documents relating to the facts at issue in the above-described securities class action
and derivative cases. The Company rejected the shareholder demand by letter dated July 8, 2025. The parties continue to discuss the demand,
though the shareholder has not followed up on his demand since October 2025.
The
Company and other Defendants intend to defend vigorously against such claims, however, there can be no assurances as to the outcome.
Note
7 - Equity
In
August 2020, the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, “JonesTrading”,
pursuant to which the Company may sell, from time to time, through or to JonesTrading, up to an aggregate of $ 200 million of its common
stock. On June 28, 2022, the Company entered into an Amended and Restated Capital on Demand™ Sales Agreement (the “A&R
Sales Agreement”) with JonesTrading and B. Riley Securities, Inc. (“B. Riley”). The A&R Sales Agreement modifies
the original Capital on Demand™ Sales Agreement to include B. Riley Securities 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, the Company filed a registration statement on Form
S-3 (File No. 333-273911), which registration statement was amended on February 2, 2024, and 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.
The Company did not sell any shares of common stock during the year ended
December 31, 2025 under the A&R Sales Agreement. During the year ended December 31, 2024, the Company 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 A&R Sales Agreement.
The Company presently has one equity compensation plan, the 2019 Stock
Plan. The 2019 Plan has an expiration date of October 18, 2029 and the number of shares of our common stock authorized under the
plan for grant to employees, directors and consultants is 9,333,333 shares.
Stock
Options
Following
is a summary of stock option activity for the years ended December 31, 2025 and 2024:
(in thousands, except for per-share amount) Number of
Options Weighted
Average
Exercise
Price ($) Weighted
Average
Remaining
Contractual
Term
(in years) Aggregate
Intrinsic
Value ($)
Outstanding, January 1, 2024 5,445 6.80 8.70 373
Granted 154 5.47
Exercised ( 10 ) 7.39
Cancelled ( 452 ) 10.04
Outstanding, December 31, 2024 5,137 6.48 7.04 -
Granted 61 1.42
Exercised -
-
Cancelled ( 5,099 ) 6.43
Outstanding, December 31, 2025 99 5.89 7.66 -
Exercisable, December 31, 2025 48 9.42 6.03 -
During
2025, the Company granted newly hired employees options to purchase 0.1 million shares of common stock with an exercise price ranging
from $ 1.06 to $ 1.55 per share, a term of 10 years , and a vesting period of 4 years. The options have an aggregated fair value of
$ 0.1 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model
include: (1) discount rate range from 3.76 % to 4.46 % (2) expected life of 6 years, (3) expected volatility range from 88.0 % to 90.7 %,
and (4) zero expected dividends.
F- 16
During
2024, the Company granted newly hired employees options to purchase 0.2 million shares of common stock with an exercise price ranging
from $ 7.20 to $ 8.15 per share, a term of 10 years , and a vesting period of 4 years. The options have an aggregated fair value of
$ 0.6 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model
include: (1) discount rate range from 4.19 % to 4.45 % (2) expected life of 6 years, (3) expected volatility range from 80.5 % to 90.5 %,
and (4) zero expected dividends.
On
March 31, 2025, the Board of Directors approved of the cancellation of 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 the Amended and Restated 2013 Stock Plan
and the 2019 Amended and Restated Stock Plan. Such cancellations were subject to the consent of the applicable holders of the stock options,
which the Company received. The cancellation of these stock options resulted in the recording of $ 8.8 million in stock option compensation
expense for the year ended December 31, 2025. During the year ended December 31, 2024, the Company recorded stock option compensation
expense of $4.6 million.
The
fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation
expense at December 31, 2025 was $ 0.1 million related to unvested options, which is expected to be expensed over a weighted average of
2.4 years.
Restricted
Stock Units
Following
is a summary of restricted stock unit (“RSUs”) activity for the years ended December 31, 2025 and 2024:
(in thousands, except for per-share amount)
RSUs
Weighted
Average
Grant
Date Fair
Value Per Share ($)
Outstanding, January 1, 2024
305
5.89
Granted
-
-
Vested
-
-
Cancelled
( 5 )
8.31
Outstanding, December 31, 2024
300
5.85
Granted
-
-
Vested
( 300 )
-
Cancelled
-
-
Outstanding, December 31, 2025
-
-
The
RSUs vested on August 18, 2025. The fair value of the RSUs, $ 1.8 million, was determined based on the stock price on the date of the
grants and was recognized over three years. During the years ended December 31, 2025 and 2024, the Company recorded compensation expense
related to RSUs of $ 0.4 million and $ 0.6 million, respectively.
Warrants
Following
is a summary of warrant activities for the years ended December 31, 2025 and 2024:
(in thousands, except for per-share amounts) Number of
Warrants Weighted
Average
Exercise
Price Weighted
Average
Remaining
Contractual
Term
(in years) Aggregate
Intrinsic
Value
Outstanding, January 1, 2024 1,442 16.42 0.34 -
Granted -
-
Exercised -
-
Expired ( 1,435 ) 16.42
Outstanding, December 31, 2024 7 17.33 4.46 -
Granted -
-
Exercised -
-
Expired -
-
Outstanding, December 31, 2025 7 17.33 3.45 -
Exercisable, December 31, 2025 7 17.33 3.45 -
F- 17
On
April 23, 2024, warrants to purchase an aggregate of 1.4 million shares of common stock expired. These warrants were issued on April
23, 2019, when the Company completed an underwritten offering of 1.4 million shares of common stock and warrants to purchase 1.4 million
shares of common stock at a price of $ 11.55 per share and related warrant. The warrants were exercisable for a period of 5 years at an
exercise price of $ 15.00 per share.
During
the years ended December 31, 2025 and 2024, the Company recorded stock-based compensation expense related to warrants of $ 3 thousand
and $ 5 thousand, respectively.
Note
8 - Income Taxes
The
following table presents the domestic and foreign components of loss before income taxes for the years ended December 31, 2025 and 2024,
respectively:
(in
thousands)
2025
2024
Loss before Income Taxes
United States
$ ( 33,289 )
$ ( 38,243 )
Foreign
( 598 )
-
Total
$ ( 33,887 )
$ ( 38,243 )
The components of income tax provision consist of the following for the
years ended December 31, 2025 and 2024, respectively:
(in thousands)
2025
2024
Income Tax Expense
Current
Federal
$ -
$ -
State & Local
-
-
Foreign
-
-
Total
$ -
$ -
Deferred Tax Expense
Federal
$ -
$ -
State & Local
-
-
Foreign
-
-
Total
$ -
$ -
Net Income Tax Expense
$ -
$ -
No income taxes were paid during
the years ended December 31, 2025 and 2024, respectively.
Deferred income taxes reflect
the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December
31, 2025 and 2024 are as follows:
(in thousands)
2025
2024
Deferred tax assets:
Net operating losses carry forward
$ 62,548
$ 47,875
Deferred revenue
8,546
8,217
Share-based compensation
14
1,572
Research and development/orphan drug credits
24,811
23,296
Capitalized research and development expenses
20,131
20,664
Lease liabilities
414
369
Others
44
20
Total gross deferred tax assets
116,508
102,013
Less: valuation allowance
( 116,077 )
( 101,613 )
Deferred tax assets, net
431
400
Deferred tax liabilities:
Lease right-of-use assets
( 431 )
( 400 )
Total gross deferred tax assets
( 431 )
( 400 )
Deferred tax assets, net
$ -
$ -
In assessing the realizability
of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely
than not that some portion of the deferred income tax will not be realized. The realization of gross deferred tax assets is dependent
on several factors, including the generation of sufficient taxable income prior to expiration of the net operating loss carryforwards.
At December 31, 2025 and 2024, the Company has recorded a full valuation allowance against its net deferred tax assets of approximately
$ 116.1 million and $ 101.6 million respectively. The change in the valuation allowance during the year ended December 31, 2025 was $ 14.5
million.
F- 18
At December 31, 2025, the Company
had federal net operating loss (NOL) carryforwards of $ 218.9 million At December 31, 2025, the Company had foreign NOL carryforwards of
$ 48 thousand. At December 31, 2025 the Company had federal research and development and Orphan drug credit credits of $ 24.8 million. Federal
NOL carryforwards of $ 104.8 million generated prior to 2018 will begin to expire if unused beginning in 2026, when $ 3.6 million in NOLs
are due to expire. The Company’s largest NOLs will begin to expire in 2034 - 2037, with each year in excess of $ 15 million. NOLs
generated in 2018 and later years of $ 114.6 million have an indefinite life, but will be limited to 80 % of their value.
Sections 382 and 383 of the Internal
Revenue Code of 1986 subject the future utilization of net operating losses and certain other tax attributes, such as research and experimental
tax credits, to an annual limitation in the event of certain ownership changes. The Company may be subject to the net operating loss utilization
provision of Section 382 of the Internal Revenue Code. The effect of an ownership change would be the imposition of an annual limitation
of the use of NOL carryforwards attributable to periods before the change. The amount of the annual limitation depends upon the value
of the Company immediately before the change, changes to the Company’s capital during a specified period prior to the change, and
the federal published interest rate. Although the Company has not completed an analysis under Section 382 of the Code, it is likely that
the utilization of the NOLs will be limited.
For state income tax purposes,
the Company has $ 204.6 million of unused NOLs at December 31, 2025 available for carry forward to future years. These NOLs will begin
to expire in 2035 if unused.
The
Company has federal research and development tax credits of $ 8.1 million at December 31, 2025, which will begin to expire in 2033 if
unused and orphan drug credits of $ 16.7 million which will begin to expire in 2037 if unused.
The
difference between the income tax provision and the amount that would result if the U.S. Federal statutory rates were applied to pre-tax
losses for the year ended December 31, 2025 and 2024 after the adoption of ASU 2023-09 are as follows:
(in thousands)
December 31,
2025
December 31,
2024
Federal statutory income taxes
$ ( 7,116 )
( 21.0 )%
$ ( 8,031 )
( 21.0 )%
State income taxes
-
-
%
( 1,275 )
( 3.3 )%
Foreign tax effects
126
0.4 %
-
-
%
Research and development/orphan drug tax credit
( 1,514 )
( 4.5 )%
( 2,787 )
( 7.3 )%
Stock-based compensation
2,089
6.2 %
259
0.7 %
Non-taxable or nondeductible items:
Other
347
1.0 %
788
2.0 %
162M- disallowed salary
1,003
2.9 %
-
-
%
Change in valuation allowance
5,065
15.0 %
11,046
28.9 %
Provision for income tax
$ -
-
$ -
-
Entities
are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns.
The Company has analyzed its tax positions and has concluded that as of December 31, 2025 there were no uncertain positions. The Company’s
U.S. federal and state net operating losses have occurred since its inception in 2009 and as such, tax years subject to potential tax
examination could apply from that date. This is because the utilization of net operating losses from prior years opens the relevant year
to audit by the IRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included
in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for
the years ended December 31, 2025 and 2024.
Note
9 – Subsequent Event
In February 2026, the Chief Financial Officer of the Company tendered
his resignation. To fill this executive vacancy, the Board of Directors of the Company appointed Sandesh Seth, the current Chairman and
Chief Executive Officer, to serve as the Principal Financial Officer.
F- 19
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.