A specialized biotech firm, like a focused Amgen, dedicated to 'True Human' antibody therapies.

A drug discovery company, akin to a targeted Regeneron Pharmaceuticals, but centered on its 'True Human' antibody platform.

• True Human Monoclonal Antibodies: These therapies are developed to treat a variety of inflammatory and infectious diseases.
• Interleukin-1 Alpha Therapies: These therapies target interleukin-1 alpha to treat medical conditions such as cancer, stroke, heart attack, and arthritis.
• True Human COVID-19 Therapy: A specific therapy under development for treating the COVID-19 mutant virus.

John Simard, Founder, Chairman of the Board, Scientific Advisor

John Simard founded XBiotech in 2005. He graduated from the biochemistry program at the University of Saskatchewan in 1992 and studied immunology at the University of Toronto. Prior to XBiotech, he launched CTL ImmunoTherapies Corp. in 1997 and spun out Allecure Corp. in 1999. In 2001, Allecure and CTL ImmunoTherapies merged with a third company to form MannKind Corp., where Mr. Simard served on the board and as President of its Immunotherapy division until 2002. In 2019, he orchestrated the sale of the True Human antibody bermekimab to Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, for $750 million. He is the inventor of over 300 issued and pending patents related to immunotherapies.

Sushma Shivaswamy, Interim Chief Executive Officer & Chief Scientific Officer

Dr. Sushma Shivaswamy was appointed Interim CEO effective December 8, 2025, and has served as XBiotech's Chief Scientific Officer since November 2017. She oversees all scientific and technical operations for research and development and GMP production of antibodies. Dr. Shivaswamy has been with XBiotech since 2009, previously serving as Vice President of Research and Development from January 2015, and as Director of Research & Development and Senior Scientist. Before joining the company, she was a postdoctoral researcher at the Center for Systems and Synthetic Biology at the University of Texas at Austin. She holds a Ph.D. in Molecular Biology from the Center for Cellular and Molecular Biology, India.

Angela Hu, Principal Financial Officer and Principal Accounting Officer

Angela Hu assumed the role of Principal Financial Officer and Principal Accounting Officer on February 10, 2023. She previously served as the Financial Controller of XBiotech Inc.

Qian Wu, Senior Vice President of Clinical Operations & Analytical Quality

Qian Wu serves as the Senior Vice President of Clinical Operations & Analytical Quality at XBiotech Inc.

The key risks to XBiotech's business include:

1. Clinical Trial Failures and Regulatory Hurdles: XBiotech faces significant risks related to the failure of its product candidates to advance through clinical development or achieve the primary endpoints in trials. The company has experienced setbacks with several drug candidates, including a Phase II trial for a staph infection drug where patients died, and the drug failed to show statistically significant improvements. Similarly, its rheumatoid arthritis treatment, Natrunix, failed to meet its primary endpoint in a Phase II study amidst "substantial irregularities". The European Medicines Agency (EMA) also rejected XBiotech's lead cancer therapy, Xilonix, citing "dubious data," an increased risk of infection in patients, and concerns regarding manufacturing processes. These failures directly impact the company's ability to gain regulatory approval and bring products to market, leading to increased expenses and delays.
2. Financial Sustainability and Reliance on Future Capital Raises: XBiotech has a history of operating losses and has accumulated a significant deficit, reporting a net loss for the fiscal year ended December 31, 2024, and expecting to continue incurring substantial expenses and operating losses for the foreseeable future. The company has "limited opportunities to generate revenue and may never sustain profitability". Its primary source of past revenue, a manufacturing deal for Bermekimab, concluded in November 2022, leaving the company with "no approved products and no guaranteed future revenue" unless new milestones, royalties, or partnerships are secured. The ongoing research and development (R&D) and clinical trial expenses will necessitate future capital raises, which are subject to market conditions and the company's cash burn rate.
3. Competition and Intellectual Property Risks: XBiotech operates in a highly competitive biopharmaceutical industry and faces the risk that competitors may discover, develop, or commercialize products more rapidly or successfully. Its "True Human antibodies will face scrutiny against established treatments". Additionally, the company faces risks associated with intellectual property, including potential inability to obtain or protect necessary intellectual property rights, the possibility of its technology infringing upon third-party rights, and difficulties in licensing essential intellectual property on reasonable terms.

Addressable Markets for XBiotech (XBIT) Main Products or Services:

• True Human Monoclonal Antibodies for Various Diseases (Inflammatory and Infectious Diseases, including those targeted by Interleukin-1 alpha therapies for conditions like cancer and arthritis): The global monoclonal antibodies market was estimated at USD 237.64 billion in 2023 and is expected to surpass USD 679.03 billion by 2033, growing at a CAGR of 11.07% from 2024 to 2033. North America held the largest share of this market, accounting for 48% in 2023.
  • For oncology applications, the monoclonal antibodies market generated 49.35% of global revenue in 2025.
  • For autoimmune diseases, including conditions like arthritis that XBiotech targets with IL-1α therapies, the monoclonal antibodies market is projected to grow at a lucrative rate due to increasing prevalence. This segment is also expected to post the strongest compound annual growth rate (CAGR) among indications through 2031.
• Interleukin-1 Alpha (IL-1α) Therapies (specific market for this product): null. While the market for Interleukin-1 alpha (IL-1α)-related products is experiencing significant growth due to the rising prevalence of inflammatory diseases, precise market figures for the overall IL-1α market for the period 2019-2033 are unavailable.
• True Human COVID-19 Therapy: The global COVID-19 therapeutics market size was valued at US$ 30.7 billion in 2021. This market is projected to contract to more than US$ 16.2 billion by the end of 2031. Another estimate places the global COVID-19 therapeutics market size at USD 32.54 billion in 2025, with an expected decline to USD 8.70 billion by 2033.

XBiotech Inc. (XBIT) is a biopharmaceutical company focused on discovering, developing, and commercializing True Human monoclonal antibodies. As a clinical-stage company, its future revenue growth over the next 2-3 years will primarily be driven by the successful advancement, regulatory approval, and potential commercialization of its pipeline products.

Here are 3-5 expected drivers of future revenue growth for XBiotech:

1. Commercialization of Natrunix for Oncology Indications: XBiotech is actively pursuing interleukin-1 alpha (IL-1α) therapies for various medical conditions, including cancer. The company announced promising results from a Phase 1/2 study for advanced pancreatic cancer using Natrunix in combination with standard chemotherapy in June 2024. Ongoing discussions with the FDA regarding a regulatory path for Natrunix in oncology suggest that successful clinical trials and subsequent regulatory approval could lead to significant revenue generation.
2. Advancement and Commercialization of True Human Anti-infective Antibody Therapies: XBiotech has identified several major areas of urgent unmet medical need within infectious diseases and is dedicated to advancing its pipeline of True Human anti-infective antibody therapies. Successful progression through clinical trials and eventual market entry for these therapies represent a potential new stream of revenue.
3. Commercialization of Hutrukin for Stroke: The company completed a Phase I study for Hutrukin, a True Human antibody therapeutic designed to reduce brain injury after reperfusion procedures in stroke patients, at the end of 2023. This study demonstrated that high bolus doses of Hutrukin were safe and well-tolerated. While a Phase II study is currently on hold pending clarification of regulatory paths for other programs, successful future clinical development and regulatory approval of Hutrukin could contribute to revenue growth.
4. Potential for IL-1α Therapies in other Inflammatory Diseases: Beyond specific programs, XBiotech maintains a broader focus on developing a pipeline of product candidates targeting inflammatory diseases. While the rheumatology program for rheumatoid arthritis faced setbacks and is currently on hold due to irregularities in a Phase II study, the company continues to believe in the potential for Natrunix as a treatment for arthritic diseases. Future successful development and commercialization of IL-1α therapies for other inflammatory conditions could serve as a revenue driver.

Share Repurchases

• XBiotech announced an $80 million buyback offer on May 17, 2023.

Inbound Investments

• XBiotech received $75 million from an antibody sale of bermekimab on June 30, 2021.
• In January 2024, XBiotech announced it expects to receive $10 million in funding.

Capital Expenditures

• Capital expenditures in the most recent reported quarter totaled approximately $0.11 million USD.
• XBiotech plans to begin constructing a new research and development facility on its 48-acre campus in Austin, Texas, to support commercialization and infectious disease programs, as announced in January 2024.