XBIT 10-Q
XBiotech Inc. (XBIT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Commission File Number
(Exact name of registrant as specified in charter)
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British Columbia, |
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(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
(Address of principal executive offices)(Zip Code)
Telephone Number (
(Registrant’s telephone number, including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company• |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of November 13, 2024, there were
XBIOTECH INC.
THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2024
INDEX
CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. You can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These forward-looking statements include, but are not limited to statements about:
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our ability to obtain regulatory approval to market and sell our product candidates in the United States, Europe and elsewhere; |
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the initiation, timing, cost, progress and success of our research and development programs, preclinical studies and clinical trials for our product candidates; |
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our ability to advance product candidates into, and successfully complete, clinical trials; |
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our ability to successfully commercialize the sale of our product candidates in the United States, Europe and elsewhere; |
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our ability to recruit sufficient numbers of patients for our future clinical trials for our pharmaceutical products; |
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our ability to achieve profitability; |
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the implementation of our business model and strategic plans; |
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our ability to develop and commercialize product candidates for orphan and niche indications independently; |
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our commercialization, marketing and manufacturing capabilities and strategy; |
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our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; |
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our expectations regarding federal, state and foreign regulatory requirements; |
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the therapeutic benefits, effectiveness and safety of our product candidates; |
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the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our products and product candidates; |
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the rate and degree of market acceptance and clinical utility of our future products, if any; |
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our expectations regarding market risk, including interest rate changes, foreign currency fluctuations and regional or global economic impacts caused by public health threats, such as the outbreak of coronavirus or other infectious diseases; |
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our ability to engage and retain the employees required to grow our business; |
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our future financial performance and projected expenditures; |
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developments relating to our competitors and our industry, including the success of competing therapies that are or become available; and |
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estimates of our expenses, future revenue, capital requirements and our needs for additional financing. |
All forward looking statements in this Quarterly Report on Form 10-Q involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those under the heading “Risk Factors” included in our annual report for the year ended December 31, 2023 filed with the SEC on March 15, 2024, and under the heading “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain medical conditions, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
XBiotech Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
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September 30, 2024 (Unaudited) |
December 31, 2023 |
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Total assets |
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See accompanying notes to unaudited condensed consolidated financial statements.
XBiotech Inc.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share data)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2023 |
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Operating expenses: |
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Research and development |
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Net loss |
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Net loss per share—basic and diluted |
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Shares used to compute basic and diluted net loss per share |
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See accompanying notes to unaudited condensed consolidated financial statements.
XBiotech Inc.
Condensed Consolidated Statements of Comprehensive Loss (unaudited)
(in thousands)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2023 |
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Net loss |
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Reclassification adjustment from dissolution of Germany subsidiary |
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Comprehensive loss |
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See accompanying notes to unaudited condensed consolidated financial statements.
XBiotech Inc.
Condensed Consolidated Statements of Shareholders' Equity (unaudited)
(in thousands)
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Balance at June 30, 2024 |
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Net loss |
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Issuance of common stock under stock option plan |
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Balance at September 30, 2024 |
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Balance at June 30, 2023 |
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Net loss |
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Issuance of common stock under stock option plan |
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Share-based compensation expense |
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Balance at September 30, 2023 |
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| Number of Shares | Common Stock Amount | Accumulated Deficit |
Total |
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Balance at December 31, 2023 |
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Net loss |
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Issuance of common stock under stock option plan |
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Share-based compensation expense |
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Balance at September 30, 2024 |
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Number of Shares |
Common Stock and Additional Paid in Capital |
Accumulated Other Comprehensive Income | Accumulated Deficit | Total | ||||||||||||||||
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Balance at December 31, 2022 |
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Net loss |
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Tender offer |
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Issuance of common stock under stock option plan |
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Reclassification adjustment from dissolution of German subsidiary |
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Balance at September 30, 2023 |
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See accompanying notes to unaudited condensed consolidated financial statements.
XBiotech Inc.
Condensed Consolidated Statements of Cash Flows (unaudited)
(in thousands)
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Nine Months Ended September 30, |
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2023 |
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Operating activities |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Share-based compensation expense |
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Changes in operating assets and liabilities: |
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Cash and cash equivalents, end of period |
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Supplemental Information: |
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Accrued purchases of property and equipment |
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See accompanying notes to unaudited condensed consolidated financial statements.
XBiotech Inc.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. Organization
XBiotech Inc. (“XBiotech” or the “Company”) was incorporated in Canada on March 22, 2005. The Company’s headquarters are located in Austin, Texas. XBiotech USA, Inc., a wholly-owned subsidiary of the Company, was incorporated in Delaware, United States in November 2007. XBiotech Germany GmbH, a wholly-owned subsidiary of the Company, was incorporated in Germany in January 2014. XBiotech Germany GmbH was dissolved in February 2023.
Since its inception, XBiotech has focused on advancing technology to rapidly identify and clone antibodies from individuals that have resistance to disease. At the heart of the Company is a proprietary technical knowhow to translate natural human immunity into therapeutic product candidates. The Company has in its pipeline both anti-infective and anti-inflammatory candidate therapeutics derived from this technology.
An area of medical focus for XBiotech are therapies that block a potent substance naturally produced by body, known as interleukin-1 alpha (IL-1a), that mediates tissue breakdown, angiogenesis, the formation of blood clots and inflammation. IL-1a is a protein that is on or in cells of the body and is involved in the body’s response to injury or trauma. In almost all chronic and in some acute injury scenarios (such as stroke or heart attack), IL-1a may mediate harmful disease-related activity.
At the end of 2019, XBiotech sold a True Human™ antibody that blocked IL-1a activity for $
The Company continues to be subject to a number of risks common to companies in similar stages of development. Principal among these risks are the uncertainties of technological innovations, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors and protection of proprietary technology. The Company’s ability to fund its planned clinical operations, including completion of its planned trials, is expected to depend on the amount and timing of cash receipts from future collaboration or product sales and/or financing transactions. The Company believes that its cash and cash equivalents of $
2. Significant Accounting Policies
Basis of Presentation
The condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss and shareholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the condensed consolidated statement of cash flows for the nine months ended September 30, 2024 and 2023 were prepared by management without audit. In the opinion of management, all adjustments necessary for the fair presentation of the financial position, results of operations, and changes in financial position for such periods, have been made.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2023. The results of operations for three and nine months periods ended September 30, 2024 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2023 contains financial information taken from the audited XBiotech Inc. consolidated financial statements as of that date.
Basis of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions have been eliminated upon consolidation.
Use of Estimates
The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. GAAP requires management to make estimates and assumptions that affect the reported values of amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.
Research and Development Costs
All research and development costs are charged to expense as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract clinical trial research services, the costs of laboratory consumables, equipment and facilities, license fees and other external costs. Costs incurred to acquire licenses for intellectual property to be used in research and development activities with no alternative future use are expensed as incurred as research and development costs.
Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
Clinical Trial Accruals
Expense accruals related to clinical trials are based on actual services received and efforts expended pursuant to contracts with third party service providers which conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. The Company accrues costs based on the actual services rendered in the period over which services were performed and the level of effort expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results.
Income Taxes
In December 2023, the FASB issued ASU 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures" ("ASU 2023-09"), which enhances the transparency and decision usefulness of income tax disclosures. Adjustments to the annual disclosure of income taxes include: (1) A tabular rate reconciliation comprised of eight specific categories, (2) Incomes taxes paid, disaggregated between significant national, state, and foreign jurisdictions, (3) Eliminates requirements to disclose the nature and estimate of reasonably possible changes to unrecognized tax benefits in the next 12 months or that an estimated range cannot be made, and (4) Adds a requirement to disclose income (or loss) from continuing operations before income tax expense (or benefit) and income tax expense (or benefit) from continuing operations disaggregated between domestic and foreign. The ASU is effective for public business entities for fiscal years beginning on or after December 15, 2024 with early adoption permitted. The amendments in ASU 2023-09 should be applied on a prospective basis and retrospective application is permitted. The Company is in the process of evaluating the impact of adoption of ASU 2023-09 on the Company's consolidated financial statements and disclosures.
The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company measures deferred tax assets and liabilities using the enacted tax rates for the years and jurisdictions in which the temporary differences are expected to be recovered. A change to the tax rates used to measure the Company’s deferred taxes is recognized in income during the period in which the new rate(s) were enacted.
The Company recognizes deferred tax assets to the extent the Company’s assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including the future reversals of existing taxable temporary differences, projected future taxable income exclusive of reversing temporary differences and carryforwards, tax-planning strategies, taxable income in prior carryback years if permitted under tax law, and the results from prior years. If the Company determines it is more likely than not, that all or a portion of a deferred tax asset will not be realized a valuation allowance is recorded with a charge to income tax expense. Alternatively, if the Company determines that all or a portion of a deferred tax asset previously not meeting the more likely than not threshold will be realized, the Company reduces its valuation allowance and recognizes a benefit in income tax expense.
The Company recognizes and measures uncertain tax benefits in accordance with ASC 740 based on a two-step process in which (1) the Company determines whether it is more likely than not that the tax position will be sustained based on the technical merits of the position, and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than fifty percent likely to be realized upon ultimate settlement with the related tax authority. The Company's policy is to recognize interest and penalties, if any, in income tax expense.
Share-Based Compensation
The Company accounts for its share-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all share-based payments to employees, including grants of employee stock options, to be recognized in the statements of operations based on their grant date fair values. For stock options granted to employees and to members of the board of directors for their services on the board of directors, the Company estimates the grant date fair value of each option award using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. To determine the fair value of its common stock, the Company uses the closing price of the Company’s common stock as reported by NASDAQ. For awards subject to service-based vesting conditions, the Company recognizes share-based compensation expense, equal to the grant date fair value of stock options, on a straight-line basis over the requisite service period. The Company accounts for forfeitures as they occur rather than on an estimated basis.
Share-based compensation expense recognized for the three months and nine months ended September 30, 2024 and 2023 was included in the following line items on the condensed consolidated statements of operations (in thousands).
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Three Months Ended |
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Research and development |
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General and administrative |
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The fair value of each option is estimated on the date of grant using the Black-Scholes method with the following assumptions:
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Weighted-average grant date fair value per share |
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Cash and Cash Equivalents
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consisted primarily of cash on deposit in U.S., German and Canadian banks. Cash and cash equivalents are stated at cost which approximates fair value.
Interest Bearing Time Deposit
During 2023 the Company held guaranteed investment certificates with a financial institution. The guaranteed investment certificates had a 12 month term at origination with interest receivable at maturity. The guaranteed investment certificates matured in July 2023. There has been no related activity in 2024.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents. The Company holds these investments in highly-rated financial institutions, and limits the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
Property and Equipment
Property and equipment, which consists of land, construction in process, furniture and fixtures, computers and office equipment, scientific equipment, vehicles and building are stated at cost and depreciated over the estimated useful lives of the assets, with the exception of land and construction in process which are not depreciated, using the straight line method. The useful lives are as follows:
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Furniture and fixtures |
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Office equipment |
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Scientific equipment |
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Vehicles |
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Mobile facility |
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Building |
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Costs of major additions and betterments are capitalized; maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and the resulting gain or loss is recognized.
Impairment of Long-Lived Assets
The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment. Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has recognized any impairment through September 30, 2024.
Convertible Loan, Related Party
On January 3, 2024, the Company entered into a Convertible Loan Agreement (the “Loan”) with John Simard, the Company’s Founder, President, Chief Executive Officer and Chairman. The Loan provided $
Foreign Currency Transactions
Certain transactions are denominated in a currency other than the Company’s functional currency of the U.S. dollar, and the Company generates assets and liabilities that are fixed in terms of the amount of foreign currency that will be received or paid. At each balance sheet date, the Company adjusts the assets and liabilities to reflect the current exchange rate, resulting in a translation gain or loss. As of September 30, 2024, the only significant assets denominated in a foreign currency were certain cash accounts, which were remeasured into the functional currency (U.S. dollar) as of September 30, 2024, resulting in a foreign exchange gain of $
Comprehensive Income (Loss)
ASC Topic 220, Comprehensive Income, requires that all components of comprehensive income (loss), including net income (loss), be reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation adjustments.
Segment and Geographic Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company’s operations and manage its business as operating segment. Substantially all of the Company’s operations are in the U.S. geographic segment.
Net Loss Per Share
Net income/loss per share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted EPS is computed by dividing net income/loss by the weighted average number of common shares and common share equivalents outstanding (if dilutive) during each period. The Company does not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. For the three months ended September 30, 2024,
Subsequent Events
The Company considered events or transactions occurring after the balance sheet date but prior to the date the condensed consolidated financial statements were available to be issued for potential recognition or disclosure in its consolidated financial statements.
3. Property and Equipment
Net property and equipment, after deducting accumulated depreciation, consisted of the following as of September 30, 2024 and December 31, 2023 (in thousands):
|
September 30, 2024 |
December 31, 2023 |
|||||||
|
Manufacturing equipment |
$ | $ | ||||||
|
Winnebago building |
||||||||
|
Other fixed assets |
||||||||
|
Total property and equipment |
$ | $ | ||||||
4. Common Stock
Pursuant to its Articles of Incorporation, the Company has an unlimited number of shares available for issuance with par value.
On May 17, 2023, XBiotech announced that it had commenced a “modified Dutch auction” tender offer to purchase up to $
On June 20, 2023, the Company announced the final results of its “modified Dutch Auction” tender offer. The Company accepted for purchase
During the year ended December 31, 2023,
During the nine months ended September 30, 2024,
5. Common Stock Options
On November 11, 2005, the Board of Directors of the Company adopted the 2005 Incentive Stock Option Plan (the “2005 Plan”), and on March 24, 2015, the board of directors of the Company adopted the 2015 Equity Incentive Plan (the 2015 Plan”) pursuant to which the Company may grant incentive stock and non-qualified stock options to directors, officers, employees or consultants of the Company or an affiliate or other persons as the Compensation Committee may approve.
All options under both Plans will be non-transferable and may be exercised only by the participant, or in the event of the death of the participant, a legal representative until the earlier of the options’ expiry date or the first anniversary of the participant’s death, or such other date as may be specified by the Compensation Committee.
The term of the options is at the discretion of the Compensation Committee, but may not exceed
The number of common shares reserved for issuance to any one person pursuant to the 2005 Plan shall not, in aggregate, exceed
A summary of changes in common stock options issued under the 2005 Plan and under the 2015 Plan is as follows:
|
Options |
Exercise Price |
Weighted-Average |
||||||||||
|
Options outstanding at December 31, 2023 |
$ |
$ | ||||||||||
|
Granted |
||||||||||||
|
Exercised |
( |
) | ||||||||||
|
Forfeitures |
( |
) | ||||||||||
| Options outstanding at September 30, 2024 |
$ |
$ | ||||||||||
|
Options |
Exercise Price |
Weighted-Average |
||||||||||
|
Options outstanding at December 31, 2022 |
$ |
$ | ||||||||||
|
Granted |
||||||||||||
|
Exercised |
( |
) | ||||||||||
|
Forfeitures |
( |
) | ||||||||||
|
Options outstanding at September 30, 2023 |
$ |
$ | ||||||||||
As of September 30, 2024, there was approximately $
6. Income Taxes
The Company's effective tax rates for the three months ended September 30, 2024 and September 30, 2023, were -
The Company's effective tax rates for the nine months ended September 30, 2024 and September 30, 2023, were
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
XBiotech Inc. (“XBiotech” or the “Company) is a pre-market biopharmaceutical company engaged in discovering and developing True Human™ monoclonal antibodies for treating a variety of diseases. True Human™ monoclonal antibodies are those which occur naturally in human beings—as opposed to being derived from animal immunization or otherwise engineered. We believe that naturally occurring monoclonal antibodies have the potential to be safer and more effective than their non-naturally occurring counterparts. XBiotech is focused on developing its True Human™ pipeline and manufacturing system.
Following the Janssen Transaction in December 2019, the tender offer in February 2020, and the dividends paid in July 2021, the accumulated deficit as of September 30, 2024 was ($80.3) million. We had net losses before income tax of $5.0 million and $28.0 million for the three months and nine months ended September 30, 2024, respectively, compared to $7.1 million and $19.6 million for the three months and nine months ended September 30, 2023, respectively. During the next year, we don’t expect any revenues. In addition, we expect to incur significant and increasing operating losses for the foreseeable future as we advance our drug candidates from discovery through preclinical testing and clinical. In addition to these increasing research and development expenses, we expect general and administrative costs to increase, particularly in consideration of current inflationary trends. We will need to generate significant revenues to achieve or sustain profitability, and we may never do so. As of September 30, 2024, we had 92 employees.
Research and Development Expenses
Research and development expense consists of expenses incurred in connection with identifying and developing our drug candidates. These expenses consist primarily of salaries and related expenses, stock-based compensation, the purchase of equipment, laboratory and manufacturing supplies, facility costs, costs for preclinical and clinical research, development of quality control systems, quality assurance programs and manufacturing processes. We charge all research and development expenses to operations as incurred.
The clinical development costs may further increase going forward with potentially more advanced studies in the future as we evaluate our clinical data and pipeline.
Clinical development timelines, likelihood of success and total costs vary widely. We do not currently track our internal research and development costs or our personnel and related costs on an individual drug candidate basis. We use our research and development resources, including employees and our drug discovery technology, across multiple drug development programs. As a result, we cannot state precisely the costs incurred for each of our research and development programs or our clinical and preclinical drug candidates. From inception through September 30, 2024, we have recorded total research and development expenses, including share-based compensation, of $303.7 million. Our total research and development expenses for the three months and nine months ended September 30, 2024 were $7.1 million and $29.9 million, respectively, compared to $7.5 million and $25.05 million for the three months and nine months ended September 30, 2023, respectively. Share-based compensation related to research and development accounted for $0.2 million and $0.7 million for the three months and nine months ended September 30, 2024, respectively, compared to $0.8 million and $2.2 million for the three months and nine months ended September 30, 2023, respectively.
Research and development expenses, as a percentage of total operating expenses for the three months and nine months ended September 30, 2024 were 90% and 89%, respectively, compared to 89% and 87% for the three months and nine months ended September 30, 2023, respectively. The percentages of research and development expenses compared to total operating expenses, excluding share-based compensation, for the three months and nine months ended September 30, 2024 were 91% and 90%, respectively, compared to 89% and 87% for the three months and nine months ended September 30, 2023.
We will select drug candidates and research projects for further development on an ongoing basis in response to their preclinical and clinical success and commercial potential. For research and development candidates in early stages of development, it is premature to estimate when material net cash inflows from these projects might occur.
General and Administrative Expenses
General and administrative expense consists primarily of salaries and related expenses for personnel in administrative, finance, business development, and human resource functions, as well as the legal costs of pursuing patent protection of our intellectual property and patent filing, maintenance expenses, share–based compensation, and professional fees for legal services. Our total general and administration expenses for the three months and nine months ended September 30, 2024 were $0.8 million and $3.8 million, respectively, compared to $1.0 million and $3.9 million for the three months and nine months ended September 30, 2023, respectively. Share-based compensation related to general and administration accounted for $0.1 million and $0.7 million for the three months and nine months ended September 30, 2024, respectively, and $0.1 million and $0.4 million for the three months and nine months ended September 30, 2023, respectively.
General and administrative expenses, as a percentage of total operating expenses for the three months and nine months ended September 30, 2024 were 10% and 11%, respectively, compared to 11% and 13% for the three months and nine months ended September 30, 2023, respectively. The percentages of general and administrative expense compared to total operating expenses, excluding share-based compensation, for the three months and nine months ended September 30, 2024 were 9% and 10%, respectively, compared to 11% and 13% for the three months and nine months ended September 30, 2023.
Critical Accounting Policies
Our Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared in conformity with generally accepted accounting principles in the United States (US GAAP). The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and expenses incurred during the reported periods.
We base estimates on our historical experience, known trends and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are more fully described in the notes to our financial statements appearing in this Quarterly Report on Form 10-Q.
Income Taxes
We account for income taxes under the asset and liability method. We record deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which we expect to recover or settle those temporary differences. We recognize the effect of a change in tax rates on deferred tax assets and liabilities in the results of operations in the period that includes the enactment date. We assess the likelihood that deferred tax assets will be realized, and we recognize a valuation allowance if it is more likely than not that some portion of the deferred tax assets will not be realized. This assessment requires judgment as to the likelihood and amounts of future taxable income by tax jurisdiction. To date, with the exception of certain Canada deferred tax assets that will reverse in a period in which they may be carried back, we have provided a valuation allowance against our deferred tax assets as we believe the objective and verifiable evidence of our historical pretax net losses outweighs any positive evidence of our forecasted future results. Although we believe that our tax estimates are reasonable, the ultimate tax determination involves significant judgment. We will continue to monitor the positive and negative evidence and will adjust the valuation allowance as sufficient objective positive evidence becomes available.
We account for uncertain tax positions by recognizing the financial statement effects of a tax position only when, based upon technical merits, it is more likely than not that the position will be sustained upon examination. We recognize potential accrued interest and penalties associated with unrecognized tax positions within our global operations in income tax expense.
Clinical Trial Accruals
Expense accruals related to clinical trials are based on actual services received and efforts expended pursuant to contracts with third party service providers which conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. The Company accrues costs based on the actual services rendered in the period over which services were performed and the level of effort expended in each period based upon patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Any estimates of the level of services performed or the costs of these services could differ from actual results.
Results of Operations
Expenses
Research and Development
Research and Development costs are summarized as follows (in thousands):
|
Three Months Ended September 30, |
Increase |
% Increase |
||||||||||||||
|
2024 |
2023 |
(Decrease) |
(Decrease) |
|||||||||||||
|
Salaries and related expenses |
$ | 2,697 | $ | 2,429 | $ | 268 | 11 | % | ||||||||
|
Laboratory and manufacturing supplies |
1,104 | 712 | 392 | 55 | % | |||||||||||
|
Clinical trials and sponsored research |
1,303 | 1,595 | (292 | ) | -18 | % | ||||||||||
|
Share-based compensation |
242 | 824 | (582 | ) | -71 | % | ||||||||||
|
Other |
1,781 | 1,987 | (206 | ) | -10 | % | ||||||||||
|
Total |
$ | 7,127 | $ | 7,547 | $ | (420 | ) | -6 | % | |||||||
|
Nine Months Ended September 30, |
Increase |
% Increase |
||||||||||||||
|
2024 |
2023 |
(Decrease) |
(Decrease) |
|||||||||||||
|
Salaries and related expenses |
$ | 13,757 | $ | 10,977 | $ | 2,780 | 25 | % | ||||||||
|
Laboratory and manufacturing supplies |
3,394 | 2,818 | 576 | 20 | % | |||||||||||
|
Clinical trials and sponsored research |
6,416 | 3,147 | 3,269 | 104 | % | |||||||||||
|
Share-based compensation |
738 | 2,235 | (1,497 | ) | -67 | % | ||||||||||
|
Other |
5,631 | 5,867 | (236 | ) | -4 | % | ||||||||||
|
Total |
$ | 29,936 | $ | 25,044 | $ | 4,892 | 20 | % | ||||||||
We do not currently track our internal research and development costs or our personnel and related costs on an individual drug candidate basis. We use our research and development resources, including employees and our drug discovery technology, across multiple drug development programs. As a result, we cannot state precisely the costs incurred for each of our research and development programs or our clinical and preclinical drug candidates.
Research and development expenses decreased $0.4 million to $7.1 million for the three months ended September 30, 2024, compared to $7.5 million for the three months ended September 30, 2023. The decrease of in share-based compensation, which was due to the decreased stock option expense per share of new grants compared to the expense of fully amortized grants. Clinical trials and sponsored research expense decreased because of one study fully completed in the second quarter of 2024.
Research and development expenses increased $4.9 million to $29.9 million for the nine months ended September 30, 2024, compared to $25.0 million for the nine months ended September 30, 2023. The increase was primarily due to the rise in the clinical trial activities, related to the new study being initiated in the second quarter of 2023. The increase of salaries and related expenses was mainly due to a company-wide bonus distributed in January 2024 and the bonus to the Chief Executive Officer. In addition, there is a decrease in share-based compensation, which was due to the decreased stock option expense per share of new grants compared to the expense of fully amortized grants.
General and Administrative
General and administrative costs are summarized as follows (in thousands):
|
Three Months Ended September 30, |
Increase |
% Increase |
||||||||||||||
|
2024 |
2023 |
(Decrease) |
(Decrease) |
|||||||||||||
|
Salaries and related expenses |
$ | 152 | $ | 138 | $ | 14 | 10 | % | ||||||||
|
Patent filing expense |
155 | 127 | 28 | 22 | % | |||||||||||
|
Share-based compensation |
123 | 131 | (8 | ) | -6 | % | ||||||||||
|
Professional fees |
205 | 410 | (205 | ) | -50 | % | ||||||||||
|
Other |
142 | 167 | (25 | ) | -15 | % | ||||||||||
|
Total |
$ | 777 | $ | 973 | $ | (196 | ) | -20 | % | |||||||
|
Nine Months Ended September 30, |
Increase |
% Increase |
||||||||||||||
|
2024 |
2023 |
(Decrease) |
(Decrease) |
|||||||||||||
|
Salaries and related expenses |
$ | 1,298 | $ | 1,136 | $ | 162 | 14 | % | ||||||||
|
Patent filing expense |
640 | 524 | 116 | 22 | % | |||||||||||
|
Share-based compensation |
387 | 339 | 48 | 14 | % | |||||||||||
|
Professional fees |
742 | 1,171 | (429 | ) | -37 | % | ||||||||||
|
Other |
720 | 709 | 11 | 2 | % | |||||||||||
|
Total |
$ | 3,787 | $ | 3,879 | $ | (92 | ) | -2 | % | |||||||
General and administrative expenses decreased $196 thousand to $0.8 million for the three months ended September 30, 2024 compared to $1.0 million for the three months ended September 30, 2023. General and administrative expenses decreased $92 thousand to $3.8 million for the nine months ended September 30, 2024 compared to $3.9 million for the nine months ended September 30, 2023.
The three months decrease was primarily due to the decrease of professional fees, related to the stock service and the tax service.
Compared to the nine months ended September 30, 2023, the decrease in the general and administrative expense in the nine months ended September 30, 2024 was also primarily caused by the service fees associated with the tender offer in June 2023 and tax service. The increase of salaries and related expenses was due to a company-wide bonus distributed in January 2024 and the bonus to the Chief Executive Officer. In addition, the patent filing expense increased mainly due to the transfer of patents from Janssen to XBiotech.
Other income (loss)
The following table summarizes other income (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
|
Interest income |
$ | 2,369 | $ | 2,529 | $ | 7,716 | $ | 7,818 | ||||||||
|
Interest expense |
(203 | ) | - | (603 | ) | - | ||||||||||
|
Other income |
25 | - | 25 | 880 | ||||||||||||
|
Foreign exchange gain (loss) |
707 | (1,065 | ) | (1,429 | ) | 646 | ||||||||||
|
Total |
$ | 2,898 | $ | 1,464 | $ | 5,709 | $ | 9,344 | ||||||||
The interest income for the three months and nine months ended September 30, 2024 and 2023 was from the interest generated from the Company’s Canadian bank account and interest bearing time deposit. The interest expense for the three months and nine months ended September 30, 2024, was the interest for the related party convertible loan. In June 2023, the Company received a sum of $750 thousand from American Stock Transfer & Trust Company, LLC which was recorded as other income, in accordance with the terms outlined in the settlement agreement. Foreign exchange gain (loss) was mainly due to the fluctuation between the US dollar and the Canadian dollar in the three months and nine months ended September 30, 2024 compared to 2023.
Liquidity and Capital Resources
Our cash requirements could change materially as a result of the progress of our research and development and clinical programs, licensing activities, acquisitions, divestitures or other corporate developments.
Since our inception on March 22, 2005, we have funded our operations principally through private placements and public offerings of equity securities, which have provided aggregate cash proceeds of approximately $118.4 million as of September 30, 2024. We received $675 million in cash proceeds from the Janssen Transaction in the year ended December 31, 2019. In June 2021, we received the remaining $75 million in cash from the escrow receivable from the same transaction. In July 2021, we paid $75 million in dividends to shareholders. At September 30, 2024, we had cash and cash equivalents of $183.1 million as compared to cash and cash equivalents of $202.2 million at September 30, 2023. The following table summarizes our sources and uses of cash (in thousands):
|
Nine Months Ended September 30, |
||||||||
|
Net cash (used in) provided by: |
2024 |
2023 |
||||||
|
Operating activities |
$ | (24,423 | ) | $ | (15,292 | ) | ||
|
Investing activities |
(1,220 | ) | 61,612 | |||||
|
Financing activities |
10,167 | (9 | ) | |||||
|
Effect of foreign exchange rate on cash and cash equivalents |
(1,429 | ) | (1,426 | ) | ||||
|
Net change in cash and cash equivalents |
$ | (16,905 | ) | $ | 44,885 | |||
During the nine months ended September 30, 2024 and 2023, our operating activities used net cash of $24.4 million and $15.2 million, respectively. The use of net cash in each of these periods primarily resulted from our net losses. The increase in net cash used in operations for the nine months ended September 30, 2024 in comparison to the nine months ended September 30, 2023 was mainly due to the increase in salaries and related expenses and clinical trial expense.
During the nine months ended September 30, 2024 and 2023, our investing activities used net cash of $1.2 million and generated net cash of $61.6 million, respectively. In July 2022, we purchased interest bearing time deposits in the amount of $59.5 million. Upon maturity in July 2023, we obtained both the principal amount and the accrued interest.
During the nine months ended September 30, 2024, our financing activities provided net cash of $10.2 million. On January 3, 2024, we entered into a Convertible Loan Agreement (the “Loan”) with John Simard, the Company’s Founder, President, Chief Executive Officer and Chairman, which provided $10 million net cash for the construction of a new, state-of-the-art research and development facility at the Company's property at 5217 Winnebago Lane in Austin, Texas. Additionally, during the nine months ended September 30, 2024, employees exercised stock options to purchase 42,442 shares of our common stock for approximately $167 thousand in net proceeds. On June 20, 2023, we used approximately $14 thousand to purchase 3,561 common shares at a price of $4.00 per share, relating to the tender offer completed in June 2023. During the nine months ended September 30, 2023, employees exercised stock options to purchase 1,250 shares of our common stock for approximately $5 thousand in net proceeds.
We expect to continue to incur operating losses in the future. We do not expect to receive any additional revenue under the clinical manufacturing agreement with Janssen. Further, we may not receive any product revenue until a drug candidate has been approved by the FDA, EMA or similar regulatory agencies in other countries and successfully commercialized. As of September 30, 2024, our principal sources of liquidity were our cash and cash equivalents, which totaled approximately $183.1 million.
Off-Balance Sheet Arrangements
Since inception, we have not engaged in any off-balance sheet activities, including the use of structured finance, special purpose entities or variable interest entities.
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Item 3. |
The Company is not currently exposed to material market risk arising from financial instruments, changes in interest rates or commodity prices, or fluctuations in foreign currencies. The Company has no need to hedge against any of the foregoing risks and therefore currently engages in no hedging activities.
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Item 4. |
Management's Evaluation of our Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, an evaluation was carried out by the Company’s management, with the participation of the Chief Executive Officer and Director of Finance (Principal Financial Officer), of the effectiveness of the Company’s disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 as amended. Based on such evaluation, the Chief Executive Officer and Director of Finance (Principal Financial Officer) concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed in the reports the Company files or furnishes under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and regulations, and are operating in an effective manner.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
PART II - OTHER INFORMATION
There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2023. Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, as well as other risks and uncertainties, could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading price of shares of our Common Stock. Additional risks not currently known or currently material to us may also harm our business.
Item 2. Unregistered Sale of Equity Securities and Use of Proceeds
Not Applicable.
Item 3. Defaults Upon Senior Securities
Not Applicable.
Item 4. Mine Safety Disclosures
Not Applicable.
Applicable.
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101 |
The following financial statements from the XBiotech Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline Extensive Business Reporting Language (XBRL): (i) condensed consolidated balance sheets at September 30, 2024 and December 31, 2023, (ii) condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023, (iii) condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2024 and 2023, (iv) condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2024 and 2023; (v) condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023 and (vi) notes to condensed consolidated financial statements (detail tagged). |
|
104 |
Cover Page Interactive Data File (embedded within the iXBRL document). |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Date: November 13, 2024 |
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XBIOTECH INC. |
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By: |
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/S/ John Simard |
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John Simard |
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President, Chief Executive Officer and Director (Principal Executive Officer) |
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Date: November 13, 2024 |
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By: |
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/S/ Angela Hu |
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Angela Hu |
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Director of Finance (Principal Financial Officer) |