Annuncio • Jul 08
XBiotech Inc., Annual General Meeting, Aug 29, 2025 XBiotech Inc., Annual General Meeting, Aug 29, 2025. Location: via the internet, United States Annuncio • 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. Annuncio • 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. Annuncio • 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 • Jan 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 35% per year over the past 5 years. Revenue is less than US$1m (US$300k revenue). Annuncio • 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. Annuncio • 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 93 percentage points per year, which is a significant difference in performance. Annuncio • 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. Annuncio • 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 13
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 108 percentage points per year, which is a significant difference in performance. Reported Earnings • May 11
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 94 percentage points per year, which is a significant difference in performance. Reported Earnings • Mar 17
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. Annuncio • 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 63 percentage points per year, which is a significant difference in performance. Annuncio • Oct 14
XBiotech Inc. Announces First Patient Enrolled into the French National Cancer Institute Sponsored Phase I/Ii/Iii Clinical Study for Natrunix™ Therapy for Colorectal Cancer XBiotech announced the enrollment of the first patient in a multicenter, randomized clinical study for Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer. The much anticipated clinical study for XBiotech’s candidate cancer treatment is being funded by the French National Cancer Institute (INCA). The study is headed by renown oncologists Dr. François Ghiringhelli and Dr. Come Lepage, Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Professor at the Department of Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France, respectively. Investigators are combining XBiotech’s Natrunix with trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer. Subjects receiving the experimental therapy have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. Subjects are randomized to receive Natrunix plus trifluridine/tipiracil chemotherapy or placebo plus the chemotherapy. The study is designed to seamlessly proceed through Phase III development based on achievement of certain efficacy milestones in the Phase I/II portions. Natrunix is a therapeutic monoclonal antibody discovered, manufactured, and undergoing clinical development by XBiotech. The antibody blocks the activity of substance produced by tumors and inflammatory cells that stimulates new blood vessel formation and breaks down connective tissue at the site of the tumor, allowing tumors to grow and spread. The same substance also activates blood vessels, making them sticky to enhance migration of circulating tumor cells to new sites of metastasis. Natrunix potently blocks the action of the substance, known as IL-1, which is also produced in response to chemotherapy. Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths annually in the United States alone. 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 57 percentage points per year, which is a significant difference in performance. Annuncio • Jun 26
XBiotech Inc.(NasdaqGS:XBIT) dropped from Russell 2000 Dynamic Index XBiotech Inc.(NasdaqGS:XBIT) dropped from Russell 2000 Dynamic Index Annuncio • Jun 21
XBiotech Announces Successful Completion of Phase I Portion of Pancreatic Cancer Study XBiotech Inc. announced it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer. Enrollment in the Phase II portion is commencing immediately. Thirty leading cancer centers across the United States are involved in the Phase I/II study. Pancreatic cancer is the4(th) leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022 about 50,000 people will die from pancreatic cancer in the United States. The Natrunix antibody therapy represents a approach to therapy--with the aim to of reducing treatment related toxicity of chemotherapy while also blocking the tumor-associated signals that spurn growth and spread of tumors. The key is Natrunix's ability to specifically target the body's response to injury. Chemotherapy and tumors both elicit an injury response from the body, and this response may counteract some of the beneficial effects of therapy while at the same time cause substantial morbidity. This injury response plays a crucial role in the growth, spread and morbidity of cancer. Natrunix targets this common pathway activated by cytotoxic therapy and paraneoplastic inflammation. Used in combination with chemotherapy, Natrunix is therefore being assessed for its ability to reduce the side effects of chemotherapy treatment and mediate anti-tumor effects. The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of "possibly, probably, or definitely related dose limiting toxicity (DLT)" associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continued to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects. The Phase II portion of the study is commencing immediately. Key endpoints in the Phase II portion will be progression-free survival, overall survival and time-to-treatment-failure. The Phase II portion is enrolling 60 subjects that will be 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. Subjects will receive the treatment for up to 12 cycles and will be allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. Annuncio • May 14
XBiotech Inc., Annual General Meeting, Jun 22, 2022 XBiotech Inc., Annual General Meeting, Jun 22, 2022, at 10:00 Central Daylight. Location: at the Company’s principal executive offices located at 5217 Winnebago Lane, Austin United States 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, 2022; 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. Reported Earnings • May 11
First quarter 2022 earnings released: US$0.18 loss per share (vs US$0.087 loss in 1Q 2021) 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). 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 10% 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 17
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat 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%. 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. Annuncio • Jan 27
XBiotech Announces First Patient Enrolled in Phase I Clinical Trial for Novel Arthritis Therapy Natrunix-SQ XBiotech Inc. enrolled the first patient in a randomized, double-blind, placebo-controlled clinical study to evaluate safety and pharmacokinetics of Natrunix-SQ. Natrunix-SQ targets a crucial inflammatory pathway involved in pain and joint destruction in various forms of arthritis. XBiotech believes that Natrunix-SQ may be the most effective means of blocking the inflammatory pathway involved in arthritis and thus could represent a breakthrough treatment for arthritides. The Phase I study represents the launch of the clinical program for Natrunix-SQ for the treatment of rheumatological diseases. The Phase I study will evaluate Natrunix-SQ blood levels in the context of increasing doses. These findings will guide follow-up studies with Natrunix-SQ. Upon successful completion of the Phase I study, multiple Phase II studies to evaluate Natrunix-SQ in rheumatology are planned. Natrunix-SQ is an antibody derived from a human donor where it was acting to naturally neutralize inflammation. Natrunix-SQ binds and neutralizes the action of one of the most potent inflammation-causing substances known to be produced by the body—interleukin-1. The body’s production of interleukin-1 has for decades been viewed as a key target for treating inflammatory disease. To date, therapies that block interleukin-1 have been successfully developed and marketed. However, no therapy to date has been developed that neutralizes interleukin-1 like Natrunix-SQ. Interleukin-1 is made up of two distinct components: IL-1a and IL-1b. Natrunix-SQ is the first therapeutic to directly and specifically target and neutralize the activity of IL-1a. In recent years, world-class research has shown that IL-1 a may in many cases be the crucial target in blocking the disease-causing activities of interleukin-1. The unique approach of Natrunix-SQ to blocking interleukin-1-driven inflammation holds promise as a new generation of anti-inflammatory therapy in arthritis. As a naturally derived human antibody, it is also by design expected to be among the safest and best tolerated medicines possible. 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 10
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 57% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Aug 11
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 53% per year, which means it is tracking significantly ahead of earnings growth. Annuncio • Jun 25
XBiotech Inc. Announces First Patient Enrolled in Clinical Trial Evaluating XB2001 for the Treatment of Pancreatic Cancer XBiotech Inc. has enrolled the first patient in its 1-BETTER study, a randomized, double-blind, placebo-controlled clinical study to evaluate XB2001 in combination chemotherapy for treatment of Pancreatic Cancer. XBiotech’s novel anti-cancer agent, XB2001, is being assessed in combination with ONIVYDE + 5-FU/LV chemotherapy regimens. Safety and tolerability of the regimen, as well as progression-free survival, overall survival and time-to-treatment-failure will be assessed in the study. XB2001 blocks inflammation pathways turned on by tumors that help tumors vascularize, spread and cause collateral damage to healthy tissues. By using XB2001 to block inflammation in pancreatic cancer, investigators also hope to see a reduction in serious adverse events and reduced hospitalizations of subjects. Moreover, the anti-inflammatory effects of XB2001 may make the chemotherapy more effective and less toxic. The study is also investigating a novel clinical endpoint that XBiotech calls the “clinical benefit response”, which involves radiological assessment of muscle mass and patient reported measures of pain, fatigue and appetite. In earlier clinical studies in advanced cancer patients, XBiotech discovered that subjects with preserved muscle mass and stabilization or improvement of these symptoms, had dramatically improved overall survival. The Company previously validated this endpoint in a phase III study in colorectal cancer patients and will explore this endpoint now with its new drug in pancreatic cancer. The current study will commence with a Phase 1 portion to establish safety, tolerability and dosing of XB2001 in combination with ONIVYDE+5-FU/LV. The Phase I portion will serve to establish a recommended Phase 2 dose, which will involve enrollment of 60 patients randomized to receive either placebo+ONIVYDE+5-FU/LV or XB2001+ONIVYDE+5-FU/LV for up to 12 cycles. Annuncio • May 04
French National Cancer Institute and XBiotech Join forces to Conduct Innovative Phase II/III Adaptive Multicenter Clinical Study for XBiotech’s New Cancer Drug for Colorectal Cancer XBiotech announced that it had reached an agreement to supply its new cancer drug XB20-01 to INSERM, and its Federation of Digestive Oncology group, a French organization which supports world-leading innovation for treating colorectal cancer. Colorectal is one of the most common forms of cancer in Europe and the United States, with nearly 150,000 new cases and 53,000 deaths expected in the US alone in 2021. The current chemotherapy regimen uses a Trifluridine/Tipiracil combination, drugs that interfere with the genetic material of cells in an effort to kill tumors. However, inflammation and toxicity from the chemotherapy is offset only by modest response rates and less than ideal outcomes. Thus, there is significant unmet medical need for this group of colorectal cancer patients. XBiotech's new drug candidate XB20-01 targets an inflammatory process potentially involved in the growth and spread of colorectal cancer; and the new drug may also block inflammation caused by chemotherapy, potentially reducing side effects and improving the treatment effect of chemotherapy. Cytotoxic chemotherapy agents result in systemic toxicity—considered to be a trade-off for potential anti-tumor activity. Toxicity is of acute importance clinically, but consequences of inflammatory responses induced by cytotoxic agents may also have a more profound impact, promoting tumor growth, and compromising the efficacy and durability of the therapy itself. Cytotoxic agents upregulate inflammatory pathways, including activation of leukocytes, vascular endothelium, and stromal cells of the tumor microenvironment. IL-1a is believed to play a key role in pro-tumor and treatment related inflammatory pathways. XBiotech’s new drug XB20-01 is a naturally occurring antibody that potently neutralizes IL-1a and is thus a safe and promising approach to block inflammation that occurs with advanced malignancies and chemotherapy. Unchecked, IL-1a can stimulate angiogenesis, enhancing blood and nutrient supply to the tumor; IL-1a may also act to recruit unwanted leukocytes (such as myeloid suppressor cells) into the tumor, that can suppress the ability of the body’s immune system to fight off the tumor; and systemically, IL-1a can mediate metabolic dysfunction, and cause fatigue, anorexia, and anxiety in cancer patients. IL-1a is thus a unique target for addressing paraneoplastic inflammation—with XBiotech’s new drug therapy holding promise for treating a wide array of cancers. Is New 90 Day High Low • Feb 16
New 90-day high: €17.10 The company is up 3.0% from its price of €16.59 on 18 November 2020. The German market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 17% over the same period. Annuncio • Jan 22
XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain XBiotech Inc. announced that its COVID-19 candidate True Human™ antibody therapy may also be used for treating the COVID-19 mutant virus that recently emerged in the UK and is now rapidly spreading across the US. The mutant COVID-19 virus has alterations to the spike protein that reportedly make the virus more contagious, and these mutations might also enable the virus to escape existing vaccines or therapies. XBiotech’s candidate therapy specifically targets the so-called spike protein of the virus and potently neutralizes the virus’ ability to infect cells. The company analyzed its candidate COVID-19 therapy for its ability to bind the spike protein of the mutant COVID-19 virus and was found to have the same high affinity for spike protein of both the original COVID-19 and mutant COVID-19 viruses. These findings provide quick and convincing evidence that XBiotech’s candidate True Human™ therapy, which was potently effective in neutralizing the original strain of COVID-19, could be expected to be similarly effective at neutralizing the mutant strain of the virus. The new mutant COVID-19 virus has undergone changes that include small differences in the so-called spike protein of the virus. Scientists at XBiotech used a method employing bio-layer interferometry to analyze binding of its COVID-19 True Human™ antibody to the spike protein of the mutant strain. These studies showed the antibody bound to the mutant spike protein with same high affinity as it does to the original COVID-19 virus. The higher rate of transmission of the mutant COVID-19 virus means that it could quickly become the dominant form of the virus in the US. The CDC in fact predicts the new variant will be the main cause of COVID infections in the USA by March, 2021. A therapy that could be used to treat both COVID-19 and the mutant strains of the virus could be of crucial importance as the mutant virus spreads. The Company has engineered production capable cell lines and is prepared to establish manufacturing processes for clinical development as necessary. Is New 90 Day High Low • Dec 22
New 90-day low: €13.80 The company is down 19% from its price of €17.00 on 23 September 2020. The German market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 7.0% over the same period. Annuncio • Nov 20
Xbiotech Data Shows Effective Anti-Virus Activity for True Human Antibodies in Its Candidate Influenza-Covid-19 Therapeutic Cocktail XBiotech Inc. announced new data for its breakthrough candidate therapy for treating infections of influenza and COVID-19. The Company continues to analyze components of its so-called FLUVID™ therapy as it develops manufacturing capability for a product candidate. The True Human antibodies targeting the virus causing COVID-19 were found to effectively neutralize a test virus at concentrations about four-times better than the antibodies the FDA is now considering for emergency use authorization. Ongoing research has also found that the True Human antibodies in this therapeutic cocktail that target influenza are capable of rescuing 100% of animals that receive an otherwise lethal dose of flu virus. The latest research findings suggest the FLUVID™ therapy, designed to be effective against all known strains of influenza in addition to the COVID-19 virus, could provide a uniquely effective therapy for treating complex infections from one or more of these viruses. There is no other therapy available to treat both COVID-19 and Influenza infections that occur together. With the resurgence of the COVID-19 virus during this oncoming flu season, the company faced with the likelihood that many people will be infected by both influenza and COVID-19 viruses. Co-infections, or “superinfections”, may increase severity of disease and further complicate treatment. A therapy that could treat COVID-19+Influenza co-infections is urgently needed. While the COVID-19 pandemic has only recently emerged, the FLUVID™ candidate therapy is the result of years of Research and Development at XBiotech, incorporating extraordinary influenza True Human antibodies that have been systematically evaluated for their ability to target virtually all known strains of influenza viruses. Whereas the True Human COVID-19 antibodies were derived from patients who recovered rapidly without serious illness and therefore should have potent neutralizing capability against the virus. The influenza strains that will be targeted by FLUVID include: seasonal H1N1 and H3N2 strains; pandemic strains H1N1, H2N2, H3N2; avian influenza strains H5N1, H5N2 and H7N9; and even H9N2 and H10N8, which are currently in poultry but are believed to have pandemic potential in humans. Annuncio • Sep 22
XBiotech Developing True Human Antibody Combination as Candidate Treatment for Influenza-COVID-19 Co-Infections XBiotech Inc. announced it is developing a new breakthrough candidate therapy it calls FLUVID™ for treating illness caused by combined infections with influenza and COVID-19. With the global spread of the novel COVID-19 virus, there will be added risk during flu seasons that people may be infected by both influenza and COVID-19 viruses. Co-infections with the two viruses, or superinfections, may increase severity of disease and further complicate treatment. FLUVID therapy will combine XBiotech’s breakthrough influenza True Human antibodies together with its recently discovered COVID-19 antibodies into one treatment. As flu season approaches amid concerns over a potential deadly “twindemic”, FLUVID is an urgently needed and potential breakthrough therapy to treat combined infections with influenza and COVID-19 viruses. FLUVID could be used to provide immunity to infection or to treat infections once they have occurred.
FLUVID is the culmination of years of research and development. It incorporates extraordinary influenza antibodies that target all known strains of influenza, combined with the Company’s recently discovered COVID-19 antibody, passive immunity derived from patients who recovered rapidly from the virus without serious illness. FLUVID harnesses the best in human immunity to provide what is expected to be a safe and effective therapy against both deadly viruses.
Multiple strains of influenza are responsible for the seasonal illnesses and pandemics experienced around the globe. However, among these multiple influenza strains, there are small portions of the virus that are common among all the strains. For years, XBiotech scientists diligently screened human donors for antibodies capable of targeting these regions shared among influenza viruses. By identifying antibodies that target the shared areas of the influenza viruses, XBiotech is able to develop a single therapy that could be used to treat virtually all known strains. Annuncio • Jul 02
XBiotech Inc.(NasdaqGS:XBIT) dropped from Russell 3000 Growth Index XBiotech Inc.(NasdaqGS:XBIT) dropped from Russell 3000 Growth Index 