Good morning, ladies and gentlemen and welcome to the Q2, 2016 Xbiotech Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like over to Meg Lewis.

Thank you, operator. Before turning the call over to management, I would like to make the following remarks. During this call, forward-looking statement including declarations regarding management’s beliefs and expectations will be made. In some cases you can identify forward-looking statements by terminologies such as may, will, should, would, could, expect, plan contemplate, anticipate, beliefs, estimates, predicts, reject, intend, or continue or the negative of such terms or other comparable terminology although not all forward-looking statements contains 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. The risks and uncertainties are subject to the disclosures set forth under risk factors in XBiotech’s SEC filings. Forward-looking statements are not guarantees of future performance and actual results of operation, 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 call. Any forward-looking statements that we make on this call speak only as of the date of this call. XBiotech assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise after the date of this call. At this time it is now my pleasure to turn the call over to John Simard, Founder, President and CEO of XBiotech.

Thanks, Meg and thank you all for joining us this morning for our second quarter and 2016 update. I’m going to provide a brief review of recent developments, and then provide an opportunity for Q&A for the audience. At that time, our Medical Director, Mike Stecher and I will be available to answer your questions. I’d like to start with some recent highlights pertaining to our European study. In July, XBiotech presented data from the pivotal European trial for Xilonix at the European Society for Medical Oncology World Congress in Barcelona, Spain. An oral presentation was made there by Dr. Tamas Hickish and there we also met with key opinion leaders to discuss our findings. It was a very interesting meeting sure there may be some questions to follow. More recently, we had an in person meeting with the European regulators in Europe to discuss our marketing authorization application, and the application I can tell you remains on schedule and we are currently devoting a good deal of effort to advancing the process. On other fronts, we continue to move forward with our Global Phase 3 study in colorectal cancer. We call this our XCITE study, which is proceeding under FDA fast track designation. Our enrolment in this study remains on track and we anticipate completing enrolment around years’ end. Recently, data and monitoring committee meeting was held following randomization of 400 subjects. This is a standard process to evaluate the study principally for safety and they found no safety concerns and allow the study to proceed as planned. Another DMC meeting is scheduled to occur after 600 patients have been enrolled. We do have another oncology study in non-small cell lung cancer that has actually been in the planning stage for some time. We are organizing this study with…

[Operator Instructions] And your first question comes from the line of Kumar Raja. Your line is open.

Good morning, John. Congratulations on all the progress. I have got questions here. First for the XCITE study, when do you expect the first planned efficacy analysis and what efficacy parameters will you be looking at during this efficacy analysis?

Thanks, Kumar for calling in. Mike will answer that for you.

So it’s typical to know exactly when to expect the first efficacy. We are following the event rate very closely. Right now we’re projecting that it could occur anytime between the very end of the year and Q1 of next year. So, as you know, the efficacy analysis is based on the number of events. As far as the fixed size, we are looking for, is the same as -- what we would have to see at the end of the study. We just have to be very highly significant so that the p-values what drives that. So it would be a difficult bar to reach on the first interim but we are hopeful and so, sometimes between end of the year and then Q1 of next year.

And for European review of Xilonix, what can you guys say about the interaction with the European regulators and also thoughts on why there was a change from expedited review to standard review and also the timing for the publication of the Eurpean data?

So, we’ve had a clarification meeting with the regulators and this is a standard meeting where we are able to ask questions and those very productive, we are able get some more details as to what they are thinking and we are able to give them some insight into our data. As far as the change in status, again this was something that we found to be pretty standard with the novel endpoint that they needed some additional time to review responses. As far as the publication that’s currently under review and we hope to have something to announce soon.

And final question on the combination trial with Tarceva, non-small cell lung cancer. What are your expectations in terms of safety profile there? Obviously, you are combining two drugs there. You said that you guys are seeing some positive interaction in terms of efficacy. What effects are you seeing in terms of safety there?

So the study hasn’t started yet, but our anticipation would be that there will be no change in the safety profile of the drug combining it with Tarceva. There is no reason to believe that combination with EGFR inhibitor would cause any change in the adverse event profile of Xilonix. We are quite hopeful though that it might improve the safety profile of Tarceva though as you know skin toxicity is a major issue with EGFR inhibitors. And as we mentioned on the call today and several times before, we’ve seen some pretty good results in dermatology, reduction in psoriatic, skin lesions and acne. So, we would hope that potentially we could see an improvement in the safety profile of Tarceva along with an improved efficacy combination.

Okay. Great. Thanks for taking my questions.

Yes. Thanks again for calling in this morning.

[Operator Instructions] Your next question comes from the line of Tom Costas, Private Investor. Your line is open.

Hello, yes. My name is Tom Costas. I’m private investor. I had read an article about the European Society of Medical Oncology questioning your Phase 3 study and I was wondering is there anything more to say about their opinion and how you plan to address that?

Well, people are welcome to their opinions. We didn’t see anything credible or illuminating in the review by -- that was put out by the ESMO individual. One of the things I should note is he failed to mention his affiliations with competitor drug products. He is the spokesperson for Regorafenib. And at the Regorafenib launch, he admitted that statement. And Regorafenib is really the target for us in the marketplace and will be the loser should we get approved. So there is special interest in that individual and we didn’t see any new insight or analysis there. So there wasn’t really too much that we saw to address.

But do you anticipate his opinion has any effect on the medical community in Europe adopting your drug, should it be approved?

I can’t really comment on that. I don’t know that one individual’s opinion could influence an entire medical community but I will leave that up for you to ponder. I really couldn’t speak to that.

All right. Well, thank you very much.

Thank you.

Your next question comes from the line of Manish Pal [ph] from MHP Capital. Your line is open.

Thank you. Good morning. I just have two quick questions. One is can you talk about the time of the disposition for European disposition? Is that Q4 still because in the press release it says Q4 and then your 10-Q says anticipated by probably Q4? So is Q4 still looking like a good date for you guys for Europe?

Yes, it is. Yes, it is.

Okay. Great.

Yes. I’m sorry. The language isn’t definitive but that is the lower expectation.

Okay. And with regard to the endpoint, I know when you did the trial the endpoint was already discussed with the European Union. Now they are asking for more time, which is why they changed the disposition of the trial -- of the expedited process. Was there a change with regard to that, or was that something that just they just changed their mind?

No, there is no change of the mind. It’s interesting the way that organization is set up is you go to a body for a scientific advice in study design. And we spent a considerable amount of time with them in that process. But when you move to the registration part of it, it’s a completely different group and even though there is some communication between them, the new group has to learn, relearn the study design and the data and why it was done and how it was done all over again. So it’s not like this group was familiar with it.

Okay. That helps a lot. And then just really quickly, I know you are not in partnership this quarter. Can you talk about your pipeline of other partnership opportunities given your robust pipeline of drug candidates? Thank you.

Yes. Sure, we have a number of discussions ongoing. Part of our core strategic concept here in this company was to put our own legs under us, right. And that goes with our manufacturing, our ability to take drugs to market through our internal process from bench to market. So when we look for partnerships we look for those that really suit us not for things that are short term band-aids or ways to get us to the end, it’s really things are strategic fit. So, we are engaged in that and we do have a number of interesting discussions going on that does support our strategy.

Okay. Thank you.

Thank you.

Ladies and gentlemen, there are no questions at this time. I now like to turn the conference back over to John Simard.

Thank you again all of you for spending some time with us this morning. I hope that was of some help and I do look forward to our next opportunity to update you and hopefully some of you can come to our new facility opening here next month. Have a nice day and until we meet again.

This concludes today’s conference call. Thank you for your participation and have a wonderful day. You may all disconnect.