ACC 317 Managerial Accounting: Assignment 1 Start-up Budgeting
Company Information
XBiotech (NASDAQ) Symbol:XBIT Headquarters 8201 E Riverside Dr. Bldg 4,Ste. 100 Austin Texas - 78744 Phone : 1-512-386-2900 Email:[email protected] Website:www.xbiotech.com Industry Classification: Pharmaceuticals and Biotechnology > Biopharmaceuticals/Biotechnology Business Summary XBiotech is a biopharmaceutical company focused on developing next generation therapeutic antibodies. The company was founded in 2005 by John Simard with a mission to develop a next generation of better, safer therapeutic antibodies. It is building on a foundation of remarkable new therapies, innovative approaches to commercialization and a commitment to realizing treatments for unmet medical needs worldwide. XBiotech is focused on developing biological therapies - including a pipeline of True Human™ antibodies and proven blockbuster biosimilars. It has developed the manufacturing technology to enable production of biological drugs with an unprecedented low cost of goods. The company has conducted a number of Phase I/II clinical trials for its lead product candidate Xilonix™ that is used in improving survival in metastatic colorectal cancer patients. It has discovered a True Human antibody for treating methicillin resistant staphylococcus aureus (S. aureus) infections. XBiotech’s antibody therapy is designed to neutralize a key immune evasion mechanism of the bacteria, enabling the body’s immune system to naturally, safely and effectively eradicate S. aureus infection. Its Xilonix™ is a first-in- class True Human™ monoclonal (IgG1k) antibody that neutralizes biological activity of interleukin-1a. The company’s Xilonix™ was cloned from an affinity matured, human immune response-with no in vitro sequence modifications to improve binding affinity. Its Xilonix™ may be used as a monotherapy without concomitant medications to reduce adverse reactions. The company’s True Human™ antibody gene is cloned directly from a human gene, using proprietary methods and technology to ensure faithful reproduction of the original human gene. Its True Human™ antibodies will be "invisible" to the body's immune system and thus exhibit better safety, efficacy and commercial value compared to earlier generation antibody therapeutics. The company’s clinical trial areas include: Oncology, MRSA, Cardiovascular Disease, Dermatology, Type 2 Diabetes, etc. XBiotech has agreements with: Brigham and Women's Hospital, The NCIC Clinical Trials Group (NCIC CTG), Lonza Sales AG, Strox Biopharmaceuticals LLC, US Oncology Research Inc, etc. Its partners include: Sarah Cannon, South Texas Blood & Tissue Center, Pelota Ventures LLC, Jacesa Investments Limited, etc.
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Table of Contents Product Glance -------------------------- 3
Products by Therapy Area -------------------------- 4
Product Pipeline/Summary -------------------------- 5
Management Profile -------------------------- 6
Recent News -------------------------- 12
Company Announcemets -------------------------- 12
Deals and Alliances -------------------------- 15
Financials -------------------------- 17
Intellectual Property -------------------------- 19
Product Updates -------------------------- 20
Regulatory -------------------------- 27
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Product Glance Products By Phase of Development
No. of Projects By Phase of Development
Trial Phase No.of Products
Pending Approval 1 Phase II 1 PreClinical 2 Research 6
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Products by Therapy Area
No.of Products by Therapy Area
Therapy Area No.of Products
Immunology and Inflammation 4 Oncology 3 Infectious Diseases 2 Dermatology 2 Endocrine, Metabolic and Genetic Disorders 2
Gastroenterology 1 Hematology 1 Respiratory 1 Cardiovascular 1
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Product Pipeline
Product Name Condition Treated Trial Phase Source Partner
Xilonix Acne Vulgaris PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Colorectal Cancer PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Hematological Malignancies PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Metastatic Colorectal Cancer PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Non-Insulin-Dependent Diabetes Mellitus PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Non-Small Cell Lung Cancer PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Oncology PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Plaque Psoriasis PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Restenosis PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Rheumatoid Arthritis PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Skin Ulcers PA XBiotech, Inc.~18503 US Oncology Research, Inc. Xilonix Vascular Diseases PA XBiotech, Inc.~18503 US Oncology Research, Inc. 514G3 Staphylococcal Infections II -- -- Anticancer monoclonal antibody XBIOTECH Oncology PC -- --
Anti-Ebola Antibodies XBIOTECH Ebola Viral Infections PC -- --
X083NAB Crohn's Disease R -- -- X083NAB Insulin-Dependent Diabetes Mellitus R -- -- X083NAB Psoriasis R -- -- X082NAB Systemic Lupus Erythematosus R -- -- X081NAB Hypereosinophilic Syndrome R -- -- X072NAB Chronic Obstructive Pulmonary Disease R -- -- X071NAB Autoimmune Disorders R -- -- X071NAB Multiple Myeloma R -- -- IL-6 Antibody XBIOTECH Autoimmune Disorders R -- --
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Management Profile
John Simard -- Chairman, Chief Executive Officer, Founder, President and Director
Mr. Simard founded XBiotech in 2005. Prior to XBiotech, he was founder and Chief Executive Officer of the therapeutic vaccine developer CTL ImmunoTherapies Corp., headquartered in Los Angeles with over 100 scientists and support staff. Mr. Simard also founded AlleCure Corp., of Valencia, California, a developer of immune-modulating therapies. In 2001, AlleCure and CTL ImmunoTherapies merged to form MannKind Corp., where Mr. Simard served as Corporate Vice President and Member of the Board. Mr. Simard invented the core technologies which form the basis for each of the commercialization programs. Operationally, he has championed an integrated approach to drug development, undertaking R&D, manufacturing and clinical regulatory programs under one roof - which he has used as an effective means to conserve capital and control timelines. Mr. Simard holds a degree in Biochemistry from the University of Saskatchewan and attended graduate studies in Medical Biophysics/Immunology at the University of Toronto. He has numerous patents related to cancer therapy, therapeutic vaccines and therapeutic antibodies, as well as substantial peer-reviewed scientific publications and the textbook "Immune Response Genes".
Scott Whitehurst -- Chief Financial Officer
Whitehurst joins XBiotech from Amgen, where he served as Vice President of Finance, Operations, for the past eight years. While at Amgen, he was instrumental in developing and implementing a strategy to optimize Amgen’s manufacturing network and supply chain and in creating Amgen’s Global Business Services unit. He also served as Chief Financial Officer of Novartis Animal Health in Basel, Switzerland. Prior to his time at Novartis, Whitehurst spent 14 years at the Hewlett-Packard Co. in various financial management positions throughout the world, ultimately becoming Vice President of Finance responsible for some of the company's largest divisions, regions and acquisitions.
Trey Benson -- Commercial Head
Benson's extensive experience has seen him serve as Vice President of Marketing at Edgemont Pharmaceuticals, as well as nine years at Xenoport, Inc., where he held titles of Senior Director, Strategic Product Planning; Executive Director, Commercial Development; and as Vice President of Marketing and Commercial Development. At Xenoport, Inc., Benson led all Horizant (gabapentin enacarbil) promotional activities, including launch planning in co-promotion collaboration with GSK, building the commercial organization and marketing team, and being responsible for sales performance. Benson began his career with Abbott Laboratories and Eli Lilly, and has been continuously recognized for his excellence in commercialization, product strategy, and marketing.
Stanley Kim -- Vice President of Corporate Development and Intellectual Property
Kim has been responsible for engineering XBiotech’s intellectual property portfolio since 2007. Dr. Kim focus has been creating and managing an evolving a strategic and tactical program to strengthen XBiotech’s patent position with respect to True Human antibodies, and the treatment of chronic inflammation. Dr. Kim also acts as counsel on technical legal and business matters such as clinical trials, in- and out- licensing, vendor agreements, collaborations, and finance. Prior to joining XBiotech, Dr. Kim was a partner at a law firm where he led the firm's patent and life sciences practices. A registered patent attorney, Dr. Kim has considerable experience in procuring domestic and foreign patents, licensing and joint ventures, intellectual property opinions and due diligence, strategic patent portfolio development, and intellectual property litigation matters. Dr. Kim is himself an inventor of several patents, has published several legal articles, has been an invited speaker in numerous forums, and has founded or co-founded several different technology companies. Dr. Kim holds a bachelor's degree in Biology from Bowdoin College, a Ph.D. in Microbiology and Immunology from the University of Miami, and a law degree from Suffolk University.
Erika Geimonen -- Vice President of Business Development
Dr. Geimonen is Vice President of Business Development of this company. She brought success in negotiating Pharma and Biotech deals and M&As to XBiotech. She has a diverse BD background, including substantive in- and out- licensing, product management, acquisitions, operations and strategic planning coupled with extensive technical knowledge in life sciences. Dr. Geimonen has accomplished licensing deals related to medical devices, small molecule entities, antibodies, delivery and inhalation systems, oncology related products, anti- infectives, animal products and platform technologies. She was involved in acquisitions of branded and specialty pharmaceutical companies. Dr. Geimonen held different scientific positions at Stony Brook University and Helsinki University, Finland. She has a Ph.D. in Biochemistry
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from Moscow State University, and a M.S. in Management and Policy from the State University of New York.
Kelly R. Thornburg -- Senior Vice President, Operations
Thornburg joined as Senior Vice President, Operations and spent 16 years at Amgen where he held a variety of senior level positions. Thornburg served as an Executive Director, Quality Site Head at Amgen’s Colorado facility, where he managed all aspects of Amgen’s quality functions with responsibility for two protein drug substance manufacturing plants and GMP warehouse facilities. Before that, Thornburg served as Executive Director, Quality Control, where he managed the Quality Control Laboratory function for the Amgen Manufacturing site in Juncos, Puerto Rico.
Norma I. Gonzalez -- Vice President of Quality
Ms. Gonzalez was one of the first employees to join XBiotech’s operation in Austin, Texas in 2008. She played a crucial role in launching XBiotech’s manufacturing program and establishing the company’s bioreactor system for the production of clinical trial drug product. Ms. Gonzalez transitioned to developing a full quality program, to enable cGMP compliance and growth of the company’s manufacturing program. Ms. Gonzalez continues to prepare the company to enable pivotal study and commercial scale production. Before joining XBiotech, Ms. Gonzalez was Director of Quality at a world-leading leading manufacturer of heart valves, Carbomedics. During her tenure at Carbomedics, Ms. Gonzalez held various roles including Director of R&D, Director of Manufacturing Mechanical Heart Valve, and Director of Tissue valve and Quality. Prior to Carbomedics, Ms. Gonzalez worked for Shiley Caribbean as a Quality Control & Manufacturing Manager as well as Baxter-Travenol as a Microbiology/QC Supervisor. Ms. Gonzalez holds a B.Sc. in Biology from University of Puerto Rico.
Queena Han -- Vice President, Finance & Human Resources and Secretary
Ms. Han has been responsible for XBiotech’s accounting, auditing and budgeting since 2005 when the company was incorporated in Vancouver, Canada. She played an important role working with others to build XBiotech in the U.S. She is responsible for financial planning and budgeting, reporting, auditing, taxation, internal control, insurance, legal and regulatory compliance regarding all financial functions, and maintenance of cash flow position. She serves as a liaison among directors, investors and the company. She is also responsible for all aspects of Human Resources within the company. Ms. Han has over 20 years experience in accounting and finance, and has held several executive positions. Prior to joining XBiotech, she served as Chief Financial Officer (CFO) for a public company with a nation-wide pay phone hardware and service business. Ms. Han has a B.A in accounting and holds the Certified General Accountant designation in Canada. She is a professional member of SHRM and holds the Human Resource Management Certification from UT Austin.
Jim Ferguson -- Senior Director of CMC Compliance
Jim Ferguson joined XBiotech in 2008 and has played several roles in the Company. As Sr. Director of Chemistry Manufacturing and Controls (CMC) Compliance at XBiotech, Jim oversees regulatory compliance throughout the development cycle and is primary author of all CMC regulatory submissions. He also plays an important role in providing scientific and technical expertise in the areas of pharmaceutics, process development, assay development and instrumentation. He has worked in the area of GMP biologics development for 12+ years, and previously for 10+ years as a bench-level biochemist. Mr. Ferguson studied biochemistry at the University of Toronto and operated the biotechnology core facility at the Ontario Cancer Institute in Toronto. He then worked in various capacities at CTL ImmunoTherapies (MannKind Corporation) in Los Angeles, starting as formulation chemist, and ending as Director of Clinical Manufacturing. Mr. Ferguson graduated from the University of Toronto with a B.Sc. in Biochemistry.
Gregory Daniel Frank -- Director of Business Development
Dr. Frank is focused on partnering (out-licensing) XBiotech's lead compounds for continued clinical development and commercialization. Dr. Frank has 15 years of experience in pharmaceutical licensing, business development, marketing, market research, strategic alliances, and sales. Prior to XBiotech, Dr. Frank was involved in business development for all aspects of SRI International's business model, driving funding and partnering for basic research, drug discovery, and contract research (CRO) services. Dr. Frank brings a diverse background and a deep understanding of drug development and the market forces that influence the pharmaceutical industry to his BD role. He graduated with a degree in Biology from the University of California at Santa Cruz and a Ph.D. in Immunology from Stanford University. Dr. Frank is a member of the Board of Governors for the Stanford University Medical Center Alumni Association (SUMCAA).
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Robert Lindsey -- Senior Vice President Corporate Development and General Counsel
Mr. Lindsey joins XBiotech from Dell where he served as Legal Director. In that capacity, Mr. Lindsey acted as the sole securities counsel for Dell and was the primary attorney responsible for the treasury, accounting, investor relations, corporate communications and internal audit groups. Most recently, Mr. Lindsey played a key role in Dell’s going private transaction, which was the largest technology leveraged buy-out to date. As a registered patent attorney, at Dell Mr. Lindsey also helped evaluate intellectual property in respect to M&A transactions. Mr. Lindsey holds a B.A. in Chemistry from Harvard University and a J.D. from the University of Virginia. Previously, he was a member of the corporate and securities group of Gibson, Dunn and Crutcher, LLP, a global 1,100 member law firm, where he was involved in the issuance of billions of dollars of securities and advised dozens of Fortune 500 clients on corporate and SEC related matters. As a Chartered Financial Analyst (CFA), Mr. Lindsey also has significant non-legal finance experience.
Josh Combs -- Vice President of Manufacturing
Gary Gonzales -- Vice President, Clinical Operations
Mr. Gonzales joins XBiotech from INC Research where he managed large, global pivotal phase III trials. Mr. Gonzales has B.S. & M.S. degrees in chemistry and biology and also holds a M.B.A. Mr. Gonzales comes to XBiotech with 20 years of industry experience with clinical operations and program management expertise and directly contributed to all stages of development for Lemtrada™ (alemtuzumab), a therapeutic monoclonal antibody.
David J. Combs -- Vice President, Manufacturing
Combs oversees a team that manages all aspects of the manufacturing program—from initiation of cell culture process to fill and finish of drug product. Dr. Combs also oversees a team of research scientists working on both upstream and downstream process development, including media development and product purification technology. In addition, he heads up efforts to develop a custom bioreactor system that will reduce XBiotech’s capital requirements for manufacturing expansion. Dr. Combs previously worked for The Cancer Research Institute at Scott and White Memorial Hospital where he served as Senior Scientist, in charge of pre-clinical development, process development, manufacturing and formulation of immuno-toxins used for clinical trials. While at Scott and White, Dr. Combs was involved in the design and set up of a cGMP facility and has extensive experience designing and running bioreactors used for the production of therapeutics. Dr. Combs has a B.Sc. in Biology from Tarleton State University and a Ph.D. in Cellular and Molecular Biology from The University of Texas at Austin.
Sushma Shivaswamy -- Vice President of Research and Development
Shivaswamy joined XBiotech in 2009 as a senior research scientist and quickly advanced to lead the research and development. The multidisciplinary R&D group has pioneered development of the Company’s technology platform for discovery of True Human™ antibodies. Dr. Shivaswamy has lead the group in the development of new approaches for screening human blood for novel True Human™ antibodies based on super-high-stringency mining technology. She has also led the group to establish the Company’s new molecular cloning and proteomics strategies for identifying the True Human™ therapeutics. Dr. Shivaswamy’s program has also included development of the high- output manufacturing cell lines, for producing antibodies in mammalian cells for large-scale commercial production. Dr. Shivaswamy has an academic background in regulation of eukaryotic gene expression, and is an expert in molecular genetics. Prior to joining XBiotech, Dr. Shivaswamy was a postdoctoral researcher at the Center for Systems and Synthetic Biology at the University of Texas at Austin. She has a Ph.D. degree in Molecular Biology from the Center for Cellular and Molecular Biology, India.
Fabrizio Bonanni -- Director, Chairman of Audit Committee and Member of Compensation, Nominating and Corporate Governance Committee
Dr. Fabrizio Bonanni served senior operating roles at Amgen Inc. from 1999-2012. These included Executive Vice President, Operations from (2007-2012). Prior to overseeing operations, he served as Senior Vice President, Manufacturing, Senior Vice President, Quality and Compliance. Earlier, Dr. Bonanni held various management positions at Baxter International, Inc. from 1974 to 1999, including positions as Corporate Vice President, Regulatory and Clinical Affairs and Corporate Vice President, Quality System.
Seema Kumar -- Director of Quality Control
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Kumar has grown XBiotech’s quality control program since early 2008. Dr. Kumar leads a multidisciplinary team engaged in testing quality and stability of drug product during manufacturing, and as final product, in compliance with cGMP and regulatory guidelines. Under her direction is also clinical pharmacokinetics analysis of drug product in compliance with CLIA regulations. Dr. Kumar brings an extensive background in development, implementation and optimization of bioanalytical, biochemical & biophysical methods for the characterization therapeutic antibodies. Dr. Kumar earned a Ph.D. in Biophysics/Biophysical Chemistry from Johns Hopkins University. In her scientific career, she developed state-of-the-art biophysical and bioanalytical methods, authored internationally recognized scientific articles, and has lectured on the subject at numerous international conferences.
Prasant Mohanty -- Director of Biostatistics
Mohanty is a medical statistical expert and is responsible at XBiotech for creating statistical models, sample size and power calculation, experimental design and analysis of clinical trials. As a key member of the Copmany’s clinical and regulatory team, Dr. Mohanty analyzes and interprets data from individual trials, determines strategy and development of internal guidelines, as well as providing statistical expertise for issues in preclinical and clinical research. Dr. Mohanty spent several years with Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, TX as a clinical biostatistician, and five years with Texas Medicaid Healthcare Partnership, Austin TX, as Healthcare Policy Analyst, and three years as an Epidemiologist with Texas Healthcare Information Council (a state agency under Texas Health and Human Services Commission). Dr. Prasant is a SAS Certified Professional, and also holds a Clinical Research Professional certification. Dr. Mohanty has had more than 20 peer-reviewed publications within only the last three years. Dr. Mohanty received his medical degree from S.C.B. Medical College, Orissa, India. He completed his Master of Public Health degree in epidemiology and biostatistics from the University of North Texas Health Science Center, Fort Worth, Texas.
Martin Schmieg -- Chief Financial Officer
Martin has over twenty years of experience launching and building businesses in the life sciences industry. He has successfully demonstrated an ability to drive companies with innovative technology to successful product based enterprises while increasing market capitalization values through proven financial management, negotiating and fundraising skills. He has previously served as Chief Financial Officer to Isolagen, Inc., Sirna Therapeutics, Inc., Advanced Bionics Corporation and Cytometrics, Inc. Martin holds a BS in Business Administration from LaSalle University and has guest lectured at the MIT Sloan Sloan School of Management and the University of Pennsylvania School of Engineering, Arts and Sciences.
Bruce Maurer -- Chief Financial Officer and Vice President
Mr. Maurer was Corporate Treasurer at Silicon Laboratories, a semiconductor design company headquartered in Austin, Texas, from 2003 to 2011, and Director of Finance from 1999 to 2003, where he helped launch its initial public offering in March, 2000. From 1985 to 1999, he served as the Chief Financial Officer of Silicon Metrics, and held various operational, finance and management roles at Cirrus Logic, Dell Computer and Price Waterhouse in Austin, Texas. Mr. Maurer received a B.B.A. in Accounting with highest honors from the University of Texas and is a Certified Public Accountant.
Dawn McCollough -- Head Clinical Operations
McCollough joins XBiotech from Biogen, Inc., where she served as head of Medical Research Operations and led the Medical Research team, which included the company’s Clinical Trial Review Committee. Prior to Biogen, McCollough was head of the Global Monitoring Organization for North America at Novartis Vaccines and Diagnostics, Inc., based in Cambridge, Mass. McCollough began her Novartis career in their Vaccines and Diagnostics division in Siena, Italy, as Global Head of Clinical Trial Governance. She has been recognized consistently for her high performance and was chosen as a top Women’s Leader by both companies.
Thorpe Mckenzie -- Director, Chairman of Nominating and Corporate Governance Committee and Member of Audit Committee
Mr. McKenzie is Managing Director of Pointer Management Company, Chattanooga, Tennessee, which he co-founded in 1990 to invest in hedge funds and similar types of partnerships utilizing a fund of funds approach. From 1982 until 1990, he was a private investor in New York City, and a director of several public and private companies. From 1980 until 1982, he was founding general partner of TIGER, a global hedge fund. From 1971 until 1980, he was a Vice President of Kidder, Peabody & Co., Inc. in New York. Mr. McKenzie is a graduate of the University of North Carolina in Chapel Hill, and the Wharton Graduate division of the University of Pennsylvania in Philadelphia.
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Hector McKay-Dunn -- Director
Mr. MacKay-Dunn is a senior partner at Farris, Vaughan, Wills & Murphy LLP based in Vancouver with over 25 years of experience advising early stage and high growth private and public companies in a broad range of industries on domestic and cross border public and private securities offerings, mergers and acquisitions, tender offers and international partnering transactions. Mr. MacKay-Dunn advises clients in a variety of commercial industries, including biotechnology, technology, cleantech, new media, mining, transportation, personal and health fitness. Mr. MacKay-Dunn was named in the 2011 Lexpert/American Lawyer Guide to the Leading 500 Lawyers in Canada and listed in The Best Lawyers in Canada. Mr. MacKay-Dunn is immediate past Chair of the BC Innovation Council, a director of LifeSciences BC, BC Leading Edge Endowment Fund, and Tennis Canada and is also a member of the University of British Columbia Industry Liaison Advisory Council and Faculty of Science Dean’s Advisory Counsel.
Daniel Vasella -- Director, Chairman of Compensation Committee and Member of Audit Committee
Daniel Vasella has served as a director since November 4, 2014. Dr. Vasella is the Honorary Chairman and Former Chairman and Chief Executive Officer, Novartis AG, a company that engages in the research, development, manufacture and marketing of health care products worldwide. Dr. Vasella served as Chairman of Novartis from 1999 to February 2013 and as Chief Executive Officer from 1996 to January 2010. From 1992 to 1996, Dr. Vasella held the positions of Chief Executive Officer, Chief Operating Officer, Senior Vice President and Head of Worldwide Development and Head of Corporate Marketing at Sandoz Pharma AG. Dr. Vasella is a director of American Express, Inc., PepsiCo, Inc., a member of the International Business Leaders Advisory Council for the Mayor of Shanghai, a foreign honorary member of the Academy of Arts and Sciences, a trustee of the Carnegie Endowment for International Peace and a member of several industry associations and educational institutions.
Rolf Zinkernagel -- Advisor
Zinkernagel is a member of the Board of Directors of Novartis AG, a world leading pharmaceutical company. Dr. Zinkernagel is among the most distinguished medical researchers and immunologists, his recognition including the Nobel Prize for Medicine (1996). Dr. Zinkernagel is formerly Head of the Institute for Experimental Immunology, University of Zurich.
Michael Stecher -- Medical Director
Dr. Stecher is focused on developing clinical programs to treat chronic inflammatory diseases by targeting the interleukin-1 system. He has worked with an acclaimed group of international physician researchers and scientists to help develop breakthrough clinical programs for the treatment of diseases with underlying chronic inflammatory processes. Dr. Stecher is board certified in family medicine. Dr. Stecher graduated from the University of Kansas School of Medicine in 2002 and completed his work in family practice medicine at Austin Brackenridge Hospital where he ultimately served as chief resident of Family Medicine.
Alexander Knuth -- Advisory Board Member
Dr. Knuth is Chief of Oncology, University of Zurich, Switzerland. He is also scientific advisor for the Ludwig Institute for Cancer Research, where he was head of clinical research, overseeing operations for an organization comprising 2,780 medical researchers.
Ernst Butler -- Advisory Board Member
Mr. Bütler is a Member of the Board of Bank Frey & Co AG, Zurich; Chairman of the Board of Alegra Capital Ltd., Zürich; Member of the Board, Solarfun Holding Ltd., China; Chairman of the Board of AA-Capital Ltd., Zurich; and Member of KPMG’s Audit Committee Institute and of PricewaterhouseCooper’s Audit Committee Forum. Mr. Bütler was formerly a Partner and Head of Business Unit for Partners Group, Zug; Managing Director and Co-Head Investment Banking, Credit Suisse First Boston, Zürich/London; and Managing Director & Head Multinational Division, Credit Suisse.
Reto Crameri -- Scientific Advisor
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Crameri is the Head of Allergology, Swiss Institute of Allergy Research. Dr. Crameri is on the Editorial Board of The Biochemical Journal, International Archives of Allergy and Immunology, deputy editor of Mycoses. Dr. Crameri is a world expert on the use of phage display and robot-based high throughput screening technology for fast identification of medically important target molecules. His publication record includes more than 160 articles in international peer-reviewed journals, and about 60 book chapters and other publications.
Craig Rademaker -- Advisory Board Member
Mr. Rademaker has over 25 years experience in the financial industry, covering a multitude of areas and industries, both private and public. These include institutional and retail brokerage, principal trading, equity and debt raising, mergers and acquisitions advice and venture capital as facilitator and principal investor. Mr. Rademaker is the President of Pearse Capital. He holds a B. A. in Economics from Simon Fraser University.
Ashley Otero -- Director, Investor Relations
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Recent News Company Announcemets
06/09/2016 -- XBiotech Appoints Trey Benson as New Commercial Head to Lead Strategic Commercial Development for the Company’s Extensive Product Portfolio
On June 8, 2016 XBiotech announced that Trey Benson has joined the company as Commercial Head, effective June 6. Benson has more than two decades of global healthcare experience, with over 16 years of marketing and commercial development in the pharmaceutical industry, in both established and start-up organizations.
05/17/2016 -- XBiotech Names Industry Veteran Dawn McCollough to Head Clinical Operations
On May 16, 2016 XBiotech announced that Dawn McCollough has joined the company as Vice President of Clinical Operations, effective May 16. McCollough has more than two decades of global industry experience and has overseen all phases of clinical trial drug development across multiple therapeutic areas.
05/04/2016 -- XBiotech Appoints Amgen Veteran Scott Whitehurst as Chief Financial Officer
On May 3, 2016 XBiotech Inc. announced the appointment of Scott Whitehurst as Chief Financial Officer. He will oversee the Company’s financial operations, capital requirements and investor relations function, reporting to John Simard, XBiotech Founder, Chairman and Chief Executive Officer.
11/21/2015 -- Xbiotech Added to The MSCI US Small Cap 1750 and The MSCI Investable Market 2500 Indexes
On November 20, 2015 XBiotech Inc. announced that the Company is being added to the MSCI US Small Cap 1750 and the MSCI Investable Market 2500 Indexes as part of the November 2015 Semi-Annual Index Review for the MSCI Equity Indexes. All changes will be implemented as of market close on November 30, 2015. These changes have been posted on the Index Review web page on MSCI's web site.
10/27/2015 -- Xbiotech Initiates Program to Develop Antibody Against Clostridium Difficile
On October 26, 2015 XBiotech announced the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. difficile) infection. Using its proprietary True Human technology, the Company has begun screening human blood samples from donors to identify and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection.
06/25/2015 -- Xbiotech Added To Russell 2000 Index
On June 24, 2015 XBiotech Inc. announced that the Company has been added to the Russell 2000 Index, Russell 3000 Index, Russell Global Index, and Russell Microcap Index as part of Russell Investments' annual index rebalance on June 29, 2015.
06/09/2015 -- Xbiotech appoints Kelly R. Thornburg as Senior Vice President of Operations
On June 8, 2015 XBiotech announced that Kelly R. Thornburg has joined the company as Senior Vice President of Operations. Mr. Thornburg brings more than 30 years of pharmaceutical operations experience to XBiotech, the prior 16 years spent at Amgen, Inc.
03/13/2015 -- XBiotech Launches Website and Call Center to Inform Cancer Patients about New Xilonix Therapy and Phase III Clinical Study
On March 12, 2015 XBiotech announced that it has launched a website and call center to help patients with metastatic colorectal cancer learn about its U.S. Pivotal Phase III clinical trial.
11/05/2014 -- XBiotech Adds Daniel Vasella to its Board of Directors
On November 4, 2014 XBiotech announced that Dr. Daniel Vasella has joined the Company as a member of the Board of Directors. Dr.
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Vasella was CEO of Sandoz Pharma AG, where he helped engineer one of the largest mergers in pharmaceutical history, uniting Sandoz AG and Ciba-Geigy to form Novartis AG. After the merger, Dr. Vasella was appointed Chief Executive Officer of Novartis AG and ultimately Chairman of the Board, a position he held until 2013. Dr. Vasella was considered by Time Magazine as one of the world’s 100 most influential people, and the Financial Times described him as the most influential European business leader of the last quarter century. Dr. Vasella was known for creating and driving a culture of innovation at Novartis, where it is claimed that he reduced time to market while doubling the number of drugs in late stage development compared to other leading pharma companies.
09/12/2014 -- XBiotech Purchases Automated Vial Filling Machine, Prompting Increased Manufacturing Capabilities
On September 11, 2014 XBiotech announced that it has taken delivery on its new high throughput filling machine that the Company says will be used to dramatically increase its fill finish capabilities. The fully integrated system is designed to fill, stopper and crimp vials, which is the final step in the manufacturing process. Additionally, the unit is said to contain an in-line feed back loop and a laser scanning system to provide a high level of quality compared to less sophisticated filling systems. The Company says the high-speed equipment will allow for an entire lot of drug product to be filled in hours, rather than batching and filling over days with the current process. The equipment will apparently allow for production of over 2,000,000 units of drug product annually, which the Company claims is enough to support launch of its commercial production operation.
06/24/2014 -- XBiotech Announces Addition of Vice President of Clinical Operations
On June 23, 2014 XBiotech announced that Gary Gonzales has joined the Company as Vice President of Clinical Operations. Mr. Gonzales will lead XBiotech’s clinical trial team and manage the Company’s international clinical operations.
04/16/2014 -- XBiotech Welcomes Addition of Senior Vice President Corporate Development & General Counsel
On April 15, 2014 XBiotech announced that Robert Lindsey has joined the Company as Senior Vice President Corporate Development & General Counsel. Mr. Lindsey joins XBiotech from Dell where he served as Legal Director. In that capacity, Mr. Lindsey acted as the sole securities counsel for Dell and was the primary attorney responsible for the treasury, accounting, investor relations, corporate communications and internal audit groups. Most recently, Mr. Lindsey played a key role in Dell’s going private transaction, which was the largest technology leveraged buy-out to date. As a registered patent attorney, at Dell Mr. Lindsey also helped evaluate intellectual property in respect to M&A transactions.
08/30/2013 -- XBiotech Announces Addition to its Board of Directors
On August 29, 2013 XBiotech announced that Dr. Fabrizio Bonanni has joined the Company as a member of the Board of Directors. Dr. Bonanni joins XBiotech after stepping down from Amgen this year where he ended his tenure as that Company’s most senior officer in charge of operations. At Amgen, Dr. Bonanni held the position of Executive Vice President of Operations from 2007-2012, and between 1999-2007 held Senior Vice President positions in charge of manufacturing, quality and regulatory compliance. Prior to Amgen, Dr. Bonanni held the position of Corporate Vice President of Regulatory and Clinical Affairs at Baxter International.
03/27/2013 -- XBiotech Announces Incorporation of Its Wholly Owned Subsidiary XBiotech Japan KK
On March 26, 2013 XBiotech announced the incorporation of its wholly owned Japanese subsidiary, XBiotech Japan KK. The creation of the Japanese Company is reportedly the first step in XBiotech’s strategy to expand its clinical operations and ultimately product reach into the unique Japanese market place.
02/27/2013 -- XBiotech Expands Portfolio to Include Biosimilars
On Februay 26, 2013 XBiotech announced that it is entering the biosimilar business. The Company is launching its biosimilar business with development of two of the world’s leading therapeutic antibodies, one an oncology and the other an anti-inflammatory product. Entering into the biosimilar space will complete what XBiotech considers is its strategic portfolio of therapeutic antibodies. The Company believes that its manufacturing technology will lower production costs for biological products by an order of magnitude compared to other developers of generic biologics. Moreover, the Company claims that the flexibility and short lead-times needed to build production capacity is ideally suited for addressing the uncertain market conditions for biosimilars. The Company aims to enter into clinical trials with its first biosimilar product within the next year and launch into the market place by 2017.
04/14/2012 -- XBiotech Breaking Ground On 67,000sf Manufacturing Facility
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On April 13, 2012 XBiotech announced that the first Phase of development for the commercial facility that will host production of the world's first True Human Antibody will commence on April 16th, 2012. XBiotech received approval to begin construction by the City of Austin on March 9, 2012.
09/13/2011 -- Early Results from XBiotech’s Clinical Study in Cachexia Hint at Breakthrough Treatment
On September 12, 2011 XBiotech announced that it has been studying the effects of its True Human antibody therapy to ameliorate the complications of cachexia in late stage cancer patients at MD Anderson Cancer Center. Under the direction of Dr. David Hui (M.D., M.Sc., F.R.C.P.C.) Assistant Professor, Department of Palliative Care and Rehabilitation Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, the ability for the antibody therapy to treat the dreaded complication of cachexia in cancer patients was evaluated.
07/02/2011 -- New Media Formulation in the Works
On July 1, 2011 XBiotech announced that scientists within the Manufacturing team at XBiotech are working on a new media formulation that is significantly less costly than the current off-the-shelf media formulations. This new media contains all the necessary amino acids, sugars and vitamins that are required in our manufacturing process, where media costs are among the single biggest cost item.
02/01/2011 -- XBiotech hires new Chief Financial Officer
On January 31, 2011 XBiotech announced the hiring of Mr. Martin Schmieg as its new Chief Financial Officer. Martin has over twenty years of experience launching and building businesses in the life sciences industry.
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Deals and Alliances
06/29/2016 -- XBiotech Signs Agreement With Megapharm To Market Xilonix In Israel
On June 28, 2016 XBiotech Inc announced that it has entered into an exclusive licensing agreement with Megapharm Ltd., to commercialize Xilonix in Israel for the treatment of advanced colorectal cancer.
02/12/2016 -- XBiotech Engages in Research for Heart Attack Antibody Therapy
On February 11, 2016 XBiotech Inc announced the signing of a Material Transfer Agreement (MTA) with Brigham and Women’s Hospital and Massachusetts General Hospital. XBiotech will provide Antibodies to block the inflammatory mediator interleukin 1 alpha while Novartis Pharmaceuticals will provide an interleukin 1 beta antibody to a research team headed by cardiovascular medicine specialist Dr. Peter Libby. The research team will conduct pre-clinical studies to assess the potential of these antibodies to reduce injury to the heart muscle after heart attack and to calm inflammation in atherosclerotic plaques.
12/12/2015 -- Xbiotech Announces Agreement with The NCIC Clinical Trials Group to Collaborate on Phase II Study in Non-Small Cell Lung Cancer (NSCLC)
On December 11, 2015 XBiotech Inc. announced that it has an agreement with the NCIC Clinical Trials Group (NCIC CTG) to develop a Phase II study to assess Xilonix in combination with Tarceva for treatment of NSCLC. The proposed study, which will enroll approximately 75 patients, is projected to launch in Canada in Q2 2016.
11/10/2015 -- Xbiotech Announces Positive Results For Its Anti-Ebola Therapeutic Candidates Following Evaluation By Usamriid
On November 9, 2015 XBiotech announced positive results for its True Human antibody therapeutic against Ebola virus infection. The results were part of the Company's collaborative research with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID tested the Company's recently developed therapeutic antibodies for their ability to neutralize live virus. The results showed that 8 out of 10 of the antibodies tested were able to effectively neutralize the Ebola virus.
09/02/2015 -- XBiotech expanded its XCITE cancer study into Europe in cooperation with KCR
On September 1, 2015 XBiotech announced that it expanded its "XCITE" cancer study into Europe. This milestone was done in cooperation with KCR, Contract Research Organization (CRO) operating in 19 countries in Europe as well as the U.S.
04/04/2014 -- XBiotech Announces In-Licensing of Technology from Strox Biopharmaceuticals
On April 3, 2014 XBiotech announced that it acquired the patent estate of Strox Biopharmaceuticals relating to antibody therapies for methicillin resistant staphylococcus aureus (MRSA). XBiotech is developing next generation natural immune therapies to address serious and drug resistant bacterial infections. The in-licensed technology is reportedly intended to expand and strengthen XBiotech’s position for its infectious disease product development program. Included in the deal are both issued and pending patents for antibody technologies useful for either prophylaxis or therapeutic intervention for resistant and potentially life threatening infections. Terms of the in-licensing agreement are reported to include an upfront cash payment, royalty on sales and XBiotech will assume costs and responsibilities for all patent prosecution and maintenance.
09/19/2013 -- XBiotech Announces Collaboration with US Oncology Research in Pivotal Phase III Trial for Anti-Cancer Drug Xilonix
On September 18, 2013 XBiotech announced its collaboration with US Oncology Research to conduct a pivotal Phase III Trial for colorectal cancer. Through the collaboration, US Oncology Research will leverage its national network of affiliated oncology centers to treat patients with XBiotech’s new anti-cancer therapy and report clinical outcomes. Patients enrolled in the trial will receive at least the current standard of care. With nearly 225 affiliated treatment research locations, US Oncology Research is one of the largest organizations in America focused on bringing physicians, clinics and patients together for innovative cancer care. Based on earlier clinical studies, it’s anticipated that XBiotech’s new therapy for colorectal cancer could show an improved survival rate for colorectal cancer patients, while at the same time
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facilitate recovery from the effects of cachexia, which is present in most patients with advanced colorectal cancer.
06/02/2011 -- XBiotech closes deal with South Texas Blood and Tissue Center
On June 1, 2011 XBiotech announced that it has launched a clinical collaboration with South Texas Blood and Tissue Center and is now obtaining hundreds of blood samples from donors to screen for antibodies using our proprietary antibody discovery technology. The objective of this collaboration is to identify True Human antibodies from individuals, and to clone these rare genes involved in producing them. These True Human antibodies can be used to treat inflammatory and infectious diseases that affect humans. Ture Human antibodies are the newest generations of therapeutic antibodies and are expected to deliver safer, more efficacious treatments.
04/02/2011 -- XBiotech purchases the First ClonePix 2
On April 1, 2011 XBiotech announced that it is the First Company in the US to acquire a ClonePix 2 advanced robotic system for identifying high producing cells for our manufacturing program. ClonePix 2 is the second-generation system from Molecular Devices (formerly Genetix). The ClonePix 2 utilizes fluorescence, white light imaging, and advanced image analysis capabilities to: automatically screen more clones in less time, select cells with optimal expression levels, and pick colonies with accuracy and confidence.
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Financials
05/12/2016 -- Xbiotech to Provide First Quarter 2016 Business Update on May 18
On May 11, 2016 XBiotech Inc. announced that it will host a live conference call and webcast on May 18, 2016, at 8:30 a.m. ET, to provide a quarterly overview for the first quarter ended March 31, 2016.
03/23/2016 -- XBiotech to Provide Fourth Quarter and Full Year 2015 Business update
On March 22, 2016 XBiotech announced that it will host a conference call and live audio webcast on Wednesday, March 30, 2016, at 8:30 a.m. Eastern Time, to provide an overview of its corporate and clinical activities. The call will encompass developments during the fourth quarter and year ended December 31, 2015.
11/13/2015 -- Xbiotech Provides Third Quarter 2015 Corporate And Clinical Update
On November 12, 2015 XBiotech Inc provided a corporate and clinical update for the third quarter ended September 30, 2015. The Company's CEO and other key members of XBiotech's management team will provide updates on the company's clinical, R&D and manufacturing operations during this morning's conference call and audio webcast today at 8:30 a.m. ET.
11/06/2015 -- Xbiotech To Provide Third Quarter Business Update
On November 5, 2015 XBiotech announced that it will host a conference call and live audio webcast on November 12, 2015, at 8:30 a.m. ET, to provide an overview of its corporate and clinical activities. The call will encompass developments during the third quarter ended September 30, 2015.
07/29/2015 -- Xbiotech Provides Second Quarter 2015 Corporate And Clinical Update
On July 28, 2015 XBiotech Inc. provided a corporate and clinical update for the second quarter ended June 30, 2015. This marks XBiotech's first time hosting a quarterly investor call and it provides an opportunity to review the significant accomplishments achieved during the Company's first full quarter as a public company.
07/16/2015 -- Xbiotech to Provide Second Quarter Business Update
On July 15, 2015 XBiotech Inc. announced that it will host its inaugural quarterly business update conference call and live webcast on July 28, 2015, at 8:30am Eastern Time.
04/18/2015 -- XBiotech Closes Initial Public Offering
On April 17, 2015 XBiotech Inc. announced the closing of its initial public offering of 4,000,000 shares of its common stock at an initial public offering price of $19.00 per share for a total offering amount of $76,000,000, before the underwriting discounts and commissions and other company expenses.
04/16/2015 -- XBiotech Announces Pricing of Initial Public Offering
On April 15, 2015 XBiotech Inc announced the pricing of its initial public offering of 4,000,000 shares of its common stock at an initial public offering price of $19.00 per share for a total offering amount of $76,000,000, before the underwriting discount. The shares are expected to begin trading on the Nasdaq Global Select Market on April 15, 2015 under the ticker symbol “XBIT.”
02/25/2015 -- XBiotech Plans to Conduct Initial Public Offering of its Common Stock
On February 24, 2015 XBiotech announced that it plans to conduct an initial public offering of its common stock. The offering is expected to commence after the SEC completes the review process of its registration statement, which it publicly filed with the SEC on February 2, 2015, subject to market and other conditions. The number of shares to be offered and the price range for the offering have not yet been determined.
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04/07/2011 -- XBiotech Closes Funding Round
On April 6, 2011 XBiotech announced that the funding round the company informed on November 15, 2010 is now closed.
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Intellectual Property
10/20/2015 -- Xbiotech Strengthens Intellectual Property Portfolio For Its True Human Antibody Technology
On October 19, 2015 XBiotech announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 13/547,497, titled "Identifying Affinity-Matured Human Antibodies." The patent covers XBiotech's methods for amplifying, screening, and cloning antibody-encoding genes from human donors previously determined to possess antibodies that bind target antigens of interest. The patent further strengthens XBiotech's novel True Human antibody technology, which harnesses natural human immunity to produce breakthrough antibody therapies for a wide range of diseases.
03/12/2014 -- XBiotech Issued Patent for Antibody Therapy to Treat Chronic Sterile Inflammatory Diseases
On March 11, 2014 XBiotech announced that the United States Patent and Trademark Office (USPTO) granted another key patent to support the Company’s growing portfolio around its lead product candidate. The new patent grants XBiotech exclusive rights to target a unique molecule associated with chronic sterile inflammation. The patent relates to antibodies and methods of using these antibodies to treat, prevent, and detect disease progression associated with a key mediator of chronic inflammation. USPTO issuance of the patent further establishes XBiotech as a pioneer in a new generation of antibody therapy to treat the crucial inflammatory process involved in progression or exacerbation of multiple chronic diseases. The Company reports that in the past year, 7 patents have been issued relating to its lead therapy and that over 100 patent applications are currently pending.
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Product Updates
07/03/2016 -- Xbiotech Presents Pivotal Phase III Data Showing Xilonix Demonstrated Significant Clinical Response In Advanced Colorectal Cancer Patients Refractory To Further Treatment
On July 2, 2016 XBiotech Inc. has presented positive results from a pivotal Phase III trial of Xilonix, the company's lead monoclonal (IgG1k) antibody immunotherapy for the treatment of advanced colorectal cancer (CRC). In the study, Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76% relative increase in clinical response rate (CRR), a novel measure of anti-cancer activity, after 8 weeks of therapy compared to placebo (33% vs. 19%, respectively; p=.0045). In addition, clinical response correlated with improved overall survival. Among responders (in both treatment and placebo arms), clinical response was associated with a 2.7-fold increase in overall survival (11.5 versus 4.2 months in responders vs. non-responders, respectively). Overall survival was not compared between treatment arms because after 8 weeks, all patients were eligible to receive study drug. Treatment with Xilonix was well tolerated, with an adverse event profile comparable to placebo. The data were presented at the 18th European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain.
05/25/2016 -- XBiotech to Present Positive Preliminary Survival Data on Xilonix at the 18th European Society of Medical Oncology’s World Congress on Gastrointestinal Cancer
On May 24, 2016 XBiotech Inc. announced that its upcoming presentation of pivotal Phase III data for Xilonix, the Company's lead therapy developed for the treatment of advanced colorectal cancer, will include positive preliminary findings on survival. The data are being presented July 2 at the 18th ESMO World Congress on Gastrointestinal Cancer in Barcelona, Spain.
05/19/2016 -- XBiotech Provides First Quarter 2016 Corporate and Clinical Update
On May 18, 2016 XBiotech Inc. has provided a business update for the first quarter ended March 31, 2016. Company Founder and Chief Executive Officer John Simard, along with XBiotech’s senior leadership and management team, reviewed first-quarter clinical developments and provided updates on the company’s pipeline, research and development operations and new manufacturing facility during this morning’s conference call and audio webcast at 8:30 a.m. ET.
04/20/2016 -- XBiotech to Present Pivotal Phase III Data on Xilonix at European Society of Medical Oncology’s World Congress on Gastrointestinal Cancer
On April 19, 2016 XBiotech Inc announced that it will present pivotal Phase III data for Xilonix, the Company’s lead therapy developed for the treatment of advanced colorectal cancer, at the 18th ESMO World Congress on Gastrointestinal Cancer. This will be the first presentation of the Phase III data at a major scientific congress. The 18th ESMO World Congress on Gastrointestinal Cancer, considered the premier scientific event for gastrointestinal cancer, will be held June 29 to July 2 in Barcelona, Spain.
03/29/2016 -- XBiotech Advances to Phase II Portion of Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
On March 28, 2016 XBiotech announced that the last patient in the Phase I portion of its ongoing clinical study had cleared the safety window for its novel antibody therapy, 514G3, for the treatment of all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).
03/10/2016 -- Xbiotech Enrolls Final Patient In Phase I Portion of Clinical Study Of Novel True Human Therapeutic Antibody For Treating Serious Infections Due To Staphylococcus Aureus
On March 9, 2016 XBiotech announced completion of enrollment in the Phase I portion of the ongoing clinical study to evaluate its antibody treatment for Staphylococcus aureus (S. aureus) infections. The Company is developing a True Human antibody to treat serious, blood-borne infections caused by S. aureus including methicillin-resistant (MRSA) strains.
03/03/2016 -- XBiotech to Deliver Presentation on Novel Study Design and Phase III Results From European Study on Xilonix During Meeting at the European Parliament
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On March 2, 2016 XBiotech announced that its Medical Director Michael Stecher, M.D., will be included in a delegation assembled by EuropaColon to present the latest colorectal cancer research and advocacy-related perspective in a meeting at the European Parliament hosted by MEP Dr Alfred Sant.
02/19/2016 -- XBiotech to Present at 4th Annual Sachs Cancer BioPartnering & Investment Forum
On February 18, 2016 XBiotech announced that Kalidip “KC” Choudhury, Ph.D, Vice President of Business Development, and Michael Stecher, M.D., Medical Director, will present at the 4th Annual Sachs Cancer BioPartnering & Investment Forum on February 24th at 3pm in New York, NY.
01/22/2016 -- Xbiotech To Attend And Present At The ASCO 2016 Gastrointestinal Cancers Symposium
On Janaury 21, 2016 XBiotech announced that on January 23, 2016, Dr. Michael Stecher, the Company’s Medical Director, will present as part of the Trials in Progress Poster Session at the American Society of Clinical Oncology (ASCO) 2016 Gastrointestinal Cancers Symposium in San Francisco, CA. The poster presentation, titled “Phase III double-blinded, placebo-controlled study of MABp1 for improving survival in metastatic colorectal cancer,” is part of a special update for the gastrointestinal oncology community on XCITE, an ongoing FDA Fast Tracked, Pivotal Phase III study of XBiotech’s cancer drug Xilonix for the treatment of metastatic colorectal cancer.
01/09/2016 -- XBiotech Reports Additional Positive Data from Phase III European Trial of Xilonix in Advanced Colorectal Cancer
On January 8, 2016 XBiotech announced that it has completed data analysis for its Phase III European study and will hold a conference call to provide additional important information regarding the activity of Xilonix in the treatment of advanced, symptomatic colorectal cancer.
01/08/2016 -- XBiotech Advances to Final Dosing Cohort in Phase I/II Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
On January 7, 2016 XBiotech announced the completion of the second dose cohort in its Phase I/II clinical study of 514G3, its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA). Having met this milestone, XBiotech will advance to the third dose level in the Phase I portion of the study. The dose will be increased by a factor of four, and represents the final of three planned dosing cohorts.
01/08/2016 -- XBiotech to Host Overview of Strategy and Findings for its European Phase III Trial for treatment of Colorectal Cancer with Xilonix
On January 7, 2016 XBiotech announced that it will host a conference call and live audio webcast on January 8, 2016, at 8:30 a.m. ET, to provide an overview of its strategy and findings for its European Phase III clinical study to evaluate a first-of-a-kind human therapeutic antibody, Xilonix, in the treatment of advanced colorectal cancer.
12/08/2015 -- XBiotech Announces Positive Results in European Phase III Study for Its Breakthrough Therapy for Colorectal Cancer
On December 7, 2015 XBiotech announced that it met the primary endpoint in its European Phase III clinical study of Xilonix, a novel therapy for patients with symptomatic, advanced colorectal cancer. Patients enrolled in the double-blinded, placebo-controlled study had refractory, metastatic colorectal cancer and suffered from cancer-associated symptoms such as fatigue, pain, elevated inflammatory markers, weight loss and reduced physical ability at baseline. Patients were randomized 2:1 to receive either Xilonix therapeutic antibody or placebo, respectively.
11/24/2015 -- Xbiotech Provides Update on Phase III Oncology Study in Europe
On November 23, 2015 XBiotech announced the findings related to enrollment in the study. The Company is reporting that data cleaning has revealed a fewer number of per protocol patients available for primary endpoint evaluation. The Company found 25 patients dropped off study prior to receiving any dosing with drug or placebo. Analysis of patient blood samples also revealed that 14 patients erroneously received either placebo or study drug. In addition, 33 patients completed the study but failed to receive scheduled DEXA scans, properly complete EORTC evaluation, or both. The Company reports that these combined irregularities compromises data from 72 patients in the study.
11/13/2015 -- Xbiotech Provides Third Quarter 2015 Corporate And Clinical Update
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On November 12, 2015 XBiotech Inc provided a corporate and clinical update for the third quarter ended September 30, 2015. The Company's CEO and other key members of XBiotech's management team will provide updates on the company's clinical, R&D and manufacturing operations during this morning's conference call and audio webcast today at 8:30 a.m. ET.
11/12/2015 -- Xbiotech Identifies Positive Donors For Anti-Clostridium Difficile Therapeutic Antibody Only Two Weeks After Initial Screening
On November 11, 2015 XBiotech announced that it has already identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate. Just two weeks after initial screening of blood donations from healthy volunteers, XBiotech has identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. Identifying natural antibodies against C. difficile in the healthy population is the first step in the discovery process for True Human therapeutic antibodies. Since it is unknown at the onset whether or not natural antibodies will be present in the healthy population, the Company believes that identifying these antibodies, especially so quickly, is a good indication that they are important in protection against disease.
09/02/2015 -- XBiotech Advances Phase I/II Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus
On September 1, 2015 XBiotech announced the completion of the first cohort in its Phase I/II clinical study of a novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus.
08/18/2015 -- XBiotech Completes Enrollment for Xilonix Phase III Registration Study in Europe
On August 17, 2015 XBiotech announced that it has completed enrollment of the Company’s pivotal, randomized double-blinded placebo controlled Phase III study in Europe of Xilonix for the treatment of advanced colorectal cancer. Xilonix, a novel anti-cancer agent, is being developed via a ground-breaking regulatory path that XBiotech established in collaboration with the scientific advisory committee of the European Medicines Agency (EMA). The Phase III program has now met the enrollment objective for study completion and the Company remains on track to announce results by year end.
08/08/2015 -- Xbiotech Announces Expansion Of Global Phase III Registration Study In Europe Using Xilonix For Treatment Of Metastatic Colorectal Cancer
On August 7, 2015 XBiotech announced that it has expanded its "XCITE" cancer study into Europe.
07/29/2015 -- Xbiotech Provides Second Quarter 2015 Corporate And Clinical Update
On July 28, 2015 XBiotech Inc. provided a corporate and clinical update for the second quarter ended June 30, 2015. This marks XBiotech's first time hosting a quarterly investor call and it provides an opportunity to review the significant accomplishments achieved during the Company's first full quarter as a public company.
07/08/2015 -- Xbiotech Announces Publication of Clinical Results Supporting its True Human Antibody Therapy for Type II Diabetes Mellitus
On July 7, 2015 XBiotech announced the publication of clinical results from an open label pilot study for its antibody therapy for treatment of Type II diabetes.
07/07/2015 -- XBiotech Treats First Patient in Phase I/II Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
On July 6, 2015 XBiotech Inc. announced the treatment of first patient in its Phase I/II clinical study.
07/02/2015 -- XBiotech Conducts Investigators Meeting to Update the Status of its Phase III Registration Study Underway in Europe
On July 1, 2015 XBiotech announced that it held an investigators meeting to update clinicians and support staff on the overall status of the Company’s Phase III study in colorectal cancer. The Company is conducting a double-blinded, placebo-controlled registration study of its anticancer agent for the treatment of advanced colorectal cancer. The novel anti-cancer agent, Xilonix, is being developed with a regulatory
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path that the Company established in collaboration with the scientific advisory committee of the EMA.
06/16/2015 -- XBiotech Announces Publication of Phase II Clinical Results for its True Human Antibody MABp1 for treating Acne Vulgaris in the Journal of Drugs in Dermatology
On June 15, 2015 XBiotech announced positive results from the Company's Phase II study of its MABp1 antibody for treating acne vulgaris. Findings are published in the June 2015 issue of Journal of Drugs in Dermatology1. The study concluded that MABp1, due to its unique molecular target, may be a safe and effective means of treating not only inflammatory acne lesions, but also improving feelings of depression and anxiety commonly associated with acne.
05/29/2015 -- XBiotech Launching Phase I/II Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
On May 28, 2015 XBiotech Inc announced that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company’s IND, enabling launch of its therapy for S. aureus infections.
05/27/2015 -- XBiotech Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate
On May 26, 2015 XBiotech announced that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.
05/19/2015 -- XBiotech Secures Approval from Data Safety Monitoring Board to Continue Phase III Registration Study in Europe for its Novel Cancer Immunotherapy
On May 18, 2015 XBiotech announced that the Data Safety Monitoring Board (DSMB) has recommended continuation of the Company’s Phase III registration study underway in Europe.
04/30/2015 -- XBiotech Enrolls First Patient Under Revised Protocol for U.S. Phase III Registration Study Using Xilonix for Treatment of Metastatic Colorectal Cancer
On April 29, 2015 XBiotech announced that it has enrolled the first patient into its revised U.S. Phase III study of Xilonix in metastatic colorectal cancer patients.
04/25/2015 -- XBiotech Completes Investigator Conference for U.S. Colorectal Cancer Trial
On April 24, 2015 XBiotech held an Investigator Conference on Friday, April 24th in Austin, TX in preparation for initiation of the revised U.S. Phase III colorectal cancer study. The Company hosted more than 40 doctors and other healthcare professionals who are recruiting patients into the study. The meeting included talks from John Simard (President and CEO, XBiotech, Inc.) on targeting IL-1a in cancer, Dr. Michael Stecher (Medical Director, XBiotech, Inc.) on key changes to the revised protocol, as well as Dr. George Fisher (Principal Investigator of the study and Professor of Medicine, Stanford University School of Medicine) on results from the initial study, which he has previously presented at ASCO GI in January 2015.
04/02/2015 -- XBiotech Announces Publication of Positive Clinical Results for Xilonix in Non-Small Cell Lung Cancer
On April 2, 2015 XBiotech Inc. announced that results from a subset of non-small cell lung cancer (NSCLC) patients treated in a study of the Company’s lead True Human antibody, Xilonix, conducted at MD Anderson Cancer Center in Houston, TX, will be published in an upcoming edition of Investigational New Drugs.
03/13/2015 -- XBiotech Launches Website and Call Center to Inform Cancer Patients about New Xilonix Therapy and Phase III Clinical Study
On March 12, 2015 XBiotech announced that it has launched a website and call center to help patients with metastatic colorectal cancer learn about its U.S. Pivotal Phase III clinical trial.
03/13/2015 -- XBiotech Launches Website and Call Center to Facilitate Recruitment for U.S. Phase III Study of Xilonix in Metastatic Colorectal Cancer
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On March 12, 2015 XBiotech announced that it has launched a website and call center to help patients with metastatic colorectal cancer learn about its U.S. Pivotal Phase III clinical trial.
03/05/2015 -- XBiotech Announces Phase II Psoriasis Study Results in JAMA Dermatology
On March 5, 2015 XBiotech announced that results from its Phase II pilot study in patients with moderate to severe plaque psoriasis have been published in JAMA Dermatology.
09/03/2014 -- XBiotech Halts Study, Reports Positive Phase III Results with Antibody Therapy for Cancer
On September 2, 2014 XBiotech announced interim results from its fast-tracked Phase III study being conducted in the US for its anti-cancer agent Xilonix.
08/02/2014 -- XBiotech Enrolls First Patient in Phase III European Registration Study Using Xilonix for Treatment of Colorectal Cancer
On August 1, 2014 XBiotech has enrolled the first patient into its European Phase III study using its novel cancer drug Xilonix for the treatment of colorectal cancer.
04/18/2014 -- XBiotech Announces Phase I/II Study Results in Lancet Oncology
On April 17, 2014 XBiotech announced that results from its Phase I/II oncology study conducted at MD Anderson Cancer Center in Houston, TX were published in Lancet Oncology. The featured article describes the outcome in 52 advanced cancer patients treated with Xilonix, XBiotech’s novel, non-cytotoxic, anti-tumor therapy. The so called true human antibody therapy was reported to have an excellent safety profile. The report describes comprehensive measures of patient performance during therapy with Xilonix. It was reported that overall, patients constitutional symptoms improved, including reduction in pain and fatigue. A highlight of the report was the finding that almost two- thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (which is another way of referring to muscle mass) but moreover, that these same patients had dramatic improvement in overall survival.
01/17/2014 -- XBiotech Announces Launch of Study to Treat Pyoderma Gangrenosum (PG)
On January 16, 2014 XBiotech announced that it has launched a Phase II study to treat a rare but debilitating disorder, Pyoderma Gangrenosum (PG). This study is based on efficacy seen with anti-IL-1Alpha therapeutic antibody in previous dermatological clinical studies such as psoriasis and acne. PG is expected to be considered an “orphan indication” by the FDA, facilitating expedited clinical development to market.
09/05/2013 -- XBiotech Announces it is Developing Therapy for MRSA
On September 4, 2013 XBiotech announced that it has completed discovery and has begun pre-clinical development of a new True Human antibody therapy for methicillin resistant staphylococcus aureus (MRSA). The new antibody therapy is expected to be effective at neutralizing drug resistant staphylococcus infection by circumventing key immune evasion strategies of the bacteria, thereby facilitating natural clearance of the bacteria by the patient’s own immune system. The Company believes that the therapy could represent a breakthrough in the management of infectious disease. XBiotech reports that the MRSA antibody came out of its True Human antibody discovery program for identifying and cloning pharmacologically relevant antibodies from human donors. XBiotech expects this product candidate to enter human clinical trials next year.
06/01/2013 -- XBiotech Announces Development of A Novel True Human Antibody Therapeutic
On May 31, 2013 XBiotech announced its development of a novel True Human therapeutic antibody. The Company reports that the antibody neutralizes a pro-inflammatory molecule known as interleukin-6 (IL-6). Agents targeting IL-6 have been effective therapy for a number of autoimmune or oncology-related diseases. Other therapeutic antibody products targeting IL-6 have already reached clinical trials and the market place, but the Company believes that its antibody will represent a substantial improvement over these existing agents. True Human antibodies, which are cloned directly from a human immune response, are expected to be the safest, best tolerated antibody therapeutics. The Company is now developing a manufacturing process for the antibody, and expects to be ready for clinical studies in early 2014.
05/16/2013 -- XBiotech Announces Results for its Xilonix Treatment of Non-Small Cell Lung Cancer (NSCLC)
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On May 15, 2013 XBiotech announced its recent findings for Non-Small Cell Lung Cancer (NSCLC). Sixteen advanced NSCLC patients were treated at MD Anderson Cancer Center with the Company’s True Human Therapeutic Antibody Xilonix. The patients receiving Xilonix had failed all conventional therapy and had progressive disease upon receiving treatment with Xilonix. Over half of the patients treated recovered significant amounts of lean body tissue during treatment; as well, these patients showed a trend toward improved overall physical and functional well-being. A key outcome, however, was the observation that patient overall survival outcomes appeared significantly better than what would be expected for this late stage NSCLC patient population. Stratification of survival outcomes based on patient pretreatment history also provided some interesting findings. Sixty-three percent of the NSCLC patients treated in the study had actually received—and failed—previous treatment regimens with the anti-cancer agent Tarceva. Surprisingly, these patients appeared to have considerably better survival outcomes than patients with other pre-treatment histories.
04/25/2013 -- XBiotech Enrolls First Patient in Phase III Pivotal Trial of Xilonix
On April 24, 2013 XBiotech announced the enrollment of the first patient into its Phase III trial of Xilonix. The pivotal study is designed to improve health and survival of late stage colorectal cancer patients with associated cachexia. The patient was enrolled by Dr. Eric Roeland at UC San Diego’s Moores Cancer Center. The study is randomized to evaluate overall survival in patients treated with Xilonix and will be conducted initially in the United States before expanding elsewhere. A total enrollment of approximately 650 patients is expected. Study completion is anticipated in late 2014 with results potentially enabling marketing approval. XBiotech announced FDA Fast Track Designation for Xilonix in this indication at the end of last year.
12/13/2012 -- XBiotech Announces Positive Phase II Clinical Trial Results for Lead Candidate MABp1 in Acne Vulgaris
On December 12, 2012 XBiotech Inc. announced positive Phase II clinical trial results in the treatment of acne vulgaris. The trial was conducted as an open label study using XBiotech’s lead candidate, True Human monoclonal antibody MABp1, in patients with moderate to severe disease. Patients enrolled in the study demonstrated continual improvement in lesions over the course of therapy, with up to 42 percent reduction in eight weeks. The excellent safety profile of MABp1 demonstrated across multiple therapeutic indications to date, and strong initial results in this trial, provide the basis for further development of the first biologic therapy targeting the inflammatory cytokine IL-1a for acne treatment.
11/21/2012 -- XBiotech Reports Positive Phase II Interim Analysis Results in Vascular Disease
On November 20, 2012 XBiotech announced positive interim analysis results from a Phase II study in patients receiving MABp1 to reduce restenosis after percutaneous revascularization of the Superficial Femoral Artery (SFA). Patients receiving MABp1 demonstrated a 58 percent reduction in Major Adverse Cardiovascular Events (MACE) and 60 percent longer patency in treated vessels compared to control patients. This is the first report of MAB therapy in restensois and fourth clinical indication where the Company’s lead candidate, MABp1, has demonstrated strong safety and effectiveness. Positive results in cachexia, psoriasis, and type 2 diabetes have also recently been reported by XBiotech.
10/30/2012 -- XBiotech Reports Positive Phase II Interim Analysis Results From Type II Diabetes Study
On October 29, 2012 XBiotech announced positive interim analysis results from a Phase II study using a True Human monoclonal antibody (MABp1) in patients with Type II diabetes. Results from this study continue to reinforce the role of IL-1a as a master regulator of chronic inflammation in multiple disease states, and the therapeutic benefits of neutralizing antibodies produced from the XBiotech platform. The Company recently announced FDA Fast Track Designation for development of cancer associated cachexia therapy, as well as positive results from a Phase II study in psoriasis, using MABp1.
10/18/2012 -- XBiotech Announces Progress in Clinical Development of Treatment for Psoriasis
On October 17, 2012 XBiotech announced positive preliminary results from their Phase II study using a True Human monoclonal antibody (MABp1) in patients with moderate to severe psoriasis. Data from the trial indicate a relatively rapid response in skin lesion severity following an initial subcutaneous injection, and continued improvement over 70 days with a maximum of three injections. Preliminary results demonstrated a 30 percent improvement in Psoriasis Area and Severity Index (PASI) scores within three weeks of receiving the initial subcutaneous dose. Full data from the study will be submitted to a peer-reviewed journal for future publication.
09/25/2011 -- XBiotech Hosts Clinical Investigators
On September 24, 2011 XBiotech announced that it has hosted its clinical investigators in vascular disease over the weekend at a conference at the Barton Springs Resort in Austin, Texas. The investigator groups are involved in the multi-center clinical program titled
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“Open Label Randomized Study of the Safety, Pharmacokinetics and Preliminary Efficacy of an Anti-Inflammatory Antibody (CV-18C3) in Reducing Restenosis in Patients Undergoing Percutaneous Femoro-Popliteal Revascularization”. At its conclusion, the study will have enrolled 80 patients to determine if the Company’s lead therapeutic antibody to treat vascular inflammation can reduce the severity of restenosis in patients with advanced vascular disease in the leg.
08/19/2011 -- All Five U.S. Sites for Restenosis Clinical Trial Have Been Selected and Initiated
On August 18, 2011 XBiotech announced that all 5 investigative sites for ongoing study in restenosis have been initiated. The investigational new drug application (IND) to commence the study was approved earlier this summer, while sites were continuing to be enrolled and initiated. Five sites with state of the art cardiology or vascular surgery operations were planned to be included in the program, and now these sites have been fully commissioned and are able to enroll patients. The study, titled “Phase II Open Label, Randomized Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-inflammatory Therapeutic Antibody (CV-18C3) in Reducing the Risk of Restenosis in Patients Undergoing Percutaneous Femoro-popliteal Revascularization” is considered to be a groundbreaking application of antibody therapy, in an area of medicine where vast unmet medical need still exists.
07/19/2011 -- XBiotech Enrolls 1st Patient in Restenosis Study
On July 18, 2011 XBiotech announced the enrollment of the first patient in Phase II clinical trial for the treatment of restenosis after surgical intervention. By directly targeting vascular inflammation after injury, this treatment has the potential to make a positive impact in the lives of millions of patients every year.
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Regulatory
04/05/2016 -- European Medicines Agency Grants Accelerated Assessment of Marketing Authorization Application for Xilonix, XBiotech’s True Human Therapeutic Antibody Treatment for Advanced Colorectal Cancer
On April 4, 2016 XBiotech Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated review for Marketing Authorization of Xilonix, the Company’s first-in-class True Human monoclonal (IgG1k) antibody treatment for advanced colorectal cancer.
03/24/2016 -- Xbiotech Announces European Medicines Agency (EMA) Validates Marketing Authorization Application (MAA) for Xilonix in The Treatment of Advanced Colorectal Cancer
On March 23, 2016 XBiotech Inc. announced that the Company’s Marketing Authorization Application (MAA) for Xilonix, which is intended for the treatment of advanced colorectal cancer, has been validated by the European Medicines Agency (EMA). With this validation, the application process is complete and the EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin the assessment of Xilonix through the centralized review procedure. If approved through this procedure, Xilonix will be licensed in all EU member states.
03/09/2016 -- Xbiotech Announces Submission Of Marketing Authorization Application (MAA) For Candidate Colorectal Cancer Therapy To European Medicines Agency (EMA)
On March 8, 2016 XBiotech Inc. announced that the Company has now submitted its Marketing Authorization Application (MAA) for its candidate therapy (Xilonix) for advanced colorectal cancer to the European Medicines Agency (EMA).
03/05/2016 -- European Medicines Agency Grants Eligibility for Submission of XBiotech’s Marketing Authorization Application (MAA)
On March 4, 2016 XBiotech Inc. announced that the Company has been granted eligibility by the European Medicines Agency (EMA) to submit a Marketing Authorization Application (MAA) for its candidate therapy Xilonix for the treatment of advanced colorectal cancer.
10/02/2015 -- Xbiotech Receives Fda Fast Track Designation For Its Novel True HumanTherapeutic Antibody For Treating Serious Infections Due To Staphylococcus Aureus
On October 1, 2015 XBiotech announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).
05/29/2015 -- XBiotech Launching Phase I/II Clinical Study of Novel True Human Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
On May 28, 2015 XBiotech Inc announced that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company’s IND, enabling launch of its therapy for S. aureus infections.
01/31/2014 -- XBiotech and European Medicines Agency (EMA) Agree on Phase III Registration Study for Treatment of Colorectal Cancer
On January 30, 2014 XBiotech announced that its collaboration with the European Medicines Agency (EMA) has resulted in establishment of a regulatory path for Xilonix registration in the European Union for the treatment of colorectal cancer. XBiotech AG will soon launch its Phase III registration study in Europe to evaluate Xilonix in patients with treatment-resistant colorectal cancer. Cancer treatment centers in at least 6 countries will be involved in the registration study, which is expected to take 12 months to complete.
01/04/2013 -- XBiotech Receives Fast Track Designation from FDA for True Human Monoclonal Antibody Therapy Targeting Inflammatory Cytokine IL-1a for Restenosis
On January 3, 2013 XBiotech announced that the company has been granted Fast Track designation by the FDA for its therapeutic
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monoclonal antibody MABp1 (CV-18C3) as a treatment to reduce the need for re-intervention after superficial femoral artery (SFA) revascularization.
10/04/2012 -- XBiotech Receives Fast Track Designation from FDA for Anti-Cachexia Drug Xilonix
On October 3, 2012 XBiotech announced that it has been granted Fast Track designation for its anti-cachexia drug Xilonix. The Company’s groundbreaking therapeutic antibody was shown in a previous clinical study at MD Anderson Cancer Center in Texas to stop or reverse cachexia in about a third of all advanced cancer patients treated. Anti-tumor and anti-cachexia effects were seen in many different types of cancer. In patients with advanced colorectal cancer, the reversal of cachexia resulted in a dramatic improvement in life expectancy, with patients that responded to treatment having a median survival of 474 days, versus a median of 72 days in others.
03/31/2012 -- XBiotech Announces FDA Approval to Launch a Groundbreaking Study, titled “A Pivotal Phase II Study to Evaluate MABP1 as A Treatment for Cachexia in Subjects with Metastatic Cancers.”
On March 30, 2012 XBiotech announced the FDA approval to launch a groundbreaking study, titled “A Pivotal Phase II Study to Evaluate MABp1 as A Treatment for Cachexia in Subjects with Metastatic Cancers.”
07/02/2011 -- XBiotech Receives FDA Approval
On July 1, 2011 XBiotech announced that the company has received approval from the Food and Drug Administration (FDA) to commence its Phase II clinical trial for the treatment of psoriasis. The FDA has approved the launch of the clinical program titled "A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-Inflammatory Therapeutic Antibody in Subjects with Moderate to Severe Plaque Psoriasis". This study will involve 10 patients, and will be conducted at a leading center for psoriasis research-the University of Michigan in Ann Arbor.
05/04/2011 -- XBiotech Receives Swissmedic Approval
On May 3, 2011 XBiotech announced that the company received approval from the Swiss regulatory agency, "Swissmedic," to commence a Phase I clinical trial for the treatment of Type II diabetes. Swissmedic has approved launch of the clinical program titled "A Phase I Study of the Safety and Pharmacokinetics of an Anti-Inflamatory Therapeutic Antibody (MABp1) in Patients with Type II Diabetes Mellitus".
04/14/2011 -- XBiotech Receives FDA Approval
On April 13, 2011 XBiotech announced that the company received approval from the Food and Drug Administration (FDA) to commence a Phase I clinical trial for the treatment of leukemia. The FDA has approved launch of the clinical program titled "A Phase I Trial of CA-18C3 in Advanced Hematologic Malignancies."
04/02/2011 -- XBiotech Receives FDA Approval
On April 1, 2011 XBiotech announced that the company received approval from the Food and Drug Administration (FDA) to commence its Phase II clinical trial for the treatment of restenosis.
01/22/2011 -- XBiotech files IND for Type II Diabetes
On January 21, 2011 XBiotech announced that it has filed Investigational New Drug (IND) application with the Swissmedic for the treatment of type II diabetes. The primary objectives of the proposed clinical study are to evaluate the safety and pharmacokinetics of XBiotech's True Human anti-IL-1a monoclonal antibody (MABp1) in patients with type II diabetes and to assess preliminary efficacy in glycemic control and improvement in b-cell function. The Principal Investigator for the study is Marc Y. Donath, M.D., Professor and Chief, Department of Endocrinology, University Hospital Basel, Switzerland. The study will take place at the University Hospital Basel, Switzerland.
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