ChemoCentryx, Inc.
Q1 2015 Earnings Call Transcript

Published: 7 May 2015

[Operator:]

Welcome to the ChemoCentryx First Quarter 2015 Financial Results Conference Call. [Operator Instructions]. 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.

[Susan Kanaya:]

Thank you. Good afternoon and welcome to the ChemoCentryx First Quarter 2015 Financial Results Conference Call. This afternoon we issued a press release providing financial results and company highlights for the quarter ended March 31, 2015. This press release is available on our website at www.chemocentryx.com. Joining me on the conference 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 first quarter 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 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, May 6, 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.

[Thomas Schall:]

Thank you, Susan and thank you to everyone for joining us on our first quarter financial results conference call. Today I will discuss our accomplishments since our Q4 conference call and then we will summarize the key milestones that we continue to expect to achieve in 2014. We sustained the momentum in our clinical programs during the first quarter and I’ve several noteworthy accomplishments that are outlined during today's call. These mostly pertain to our two most advanced clinical programs. Our chemokine receptor CCR2 program utilizing our two orally administrated potent and selective inhibitors known as CCX140 and CCX872 as well as our compliment C5a receptor program with our lead drug candidate CCX168. These programs constitute two of the four pillars of value to which I’ve referred to in the past specifically in these two value areas today I will discuss the following three key topics. First plans for the initial presentation of Phase 2 clinical trial data from our lead CCR2 inhibitor, CCX140 in patients with diabetic nephropathy. Second, the expansion and presentation of our data from our second orally administered CCR2 inhibitor, CCX872 as we go forward in clinical trials with patients with pancreatic cancer. And third, continued clinical development progress in our compliment C5a receptor program with CCX168, are orally available small molecule inhibitor of the C5a receptor that is now being evaluated in three different disease settings, ANCA-associated vasculitis, atypical hemolytic uremic syndrome and IgA mediated nephropathy. Let's begin with our recent accomplishments from our CCR2 program. We believe that the chemokine receptor CCR2 plays a crucial role in the progression of diabetic chronic kidney disease or diabetic nephropathy. Moreover should our CCR2 inhibitors CCX140 successfully achieve positive Phase 3 result and obtain regulatory approval it may indeed change the treatment paradigm for this disease. As we reported last December our Phase 2 clinical trial data of CCX140 achieved its primary end point of reduction of protein levels in the urine as measured by urinary albumin creatinine ratio or UACR. These results showed a statistically significant improvement in UACR from baseline in the patients who received orally daily doses of 5mg CCX140 they can continuously for a 52-week period in addition to the standard of care when compared to those patients taking the standard of care alone. Additional we noted important features across secondary endpoints such as the estimated glomerular filtration rate or eGFR particularly in pre-specified patient sub-sets in the trial. We believe that the cumulative result of the Phase 2 trial with CCX140 will inform fundamentally our design of the Phase 3 trial. The medical community will see some of these results presented later this month at the European renal association, European Dialysis and Transplant Association or ERA EDTA meeting which will be held in London. The Phase 2 CCX140 results have been selected as a late breaker oral presentation to be presented by Professor Dick de Zeeuw, M.D., Ph.D., from the Department of Clinical Pharmacy and Pharmacology at the University Medical Center in Groningen, The Netherlands on Friday, May 29th at 11

[Susan Kanaya:]

Thank you, Tom. As I mentioned earlier our 2015 first quarter financial results were included in our press release provided earlier this afternoon. Research and development expenses were 8.4 million for the three months ended March 31, 2015 were closely in-line with the 8.2 million reported the same period in 2014. The increase from 2014 to 2015 was primarily attributed the higher expenses associated with CCX168 due to continued patient enrollment in the clear Phase 2 clinical trial in Europe and the classic Phase 2 clinical trial in North America with the treatment of AAV. Further preparation for and the initiation of a clinical trial of CCX872 or second CCR2 inhibitors patients with non-resectable pancreatic cancer at the end of 2014 also contributed to this increase. These increases were partially offset by lower expenses associated CCX140 due to the completion of our Phase 2 clinical trials in patients with diabetic nephropathy in the fourth quarter of 2014. General and administrative expenses were 3.7 million for the three months ended March 31, 2015 compared to 3.5 million with a comparable period in 2014. This increase was primarily due to higher employment related expenses including stock based compensation expense or stock option grants and restricted stock unit awards and increased professional service and travel expenses relating to our business development effort. Total shares outstanding at March 31, 2015 were approximately 43.7 million shares, cash, cash equivalent and investments totaled 104.8 million at March 31, 2015. With that I will now turn the call back over to you Tom.

[Thomas Schall:]

Thank you, Susan. We anticipate several milestones for both our CCR2 and C5a receptor programs which we expect to drive momentum in 2015. Starting with our CCR2 program we look forward to the first presentation of study results from the CCX140 Phase 2 trial in patients with diabetic nephropathy and a late breaker oral presentation at the ERA EDTA meeting in London on May 29th. And we look forward to subsequent presentation of further data and potential peer reviewed publications as well through the year. We continue to prepare for an end of Phase 2 meeting with regulatory agencies for CCX140 and we plan to report initial data from an open label clinical trial of CCX872 in patients with non-resectable pancreatic cancer in the fourth quarter of 2015. In our complement C5a receptor program we look forward to completing enrollment by mid-year in the CCX168 Phase 2 clear trial in Europe in patients with AAV and announced top line results by the end of this year. Second, continuing enrollment in the CCX168 Phase 2 classic trial in North America in patients with AAV and in the Phase 2a proof of concept clinical trial in patients with IgA nephropathy. Third, presenting our data supporting the anti-thrombogenic potential of CCX168 in serum from patients with AHUS later this month also at the ERA EDTA meeting and lastly we plan to report initial data from the Phase 2a proof of concept in AHUS trial by year-end. In closing, I'm very pleased with the first quarter's continued progress and I look forward to sharing more news with you in the coming months. We will now take your questions. Operator?

[Operator:]

[Operator Instructions]. Our first question comes from the line of Brian Klein of Stifel. Your line is open.

[Brian Klein:]

So first on CCX140, can you give us a sense of when you might start a registration Phase 3 program for that molecule?

[Thomas Schall:]

As you can imagine Brian, the Phase 2 study has generated a tremendous amount of data some of the data still being analyzed actually but all of which is informing our Phase 3 trial design. We have got a number of steps we need to go through before we begin Phase 3 including the final analysis of such data. We see some very important information we think in some of the pre-specified subset analysis which may inform our Phase 3 trial population. In addition we have got to obviously get our package completed and submitted for end of Phase 2 meeting with FDA and other regulatory agencies. That work is all ongoing. I’ve also mentioned in the past that this is a program where there is a tremendous amount of value obviously. We would like to be able to work in this indication around the world and that’s a fairly tall order. So partnering discussions are also part of the mix. So all that’s by way of saying that we’re moving as rapidly as we can to achieve all of those different tasks and we would - we’re working as expeditiously as we can to launch the Phase 3 study. It will take few quarters at least and we will keep you updated over the next quarter or two as to our projected start time of such trial.

[Brian Klein:]

And then just a quick question on CCX168, in terms of the open label trial in AHUS will those patients be refractory to Soliris or will they be untreated patients?

[Pirow Bekker:]

The patients are not required to be refractory to Soliris so they would not necessarily have to have had Soliris in the past.

[Brian Klein:]

And then just lastly on your CCR9 program, any update there on the partnering?

[Thomas Schall:]

None to discuss today Brian but we will certainly keep you posted, there is some very interesting science and publications around the science coming along around CCR9 in IBD and I think that’s going to be very exciting and I believe others in the industry are finding it quite interesting as well.

[Operator:]

Our next question comes from the line of Anupam Rama of JPMorgan. Your line is open.

[Anupam Rama:]

Just a quick one on CCX140 at the conference, ERA EDTA later this month, what additional analysis will be presented beyond kind of what we already know, is there something specific you point us to and then just a quick one CCX168 in IgA nephropathy. Can you just review the timeline there, I might have missed it but I think patient enrollment is supposed to start mid-year and then data potentially by the end of the year, I just wanted a quick clarification on that thing.

[Thomas Schall:]

I will take part of the last question first, we have already started enrolling patients in that trial but there is this interesting run-in period with maximum doses of RAAS inhibitors to stabilize those patients if you will and then we start giving them the CCX168. So we have patients in the trial, they will start getting their 168 dose in fairly short order and it is an open label trial. So we will be able to start reading out some of the additional information of data, I hope by the end of the year. So, that will be information that I think we’re looking forward to then, at least with some of the initial criteria around tolerability as well as possibly efficacy data looking at some of the primary endpoints as we come out of that study, or primary efficacy assessment. In terms of the ERA EDTA meeting, so we’re very fortunate to have a late breaker presentation but as you know well know the flip side of that is these late tend to be given very small slots of time. So 13 minutes for presentation. So essentially because this is the first presentation of the raw data if you will in a public forum, it's probably going focused mostly on trial design, patient demographics rather and disposition, safety and primary endpoint and obviously things that impact the primary endpoint assessment. So it's going to be very thorough in the treatment of the primary endpoint which I think is appropriate. We hope that there will be some time for other stuff that we have been analyzing in the secondary but I think the real deep data dive is going to be part of both publications that are under preparation right now with us in our clinical colleagues as well as subsequent meetings this year including major meetings like ASN. Pirow, you may have a different understanding that’s I think.

[Pirow Bekker:]

I think that’s coming along as the mix major meeting, so we anticipate you’ve at least an additional presentation on the CCX140 program there and also potentially on some of the other programs.

[Operator:]

[Operator Instructions]. Our next question comes from the line of Yaron Werber of Citi. Your line is open.

[Kumaraguru Raja:]

This is Kumaraguru Raja in for Yaron. For the AHUS trial how many patients do you plan to recruit and what challenges do you foresee in recruiting these patients? And also for the serum data you will be presenting in this AHUS patient, what kind of controls did you use in this trial and how do they compare and how do you think the serum data will be replicated in humans?

[Thomas Schall:]

I will take the last part and then I will turn the clinical enrollment part back to Pirow. So the serum experiments are very interesting. We take serum from people with diagnosed AHUS some of whom we know the genetic deficiency, that lead to the dysregulation that leads ultimately to their AHUS disorder. And then we essentially in the next vivo setting look at the thrombogenic potential of those serum [ph] as flowed over activated microvascular and [indiscernible] and as you can well imagine with the AHUS sera but the not the sera of normal individuals we get quite big- thrombi which are easy to read in a semi-automated way. So the controls are all important as you quite rightly pointed out. In the data we present some of the data we will show controls with eculizumab or Soliris says the positive control and in those data sets and we have discussed some of these in public already. We have essentially a dose response with CCX18 where we can get equivalent or nearly equivalent in addition of thrombus formation ex vivo as both eculizumab and soluble compliment CR1 inhibitor as well which essentially knocks out all the compliment activation in the assay. So we also know too that the inhibitory activity of CCX168 is in those comparisons as good as the positive controls and we use all controls at therapeutically relevant levels in the assay that is levels we know we achieve in dosed patients and typically trough levels so those are very interesting experiments while controlled and as I mentioned we will be presenting all those details in London later this month. And Pirow, I will let you address what some of the challenges might in trials of that nature.

[Pirow Bekker:]

Yes, so Kumar, the target enrollment for the study is 10 patients at least initially so it's designed to be obviously the first pilot clinical trial in this study. It is because of the rarity of this disease challenge to enroll this number of patients. However we’re working with an investigator that has a large referral network and referral hospital to essentially manage these patients. So we are quite optimistic that we will be able to achieve this enrollment target.

[Operator:]

At this time I'm showing no further questions in the queue. I would like to turn the call back over to Mr. Thomas Schall, Chief Executive Officer for any closing remarks.

[Thomas Schall:]

Thank you very much. And I would like to thank everyone for their participation and their attention today. I very much look forward to updating you next quarter on the continued momentum in these and other programs of ChemoCentryx's. Thanks everyone. Have a very nice afternoon.

[Operator:]

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.