XBIOTECH INC. (NASDAQ:XBIT) Files An 8-K Other Events
Item 8.01 Other Events.

On December 16, 2016, XBiotech Inc. (the “Company”) announced that it has received the Day 180 List of Outstanding Issues (the “LoOIs”) from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (the “CHMP”) in connection with the Company’s Marketing Authorization Application (the “MAA”) for Xilonix. Xilonix is an investigational drug candidate being evaluated for the treatment of advanced colorectal cancer.

Major objections remain relating to clinical and quality matters. Clinical objections pertain primarily to benefit risk justification of the therapy and pharmacokinetics. Quality objections relate to qualification of the cell line used to produce the antibody and scaled down systems used to demonstrate robustness of the purification process as well as clarification of critical process controls. No objections remain regarding non-clinical aspects of the application. The Company believes the CHMP’s requests are addressable. The Company plans to submit its responses to the LoOls within 60 days, in line with an updated regulatory timetable.

This Form 8-K and related presentation contains forward-looking statements, including declarations regarding management’s beliefs and expectations, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. Applicable risks and uncertainties include the risks that the interim data from this clinical trial may not be predictive of the results from the completed clinical trial, that the Company will be unable to successfully complete this clinical trial by year end and the other disclosures set forth in "Risk Factors" in our SEC filings.

About XBIOTECH INC. (NASDAQ:XBIT)

XBiotech Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in discovering and developing True Human monoclonal antibodies for treating a range of diseases. The Company focuses on bringing its lead product candidate, Xilonix (MABp1), to market. The Company has also developed a True Human monoclonal antibody discovery platform and manufacturing system. The Company’s therapeutic antibody Xilonix is being evaluated as a monotherapy to treat advanced stages of colorectal cancer. Xilonix neutralizes a pro-inflammatory protein produced by leukocytes and other cells, interleukin-1 alpha (IL-1a). The Company completed a Phase I and II clinical trial for MABp1 as a treatment for cancer at MD Anderson Cancer Center. The Company is also investigating MABp1 in clinical trials for other indications, including vascular disease, type II diabetes, acne and psoriasis.

XBIOTECH INC. (NASDAQ:XBIT) Recent Trading Information

XBIOTECH INC. (NASDAQ:XBIT) closed its last trading session down -0.54 at 9.44 with 551,249 shares trading hands.