Financial Statements and Supplementary
−Removed: INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: AUDITED FINANCIAL STATEMENTS:
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 688 ) F-2
−Removed: CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2024 AND 2023 F-3
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 F-4
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 F-5
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 F-6
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-7
−Removed: Report of Independent Registered Public Accounting Firm
−Removed: To the Stockholders and Board of Directors of
−Removed: INmune Bio Inc.
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated
−Removed: balance sheets of INmune Bio Inc.
−Removed: (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements
−Removed: of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended
−Removed: December 31, 2024, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial
−Removed: statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023., and the
−Removed: 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
−Removed: principles generally accepted in the United States of America .
−Removed: Explanatory Paragraph – Going Concern
−Removed: The accompanying financial statements have been
−Removed: prepared assuming that the Company will continue as a going concern.
−Removed: As more fully described in Note 2, the Company has incurred significant
−Removed: losses and negative cash flows from its operating activities and is projecting insufficient liquidity to meet its obligations and sustain
−Removed: its operations.
−Removed: These conditions raise substantial doubt about the Company's ability to continue as a going concern.
−Removed: Management's plans
−Removed: in regard to these matters are also described in Note 2.
−Removed: The financial statements do not include any adjustments that might result from
−Removed: the outcome of this uncertainty.
−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 audits.
−Removed: are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
−Removed: required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and
−Removed: 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 audit 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 internal
−Removed: control over financial reporting.
−Removed: 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.
−Removed: We determined that there are no critical audit matters.
−Removed: /s/ Marcum LLP
−Removed: We have served as the Company’s auditor since 2017.
−Removed: Houston, Texas
−Removed: March 27, 2025
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED BALANCE SHEETS
−Removed: (In thousands, except share and per share amounts)
−Removed: CURRENT ASSETS
−Removed: Cash and cash equivalents
−Removed: Research and development tax credit receivable
−Removed: Other tax receivable
−Removed: Prepaid expenses and other current assets
−Removed: Prepaid expenses – related party
−Removed: TOTAL CURRENT ASSETS
−Removed: Operating lease – right of use asset
−Removed: Acquired in-process research and development intangible assets
−Removed: LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY
−Removed: CURRENT LIABILITIES
−Removed: Accounts payable and accrued liabilities
−Removed: Accounts payable and accrued liabilities – related parties
−Removed: Deferred liabilities
−Removed: Current portion of long-term debt, net
−Removed: Operating lease, current liability
−Removed: TOTAL CURRENT LIABILITIES
−Removed: Long-term operating lease liability
−Removed: TOTAL LIABILITIES
−Removed: COMMITMENTS AND CONTINGENCIES
−Removed: Redeemable common stock, $ 0.001 par value;
−Removed: 0 and 75,697 shares issued and outstanding, respectively (Note 9)
−Removed: STOCKHOLDERS’ EQUITY
−Removed: Preferred stock, $ 0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding
−Removed: Common stock, $ 0.001 par value, 200,000,000 shares authorized, 22,280,451 and 17,950,776 shares issued and outstanding, respectively
−Removed: Additional paid-in capital
−Removed: Accumulated other comprehensive loss
−Removed: Accumulated deficit
−Removed: TOTAL STOCKHOLDERS’ EQUITY
−Removed: TOTAL LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS’ EQUITY
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: thousands, except share and per share amounts)
−Removed: OPERATING EXPENSES
−Removed: General and administrative
−Removed: Research and development
−Removed: Total operating expenses
−Removed: LOSS FROM OPERATIONS
−Removed: OTHER INCOME (EXPENSE), NET
−Removed: Other income (expense), net
−Removed: Total other income (expense), net
−Removed: Net loss per common share – basic and diluted
−Removed: Weighted average number of common shares outstanding – basic and diluted
−Removed: COMPREHENSIVE LOSS
−Removed: Other comprehensive income (loss) – foreign currency translation
−Removed: Total comprehensive loss
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: (In thousands, except share amounts)
−Removed: Comprehensive
−Removed: Stockholders’
−Removed: Income (loss)
−Removed: Balance as of January 1, 2023
−Removed: Issuance of common stock for cash, net
−Removed: Reclassification to redeemable common stock
−Removed: Cashless exercise of warrants
−Removed: Stock-based compensation
−Removed: Loss on foreign currency translation
−Removed: Balance as of December 31, 2023
−Removed: Common stock issued for cash
−Removed: Common stock and warrants issued for cash
−Removed: Reclassification from redeemable common stock
−Removed: Exercise of warrants for cash
−Removed: Stock-based compensation
−Removed: Gain on foreign currency translation
−Removed: Balance as of December 31, 2024
−Removed: $ ( 163,104 )
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: (In thousands)
−Removed: CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Stock-based compensation
−Removed: Accretion of debt discount
−Removed: Changes in operating assets and liabilities:
−Removed: Research and development tax credit receivable
−Removed: Other tax receivable
−Removed: Prepaid expenses and other current assets
−Removed: Prepaid expenses – related party
−Removed: Accounts payable and accrued liabilities
−Removed: Accounts payable and accrued liabilities – related parties
−Removed: Deferred liabilities
−Removed: Accrued liability – long-term
−Removed: Operating lease liability
−Removed: Net cash used in operating activities
−Removed: CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Net proceeds from sale of common stock and warrants
−Removed: Repayment of debt
−Removed: Net proceeds from the exercise of stock options
−Removed: Net cash provided by (used in) financing activities
−Removed: Impact on cash from foreign currency translation
−Removed: NET DECREASE IN CASH
−Removed: CASH AT BEGINNING OF YEAR
−Removed: CASH AT END OF YEAR
−Removed: SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
−Removed: Cash paid for income taxes
−Removed: Cash paid for interest expense
−Removed: See accompanying notes to these consolidated financial
−Removed: INMUNE BIO INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: NOTE 1 – ORGANIZATION AND BASIS
−Removed: OF PRESENTATION
−Removed: Organization and Business Overview
−Removed: INmune Bio Inc.
−Removed: (the “Company” or
−Removed: “INmune Bio”) was organized in the State of Nevada on September 25, 2015 and is a clinical stage biotechnology pharmaceutical
−Removed: company focused on developing and commercializing its product candidates to treat diseases where the innate immune system is not functioning
−Removed: normally and contributing to the patient’s disease.
−Removed: INmune Bio has three product platforms.
−Removed: The DN-TNF product platform utilizes
−Removed: dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of
−Removed: many diseases.
−Removed: DN-TNF is currently being developed for Alzheimer’s and treatment resistant depression (“XPro”) and cancer
−Removed: (“INB03”) and an out-licensing strategy.
−Removed: The CORDStrom product platform is a pooled, human umbilical cord mesenchymal stem
−Removed: cell product currently being developed to treat recessive dystrophic epidermolysis bullosa (“RDEB”).
−Removed: The Natural Killer Cell
−Removed: Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with
−Removed: INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic
−Removed: malignancies, solid tumors and chronic inflammation.
−Removed: Basis of Presentation and Principles of
−Removed: Consolidation
−Removed: The accompanying consolidated financial statements
−Removed: of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States
−Removed: of America and the rules of the Securities and Exchange Commission (“SEC”).
−Removed: The consolidated financial statements herein have been prepared in accordance
−Removed: with US GAAP and include the accounts of INmune Bio, its wholly-owned United Kingdom subsidiary, and its wholly-owned Australia subsidiary
−Removed: (collectively, the “Company”).
−Removed: All significant intercompany accounts and transactions have been eliminated.
−Removed: NOTE 2 – GOING CONCERN
−Removed: These consolidated financial statements have been
−Removed: prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization
−Removed: of assets and the satisfaction of liabilities in the normal course of business.
−Removed: The Company has incurred significant losses and
−Removed: negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant
−Removed: revenue from the commercialization of its product candidates.
−Removed: The Company had net losses of approximately $ 42.1 million and $ 30.0 million
−Removed: and negative cash flows from operating activities of approximately $ 33.4 million and $ 12.0 million for the years ended December 31, 2024
−Removed: and 2023, respectively, and an accumulated deficit of approximately $ 163.1 million and $ 121.0 million as of December 31, 2024 and 2023,
−Removed: respectively.
−Removed: Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting
−Removed: insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued.
−Removed: These conditions
−Removed: and events raise substantial doubt about the Company’s ability to continue as a going concern for the twelve months following the
−Removed: issuance of these financial statements.
−Removed: In response to these conditions, management is
−Removed: currently evaluating different strategies to obtain the required funding of future operations.
−Removed: Financing strategies may include, but are
−Removed: not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding,
−Removed: collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties.
−Removed: There can be no assurances
−Removed: that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable
−Removed: Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation
−Removed: of such plans cannot be considered probable.
−Removed: As a result, the Company has concluded that management’s plans do not alleviate substantial
−Removed: doubt about the Company’s ability to continue as a going concern.
−Removed: The consolidated financial statements do not include
−Removed: any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities
−Removed: that might result from the outcome of this uncertainty.
−Removed: NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: Use of Estimates
−Removed: Preparing financial statements in conformity with
−Removed: US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses.
−Removed: Actual results and outcomes may differ from management’s estimates and assumptions.
−Removed: Fair Value of Financial Instruments
−Removed: The Company measures certain assets and liabilities
−Removed: in accordance with authoritative guidance which requires fair value measurements to be classified and disclosed in one of the following
−Removed: three categories:
−Removed: Quoted prices (unadjusted)
−Removed: in active markets that are accessible at the measurement date for assets or liabilities.
−Removed: Observable prices that
−Removed: are based on inputs not quoted on active markets but corroborated by market data.
−Removed: Unobservable inputs are
−Removed: used when little or no market data is available.
−Removed: Assets and liabilities are classified based on
−Removed: the lowest level of input that is significant to the fair value measurements.
−Removed: The Company reviews the fair value hierarchy classification
−Removed: on a quarterly basis.
−Removed: Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets
−Removed: or liabilities within the fair value hierarchy.
−Removed: The Company did not have any transfers of assets and liabilities between the levels of
−Removed: the fair value measurement hierarchy during the years presented.
−Removed: The carrying amounts of financial instruments
−Removed: such as cash and cash equivalents, research and development tax credit receivable, other receivable, prepaid expenses, and accounts payable
−Removed: and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments.
−Removed: Risks and Uncertainties
−Removed: is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development
−Removed: by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government
−Removed: regulations and the need to obtain additional financing to fund operations.
−Removed: Product candidates currently under development will require
−Removed: significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval
−Removed: prior to commercialization.
−Removed: These efforts require significant amounts of additional resources, adequate personnel, infrastructure and
−Removed: extensive compliance and reporting.
−Removed: The Company’s
−Removed: product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale.
−Removed: be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s
−Removed: intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval
−Removed: or that any approved products will be commercially viable.
−Removed: Even if the Company’s product development efforts are successful, it
−Removed: is uncertain when, if ever, the Company will generate any revenue from any of its products.
−Removed: The Company operates in an environment of
−Removed: rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies.
−Removed: relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the clinical
−Removed: trial programs.
−Removed: These programs could be adversely affected by a significant interruption in these manufacturing services.
−Removed: Cash and Cash Equivalents
−Removed: The Company considers all highly liquid instruments
−Removed: purchased with an original maturity of three months or less to be cash equivalents.
−Removed: The Company holds cash in banks in excess of Federal
−Removed: Deposit Insurance Corporation insurance limits.
−Removed: However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated
−Removed: financial institutions.
−Removed: Research and Development Tax Incentive Receivable
−Removed: The Company, through its wholly-owned subsidiary
−Removed: in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying
−Removed: research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of
−Removed: research and development expense.
−Removed: The Australian research and development tax incentive is recognized when there is reasonable assurance
−Removed: that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured.
−Removed: At each period end, management estimates the reimbursement available to the Company based on available information at the time.
−Removed: The Company, through its wholly-owned subsidiary
−Removed: in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that
−Removed: a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives
−Removed: are reflected as a reduction of research and development expense.
−Removed: The United Kingdom research and development tax incentive is recognized
−Removed: when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the
−Removed: consideration can be reliably measured.
−Removed: At each period end, management estimates the reimbursement available to the Company based on available
−Removed: information at the time.
−Removed: Intangible Assets
−Removed: The Company capitalizes costs incurred in connection
−Removed: with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under
−Removed: applicable license agreements;
−Removed: patent applications (principally legal fees), patent purchases, and trademarks related to its cell line
−Removed: as intangible assets.
−Removed: Acquired in-process research and development costs that do not have alternative uses are expensed as incurred.
−Removed: the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its
−Removed: DN-TNF platform), the useful life will be determined, and the in-process research and development intangible assets will be amortized.
−Removed: During the fourth quarter and if business factors
−Removed: indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research
−Removed: and development.
−Removed: If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed.
−Removed: The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount.
−Removed: If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount
−Removed: equal to that excess.
−Removed: During the years ended December 31, 2024 and 2023, the Company performed a qualitative assessment of its in-process
−Removed: research and development and determined that there were no indicators of impairment.
−Removed: Basic and Diluted Loss per Share
−Removed: Basic loss per share is computed by dividing net
−Removed: loss available to common shareholders by the weighted average number of outstanding common shares during the period.
−Removed: Diluted loss per
−Removed: share gives effect to all dilutive potential common shares outstanding during the period.
−Removed: Dilutive loss per share excludes all potential
−Removed: common shares if their effect is anti-dilutive.
−Removed: For all periods presented, there is no difference in the number of shares used to calculate
−Removed: basic and diluted shares outstanding due to the Company’s net loss position.
−Removed: At December 31, 2024, the Company had 7,203,307 potentially issuable shares
−Removed: of common stock upon the exercise of stock options and 3,944,238 potentially issuable shares of common stock upon the exercise of warrants.
−Removed: At December 31, 2023, the Company had 5,496,000
−Removed: potentially issuable shares of common stock upon the exercise of stock options and 45,386 potentially issuable shares of common stock
−Removed: upon the exercise of warrants.
−Removed: Revenue Recognition
−Removed: The Company recognizes revenue when the customer
−Removed: obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange
−Removed: for those goods or services.
−Removed: The Company recognizes revenue following the five-step model prescribed under ASC Topic 606:
−Removed: contract(s) with a customer;
−Removed: (2) identify the performance obligations in the contract;
−Removed: (3) determine the transaction price;
−Removed: the transaction price to the performance obligations in the contract;
−Removed: and (5) recognize revenues when (or as) the Company satisfies the
−Removed: performance obligations.
−Removed: The Company records the expenses related to revenue in research and development expense, in the periods such
−Removed: expenses were incurred.
−Removed: The Company records deferred revenues when cash
−Removed: payments are received or due in advance of performance, including amounts which are refundable.
−Removed: The Company’s 2024 and 2023 revenue was
−Removed: from the sale of mesenchymal stromal cells to one customer in the United Kingdom and was recognized when the MSC’s were delivered
−Removed: to the customer.
−Removed: Stock-Based Compensation
−Removed: The Company utilizes the Black-Scholes option
−Removed: pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions,
−Removed: including expected volatility and expected life.
−Removed: Changes in these inputs and assumptions can materially affect the measure of estimated
−Removed: fair value of our share-based compensation.
−Removed: These assumptions are subjective and generally require significant analysis and judgment to
−Removed: When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions
−Removed: may be derived from our historical experience with stock-based payment arrangements.
−Removed: The appropriate weight to place on historical experience
−Removed: is a matter of judgment, based on relevant facts and circumstances.
−Removed: The Company accounts for forfeitures of stock options as they occur.
−Removed: Research and Development
−Removed: Research and development (“R&D”)
−Removed: costs are expensed as incurred.
−Removed: Research and development credits are recorded by the Company as a reduction of research and development
−Removed: Major components of research and development costs include cash compensation, stock-based compensation, clinical trials and related
−Removed: clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, costs of pre-clinical
−Removed: trials, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development
−Removed: activities on the Company’s behalf.
−Removed: The Company recognizes grants as contra research
−Removed: and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes
−Removed: as expenses the related costs for which the grants are intended to compensate.
−Removed: The Company follows the liability method of accounting
−Removed: for income taxes.
−Removed: Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable
−Removed: to differences between the financial statement carrying values and their respective income tax basis (temporary differences).
−Removed: on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
−Removed: Foreign Currency Translation
−Removed: The Company’s financial statements are presented
−Removed: dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S.
−Removed: based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”)
−Removed: for its Australian-based operations.
−Removed: All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’
−Removed: equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the
−Removed: The resulting translation adjustments are reported under other comprehensive income.
−Removed: Gains and losses resulting from the translations
−Removed: of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss.
−Removed: Recent Accounting Pronouncements
−Removed: In November 2023, the FASB issued ASU 2023-07,
−Removed: Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which enhances
−Removed: the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements, including those
−Removed: companies with a single operating segment.
−Removed: ASU 2023-07 is effective retrospectively for fiscal years beginning after December 15, 2023
−Removed: and for interim periods within fiscal years beginning after December 15, 2024.
−Removed: The Company adopted ASU 2023-07 for the year ended December
−Removed: See Note 13 for segment disclosures.
−Removed: In December 2023, the FASB issued ASU 2023-09, Income
−Removed: Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures (“ASU 2023-09”).
−Removed: The guidance in ASU 2023-09 improves the
−Removed: transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated
−Removed: by jurisdiction.
−Removed: The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption
−Removed: The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements.
−Removed: In November 2024, the FASB issued ASU 2024-03,
−Removed: Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40):
−Removed: Disaggregation of Income
−Removed: Statement Expenses (“ASU 2024-03”).
−Removed: ASU 2024-03 requires additional disclosure of specific types of expenses included
−Removed: in the expense captions presented on the face of the income statement as well as disclosures about selling expenses.
−Removed: ASU 2024-03 is effective
−Removed: for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted.
−Removed: ASU 2024-03 may be applied prospectively with the option for retrospective application for all prior periods presented.
−Removed: The Company is
−Removed: currently evaluating the impact of adopting this guidance on the Company’s current financial position, results of operations or financial
−Removed: statement disclosures.
−Removed: Subsequent Events
−Removed: The Company has evaluated all transactions through
−Removed: the financial statement issuance date for subsequent disclosure consideration.
−Removed: NOTE 4 – RESEARCH AND DEVELOPMENT
−Removed: According to UK tax law, the Company is allowed
−Removed: an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements.
−Removed: The Company’s UK subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
−Removed: 31, 2024 and 2023, the Company had a research and development tax credit receivable of $ 0 for R&D expenses incurred in the UK.
−Removed: the years ended December 31, 2024 and 2023, the Company received $ 0 and $ 2,710,000 of R&D tax credit reimbursements, respectively,
−Removed: According to AUS tax law, the Company is allowed
−Removed: an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements.
−Removed: The Company’s Australian subsidiary submits R&D tax credit requests annually for research and development expenses incurred.
−Removed: At December 31, 2024 and 2023, the Company had a research and development tax credit receivable of $ 1,181,000 and $ 1,905,000 , respectively,
−Removed: for R&D expenses incurred in Australia.
−Removed: During the years ended December 31, 2024 and 2023, the Company received $ 2,475,000 and $ 6,557,000
−Removed: of R&D tax credit reimbursements, respectively, from Australia.
−Removed: License Agreement
−Removed: 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc.
−Removed: which discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor.
−Removed: On June 10, 2021, the Company
−Removed: and Xencor entered into a First Amendment to License Agreement pursuant to which, among other things, Section 3.2 of the Xencor License
−Removed: Agreement was amended to change the due diligence milestones.
−Removed: Pursuant to the Xencor License Agreement, Xencor granted the Company an
−Removed: exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license
−Removed: agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s
−Removed: proprietary protein known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants
−Removed: of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients,
−Removed: in any dosage or formulation (“Licensed Products”).
−Removed: The Company believes the protein has numerous medical applications.
−Removed: additional alternative applications of the technology are available under the Xencor License Agreement.
−Removed: also agreed to pay Xencor a 5 % royalty on Net Sales of all Licensed Products in a given
−Removed: calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later
−Removed: of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the
−Removed: first sale to a third party of the licensed product in such country.
−Removed: INKmune License Agreement
−Removed: On October 29, 2015, the Company entered into
−Removed: an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”).
−Removed: Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate
−Removed: any improvements or additions to the patents that may be developed in the future.
−Removed: In consideration for the patent rights, the Company
−Removed: agreed to the following milestone payments:
−Removed: (in thousands)
−Removed: Each Phase I initiation
−Removed: Each Phase II initiation
−Removed: Each Phase III initiation
−Removed: Each NDA/EMA filing
−Removed: Each NDA/EMA awarded
−Removed: In addition, the Company agreed to pay the licensor
−Removed: a royalty of 1 % of net sales during the life of each patent granted to the Company.
−Removed: The License is owned by Immune Ventures.
−Removed: the Company’s President and a member of our Board of Directors, David Moss, its Chief Financial Officer and Treasurer and Mark Lowdell,
−Removed: its Chief Scientific Officer, are the owners of Immune Ventures.
−Removed: No sales have occurred under this license.
−Removed: During December 2023, the
−Removed: Company initiated a Phase I trial with INKmune in patients with metastatic castration-resistant prostate cancer and has recorded a $ 25,000
−Removed: payable to Immune Ventures as of December 31, 2024.
−Removed: The term of the agreement began on October 29,
−Removed: 2015 and ends on a country-by-country basis on the date of the expiration of the last to expire patent rights where patent rights exists,
−Removed: unless terminated earlier in accordance with the agreement.
−Removed: Upon the termination of the agreement, we shall have a fully paid up, perpetual,
−Removed: royalty-free license without further obligation to Immune Ventures.
−Removed: The agreement can be terminated by Immune Ventures if, after 60 days
−Removed: from the Company’s receipt of notice that the Company has not made a payment under the agreement, and the Company still does not
−Removed: make this payment.
−Removed: On July 20, 2018 and October 30, 2020, the parties amended the agreement under which the Company was required
−Removed: achieve milestones pursuant to the agreement.
−Removed: On April 17, 2023, the parties executed an additional
−Removed: amendment to the agreement under which the Company removed the due diligence requirements to achieve reasonable commercial efforts to
−Removed: bring INKmune to market.
−Removed: This removed all requirements of clinical trial timelines and the filing timelines of an NDA or equivalent.
−Removed: other provisions in the INKmune License Agreement shall continue in full force and effect.
−Removed: University of Pittsburg License Agreement
−Removed: On October 3, 2017, the Company entered into an
−Removed: Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh.
−Removed: Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights,
−Removed: obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System
−Removed: of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).
−Removed: Consideration under the PITT Agreement includes:
−Removed: maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments.
−Removed: Annual maintenance fees under the PITT Agreement
−Removed: include $ 25,000 due on June 26, 2025 and thereafter until first commercial sale.
−Removed: The Company had no amounts owed pursuant to the PITT
−Removed: Agreement as of December 31, 2024.
−Removed: Upon first commercial sale of a product making
−Removed: use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5 % of Net Sales each calendar
−Removed: As of December 31, 2024, there have been no commercial sales of product making use of the licensed technology under the PITT
−Removed: Moreover, under the PITT Agreement the Licensee
−Removed: is required to make milestone payments as follows:
−Removed: (in thousands)
−Removed: Each Phase I initiation
−Removed: Each Phase III initiation
−Removed: First commercial sale of product making use of licensed technology
−Removed: The PITT Agreement expires upon the earlier of:
−Removed: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement;
−Removed: or (ii) the date that is 20 years
−Removed: from the effective date of the agreement (June 26, 2037).
−Removed: The Licensee may terminate the PITT Agreement
−Removed: upon 3 months prior written notice provided all payments under the license are current.
−Removed: The Licensor may terminate the PITT Agreement
−Removed: upon written notice if:
−Removed: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after
−Removed: receiving written notice;
−Removed: or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to
−Removed: the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
−Removed: NOTE 5 – FAIR VALUE MEASUREMENTS
−Removed: The following table presents the hierarchy
−Removed: for assets and liabilities measured at fair value on a recurring basis:
−Removed: (in thousands)
−Removed: December 31, 2024:
−Removed: Cash equivalents
−Removed: Treasury bills
−Removed: Money market funds
−Removed: Total cash equivalents
−Removed: (in thousands)
−Removed: December 31, 2023:
−Removed: Cash equivalents
−Removed: Money market fund
−Removed: Total cash equivalents
−Removed: NOTE 6 – LEASE
−Removed: In September 2021, the Company signed a lease with a third party for
−Removed: office space in Boca Raton, Florida.
−Removed: The lease agreement has a 64-month term and commenced during the fourth quarter of 2021.
−Removed: Below is a summary of the Company’s right-of-use
−Removed: assets and liabilities:
−Removed: (in thousands, except years and rate) December 31,
−Removed: 2024 December 31,
−Removed: Right-of-use asset $ 307 $ 414
−Removed: Operating lease, current liability 140 119
−Removed: Long-term operating lease liability 244 397
−Removed: Total lease liability $ 384 $ 516
−Removed: Weighted-average remaining lease term 2.3 years 3.3 years
−Removed: Weighted-average discount rate 12.0 % 12.0 %
−Removed: NOTE 7 – RELATED PARTY TRANSACTIONS
−Removed: At December 31, 2024 and 2023,
−Removed: the Company recorded $ 0 and $ 112,000 , respectively, of prepaid expenses – related party for payments made to UCL in advance
−Removed: of medical research to be provided.
−Removed: During the years ended December 31, 2024 and 2023, the Company paid UCL $ 321,000 and $ 573,000 ,
−Removed: respectively.
−Removed: UCL is a wholly owned subsidiary of the University of London.
−Removed: The Company’s Chief Scientific and Manufacturing Officer
−Removed: is a professor at the University of London.
−Removed: years ended December 31, 2024 and 2023, the Company paid AmplifyBio $ 384,000 and $ 77,000 , respectively, to perform certain research and
−Removed: development on behalf of the Company.
−Removed: The CEO of AmplifyBio is on the Board of Directors of the Company.
−Removed: During 2021, the Company entered
−Removed: into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together
−Removed: (the “Lenders”) in which the Company borrowed $ 15 million.
−Removed: The Term Loan was secured by the Company’s assets.
−Removed: December 2024, the Company paid off the Term Loan in full.
−Removed: During February 2025, the Company entered into a letter agreement with the
−Removed: Lenders whereby the Term Loan was terminated.
−Removed: years ended December 31, 2024 and 2023, the Company recognized interest expense of $ 789,000 and $ 2,278,000 , respectively, related to the
−Removed: NOTE 9 – STOCKHOLDERS’ EQUITY
−Removed: Registered Direct Offerings
−Removed: During September 2024, the Company entered into
−Removed: securities purchase agreements with investors whereby the Company sold 2,341,260 shares of the Company’s common stock
−Removed: and warrants to purchase an additional 2,341,260 shares of the Company’s common stock exercisable six months from the
−Removed: issuance date in a registered direct offering in exchange for gross proceeds of $ 13.0 million (net proceeds of approximately $ 12.0 million).
−Removed: Directors and
−Removed: officers that participated in the offering paid a combined offering price of $ 6.50 per share and warrant, and other investors paid
−Removed: $ 5.50 per share and warrant.
−Removed: The exercise price of the warrants is $ 6.40 , and are exercisable beginning on March 16, 2025 and
−Removed: will terminate on March 16, 2030 unless accelerated pursuant to the terms of the warrant agreements.
−Removed: The Company determined the warrants
−Removed: were equity classified.
−Removed: The fair value of the warrants was approximately $ 9.1 million and was calculated using the Black-Scholes
−Removed: option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 3.41 % based on the applicable
−Removed: US Treasury bill rate (2) expected life of 5.5 years, (3) expected volatility of approximately 92 % based on the trading
−Removed: history of the Company, and (4) zero expected dividends.
−Removed: During April 2024, the Company entered into a
−Removed: securities purchase agreement with an investor whereby the Company sold 986,000 shares of the Company’s common stock and
−Removed: warrants to purchase an additional 986,000 shares of the Company’s common stock in a registered direct offering in exchange
−Removed: for gross proceeds of approximately $ 9.7 million (net proceeds of approximately $ 8.9 million).
−Removed: The exercise price of the warrants
−Removed: is $ 9.84 and the term of the warrants is the earlier of (1) April 29, 2026 or (2) thirty trading days following the reporting of
−Removed: positive top line data in the Phase 2 Alzheimer’s program of XPro1595.
−Removed: The Company determined that the warrants were equity
−Removed: The fair value of the warrants was approximately $ 5.8 million and was calculated using the Black-Scholes option-pricing
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 4.97 % based on the applicable US Treasury
−Removed: bill rate (2) expected life of 2.0 years, (3) expected volatility of approximately 77 % based on the trading history of
−Removed: the Company, and (4) zero expected dividends.
−Removed: During April 2024, the Company entered into securities
−Removed: purchase agreements with investors whereby the Company sold 571,592 shares of the Company’s common stock and warrants
−Removed: to purchase an additional 571,592 shares of the Company’s common stock in a registered direct offering in exchange for
−Removed: gross proceeds of approximately $ 4.8 million (net proceeds of approximately $ 4.5 million).
−Removed: Directors and
−Removed: officers that participated in the offering paid a combined offering price of $ 8.445 per share and warrant, and other investors paid
−Removed: $ 8.32 per share and warrant.
−Removed: The exercise price of the warrants is $ 9.152 , and the term is the earlier of two years from the issuance
−Removed: of the warrants and thirty trading days following the release of top line data in the Phase 2 Alzheimer’s program, provided that
−Removed: directors and officers of the Company that are subject to a blackout with respect to trading in the Company’s stock will have an
−Removed: additional 60 days from the termination of the blackout date to exercise the warrant.
−Removed: The Company determined the warrants were equity
−Removed: The fair value of the warrants was approximately $ 3.0 million and was calculated using the Black-Scholes option-pricing
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 4.89 % based on the applicable US Treasury
−Removed: bill rate (2) expected life of 2.0 years, (3) expected volatility of approximately 78 % based on the trading history of
−Removed: similar companies, and (4) zero expected dividends.
−Removed: Common Stock – At the Market Offering
−Removed: During March 2021, the Company entered into a
−Removed: sales agreement (“Sales Agreement”) with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”)
−Removed: offering program of up to $ 45 million of common stock, which the Company amended in August 2023.
−Removed: The Company was required to pay
−Removed: BTIG a commission of 3 % of the gross proceeds from the sale of shares.
−Removed: During the year ended December 31, 2024, the Company issued
−Removed: and sold 198,364 shares of common stock at an average price of $ 10.56 per share under the ATM program.
−Removed: The aggregate net
−Removed: proceeds were approximately $ 2.0 million after BTIG’s commission expenses.
−Removed: During August 2024, the Company entered into an
−Removed: amended and restated at-the-market sales agreement with RBC Capital Markets LLC and BTIG (together, the “Sales Agents”) relating
−Removed: to the offer and sale of shares of our common stock with an aggregate offering price of up to $ 75.0 million.
−Removed: This amended and restated
−Removed: at-the-market sales agreement replaced the Sales Agreement entered into with BTIG in March 2021, as amended in August 2023.
−Removed: is required to pay the Sales Agents a commission of 3 % of the gross proceeds from the sale of shares.
−Removed: the year ended December 31, 2024, the Company issued and sold 48,762 shares of common stock at an average price of $ 6.96 per
−Removed: share under the ATM program.
−Removed: The aggregate net proceeds were approximately $ 0.3 million after commission expenses.
−Removed: At December 31,
−Removed: 2024, the Company had $ 74.7 million of common stock available under the amended and restated at-the-market agreement.
−Removed: July 2023, the Company sold 75,697 shares of its common stock at an average price of $ 10.56 per share under the ATM program.
−Removed: The aggregate net proceeds were approximately $ 775,000 after offering expenses.
−Removed: These shares were inadvertently sold under a registration
−Removed: statement filed with the SEC that had in fact expired prior to the time the shares were sold.
−Removed: As of December 31, 2023, the
−Removed: Company reclassified 75,697 shares, with an aggregate purchase price of $ 799,000 of its common stock as temporary equity
−Removed: presented outside stockholders’ equity as a result of potential rescission rights.
−Removed: There have been no claims or demands to
−Removed: exercise such rights.
−Removed: As of December 31, 2024, the rescission rights for these shares have lapsed and the shares were reclassified
−Removed: to permanent equity.
−Removed: Stock options
−Removed: On June 1, 2023, the Company’s shareholders
−Removed: approved an amendment to the 2021 Incentive Stock Plan (“2021 Amended and Restated Incentive Stock Plan”) to increase the
−Removed: shares of the Company’s common stock available for issuance thereunder to 4,000,000 shares.
−Removed: the Company granted certain employees and directors options to purchase 1,964,307 shares of its common stock pursuant to the
−Removed: 2021 Incentive Stock Plan.
−Removed: The stock options had a fair value of approximately $ 11.6 million that was calculated using the Black-Scholes
−Removed: option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 3.90 % - 4.46 % based
−Removed: on the applicable US Treasury bill rate (2) expected life of 5.5 – 10.0 years, (3) expected volatility of approximately 100 %
−Removed: - 106 % based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: During 2023, the Company granted certain employees
−Removed: and directors options to purchase 665,000 shares of its common stock pursuant to the 2017 and 2019 Incentive Stock Plans and
−Removed: 2021 Amended and Restated Incentive Stock Plan.
−Removed: The stock options had a fair value of approximately $ 4.9 million that was calculated
−Removed: using the Black-Scholes option-pricing model.
−Removed: Variables used in the Black-Scholes option-pricing model include:
−Removed: (1) discount rate of 3.84 %
−Removed: – 3.99 % based on the applicable US Treasury bill rate (2) expected life of 6.0 – 6.25 years, (3)
−Removed: expected volatility of approximately 91 % based on the trading history of similar companies, and (4) zero expected dividends.
−Removed: At December 31, 2024, the Company had 121,243
−Removed: shares reserved for issuance pursuant to the 2021 Amended and Restated Incentive Stock Plan and 15,975 shares available pursuant to the
−Removed: 2019 Stock Incentive Plan.
−Removed: The following table summarizes stock option activity :
−Removed: (in thousands, except share and per share amounts) Number of
−Removed: Shares Weighted-
−Removed: Price Weighted-
−Removed: (years) Aggregate
−Removed: Outstanding at December 31, 2022 4,841,417 $ 8.60 6.28 -
−Removed: Options granted 665,000 $ 9.69 10.0 -
−Removed: Options exercised -
−Removed: Options cancelled ( 10,417 ) $ 12.44 - -
−Removed: Outstanding at December 31, 2023 5,496,000 $ 8.73 6.18 -
−Removed: Options granted 1,964,307 $ 7.06 10.0 -
−Removed: Options cancelled ( 149,000 ) $ 9.90 - -
−Removed: Options exercised ( 108,000 ) $ 3.91 - -
−Removed: Outstanding at December 31, 2024 7,203,307 $ 8.29 6.49 $ 1,218
−Removed: Exercisable at December 31, 2024 4,988,685 $ 8.68 5.20 $ 1,218
−Removed: During the years ended December 31, 2024 and 2023, the Company
−Removed: recognized stock-based compensation expense of $ 7,605 ,000 and $ 7,368 ,000, respectively, related to stock options.
−Removed: As of December 31,
−Removed: 2023, there was $ 12,213,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized
−Removed: over a weighted-average period of 2.37 years.
−Removed: The Company issued warrants to the Company’s
−Removed: lenders upon obtaining a loan in June 2021.
−Removed: The warrants have a 10 -year term and an exercise price of $ 14.05 .
−Removed: At December 31, 2024
−Removed: and 2023, respectively, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $0 .
−Removed: 2024, the Company issued 1,557,592 warrants to investors in connection with the sale of common stock.
−Removed: At December 31, 2024, 1,557,592 of
−Removed: these warrants are outstanding and are exercisable for cash at a weighted average price of $ 9.59 per share.
−Removed: The intrinsic value of
−Removed: these warrants was $0 as of December 31, 2024.
−Removed: During September
−Removed: 2024, the Company issued 2,341,260 warrants to investors in connection with the sale of common stock.
−Removed: At December 31, 2024, 2,341,260 of
−Removed: these warrants are outstanding and are exercisable for cash at a weighted average price of $ 6.40 per share.
−Removed: The intrinsic value of
−Removed: these warrants was $0 as of December 31, 2024.
−Removed: During the year ended December 31, 2023, a third
−Removed: party exercised 28,688 warrants on a cashless basis in exchange for 4,781 shares of common stock.
−Removed: Stock-based Compensation by Class of Expense
−Removed: The following summarizes the components of stock-based
−Removed: compensation expense in the consolidated statements of operations for the years ended December 31, 2024 and 2023, respectively:
−Removed: (in thousands)
−Removed: Research and development
−Removed: General and administrative
−Removed: Shareholder Rights Agreement
−Removed: On December 30, 2020, the Board of Directors (the
−Removed: “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company
−Removed: and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each,
−Removed: a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business
−Removed: on January 11, 2021.
−Removed: When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth
−Removed: of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $ 0.001 per share,
−Removed: of the Company, at an exercise price of $ 300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to
−Removed: Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered
−Removed: persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board.
−Removed: The Rights Agreement was amended in 2021, 2022, 2023 and 2024 to extend the expiration date and shall expire on December 30, 2025.
−Removed: Preferred Stock
−Removed: In 2020, the Company designated 45,000 shares
−Removed: of its preferred stock with par value of $ 0.001 per share as Series A Junior Participating Preferred Stock.
−Removed: The remaining 9,955,000 shares
−Removed: of preferred stock with par value of $ 0.001 remain undesignated.
−Removed: None of the preferred shares were issued and outstanding at December 31,
−Removed: 2024 and 2023.
−Removed: NOTE 10 – INCOME TAXES
−Removed: Loss before income taxes summarized by region
−Removed: was as follows:
−Removed: (in thousands)
−Removed: United States
−Removed: Total loss before income taxes
−Removed: The provision for income taxes consists of the
−Removed: following components:
−Removed: Current expense (benefit)
−Removed: Current income tax expense
−Removed: Deferred expense (benefit)
−Removed: Deferred income tax
−Removed: Net deferred taxes
−Removed: A reconciliation of income tax benefit computed
−Removed: using the federal statutory income tax rate to the Company’s tax expense is as follows:
−Removed: (in thousands, except percentage)
−Removed: Federal tax benefit at statutory rate ( 21 %)
−Removed: Stock-based compensation
−Removed: State income tax benefit, net of federal tax effect
−Removed: Foreign tax differential
−Removed: Research credits
−Removed: Return to provision adjustment
−Removed: Change in valuation allowance
−Removed: Income tax benefit
−Removed: The principal components of deferred tax assets
−Removed: and liabilities consist of the following at December 31, 2024 and 2023, respectively:
−Removed: (in thousands)
−Removed: Deferred tax assets
−Removed: Stock-based compensation
−Removed: Research and development
−Removed: Federal NOL carryforwards
−Removed: State NOL carryforwards
−Removed: Foreign NOL carryforwards
−Removed: Total deferred tax assets
−Removed: Less valuation allowance
−Removed: Net deferred tax assets
−Removed: We file income tax returns in the United States,
−Removed: the United Kingdom and Australia.
−Removed: The Company is no longer subject to Internal Revenue Service tax examinations by tax authorities
−Removed: for years prior to 2021.
−Removed: The United Kingdom and Australia are no longer subject to income tax examination for years prior to
−Removed: 2023 and 2022, respectively.
−Removed: As of December 31, 2024, the Company has a federal net operating loss
−Removed: carryforward of approximately $ 41.4 million, a United Kingdom net operating loss carryforward of $ 17.4 million and an Australia net operating
−Removed: loss carryforward of $ 19.7 million.
−Removed: The federal net operating loss carryforwards for 2017 will begin to expire in the year ending December
−Removed: The remaining federal net operating loss carryforwards generated after 2017 have no expiration.
−Removed: The United Kingdom and Australia
−Removed: net operating losses have no expiration.
−Removed: The Company has net operating loss carryforwards in California and Florida of $ 14.9 million and
−Removed: $ 24.2 million, respectively, of which the California net operating losses will begin to expire in the year ending December 31, 2037, and
−Removed: the Florida net operating losses have no expiration.
−Removed: The Company’s gross deferred tax assets
−Removed: of $ 25.7 million and $ 19.6 million at December 31, 2024 and 2023, respectively, primarily consist of net operating loss carryforwards
−Removed: for income tax purposes.
−Removed: A valuation allowance is required to be recorded when it is not more likely than not that some portion or all
−Removed: of the net deferred tax assets will be realized.
−Removed: Since the Company cannot be assured of generating taxable income and thereby realizing
−Removed: the net deferred tax assets, a full valuation allowance has been recorded.
−Removed: The change in the valuation allowance was $ 6,081,000 during
−Removed: the year ended December 31, 2024.
−Removed: The Company recognizes uncertain tax positions
−Removed: in accordance with ASC 740 on the basis of evaluating whether it is more likely than not that the tax positions will be sustained upon
−Removed: examination by tax authorities.
−Removed: For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest
−Removed: amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement.
−Removed: As of December 31, 2024, and 2023,
−Removed: the Company has no significant uncertain tax positions.
−Removed: There are no unrecognized tax benefits included on the balance sheet that would,
−Removed: if recognized, impact the effective tax rate.
−Removed: The Company does not anticipate there will be a significant change in unrecognized tax benefits
−Removed: within the next 12 months.
−Removed: NOTE 11 – COLLABORATIVE AGREEMENTS
−Removed: During September 2020, the Company was awarded
−Removed: a grant from the National Institutes of Health (“NIH”).
−Removed: The grant will support a Phase 2 study of XPro in patients with treatment
−Removed: resistant depression.
−Removed: During 2024, the grant was reduced from approximately $ 2.9 million to approximately $ 2.0 million.
−Removed: As of December
−Removed: 31, 2024, the Company has not received any proceeds pursuant to this grant.
−Removed: 12 – COMMITMENTS AND CONTINGENCIES
−Removed: During September
−Removed: 2021, the Company signed a lease agreement with a third party for office space in Boca Raton, Florida.
−Removed: The operating lease has a 64 -month
−Removed: term and commenced during the fourth quarter of 2021.
−Removed: Future minimum payments pursuant
−Removed: to the leases are as follows:
−Removed: (in thousands, except years)
−Removed: Total lease payments
−Removed: imputed interest
−Removed: Present value of future lease payments
−Removed: operating lease, current liabilities
−Removed: Long-term operating lease liabilities
−Removed: During the years ended December 31, 2024 and 2023,
−Removed: the Company recognized $ 161,000 and $ 163,000 , respectively, in operating lease expense, which is included in general and administrative
−Removed: expenses in the Company’s consolidated statement of operations.
−Removed: has an ongoing dispute with a vendor in which the Company believes that the vendor did not properly provide services for which they have
−Removed: invoiced the Company.
−Removed: As of December 31, 2024, the Company has outstanding invoices with the vendor which aggregate approximately $ 1.6 million,
−Removed: of which the Company has recorded approximately $ 0.2 million, which is the Company’s estimate of the obligation incurred, and
−Removed: the remaining $ 1.4 million has not been recorded by the Company as the Company believes the invoices were sent erroneously.
−Removed: and the vendor are still attempting to resolve the dispute and legal proceedings have not been threatened.
−Removed: is subject to claims and suits that arise from time to time in the ordinary course of our business.
−Removed: Although management currently believes
−Removed: that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s
−Removed: consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may
−Removed: change in the future.
−Removed: 13 – SEGMENT INFORMATION
−Removed: operates as one operating segment.
−Removed: The Company’s chief operating decision maker (“CODM”) is its Chief Financial Officer,
−Removed: who reviews the financial statements on a consolidated basis.
−Removed: The CODM uses the Company’s long-range plan to allocate resources.
−Removed: The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results using
−Removed: consolidated loss from operations.
−Removed: Significant expenses
−Removed: within loss from operations, as well as within net loss, include research and development and general and administrative expenses, which
−Removed: are each separately presented on the Company’s Consolidated Statements of Operations and Comprehensive Loss.
−Removed: Other segment items
−Removed: within net loss include other income (expense), net.
−Removed: The Company’s long-lived
−Removed: assets consist primarily of acquired in-process research and development intangible assets which are located in the United States.
−Removed: 14 – SUBSEQUENT EVENTS
−Removed: Cordstrom License Agreement
−Removed: On February 6, 2025, the Company and GOSH entered into a license agreement
−Removed: for the exclusive commercial use to clinical trial data associated with the Mission EB study investigating the potential of CORDStrom
−Removed: to treat RDEB in pediatric patients.
−Removed: The Company owns the intellectual property covering CORDStrom, the investigational medicinal product
−Removed: used in the Mission EB study.
−Removed: In addition, the Company owns intellectual property and maintains trade secret protections covering the
−Removed: manufacturing of CORDStrom.
−Removed: With this license to the clinical trial data, the Company intends to prepare applications seeking marketing
−Removed: authorization of CORDStrom for treatment of pediatric RDEB in each of the FDA, EMA, and MHRA.
−Removed: Terms of the license agreement include an
−Removed: upfront payment of £ 250,000 (approximately $ 0.3 million at February 6, 2025) and a single milestone payment of up to £ 6,000,000
−Removed: (approximately $ 7.5 million at February 6, 2025) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA.
−Removed: In addition to these financial terms, the Company has also agreed to certain patient access obligations, including sponsoring the supply
−Removed: of CORDStrom to UK patients enrolled in an open label continuation of the Mission EB study.
−Removed: Sales of Common Stock
−Removed: During the period from January 1, 2025 through March 27, 2025, the
−Removed: Company sold 649,860 shares of its common stock through its ATM program for net proceeds of $ 5.3 million.
+Added: The audited consolidated financial statements of the Company, together
+Added: with the reports thereon of Marcum LLP and CBIZ CPAs P.C., independent registered public accounting firms, are included in this Annual
+Added: Report on Form 10-K beginning on page F-1.
Changes in and Disagreements with Accountants
1 unchanged sentence
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.