Tillkännagivande • Jun 15
XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug For The Treatment Of Active Axial Spondyloarthritis XBiotech announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the U.S. Food and Drug Administration’s (FDA) 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the resumption of XBiotech’s rheumatology program. The clinical protocol was developed under the leadership of Study Chair Marina Magrey, M.D., and with expert guidance from a distinguished panel of SPARTAN leaders and rheumatology experts. PT064 will evaluate 400 mg of vilamakitug administered as 16 weekly subcutaneous injections versus placebo in 150 adult participants with active axial spondyloarthritis (axSpA). The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16. The study also includes a 12-week open-label extension in which all participants receive vilamakitug. Despite the availability of approved biologic therapies, a substantial proportion of patients continue to experience inadequate disease control, representing a significant and persistent unmet medical need. Vilamakitug (also known as XB2001 and Natrunix™) is an IgG4 monoclonal antibody that neutralizes interleukin-1a (IL-1a), a proximal pro-inflammatory cytokine that can contribute to synovial and entheseal inflammation, osteoclast-mediated bone resorption, cartilage degradation, and inflammatory joint pain in spondyloarthritis. By targeting this upstream inflammatory mediator, vilamakitug is hypothesized to reduce both structural damage and disease activity, including in patients who have had an inadequate response to currently approved biologic therapies. New Risk • Jan 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 71% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$78.4m market cap). Tillkännagivande • Jul 08
XBiotech Inc., Annual General Meeting, Aug 29, 2025 XBiotech Inc., Annual General Meeting, Aug 29, 2025. Location: via the internet, United States New Risk • Feb 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.1m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 75% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$99.1m market cap). Tillkännagivande • Jan 02
XBiotech Inc. Announces Appointment of Tak W. Mak, Ph.D. to the Board of Directors XBiotech Inc. announced the December 24, 2024 appointment of Tak W. Mak, Ph.D. to the Company’s Board of Directors. Pursuant to Section 14.4 of the Company’s Articles, the Board has appointed Dr. Mak to fill the existing vacancy on the board. Dr. Mak will serve until the next annual general meeting and will receive similar compensation to the other members. Dr. Mak is a world-renowned scientist who serves as a professor in the Departments of Medical Biophysics and Immunology at the University of Toronto and has been inducted into the Canadian Medical Hall of Fame. In 1984, he identified and cloned the T cell receptor, which advanced basic and applied fields of immunology and opened the door for the development of modern immunotherapies. In 1993, Dr. Mak launched the Amgen Research Institute in Toronto, firmly establishing Toronto as one of the world’s leading centers of biomedical research. Dr. Mak’s work led to medical innovation that changed the foundation of oncology—identification of the immune checkpoint inhibitor CTLA-4, has become one of the most important therapeutic targets in oncology today. Dr. Mak cofounded Agios Pharmaceuticals, a cellular metabolism-focused biotechnology company that has developed multiple FDA-approved cancer treatments. The Cancer Research Institute awarded Dr. Mak the 2023 William B. Coley Award for Distinguished Research in Basic and Tumor Immunology, which is the CRI’s highest scientific honor. Independent directors W. Thorpe McKenzie and Jan-Paul Waldin will continue to serve as members of the Company’s Audit Committee. Tillkännagivande • Jun 19
XBiotech Results from Randomized Double-Blinded Phase 1/2 Study Suggest Potential Breakthrough Treatment for Advanced Pancreatic Cancer XBiotech announced data from its Phase 1/Phase 2 randomized, double-blind, placebo-controlled multi-center study for advanced pancreatic cancer. Known as 1-BETTER, the study examined Natrunix (anti-interleukin-1alpha) antibody in combination with an established chemotherapy regimen (ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV), a regimen that is already widely used for treating pancreatic cancer but is associated with difficult toxicities and less then ideal survival outcomes. Natrunix was being evaluated as an anti-cancer agent for use in cytotoxic chemotherapy combinations where the Company believes it might potentially also improve tolerability of the chemotherapy. The Phase 1 portion was a dose escalation study in metastatic pancreatic cancer patients to determine if dose limiting toxicities (DLTs) occurred in combination with the ON+5FU+LV regimen in second- or third-line setting. DLTs were not expected with Natrunix and none were seen. The Natrunix dose in the Phase 2 portion was thus the highest dose used in the Phase 1 portion. Sixty-five subjects were randomized into the Phase 2 study on a 1:1 basis to receive either Natrunix+ ON+5FU+LV (Arm1) or Placebo +ON+5FU+LV (Arm2). There were 33 subjects enrolled into Arm1 and 32 into Arm2. The Phase 2 treatment period was 24-weeks with subjects receiving therapy once every other week for a total of 12 cycles. Subjects included in the study had confirmed metastatic, unresectable, or recurrent pancreatic adenocarcinoma of exocrine pancreas and were required to have had disease progression after one prior gemcitabine-based therapy or one FOLFIRINOX and gemcitabine containing therapy. All patients were required to have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1). The primary endpoint for the Phase 2 study was to assess the safety and tolerability of Natrunix when used with the ON+5FU+LV combination. Overall, there were fewer adverse events (AEs) of any kind during the 24-week treatment period for the Natrunix arm compared to placebo (297 vs 336), with markedly fewer events in specific categories of adverse events during that time. There was a 28% reduction in the number of subjects experiencing significant adverse events (SAEs) in the Natrunix arm (9 out of 33) versus placebo (12 out of 32) that occurred during the 24-week treatment period. Subjects receiving the Natrunix ON+5FU+LV regimen also had about a 33% reduction in hospitalization (80 days versus 120 days) during the 24-week treatment period compared to subjects receiving placebo + ON+5FU+LV combination. Subjects receiving the Natrunix combination also reported a 22% reduction in fatigue (28 vs 36), 32% improved appetite (19 vs 28) and 41% reduction in pain (17 vs 29) as of the last day of the 24-week treatment period compared to subjects receiving the placebo ON+5FU+LV combination. Severe diarrhea that can be life -threatening is a significant complication for the ON+5FU+LV regimen. There was a two-fold reduction (9% versus 19%) in the incidence of severe diarrhea during the 24-week treatment regimen for patients receiving the Natrunix + ON+5FU+LV combination compared to placebo + ON+5FU+LV. Overall Survival (OS), one of the secondary endpoints for the Phase 2 study, was conventionally defined in as time from randomization to death. The sample size for the study included intent-to-treat analysis of 33 subjects randomized into the Natrunix + ON+5FU+LV arm versus 32 subjects in Placebo + ON+5FU+LV arm. A Kaplan-Meier Survival Curve using a product limit comparison method was performed. This data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas 8 subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330. Considering the small sample size, the borderline statistically significant p-value of p = 0.096 suggests prolonged survival for subjects receiving the Natrunix regimen. While there was a relatively small number of pancreatic cancer patients enrolled in the Phase 2 portion of the study, in the Company’s opinion, the findings show better outcomes for the Natrunix + ON+5FU+LV group as compared to the control arm. The Company believes that the reduced number of serious and adverse events, the significant reduction in hospitalization, and improved OS during the respective time periods described above for each of these metrics suggest that Natrunix could represent a breakthrough advance for the treatment of pancreatic cancer. Tillkännagivande • May 03
XBiotech Inc., Annual General Meeting, Jun 20, 2024 XBiotech Inc., Annual General Meeting, Jun 20, 2024, at 10:00 Central Standard Time. Agenda: To elect the five nominees for director named herein to serve until the next annual meeting and their successors are duly elected and qualified; to ratify the selection by the Audit Committee of the Board of Directors of Whitley Penn LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2024; to approve, on an advisory basis, the compensation of the Company's named executive officers; and to conduct any other business properly brought before the meeting. New Risk • Feb 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 35% per year over the past 5 years. Revenue is less than US$1m (US$300k revenue). Minor Risk Share price has been volatile over the past 3 months (10% average weekly change). Tillkännagivande • Jan 04
XBiotech Inc. announced that it expects to receive $10 million in funding XBiotech Inc. announced that it has entered into a convertible loan agreement for the gross proceeds of $10 million on January 3, 2024. The loan will have an interest rate of 8%. The loan will be convertible at a conversion price of $4.048 per share. The transaction will include participation from John Simard, the Company’s Founder, President, Chief Executive Officer and Chairman. Tillkännagivande • Nov 17
Xbiotech Appoints Alan Kivitz M.D. Lead Investigator & Study Chairman for Its Clinical Research Program for Natrunix in Rheumatoid Arthritis XBiotech announced that Alan Kivitz M.D. is now Lead Investigator & Study Chairman for its clinical research program for Natrunix in Rheumatoid Arthritis. Dr. Kivitz has had a prodigious medical career treating arthritis and rheumatic diseases. He received his medical degree from Albany Medical College, New York, trained in internal medicine at the North Shore University Hospital and Memorial Sloan Kettering Cancer in New York and then completed rheumatology studies at Albany Medical College. Dr. Kivitz has authored over 500 research articles, abstracts, and clinical studies relating to osteoarthritis, osteoporosis and rheumatoid arthritis and has lectured on his findings around the world. Dr. Kivitz has served on advisory boards for major drug developers, including AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Janssen, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Takeda, and UCB. Above all Dr. Kivitz is focused on finding new approaches to treat arthritis and rheumatic disorders. Reported Earnings • Nov 10
Third quarter 2023 earnings released: US$0.24 loss per share (vs US$0.42 loss in 3Q 2022) Third quarter 2023 results: US$0.24 loss per share (improved from US$0.42 loss in 3Q 2022). Net loss: US$7.36m (loss narrowed 42% from 3Q 2022). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 92 percentage points per year, which is a significant difference in performance. Tillkännagivande • Sep 27
Xbiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, A Novel Candidate Therapy for Stroke XBiotech Inc. announced that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke. The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled. XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin. The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Sequential dose escalation was conducted using three cohorts of subjects, each receiving a single intravenous infusion of either placebo or Hutrukin, with eight subjects in each cohort. Hutrukin is a candidate drug being developed to reduce brain injury following ischemic stroke. Globally, one in four people over age 25 will experience a stroke--the leading cause of disability and second leading cause of death in the world. An ischemic stroke occurs when a blood clot obstructs a blood vessel that supplies the blood to the brain. Blockage of blood flow to the brain results in brain injury, loss of brain function, or death. Emergency treatment for stroke includes "clot-busting" drugs or mechanical catheters to re-open arteries, both of which are associated with a phenomenon known as reperfusion injury. Reperfusion injury is the damage that occurs to previously healthy brain tissue after a clot is removed from the artery and blood supply is returned to the healthy but hypoxic brain tissue. This secondary damage is believed to be the result of an inflammatory response resulting from the return of blood cells to the region of the brain that had been previously deprived of blood and oxygen (which is the hypoxic brain tissue). When administered immediately prior to artery-opening procedures, Hutrukin may reduce the inflammatory injuries associated with reperfusion. No drug or treatment is currently available to reduce or prevent reperfusion injury. Hutrukin potentially represents a unique and major advance for stroke victims. Tillkännagivande • Aug 31
Xbiotech Announces Enrollment Completion of Phase II, Placebo Controlled, Multicenter Study for Natrunix in Pancreatic Cancer XBiotech Inc. announced completion of enrollment of the Phase II portion of its 1-BETTER study—a Phase I/II randomized, double-blind, placebo-controlled clinical study for Natrunix in combination with chemotherapy for treating pancreatic cancer. Natrunix is indistinguishable from a naturally occurring antibody present in a healthy human. Natrunix binds and neutralizes a potent substance, a so called cytokine known as interleukin-1a (IL-1a), that causes connective tissue breakdown, growth of new blood vessels, and recruitment of white blood cells. Malignant tumors, like pancreatic cancer, stimulate the body’s production of IL-1a that induce tumor neovascularization, growth and spread. Additionally, IL-1a acts as an alarm signal when there is body injury (such as when tumors grow), enhancing pain perception, metabolism, appetite, fatigue, and anxiety. The insult from chemotherapy also induces IL-1a production. Adding Natrunix to your chemotherapy regimen may therefore provide numerous benefits, including anti-tumor activity, reduction in chemotherapy side effects, improvement in chemotherapy activity—including increasing the number of cycles of therapy that can be tolerated while improving quality of life. Twenty-two leading cancer centers across the United States have been involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022, an estimated 50,000 people died from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy. The Phase II portion enrolled 65 subjects using the maximum dose studied from the Phase I study that were randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Key endpoints in the Phase II portion are safety and tolerability, progression-free survival, overall survival and time-to-treatment-failure. Reported Earnings • Aug 12
First half 2023 earnings released: US$0.41 loss per share (vs US$0.56 loss in 1H 2022) First half 2023 results: US$0.41 loss per share (improved from US$0.56 loss in 1H 2022). Net loss: US$12.6m (loss narrowed 26% from 1H 2022). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 107 percentage points per year, which is a significant difference in performance. Reported Earnings • May 12
First quarter 2023 earnings released: US$0.13 loss per share (vs US$0.18 loss in 1Q 2022) First quarter 2023 results: US$0.13 loss per share (improved from US$0.18 loss in 1Q 2022). Net loss: US$3.82m (loss narrowed 29% from 1Q 2022). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 96 percentage points per year, which is a significant difference in performance. Reported Earnings • Mar 16
Full year 2022 earnings released: US$1.08 loss per share (vs US$0.58 loss in FY 2021) Full year 2022 results: US$1.08 loss per share (further deteriorated from US$0.58 loss in FY 2021). Net loss: US$32.9m (loss widened 89% from FY 2021). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 93 percentage points per year, which is a significant difference in performance. Tillkännagivande • Feb 16
XBiotech Inc. Announces Executive Changes XBiotech Inc. announced that on February 10, 2023, Angela Hu, who presently serves as the Financial Controller of the company, assumed the role as the Company’s principal financial officer and principal accounting officer. Ms. Hu will succeed Queena Han, whose employment as Vice President, Finance and Human Resource ended on February 3, 2023. Ms. Hu, age 39, joined XBiotech in 2015, where she managed the monthly and quarterly accounting process for payroll, stock-based compensation, accruals, pre-paids, fixed assets, budgeting, and reviewed accounting entries. Since 2017, she has been responsible for driving the quarter-end close process and preparing quarterly and yearly financial statements, supporting and filing SEC reports (including the Company’s Form 10-K, Form 10-Q, and annual proxy filings), and providing information to the Company’s external auditor and tax provider to assist them with auditing the Company’s financial statements and tax filings. She now assumes the role of Director of Finance and will lead the Company’s accounting and finance activities. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board & Independent Director Peter Libby was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Nov 11
Third quarter 2022 earnings released: US$0.42 loss per share (vs US$0.11 loss in 3Q 2021) Third quarter 2022 results: US$0.42 loss per share (further deteriorated from US$0.11 loss in 3Q 2021). Net loss: US$12.7m (loss widened 288% from 3Q 2021). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 60 percentage points per year, which is a significant difference in performance. Reported Earnings • Aug 11
Second quarter 2022 earnings released: US$0.38 loss per share (vs US$0.17 loss in 2Q 2021) Second quarter 2022 results: US$0.38 loss per share (down from US$0.17 loss in 2Q 2021). Revenue: US$1.53m (down 66% from 2Q 2021). Net loss: US$11.6m (loss widened 127% from 2Q 2021). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 54 percentage points per year, which is a significant difference in performance. Reported Earnings • May 11
First quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2022 results: US$0.18 loss per share (down from US$0.087 loss in 1Q 2021). Revenue: US$500.0k (down 90% from 1Q 2021). Net loss: US$5.40m (loss widened 110% from 1Q 2021). Revenue exceeded analyst estimates by 81%. Earnings per share (EPS) missed analyst estimates. Over the last 3 years on average, earnings per share has fallen by 39% per year but the company’s share price has only fallen by 14% per year, which means it has not declined as severely as earnings. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board & Independent Director Peter Libby was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Mar 18
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$0.58 loss per share (down from US$0.36 loss in FY 2020). Revenue: US$18.4m (down 58% from FY 2020). Net loss: US$17.4m (loss widened 55% from FY 2020). Products in clinical trials Phase I: 2 Revenue exceeded analyst estimates by 81%. Earnings per share (EPS) missed analyst estimates. Over the last 3 years on average, earnings per share has fallen by 11% per year whereas the company’s share price has fallen by 6% per year. Board Change • Dec 06
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board & Independent Director Peter Libby was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Nov 11
Third quarter 2021 earnings released: US$0.11 loss per share (vs US$0.087 loss in 3Q 2020) The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: US$4.52m (down 57% from 3Q 2020). Net loss: US$3.26m (loss widened 29% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has increased by 56% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Aug 12
Second quarter 2021 earnings released: US$0.17 loss per share (vs US$0.24 loss in 2Q 2020) The company reported a soft second quarter result with weaker revenues and control over costs, although losses reduced. Second quarter 2021 results: Revenue: US$4.53m (down 71% from 2Q 2020). Net loss: US$5.12m (loss narrowed 25% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has increased by 55% per year, which means it is tracking significantly ahead of earnings growth. Recent Insider Transactions Derivative • Jul 13
Board Member exercised options to buy US$452k worth of stock. On the 9th of July, Peter Libby exercised options to buy 25k shares at a strike price of around US$7.76, costing a total of US$194k. Since March 2021, Peter has not owned shares directly. Company insiders have collectively bought US$3.0m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions Derivative • Mar 23
Founder exercised options to buy US$9.8m worth of stock. On the 22nd of March, John Simard exercised options to buy 500k shares at a strike price of around US$7.50, costing a total of US$3.8m. This transaction amounted to 13% of their direct individual holding at the time of the trade. Since September 2020, John has owned 3.72m shares directly. Company insiders have collectively bought US$2.8m more than they sold, via options and on-market transactions, in the last 12 months. Is New 90 Day High Low • Feb 03
New 90-day high: US$19.83 The company is up 3.0% from its price of US$19.16 on 04 November 2020. The American market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 24% over the same period. Is New 90 Day High Low • Dec 23
New 90-day low: US$16.72 The company is down 13% from its price of US$19.12 on 23 September 2020. The American market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 21% over the same period. Recent Insider Transactions Derivative • Nov 24
Independent Director notifies of intention to sell stock W. McKenzie intends to sell roughly 375.00k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of November. If the sale is conducted around the recent share price of US$19.80, it would amount to US$7.4m. Since December 2019, McKenzie's direct individual holding has decreased from 3.64m shares to 2.98m. Company insiders have collectively bought US$209k more than they sold, via options and on-market transactions, in the last 12 months.