UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) April 29, 2015
XBIOTECH INC.
(Exact name of registrant as specified in its charter)
British Columbia, Canada
(State of Incorporation)
001-37347
(Commission File Number)
N/A
(IRS Employer Identification No.)
| 8201 E Riverside Dr. Bldg 4, Ste 100 Austin, Texas |
78744 |
| (Address of principal executive offices) | (Zip Code) |
(512) 386-2930
(Registrant's telephone number, including area code)
________________________________________________________________________________
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On April 29, 2015, the independent members of the Board of Directors of XBiotech Inc. (the "Company") authorized a cash bonus award to John Simard, its Chief Executive Officer and President, in the amount of $550,000 with respect to his performance in fiscal 2014.
Item 8.01. Other Events.
On April 29, 2015, the Company, announced that it has enrolled the first patient into its revised U.S. Phase 3 study of Xilonix(TM) in metastatic colorectal cancer patients. A copy of the Company's press release announcing the foregoing is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1
Press Release of XBiotech Inc., issued April 29, 2015
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| XBIOTECH INC.
(Registrant) |
||
| May 5, 2015
(Date) |
/s/ JOHN SIMARD
John Simard Chief Executive Officer and President |
EXHIBIT INDEX
|
Exhibit No. |
Description |
|
99.1 |
Press Release, issued April 29, 2015 |
EXHIBIT 99.1
XBiotech Enrolls First Patient Under Revised Protocol for U.S. Phase 3 Registration Study Using Xilonix(TM) for Treatment of Metastatic Colorectal Cancer
Revised Phase 3 Study Now Open to More Patients With Colorectal Cancer
AUSTIN, Texas, April 29, 2015 (GLOBE NEWSWIRE) -- XBiotech (Nasdaq:XBIT), a leading developer of next-generation True Human™ therapeutic antibodies, announced today that it has enrolled the first patient into its revised U.S. Phase 3 study of Xilonix™ in metastatic colorectal cancer patients. Xilonix, XBiotech's monoclonal True Human antibody therapy, is designed to block chronic inflammation associated with malignant tumor growth.
The U.S. Phase 3 study was initially launched in March 2013, and patients were recruited at more than 60 U.S. cancer centers. The Company previously paused the study to propose to the FDA changes in inclusion criteria to allow broader eligibility for cancer patient enrollment. The newly approved protocol enables recruitment of advanced, refractory colorectal cancer patients that includes those who have failed all standard therapies.
Dr. George Fisher, Principal Investigator of the study and Professor of Medicine, Stanford University School of Medicine, said, "Metastatic colorectal cancer is a devastating disease and one of the leading causes of cancer-related deaths in the world. Patients diagnosed with this disease have limited treatment options, thus new therapies are urgently needed. Xilonix is intended to target the inflammatory environment of tumor cells and in so doing, slow the growth and spread of the cancer while improving the symptoms associated with advanced disease. Preliminary results have been encouraging and the absence of serious side effects would be a welcome change from standard chemotherapy agents."
John Simard, President and CEO of XBiotech, commented, "We are very pleased to have begun enrollment in this global Phase 3 study of Xilonix in metastatic colorectal cancer under the revised protocol. This is an important milestone for our Xilonix pipeline as well as our True Human antibody therapy platform."
At the time of the protocol revision, 40 patients had entered the study with approximately equal numbers in each arm. An analysis of the primary and secondary endpoints of the study was conducted, and though statistical significance was unachievable due to the relatively small number of patients (the statistical model was designed for 656 patients), the trends observed were encouraging and suggested continuation of the study.
About XBiotech
At XBiotech we are rethinking the way medicines are discovered and commercialized. From pioneering ways to create safer drugs that harness our natural immunity to disease, to developing simple but cutting edge technology that enables rapid transition to large-scale manufacturing—at XBiotech we are leading innovation in the biotechnology industry.
CONTACT: Ashley Otero
XBiotech
aotero@xbiotech.com
512.386.2930
Tiberend Strategic Advisors, Inc.:
Joshua Drumm, Ph.D. (investors)
jdrumm@tiberend.com
212.375.2664
Janine McCargo (media)
jmccargo@tiberend.com
646.604.5150