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 sheets of Actinium Pharmaceuticals, Inc. (the “Company”) as of December
31, 2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each
of the two years in the period ended December 31, 2024 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, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024,
in conformity with accounting principles generally accepted in the United States of America.
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 audits. 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 audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits 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 audits,
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
audits 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 audits 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 audits
provide 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 since 2012 .
Houston,
Texas
March
31, 2025
F- 1
Actinium
Pharmaceuticals, Inc.
Consolidated Balance Sheets
(amounts
in thousands, except share and per share data)
December 31,
2024
December 31,
2023
Assets
Current Assets:
Cash and cash equivalents
$ 72,904
$ 76,677
Prepaid expenses and other current assets
1,602
1,586
Total Current Assets
74,506
78,263
Property and equipment, net of accumulated depreciation of $ 891 and $ 694
364
550
Restricted cash – long term
324
313
Operating lease right-of-use assets
1,685
2,289
Finance leases right-of-use assets
20
30
Total Assets
$ 76,899
$ 81,445
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,568
$ 7,953
Operating leases current liability
569
530
Finance leases current liability
11
11
Total Current Liabilities
8,148
8,494
Long-term license revenue deferred
35,000
35,000
Long-term operating lease obligations
984
1,553
Long-term finance lease obligations
9
19
Total Liabilities
44,141
45,066
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 and 27,634,213 shares issued and outstanding at December 31, 2024 and 2023, respectively
31
28
Additional paid-in capital
408,553
373,934
Accumulated deficit
( 375,826 )
( 337,583 )
Total Stockholders’ Equity
32,758
36,379
Total Liabilities and Stockholders’ Equity
$ 76,899
$ 81,445
See
accompanying notes to the consolidated financial statements.
F- 2
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Operations
(amounts
in thousands, except share and per share data)
For the Year ended
December 31,
2024
2023
Revenue
Revenue
$ -
$ -
Other Revenue
-
81
Total revenue
-
81
Operating expenses:
Research and development, net of reimbursements
30,045
38,670
General and administrative
12,076
13,331
Total operating expenses
42,121
52,001
Loss from operations
( 42,121 )
( 51,920 )
Other income:
Interest income – net
3,878
3,102
Total other income
3,878
3,102
Net loss
$ ( 38,243 )
$ ( 48,818 )
Net loss per common share – basic and diluted
$ ( 1.27 )
$ ( 1.83 )
Weighted average common shares outstanding – basic and diluted
30,070,028
26,604,045
See
accompanying notes to the consolidated financial statements.
F- 3
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
For the Years Ended December 31, 2024 and 2023
(amounts in thousands, except share amounts)
Additional
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2023
25,674,823
$ 26
$ 355,220
$ ( 288,765 )
$ 66,481
Stock-based compensation
13,144
-
3,842
-
3,842
Sale of common stock, net of offering costs
1,902,005
2
14,610
-
14,612
Issuance of common stock from exercise of stock options
44,241
-
262
262
Net loss
-
-
-
( 48,818 )
( 48,818 )
Balance, December 31, 2023
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
See
accompanying notes to the consolidated financial statements.
F- 4
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(amounts
in thousands)
For the Year ended
December 31,
2024
2023
Cash Flows from Operating Activities:
Net loss
$ ( 38,243 )
$ ( 48,818 )
Adjustments to reconcile net loss to net cash used in/provided by operating activities:
Stock-based compensation expense
5,292
3,842
Depreciation expense
197
207
Amortization of right-of-use assets
614
583
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 15 )
49
Accounts payable and accrued expenses
( 387 )
( 2,177 )
Operating lease right-of-use assets
-
( 527 )
Operating lease liabilities
( 530 )
( 494 )
Net Cash Used In
Operating Activities
( 33,072 )
( 47,335 )
Cash Flows Used in Investing Activities:
Purchase of property and equipment
( 11 )
( 153 )
Net Cash Used In Investing Activities
( 11 )
( 153 )
Cash Flows from Financing Activities:
Payments on finance leases
( 9 )
( 4 )
Proceeds from sales of shares of common stock, net of offering costs
29,255
14,612
Proceeds from the exercise of stock options
75
262
Net Cash Provided By Financing Activities
29,321
14,870
Net change in cash, cash equivalents and restricted cash
( 3,762 )
( 32,618 )
Cash, cash equivalents and restricted cash at beginning of year
76,990
109,608
Cash, cash equivalents and restricted cash at end of year
$ 73,228
$ 76,990
Supplemental disclosures of cash flow information:
Cash paid for interest
$ -
$ -
Cash paid for taxes
$ -
$ -
Supplemental disclosure of non-cash investing and financing activities:
Right-of-use assets obtained in exchange for lease liabilities
$ -
$ 30
See
accompanying notes to the consolidated financial statements.
F- 5
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, 2024 and December 31, 2023:
(in thousands)
December 31,
2024
December 31,
2023
Cash and cash equivalents
$ 72,904
$ 76,677
Restricted cash – long-term
324
313
Cash, cash equivalents and restricted cash
$ 73,228
$ 76,990
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.
Leases
- The Company has an operating lease for corporate office 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.
F- 6
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 .
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. Revenue and related expenses are presented gross in the
consolidated statements of operations. There was no grant revenue for the year ended December 31, 2024.
F- 7
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 includes 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.
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 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.
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.
F- 8
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, 2024 and 2023, 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,
2024
December 31,
2023
Stock Options
5,137
5,445
Restricted Stock Units
300
305
Warrants
7
1,442
Total
5,444
7,192
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 November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280), Improvements
to Reportable Segment Disclosures , which provides improvements to reportable segment disclosure requirements, primarily through enhanced
disclosures around segment expenses. ASU 2023-07 requires the Company to disclose significant segment expenses that are regularly provided
to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss. ASU 2023-07
also requires that the Company 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.
The Company must also disclose the CODM’s title and position, as well as certain information around the measures used by the CODM
and an explanation of how the CODM uses the reported measures in assessing segment performance and deciding how to allocate resources.
For public entities with a single reportable segment, the entity must provide all the disclosures required pursuant to ASU 2023-07 and
all existing segment disclosures under Topic 280. The amendments of ASU 2023-07 are effective for the Company for annual periods beginning
January 1, 2024, and effective for interim periods beginning January 1, 2025. The Company 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.
Recently
Issued Accounting Pronouncements - 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, 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. The Company will evaluate
the impact of ASU 2024-03 on its financial statements.
In
December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , to enhance the
transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide improvements primarily related
to the rate reconciliation and income taxes paid information included in income tax disclosures. The Company 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, the Company 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 January 1, 2025, including interim periods. The Company will evaluate the impact of ASU 2023-09 on its financial statements.
F- 9
Note
2 - Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following at December 31, 2024 and 2023:
December 31,
December 31,
2024
2023
Prepaid insurance
$ 608
$ 614
Prepaid clinical trial expenses
637
746
Other prepaid expenses and other current assets
357
226
Total prepaid expenses and other current assets
$ 1,602
$ 1,586
Note
3 - Property and Equipment
Property
and equipment consisted of the following at December 31, 2024 and 2023:
December 31,
December 31,
(in thousands)
Lives
2024
2023
Lab equipment
5 years
$ 817
$ 806
Office equipment and furniture
3 - 7 years
438
438
Less: accumulated depreciation
( 891 )
( 694 )
Property and equipment, net
$ 364
$ 550
Depreciation
expense consisted of the following for the years ended December 31, 2024 and 2023, respectively:
December 31,
December 31,
(in thousands)
2024
2023
Research and development
$ 161
$ 175
General and administrative
36
32
Total depreciation expense
$ 197
$ 207
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.
F- 10
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.
As
of December 31, 2024, the Company has two leases which have been capitalized in accordance with ASC 842, one for corporate office 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. During the year ended December 31, 2023, the Company spent $ 0.5
million on improvements at its corporate office space, which were included in the value of the operating right-to-use asset.
The
components of lease expense are as follows:
(in thousands)
Year ended
December 31,
2024
Year ended
December 31,
2023
Operating lease expense
$ 691
$ 691
Finance lease cost
Amortization of right-to-use assets
$ 10
$ 3
Interest on lease liabilities
$ 2
$ -
Total finance lease cost
12
$ 3
Supplemental
cash flow information related to leases are as follows:
Year ended
(in thousands)
December 31,
2024
December 31,
2023
Cash flow information:
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 618
$ 606
Operating cash flow use from finance leases
$ 11
$ -
Financing cash flow use from finance leases
$ 9
$ 4
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ -
Finance leases
$ -
$ 30
Weighted
average remaining lease terms are as follows at December 31, 2024:
Weighted average remaining lease term:
Operating leases 2.6 years
Finance leases 2.0 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
4.8 %
Finance leases
6.2 %
F- 11
Maturities
of lease liabilities are as follows:
Year ending December 31,
Operating
Leases
Finance
Leases
2025
630
11
2026
643
11
2027
380
-
Total lease payments
$ 1,653
$ 22
Less imputed interest
( 100 )
( 2 )
Present value of lease liabilities
$ 1,553
$ 20
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, 2023 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 condensed 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, 2024 and December 31, 2023; 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.
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.
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. During the year ended December 31, 2023, the Company sold 1.9 million shares of common stock, resulting
in gross proceeds of $ 15.1 million and net proceeds of $ 14.6 million.
F- 12
The
Company presently has one equity compensation plan, the 2019 Amended and Restated Stock Plan, (the “2019 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.
The
Company had two equity compensation plans that expired on September 9, 2023; the Company’s Amended and Restated 2013 Stock Plan
and the Company’s 2013 Equity Incentive Plan.
Stock
Options
Following
is a summary of stock option activity for the years ended December 31, 2024 and 2023:
(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, 2023 3,396 8.00 8.85 15,204
Granted 2,402 5.28
Exercised ( 44 ) 5.92
Cancelled ( 309 ) 8.30
Outstanding, December 31, 2023 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 -
Exercisable, December 31, 2024 2,555 10.63 7.84 -
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.
During
2023, the Company granted its employees and members of the Board of Directors options to purchase 2.4 million shares of common stock
with an exercise price ranging from $ 5.00 to $ 11.60 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The
options have an aggregated fair value of $ 9.0 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 3.5 % to 4.82 % (2) expected life of 6 years, (3) expected
volatility range from 79.0 % to 81.6 %, and (4) zero expected dividends.
During
the years ended December 31, 2024 and 2023, options to purchase 0.5 million and 0.3 million common shares were cancelled, respectively,
upon the termination of employment.
The fair values of all options
issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at December 31,
2024 was $ 9.1 million related to unvested options, which is expected to be expensed over a weighted average of 2.6 years. During 2024
and 2023, the Company recorded total option expense of $ 4.6 million and $ 3.2 million, respectively.
Restricted
Stock Units
Following
is a summary of restricted stock unit (“RSUs”) activity for the years ended December 31, 2024 and 2023:
(in thousands, except for per-share amount)
RSUs
Weighted
Average
Grant Date Fair Value Per Share ($)
Outstanding, January 1, 2023
325
5.96
Granted
5
8.31
Vested
-
-
Cancelled
( 25 )
7.31
Outstanding, December 31, 2023
305
5.89
Granted
-
-
Vested
-
-
Cancelled
( 5 )
8.31
Outstanding, December 31, 2024
300
5.85
F- 13
The
RSUs vest at the earliest of a change of control event, the termination of the recipient’s continuous service status for any reason
other than by the Company for cause and the third anniversary of the date of the grant. The fair value of the RSUs, $ 1.8 million, was
determined based on the stock prices on the dates of the grants and each RSU grant is being recognized over its respective three-year
period. The unrecognized compensation expense at December 31, 2024 of $ 0.4 million is expected to be expensed over a weighted average
of 0.6 years. During 2024 and 2023, the Company recorded compensation expense related to RSUs of $ 0.6 million and $ 0.6 million, respectively.
Warrants
Following
is a summary of warrant activities for the years ended December 31, 2024 and 2023:
(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, 2023 1,443 16.58 1.33 5
Granted 2 8.77 10.00
Exercised -
-
Expired ( 3 ) 106.80
Outstanding, December 31, 2023 1,442 16.42 0.34 -
Granted -
-
Exercised -
-
Expired ( 1,435 ) 16.42
Outstanding, December 31, 2024 7 17.33 4.46 -
Exercisable, December 31, 2024 7 17.77 4.25 -
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, 2024 and 2023, the Company recorded stock-based compensation expense related to warrants of $ 5 thousand
and $ 6 thousand, respectively.
Note
8 - Income Taxes
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, 2024 and 2023 are as follows:
(in thousands)
2024
2023
Deferred tax assets:
Net operating losses carry forward
$ 47,875
$ 41,698
Deferred revenue
8,217
8,219
Share-based compensation
1,572
1,512
Research and development/orphan drug credits
23,296
20,509
Capitalized research and development expenses
20,664
18,684
Others
( 11 )
( 57 )
Less: valuation allowance
( 101,613 )
( 90,565 )
Deferred tax assets, net
$ -
$ -
The
Company has recorded a valuation allowance of $ 101.6 million and $ 90.6 million against its deferred tax assets at December 31, 2024 and
2023 respectively, because management determined that it is not more-likely-than not that those assets will be realized.
F- 14
For
federal income tax purposes, the Company has $ 189.3 million of unused net operating losses (“NOLs”) at December 31, 2024
available for carry forward to future years. NOLs of $ 104.8 million generated prior to 2018 will begin to expire if unused beginning
in 2026 when approximately $ 3.9 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 $ 84.6 million have an indefinite life, but will be
limited to 80 % of their value if used in a tax year ending after January 1, 2023.
For
state income tax purposes, the Company has $ 327.8 million of unused NOLs at December 31, 2024 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 $ 6.7 million at December 31, 2024, which will begin to expire in 2033 if
unused and orphan drug credits of $ 16.5 million which will begin to expire in 2037 if unused.
Federal
and state tax laws impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership
change for tax purposes, as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize
these carryforwards may be limited as a result of an ownership change which may have already happened or may happen in the future. Such
an ownership change could result in a limitation in the use of the net operating losses in future years and possibly a reduction of the
net operating losses available.
The
Tax Cuts and Jobs Act of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning
after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities
and amortize them over five years for U.S. activities and 15 years for non-U.S. activities. Since this has been the Company's policy
since 2018, the current year capitalization of research and development costs in accordance with IRC 174 was $ 28.0 million for a total
accumulated gross amount of $ 87.9 million as of December 31, 2024.
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, 2024 and 2023 are as follows:
(in thousands)
December 31,
2024
December 31,
2023
Federal statutory income taxes
$ ( 8,031 )
( 21.0 )%
$ ( 10,252 )
( 21.0 )%
State income taxes
( 1,275 )
( 3.3 )%
( 1,743 )
( 3.6 )%
Deferred true-up
259
0.7 %
176
0.4 %
Research and development/orphan drug tax credit
( 2,787 )
( 7.3 )%
( 3,263 )
( 6.7 )%
Other
788
2.0 %
608
1.2 %
Change in valuation allowance
11,046
28.9 %
14,474
29.7 %
Provision for income tax
$ -
-
$ -
-
Note 9 - 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. FSuSuch 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.
F- 15
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.