Good day, ladies and gentlemen. And welcome to the ChemoCentryx Fourth Quarter 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference call is being recorded. I would now like to turn the call over to Susan Kanaya, Senior Vice President and Chief Financial Officer at ChemoCentryx. Ms. Kanaya, please go ahead.

Thank you. Good afternoon. And welcome to the ChemoCentryx's fourth quarter 2014 financial results conference call. This afternoon we issued a press release providing financial results and company highlights for the quarter ended December 31, 2014. This press release is available on our website at www.chemocentryx.com. Joining me on the call today is Dr. Thomas Schall, President and Chief Executive Officer of ChemoCentryx, who will provide a corporate update and review our anticipated milestones for 2015. Following his comments, I will provide an overview of the financial highlights for the fourth quarter and 2015 financial guidance, before turning the call back over to Tom for closing remarks. As a reminder, during today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These risks are described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K to be filed on March 13, 2015. You are cautioned not to place undue reliance on these forward-looking statements, and ChemoCentryx disclaims any obligation to update such statements. In addition, this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, March 12, 2015. ChemoCentryx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. I will now turn the call over to Tom.

Thank you, Susan, and thank you to everyone for joining us on our fourth quarter financial results conference call. Today, I will discuss our recent accomplishments and then turn to the important milestones in the pipeline that we expect to achieve in 2015. We made a great deal of progress in 2014, culminating December with the successful Phase II clinical results for CCX140, which is our lead inhibitor targeting the chemokine receptor known as CCR2 in diabetic nephropathy. I am also pleased to see that momentum carrying into 2015, exemplified by the recent initiation of a clinical study in pancreatic cancer with our second-generation CCR2 inhibitor CCX872. I have previously described our pipeline as comprising four key opportunity categories or four pillars of value. In our prepared remarks today, I will focus primarily on two of the four pillars of value, which we expect to drive much of the progress in our pipeline this year, specifically, our chemokine receptor CCR2 inhibitor program and our complement C5a receptor inhibitor program. Specifically, I will discuss the following three key topics. First, I will discuss our CCX140 Phase II diabetic nephropathy trial results and our plans to further advance that program in 2015 and beyond. Second, I'll describe our plans to expand our CCR2 program into oncology, including our initiative advancing our second-generation inhibitor CCX872 into pancreatic cancer. And third, I'll update you on our progress to advance our complement C5a receptor inhibitor program in ANCA-associated vasculitis and our efforts to further expand the program into other orphan indications, specifically, atypical hemolytic uremic syndrome. First, I'll start with our CCR2 program. Many lines of evidence suggest that the chemokine receptor known as CCR2 plays a crucial role in the progression of diabetic chronic kidney disease or diabetic nephropathy. We believe that inhibition of…

Thank you, Tom. As I mentioned earlier, our 2014 fourth quarter financial results were included in our press release provided earlier this afternoon. There was no revenue recognized for the three months ended December 31, 2014, compared to $0.7 million in the same period in 2013. The decrease in revenues from 2013 to 2014 is primarily due to funding of clinical support from former partner, GlaxoSmithKline for CCX168 in 2013. Research and development expenses were $9.1 million for the three months ended December 31, 2014, compared to $7.4 million for the comparable period in 2013. Higher expenses associated with CCX168 or C5aR inhibitor reflect the increased patient enrollment rate in the ongoing European CLEAR trial and expansion of Phase II clinical development for the same in North America. This increase was partially offset by lower expenses in our CCR2 program, primarily for CCX140, due to the completion of the Phase II clinical trial in patients with diabetic nephropathy. General and administrative expenses were $3.2 million for the three months ended December 31, 2014, compared to $3 million in 2013. This increase was primarily due to higher stock-based compensation for stock option grant and restricted stock unit awards. Total shares outstanding at December 31, 2014 were approximately 43.4 million shares. Cash, cash equivalents and investments totaled $114.6 million at December 31, 2014 Before I turn the call back over to Tom, let me summarize our 2015 financial guidance. Our projected cash utilization for 2015 is expected to range from $45 million to $49 million. We therefore expect to end the year with cash and investments of approximately $70 million. With that, I will now turn the call back over to you, Tom.

Thank you, Susan. We anticipate several milestones for both our CCR2 and C5a receptor program, which we expect to drive momentum in 2015. Starting with CCR2 program, we look forward to first presenting detail study results from the CCX140 Phase II trial in patients with diabetic nephropathy at upcoming medical meetings, second preparing for an end-of-Phase II meeting with regulatory agencies, and announcing initial data from our open label clinical trial from CCX872 and patients with non- resectable pancreatic cancer in the second half of 2015. In our complement C5a receptor program for CCX168, we look forward to first completing enrollment in the CCX168 Phase II CLEAR trial in Europe in patients with AAV, second continuing enrollment in the Phase II CLASSIC trial in North America in patients with AAV, and in the Phase IIa proof-of-concept clinical trial in patients with IgA nephropathy, third presenting data supporting the anti-thrombogenic effect of CCX168 in serum from patients with aHUS in the second quarter of 2015v, and initiating a CCX168 Phase II proof-of-concept clinical trial in patients with atypical hemolytic uremic syndrome or aHUS. On the corporate development front, with our two lead programs yielding positive Phase II data, our alliance discussions continue to intensify and we look forward to advancing these partnering efforts in 2015. In closing, we have much to accomplish in 2015 and we remain intensely focused on the execution of all of our clinical opportunities and partnering initiatives. We will now take your questions. Operator?

[Operator Instructions] And our first question comes from Brian Klein from Stifel. Your line is open. Please go ahead.

Hi, guys. Thank you for taking my questions and nice progress.

Thank you, Brian.

First question is on CCX140. So you reported the data last year, it looked very good. Just wondering why the delay in meeting with the FDA in for the second half of this year. Is there any chance that you could expedite that meeting to the first half? And secondly, have you already started to think about a registrational program and maybe give us some insights there?

Yes. Brian, all good questions. I would like to add to that I had the great pleasure today of being joined not just by Susan Kanaya but by Pirow Bekker, our Chief Medical Officer. So Pirow will also fill some of the questions as well. Let me a little bit of the stab at the first part of your question at least. So clearly, what we have is a trial with many hundreds of people, several important analyses that were pre-specified and prospective. We are still doing those analyses. As I mentioned, we have very recent information about the upper third pre-specified subpopulation with the high proteinuria where they showed quite a marked, even more marked improvement than the all patients population in the eGFR slopes. And so those are very important both for thinking about the total package of data that we need to put in a briefing document for the FDA, as well as the second part of what you are asking how to think about the Phase III clinical trial. So to the extent that we are moving as expeditiously as possible to getting our documentation together and putting it to the FDA and scheduling a meeting, as you may well imagine those, while it sounds straight forward, actually involve an enormous amount of data and we are in the process of getting that package together. We will get it to the FDA as expeditiously as we can. They, of course, need chance to review it and then get calendar it for the meeting, and obviously we will push forward with that. As I alluded to, one of the compelling features coming out of some of these pre-specified analysis is, are there populations that would be attractive in terms of both numbers of patients and time to…

No. I think, Tom, you’ve answered it well. I think, Brian, we are beginning to really sort of hone the design of the Phase III trial that we will be discussing with the regulatory agencies. And as Tom has pointed out, we are seeing evidence that CCX140 is particularly effective in the patients with the high level of baseline albumin urea. It's also true that that patient population have a pretty steep decline in eGFR in -- that would actually be very meaningful in a Phase III study in the control group. So those aspects are all important in terms of design of the Phase III study and we’re beginning to put together what that study might look like.

Great. Thank you. And then just two more quick questions, first, on CCX872, have you looked at combining that drug preclinically with other immuno-oncology or Checkpoint Inhibitors agent? And the second question is on CCX140, the data from the CLEAR trial, have you discussed with the European regulators about potentially utilizing that for an accelerated approval? Thank you.

Thank you, Brian. We have ongoing work right now on the combination approach of CCR2 inhibition with other emerging therapies such as Checkpoint Inhibitors, yes, we do. We’ll be talking about some more of that work a little later on in this year. So we don’t have any details to give you right now. It’s very relevant, however, because even with the Checkpoint Inhibitors emerging is certainly very significant therapies. There is some limitations in dose, as you know and others will perceive for Checkpoint Inhibitors. So still a lot of benefit to be gained by looking at combinations and we're very optimistic about some of that work and the data we will be able to present a little later on. And the other question about CCX168. So, Pirow, perhaps, you want to say something about that.

Brian, I think, the steps 3 of the CLEAR trial is going to provide us with a complete data set for this Phase II study, which I think will provide us with sufficient number of patients and a robust data say to approach agencies with regard to potential accelerated approval. So that's what I think our plan is at this point.

Great. Thank you for taking my question.

Thank you.

Thank you. Our next question comes from Anupam Rama from J.P. Morgan. Your line is open. Please go ahead.

Hey, guys. Thanks so much for taking the question. Just wanted to follow-up on Brain’s question on 872. Just with initial data expected in 2015, can you talk about sort of the benchmark for the trial from an efficacy perspective? So just kind of move that program forward, I know you’re doing some combination work in the background but just maybe in reference to the Pfizer trial that readout because to you, I think they only showed a partial response and stable disease response data. I don’t think we’ve done PFS data from them. And then just a quick one on CCX140, I’m assuming that’s the plan is still to go into an end of Phase II meeting with the partner?

Let me handle the last question first and I'll turn the first question over to Pirow. Thank you, Anupam. So, we certainly are moving forward as expeditiously, as we can to develop the clinical program for Phase III. As you know, our financial model does not entirely predict having Phase III development be done on all of our sole investments. So, we are actively looking at partnership opportunities for 140. I think there would be some preference if I'm also a potential partner to be involved in the end of Phase II discussions. However, I would not consider that a necessarily an absolute gaining item for us to go on, as we build out our clinical development plan.

Got it.

With regard to your first question, you’re absolutely correct, Anupam. So with the Pfizer study, they only had a 12-week treatment period and so they showed a partial response rate of about 50%. I think the number was 48% at the 12-week time point, compared to the historical control of 28%, so three substantial improvement in the partial response rate. Unfortunately, they did not dose beyond 12-week, so they could not comment or provide data on progression-free survival. Our intent is to dose beyond 12 weeks, so that we could actually generate some data on progression-free survival and overall survival. And for that, the historical data is about 50% progression-free survival, right with fulfilling us only. So, I think we will be looking obviously for an improvement in that right. Our study depending on whether you have the full complete dataset or not, we will be looking at about a 60% plus progression-free survival rate to be clinically meaningful.

Great. Thanks so much for taking the questions.

Thank you.

Thank you. [Operator Instructions] And our next question comes from Yaron Werber from Citi. Your line is open. Please go ahead.

Hi, guys. This is [Kenon] [ph] on for Yaron. Congratulations on the quarter and finishing up. Just a couple of questions. So if I’m just doing some sort of back the envelope calculations on eGFR, if third of the patients with the high albumin had 66% of eGFR, based on the 44% overall, is the other two-thirds of the population around 33% eGFR improvement? And then based on that, would you be looking at going into patients with high albumin for your Phase III?

Very good question. So what we really -- one of the reasons we did the pre-specified analyses is to look at the population that might be most amenable as a Phase III population among other things. So, I'll stress that the all-patients population, which ranges from 100 milligrams of albumin to a gram of creatinine in UACR up to 3,000. So it’s a fairly broad stretch, showed us a 44% improvement in eGFR. So the question is relevant, if you divide that into tertiles and the upper tertile of 800 mgs per gram of creatinine and above gives you 66% improvement then arithmetically some of the other cells was probably somewhat lower and you are quite correct. So what we see is the higher the albuminuria, the more profound the slope change in eGFR. And that's relevant obviously as we think about doing a Phase III trial. You could, in fact, based on the fact that the efficacy shifts seems to be quite pronounced in eGFR. And by the way for historical reference, drugs have been approved in the space mostly ACEs and ARBs. Losartan comes to mind because it has the most extensive data published from clinical trial. Losartan only gave us 16% eGFR slope change annualized benefit over the background medication at the time it was tested in Phase III. So we are really outstripping some of the historical magnitudes of benefit that one sees for approved agents in diabetic nephropathy. It’s interesting to scale in that way to think about those references. So when we think about the fact that we could in fact design a Phase III clinical trial that covers all the patients that we had in our original phase II trial design and that would take a certain number of patients over a certain…

Got it. Thank you. That is super helpful. And then actually just one other sort of housekeeping question, during your financial guidance for 2015, is that including beginning a Phase III trial? And is that assuming sort of a partnership just trying to figure out how to accurately model it?

Right. So Susan, I’m saying, go ahead.

Sure. Thank you. So this is just a baseline cash utilization projection, does not assume any partnership activity and not initiating a Phase II, III study at this time.

Okay. Great. Thank you so much and congrats again.

Thank you very much.

Thank you. Our next question comes from Yatin Suneja from Cowen and Company. Your line is open. Please go ahead.

Hi, guys. Thank you for taking my question. I just have a -- I just have a quick question on the proof-of-concept trial that you are planning to initiate in aHUS. Could you maybe give us more idea in terms of what patient population are you going to enroll? Are you going to enroll? Are you going to enroll some of these naive patients, some of these treated patients where you would be conducting this trial U.S., ex-U.S.? And then I think I missed the endpoint that you talked about earlier, so if you can just repeat that, that would be great? Thank you.

Certainly, Yatin. Thank you. I’ll let Pirow handle most of this question, but I’ll just give you some quick background. We have tested the sera of diagnosed aHUS patients in ex vivo assays where we run that sera over activated microvascular endothelial cells mimicking what happens we think in the real world and vessels including the kidney -- I'm sorry blood vessels of the kidney and other organs, but predominantly kidney. And what happens in that reaction is you get huge thrombus formation in the presence of that sera from the patients. Whereas if you run a normal person sera in the same assay you don't get thrombus occurring in that reaction. When we incubate that reaction with our drug, CCX168 we can inhibit the formation of the thrombus. We also see the inhibition of that formation of thrombus with eculizumab, Soliris. So the effects seem to be quite comparable at least as we take the patient sera out of the body and incubate with these therapeutically relevant agents, one of which is approved. So that's the background of what we are doing. In terms of how we are going in our dose to patients directly and what they look like, I’ll let Pirow take that part of the question.

Thanks, Tom. So again, this is a proof-of-concept study. We will be dosing our effective dose that we’ve shown in the ANCA-associated vasculitis study in Europe, the CLEAR study. So this is a 50-milligram twice daily. The dosing period is 15 days. We are planning to enroll up to approximately 10 patients in the study. And we want to, first of all, look at safety tolerability of the compound. These patients are patients with diagnosed aHUS who are on dialysis. And we will be looking at from an efficacy point of view, we will take the blood from these patients and evaluate that in the thrombus assay, as well as Thomas pointed out we’ve conducted some in vitro studies already with that. And we will also be looking at clinical outcome parameters, platelet counts, hemoglobin, LDH, C5a levels, C5b at complex levels and so on in these patients.

Great. Thank you very much.

Thank you. I am showing no further questions at this time. I would like to hand the conference back over to Mr. Tom Schall.

Thank you very much. I really appreciate everyone's participation today and their questions. I look forward to talking more about our progress next quarter and wish everyone a great afternoon. Thanks again.