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XBiotech Inc.

For the period ended Sep 30, 2025. Filed Nov 12, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 12, 2025

XBIT$1.89+1.1%Stored close · as of Nov 6, 2026
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended September 30, 2025

or

☐Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number 001-37437

XBIOTECH INC.

(Exact name of registrant as specified in charter)

British Columbia, Canada__
(State or other jurisdiction of incorporation or organization)(IRS Employer Identification No.)

5217 Winnebago Ln, Austin, TX 78744

(Address of principal executive offices) (Zip Code)

Telephone Number (512)386-2900

(Registrant’s telephone number, including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, no par valueXBITNASDAQ Global Select Market

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.

Yes ☒ No ☐

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). Yes ☒ No ☐

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.

Large accelerated filer☐Accelerated filer☐
Non-accelerated filer☒Smaller reporting company☒
Emerging growth company•☐

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☐ No ☒

As of November 12, 2025, there were 30,487,731 shares of the Registrant's common stock issued and outstanding.

XBIOTECH INC.

THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2025

INDEX

PART I—FINANCIAL INFORMATION
Item 1.Condensed Consolidated Financial Statements6
Condensed Consolidated Balance Sheets as of September 30, 2025 (unaudited) and December 31, 20246
Condensed Consolidated Statements of Operations for the Three Months and Nine Months Ended September 30, 2025 (unaudited) and 2024 (unaudited)7
Condensed Consolidated Statements of Shareholders’ Equity for the Three Months and Nine Months Ended September 30, 2025 (unaudited) and 2024 (unaudited)8
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 (unaudited) and 2024 (unaudited)10
Notes to Condensed Consolidated Financial Statements (unaudited)11
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations19
Item 3.Quantitative and Qualitative Disclosures About Market Risk24
Item 4.Controls and Procedures24
PART II—OTHER INFORMATION
Item 1.Risk Factors26
Item 2.Unregistered Sale of Equity Securities and Use of Proceeds26
Item 3.Defaults Upon Senior Securities26
Item 4.Mine Safety Disclosures26
Item 5.Other Information26
Item 6.Exhibits26

SIGNATURES

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:

●our ability to obtain regulatory approval to market and sell our product candidates in the United States, Europe and elsewhere;
●the initiation, timing, cost, progress and success of our research and development programs, preclinical studies and clinical trials for our product candidates;
●our ability to advance product candidates into, and successfully complete, clinical trials;
●our ability to successfully commercialize the sale of our product candidates in the United States, Europe and elsewhere;
●our ability to recruit sufficient numbers of patients for our future clinical trials for our pharmaceutical products;
●our ability to achieve profitability;
●the implementation of our business model and strategic plans;
●our ability to develop and commercialize product candidates for orphan and niche indications independently;
●our commercialization, marketing and manufacturing capabilities and strategy;
●our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
●our expectations regarding federal, state and foreign regulatory requirements;
●the therapeutic benefits, effectiveness and safety of our product candidates;
●the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our products and product candidates;
●the rate and degree of market acceptance and clinical utility of our future products, if any;
●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;
●our ability to engage and retain the employees required to grow our business;
●our future financial performance and projected expenditures;
●developments relating to our competitors and our industry, including the success of competing therapies that are or become available; and
●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, 2024 filed with the SEC on March 18, 2025, 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.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

September 30, 2025 (Unaudited)December 31, 2024
Assets
Current assets:
Cash and cash equivalents$147,367$172,677
Accrued interest receivable450700
Income tax receivable75158
Prepaid expenses and other current assets1,0591,032
Total current assets148,951174,567
Property and equipment, net23,47324,526
Total assets$172,424$199,093
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable$1,043$2,223
Accrued expenses2,4222,632
Income tax payable100-
Convertible loan, related party-10,000
Convertible loan, third party-250
Total current liabilities3,56515,105
Long-term liabilities:
Income tax payable1,7791,720
Total liabilities5,34416,825
Shareholders’ equity:
Preferred stock, no par value, unlimited shares authorized, no shares outstanding--
Common stock, no par value, unlimited shares authorized, 30,487,731 shares issued and outstanding at September 30, 2025 and December 31, 2024276,565273,105
Accumulated deficit(109,485)(90,837)
Total shareholders’ equity167,080182,268
Total liabilities and shareholders’ equity$172,424$199,093

See accompanying notes to unaudited condensed consolidated financial statements.

Condensed Consolidated Statements of Operations (unaudited)

(in thousands, except share and per share data)

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
(unaudited)(unaudited)(unaudited)(unaudited)
Operating expenses:
Research and development$5,080$7,127$22,032$29,936
General and administrative9677773,8983,787
Total operating expenses6,0477,90425,93033,723
Loss from operations(6,047)(7,904)(25,930)(33,723)
Other income:
Interest income1,4272,3694,4607,716
Interest expense-(203)(88)(603)
Other (expense) income(85)2590625
Foreign exchange (loss) gain(1,201)7072,163(1,429)
Total other income1412,8987,4415,709
Loss before income taxes(5,906)(5,006)(18,489)(28,014)
Income tax expense(102)(9)(159)(9)
Net loss$(6,008)$(5,015)$(18,648)$(28,023)
Net loss per share—basic and diluted$(0.20)$(0.16)$(0.61)$(0.92)
Shares used to compute basic and diluted net loss per share30,487,73130,472,55730,487,73130,459,178

XBiotech Inc.

Condensed Consolidated Statements of Shareholders' Equity (unaudited)

(in thousands, except share data)

Number of SharesCommon Stock AmountAccumulated DeficitTotal
Balance at June 30, 202530,487,731$276,541$(103,477)$173,064
Net loss--(6,008)(6,008)
Share-based compensation expense-24-24
Balance at September 30, 202530,487,731$276,565$(109,485)$167,080
Number of SharesCommon Stock AmountAccumulated DeficitTotal
Balance at June 30, 202430,463,156$272,015$(75,314)$196,701
Net loss--(5,015)(5,015)
Issuance of common stock under stock option plan16,25064-64
Share-based compensation expense-365-365
Balance at September 30, 202430,479,406$272,444$(80,329)$192,115
Number of SharesCommon Stock AmountAccumulated DeficitTotal
Balance at December 31, 202430,487,731$273,105$(90,837)$182,268
Net loss--(18,648)(18,648)
Share-based compensation expense-3,460-3,460
Balance at September 30, 202530,487,731$276,565$(109,485)$167,080
Number of SharesCommon Stock AmountAccumulated DeficitTotal
Balance at December 31, 202330,436,964$271,152$(52,306)$218,846
Net loss--(28,023)(28,023)
Issuance of common stock under stock option plan42,442167-167
Share-based compensation expense-1,125-1,125
Balance at September 30, 202430,479,406$272,444$(80,329)$192,115

Condensed Consolidated Statements of Cash Flows (unaudited)

(in thousands)

Nine Months Ended September 30,
2025 · 2024
(unaudited) · (unaudited)
Operating activities
Net loss$(18,648)$(28,023)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation1,3081,306
Foreign exchange (gain) loss(2,163)1,429
Share-based compensation expense3,4601,125
Changes in operating assets and liabilities:
Income tax receivable83(66)
Accrued interest receivable250130
Prepaid expenses and other current assets(27)(285)
Accounts payable(1,180)(1,017)
Accrued expenses(210)986
Income tax payable159(8)
Net cash used in operating activities(16,968)(24,423)
Investing activities
Purchase of property and equipment(255)(1,220)
Net cash used in investing activities(255)(1,220)
Financing activities
(Payment on) proceeds from convertible loan, related party(10,000)10,000
Payment on convertible loan, third party(250)-
Issuance of common stock under stock option plan-167
Net cash (used in) provided by financing activities(10,250)10,167
Effect of foreign exchange rate on cash and cash equivalents2,1631,429
Net change in cash and cash equivalents(25,310)(16,905)
Cash and cash equivalents, beginning of period172,677200,023
Cash and cash equivalents, end of period$147,367$183,118
Supplemental Information:
Accrued purchases of property and equipment$-$6
Cash paid for interest$486$400

**XBiotech Inc.

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