FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
−Removed: To the Stockholders and Board of Directors of
−Removed: Actinium Pharmaceuticals, Inc.
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying
−Removed: consolidated balance sheets of Actinium Pharmaceuticals, Inc.
−Removed: (the “Company”) as of December 31, 2023 and 2022, and the
−Removed: related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the
−Removed: period ended December 31, 2023 and the related notes (collectively referred to as the “financial statements”).
−Removed: opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31,
+Added: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: the Stockholders and Board of Directors of
+Added: Pharmaceuticals, Inc.
+Added: on the Financial Statements
+Added: have audited the accompanying consolidated balance sheets of Actinium Pharmaceuticals, Inc.
+Added: (the “Company”) as of December
+Added: 31, 2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each
+Added: of the two years in the period ended December 31, 2024 and the related notes (collectively referred to as the “financial statements”).
+Added: 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.
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
−Removed: and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable
−Removed: rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the
−Removed: standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
−Removed: statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged
−Removed: to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding
−Removed: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
−Removed: internal control over financial reporting.
+Added: financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain
+Added: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits,
+Added: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess
−Removed: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
−Removed: to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
−Removed: the overall presentation of the financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matters
−Removed: Critical audit matters are matters arising from
−Removed: the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
−Removed: subjective, or complex judgments.
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
+Added: Audit Matters
+Added: audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
+Added: communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
We determined that there are no critical audit matters.
−Removed: /s/ Marcum llp
−Removed: We have served as the Company’s auditor since 2012 .
−Removed: Houston, Texas
−Removed: March 29, 2024
−Removed: Actinium Pharmaceuticals, Inc.
+Added: have served as the Company’s auditor since 2012 .
+Added: Pharmaceuticals, Inc.
Consolidated Balance Sheets
−Removed: (amounts in thousands, except share and per share
+Added: in thousands, except share and per share data)
Current Assets:
Cash and cash equivalents
−Removed: Restricted cash – current
Prepaid expenses and other current assets
25 unchanged sentences
Total Liabilities and Stockholders’ Equity
−Removed: See accompanying notes to the consolidated financial
−Removed: Actinium Pharmaceuticals, Inc.
+Added: accompanying notes to the consolidated financial statements.
+Added: Pharmaceuticals, Inc.
Consolidated Statements of Operations
−Removed: (amounts in thousands, except share and per share
+Added: in thousands, except share and per share data)
For the Year ended
11 unchanged sentences
Weighted average common shares outstanding – basic and diluted
−Removed: See accompanying notes to the consolidated financial
−Removed: Actinium Pharmaceuticals, Inc.
+Added: accompanying notes to the consolidated financial statements.
+Added: Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
6 unchanged sentences
Sale of common stock, net of offering costs
+Added: Issuance of common stock from exercise of stock options
Balance, December 31, 2023
5 unchanged sentences
$ ( 375,826 )
−Removed: See accompanying notes to the consolidated financial
−Removed: Actinium Pharmaceuticals, Inc.
+Added: accompanying notes to the consolidated financial statements.
+Added: Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
−Removed: (amounts in thousands)
+Added: in thousands)
For the Year ended
2 unchanged sentences
Stock-based compensation expense
−Removed: Depreciation and amortization expense
+Added: Depreciation expense
+Added: Amortization of right-of-use assets
Changes in operating assets and liabilities:
1 unchanged sentence
Accounts payable and accrued expenses
−Removed: Other revenue deferred – current liability
−Removed: Long-term license revenue deferred
Operating lease right-of-use assets
Operating lease liabilities
−Removed: Net Cash Used In/Provided By Operating Activities
+Added: Net Cash Used In
+Added: Operating Activities
Cash Flows Used in Investing Activities:
14 unchanged sentences
Right-of-use assets obtained in exchange for lease liabilities
−Removed: Equipment obtained in exchange for security deposit
−Removed: See accompanying notes to the consolidated financial
−Removed: Actinium Pharmaceuticals, Inc.
+Added: accompanying notes to the consolidated financial statements.
+Added: Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
−Removed: Note 1 – Description of Business and Summary
−Removed: of Significant Accounting Policies
−Removed: Nature of Business –
−Removed: Actinium Pharmaceuticals, Inc.
−Removed: is a biopharmaceutical company developing ARCs and other targeted radiotherapies to deliver cancer-killing
−Removed: radiation with cellular level precision to treat patients with high unmet medical needs.
−Removed: Principles of Consolidation
−Removed: - The consolidated financial statements include the Company’s accounts and those of the Company’s wholly owned subsidiaries.
+Added: 1 - Description of Business and Summary of Significant Accounting Policies
+Added: of Business - Actinium Pharmaceuticals, Inc.
+Added: is a biopharmaceutical company developing ARCs and other targeted radiotherapies to
+Added: deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.
+Added: of Consolidation - The consolidated financial statements include the Company’s accounts and those of the Company’s wholly
+Added: owned subsidiaries.
All significant intercompany accounts and transactions have been eliminated.
−Removed: Use of Estimates in Financial
−Removed: Statement Presentation - The preparation of these consolidated financial statements in conformity with accounting principles generally
−Removed: accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period.
+Added: of Estimates in Financial Statement Presentation - The preparation of these consolidated financial statements in conformity with
+Added: accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect
+Added: the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses
+Added: during the reporting period.
Actual results could differ from those estimates.
−Removed: Cash and Cash
−Removed: Equivalents and Restricted Cash- The Company considers all highly liquid accounts with original maturities of three months or
−Removed: less to be cash equivalents.
−Removed: The Company holds most of its cash equivalents in a Money Market account comprised of US Treasury
+Added: Information - The Company operates as a single operating and reportable segment for the purposes of assessing performance and allocating
+Added: The Company’s chief operating decision maker is its Chief Executive Officer, who reviews total assets in the consolidated
+Added: balance sheets and net loss and its components in the consolidated statements of operations:
+Added: research and development expenses, general and administrative expenses, and interest income, for the purposes of making operating decisions,
+Added: assessing financial performance, and allocating resources.
+Added: All assets are in the United States.
+Added: and Cash Equivalents and Restricted Cash - The Company considers all highly liquid accounts with original maturities of three months
+Added: or less to be cash equivalents.
+Added: The Company holds most of its cash equivalents in a Money Market account comprised of U.S.
+Added: Treasury notes.
Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation insured limits.
−Removed: Following is a summary of
−Removed: cash, cash equivalents and restricted cash at December 31, 2023 and December 31, 2022:
+Added: is a summary of cash, cash equivalents and restricted cash at December 31, 2024 and December 31, 2023:
(in thousands)
Cash and cash equivalents
−Removed: Restricted cash – current
Restricted cash – long-term
Cash, cash equivalents and restricted cash
−Removed: Restricted cash relates to
−Removed: certificates of deposit held as collateral for letters of credit issued in connection with the Company’s leases of corporate office
−Removed: Equipment - Machinery and equipment are recorded at cost and depreciated on a straight-line basis over estimated useful lives of
−Removed: three to five years.
−Removed: Furniture and fixtures are recorded at cost and depreciated on a straight-line basis over estimated useful
−Removed: lives of seven years.
−Removed: When assets are retired, the cost and related accumulated depreciation are removed from the accounts, and any
−Removed: related gain or loss is reflected in operations.
+Added: cash relates to certificates of deposit held as collateral for letters of credit issued in connection with the Company’s leases
+Added: of corporate office spaces.
+Added: and Equipment - Machinery and equipment are recorded at cost and depreciated on a straight-line basis over estimated useful lives
+Added: of three to five years .
+Added: Furniture and fixtures are recorded at cost and depreciated on a straight-line basis over estimated useful lives
+Added: of seven years .
+Added: When assets are retired, the cost and related accumulated depreciation are removed from the accounts, and any related
+Added: gain or loss is reflected in operations.
Repairs and maintenance expenditures are charged to operations when incurred.
Capitalized lease
−Removed: assets are recorded at the lesser of the present value of minimum lease payments or fair value and amortized over the estimated
−Removed: useful life of the related property or term of the lease.
−Removed: Company has an operating lease for corporate office space and a finance lease for office equipment located at the corporate office space.
+Added: assets are recorded at the lesser of the present value of minimum lease payments or fair value and amortized over the estimated useful
+Added: life of the related property or term of the lease.
+Added: - The Company has an operating lease for corporate office space and a finance lease for office equipment located at the corporate
+Added: office space.
Leases with an initial term of 12 months or less are not recorded on the balance sheet;
−Removed: lease expense for these leases is recognized on
−Removed: a straight-line basis over the lease term.
−Removed: Fair Value Measurement
−Removed: - 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
−Removed: between market participants.
−Removed: A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted
−Removed: prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
−Removed: Revenue Recognition -
−Removed: The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From Contracts With Customers
−Removed: Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services,
−Removed: in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services.
−Removed: revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps:
−Removed: (i) identify the contract(s)
−Removed: with a customer;
+Added: lease expense for these leases
+Added: is recognized on a straight-line basis over the lease term.
+Added: Value Measurement - Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability,
+Added: in an orderly transaction between market participants.
+Added: A fair value hierarchy has been established for valuation inputs that gives the
+Added: highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
+Added: Recognition - The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From
+Added: Contracts With Customers (“ASC 606”).
+Added: Under ASC 606, an entity recognizes revenue when its customer obtains control of
+Added: promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods
+Added: To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps:
+Added: (i) identify the contract(s) with a customer;
(ii) identify the performance obligations in the contract;
−Removed: (iii) determine the transaction price, including variable
−Removed: consideration, if any;
+Added: (iii) determine the transaction
+Added: price, including variable consideration, if any;
(iv) allocate the transaction price to the performance obligations in the contract;
−Removed: and (v) recognize revenue as
−Removed: the entity satisfies a performance obligation.
−Removed: The Company only applies the five-step model to contracts when it is probable that the
−Removed: entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.
−Removed: At contract inception, once
−Removed: the contract is determined to be within the scope of ASC 606, the Company assesses whether the promised goods or services promised within
−Removed: each contract are distinct and, therefore, represent a separate performance obligation.
−Removed: Goods and services that are determined not
−Removed: to be distinct are combined with other promised goods and services until a distinct bundle is identified.
−Removed: In determining whether goods
−Removed: or services are distinct, the Company evaluates certain criteria, including whether (i) the customer can benefit from the good or
−Removed: service either on its own or together with other resources that are readily available to the customer (capable of being distinct) and
−Removed: (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context of the
−Removed: The Company then determines
−Removed: the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange for the promised goods
−Removed: or services for each performance obligation and recognizes the associated revenue as each performance obligation is satisfied.
−Removed: The Company’s
−Removed: estimate of the transaction price for each contract includes all variable consideration to which it expects to be entitled.
−Removed: Variable consideration
−Removed: includes payments in the form of collaboration milestone payments.
−Removed: If an arrangement includes collaboration milestone payments, the Company
−Removed: evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price
−Removed: using the most likely amount method.
−Removed: If it is probable that a significant revenue reversal would not occur, the associated milestone value
−Removed: is included in the transaction price.
−Removed: ASC 606 requires the Company
−Removed: to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining
−Removed: the transaction price of the contract and identifying the performance obligations to which that amount should be allocated.
−Removed: standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised good or service separately
−Removed: to a customer.
−Removed: The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance
−Removed: obligation as each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based
−Removed: on the use of an output or input method.
−Removed: Collaborative Arrangements
−Removed: - The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain transactions
−Removed: between the Company and collaborators be recorded in its consolidated statements of operations on either a gross basis or net basis, depending
−Removed: on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships.
−Removed: evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the nature of the
−Removed: underlying activity.
−Removed: When the Company has concluded that it has a customer relationship with one of its collaborators, the Company follows
−Removed: the guidance of ASC 606 .
−Removed: Grant Revenue – The
−Removed: Company has a grant from a government-sponsored entity for research and development related activities that provides for payments
−Removed: for reimbursed costs, which included overhead and general and administrative costs as well as an administrative fee.
−Removed: recognizes revenue from grants as it performed services under this arrangement.
−Removed: Associated expenses are recognized when incurred as
−Removed: research and development expense.
−Removed: Revenue and related expenses are presented gross in the consolidated statements of operations.
−Removed: License Revenue –
−Removed: The Company entered into a product licensing agreement whereby the Company allowed a third party to commercialize a certain product
−Removed: in specified territories using the Company’s trademarks.
−Removed: The terms of this arrangement includes payment to the Company for a combination
−Removed: of one or more of the following:
+Added: and (v) recognize revenue as the entity satisfies a performance obligation.
+Added: The Company only applies the five-step model to contracts
+Added: 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
+Added: to the customer.
+Added: contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the promised goods
+Added: or services promised within each contract are distinct and, therefore, represent a separate performance obligation.
+Added: Goods and services
+Added: that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified.
+Added: determining whether goods or services are distinct, the Company evaluates certain criteria, including whether (i) the customer can
+Added: benefit from the good or service either on its own or together with other resources that are readily available to the customer (capable
+Added: of being distinct) and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct
+Added: in the context of the contract).
+Added: Company then determines the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange
+Added: for the promised goods or services for each performance obligation and recognizes the associated revenue as each performance obligation
+Added: is satisfied.
+Added: The Company’s estimate of the transaction price for each contract includes all variable consideration to which it
+Added: expects to be entitled.
+Added: Variable consideration includes payments in the form of collaboration milestone payments.
+Added: If an arrangement includes
+Added: collaboration milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates
+Added: the amount to be included in the transaction price using the most likely amount method.
+Added: If it is probable that a significant revenue
+Added: reversal would not occur, the associated milestone value is included in the transaction price.
+Added: 606 requires the Company to allocate the arrangement consideration on a relative standalone selling price basis for each performance
+Added: obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should
+Added: be allocated.
+Added: The relative standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised
+Added: good or service separately to a customer.
+Added: The Company then recognizes as revenue the amount of the transaction price that is allocated
+Added: to the respective performance obligation as each performance obligation is satisfied, either at a point in time or over time, and if
+Added: over time, recognition is based on the use of an output or input method.
+Added: Collaborative
+Added: Arrangements - The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain
+Added: transactions between the Company and collaborators be recorded in its consolidated statements of operations on either a gross basis or
+Added: net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships.
+Added: The Company evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the
+Added: nature of the underlying activity.
+Added: When the Company has concluded that it has a customer relationship with one of its collaborators,
+Added: the Company follows the guidance of ASC 606 .
+Added: Revenue - The Company has a grant from a government-sponsored entity for research and development related activities that
+Added: provides for payments for reimbursed costs, which included overhead and general and administrative costs as well as an
+Added: administrative fee.
+Added: The Company recognizes revenue from grants as it performed services under this arrangement.
+Added: Associated expenses
+Added: are recognized when incurred as research and development expense.
+Added: Revenue and related expenses are presented gross in the
+Added: consolidated statements of operations.
+Added: There was no grant revenue for the year ended December 31, 2024.
+Added: Revenue - The Company entered into a product licensing agreement whereby the Company allowed a third party to commercialize a certain
+Added: product in specified territories using the Company’s trademarks.
+Added: The terms of this arrangement includes payment to the Company
+Added: for a combination of one or more of the following:
upfront license fees;
development, regulatory and sales-based milestone payments;
−Removed: and royalties on net
−Removed: sales of licensed products.
−Removed: The Company uses its judgment to determine whether milestones or other variable consideration should be included
−Removed: in the transaction price.
−Removed: Upfront license fees :
−Removed: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified
−Removed: in the arrangement, the Company will recognize revenue from upfront license fees allocated to the license when the license is transferred
−Removed: to the licensee and the licensee is able to use and benefit from the license.
−Removed: For licenses that are bundled with other promises, the Company
−Removed: determines whether the combined performance obligation is satisfied over time or at a point in time.
−Removed: Development, regulatory
−Removed: or commercial milestone payments :
−Removed: At the inception of each arrangement that includes payments based on the achievement of certain
−Removed: development, regulatory and sales-based or commercial events, the Company evaluates whether the milestones are considered probable of
−Removed: being achieved and estimates the amount to be included in the transaction price using the most likely amount method.
−Removed: If it is probable
−Removed: that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.
−Removed: Milestone payments
−Removed: that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered probable of
−Removed: being achieved until regulatory approval is received.
−Removed: At the end of each subsequent reporting period, the Company will re-evaluate the
−Removed: probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjust the Company’s
+Added: and royalties on net sales of licensed products.
+Added: The Company uses its judgment to determine whether milestones or other variable consideration
+Added: should be included in the transaction price.
+Added: license fees :
+Added: If the license to the Company’s intellectual property is determined to be distinct from the other performance
+Added: obligations identified in the arrangement, the Company will recognize revenue from upfront license fees allocated to the license when
+Added: the license is transferred to the licensee and the licensee is able to use and benefit from the license.
+Added: For licenses that are bundled
+Added: with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time.
+Added: regulatory or commercial milestone payments :
+Added: At the inception of each arrangement that includes payments based on the achievement
+Added: of certain development, regulatory and sales-based or commercial events, the Company evaluates whether the milestones are considered
+Added: probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method.
+Added: is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.
+Added: Milestone payments that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered
+Added: probable of being achieved until regulatory approval is received.
+Added: At the end of each subsequent reporting period, the Company will re-evaluate
+Added: 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.
1 unchanged sentence
revenue during the period of adjustment.
−Removed: Sales-based milestone payments
−Removed: and royalties :
−Removed: For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, the
−Removed: Company will determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate
−Removed: 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
−Removed: obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: Upfront payments and fees
−Removed: may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements or
−Removed: when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when the uncertainty
−Removed: associated with any variable consideration is subsequently resolved.
−Removed: Amounts payable to the Company are recorded as accounts receivable
−Removed: when the Company’s right to consideration is unconditional.
−Removed: Research and Development
−Removed: Costs - Research and development costs are expensed as incurred.
−Removed: These costs include the costs of manufacturing drug product, the
−Removed: costs of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to facilities and
−Removed: Research and development reimbursements are recorded by the Company as a reduction of research and development costs.
−Removed: Share-Based Payments -
−Removed: The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model.
−Removed: fair value determined represents the cost for the award and is recognized over the vesting period during which an employee is required
−Removed: to provide service in exchange for the award.
+Added: milestone payments and royalties :
+Added: For arrangements that include sales-based royalties, including milestone payments based on the
+Added: volume of sales, the Company will determine whether the license is deemed to be the predominant item to which the royalties or sales-based
+Added: 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)
+Added: when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
+Added: payments and fees may require deferral of revenue recognition to a future period until the Company performs its obligations under these
+Added: arrangements or when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when
+Added: the uncertainty associated with any variable consideration is subsequently resolved.
+Added: Amounts payable to the Company are recorded as accounts
+Added: receivable when the Company’s right to consideration is unconditional.
+Added: and Development Costs - Research and development costs are expensed as incurred.
+Added: These costs include the costs of manufacturing drug
+Added: product, the costs of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to
+Added: facilities and equipment.
+Added: Research and development reimbursements are recorded by the Company as a reduction of research and development
+Added: Payments - The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing
+Added: The fair value determined represents the cost for the award and is recognized over the vesting period during which an employee
+Added: is required to provide service in exchange for the award.
The Company accounts for forfeitures of stock options as they occur.
−Removed: Income Taxes - The
−Removed: Company accounts for income taxes in accordance with ASC 740 Income Taxes , which requires the asset and liability method to calculate
−Removed: deferred taxes.
−Removed: Deferred taxes are recognized based on the differences between the financial reporting and income tax bases of assets
−Removed: and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
−Removed: reviews deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred tax asset will be
−Removed: fully realized.
−Removed: ASC 740 prescribes guidance
−Removed: for the financial statement recognition, measurement and disclosure of uncertain tax positions.
−Removed: Tax positions must meet a “more-likely-than-not”
−Removed: recognition threshold to be recognized.
−Removed: There were no tax positions for which it is considered reasonably possible that the total amounts
−Removed: of unrecognized tax benefits will significantly increase or decrease within the next year.
−Removed: The Company recognizes interest related to
−Removed: unrecognized tax benefits in interest expense and penalties in operating expenses.
−Removed: Net Loss Per Common Share
−Removed: - Basic loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of
−Removed: common shares outstanding during the reporting period.
−Removed: For periods of net loss, diluted loss per share is calculated similarly to basic
−Removed: loss per share because the impact of all potential dilutive common shares is anti-dilutive.
−Removed: For the years ended December
−Removed: 31, 2023 and 2022, the Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock units
−Removed: and warrants, have not been included in the computation of diluted net loss per share as the result would have been anti-dilutive.
+Added: Taxes - The Company accounts for income taxes in accordance with ASC 740 Income Taxes , which requires the asset and liability
+Added: method to calculate deferred taxes.
+Added: Deferred taxes are recognized based on the differences between the financial reporting and income
+Added: tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to
+Added: The Company reviews deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred
+Added: tax asset will be fully realized.
+Added: 740 prescribes guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions.
+Added: Tax positions
+Added: must meet a “more-likely-than-not” recognition threshold to be recognized.
+Added: There were no tax positions for which it is considered
+Added: reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year.
+Added: The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses.
+Added: Loss Per Common Share - Basic loss per common share is computed by dividing the net loss available to common stockholders by the
+Added: weighted average number of common shares outstanding during the reporting period.
+Added: For periods of net loss, diluted loss per share is
+Added: calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive.
+Added: the years ended December 31, 2024 and 2023, the Company’s potentially dilutive shares, which include outstanding common stock options,
+Added: restricted stock units and warrants, have not been included in the computation of diluted net loss per share as the result would have
+Added: been anti-dilutive.
(in thousands)
1 unchanged sentence
Restricted Stock Units
−Removed: Subsequent Events -
−Removed: The Company’s management reviewed all material events through the date the consolidated financial statements were issued for subsequent
−Removed: event disclosure consideration.
−Removed: Recently Issued Accounting
−Removed: Pronouncements - In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures ,
−Removed: to enhance the transparency and decision usefulness of income tax disclosures.
−Removed: The amendments in ASU 2023-09 provide improvements primarily
−Removed: related to the rate reconciliation and income taxes paid information included in income tax disclosures.
−Removed: The Company would be required
−Removed: to disclose additional information regarding reconciling items equal to or greater than five percent of the amount computed by multiplying
−Removed: pretax income (loss) by the applicable statutory tax rate.
−Removed: Similarly, the Company would be required to disclose income taxes paid (net
−Removed: of refunds received) equal to or greater than five percent of total income taxes paid (net of refunds received).
−Removed: The amendments in ASU
−Removed: 2023-09 are effective January 1, 2025, including interim periods.
−Removed: Early adoption is permitted for annual financial statements that have
−Removed: not yet been issued or made available for issuance.
−Removed: The Company will evaluate the impact of ASU 2023-09 on its financial statements.
−Removed: In November 2023, FASB issued
−Removed: ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures , which provides improvements
−Removed: to reportable segment disclosure requirements, primarily through enhanced disclosures around segment expenses.
−Removed: ASU 2023-07 requires the
−Removed: Company to disclose significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”)
−Removed: and included within each reported measure of segment profit or loss.
−Removed: ASU 2023-07 also requires that the Company disclose an amount for
−Removed: other segment items by reportable segment, a description of their composition and provide all annual disclosures about a reportable segment’s
−Removed: profit or loss and assets pursuant to Topic 280 during interim periods.
−Removed: The Company must also disclose the CODM’s title and position,
−Removed: as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the reported measures in
−Removed: assessing segment performance and deciding how to allocate resources.
−Removed: For public entities with a single reportable segment, the entity
−Removed: must provide all the disclosures required pursuant to ASU 2023-07 and all existing segment disclosures under Topic 280.
+Added: Events - The Company’s management reviewed all material events through the date the consolidated financial statements were
+Added: issued for subsequent event disclosure consideration.
+Added: Adopted Accounting Pronouncements - In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280), Improvements
+Added: to Reportable Segment Disclosures , which provides improvements to reportable segment disclosure requirements, primarily through enhanced
+Added: disclosures around segment expenses.
+Added: ASU 2023-07 requires the Company to disclose significant segment expenses that are regularly provided
+Added: to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss.
+Added: also requires that the Company disclose an amount for other segment items by reportable segment, a description of their composition and
+Added: provide all annual disclosures about a reportable segment’s profit or loss and assets pursuant to Topic 280 during interim periods.
+Added: The Company must also disclose the CODM’s title and position, as well as certain information around the measures used by the CODM
+Added: and an explanation of how the CODM uses the reported measures in assessing segment performance and deciding how to allocate resources.
+Added: For public entities with a single reportable segment, the entity must provide all the disclosures required pursuant to ASU 2023-07 and
+Added: all existing segment disclosures under Topic 280.
+Added: The amendments of ASU 2023-07 are effective for the Company for annual periods beginning
+Added: January 1, 2024, and effective for interim periods beginning January 1, 2025.
+Added: The Company adopted this standard effective January 1,
+Added: 2024 and reported on it in this Annual Report on Form 10-K for the year ended December 31, 2024.
+Added: Issued Accounting Pronouncements - In November 2024, FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense
+Added: Disaggregation Disclosures (Subtopic 220-40), to improve the disaggregation of expenses within the consolidated statement of operations.
+Added: The amendments in ASU 2024-03 require disclosures, in the notes to the consolidated financial statements, specified information about
+Added: certain costs and expenses.
+Added: The amendments require that at each interim and annual reporting period an entity disclose (a) employee compensation,
+Added: (b) depreciation, and (c) intangible asset amortization included in each relevant expense caption;
+Added: include certain amounts that are already
+Added: required to be disclosed under current GAAP in the same disclosure as the other disaggregation requirements;
+Added: and disclose a qualitative
+Added: description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively.
The amendments
−Removed: of ASU 2023-07 are effective for the Company for annual periods beginning January 1, 2024, and effective for interim periods beginning
−Removed: January 1, 2025.
−Removed: Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.
−Removed: The Company will evaluate the impact of ASU 2023-07 on its financial statements.
−Removed: In October 2021, FASB issued
−Removed: ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers ,
−Removed: which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance with
−Removed: To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue
−Removed: Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities
−Removed: consistent with how they were recognized and measured in the acquiree’s financial statements.
−Removed: The amendments of ASU 2021-08 are
+Added: in ASU 2024-03 are effective January 1, 2027, and effective for interim periods beginning January 1, 2028.
+Added: The Company will evaluate
+Added: the impact of ASU 2024-03 on its financial statements.
+Added: December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures , to enhance the
+Added: transparency and decision usefulness of income tax disclosures.
+Added: The amendments in ASU 2023-09 provide improvements primarily related
+Added: to the rate reconciliation and income taxes paid information included in income tax disclosures.
+Added: The Company will be required to disclose
+Added: additional information regarding reconciling items equal to or greater than five percent of the amount computed by multiplying pretax
+Added: income (loss) by the applicable statutory tax rate.
+Added: Similarly, the Company will be required to disclose income taxes paid (net of refunds
+Added: received) equal to or greater than five percent of total income taxes paid (net of refunds received).
+Added: The amendments in ASU 2023-09 are
effective January 1, 2025, including interim periods.
−Removed: The Company will evaluate the impact of ASU 2021-08 on any future business combinations
−Removed: the Company may enter in the future.
−Removed: Note 2 - Prepaid Expenses and Other Current
−Removed: Prepaid expenses and other
−Removed: current assets consisted of the following at December 31, 2023 and 2022:
+Added: The Company will evaluate the impact of ASU 2023-09 on its financial statements.
+Added: 2 - Prepaid Expenses and Other Current Assets
+Added: expenses and other current assets consisted of the following at December 31, 2024 and 2023:
Prepaid insurance
2 unchanged sentences
Total prepaid expenses and other current assets
−Removed: Note 3 - Property and Equipment
−Removed: Property and equipment consisted
−Removed: of the following at December 31, 2023 and 2022:
+Added: 3 - Property and Equipment
+Added: and equipment consisted of the following at December 31, 2024 and 2023:
(in thousands)
3 unchanged sentences
Property and equipment, net
−Removed: Depreciation expense consisted
−Removed: of the following for the years ended December 31, 2023 and 2022, respectively:
+Added: expense consisted of the following for the years ended December 31, 2024 and 2023, respectively:
(in thousands)
2 unchanged sentences
Total depreciation expense
−Removed: Note 4 - Leases
−Removed: The Company determines if
−Removed: an arrangement is a lease at inception.
−Removed: This determination generally depends on whether the arrangement conveys to the Company the right
−Removed: to control the use of a fixed asset for a period of time in exchange for consideration.
−Removed: Control of an underlying asset is conveyed to
−Removed: the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using
−Removed: the underlying asset.
−Removed: The Company has lease agreements which include lease and non-lease components, which the Company has elected to
−Removed: account for as a single lease component for all classes of underlying assets.
−Removed: Lease expense for variable lease components are recognized
−Removed: when the obligation is probable.
−Removed: The Company made an accounting policy election to exclude from balance sheet reporting those leases with
−Removed: initial terms of 12 months or less.
−Removed: Right-of-use assets and liabilities
−Removed: are recognized at commencement date based on the present value of lease payments over the lease term.
−Removed: ASC 842 requires a lessee to discount
−Removed: its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental
−Removed: borrowing rate.
−Removed: As an implicit interest rate was not readily determinable in the Company’s leases, the incremental borrowing rate
−Removed: was used based on the information available at commencement date in determining the present value of lease payments.
−Removed: The lease term for all of
−Removed: the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option
−Removed: 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)
−Removed: the lease controlled by the lessor.
−Removed: Options for lease renewals have been excluded from the lease term (and lease liability) for the Company’s
−Removed: leases as the reasonably certain threshold is not met.
−Removed: At December 31,
−Removed: 2023, the Company has two leases which have been capitalized in accordance with ASC 842, one for corporate office space and one for
−Removed: office equipment.
+Added: Company determines if an arrangement is a lease at inception.
+Added: This determination generally depends on whether the arrangement conveys
+Added: to the Company the right to control the use of a fixed asset for a period of time in exchange for consideration.
+Added: Control of an underlying
+Added: 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
+Added: benefits from using the underlying asset.
+Added: The Company has lease agreements which include lease and non-lease components, which the Company
+Added: has elected to account for as a single lease component for all classes of underlying assets.
+Added: Lease expense for variable lease components
+Added: are recognized when the obligation is probable.
+Added: The Company made an accounting policy election to exclude from balance sheet reporting
+Added: those leases with initial terms of 12 months or less.
+Added: assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term.
+Added: requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily
+Added: determined, its incremental borrowing rate.
+Added: As an implicit interest rate was not readily determinable in the Company’s leases,
+Added: the incremental borrowing rate was used based on the information available at commencement date in determining the present value of lease
+Added: lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered
+Added: by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option
+Added: to extend (or not to terminate) the lease controlled by the lessor.
+Added: Options for lease renewals have been excluded from the lease term
+Added: (and lease liability) for the Company’s leases as the reasonably certain threshold is not met.
+Added: of December 31, 2024, the Company has two leases which have been capitalized in accordance with ASC 842, one for corporate office space
+Added: and one for office equipment.
The Company entered into a lease for corporate office space effective June 1, 2022.
−Removed: The lease has a term of 5
−Removed: years 2 months , with an expiration date on July 30, 2027 and current annual rent of $ 0.6 million.
+Added: The lease has a term
+Added: 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
−Removed: for certain other costs, such as insurance, utilities and maintenance During the year ended December 31, 2023, the Company spent
−Removed: $ 0.5 million on improvements at its corporate office space, which has been included in the value of the operating right-to-use
−Removed: The components of lease expense are as follows:
+Added: for certain other costs, such as insurance, utilities and maintenance.
+Added: During the year ended December 31, 2023, the Company spent $ 0.5
+Added: million on improvements at its corporate office space, which were included in the value of the operating right-to-use asset.
+Added: components of lease expense are as follows:
(in thousands)
4 unchanged sentences
Total finance lease cost
−Removed: Supplemental cash flow information related to leases
−Removed: are as follows:
+Added: cash flow information related to leases are as follows:
(in thousands)
8 unchanged sentences
Finance leases
−Removed: Weighted average remaining lease terms are as follows
−Removed: at December 31, 2023:
+Added: average remaining lease terms are as follows at December 31, 2024:
Weighted average remaining lease term:
−Removed: Operating leases
−Removed: Finance leases
−Removed: As the interest rate implicit
−Removed: in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate
−Removed: based on the information available in determining the present value of lease payments.
−Removed: The Company’s incremental borrowing rate
−Removed: 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
−Removed: on a secured basis.
−Removed: Below is information on the weighted average discount rates used at the time that the leases were evaluated:
+Added: Operating leases 2.6 years
+Added: Finance leases 2.0 years
+Added: the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its
+Added: incremental borrowing rate based on the information available in determining the present value of lease payments.
+Added: The Company’s
+Added: incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company
+Added: would have had to pay to borrow on a secured basis.
+Added: Below is information on the weighted average discount rates used at the time that
+Added: the leases were evaluated:
Weighted average discount rates:
1 unchanged sentence
Finance leases
−Removed: Maturities of lease liabilities are as follows:
+Added: of lease liabilities are as follows:
Year ending December 31,
2 unchanged sentences
Present value of lease liabilities
−Removed: Note 5 - Other Revenue
−Removed: The Company determined that
−Removed: certain collaborations with a third party were within the scope of ASC 606.
−Removed: The collaboration agreement was made up of multiple modules
−Removed: related to various research activities.
−Removed: The Company identified a single performance obligation to provide research services within each
−Removed: module for which the Company receives monetary consideration.
−Removed: The third party can choose to proceed with each module or can terminate
−Removed: the agreement at any time.
−Removed: The Company recognizes revenue for each module on a straight-line basis over the expected module period.
−Removed: for succeeding modules is not recognized until all contingencies are resolved, inclusive of the third party’s ability to terminate
−Removed: The consideration is recognized to revenue over each module.
−Removed: There was no corresponding revenue recognized from a collaboration
−Removed: during the year ended December 31, 2023 and revenue of $ 0.9 million was recognized during the year ended December 31, 2022.
−Removed: The Company has a grant from
−Removed: a government-sponsored entity for research and development related activities that provides for payments for reimbursed costs, which includes
−Removed: overhead and general and administrative costs as well as an administrative fee.
−Removed: The Company recognized revenue from grants as it performed
−Removed: services under this arrangement.
−Removed: Associated expenses are recognized when incurred as research and development expense.
−Removed: Other revenue recognized
−Removed: from this grant during the years ended December 31, 2023 and December 31, 2022 was $ 0.1 million in each year.
−Removed: On April 7, 2022, the Company
−Removed: entered into a license and supply agreement (the “License Agreement”) with Immedica Pharma AB (“Immedica”), pursuant
−Removed: to which Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab) in the European Economic
−Removed: Area, Middle East and North Africa (EUMENA) including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon,
−Removed: Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates,
−Removed: the United Kingdom, the Vatican City and Yemen.
−Removed: Upon signing, the Company was entitled to an upfront payment of $ 35 million from Immedica,
−Removed: which was received in May 2022.
−Removed: Under the terms of the License Agreement, the Company is eligible to receive regulatory and commercial
−Removed: milestone payments and is entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that
−Removed: may result from the License Agreement.
−Removed: The Company will continue to be responsible for certain clinical development activities and the
−Removed: manufacturing of Iomab-B and will retain commercialization rights in the U.S.
−Removed: and rest of the world.
−Removed: The Company’s contract
−Removed: liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue deferred in its condensed
−Removed: consolidated balance sheets, depending on the short-term or long-term nature of the payments to be recognized.
−Removed: The Company’s contract
−Removed: liabilities primarily consist of advanced payments from licensees.
−Removed: Long-term license revenue deferred was $ 35.0 million at December 31,
−Removed: 2023 and December 31, 2022;
−Removed: this deferred revenue will be recognized upon European Union regulatory approval of Iomab B.
−Removed: Note 6 - Commitments and Contingencies
−Removed: On June 15, 2012, the
−Removed: Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”) to
−Removed: build upon previous and ongoing clinical trials with apamistamab (licensed antibody).
+Added: 5 - Other Revenue
+Added: Company has a grant from a government-sponsored entity for research and development related activities that provides for payments for
+Added: reimbursed costs, which includes overhead and general and administrative costs as well as an administrative fee.
+Added: The Company recognized
+Added: revenue from grants as it performed services under this arrangement.
+Added: Associated expenses are recognized when incurred as research and
+Added: development expense.
+Added: Other revenue recognized from this grant during the year ended December 31, 2023 was $ 0.1 million.
+Added: April 7, 2022, the Company entered into a license and supply agreement (the “License Agreement”) with Immedica Pharma AB
+Added: (“Immedica”), pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab)
+Added: in the European Economic Area, Middle East and North Africa (“EUMENA”), including Algeria, Andorra, Bahrain, Cyprus, Egypt,
+Added: Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria,
+Added: Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.
+Added: Upon signing, the Company was entitled to
+Added: an upfront, non-refundable payment of $ 35 million from Immedica, which was received in May 2022.
+Added: Under the terms of the License Agreement,
+Added: the Company is eligible to receive certain regulatory and commercial milestone payments and royalties on net sales of the product in
+Added: certain countries that may result from the License Agreement.
+Added: The Company continues to retain commercialization rights in the U.S.
+Added: rest of the world.
+Added: Company’s contract liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue
+Added: deferred in its condensed consolidated balance sheets, depending on the short-term or long-term nature of the payments to be recognized.
+Added: The Company’s contract liabilities primarily consist of advanced payments from licensees.
+Added: Long-term license revenue deferred was
+Added: $ 35.0 million at December 31, 2024 and December 31, 2023;
+Added: this deferred revenue will be recognized upon European Union’s regulatory
+Added: approval of Iomab-B or provision of definitive feedback that Iomab-B will not receive approval in the European Union.
+Added: 6 - Commitments and Contingencies
+Added: June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”)
+Added: 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.
−Removed: The Company has been granted exclusive rights to the antibody and related master cell bank
−Removed: developed by FHCRC.
−Removed: A milestone payment of $ 1 million will be due to FHCRC upon FDA approval of the first drug utilizing the
−Removed: licensed antibody.
+Added: The Company has been granted exclusive rights to the antibody and related master cell bank developed
+Added: 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.
−Removed: Note 7 - Equity
−Removed: In August 2020, the Company entered into the Capital on Demand™
−Removed: Sales Agreement with JonesTrading Institutional Services LLC, “JonesTrading”, pursuant to which the Company may sell, from
−Removed: time to time, through or to JonesTrading, up to an aggregate of $ 200 million of its common stock.
−Removed: On June 28, 2022, the Company entered
−Removed: into an Amended and Restated Capital on Demand™ Sales Agreement (the “A&R Sales Agreement”) with JonesTrading and
+Added: August 2020, the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, “JonesTrading”,
+Added: 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
+Added: On June 28, 2022, the Company entered into an Amended and Restated Capital on Demand™ Sales Agreement (the “A&R
+Added: Sales Agreement”) with JonesTrading and B.
Riley Securities, Inc.
−Removed: The A&R Sales Agreement modifies the original Capital on Demand™ Sales Agreement
−Removed: to include B.
+Added: The A&R Sales Agreement modifies
+Added: the original Capital on Demand™ Sales Agreement to include B.
Riley Securities as an additional sales agent thereunder.
−Removed: Shares of common stock are offered pursuant to a shelf registration
−Removed: statement on Form S-3 (File No.
−Removed: 333-242322) filed with the SEC on August 7, 2020 (the “Prior Shelf Registration Statement”).
−Removed: On August 11, 2023, the Company filed a new registration statement on Form S-3 (File No.
−Removed: 333-273911), and amended on February 2, 2024,
−Removed: which was declared effective on February 5, 2024, to replace the Prior Shelf Registration Statement, including a base prospectus which
−Removed: covers the offering, issuance and sale of up to $ 500 million of common stock, preferred stock, warrants, units and/or subscription rights;
−Removed: and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $ 200 million
−Removed: of common stock that may be issued and sold under the Amended Sales Agreement.
−Removed: During the year ended December
−Removed: 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
−Removed: During the year ended December 31, 2022, the Company sold 3.5 million shares of common stock, resulting in gross proceeds of
−Removed: $ 23.9 million and net proceeds of $ 23.2 million.
−Removed: The Company presently has one equity compensation
−Removed: plan, the 2019 Amended and Restated Stock Plan, (the “2019 Plan”).
−Removed: The 2019 Plan has an expiration date of October 18,
−Removed: 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
−Removed: The Company had two equity compensation plans that
−Removed: expired on September 9, 2023;
−Removed: the Company’s Amended and Restated 2013 Stock Plan and the Company’s 2013 Equity Incentive Plan.
−Removed: Stock Options
−Removed: Following is a summary of
−Removed: stock option activity for the years ended December 31, 2023 and 2022:
−Removed: (in thousands, except for per-share amount)
+Added: of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No.
+Added: 333-242322) filed with the SEC on August
+Added: 7, 2020 (the “Prior Shelf Registration Statement”).
+Added: On August 11, 2023, the Company filed a registration statement on Form
+Added: S-3 (File No.
+Added: 333-273911), which registration statement was amended on February 2, 2024, and declared effective on February 5, 2024,
+Added: to replace the Prior Shelf Registration Statement, including a base prospectus which covers the offering, issuance and sale of up to
+Added: $ 500 million of common stock, preferred stock, warrants, units and/or subscription rights;
+Added: and a sales agreement prospectus covering
+Added: 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
+Added: under the Amended Sales Agreement.
+Added: 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
+Added: net proceeds of $ 29.3 million.
+Added: During the year ended December 31, 2023, the Company sold 1.9 million shares of common stock, resulting
+Added: in gross proceeds of $ 15.1 million and net proceeds of $ 14.6 million.
+Added: Company presently has one equity compensation plan, the 2019 Amended and Restated Stock Plan, (the “2019 Plan”).
+Added: Plan has an expiration date of October 18, 2029 and the number of shares of our common stock authorized under the plan for grant
+Added: to employees, directors and consultants is 9,333,333 shares.
+Added: Company had two equity compensation plans that expired on September 9, 2023;
+Added: the Company’s Amended and Restated 2013 Stock Plan
+Added: and the Company’s 2013 Equity Incentive Plan.
+Added: is a summary of stock option activity for the years ended December 31, 2024 and 2023:
+Added: (in thousands, except for per-share amount) Number of
+Added: Options Weighted
+Added: Price ($) Weighted
+Added: (in years) Aggregate
Outstanding, January 1, 2023 3,396 8.00 8.85 15,204
+Added: Granted 2,402 5.28
+Added: Exercised ( 44 ) 5.92
+Added: Cancelled ( 309 ) 8.30
Outstanding, December 31, 2023 5,445 6.80 8.70 373
+Added: Granted 154 5.47
+Added: Exercised ( 10 ) 7.39
+Added: Cancelled ( 452 ) 10.04
Outstanding, December 31, 2024 5,137 6.48 7.04 -
Exercisable, December 31, 2024 2,555 10.63 7.84 -
−Removed: During 2023, the Company
−Removed: granted its employees and members of the Board of Directors options to purchase 2.4 million shares of common stock with an exercise
−Removed: 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.
−Removed: The options have an
−Removed: aggregated fair value of $ 9.0 million that was calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the
−Removed: Black-Scholes option-pricing model include:
−Removed: (1) discount rate range from 3.5 % to 4.82 % (2) expected life of 6 years, (3) expected
−Removed: volatility range from 79.0 % to 81.6 %, and (4) zero expected dividends.
−Removed: During 2022, the Company granted
−Removed: its employees and members of the Board of Directors options to purchase 2.1 million shares of common stock with an exercise price ranging
−Removed: from $ 4.96 to $ 13.54 per share, a term of 10 years, and a vesting period from 4 to 4.2 years.
−Removed: The options have an aggregated fair
−Removed: value of $ 7.7 million that was calculated using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing
−Removed: model include:
+Added: 2024, the Company granted newly hired employees options to purchase 0.2 million shares of common stock with an exercise price ranging
+Added: from $ 7.20 to $ 8.15 per share, a term of 10 years, and a vesting period of 4 years.
+Added: The options have an aggregated fair value of
+Added: $ 0.6 million that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used in the Black-Scholes option-pricing model
(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.
−Removed: During the years ended December
−Removed: 31, 2023 and 2022, options to purchase 309 thousand and 60 thousand common shares were cancelled, respectively, upon the termination of
−Removed: During 2023, 44 thousand options were exercised for shares of common stock.
−Removed: There were no exercises of options during 2022.
+Added: 2023, the Company granted its employees and members of the Board of Directors options to purchase 2.4 million shares of common stock
+Added: 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.
+Added: options have an aggregated fair value of $ 9.0 million that was calculated using the Black-Scholes option-pricing model.
+Added: Variables used
+Added: in the Black-Scholes option-pricing model include:
+Added: (1) discount rate range from 3.5 % to 4.82 % (2) expected life of 6 years, (3) expected
+Added: volatility range from 79.0 % to 81.6 %, and (4) zero expected dividends.
+Added: the years ended December 31, 2024 and 2023, options to purchase 0.5 million and 0.3 million common shares were cancelled, respectively,
+Added: upon the termination of employment.
The fair values of all options
3 unchanged sentences
and 2023, the Company recorded total option expense of $ 4.6 million and $ 3.2 million, respectively.
−Removed: Restricted Stock Units
−Removed: Following is a summary of
−Removed: restricted stock unit (“RSUs”) activity for the years ended December 31, 2023 and 2022:
+Added: 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)
3 unchanged sentences
Outstanding, December 31, 2024
−Removed: The RSUs vest at the earliest
−Removed: of a change of control event, the termination of the recipient’s continuous service status for any reason other than by the Company
−Removed: for cause and the third anniversary of the date of the grant.
−Removed: The fair value of the RSUs, $ 1.8 million, was determined based on the stock
−Removed: prices on the dates of the grants and each RSU grant is being recognized over its respective three-year period.
−Removed: The unrecognized compensation
−Removed: expense at December 31, 2023 of $ 1.0 million is expected to be expensed over a weighted average of 1.7 years.
−Removed: During 2023 and 2022, the
−Removed: Company recorded compensation expense related to RSUs of $ 0.6 million and $ 0.2 million, respectively.
−Removed: Following is a summary of
−Removed: warrant activities for the years ended December 31, 2023 and 2022:
−Removed: (in thousands, except for per-share amounts)
+Added: RSUs vest at the earliest of a change of control event, the termination of the recipient’s continuous service status for any reason
+Added: other than by the Company for cause and the third anniversary of the date of the grant.
+Added: The fair value of the RSUs, $ 1.8 million, was
+Added: determined based on the stock prices on the dates of the grants and each RSU grant is being recognized over its respective three-year
+Added: The unrecognized compensation expense at December 31, 2024 of $ 0.4 million is expected to be expensed over a weighted average
+Added: of 0.6 years.
+Added: During 2024 and 2023, the Company recorded compensation expense related to RSUs of $ 0.6 million and $ 0.6 million, respectively.
+Added: is a summary of warrant activities for the years ended December 31, 2024 and 2023:
+Added: (in thousands, except for per-share amounts) Number of
+Added: Warrants Weighted
+Added: Price Weighted
+Added: (in years) Aggregate
Outstanding, January 1, 2023 1,443 16.58 1.33 5
+Added: Granted 2 8.77 10.00
+Added: Expired ( 3 ) 106.80
Outstanding, December 31, 2023 1,442 16.42 0.34 -
+Added: Expired ( 1,435 ) 16.42
Outstanding, December 31, 2024 7 17.33 4.46 -
Exercisable, December 31, 2024 7 17.77 4.25 -
−Removed: On August 2, 2022, warrants
−Removed: to purchase an aggregate of 0.6 million shares of common stock expired.
−Removed: These warrants were issued on August 2, 2017, when the Company
−Removed: completed an underwritten offering of 0.7 million shares of common stock and warrants to purchase 0.6 million shares of common stock at
−Removed: a price of $ 22.50 per share and related warrant.
−Removed: The warrants were exercisable for a period of 5 years at an exercise price of $ 31.50
−Removed: During the years ended December
−Removed: 31, 2023 and 2022, the Company recorded stock-based compensation expense related to warrants of $ 6 thousand and $ 6 thousand, respectively.
−Removed: Note 8 - Income Taxes
−Removed: Deferred income taxes reflect
−Removed: the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and
−Removed: the amounts used for income tax purposes.
−Removed: Significant components of the Company’s deferred tax assets and liabilities at December
−Removed: 31, 2023 and 2022 are as follows:
+Added: April 23, 2024, warrants to purchase an aggregate of 1.4 million shares of common stock expired.
+Added: These warrants were issued on April
+Added: 23, 2019, when the Company completed an underwritten offering of 1.4 million shares of common stock and warrants to purchase 1.4 million
+Added: shares of common stock at a price of $ 11.55 per share and related warrant.
+Added: The warrants were exercisable for a period of 5 years at an
+Added: exercise price of $ 15.00 per share.
+Added: the years ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense related to warrants of $ 5 thousand
+Added: and $ 6 thousand, respectively.
+Added: 8 - Income Taxes
+Added: income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
+Added: reporting purposes and the amounts used for income tax purposes.
+Added: Significant components of the Company’s deferred tax assets and
+Added: liabilities at December 31, 2024 and 2023 are as follows:
(in thousands)
7 unchanged sentences
Deferred tax assets, net
−Removed: The Company has recorded a
−Removed: valuation allowance of $ 90.6 million and $ 76.1 million against its deferred tax assets at December 31, 2023 and 2022 respectively, because
−Removed: management determined that it is not more-likely-than not that those assets will be realized.
−Removed: For federal income tax purposes,
−Removed: the Company has $ 165.1 million of unused net operating losses (“NOLs”) at December 31, 2023 available for carry forward to
−Removed: future years.
−Removed: NOLs of $ 104.8 million generated prior to 2018 will begin to expire if unused beginning in 2024 when approximately $ 3.9
−Removed: million in NOLs are due to expire.
−Removed: Our largest NOLs will begin to expire in 2034 - 2037, with each year in excess of $ 15 million.
−Removed: generated in 2018 and later years of $ 60.3 million have an indefinite life, but will be limited to 80% of their value if used in a tax
−Removed: year ending after January 1, 2023.
−Removed: For state income tax purposes,
−Removed: the Company has $ 283.0 million of unused NOLs at December 31, 2023 available for carry forward to future years.
−Removed: These NOLs will begin
−Removed: to expire in 2034 if unused.
−Removed: The Company has federal research
−Removed: and development tax credits of $ 5.1 million at December 31, 2023 which will begin to expire in 2033 if unused and orphan drug credits
−Removed: of $ 15.4 million which will begin to expire in 2037 if unused.
−Removed: Federal and state tax laws
−Removed: impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership change for tax purposes,
−Removed: as defined in Section 382 of the Internal Revenue Code.
−Removed: Accordingly, the Company’s ability to utilize these carryforwards may be
−Removed: limited as a result of an ownership change which may have already happened or may happen in the future.
−Removed: Such an ownership change could
−Removed: 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.
−Removed: The Tax Cuts and Jobs Act
−Removed: of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021.
−Removed: Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize them over
−Removed: five years for U.S.
+Added: Company has recorded a valuation allowance of $ 101.6 million and $ 90.6 million against its deferred tax assets at December 31, 2024 and
+Added: 2023 respectively, because management determined that it is not more-likely-than not that those assets will be realized.
+Added: federal income tax purposes, the Company has $ 189.3 million of unused net operating losses (“NOLs”) at December 31, 2024
+Added: available for carry forward to future years.
+Added: NOLs of $ 104.8 million generated prior to 2018 will begin to expire if unused beginning
+Added: in 2026 when approximately $ 3.9 million in NOLs are due to expire.
+Added: The Company’s largest NOLs will begin to expire in 2034 - 2037,
+Added: with each year in excess of $ 15 million.
+Added: NOLs generated in 2018 and later years of $ 84.6 million have an indefinite life, but will be
+Added: limited to 80 % of their value if used in a tax year ending after January 1, 2023.
+Added: state income tax purposes, the Company has $ 327.8 million of unused NOLs at December 31, 2024 available for carry forward to future years.
+Added: These NOLs will begin to expire in 2035 if unused.
+Added: Company has federal research and development tax credits of $ 6.7 million at December 31, 2024, which will begin to expire in 2033 if
+Added: unused and orphan drug credits of $ 16.5 million which will begin to expire in 2037 if unused.
+Added: and state tax laws impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership
+Added: change for tax purposes, as defined in Section 382 of the Internal Revenue Code.
+Added: Accordingly, the Company’s ability to utilize
+Added: these carryforwards may be limited as a result of an ownership change which may have already happened or may happen in the future.
+Added: 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
+Added: net operating losses available.
+Added: Tax Cuts and Jobs Act of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning
+Added: after December 31, 2021.
+Added: Under the TCJA, the Company must now capitalize the expenditures related to research and development activities
+Added: and amortize them over five years for U.S.
activities and 15 years for non-U.S.
−Removed: Since this has been the Company's policy since 2018, the current
−Removed: year capitalization of research and development costs in accordance with IRC 174 was $ 36.9 million for a total accumulated gross amount
−Removed: of $ 79.6 million as of December 31, 2023.
+Added: Since this has been the Company's policy
+Added: since 2018, the current year capitalization of research and development costs in accordance with IRC 174 was $ 28.0 million for a total
+Added: accumulated gross amount of $ 87.9 million as of December 31, 2024.
difference between the income tax provision and the amount that would result if the U.S.
8 unchanged sentences
Provision for income tax
−Removed: Note 9 - Subsequent Event
−Removed: December 31, 2023, the Company has sold 1.8 million shares of common stock under its A&R Sales Agreement, resulting in net proceeds
−Removed: of $ 14.7 million.
−Removed: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
−Removed: ON ACCOUNTING AND FINANCIAL DISCLOSURE.
+Added: Note 9 - Subsequent Events
+Added: On March 27, 2025, a putative
+Added: class action complaint (the “Complaint”) was filed by alleged stockholder Nihil Kohil against the Company and executives Sandesh
+Added: Seth, Avinash Desai, Madhuri Vusirikala, and Sergio Giralt, styled Kohil v.
+Added: Actinium Pharmaceuticals, Inc., et al ., Case No.
+Added: 1:25-cv-02553 in the Southern District of New York, wherein, the Complaint alleges that the defendants made material misrepresentations
+Added: and omissions concerning the Iomab-B Phase 3 Sierra Trial and the plaintiff asserts claims against all defendants pursuant to section
+Added: 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, as well
+Added: as additional claims against the individual defendants pursuant to Section 20(a) of the Exchange Act.
+Added: The Complaint purports to
+Added: assert class action claims on behalf of all persons and entities that purchased or otherwise acquired Actinium securities between October
+Added: 31, 2022 and August 2, 2024.
+Added: Plaintiff seeks unspecified damages.
+Added: The defendants have not yet
+Added: responded to the complaint, and they intend to vigorously defend themselves against the plaintiff’s allegations, however, there
+Added: can be no assurances as to the outcome.
+Added: On March 31, 2025, our Board
+Added: of Directors of approved the cancellation of certain stock options to purchase 5,149,944 shares of common stock held by certain current
+Added: employees and directors that were initially granted under the Company’s Amended and Restated 2013 Stock Plan and 2019 Amended and
+Added: Restated Stock Plan.
+Added: FSuSuch cancellation is subject to the consent of the applicable holder of the stock options, which the Company is
+Added: expecting to receive shortly following the filing of this Annual Report on Form 10-K.
+Added: Our Compensation Committee intends to conduct an
+Added: analysis of our equity compensation plan and develop an equity compensation strategy that satisfies the purpose of the 2019 Plan to attract
+Added: and retain the best available personnel who can make meaningful contributions towards achieving the business objectives of the Company.
+Added: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.