Core Viewpoint - XBiotech Inc. is under investigation for potential violations of securities laws, which may have significant implications for the company and its investors [1] Group 1 - The investigation is being conducted by authorities, and impacted investors are encouraged to reach out to the Schall Law Firm for assistance [1]

Core Viewpoint - XBiotech Inc. is under investigation for potential securities fraud following the announcement of a pause in its Phase 2 rheumatoid arthritis program for the drug candidate Natrunix due to failure to meet primary endpoints and irregularities in the study [1][2][3] Group 1: Company Developments - On December 23, 2024, XBiotech announced the pause of its Phase 2 rheumatoid arthritis program for Natrunix, citing failure to meet primary endpoints and substantial irregularities in the study [2] - The irregularities included issues at the highest enrolling clinical sites, with multiple subjects being enrolled more than once, complicating the interpretation of the study results [3] - Following the announcement, XBiotech's stock price fell over 29%, dropping from $6.38 to $4.50 per share [4] Group 2: Legal Investigation - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of XBiotech investors regarding potential securities fraud by the company and its officers and/or directors [1] - The firm has a strong reputation in prosecuting securities class actions and derivative litigation across various courts in the United States [5]

NEW YORK, Dec. 27, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  XBiotech Inc. ("XBiotech" or the "Company") (NASDAQ: XBIT). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns Micron and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On December 23, 2024, XBiotech anno ...

Findings from recently completed Rheumatoid Arthritis Study raise questionsAUSTIN, Texas, Dec. 23, 2024 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announced today data that it is halting its clinical program in rheumatological disease while it seeks to understand the outcome from its recently completed Phase II, Double-Blind, Placebo-Controlled, Randomized study in Rheumatoid Arthritis. The Phase II study failed to meet its primary endpoint amid substantial irregularities that make unequivocal interpretati ...

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, 2024 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock, no par value | XBIT | NASDAQ Global Select Market | or ☐ Transition Report Pursuant to Section 13 or 15(d) of ...

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[27]. - The company has returned a total of $495 million to shareholders through stock repurchase and dividends since 2020[27]. - The company incurred a net loss for the fiscal year ended December 31, 2023, continuing a trend of significant losses since its inception in 2005[50]. - The company has not generated any revenue from product sales to date and may never sustain profitability[55]. - Total revenue for the year ended December 31, 2023 was $0, compared to $4.0 million for the year ended December 31, 2022, indicating a significant decline in manufacturing revenue[177]. - The net loss for 2023 was $(24.6) million, an improvement from $(32.9) million in 2022, with net loss per share decreasing from $(1.08) to $(0.81)[211]. - The total shareholders' equity decreased to $218.8 million in 2023 from $240.4 million in 2022, largely due to accumulated losses[209]. - The company does not expect to generate any revenues during the fiscal year of 2024[157]. Research and Development - XBiotech is developing two anti-IL-1a product candidates in parallel, targeting oncology, rheumatology, and neurology[26]. - A clinical study for the Natrunix™ True Human antibody targeting IL-1a in pancreatic cancer included 60 subjects, with results expected within weeks of data lock[30]. - A new clinical program in rheumatology commenced in August 2023, with a 210 patient study in rheumatoid arthritis currently enrolling[31]. - XBiotech completed a Phase I study for its True Human™ antibody Hutrukin, demonstrating safety and tolerability, with a Phase II study planned for 2024[32]. - Approximately $32.8 million was recognized in expenses associated with research and development during the year ended December 31, 2023[52]. - Total research and development expenses for the year ended December 31, 2023, were $32.8 million, compared to $31.5 million in 2022, with research and development expenses accounting for 88% of total operating expenses[162]. - The company has recorded total research and development expenses of $311.9 million since inception[162]. - Clinical trial costs increased significantly by 163% to $5.4 million for the year ended December 31, 2023, compared to $2.0 million for the year ended December 31, 2022[181]. Regulatory and Market Challenges - The company has no products approved by regulatory authorities for marketing or commercial sale[50]. - The FDA review process typically takes years to complete, and approval is never guaranteed, impacting the company's ability to generate revenue[61]. - Delays in clinical trials could harm the commercial prospects of product candidates and impair revenue generation[70]. - The regulatory approval process by the FDA typically takes several years and is unpredictable, with no current approvals for any product candidates[71]. - Factors leading to potential failure in obtaining marketing approval include disagreement over clinical trial design and failure to demonstrate safety and efficacy[73]. - Undesirable side effects could delay or prevent regulatory approval, impacting the commercial viability of product candidates[76]. - Coverage and adequate reimbursement from third-party payers are critical for successful commercialization of products[88]. - Delays in obtaining coverage and reimbursement for newly approved drugs may limit their market acceptance[89]. - Changes in government regulations could adversely affect the ability to obtain regulatory approvals and sustain profitability[86]. - Failure to obtain regulatory approval in foreign jurisdictions could significantly diminish the commercial prospects of product candidates[87]. Competition and Market Position - The company faces substantial competition, which may hinder its ability to commercialize products successfully[50]. - The company faces substantial competition from larger pharmaceutical and biotechnology companies with greater financial and technical resources[96]. - The success of the company's product candidates depends on market acceptance among physicians, patients, and healthcare payers, which is not guaranteed[91]. - The company may not achieve adequate market acceptance for its product candidates, which would compromise its ability to sustain profitability[93]. Operational and Financial Risks - The company may require substantial additional capital to continue clinical development and potential commercialization activities[53]. - The company is highly dependent on its Chief Executive Officer and key personnel, which poses a risk to its operations[50]. - The company may face significant liabilities from product liability lawsuits, which could limit commercialization efforts[100]. - The company must comply with numerous environmental, health, and safety laws, and failure to do so could result in substantial fines and penalties[111]. - The company is predominantly self-insured against various business disruptions, including natural disasters and public health threats, which could significantly harm future revenues and financial condition[114]. - The company has a risk of dilution to existing shareholders if additional capital is raised[137]. Shareholder and Stock Information - As of March 15, 2024, directors, executive officers, and principal shareholders own approximately 38.7% of the outstanding common stock, potentially increasing to 43.5% if stock options are fully exercised[127]. - The company repurchased $420 million of its common shares in February 2020 and distributed a $75 million cash dividend to shareholders in July 2021[128]. - XBiotech's common stock began trading on the NASDAQ Global Select Market on April 15, 2015, under the symbol "XBIT"[152]. Future Plans and Developments - The company intends to allocate net proceeds from public offerings and the Janssen Transaction to fund the development of its next generation True Human™ anti-IL-1⍺ antibody program and other antibody therapeutics[128]. - A new multi-story 46,000 ft² research and development facility is under construction to further enhance discovery and product development capabilities[39]. - The company plans to construct a new multi-story 46,000 ft² R&D facility in 2024, adjacent to its existing R&D facility[146].

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, 2023 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 ...

Financial Performance - As of June 30, 2023, XBiotech reported an accumulated deficit of $40.3 million and net losses before income tax of $8.7 million and $12.5 million for the three months and six months ended June 30, 2023, respectively, compared to $14.3 million and $20.7 million for the same periods in 2022[82]. - The company does not expect to generate any revenues in the next year and anticipates significant and increasing operating losses as it advances its drug candidates[82]. - The company expects to continue incurring operating losses in the future and does not anticipate additional revenue from the clinical manufacturing agreement with Janssen[115]. Research and Development Expenses - Total research and development expenses for the three months and six months ended June 30, 2023 were $11.3 million and $17.5 million, respectively, compared to $10.4 million and $17.2 million for the same periods in 2022, reflecting an increase of 8% and 2%[103][104]. - Research and development expenses accounted for 85% and 86% of total operating expenses for the three months and six months ended June 30, 2023, up from 77% and 80% for the same periods in 2022[88]. - Salaries and related expenses in research and development increased by 43% to $6.2 million for the three months ended June 30, 2023, compared to $4.3 million for the same period in 2022[102]. - Clinical trials and sponsored research expenses increased by 114% to $1.1 million for the three months ended June 30, 2023, compared to $0.5 million for the same period in 2022[102]. - Share-based compensation in research and development decreased to $0.8 million for the three months ended June 30, 2023, down from $1.0 million for the same period in 2022[103]. General and Administrative Expenses - General and administrative expenses for the three months and six months ended June 30, 2023 were $2.0 million and $2.9 million, respectively, down from $3.0 million and $4.3 million for the same periods in 2022[90]. - General and administrative expenses decreased by $1.0 million to $2.0 million for the three months ended June 30, 2023, compared to $3.0 million for the same period in 2022, representing a 34% decrease[105]. - Salaries and related expenses decreased by 53% to $826 thousand for the three months ended June 30, 2023, compared to $1.748 million in the same period of 2022[105]. Revenue and Income - Manufacturing revenue was $0 for the three months and six months ended June 30, 2023, compared to $1.5 million and $2.0 million for the same periods in 2022, due to the completion of the Janssen Transaction Addendum[97][98]. - Interest income increased significantly to $2.509 million for the three months ended June 30, 2023, compared to $241 thousand in the same period of 2022[109]. - Total other income for the three months ended June 30, 2023, was $4.587 million, a substantial increase from a loss of $2.158 million in the same period of 2022[109]. - The company received $750 thousand in other income in June 2023 from a settlement agreement, contributing to the increase in total other income[109]. Cash Position - Cash and cash equivalents totaled approximately $143.4 million as of June 30, 2023, down from $225.8 million at June 30, 2022[111]. - Net cash used in operating activities was $13.805 million for the six months ended June 30, 2023, compared to $11.5 million for the same period in 2022, indicating increased cash outflow[111]. Workforce - As of June 30, 2023, XBiotech had 84 employees, indicating a stable workforce as it continues its research and development efforts[82]. Financial Strategy - The company has not engaged in any off-balance sheet activities since inception, indicating a conservative financial strategy[116].

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, 2023 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 Employ ...

Financial Performance - The company incurred approximately $31.5 million in research and development expenses for the fiscal year ended December 31, 2022[81]. - As of December 31, 2022, the company reported a net loss of $32.9 million, compared to a net loss of $17.4 million for the year ended December 31, 2021[182]. - Total revenue for the year ended December 31, 2022, was $4.0 million, a decrease of 78% from $18.4 million in 2021[201][202]. - General and administrative expenses for the year ended December 31, 2022, were $6.3 million, down from $9.4 million in 2021[189]. - The company expects to incur significant and increasing operating losses for the foreseeable future as it advances drug candidates through preclinical testing and clinical trials[182]. - The company does not expect to generate any revenues during the fiscal year of 2023[182]. - Interest income rose significantly to $3.8 million in 2022 from $467 thousand in 2021, driven by interest from Canadian bank accounts[208]. - The company's cash and cash equivalents totaled approximately $157.3 million as of December 31, 2022, down from $237.0 million in 2021[211]. - Net cash used in operating activities was $(14.8) million in 2022, compared to $69.4 million provided in 2021, indicating a shift in cash flow dynamics[212]. Research and Development - XBiotech has developed a pipeline of product candidates targeting inflammatory and infectious diseases, with ongoing clinical studies in oncology and rheumatology[27][31]. - The company is developing multiple True Human™ antibodies targeting IL-1a for different medical areas to diversify risk and maximize value[32]. - The company has initiated clinical programs for anti-IL-1a therapies in various conditions, including pancreatic cancer and stroke[31]. - Total research and development expenses for the year ended December 31, 2022, were $31.5 million, an increase from $28.3 million in 2021, with research and development expenses accounting for 83% of total operating expenses[185][187]. - The company has recorded total research and development expenses of $279.1 million from inception through December 31, 2022[185]. - Share-based compensation accounted for $3.6 million in research and development expenses for the year ended December 31, 2022[185]. Regulatory and Market Challenges - The company has not obtained regulatory approval for any product candidates and may face challenges in achieving such approvals in the future[69]. - The regulatory approval process is lengthy and unpredictable, typically taking several years, and there is no guarantee of approval[100]. - The company must establish a commercial organization and secure reimbursement from third-party payers to successfully market products[92]. - New laws or regulations could impact the ability to receive necessary approvals for marketing and commercialization of product candidates[95]. - The company faces potential delays or halts in clinical trials due to undesirable side effects from product candidates, which could adversely affect revenue generation and financial condition[104]. - Regulatory authorities may impose additional warnings or restrictions on approved products if undesirable side effects are identified post-marketing, impacting market acceptance[105]. - The company recognizes the competitive nature of the therapeutic antibody market, facing numerous existing and emerging products[64]. - The company faces substantial competition from large pharmaceutical and biotechnology firms, which may lead to others developing products more successfully or faster[123]. Financial Position and Funding - The company maintains a strong cash position with no debt, allowing for continued investment in R&D and commercialization of drug candidates[30]. - The company may need to obtain additional funding to continue operations if profitability is not achieved[90]. - Raising additional capital may dilute existing shareholders and impose restrictions on the company's operations[162]. - The company believes its cash and liquid assets will be sufficient to fund operations and meet capital requirements[216]. Intellectual Property and Competitive Position - The company has a large international intellectual property portfolio to protect its technology, services, and products[66]. - The company’s ability to protect its proprietary technology through patents and trade secrets is uncertain, which could harm its competitive position[141]. - The company may face challenges in protecting its intellectual property rights, which could limit its ability to stop competitors from using similar technologies[146]. - The company may need to license intellectual property from third parties, which may not be available on commercially reasonable terms, potentially impacting its business[148]. Operational and Management Considerations - The company has identified significant unmet medical needs for True Human™ anti-infective antibody therapies, particularly for vulnerable populations[33][35]. - The company is highly dependent on its Chief Executive Officer, John Simard, whose loss could adversely affect business operations[133]. - The company may encounter difficulties in managing growth, including effective management of clinical trials and integration of new employees[134]. - As of December 31, 2022, the company had 85 full-time employees, with no collective bargaining agreements in place[59]. - As of December 31, 2022, the company had 85 employees and anticipates needing additional personnel to support future growth[130]. Market and Commercialization Risks - The company lacks an established sales and marketing infrastructure, which may hinder its ability to generate revenue from approved products[117]. - Market acceptance among physicians, patients, and healthcare payers is essential for commercial success, and failure to achieve this could compromise profitability[119]. - Coverage and adequate reimbursement from third-party payers are critical for the commercial success of any approved products, with potential delays in obtaining such coverage[115]. - The company may not be able to obtain commercially reasonable product liability insurance, which could expose it to significant liabilities[129]. - The ongoing COVID-19 pandemic has disrupted the company's operations and may continue to impact its business in 2023 and beyond[85]. - The COVID-19 pandemic has adversely impacted the supply chain, potentially disrupting manufacturing and clinical trial operations[88].