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 June 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) (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 5217 W ...

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 March 31, 2025 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number 001-37347 XBIOTECH INC. (Exact name of registrant as specified in charter) British Columbia, Canada __ (State or other jurisdiction of incorporation or organization) (IRS Employ ...

Financial Performance - XBiotech generated a total of $750 million in income from the sale of its True Human™ antibody Bermekimab between December 30, 2019, and June 30, 2021[28]. - The company returned a total of $495 million to shareholders through stock repurchase and dividends since 2020[28]. - The company has incurred significant losses since its inception and may continue to do so, with a net loss reported for the fiscal year ended December 31, 2024[52]. - The company has not generated any revenue from product sales to date and may never sustain profitability[58]. - The net loss for the year ended December 31, 2024, was $38,531,000, compared to a net loss of $24,557,000 in 2023, representing a 56.6% increase in losses[221]. - The accumulated deficit increased to $90.837 million as of December 31, 2024, compared to $52.306 million in 2023[209]. - The company does not expect to generate any revenue during the fiscal year of 2025 and anticipates significant and increasing operating losses as it advances drug candidates through testing[159]. Research and Development - XBiotech is developing two anti-IL-1a product candidates in parallel, targeting oncology, rheumatology, and neurology[27]. - A clinical study for Natrunix™ in pancreatic cancer included 60 subjects, showing reduced hospitalization and fewer serious adverse events compared to placebo[32]. - A clinical study for Natrunix in rheumatoid arthritis was completed with 233 subjects, but data was rendered uninterpretable due to enrollment irregularities[33]. - XBiotech completed a Phase I study for its True Human™ antibody Hutrukin, demonstrating safety and tolerability for stroke treatment[34]. - Research and development expenses for the year ended December 31, 2024, amounted to approximately $37.8 million[54]. - Total research and development expenses accounted for 89% of total operating expenses in 2024, up from 88% in 2023[165]. - The company recorded total research and development expenses of $349.7 million from inception through December 31, 2024[164]. - Clinical trial costs increased due to a new study initiated in the second quarter of 2023, contributing to the overall rise in research and development expenses[181]. Regulatory and Market Challenges - The company anticipates significant expenses will continue as it seeks regulatory approvals for current and future product candidates[53]. - The ability to generate revenue from product sales will depend on successful commercialization of product candidates, which have not yet received regulatory approval[62]. - The FDA review process for regulatory approval typically takes years and is not guaranteed[62]. - The regulatory approval process for product candidates is lengthy and unpredictable, typically taking several years and dependent on various factors[70]. - The FDA may require additional preclinical or clinical data, which could delay or prevent approval and commercialization plans[71]. - Clinical trials may fail to demonstrate safety and efficacy, or may not meet the statistical significance required for approval[72]. - Even with regulatory approval, products may face ongoing oversight and marketing challenges, including potential label restrictions[77]. - Coverage and adequate reimbursement from third-party payers are critical for successful commercialization, and there may be significant delays in obtaining these[87]. - The approval process in foreign jurisdictions may involve additional testing and could significantly delay product introduction[85]. - Changes in government regulations could prevent or delay regulatory approval of product candidates[84]. - The company may face litigation or product liability claims if adverse effects are identified post-approval[79]. - The occurrence of regulatory penalties could inhibit the ability to commercialize product candidates and generate revenue[81]. Competition and Market Position - The company faces substantial competition, which may hinder its ability to achieve market acceptance for its products[52]. - The company faces substantial competition from larger pharmaceutical and biotechnology companies, which may limit its ability to develop or commercialize product candidates[94]. - The success of the company's product candidates depends on market acceptance among physicians, patients, and healthcare payers, which is not guaranteed[91]. Financial Position and Capital Needs - The company may require substantial additional capital to continue clinical development and potential commercialization activities[55]. - The company funded operations through equity securities, raising approximately $118.2 million since inception, with significant cash proceeds from the Janssen Transaction[188]. - Cash and cash equivalents decreased to $172.7 million at December 31, 2024, down from $200.0 million at December 31, 2023[188]. - Net cash used in operating activities for the year ended December 31, 2024, was $31.0 million, an increase from $18.7 million in 2023, primarily due to net losses and increased expenses[189]. - The total assets decreased to $199.093 million in 2024 from $226.615 million in 2023, indicating a decline in financial position[209]. Management and Personnel - As of December 31, 2024, XBiotech had 92 full-time employees, with no collective bargaining agreements in place[43]. - The company is highly dependent on key personnel, including its Chief Executive Officer, for its operations[52]. - The company is dependent on its Chief Executive Officer, John Simard, whose loss could negatively impact the company's strategic direction[107]. - The company may struggle to attract and retain qualified personnel, which is critical for its research, development, and commercialization efforts[108]. Intellectual Property and Legal Risks - The company relies on patent protection for its proprietary technology, and the uncertainty surrounding patent issuance and enforcement could adversely affect its competitive position[116]. - The company may face challenges in protecting its intellectual property rights, which could allow competitors to develop similar technologies and products[117]. - The company faces risks related to potential infringement claims from third parties, which could result in costly litigation and diversion of resources[120]. Corporate Governance and Structure - The company has significant control over its common stock, with directors and principal shareholders owning approximately 44.2% of outstanding shares, potentially affecting corporate governance and market price[127]. - XBiotech is governed by the corporate laws in British Columbia, Canada, which may differ materially from those in Delaware, affecting shareholder rights[134].

Core Viewpoint - Pomerantz LLP is investigating claims on behalf of investors of XBiotech Inc. regarding potential securities fraud or unlawful business practices by the company and its officers [1][2]. Group 1: Company Developments - On December 23, 2024, XBiotech announced a pause in its phase 2 rheumatoid arthritis program after its candidate, Natrunix, failed to meet its primary endpoint, citing "substantial irregularities" that complicate the interpretation of findings [2]. - Following the announcement, XBiotech's stock price experienced a significant decline during intraday trading on the same day [2]. Group 2: Legal Context - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of fighting for the rights of victims of securities fraud and corporate misconduct [3].

Core Viewpoint - The article discusses a securities investigation concerning XBiotech Inc. (XBIT) and encourages stockholders to inquire about the matter [1] Group 1 - The law firm Bronstein, Gewirtz & Grossman, LLC is urging XBiotech Inc. stockholders to seek information regarding a potential investigation into the company's securities [1] - The investigation may relate to possible violations of securities laws, which could impact the stockholders' interests [1] - Stockholders are encouraged to contact the law firm for further details and to understand their rights [1]

Core Viewpoint - XBiotech Inc. is under investigation for potential violations of securities laws, prompting affected investors to reach out to the Schall Law Firm for assistance [1] Group 1 - The investigation into XBiotech Inc. suggests serious legal concerns that may impact the company's reputation and financial standing [1] - Affected investors are encouraged to take action by contacting legal representation, indicating potential for class action or legal claims [1]

Core Viewpoint - Bronstein, Gewirtz & Grossman LLC has announced an investigation into XBiotech Inc. to determine whether the company has violated securities laws, encouraging investors to reach out for more information [1] Group 1 - The investigation is focused on potential violations of securities laws by XBiotech Inc. [1] - Investors are being encouraged to contact the firm for further details regarding the investigation [1]

Core Viewpoint - The Schall Law Firm is inviting shareholders of XBiotech Inc. who have experienced losses to participate in an inquiry regarding potential securities fraud involving the company [1] Group 1 - The inquiry is focused on allegations of securities fraud that may have impacted shareholders negatively [1] - Shareholders are encouraged to join the inquiry to explore their legal options and potential recovery of losses [1] - The law firm is actively seeking to gather information and evidence related to the alleged fraud [1]

Core Viewpoint - Bronstein, Gewirtz & Grossman, LLC is encouraging investors of XBiotech Inc. (XBIT) to inquire about a securities investigation related to the company [1] Group 1 - The investigation may involve potential securities violations by XBiotech Inc. [1] - Investors are urged to seek more information regarding their rights and potential claims [1] - The firm specializes in securities class action lawsuits and is actively pursuing this matter [1]

Core Viewpoint - The Schall Law Firm is investigating XBiotech Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether XBiotech issued false or misleading statements and failed to disclose critical information to investors [2]. - XBiotech announced a pause in its phase 2 rheumatoid arthritis program for its drug candidate, Natrunix, due to not meeting the primary endpoint and experiencing "substantial irregularities" that complicate the interpretation of findings [2]. Group 2: Investor Rights - Shareholders who have suffered losses are encouraged to participate in the investigation and can contact the Schall Law Firm for a free discussion of their rights [3].