0001171843-16-013494.txt : 201612050001171843-16-013494.hdr.sgml : 2016120520161205160014ACCESSION NUMBER:0001171843-16-013494CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:33CONFORMED PERIOD OF REPORT:20161205ITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20161205DATE AS OF CHANGE:20161205

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:XBiotech Inc.CENTRAL INDEX KEY:0001626878STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:000000000STATE OF INCORPORATION:A1FISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:001-37347FILM NUMBER:162033786

BUSINESS ADDRESS:STREET 1:8201 E. RIVERSIDE DRIVESTREET 2:BUILDING 4, SUITE 100CITY:AUSTINSTATE:TXZIP:78744BUSINESS PHONE:512-386-2930

MAIL ADDRESS:STREET 1:8201 E. RIVERSIDE DRIVESTREET 2:BUILDING 4, SUITE 100CITY:AUSTINSTATE:TXZIP:78744

8-K1f8k_120516.htmFORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________________

FORM 8-K

________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934

Date of Report (Date of earliest eventreported): December 5, 2016

________________________

XBIOTECH INC.

(Exact name of Registrant as specified in its charter)

________________________

British Columbia, Canada

(State of Incorporation)

001-37347

(Commission File Number)

N/A

(I.R.S. Employer Identification No.)

8201 E Riverside Dr. Bldg 4, Ste 100

Austin, Texas

(Address of principal executive offices)

78744

(Zip Code)

(512) 386-2900

(Registrants telephone number, includingarea code)

(Former Name or Former Address, if ChangedSince Last Report)

Check the appropriate box below if the Form 8-K filing is intendedto simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencementcommunications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

Certain spokespersonsof XBiotech Inc. (the Company) plan to present the information contained in the presentation attached hereto as Exhibit99.1 to various parties including investors and prospective investors. The presentation is an overview on the Company and its capabilitiesand contains updated clinical information and related timelines.

This Form 8-K and related presentationcontains forward-looking statements, including declarations regarding management's beliefs and expectations, that involve substantialrisks 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, intendor continue or the negative of such terms or other comparable terminology, although not all forward-looking statementscontain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting futureresults 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 theresults from the completed clinical trial, that the Company will be unable to successfully complete this clinical trial by yearend and the other disclosures set forth in "Risk Factors" in our SEC filings.

Item 9.01Financial Statements andExhibits.

(d) Exhibits.

99.1XBiotechPresentation Slides

SIGNATURES

Pursuant to the requirementsof the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersignedhereunto duly authorized.

Date:December 5, 2016 XBIOTECH INC.

By: /s/John Simard

John Simard

Chief Executive Officer and President

EXHIBITINDEX

Exhibit

Number

Description

99.1 XBiotech Presentation Slides

EX-99.12exh_991.htmEXHIBIT 99.1

Exhibit 99.1

Corporate Presentation 2016 NASDAQ: XBIT Creating Breakthrough Therapies from Natural Human Immunity

1 This 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 . These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings . Forward - looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward - looking statements contained in this presentation . Any forward - looking statements that we make in this presentation speak only as of the date of this presentation . We assume no obligation to update our forward - looking statements whether as a result of new information, future events or otherwise, after the date of this presentation . Presentation Contains Forward Looking Statements

2 30,000 ft 2 R&D Laboratories, Manufacturing, Administrative 16 ,000 ft 2 Clinical Operations, Manufacturing Filling Suite, Vivarium 40,000 ft 2 Manufacturing, Quality Control Laboratory, Administrative XBiotech Facilities (New 48 acre Campus Location)

3 Incorporated in 2005, IPO April 2015 (NASDAQ XBIT) 107 Employees 86,000 ft 2 Operations in Austin, Texas Operations include R&D, Manufacturing, Sales & Marketing (planned) Incorporated in United States, Switzerland, Germany, Japan, Canada Over 100 Clinical Sites in Operation in Various Indications in 20 Countries Around the World 120+ Patents & Patents Pending Snapshot December 2016

4 Corporate Board Dr. Fabrizio Bonanni , Former Executive VP Operations Amgen, Developed Worlds Largest Biologics Manufacturing Operation Thorpe McKenzie Founding Partner of Tiger Fund, One of the Most Iconic Investment Funds in the History of Wall Street. John Simard Founder CTL ImmunoTherapies , AlleCure , MannKind , XBiotech. Dr. Daniel Vasella Chairman & CEO Novartis. Founded Novartis in merger between Ciba - Geigy and Sandoz Laboratories, creating what became the largest revenue generating Pharma in the World.

5 Pending Marketing Authorization for First - In - Class Therapy for Colorectal Cancer Rich Pipeline. Three Fast - Tracked Development Paths: Oncology , Cardiovascular, Infectious Disease 100% Ownership of Assets , $ 0 Debt Worlds Leading Disposable Manufacturing Program (GMP Certified Oct. 2016) XBiotech Today

6 Healthy Human Volunteers with Natural Immunity to Disease The Human Antibody Repertoire: A Remarkable Platform for Breakthrough Medicines

7 Program 1 Pre - Clinical Phase I Phase II Phase III Pending Marketing Authorization 2 Symptomatic Colorectal Cancer Advanced Colorectal Cancer Type II Diabetes Peripheral Vascular Disease Psoriasis Acne Pyoderma Gangrenosum Hidradentitis Suppurativa S. aureus Bacteremia C. difficile Influenza Herpes Varicella Zoster (Chickenpox) Ebola 1 All Grey Shaded Areas Involve MABp1 Targeting Interleukin - 1 a . Green - shaded programs have individual antibodies specific for each infectious agent. Fast Tracked MAA Decision Pending x x x x x x x x Fast Tracked Fast Tracked x x MAA Submission 2017 = pilot study x x x x

8 Anti - Inflammatory Programs Type II Diabetes Peripheral Vascular Disease Pyoderma Gangrenosum Psoriasis Hidradenitis Supperativa Acne

9 Peer - Reviewed Publications on Clinical Findings MABp1, a first - in - class true human antibody targeting interleukin - 1 in refractory cancers: an open - label, phase 1 dose - escalation and expansion study Xilonix , a novel true human antibody targeting the inflammatory cytokine interleukin - 1 alpha, in non - small cell lung cancer Safety, pharmacokinetics, and preliminary efficacy of a specific anti - IL - 1alpha therapeutic antibody (MABp1) in patients with type 2 diabetes mellitus

10 An open label, phase 2 study of MABp1 monotherapy for the treatment of acne vulgaris and psychiatric comorbidity A randomized phase II study of Xilonix , a targeted therapy against interleukin 1, for the prevention of superficial femoral artery restenosis after percutaneous revascularization Open - label trial of MABp1, a true human monoclonal antibody targeting interleukin 1, for the treatment of psoriasis Clinical Publications (Continued)

11 Oncology Xilonix Monotherapy in Colorectal Cancer: Two Phase III Programs Development of Novel Endpoint Radiological/Quality of Life Measure : A Direct Measure of Clinical Benefit and a S urrogate Measure of Anti - Cancer Activity Xilonix Suitable for Combination with Multiple Therapies Pluripotent Anti - Tumor Mechanism Interrupts Tumor Growth and Augments Recovery

12 Xilonix Therapy in Colorectal Cancer 40% of Advanced Colorectal Cancer Patients that Complete an 8 Week Treatment with Xilonix Achieve Clinical Response That is Nearly Twice as Many Compared to Placebo. ( Per Protocol Population for a Randomized Double - Blind Placebo Controlled Phase III Study. 40% of Xilonix Patients Met Primary Endpoint vs 23% on Placebo p= 0.0033)

13 Achieving the Clinical Response Means: Twice as Likely to Have Stable Disease 1 Five T imes Less Likely to Have Serious Adverse Events 2 1 24.1% of Patients Achieving Primary Endpoint had stable disease at 8 weeks vs 11.7% for those that did not (p=0.0062) 2 5.7% of Patients Achieving Primary Endpoint had SAEs vs 29.3% that Failed To Achieve (p < 0.001)

14 Clinical Response Associated with Wide Ranging Improvement in Health x Increase in Lean Body Mass (1.4kg) x Improved Global Quality of Life x Improved Role Function x Improved Emotional Function x Improved Social Function x Reduced Pain x Reduced Fatigue x Increased Appetite ( P < 0.001 for each category) Improvement was both statistically significant and clinically meaningful (in terms of magnitude of improvement for categories relevant to EORTC guidelines)

15 Patients Achieving Clinical Response After 8 Weeks Were Nearly Twice as Likely to Live Longer 1 After 8 weeks on Study 40% of Xilonix Patients Met Primary Endpoint vs 23% on Placebo (p< 0.0033) n =139 P=)L1H2E*B5\+,;DFAE:VJ_TRM6_[@=KRT68_R6ME=;Z(&TM;*ZW*RY9>JNYC&IF_O,5^0QM$;1+6?X'=$6D\#MNB\6L^ QM%W:>:6M)X'=$6D\#NB:SX0SM/-&T\TO:3P.Z+EI/ [HFL^!][N%MP[U$A&8A?I%NCJ+KF?F N9QX5+';H7,[1P*-JT?Q2X 25P!QYKAGMN:% SR'M=_2DS N$9XD!105#A(_>3]US8^)RSMXA$WU=M(V@?5+ODDDWDE7BM)@7;-'!9F,LNLE%1$3O4A#S3&G!"FD%*A$ I",*:[8K6L+2&0(RA3L46*5 AME1E4[%%BE"MM0[F#]50[&*6.1S)96,RG+F?W6DVO8$Z$_1=R)&;"*.1Q N0=U]UQNW*$6 414ABV'DV%=2DW _U6[SN&](S8;136VD.HS6(V1C7L87;CMF%8RD538S213.B>YVT;?NVU-K[NBK?C% 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